Module 1
The following page
The Nature of the Pharmaceutical Industry 1
The natural purpose and driving force of the
pharmaceutical industry is to increase sales of
pharmaceutical drugs for ongoing diseases and to find
new diseases to market existing drugs
By this very nature, the pharmaceutical industry has no
interest in curing diseases. The eradication of any disease
inevitably destroys a multi-billion dollar market of
prescription drugs as a source of revenues. Therefore,
pharmaceutical drugs are primarily developed to relieve
symptoms, but not to cure.
If eradication therapies for diseases are discovered and
developed, the pharmaceutical industry has an inherent
interest to suppress, discredit and obstruct these medical
breakthroughs in order to make sure that diseases
continue as the very basis for a lucrative prescription
drug market.
The economic interest of the pharmaceutical industry
itself is the main reason why no medical breakthrough
has been made for the control of the most common
diseases such as cardiovascular disease, high blood
pressure, heart failure, diabetes, cancer, and osteoporosis,
and why these diseases continue like epidemics on a
worldwide scale.
For the same economic reasons, the pharmaceutical
industry has now formed an international cartel by the
code name "Codex Alimentarius" with the aim to outlaw
any health information in connection with vitamins and
to limit free access to natural therapies on a worldwide
scale.
At the same time, the pharmaceutical companies
withhold public information about the effects and risks of
prescription drugs and life-threatening side effects are
omitted or openly denied.
In order to assure the status quo of this deceptive scheme,
a legion of pharmaceutical lobbyists is employed to
influence legislation, control regulatory agencies (e.g.
FDA), and manipulate medical research and education.
Expensive advertising campaigns and PR agencies are
used to deceiving the public.
Millions of people and patients around the world are
defrauded twice: A major portion of their income is used
up to finance the exploding profits of the pharmaceutical
industry. In return, they are offered a medicine that does
not even cure.
More Deaths Than in All Wars of Mankind Combined
As a direct consequence of the pharmaceutical business,
more people have died from preventable disease than in
all wars of mankind combined.
summarizes the steps leading to this tragedy.
The fact that vitamin C stabilizes the walls of arteries, for
example, has been known for 200 years, ever since James
Lind uncovered vitamin C deficiency as the cause of
blood loss and scurvy. Any head of a pharmaceutical
company, any Ph.D. or M.D. who denies knowing this
fact is simply incredulous. Why, then, was this
information not applied to medicine in order to combat
cardiovascular disease? Why was the official RDA for
vitamin C set at 60 mg, an amount barely sufficient to
prevent scurvy but certainly low enough to make sure
that cardiovascular diseases will become an epidemic?
The following page gives the answer.
Throughout this century, the pharmaceutical companies
knew that an optimum vitamin supply of the population
would lead to the collapse of a multi-billion dollar market
of prescription drugs. Moreover, vitamins are not
patentable and the profit margins are low. On the basis of
this analysis the survival of the pharmaceutical industry
became dependent on two strategies:
To obstruct research, information, and use of vitamins
and other natural therapies by all means available.
To promote the deception that patentable synthetic
drugs are the answer to human diseases.
The Pharmaceutical Industry Is As Indispensable for a
Country as Cancer Is for the Body
How is it that millions of people are still willing to pay
billions of dollars to the pharma-cartel for medicine that
does not cure and frequently harms?
The answer to this question is that over the past century
the pharma-cartel and their army of lobbyists have built
an intricate maze of control, infiltration, economic
incentives, bribes, manipulation, and deception. The most
important elements of this maze are summarized on the
following page. Millions of people and patients were
systematically deceived by this maze of
 Manipulation of research so that synthetic drugs
rather than natural therapies appear as "medicine,
 Prescription of this "medicine" by doctors who have
had no education in nutritional medicine and who
receive financial benefits for
prescribing pharmaceuticals but not natural
therapies,
 Deception by multi-million dollar advertising
campaigns for pharmaceutical drugs that
deliberately deceive the public about the effects and
risks of drugs and about the unethical nature of the
pharma-business,
 Regulation brought about by regulatory agencies
and legislation under the pressure of a pharma-
 lobby, disallowing established health claims
for vitamins and other natural remedies.
In the future no nation can afford to burden its
economy with a pharmaceutical industry that grows
like a cancer at the expense of the people, of
corporations and of the public sector, all of which
suffocate from exploding health care costs for a
medicine that does not cure.
A New Era of Human Health Begins
500 years ago, the Roman church was making billions of
Thaler (early dollars) by selling indulgences, an
imaginary "key to heaven"for its believers. Then the
fraud scheme collapsed and with it much of the power of
the church. Today, the pharma business uses the same
fraud scheme. It tries to sell the "key to health" to
millions of people and takes away billions of dollars in
return for an illusion: the deception that the
pharmaceutical industry is interested in your health.
Considering this unhealthy state of affairs, the urgency
for a new health care is obvious. The liberation from this
insane yoke of the pharmaceutical industry will
immediately and directly benefit millions of people, the
business community and the public sector of all nations.
This new health care system is based on an improved
knowledge and participation by millions of people. Basic
health has become understandable, doable and affordable
for everyone. The era in human history when health was
delegated to an industry that shamelessly took advantage
of it is over and gone.
The new health care system focuses on primary health
care, prevention and eradication of diseases. Health
consultants and health centers will replace many medical
high-tech centers of today. Every health food store is the
beginning for a community health center.
The new health care system is being built by dedicated
lay people together with a growing number of doctors
and health professionals. The majority of health
professionals are realizing that they themselves had been
compromised by pharmaceutical companies and had
become victims of a drug-centered health care.
Principles of a New Health Care System
1. Health is understandable for everyone. The basic
causes of human health and disease are understandable
for everyone. The fact that millions of body cells
regularly need vitamins and other bioenergy supply can
be understood by every child.
2. Health is doable for everyone. Cellular Medicine and
the daily supply of vitamins and other bioenergy carriers
allow everyone to maintain and to restore basic physical
health.
3. Health is safe for everyone. Nature itself provides us
with vitamins and other powerful preventive and
therapeutic substances to combat human diseases. They
are safe for everyone and without side effects.
4. Health is affordable for everyone. Effective health
measures to prevent the most common human diseases
can be offered in any country of the world at a fraction of
today's cost. Imple-mentation of Cellular Medicine as a
health measure immediately liberates trillions of dollars
in private and public funds.
5. Health is a human right. Having access to optimum
health is a basic human right. No pharmaceutical
company and no government has the right to limit the
spread of information about the health benefits of
vitamins and other natural therapies. Every country in the
world should amend its constitution to guarantee access
to optimum health to its citizens.
6. Effective health care focuses on prevention. Future
medical research and health care will focus on the
prevention and eradication of diseases rather than on
therapies that merely relieve the symptoms of diseases.
7. Effective health care focuses on primary health care.
Community based primary health care is the key to an
effective and affordable health care in any country of the
world. Health consultants and health centers in every
community will replace an ineffective and expensive
focus on high-tech medicine.
8. Medical research has to be under public control. Public
funds for medical research should primarily be used to
develop treatments that prevent and eradicate diseases,
rather than on merely relieving symptoms and creating
dependencies.
The Nature of the Pharmaceutical Industry 2
One of Ralph Nader's goals when he ran for president,
was to stop corporate welfare. He figured if Congress
was so thoughtful to cut welfare to mothers and children
(less than 3% of the federal budget), then perhaps it was
time to eliminate corporate welfare (greater than 17% of
the federal budget).
Nader was quick to focus in on corporate welfare to the
pharmaceutical industry, because the American people
pay for drugs twice: first in funding the research to prove
a drug is safe and effective, and then again when their
doctor prescribes the drug, you pay at the pharmacy.
Now there is a lot of talk about conspiracy theories and
doctors suppressing therapies and the FDA suppressing
therapies, but whether or not there is a conspiracy is a
moot point. There doesn't have to be a conspiracy. We
have capitalism, a system in which every person has the
right to grow up and make money. Every major
corporation has the right to make as much money as
possible, and for some reason, major corporations get
more welfare than little corporations. Thus it must be
assumed that large corporations are much more important
than small corporations.
The pharmaceutical industry is an example of the worst
parts of capitalism, capitalism at its least respectable low
and capitalism at its most ludicrous high.
The following article is reprinted with permission from
Dr Matthias Rath's book, Why Animals Don't Get Heart
Attacks . . . But People Do!
The purpose and driving force of the pharmaceutical
industry is to increase sales of pharmaceutical drugs for
ongoing diseases and to find new diseases to market
existing drugs.
By this very nature, the pharmaceutical industry has no
interest in curing diseases. The eradication of any disease
inevitably destroys a multi-billion dollar market of
prescription drugs. Therefore, pharmaceutical drugs are
primarily developed to relieve symptoms, but not to cure.
If eradication therapies for diseases are discovered and
developed, the industry has a basic interest to suppress,
discredit and obstruct these medical breakthroughs in
order to make sure that diseases continue as the very
basis for a lucrative prescription drug market.
The economic interest of the pharmaceutical industry is
the main reason why no medical breakthrough has been
made for the control of the most common diseases such
as cardiovascular disease, high blood pressure, heart
failure, diabetes, cancer, and osteoporosis, and why these
diseases continue like epidemics on a worldwide scale.
For the same economic reasons, the pharmaceutical
industry has now formed an international cartel by the
code name "Codex Alimentarius" with the aim to outlaw
any health information in connection with vitamins and
to limit free access to natural therapies on a worldwide
scale.
At the same time, the pharmaceutical companies
withhold public information about the effects and risks of
prescription drugs and life-threatening side effects are
omitted or openly denied.
In order to assure the status quo of this deceptive scheme,
a legion of pharmaceutical lobbyists is employed to
influence legislation, control regulatory agencies (e.g.,
FDA), and manipulate medical research and education.
Expensive advertising campaigns and PR agencies are
used to deceive the public.
Millions of people and patients around the world are
defrauded twice: A major portion of their income is used
to finance the exploding profits of the pharmaceutical
industry. In return, they are offered a medicine that does
not even cure.
Keep in mind that the above was written by a medical
doctor. Before there were pharmaceutical companies,
medicines were made by scientists and doctors to cure
illness. Take Dr Paul Erlich, the father chemotherapy.
Today we think of chemotherapy being used for cancer,
however, chemotherapy is simply medicine from
chemicals. Chemotherapy treats disease with drugs. Dr
Erlich wasn't a medical doctor as we define the term
today; he was a research scientist who also treated
patients. He is the discoverer of the "magic bullet" also
known as 606 (because there were 605 failures before it)
that cured syphilis. Dr Erlich set out to cure a disease. He
did not set out to treat symptoms. He was awarded the
Nobel prize for Medicine because of his work with the
immune system.
Today doctors practice medicine and scientists, when
they independently come up with a cure or a therapy that
seems to work, get harassed. Take Dr Lawrence Burton
who demonstrated to scientists and science writers his
amazing therapy that wiped out tumors in rats in two
hours. He was forced to leave the United States and set
up a clinic in the Bahamas. Or take the inventor of 714X,
Gaston Naessens was asked to leave France because he
was practicing medicine without a license (and curing
cancer without a license). He lives in Canada today and
still gets harassed by the authorities for helping to cure
cancer.
And then there's the story of Royal Rife.
Pharmaceutical companies insure their profits by
supporting medical schools and physicians. The
pharmaceutical industry is the single largest supporter of
medical schools. Thus, the schools teach the medicine
that the pharmaceutical industry wants them to teach.
Doctors get kickbacks for prescribing certain drugs.
And then there's the FDA. Former FDA Commissioner
Dr Herbert Ley stated: "The thing that bugs me is that
people think the FDA is protecting them. It isn't. What
the FDA is doing and what the public thinks it's doing are
as different as night and day."
For more information on Codex, and this is important to
all of us since they've already started to limit the use and
sale of vitamins in Germany, here are some links.
Pharmaceutical Industry in India
Introduction
The Indian pharmaceuticals market is the third largest in
terms of volume and thirteenth largest in terms of value,
as per a report by Equity Master. India is the largest
provider of generic drugs globally with the Indian
generics accounting for 20 per cent of global exports in
terms of volume. Of late, consolidation has become an
important characteristic of the Indian pharmaceutical
market as the industry is highly fragmented.
India enjoys an important position in the global
pharmaceuticals sector. The country also has a large pool
of scientists and engineers who have the potential to steer
the industry ahead to an even higher level. Presently over
80 per cent of the antiretroviral drugs used globally to
combat AIDS (Acquired Immuno Deficiency Syndrome)
are supplied by Indian pharmaceutical firms.
The UN-backed Medicines Patent Pool has signed six
sub-licences with Aurobindo, Cipla, Desano, Emcure,
Hetero Labs and Laurus Labs, allowing them to make
generic anti-AIDS medicine TenofovirAlafenamide
(TAF) for 112 developing countries.
Market Size
The Indian pharma industry, which is expected to grow
over 15 per cent per annum between 2015 and 2020, will
outperform the global pharma industry, which is set to
grow at an annual rate of 5 per cent between the same
period!. The market is expected to grow to US$ 55
billion by 2020, thereby emerging as the sixth largest
pharmaceutical market globally by absolute size, as
stated by Mr Arun Singh, Indian Ambassador to the US.
Branded generics dominate the pharmaceuticals market,
constituting nearly 80 per cent of the market share (in
terms of revenues).
India has also maintained its lead over China in
pharmaceutical exports with a year-on-year growth of
11.44 per cent to US$ 12.91 billion in FY 2015-16,
according to data from the Ministry of Commerce and
Industry. In addition, Indian pharmaceutical exports are
poised to grow between 8-10 per cent in FY 2016-17.
Imports of pharmaceutical products rose marginally by
0.80 per cent year-on-year to US$ 1,641.15 million.
Overall drug approvals given by the US Food and Drug
Administration (USFDA) to Indian companies have
nearly doubled to 201 in FY 2015-16 from 109 in FY
2014-15. The country accounts for around 30 per cent
(by volume) and about 10 per cent (value) in the US$ 70-
80 billion US generics market.
India's biotechnology industry comprising bio-
pharmaceuticals, bio-services, bio-agriculture, bio-
industry and bioinformatics is expected grow at an
average growth rate of around 30 per cent a year and
reach US$ 100 billion by 2025. Biopharma, comprising
vaccines, therapeutics and diagnostics, is the largest sub-
sector contributing nearly 62 per cent of the total
revenues at Rs 12,600 crore (US$ 1.89 billion).
Government Initiatives
The Government of India unveiled 'Pharma Vision 2020'
aimed at making India a global leader in end-to-end drug
manufacture. Approval time for new facilities has been
reduced to boost investments. Further, the government
introduced mechanisms such as the Drug Price Control
Order and the National Pharmaceutical Pricing Authority
to deal with the issue of affordability and availability of
medicines.
Mr Ananth Kumar, Union Minister of Chemicals and
Petrochemicals, has announced setting up of chemical
hubs across the country, early environment clearances in
existing clusters, adequate infrastructure, and
establishment of a Central Institute of Chemical
Engineering and Technology.
Some of the major initiatives taken by the government to
promote the pharmaceutical sector in India are as
follows:
The Government of India plans to set up around eight
mini drug-testing laboratories across major ports and
airports in the country, which is expected to improve the
drug regulatory system and infrastructure facilities by
monitoring the standards of imported and exported drugs
and reduce the overall time spent on quality assessment.
India is expected to rank among the top five global
pharmaceutical innovation hubs by 2020, based on
Government of India's decision to allow 50 per cent
public funding in the pharmaceuticals sector through its
Public Private Partnership (PPP) model.#
Indian Pharmaceutical Association (IPA), the
professional association of pharmaceutical companies in
India, plans to prepare data integrity guidelines which
will help to measure and benchmark the quality of Indian
companies with global peers.
The Government of India plans to incentivise bulk drug
manufacturers, including both state-run and private
companies, to encourage ‘Make in India’ programme and
reduce dependence on imports of Active Pharmaceutical
Ingredients (API), nearly 85 per cent of which come from
China.
The Department of Pharmaceuticals has set up an inter-
ministerial co-ordination committee, which would
periodically review, coordinate and facilitate the
resolution of the issues and constraints faced by the
Indian pharmaceutical companies.
The Department of Pharmaceuticals has planned to
launch a venture capital fund of Rs 1,000 crore (US$
149.11 million) to support start-ups in the research and
development in the pharmaceutical and biotech industry.
Road Ahead
The Indian pharmaceutical market size is expected to
grow to US$ 100 billion by 2025, driven by increasing
consumer spending, rapid urbanisation, and raising
healthcare insurance among others.
Going forward, better growth in domestic sales would
also depend on the ability of companies to align their
product portfolio towards chronic therapies for diseases
such as such as cardiovascular, anti-diabetes, anti-
depressants and anti-cancers that are on the rise.
The Indian government has taken many steps to reduce
costs and bring down healthcare expenses. Speedy
introduction of generic drugs into the market has
remained in focus and is expected to benefit the Indian
pharmaceutical companies. In addition, the thrust on rural
health programmes, lifesaving drugs and preventive
vaccines also augurs well for the pharmaceutical
companies.
Intellectual Property Rights
Intellectual property (IP) refers to creations of the
intellect for which a monopoly is assigned to designated
owners by law. Intellectual property rights (IPRs) are the
protections granted to the creators of IP, and include
trademarks, copyright, patents, industrial design rights,
and in some jurisdictions trade secrets. Artistic works
including music and literature, as well as discoveries,
inventions, words, phrases, symbols, and designs can all
be protected as intellectual property.
While intellectual property law has evolved over
centuries, it was not until the 19th century that the term
intellectual property began to be used, and not until the
late 20th century that it became commonplace in the
majority of the world..
Intellectual property rights include patents, copyright,
industrial design rights, trademarks, plant variety rights,
trade dress, geographical indications, and in some
jurisdictions trade secrets. There are also more
specialized or derived varieties of sui generis exclusive
rights, such as circuit design rights (called mask work
rights in the US) and supplementary protection
certificates for pharmaceutical products (after expiry of a
patent protecting them) and database rights (in European
law).
Objectives of Intellectual Property Law
The stated objective of most intellectual property law
(with the exception of trademarks) is to "Promote
progress." By exchanging limited exclusive rights for
disclosure of inventions and creative works, society and
the patentee/copyright owner mutually benefit, and an
incentive is created for inventors and authors to create
and disclose their work. Some commentators have noted
that the objective of intellectual property legislators and
those who support its implementation appears to be
"absolute protection". "If some intellectual property is
desirable because it encourages innovation, they reason,
more is better. The thinking is that creators will not have
sufficient incentive to invent unless they are legally
entitled to capture the full social value of their
inventions". This absolute protection or full value view
treats intellectual property as another type of "real"
property, typically adopting its law and rhetoric. Other
recent developments in intellectual property law, such as
the America Invents Act, stress international
harmonization. Recently there has also been much debate
over the desirability of using intellectual property rights
to protect cultural heritage, including intangible ones, as
well as over risks of commodification derived from this
possibility. The issue still remains open in legal
scholarship.
Pharmaceutical
The pharmaceutical industry discovers, develops,
produces, and markets drugs or pharmaceutical drugs for
use as medications. Pharmaceutical companies may deal
in generic or brand medications and medical devices.
They are subject to a variety of laws and regulations that
govern the patenting, testing, safety, efficacy and
marketing of drugs.
IPR and Pharmaceutical Industry and the Role of
IPR in Pharmaceutical R&D
What are the types of IPR involved in pharmaceutical
industry ?
• Patents
• Industrial designs
• Trademarks
• Copyright
• Trade Secrets
Why Protection/Importance of Protection
1. Protection of invention:
You have designed or developed a drug and you need
to protect it or else it is going to be stolen from you.
So the way to protect is either by getting it patented or
under trade secret. The problem with trade secret is
that it the drug can be reverse engineered and hence
your invention can be stolen. Whereas patent provides
a much more water tight protection.
2. Economic growth and competitiveness
IPR is very important for economic growth of a
company. Awarding sole rights to the inventor gives
him the privilege of reaping the profits without any
division. The marketing rights over the product are
solely the inventors and he can sell it or license it. The
company can earn a lot and reinvest it. Investing in
research and development is very important for a
company as it has to stay in the forefront.
3. Protects consumers and families
IPR’s main interest lies in public safety. Protection
and safety of public is always given importance. IPR
helps the consumer in making the right choice when
selecting a product. IPR helps in ensuring a standard
and assures quality which helps the consumer make
his choice and puts him at ease
4. Generate solutions to global challenges
Promoting innovation is very important but at the
same time you need funding to do it. IPR gives you
the right encouragement to do it. There is a need for
developing new drugs and vaccines as there are new
diseases being discovered daily or there is resistance
development by the pathogen.
5. Encourage innovation and reward entrepreneurs
It is very important that the right push is given for
inventors to keep them motivated. It is also important
that they are recognized for their work. IPR gives
them this encouragement.

It enables a free flow of information by enabling a

safe environment. When you know it is safe to share
your invention then there is going to be a safe channel
for exchange.
Module 2
Patent
What is Patent? and Nature of Patent
Patent is a monopoly granted by statute of a country for a
limited term over a new and useful invention that
involves inventive step. Invention may either for a
product or process. The rights enjoyed by owner of the
patent are proprietary in nature and the patentee or his
agent or licensees has the exclusive right to use and have
the benefits of patented invention and prevent
unauthorized use, during the period of patent protection.
Period during which the owner enjoys the benefits is
called term of the patent. Registration is a prerequisite for
patent protection and the protection granted is territorial
in nature i.e., patent granted in a country will give the
owner of the patent right only within that country.
This refers to innovations – new or improved product and
processes which are meant for industrial applications.
This is a territorial right which requires registration for a
limited time. Patent is a contract between an inventor as
an individual and the society as a whole. The inventor
has exclusive right to prevent anybody making use of
and/or selling a patented invention. Of course, this is
only for a specific duration till the inventor discloses the
details of invention to the public.
A patent can also be defined as statutory privilege
granted by government to inventors, and to other person
deriving their rights from the inventors, for fixed years to
exclude other persons from manufactureing, using or
selling a patented product or process
Unlike other rights, this protects effect, but not
expression or image. A well-crafted patent can give
monopoly right to business in its area. A patent is
expensive but the preparatory steps are economical in
nature.
The legal authority in this patent right is the World Trade
Organization (WTO) agreement with respect to Trade
Related Aspects of Intellectual Property Right (TRIPS).
This offers the international standard for the required
duration of 20 years from the date of filing the patent.
Once this period is over, people are free to make use of
this invention as they like. However, though the member
has a right to prevent others making use of his patented
invention, the owner has no right to make use or sell the
invention itself. Patents are granted under national laws
and these rights are enforceable by civil laws rather than
criminal proceedings.
For a product to be patentable following conditions
must be satisfied
Product must be new
The invention should be not known to public in any way,
anywhere in world. Pre-Product process must be kept
secret.
It must be an inventive step
The invention must be something which represents an
improvement over any existing product/process which is
available.
The improvement must not be obvious to someone with
technical skills or knowledge in the field/area of
invention.
It must have Industrial Application/Utility
The invention must be useful and have some form of
practical application. It should have some form of
practical application. It should b capable of being made
useful in some form of industry
Patentability requirements in India Detail
Introduction
This article aims to provide an introduction to
patentability requirements and concepts relating to
evaluation of inventive step as per the Patents Act, 1970,
of India. Corresponding statutory provisions in India and
other major patent jurisdictions of the world will also be
discussed briefly along with a few case laws which
helped define the judicial provisions for patentability and
inventive step.
Patentability and inventive step
The Patents Act, 1970 (hereafter referred as ‘the Act’) of
India specifies the provisions that are used by the Indian
Patent Office and the courts to determine whether a
product or a process is worthy of a patent in India. The
Act, vide Section 2(1)(m), provides that a patent may be
granted for an “invention”. Further, the definition of
“invention” is provided under Section 2(1)(j) of the Act
as a new product or process involving an inventive step
and capable of industrial application.
The three terms ‘new’, ‘inventive step’ and ‘industrial
application’, provide the three main criteria for
patentability. Accordingly, before applying for a patent,
applicants must ensure that their inventions, prima facie,
are novel, involve an inventive step, and can be used in
or by the industry. Additionally, the Act, under Section 3,
also provides a list of inventions that are specifically
barred from being patentable even if they meet the
aforementioned criteria and so, it is important that the
applicants also ensure that their inventions do not fall
under Section 3. The criteria related to novelty and
industrial applicability are generally regarded as being
well defined and understood based on the Act. However,
the patent office, practitioners, courts and patentees often
grapple with the concept of inventive step.
The Act defines the term ‘inventive step’ under Section 2
(1)(ja) as “a feature of an invention that involves
technical advance as compared to the existing knowledge
or having economic significance or both and that makes
the invention not obvious to a person skilled in the art”.
Apart from the presence of an inventive step being a
necessary condition for patentability, a lack of inventive
step is a valid ground for opposition under Sections
25(1)(e) and 25(2)(e), and for revocation under Section
64(1)(f) of the Act.
As per the definition of inventive step as set out under
Section 2(1)(ja), a feature of an invention can be
considered to possess an inventive step if it satisfies two
conditions: (i) the feature either adds to existing technical
knowledge, i.e., the prior art, or is substantially better in
terms of commercial viability; and (ii) it makes the
invention non-obvious to a person skilled in the art.
Assessment of obviousness or deficiency of inventive
step
In practice, obviousness is generally assessed using
certain thumb rules that have been laid down by various
cases in different patent jurisdictions. For example, the
European Union utilizes the ‘could-would’ approach,
where instead of only determining if a person normally
skilled in the relevant field could perform the invention,
it is determined whether he would arrive at the invention
given the relevant teaching and technology at the time of
the invention.
In the United States on the other hand, the ‘Graham
factors’ as laid down in Graham et al. v. John Deere Co.
[383 U.S. 1 (1966)] are used as guidelines for assessing
obviousness of an invention. The Graham factors involve
objectively comparing the claimed differences between
the alleged invention and the closest prior art while
keeping in mind, the level of ordinary skill in the art.
The approach to assessing non-obviousness in India is
not well defined at present since the instances of cases
addressing the issue are few. Hence, in the Indian
practice, an approach similar to those used in other major
jurisdictions, as mentioned above, is used.
Case law interpretation of inventive step in India
Judicial interpretations of obviousness and inventive step
in India may be considered to be at a relative stage of
infancy. Except certain cases, such as Bishwanath Prasad
Radhey Shyam v Hindustan Metal Industries [AIR 1982
SC 1444], and ratio from case laws of other jurisdictions,
the interpretation of obviousness and inventive step is
open for debate in India.
In Bishwanath Prasad Radhey Shyam supra, the Supreme
Court (SC) addressed improvements and combination
patents, where the importance of assessing inventive step
in these cases was outlined. The SC held that in order for
subject matter to constitute an inventive step, the alleged
invention should be more than a mere workshop
improvement. Furthermore, in the case of an
improvement patent, the improvement must itself
constitute an inventive step. If the alleged invention
constitutes known elements or a combination of known
elements, the result must be new, or result in an article
substantially cheaper or better than what existed.
It is to be noted that the considerations of cost or
economic significance, which are usually secondary
considerations in other jurisdictions, are in-built as
primary considerations both in the Act under the
definition of inventive step and in the above mentioned
case.
In another landmark case Bajaj v. TVS [Manupatra
MIPR 2009 (2) 139], which is still pending, the High
Court leaned towards understanding the technology
entailed in the concerned patents with respect to the
closest prior arts to judge whether or not the inventions
possessed a technical advance. Furthermore, the prior arts
cited in the International Search Report (ISR) for Bajaj’s
application was used by the court in understanding the
invention as well as judging the inventive step.
Further, in the patent cases of Enercon (India) Limited v.
Alloys Wobben, the Intellectual Property Appellate
Board (IPAB) dealt with the interpretation of inventive
step as a part of the proceedings. Specifically, in order
number 240/20101, which corresponds to one of the 12
cases of the Enercon litigation, the IPAB analyzed the
claims of the impugned patent for obviousness or lack of
inventive step based on the closest prior arts available at
the time of the invention. For this, the IPAB relied upon
Halsbury Laws of England, which stated the test for
inventive step as: ‘was it for practical purposes obvious
to the skilled worker, in the field concerned, in the state
of knowledge existing at the date of the patent to be
found in the literature then available to him, that he
should or would make the invention the subject of the
claim concerned.’
The IPAB then went on to define the inventive step
analyses as: ‘would a non-inventive mind have thought
of the alleged invention? If the answer is ‘no’, then the
invention is nonobvious. If the patent claimed merely
includes the development of some existing trade, in the
sense that it is a development as would suggest itself to
an ordinary person skilled in the art, it would fail the test
of non-obviousness’.
What is not patentable?
Invention of method/diagnosis practice for treatment of
Human Body
Offensive/encourages immoral or anti-social behaviour
Chemical Patent
Its not a special class
Accords a particular importance as they can be copied
Biotechnology
Bio technology plays an important role in the fields of
medicine, food, fertilizer, energy and protection of
environment. Bio-technology concerns living organisms,
such as plants, animals and micro-organisms, as well as
non-living biological material, such as seed, cells,
enzymes, plasmids and the like.
Bio Technology inventions ordinarly fall into three
categories. They are the process for the creation or
modification of living organisms and biological
materials; the results of such processes; and the use of
such results.
The TRIPS agreement makes it obligatory for the
Mamber States to protect bio-technological inventions by
allows them to exclude olants and animals from
patentability. However, it is obligatory for them to
protect micro-organisms and essentially biological
processes for the production of plants or animals. It is
also provided that members shall also provide protection
for plant varieties either by patents or by an effective sui
generic system or by any combination therof.
Reffer Diamond v Chakrobarty.
Requirement for Patents
While applying for a patent certain documents have to be
submitted as essential requirements which are enlisted as
below
1. Problem of invention.
2. Current report of the problem to be addressed.
3. Solution to the problem.
4. Extent of novelty.
5. Uses or application.
6. Inventor details
7. Resources of funds
Types of Patent
i. Product Patent
The patent is granted to particular manufacturing
process and not to product itself. Any person can
produce the same product through different process,
modifying the various parameters. The implication is
that there will be more than one producer for same
product because of possibly different process for the
manufacture of product
Weakness of process patent regime is that it gives less
protection for the inventor. There is high tendency for
competitors to reengineer the original invention by
discovering a new process with less investment.
Benefit: reduces the monopoly
ii. Process Patent
In case of Product Patent, it is an exclusive right given
to the original inventor of the product over
production. This means that no other manufacturer
can provide the same product through the same or any
other process. The implication is that there will not be
any competitor for the producer as it is the product
which is patented. Product patent system gives higher
level of protection to the inventors as there will not be
any other patent holder. TRIPS follows it;
Weakness: High Monopoly no competition
allowed
India was originally following Process Patent Regime,
but being a signatory to TRIPS and WTO, in 2005 it
switched to Product Patent Regime
iii. Utility patents
It can be granted to anyone who invents or discovers
any new and useful process, machine, manufacture or
composition of matter, or any new and useful
improvement thereof. Utility period is of 20 years.
"Process" refers to industrial and manufacturing
(production) method. "Manufacture" refers to articles
manufactured. "Composition of matter" refers to
chemical compositions and may include mixtures of
ingredients as well as new chemical compounds.
iv. Design patents
It can be granted to any one who invents a new,
original ornamental design for an article of
manufacture. A design patent protects the ornamental
design (i.e. appearance) of the article. A design patent
has duration of 14 years from the date of filing.
v. Plant patents
Plant patent can be granted to anyone who invents or
discovers and reproduces a new variety of plant. A
plant patent has a term of 20 years from the date of
filing
IPR and Patent
Depending on a number of considerations, a company
may apply for and be granted a patent for the drug, or the
process of producing the drug, granting exclusivity rights
typically for about 20 years. However, only after rigorous
study and testing, which takes 10 to 15 years on average,
will governmental authorities grant permission for the
company to market and sell the drug. Patent protection
enables the owner of the patent to recover the costs of
research and development through high profit margins
for the branded drug. When the patent protection for the
drug expires, a generic drug is usually developed and
sold by a competing company. The development and
approval of generics is less expensive, allowing them to
be sold at a lower price. Often the owner of the branded
drug will introduce a generic version before the patent
expires in order to get a head start in the generic market.
Restructuring has therefore become routine, driven by the
patent expiration of products launched during the
industry's "golden era" in the 1990s and companies'
failure to develop sufficient new blockbuster products to
replace lost revenues.
Patents have been criticized in the developing world, as
they are thought to reduce access to existing medicines.
Reconciling patents and universal access to medicine
would require an efficient international policy of price
discrimination. Moreover, under the TRIPS agreement of
the World Trade Organization, countries must allow
pharmaceutical products to be patented. In 2001, the
WTO adopted the Doha Declaration, which indicates that
the TRIPS agreement should be read with the goals of
public health in mind, and allows some methods for
circumventing pharmaceutical monopolies: via
compulsory licensing or parallel imports, even before
patent expiration.
In March 2001, 40 multi-national pharmaceutical
companies brought litigation against South Africa for its
Medicines Act, which allowed the generic production of
antiretroviral drugs (ARVs) for treating HIV, despite the
fact that these drugs were on-patent. HIV was and is an
epidemic in South Africa, and ARVs at the time cost
between 10,000 and 15,000 USD per patient per year.
This was unaffordable for most South African citizens,
and so the South African government committed to
providing ARVs at prices closer to what people could
afford. To do so, they would need to ignore the patents
on drugs and produce generics within the country (using
a compulsory license), or import them from abroad. After
international protest in favour of public health rights
(including the collection of 250,000 signatures by MSF),
the governments of several developed countries
(including The Netherlands, Germany, France, and later
the US) backed the South African government, and the
case was dropped in April of that year.
In 2016, GlaxoSmithKline (the worlds 6th largest
Pharmaceutical) announced that it would be dropping its
patents in poor countries so as to allow independent
companies to make and sell versions of its drugs in those
areas, thereby widening the public access to them.
GlaxoSmithKline published a list of 50 countries they
would no longer hold patents in, affecting 1 billion
people worldwide.
Diamond v Chakrabarty
Microbiologist Anand Chakrabarty filed a patent in 1972
in an invention for treating oil spills. This genetically
engineeded bacteria were capable of breaking down oil
spills at a much faster rate than naturally occurring
bacteria. As importantly, it was not affected by varying
environmental conditions.
Chakrabarty’s 1972 patent application contained three
groups of claims
1. Method of producing bacteria
2. An inoculums composed of a carrier material and
bacteria
3. The genetically engineered bacteria itself
Patent inspector allowed the first two groups but rejected
the third group. On appeal, the decision was reversed,
and it was held that living organisms are patentable
subject matter. Second appeal was filed by the board in
Supreme Court.
Supreme Court the question before the court was
whether the claimed microorganism constituted a
manufacture or composition of matter within the meaning
of US Patent Act. Reviewing the board’s decision, the
Supreme Court concluded that it did and asserter the
principle that anything under the sun that is made by man
is eligible for patenting.
Thus flood gates for patent and biotechnologically
relegated inventions were opened
The Harvard Mouse
Harvard researchers developed a transgenic animal, i.e.
an animal created by injecting genes from another
species into a fertilized animal egg and then surgically
implanting the egg into the mother. The injected genes
were oncogenes that triggered cancer growth, making the
oncomouse a particularly valuable tool for testing the
effects of cancer-fighting drugs. It was patented
The Pharmaceutical Industry and the Indian Patent
System and Product Patent and Process Patent
The first Indian Patent Act was enacted in 1856 which
was replaced by a more comprehensive Patents and
Design Act in 1911. The Act of 1911 allowed for
product-patents for drugs and medicines. The
consequences of having strong intellectual property laws
in place were that the foreign companies or the MNCs
enjoyed a complete monopoly and charged exorbitant
prices, and thus dominated the Indian drug market. They
were engaged mainly in the import of drugs from their
country of origin. During that time the MNCs who were
controlling 80% of the market did not come forward with
financial investment and technological help to establish
drug production centres in India. An American Senate
Committee headed by Senator Kefauver stated in 1959 in
its report that in drugs, generally, India ranks amongst the
highest priced nations of the world.
The Indian Patents Act, 1970 was a response to the
Patents Act, 1911, as according to one commentator, the
1970 Indian Patent Act stemmed from a 1959 Ayyangar
Committee report that examined the reasons for the high
cost of drugs in post - independence India and concluded
that the high prices resulted from the monopoly control
foreign based pharmaceutical companies exercised over
the production of drugs. Thanks to the prevailing patent
regime. To remedy this issue the Act of 1970 not only
excluded drugs from the product claims category but also
redefined the working of the patent as its commercial
exploitation within India, and excluded any importation
from abroad. It also introduced safeguards like the
Automatic Right to License in the case of life-saving
drugs. These safeguards along with the Drug Price
Control Order, 1970, which put a cap on the maximum
price that could be charged, ensured that life-saving
drugs are available at reasonable prices.
The Act of 1970 was hailed by many developing
countries and UNCTAD (United Nations Conference on
Trade and Development) as one of the most progressive
statutes which safeguards the interest of both the inventor
and the consumer in a balanced manner.
This Act was a product of deep consideration and long
deliberation to synchronize with the Directive Principles
of State Policy contained in the Constitution which
provides in Article 39 that:
Article 39. The State shall, in particular, direct its policy
towards securing
(a)
(b) That the ownership and control of the material
sources of the community are so distributed as
best to sub serve the common good; and
(c) That the operation of the economic system does
not result in the concentration of wealth and
means of production of the common detriment."
With a regulatory system focused on process patents
which encouraged local firms to come up with cheaper
processes through reverse engineering, thus cutting the
cost of production, helped to establish the foundation of a
strong and highly competitive domestic pharmaceutical
industry, and being in the grip of a rigid price control
framework transformed into a world supplier of bulk
drugs and medicines at affordable prices to common man
in India and the developing world.
The evolution of the domestic pharmaceutical industry
constitutes one of success stories of the Indian economy.
From being an import dependent industry in the 1950s,
the Indian pharmaceutical sector has today achieved
global recognition as a low-cost producer of high-quality
pharmaceutical products and its annual exports turnover
is in excess of $1.5 billion. This could be possible only
because there was no product patent system for drugs and
pharmaceuticals.
But under the Patents (Amendment) Act, 2005 patents
will be granted both for products and processes for all the
inventions in all fields of technology. The other
implications for the pharmaceutical sector under this new
patent system are:
a. Term of the Patent: The patent term will be
twenty years from the date of the application
under Article 33 of the TRIPS agreement
(compared to the seven years under the 1970
Act), which is applicable to all the member
countries and thus rules out all the differences in
the protection terms prevailed in different
countries;
b. Authorization for use of Patented Product:
Patents will be granted irrespective of the fact
whether the drugs were produced locally or
imported from another country; though the grant
of the patent excludes unauthorized use, sale or
manufacture of the patented item, yet there are
clauses which provide manufacturing or other
such rights of the patented item to a person other
than the patent holder under Article 31.
c. Reversal of Burden of Proof: Under Article 34
the onus of proving on the legal complaint that
process used by another enterprise is totally
different than the patented process would lie with
the defendant and he will have to prove that he is
not guilty of infringement. (in the 1970 Act, the
responsibility was with the patent holder).
This is the broad framework, which will guide the
pharmaceutical industry of India in the WTO regime.
Impact on the Pharmaceutical Sector on the
Introduction of Product Patents
This amendment to the Act of 1970 making the Indian
Patent Act TRIPS compliant has accompanied intense
debate and the striking feature of the continuing
discussions about pharmaceutical product patents is the
divergence between the strength of the claims made by
both sides and the weakness of the empirical foundations
for those claims.
Effect of Product Patent
The discontinuation of the “process-patent-alone” regime
in case of chemicals has been a crucial change as regards
patentable subject matter. ‘Process patent’ means that
only the procedure or the method used to develop a
particular drug would be patented and not the drug itself.
Others could use different method to produce that drug.
This gave rise to ‘generic medicines’. In product patent
now the product or the drug developed can be patented.
Companies can no longer develop the same drug once it
is patented. This involved removal of Section 5(1) of
Patents Act, 1970 which provided for process patents in
this field. This has meant that from January 1, 2005
product patent applications are being accepted and
examined. Included in these product patent applications
would be those applications that were made since 1995
using the “mailbox”[ix] provisions.[x] It was feared that
this might be detrimental to the system of medical care in
the country. Their contention was that it might make
certain life-saving drugs out of reach of the common
man. Before third amendment took place Indian company
freely manufactured expensive drugs by using different
procedure and this made them experts in ‘reverse
engineering’. But post-TRIPS situation, Indian generic
companies have the following basic option:
For non-patented or patent-expired drugs:
• To continue to cater to domestic and export
markets
For patented drugs:
• Undertake R&D for development of new drugs
• Collaborate with innovator companies for
manufacturing, marketing and R&D
• Manufacture patented drugs through compulsory
or voluntary licensing
Several studies have found that Indian companies
adopted this new change very fast. They started investing
in R&D. In fact, what is more fascinating is the
dominance of Indian companies in retail market post-
TRIPS. For 2007/08, of the 468 companies considered by
orG-IMS5, only 46 are controlled by foreign companies
accounting for 20 percent of the market. This is a
distinctive feature of the situation in India. Of the 20
largest companies, 16 are Indian controlled (including
cipla, Ranbaxy, Dr. Reddy’s, Lupin, Sun
pharmaceuticals, Piramal Healthcare and cadila
Healthcare) and only four are MNCs.[xii] In contrast to
the situation in the early 1970s, 39 of the top 50
companies today are Indian companies. The market share
of MNCs has declined over the years, even after the
introduction of product patent protection in January 2005
— from 23 percent in December 2004, to 22 percent in
March 2006 and 20 percent in March 2008. In some
cases it gave scope for foreign companies to open a
subsidiary in India which will be managed by Indian
company to sell their drugs. It also opened the scope of
contract research. MNCs are now very extensively
investing in India. MNCs have also started buying up
Indian companies — the most notable being the
acquisition of India’s largest pharmaceutical company,
Ranbaxy by the Japanese MNC, daiichi Sankyo in June
2008. Other acquisitions of Indian companies include
dabur by Fresenius, Matrix by Mylan and Shanta
Biotechnics by Sanofi-Aventis.
India is favoured the most because of its low cost in
R&D. This strong performance of the generic industry in
the global markets resulted from a number of its inherent
advantages. It has been argued that Indian firms have
lower costs – estimated to be one-eighth in R&D
activities and one-fifth in manufacturing – as compared
to the Western firms. The cost advantages are most
pronounced in respect of lower fixed asset costs and
labour costs, where the costs in India can be one-eighth
of the cost in the US.
Therefore, what was feared previously didn’t happen.
Indian companies used this new change in their favour
and became one of the most prominent parties in the
manufacturing and distributing of drugs in the world.
Pharmaceutical Patents in India, Development of
Patent Law in India
The principal law for patenting system in India is the
Patents Act, 1970. Initially, according to the provisions
of this law no product patent but only process patents
could be granted for inventions relating to food, drugs
and chemicals. However, since 2005 product patenting is
allowed in India.
India being a member country of World Trade
Organization (WTO) signed TRIPS (Trade Related
Aspects of Intellectual Property Rights) Agreement in
1995. TRIPS prescribed the minimum standards of IP
laws to be followed by each of its member countries.
India being a signatory of the TRIPS agreement was
under a contractual obligation to amend its Patents law to
make it compliant with the provisions of the agreement.
The first amendment in this series was in the form of the
Patents (Amendment) Act, 1999 to give a pipeline
protection till the country starts giving product patents. It
laid down the provisions for filing of applications for
product patents in the field of drugs and agrochemicals
with effect from 1st January 1995 as mailbox
applications and introduced the grant of Exclusive
Marketing Rights (EMRs) on those patents. To comply
with the second set of TRIPS obligations India further
amended the Patents Act, 1970 by the Patents
(Amendment) Act, 2002. Through this amendment
provision of 20 years uniform term of patent for all
categories of invention was introduced. This amendment
also made other changes in the principal Act like
definition of the term “invention” was made consistent
with TRIPS agreement and provision for reversal of
burden of proof in case of infringement suit on process
patent was added in the Act. The third set of amendments
in the patent law was introduced as the Patents
(Amendment) Act, 2005. Through this amendment
product patent regime was introduced in India. Mere
discovery of new form, new property or new use of a
known substance was made patentable under certain
conditions, provisions related to pre grant and post grant
oppositions were modified and provision for the grant of
compulsory license for export of patented pharmaceutical
products in certain conditions was introduced.
Criteria of Patentability
Patents are granted to those inventions which satisfy
certain conditions called as criteria of patentability.
According to the Indian Patent Act, a patentable
invention is defined as “a new product or process
involving an inventive step and capable of industrial
application”. Therefore, following are the basic
requirements for any invention to be patentable.
a) Newness: To be patentable the subject matter of
the invention must not be known before the date
of patent filing. An invention is considered new
if it is not published in any document or not used
in the country or elsewhere in the world.
b) Inventive Step: It is defined as the feature of an
invention that involve technical advancement as
compared to existing knowledge or having
economic significance or both, that makes the
invention not obvious to a person skilled in the
art.
c) Industrial Applicability: The invention must be
capable of being made or used in an industry. For
example, a new and inventive method of
removing tumor cells from patient’s body is
 industrially not applicable, thus cannot be
patented.
TYPES OF PHARMACEUTICAL PATENTS IN
INDIA
The Pharma industry is one of the most intense
“knowledge driven” sectors. Pharmaceutical research is
very costly and unpredictable in nature. Outcome of the
research can be in the form of a new, inventive and
useful product or process. In this highly competitive
market, it is imperative for the pharmaceutical companies
to protect their inventions from any unauthorized
commercial use by acquiring patent rights over the
invented product or process. Pharmaceutical patents in
India can be classified under following categories. This
classification is based on the list of Pharma patents
provided by the Indian patent office on its website.
a) Drug compound patents
These patents claim a drug compound by its chemical
structure per se. These patent claims are usually referred
as Markush type claims. A Markush claim is a claim with
multiple "functionally equivalent" chemical entities
allowed in one or more parts of the drug compound.
Drug compound patents provide the broadest possible
protection to the company’s product, since other
companies are not allowed to prepare such drug by any
route of synthesis or produce/ sell any formulation
comprising this drug before the expiry of said patent.
b) Formulation/ composition Patents
These patents claim a specific technology to prepare a
formulation and/or quantity of its key ingredients. For
example, following ayurvedic anti-retroviral composition
for treatment of Acquired Immuno Deficiency Syndrome
was claimed in the Indian patent no. 203986.
c) Synergistic combination Patents
Drug synergy occurs when two or more drugs interact
with each other in such a way that it enhances or
magnifies one or more effects of those drugs. Patents can
be obtained on new synergistic combinations of the
drugs.
For example, a synergistic combination of roflumilast
and salmeterol was claimed in the Indian patent no.
206328 as follows:
“A medicament comprising a PDE inhibitor, which is to
be administered orally, from the PDE4 inhibitors group
combined with a β2 adrenoceptor agonist in fixed or free
combination, wherein the PDE inhibitor is roflumilast, a
pharmacologically tolerable salt of roflumilast and/or the
N-oxide of roflumilast and the β2 adrenoceptor agonist is
salmeterol or a pharmacologically tolerable salt thereof”
d) Technology Patents
These patents are based on the techniques used to solve
specific technology related problems like stabilization,
taste masking, increase in the solubility etc.
For example, following taste masked formulation was
claimed in the Indian patent no. 227933.
“A pharmaceutical formulation having a masked taste,
the masking of which persists during administration of
the formulation, in particular in the form of a suspension
in an aqueous vehicle, characterized in that it comprises
at least the following elements: a) a cellulosic polymer
which is soluble in organic solvents but practically
insoluble in water, regardless of the pH; a methacrylic
polymer which is soluble in an acid medium and
practically insoluble at a neutral or alkaline pH and an
active ingredient distributed in a homogeneous manner
and in the molecular state in the mixture, which is in the
form of an atomized matrix; b) an alkaline agent of an
organic nature or an alkaline salt, which is
pharmaceutically acceptable; c) an adsorbent agent.”
e) Polymorph Patents
Polymorphs are different physical forms or crystal
structure of an already known compound. Polymorphs
are usually prepared to reduce impurities or increase
stability of the compounds. For example, Indian patent
no. 237261 claims the crystalline form B4 of atorvastatin
magnesium characterized by X-ray powder diffraction
pattern. Said crystalline form shows purity greater than
98%.
Role of Section 3(d) in polymorph patenting:
Grant of polymorph patents in India is mainly governed
by the section 3(d) of the Patents Act, 1970. This section
was amended under the Patents (Amendment) Act, 2005.
The section states:
“the mere discovery of a new form of a known substance
which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any
new property or new use for a known substance or the
mere use of a known process, machine or apparatus
unless such known process results in a new product or
employs at least one new reactant. Explanation - For the
purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives
of known substance shall be considered to be the same
substance, unless they duffer significantly in properties
with regard to efficacy.”
The section 3(d) aims to prevent the “ever greening of
patents” by providing that only those pharmaceutical
derivatives that demonstrate significantly enhanced
“efficacy” can be patented. The section 3(d) ensures that
the new forms can be patented only if they are really
meritorious, and thus patents shall not be granted for
trivial inventions. It throws light on the Indian
government’s policy of rewarding the inventors/
researchers on their true intellectual efforts and at the
same time preserving the public interest and making
them available essential commodities such as drugs at
affordable prices.
f) Biotechnology patents
Biotechnology involves the use of living organisms or
biological materials in the preparation of pharmaceutical
products. Biotechnology patents cover a wide range of
diagnostic, therapeutic and immunological products. For
example, Indian patent no. 234072 claims an aqueous,
human serum albumin-free Interferon solution containing
an interferon-alpha, a non-ionic detergent, a buffer for
adjusting pH 4.5-5.5, benzyl alcohol and optionally an
isotonizing agent. Incidentally, above Indian patent no.
234072 was the first product patent granted by the Indian
Patent office after the enactment of product patent regime
in 2005. The patent is owned by F. Hoffmann-La Roche
Ltd., Switzerland.
g) Process patents
A process patent does not claim the product per se, rather
it only covers a new and inventive process to produce a
particular product. For example, Indian patent no.
206678 claims a process to synthesize δ-lactone of
formula 3,6- dialkyl-5,6-dihydro-4-hydroxy-2h-pyran-2-
one
Under Indian Patent Act-1970, Before 1995 1995-2005
DEVELOPMENT OF PATENT LAW IN INDIA
The principal law for patenting system in India is the
Patents Act, 1970. Initially, according to the provisions
of this law no product patent but only process patents
could be granted for inventions relating to food, drugs
and chemicals. However, since 2005 product patenting is
allowed in India.
India being a member country of World Trade
Organization (WTO) signed TRIPS (Trade Related
Aspects of Intellectual Property Rights) Agreement in
1995. TRIPS prescribed the minimum standards of IP
laws to be followed by each of its member countries.
India being a signatory of the TRIPS agreement was
under a contractual obligation to amend its Patents law to
make it compliant with the provisions of the agreement.
The first amendment in this series was in the form of the
Patents (Amendment) Act, 1999 to give a pipeline
protection till the country starts giving product patents. It
laid down the provisions for filing of applications for
product patents in the field of drugs and agrochemicals
with effect from 1st January 1995 as mailbox
applications and introduced the grant of Exclusive
Marketing Rights (EMRs) on those patents. To comply
with the second set of TRIPS obligations India further
amended the Patents Act, 1970 by the Patents
(Amendment) Act, 2002. Through this amendment
provision of 20 years uniform term of patent for all
categories of invention was introduced. This amendment
also made other changes in the principal Act like
definition of the term “invention” was made consistent
with TRIPS agreement and provision for reversal of
burden of proof in case of infringement suit on process
patent was added in the Act. The third set of amendments
in the patent law was introduced as the Patents
(Amendment) Act, 2005. Through this amendment
product patent regime was introduced in India. Mere
discovery of new form, new property or new use of a
known substance was made patentable under certain
conditions, provisions related to pre grant and post grant
oppositions were modified and provision for the grant of
compulsory license for export of patented pharmaceutical
products in certain conditions was introduced [3].
Product Patent Regime in The Indian
Pharmaceuticals Industry
That he the inventor, ought to be both compensated and
rewarded …will not be denied …it would be a gross
immorality of the law to set everybody free to see (or
use) a person’s work without his consent and without
giving him an equivalent.
In keeping with the aforementioned, Intellectual Property
Laws, particularly patents, world over are formulated
with a view to uphold the basic principle of one of
Moses’ Commandment – “THOU SHALL NOT
STEAL". This is on account of the fact that an inventor’s
work is invaluable to the society and to deny reward and
compensation to him would be grossly unfair.
Introduction
As with all forms of protection for intellectual property;
the aim the patenting regime is to encourage economic
and technological developments and advancement by
rewarding intellectual creativity. The word patent means
the exclusive privilege granted by the sovereign authority
to an inventor with respect to his invention. According to
the UN definition, a patent is a legally enforceable right
granted by countries government to its inventor. The term
has been defined under Section 2(m) of the Indian
Patents Act, 1970 (hereinafter “the Act").
Patent is mainly granted for product and process patent.
Granting process patent means patenting the particular
process or method, by which a certain product has been
manufactured. In such scenarios, the end product is not
patented, however, the manufacturing process is. While,
product patent confers the exclusive right to patentee to
prevent third parties, who do not have his consent, from
the act of making, using, offering for sale, selling or
importing for those purposes that product. The Act earlier
granted only process patent in food, medicines and
chemicals but subsequently, certain amendments were
made to provisions of the Act in order for India to meet
its obligation under Agreement on Trade Related Aspects
of Intellectual Property Rights (hereinafter “the TRIPS")
and conform to the standards as laid down by it.
India And TRIPS
India’s accession to the WTO brought obligations to
implement the TRIPS, changed the conditions that had
seen the Indian pharmaceutical industry take roots. That
is to say, compliance with the WTO regime mandates all
the member countries to amend their national legislations
to bring it in conformity with its provisions. Transitional
periods were set for the members to introduce legislation
complying with the obligations under TRIPS- for
developing countries, like India, the deadline for
complying with TRIPS was the year 2000 and by virtue
of Article 65.4 of TRIPS, a special transitional provision
of an additional five years was provided for those
countries that did not grant product patents.
At the time of coming into force of TRIPS, the Act
directly contravened its Article 27 as the provision
requires the member countries to make patents available
for any inventions, whether products or processes, in all
fields of technology without discrimination, subject to
the normal tests of novelty, inventiveness and industrial
applicability. It is also required that patents be available
and patent rights enjoyable without discrimination as to
the place of invention and whether products are imported
or locally produced. However, it was not so in India as
the product patent was not granted for all products
including medicines. For the pharmaceuticals industry,
the critical issue was the (re-) introduction of the product
patent regime and the limitations that this change has
imposed on its ability to produce technologies through
reverse engineering. It was widely held that the future
prospects of the industry hinged critically on the ability
of the policy makers to exploit the flexibilities that
existed in the framework provided by TRIPS.
Amendments
In India, three amendments of 1999, 2002 and 2005 were
enacted to bring the Act in conformity with the
provisions of the TRIPS. The Patents (Amendment) Act,
1999 brought about two significant changes with respect
to product patents in India: firstly, it introduced
Exclusive Marketing Rights (ERMs), and secondly, it
introduced what came to be known as the ‘mailbox
facility’ or ‘pipeline protection’ whereby applications for
pharmaceutical and agro-chemical product patents were
accepted during the ten year transition period and a filing
date was assigned to each. At this time there was no
product patent for pharmaceuticals, they were covered by
process patent only. In the case of Cadila
Pharmaceuticals Ltd. v. Instacare Lab. Pvt. Ltd., it was
held that what is patented is the process and not the
combination drug itself.
The Second Amendment brought the Act in conformity
with all the substantive provisions the TRIPS, with the
exception of product patent protection for
pharmaceuticals as an additional transition period of five
years was applicable. The key issues included re-defining
patentable subject matter, extension of the term of patent
protection to 20 years and amending the compulsory
licensing system.
The Third Amendment, the Patent (Third Amendment)
Act, 2005, was the most significant one as it had made
India fully TRIPS compliant by inaugurating an
enforceable product patents regime under Article
65(4). It repealed the controversial Section 5(1) of the
Act thereby paving the way for product patents in the
area of pharmaceutical and other chemical inventions.
Consequently, it was feared that with the introduction of
product patents for pharmaceuticals, there will be a steep
rise in drug prices and an adverse impact on access to
important drugs.
The Amendment broadened the scope for compulsory
licenses to include situations other than medical
emergencies. Compulsory licenses are now available for
the manufacture and export of patented pharmaceutical
products to any country having ‘insufficient or no
manufacturing capacity’ in the pharmaceutical sector for
the concerned product to address public health problems,
provided that compulsory licenses have been granted by
the importing country “or such country has by
notification or otherwise allowed importation of the
patented pharmaceutical product from India." With this
amendment dawned the era of product patents in India.
The Indian Pharmaceutical Alliance (IPA) noted that it
had struck a balance between the consumers' interest and
that of innovators.
Further, Section 3(k) of the Act excluded “a computer
programme per se" from the scope of patentability. This
exclusion met with conflicting interpretations at the
patent office, with some examiners granting patents to
software combined with hardware or software with a
demonstrable technical application of some sort. The
2004 Ordinance therefore qualified this exclusion by
stating that software with a “technical application" to
industry or when “combined with hardware" would be
patentable. Owing to vigorous opposition from the free
software movement, this provision was removed from the
Act. The earlier position under the Act that a computer
programme per se is not patentable now prevails.
EMRs which provided a means for accepting patent
applications for pharmaceutical products until December
31, 2004 had been revoked under the Amendment.
The Amendment also modified and added certain new
definitions. However, new invention which has been
added is a debatable feature in the Act on two counts,
firstly, according to the authors the Act already had a
definition of invention which clearly lays down the
criteria for a valid patent which contains the word new,
the presence of this term is sufficient for statutory and
interpretative purposes and so the Amendment brings out
ambiguity in the legislative intent and hence in
interpretation. Secondly, the standard of novelty is not
consistent throughout the Act. Section 25 of the Act
provides grounds under which patents can be
opposed. This inconsistency means that a competitor of
the patent applicant would not be able to successfully
oppose a patent if the invention is known or used in any
part of the world except for India.

The Amendment further amended the definition of
“inventive steps" in order to raise the standard for
inventive step and put a check on the granting of patents
with frivolous claims by having the requirement that the
invention involve a ‘technical advance’ or have an
‘economic significance’ of some sort. The Act also
provides a new definition for a “pharmaceutical
substance" as “any new entity involving one or more
inventive steps". This definition is quite broad and
definitely has bearing on determining patentability for
pharmaceuticals in India.
The Amendment has also introduced certain procedural
changes which have put in place a multi-layered scrutiny
mechanism which the product of the applicant must
undergo before being granted protection under the Act.
Firstly, it has provided for the publication of patent
applications. Secondly, it has provided for examination
of the patent application at the request of the applicant or
any interested party, and thereafter consideration by the
Controller of the report prepared by the examiner.
Thirdly, it has revamped the procedure by which one
could oppose the grant of a patent and provides for both
pre-grant and post-grant opposition. The Amendment
introduced a post grant opposition mechanism for the
first time. Within a year of the patent being granted, a
‘person interested’ can challenge the issued patent on
grounds that are identical to the grounds available at the
pre-grant opposition stage. Thus, the Amendment has
introduced a gruelling procedure of examination and
opposition before the product of an applicant may be
granted a patent under Section 43.
Judicial Pronouncements Post-Amendment
The question whether the Act is finally TRIPs compliant
was put to test in the landmark case of Novartis AG v.
Union of India, before the Madras High Court. Patent for
imatinib mesylate sold under the trade name Glivec and
used for curing Leukemia was sought in India. The
Controller of Patents rejected patent application holding
that the subject matter of the invention was non
patentable. The two main issues which came up before
the court were that the Act as amended in 2005 did not
comply with the TRIPs agreement and that Section 3(d)
of the Act was unconstitutional. According to the
Controller there was no enhancement in the known
efficacy of the substance and hence not patentable. On
the other hand, the Drug Company Novartis argued that
the product had been granted a patent in most countries
and it deserved a patent protection by virtue of Article 27
of TRIPs.
After hearing the parties it was held that High Court was
not the right forum to be approached as there was an
alternative efficacious remedy available in the form of
Dispute Settlement Body of the WTO. Moving further
the court held that the amended Section 3(d) was not in
violation of Article 14 of the Constitution of India and
was not vague or arbitrary, and did not confer
uncontrolled discretion to the Patent Controller. The
Court also held that it was inserted with the sole motive
of preventing the ever-greening of existing patent
products or processes. The concept of ever-greening or
renewing product patents by bringing in minor changes
in properties or use has been recognised in other
countries as well but is protected indirectly through
different mechanisms. Other countries like USA have
adopted legal principles like doctrine of inherent
anticipation , doctrine of double patenting and patent
misuse doctrine for patenting derivatives and models like
‘purpose limited product claim’ for patenting new use for
patented products. In the matter, the Madras High Court
interpreted the term ‘efficacy’ as therapeutic efficacy.
The issue is still not settled since the extent to which
efficacy should be achieved for patent on derivative is
not objectified and no criterion has been provided for it.
The matter now is pending with the Supreme Court of
India.
While the Madras High Court determined the issues of
jurisdiction and constitutionality, the Intellectual
Property Appellate Board (IPAB) heard the appeal of
Novartis on merits and by virtue of its decision dated
26th June, 2009 rejected the patent application for
Gleevic, which has been granted patent protection in
almost forty other countries around the world. The Board
specifically observed that the grant of product patent for
Gleevic would create havoc in the lives of the poor and
would have a disastrous effect on the society.
In the recent case of F. Hoffmann-LA Roche Ltd. v.
CIPLA the product patent application of the plaintiffs for
‘Erlotinib’ marketed under the name ‘Tarceva’, which
was a drug used to cure metastatic non small cell lung
cancer, was opposed by CIPLA which proposed to
release a generic version of the same drug, ‘Erlocip’. The
plaintiffs commenced action against the defendants
praying that they be restrained from doing the same. The
Delhi High Court refused to grant an injunction in favour
of the plaintiffs. The Court held that the element of
public interest was not alien to the scheme of the Act as
patents are granted to make the benefit of the patented
invention available at reasonably affordable prices to the
public. Since, price of the plaintiff’s tablet was Rs. 3200
which was beyond the reach of many patients as opposed
to defendant’s product which was priced at Rs. 1600 per
tablet it was held that public interest considerations
would override the rights of the patent holder.
Conclusion
The Indian Pharmaceutical industry is in fact one of the
largest among the developing countries and is ranked
fourth in terms of its production and thirteenth in terms
of its domestic consumption. This boom in this industry
has been mainly on account of the various scientific
inventions and the Act which facilitated industries in
gaining expertise in the process of reverse engineering.

The 2005 Amendment brought with it a fledgling
entrepreneurial culture of innovation among indigenous
pharmaceutical and biotechnology firms; it also
highlighted issues and concerns for the Indian Patent
regime and the Indian pharmaceutical industry. It can be
said that the new patents regime is neither the fully-
westernized panacea hoped for by its pro-TRIPS
advocates nor the unmitigated disaster for the Indian
public predicted by its fiercest critics.
Even the pharmaceutical industry is split whether the
Amendment is in favour of the Indian market or not. On
one hand, many companies may face hardships with
respect to the generic drugs as the product patent regime
will make India dependent on the multinational
companies for technology and for permission to produce
the patented drug. Exorbitant prices will be charged and
the Indian pharmaceutical industry will become
subservient to the MNC’s. Even though the domestic
Research & Development intensity has improved during
the later part of the 1990s, the level of investment has
remained very low. Thus, it is imperative that the
indigenous capability with respect to R&D is developed
to meet the global market demands.
On the other hand, some believe that this regime
promises tremendous growth opportunities and many
companies have already invested heavily on R&D
ensuring they would not lag behind in the global market.
There has also been diversification and investment into
discovery and developing of novel drugs and healthcare
products. The introduction of product patents for
pharmaceutical inventions and the consequent threat to
an internationally renowned generic industry that has
thus far ensured the supply of affordable drugs spurred
widespread protests, both nationally and internationally,
to an extent never before witnessed in the annals of
intellectual property law making in India. With the
pharmaceutical companies having been awaken from
their slumber, and investment pouring in on R&D,
pharma industry is just poised to grow further. Indian
companies will have to examine their present strategy
and strengthen their Research and Development units.
Many foreign companies will outsource their research to
India as India does not have scarcity of trained manpower
to conduct research at lower costs compared to developed
nations.
The result is an Act that attempts to balance the
competing interests of a variety of stakeholders,
including domestic generic medicine producers, the
domestic research and development community, foreign
multinational pharmaceutical companies, civil society
groups concerned with access to medicines and
intellectual property lawyers.
Definition of Enhanced Therapeutic Efficacy of
Pharma Products SECTION 3(d) and Novartis Case
1. OBJECT OF GRANTING PATENT
A statute is best understood if we know the reason for it,
the reason being the safest guide to its interpretation. It is
essential to note that the purpose of the Patents Act, 1970
(Patents Act) is to encourage inventions and to ensure
that the inventions are working in India on a commercial
scale and to the fullest extent that is reasonably
practicable without undue delay. It must be noted that
Patents are not granted merely to enable patentees to
enjoy a monopoly over the importation of the patented
articles. In light of the same, an obligation is created and
imposed on a patentee to work the patent in India on a
commercial scale and to the fullest extent; either by the
patentee itself or through licensees authorised by it.
Novartis‟ failure to obtain Patent protection in the
present case, therefore necessitates in the granting of a
compulsory license, which is one of the flexibilities in
Patent protection, included in the Trade Related Aspects
of Intellectual Property Rights (TRIPS) Agreement, and
is in most cases desired to be avoided at all costs by
pharmaceutical giants. Needless to say, compulsory
licensing is a boon to developing countries, limiting the
prospects of an epidemic, generating easy accessibility
and affordability of basic life-saving drugs.
2. BACKGROUND
In the present case, the Supreme Court of India has in its
judgment gone beyond the specific technical and legal
issues surrounding the dispute and has taken into
consideration a much larger political and economic
perspective. What the judgment says and what it implies
has tremendous significance for the patent regimes in
developing countries beyond the secondary patenting
issues relating to Section 3(d) of the Patents Act, 1970.
The judgment reads as
“In order to understand what the law really is, it
is essential to know the “why” and “how” of the
law. Why the law is what it is and how it came to
its present form?”
In order to understand the Patents Act, 1970 as per
legislature‟s point of view, it is pertinent to look through
the glasses of the statute maker. With the introduction
and commencement of the Patents Act, 1970, India
abolished product patent protection in drugs (and food).
However, with the advent of the TRIPS Agreement of the
World Trade Organization (WTO) in 1995, product
patents have become mandatory, despite countries being
free to frame their own Patent laws.
Under the Patents (Amendment) Act, 1999, applications
for product patents for inventions relating to medicine
and drug were permitted with certain conditions and
exceptions. Nevertheless, it was only in 2005 that in
compliance with the TRIPS Agreement , India started
granting pharmaceutical patent protection, albeit with a
prerequisite in Section 3(d) of the Patents Act, 1970.
Further, applicants for such patents are allowed to make
separate applications for grant of exclusive marketing
rights to sell or distribute the article subject to certain
conditions, the principal being the patentability of the
article under the provisions of Sections 3 and 4 of the
Patents Act, 1970.
3. CONDITIONS TO BE FULFILLED FOR GRANT OF
PATENT
The Supreme Court of India has in the present case,
carved out a fine line for the grant of new patents, being
that unless a therapeutic benefit is gained from the drug
sought to be patented, a patent must not be granted,
thereby keeping with the object of the introduction of
Section 3 (d) to the Patents Act
As per the relevant law in force, the following criteria
must be fulfilled for a new product or process to qualify
as an “invention” namely:
a) It must be new and not be anticipated;
b) It must involve an inventive step; and
c) It must be capable of industrial use and application.
Further, for an invention to be patentable, it must not fall
under the categories set out in Section 3 and Section 4 of
the Patents Act. Therefore, it is clear that under the
provisions of the Patents Act, the subject matter must
satisfy the twin tests of “invention” and “patentability”,
which in the present case, the application fails. It can be
argued that whereas some items may be an “invention” as
the term is
generally understood and yet they may not qualify as an
“invention” for the purposes of the Act, others may even
qualify as an “invention” as defined under the Act and
yet may be denied patent protection for other larger
considerations as may be stipulated in the Patents Act.
However, Section 3(d) of the Patents Act, 1970 provides
an explanation that salts, esters and other derivatives of
known substances will be considered to be the same
substance, „unless they differ significantly in properties
with regard to efficacy‟, considering in future a new
form of an existing product shows some increase in
efficacy. It must be said that the law relating to such
cases is rather untouched, and niche so far and has not
been specifically dealt with in the present case.
In Novartis AG v. Union of India & Ors., the primary
issue before the Supreme Court was whether the beta
crystalline form of the drug sought to be patented, stands
the test of patentability as specified in section 3(d) of the
Patents Act, 1970.
4. BRIEF TIMELINE OF THE PRESENT CASE
Pharmaceutical conglomerate Novartis first applied for a
patent for its drug imatinib (and other derivatives of a
compound) in the United States in April 1993 and then
once again in 1994, abandoning its previous application
the preceding year. At this stage, the patent was
commonly known as the „Zimmermann’ patent, after the
name of its inventor. At the relevant time, Novartis could
not apply for a patent for its drug in India due to the non-
application of the TRIPS Agreement in India.
However, soon after the advent of the TRIPS Agreement
in India, Novartis did eventually make a patent
application in India for the beta crystalline form of
imatinibmesylate in 1998. The Apex Court has noted that
at the time of application of the Patent in India, the
legislation governing the same was in a transitional
phase, with the law being significantly different to what
it stands as today. Until 2005, the Applicant’s application
was kept in a ‘mailbox’ and was only taken out of the
„mailbox‟ for consideration after certain amendments
were made to the Patents Act, with effect from
1stJanuary 2005. At this stage, the patent application
attracted 5 pre-grant oppositions by M/s. Cancer Patients
Aid Association, NATCO Pharma Ltd., CIPLA Ltd.,
Ranbaxy Laboratories Ltd. and Hetro Drugs Ltd. A
hearing was given to all parties by the Assistant
Controller of Patents and Designs on 15
December, 2005, as per Rule 55 of the Patent Rules,
2003
Thereafter, the Assistant Controller of Patents and
Designs rejected Novarti’s application on the ground that
the invention sought was obvious to a person skilled in
the art in view of the disclosure provided in the
Zimmermann patent specifications and further disallowed
the same as per the provisions of Section 3 (d) of the
Patents Act. On 25th January, 2006, the Assistant
Controller of Patents and Designs passed an order
rejecting the patent claim filed by Novartis on the
grounds that the invention claimed by Novartis was
obvious, anticipated and that the grant of patent on the
Drug is not permitted under Section 3(d) of the Patents
Act.
Thereafter, against this Order of the Assistant Controller,
Novartis filed an appeal before the Madras High Court,
which was later transferred to the Intellectual Property
Appellate Board (IPAB). Apart from challenging the
order of the Assistant Controller, Novartis also filed two
writ petitions before the Hon‟ble Madras High Court
seeking a declaration on Section 3 (d) as unconstitutional,
as it not only violates Article 14 of the Constitution of
India but also not in compliance with the TRIPS
Agreement. The said appeal before the IPAB was
rejected on 26thJune 2009 to which the Company
preferred an appeal before the Supreme Court of India.
The Supreme Court of India has in its judgment dated
1stApril 2013 (Judgment) upheld the rejection of
Novartis‟ patent claim on the Drug.
5. SUBMISSIONS OF NOVARTIS BEFORE THE
HON’BLE SUPREME COURT
The primary submission of Novartis was that the beta
crystalline form of the drug for which the patent was
applied for in India was developed through two distinct
inventions–firstly, from imatinibtoimatinibmesylate and
secondly, from imatinibmesylateto the beta crystalline
form.
The Supreme Court of India, however, ruled that
ImatinibMesylate was a known substance at the time of
application of the patent, thereby not qualifying as an
„invention‟ under the Patents Act and not further
satisfying the criteria of therapeutic efficacy as laid down
in Section 3 (d) of the Patents Act. The Court also
recorded a finding that the pharmacological properties of
Imatinib Mesylate were known in the Zimmermann
patent and in an article published in a Cancer Research
Journal, thereby further justifying the lack of criteria for
an ‘invention’ in Novartis‟ case.
5.1. Interpretation of ‘Efficacy’ and ‘Therapeutic
Efficacy’
Section 3 of the Patents Act, 197027 specifically lays
down what are not inventions and categorically specifies
that the mere discovery of a new form of a known
substance which does not result in the enhancement of
the known efficacy of the substance or the mere
discovery of any new property or new use for a known
substance shall not be considered an
‘invention’ for the purposes of the Patents Act, 1970.
In a healthcare context, as is the present case, the term
„efficacy‟ indicates the capacity for beneficial change (or
therapeutic effect) of a given intervention (e.g. a
medicine, medical device, surgical procedure, or a public
health intervention). In the same context, a therapeutic
effect is a consequence of a medical treatment of any
kind, the results of which are to be analysed and judged
to be desirable and beneficial. The Supreme Court of
India has held the term efficacy to mean “the ability to
produce a desired or intended result”. Therefore, the test
of efficacy in the context of section 3(d) would depend
upon the result, the function or the utility that the product
under consideration is desired or intended to produce.
Consequently, the court concluded that in case of a
medicine that claims to cure a disease, the test of efficacy
could only be “therapeutic efficacy”, i.e. the capacity of
the drug for beneficial change, which must be judged
strictly and narrowly. The court also held that as per the
explanation to the provision, a mere change of form with
properties inherent to that form would not qualify as an
“enhancement of the efficacy” of a known substance,
thereby categorizing what is to be considered therapeutic
efficacy.
The Apex Court also rejected Novartis‟ claims of better
bioavailability and better physical characteristics such as
better storability of the compound, requiring the same to
be collaborated with necessary data in each case to justify
a claim for an enhancement of therapeutic efficacy. As
Novartis did not submit any material to demonstrate the
same, the application failed to satisfy the test laid down
in section 3(d) of the Patent Act. It has been held that
Section 3(d) of the Patents Act does not bar patent
protection for all incremental inventions of chemical and
pharmaceutical substances, with the determination of the
same on a case-to-case basis. Therefore, in interpreting
cases under Section 3(d) of the Patents Act, as suggested
by the Apex Court, courts in India will lay greater
emphasis on the ability of the product to materially
improve the therapeutic effect provided by the patented
drug.
It must be noted that at the time of application of the
patent, there was no criteria for any additional therapeutic
benefit being derived from the product as it was only post
the application that the said criteria was introduced to
Section 3 (d) of the Patents Act. The apex court has
remarked that the case of Novartis “appears in rather
poor light and the claim for patent for beta crystalline
form of imatinibmesylate would only appear as an
attempt to obtain patent for imatinibmesylate, which
would otherwise not be permissible in this country.”
5.2. Secondary Patents
Secondary Patents are essentially patents that are granted
in relation to new developments or improvements of the
subject matter of the primary patent, which plea in
Novartis‟ case has been rejected by the Supreme Court.
Secondary patents, which are allowed in certain cases in
the United States of America and the United Kingdom
when „enhanced utility‟ can be proved from the base
compound, do not find any safeguard in the Indian
Patents Act, 1970. Therefore, it is safe to say that unless
the Indian law is amended to provide for secondary
patents, companies Novartis‟ cannot expect patent
protection in India.
5.3. Compulsory Licensing
In the present context, considering the delicacy of the
legislature, had Novartis made the Patent application in
the United States of America a few months later, with the
advent of the TRIPS Agreement, the drug would well
have been eligible for a patent in India. Linking patenting
to therapeutic benefit is what the Apex Court has done in
its judgment in the Novartis case. The ruling is consistent
with the provisions of the TRIPS Agreement and has
been arrived at by following a transparent and
internationally accepted legal process that is not
arbitrary. As a result, other legislations that have stricter
patent regimes might also be induced to introduce similar
provisions in their patent laws to make drugs more
affordable.
It must be noted that the TRIPS Agreement also permits
compulsory licensing, which has been granted to
NATCO for SorafenibTosylate (sold as Nexavar by the
patentee, Bayer).
Amongst other problems, India suffers from the problems
of high prices of patented medicines and low access to
generics, i.e., non- patented medicines and a compulsory
license. Due to a variety of factors including poor public
health facilities and inadequate insurance facilities, drug
access is trifling in India, with Indian generic companies
lured by foreign markets.
6. REACTIONS AND REPERCUSSIONS IN THE
INDIAN ECONOMY
The immediate reaction to the judgment was one of
widespread acclaim and support, particularly from
organisations such as the WTO and Médecins Sans
Frontières (Doctors Without Borders) amongst others
that welcomed the judgment as a stronghold against ever
greening.
The Supreme Court of India has rightly observed “the
rules and regulations of the patent systems are not
governed by civil or common law but by political
economy.”
As quoted by Michel “Patent systems are not created in
the interest of the inventor but in the interest of the
national economy”.
It must be appreciated that in the Novartis case, the
Supreme Court has taken a stance wherein it is not only
justified to deny patents where incremental innovation is
trivial as in the present case, but one must significantly
prove and demonstrate some form of therapeutical
efficacy in the product. The Division Bench has given
great consideration to the impact or rather damage the
same, if granted would have to society and has
highlighted the relevance of specific conditions of a
country for deciding the appropriate patent regime.
Pharmaceutical patent protection was allowed till the
advent of the Patents Act, and was thereafter once again
re-introduced belatedly in 2005, considering the dire
consequences of non-compliance of the TRIPS
Agreement by India. The intent of the same was to
promote and provide a stimulus to investment and
innovation in research and development in India.
However, it was in the interim period that industry in
India witnessed development, somewhat unprecedented,
albeit in the absence of the pharmaceutical patent
protection. It is essential to note that prior to 1972, when
pharmaceutical patent protection was provided in India,
global pharmaceutical giants such as Novartis did not
contribute much to innovation, market growth and
development in India, as was anticipated by them, and
were un- inclined towards developing industry and
investing in manufacturing activities in India. It has only
been due to the advent of the WTO and the TRIPS
Agreement that India has been forced to re-introduce the
provisions for pharmaceutical patent protection in its
legislature.
In the present case, the fundamental basis for rejection of
the Patent application is that there is no therapeutic
benefit derived from the product, thereby eliminating the
need of consumers in paying exorbitant prices for the
product. This will have a direct effect on ‘ever greening’
as it will be even harder for producers to prove
therapeutic efficacy, now a strict criterion for patent
protection in India. The direct benefit of the above will
be to the consumer as medicines which otherwise would
have been patented having high monopoly prices will
now not be patentable, thereby being affordable.
The present ruling in the Novartis case is a relief to the
Indian market, as pharmaceutical companies are now
essentially unable to extend the life of patents by minor,
trivial modifications to their protected products. Thus it
paved the way for generic companies to sell the anti-
cancer drug and other drugs in the future, at a fraction of
the exorbitant prices charged by Novartis and
pharmaceutical giants for the product. It has been
suggested, although yet to be seen that the strict patent
requirement laid down by the Apex Court would actually
enhance innovation as pharmaceutical companies would
have to invest more in research and development to come
up with new cures rather than repackage known
compounds.
Despite the ruling receiving stiff opposition, Novartis‟
sceptical approach of withdrawing Research and
Development initiatives in India and withholding the
introduction of new drugs in the country is a knee-jerk
reaction. Much can be speculated of the impact of the
refusal of the patent protection on the profits of Novartis.
However, the same will be insignificant taking in to
account the fact that the Indian market only accounts to a
fraction of Novartis‟ emerging global market share.
Further, not paying much heed to Novartis‟ immediate
reaction, an emergent market like India is too daunting
and alluring for pharmaceutical giants to disregard,
regardless of the company.
The beneficial aspect of the ruling is that a rationale has
been set and laid down for the grant of patents, which
keeping in mind the frailty of the legislature, can only be
a strong hold for the same for times to come. It is
suggested that the same could possibly stimulate
investment for research and innovation, which is yet to
be seen. The ruling in the present case seeks to achieve a
perfect balance between Patent rights and interests of the
society and market, often unattainable and to be fair, does
considerably well in its endeavour to do so. In
developing countries such as India, especially where
innovation is absent or trivial, a country is justified in
denying a patent protection as striking a balance between
the utility of patent protection and its impact on the
market becomes difficult. In the present case, the
negative effect of monopoly and price-rise is much
stronger than the positive effect of the grant of the patent
protection in the country, thereby justifying the stance
taken by the Apex Court per se. Patent rights inevitably
reduce the accessibility of a product to patients in
developing economies, by virtue of their inflated prices.
It must be appreciated that at present, as per India‟s
Economic Development Stage, India is more of a net user
than a developer of such life saving drugs. Therefore, the
grant of patent protection in pharmaceutical products as
in Novartis‟ case would cause greater harm to the
economy than benefit as the same would essentially
bereft Indian pharmaceutical companies of the
opportunity of penetrating a market deep enough to
sustain and grow by handing over this opportunity to a
global conglomerate. India, in my opinion has the
potential to provide the market and the mechanism for
literally creating a pharmaceutical giant, which once is in
existence, would it be prudent to provide patent
protection to cases like Novartis‟. It is only at this stage
once India starts manufacturing and developing such
drugs and becomes a net-developer of the same, can it
consider providing patent protection to cases like
Novartis‟ the same. It is imperative that a balance is
achieved between the grant of patent protection and the
benefit of such grant on society, which the present ruling
does quite well. The Division Bench is evidently justified
in denying patent protection in the present case where
incremental innovation is trivial, as of the application for
a beta crystalline form of an already patent protected
product. The relevance of the patenting and the net
benefits to society is one that this ruling has laid great
emphasis on, one that must be appreciated considering
the prevalent patent regime in India.
7. CONCLUSION
The initial apprehension of the judgment enforcing a
blanket ban on patent protection to all incremental
inventions of chemical and pharmaceutical substances is
a misplaced one. The ruling, albeit a narrow one, lays
down the basis that a company must comply with in
order to be afforded protection under the regime. With
Indian law, fully compliant with the TRIPS and
International standards, it would be fair to suggest that
the judgment of the Supreme Court is a timely one,
clearly establishing a foothold on the subject matter for
the times to come in conformity to international
standards. With the stringent patent standards set across
the world, given the present Economic Development
Stage of India, the extent of poverty and lack of
availability of affordable medicines in the country, it is
only high time that India followed suit. The prevalence of
Section 3 (d) allows competition, which is useful as it
ensures that drugs will be available at a competitive price
in the market.
The ruling, besides paving the way for easing the
accessibility and availability of drugs in India, affirms
and upholds the patent regime in India, thereby
protecting genuine innovators in India. The impact of the
judgment on other Global Pharmaceutical Companies is
yet to be seen, needless to say that they would be
considerably more cautious in their approach, keeping in
mind the depth of the judgment in the present case.
Needless to say, the repercussions of the judgment, if
any, shall not be too damaging to the Indian economy, as
one with the backing of a population exceeding Two
Billion, shall always remain a beguiling market, which
will almost impossible for Pharmaceutical corporations
to overlook.
Doctrine of Equivalence
The patent laws "promote the Progress of Science and
useful Arts" by rewarding innovation with a temporary
monopoly. The monopoly is a property right; and like
any property right, its boundaries should be clear. A
patent holder should know what he owns, and the public
should know what he does not. For this reason, the patent
laws require inventors to describe their work in "full,
clear, concise, and exact terms," as part of the delicate
balance the law attempts to maintain between inventors,
who rely on the promise of the law to bring the invention
forth, and the public, which should be encouraged to
pursue innovations, creations, and new ideas beyond the
inventor's exclusive rights.
A patent contains several parts—a specification, usually
one or more drawings, and always one or more claims.
No matter how much a questioned machine, manufacture,
composition of matter or process may look like the
specification and drawings of a patent, it is only the
claims of the patent which can be infringed. For that
reason, if an issue of infringement arises, it becomes
necessary to examine the claims of the patent in question.
The first step is to "read" each claim of the patent upon
the accused structure or process. Every requirement of
each claim must be considered to see if each thing set out
in the claim also appears in the accused practice. If one
or more things set forth in a claim is not present in the
practice being reviewed, there is no infringement of that
claim. On the other hand, if each thing which is set out in
even one claim of the patent is present in the accused
structure or process, then there is direct and literal
infringement. When literal infringement is found, that is
normally the end of the inquiry.
WHAT IS DOCTRINE OF EQUIVALENTS ?
An infringement analysis determines whether a claim in a
patent literally "reads on" an accused infringer's device or
process, or covers the allegedly infringing device under
the doctrine of equivalents. The steps in the analysis are:
1. Construe the scope of the "literal" language of the
claims.
2. Compare the claims, as properly construed, with the
accused device or process, to determine whether there is
literal infringement.
3. If there is no literal infringement, construe the scope of
the claims under the doctrine of equivalents.
The doctrine of equivalents is an equitable doctrine
which effectively expands the scope of the claims beyond
their literal language to the true scope of the inventor's
contribution to the art. However, there are limits on the
scope of equivalents to which the patent owner is
entitled.
Over 150 years ago, the US Supreme Court in case
of Winans v. Denmead , 56 U.S. 330 (1853), expanded
the potential scope of patents by adopting a doctrine to
prevent “substantial copies” of an invention by providing
coverage over inventions that are “equivalent” to that
patented.
The doctrine of equivalents permits a finding of
infringement even if the accused device or method does
not literally fall within the scope of the construed patent
claims. Instead, a device or method may infringe under
the doctrine of equivalents if it performs “substantially
the same function in substantially the same way to obtain
the same result” as the patented invention. Thus, the
doctrine of equivalents permits an expansion of patent
rights beyond the literal scope of the patent claims. One
purpose of the doctrine of equivalents is to protect
patentees from those who seek “to evade liability for
infringement by making only insubstantial changes to a
patented invention.
POSITION IN THE UNITED STATES
The doctrine of equivalents is a legal rule that allows a
court to hold a party liable for patent infringement even
though the infringing device or process does not fall
within the literal scope of a patent claim, but nevertheless
is equivalent to the claimed invention.
Graver Tank & Mfg. Co., Inc. Et Al. V. Linde Air
Products Co
Linde Air Products Co., owner of the Jones patent for an
electric welding process and for fluxes to be used
therewith, brought an action for infringement against
Lincoln and the two Graver companies. The single issue
was whether the trial court's holding that the four flux
claims have been infringed will be sustained. Any issue
as to the validity of these claims was unanimously
determined by the previous decision in the
Supreme Court and attack on their validity cannot be
renewed then by reason of limitation on grant of
rehearing. The disclosure, the claims, and the prior art
have been adequately described in our former opinion
and in the opinions of the courts below.
The doctrine of equivalents evolved in response to this
experience. The essence of the doctrine is that one may
not practice a fraud on a patent. Originating almost a
century ago in the case of Winans v. Denmead it has
been consistently applied by the Courts. A patentee may
invoke this doctrine to proceed against the producer of a
device "if it performs substantially the same function in
substantially the same way to obtain the same result."
Sanitary Refrigerator Co. v. Winter . The theory on
which it is founded is that "if two devices do the same
work in substantially the same way, and accomplish
substantially the same result, they are the same, even
though they differ in name, form, or shape." Machine
Co. v. Murphy
In its early development, the doctrine was usually applied
in cases involving devices where there was equivalence
in mechanical components. Subsequently, however, the
same principles were also applied to compositions, where
there was equivalence between chemical ingredients.
Today the doctrine is applied to mechanical or chemical
equivalents in compositions or devices.
What constitutes equivalency must be determined against
the context of the patent, the prior art, and the particular
circumstances of the case. Equivalence, in the patent law,
is not the prisoner of a formula and is not an absolute to
be considered in a vacuum. It does not require complete
identity for every purpose and in every respect. In
determining equivalents, things equal to the same thing
may not be equal to each other and, by the same token,
things for most purposes different may sometimes be
equivalents. Consideration must be given to the purpose
for which an ingredient is used in a patent, the qualities it
has when combined with the other ingredients, and the
function which it is intended to perform.
The Supreme Court observed that it was difficult to
conceive of a case more appropriate for application of the
doctrine of equivalents. The disclosures of the prior art
made clear that manganese silicate was a useful
ingredient in welding compositions. Specialists familiar
with the problems of welding compositions understood
that manganese was equivalent to and could be
substituted for magnesium in the composition of the
patented flux and their observations were confirmed by
the literature of chemistry. Without some explanation or
indication that Lincolnweld was developed by
independent research, the trial court could properly infer
that the accused flux is the result of imitation rather than
experimentation or invention. Though infringement was
not literal, the changes which avoid literal infringement
are colorable only. The Supreme Court concluded that
the trial court's judgment of infringement respecting the
four flux claims was proper.
POSITION IN THE UNITED KINGDOM
Catnic Components Ltd. v. Hill & Smith Ltd. (1982)
R.P.C. 183 House of Lords
Catnic Components had a patent for a lintel, used to
provide structural support over a door or window
opening in a brick wall. Part of the specification required
a bar to "extend vertically". Hill created a virtually
identical invention that had a bar that extended at an
upwards slant, only 6 degrees from being completely
vertical. Despite the difference the device worked
entirely in the same way as Catnic's invention.
Catnic sued for patent infringement. At trial, the judge
held there was an infringement under the "pith and
marrow" doctrine. The Court of Appeal overturned the
ruling as although it held that the "vertical" requirement
was an exact and essential element of the patent, the
effect did not change. The court affirmed the use of
purposive construction to patent interpretation and found
an infringement. The House of Lords held that a patent
specification is a unilateral statement by the patentee, in
words of his own choosing, addressed to those likely to
have a practical interest in the subject matter of his
invention (i.e. "skilled in the art"), by which he informs
them what he claims to be the essential features of the
new product or process for which the letters patent grant
him a monopoly. It is called "pith and marrow" of the
claim.
A patent specification should be given a purposive
construction rather than a purely literal one derived from
applying to it the kind of meticulous verbal analysis in
which lawyers are too often tempted by their training to
indulge. The question in each case is: whether persons
with practical knowledge and experience of the kind of
work in which the invention was intended to be used,
would understand that strict compliance with a particular
descriptive word or phrase appearing in a claim was
intended by the patentee to be an essential requirement of
the invention so that any variant would fall outside the
monopoly claimed, even though it could have no material
effect upon the way the invention worked.
House of Lords further observed that :
"... both parties to this appeal have tended to treat `textual
infringement' and infringement of the ‘pith and marrow’
of an invention as if they were separate causes of action,
the existence of the former to be determined as a matter
of construction only and of the latter upon some broader
principle of colourable invasion. There is, in my view, no
such dichotomy; there is but a single cause of action and
to treat it otherwise, particularly in cases like that which
is the subject of the instant appeal, is liable to lead to
confusion."
There was a debate whether the purposive construction
test in the Catnic case in fact complied with the protocol
to Article 69 of the European Patent Convention. The
doubt was finally cleared by the House of Lords in Kirin-
Amgen v Hoechst Marion Roussel . It held that the
Protocol is a Protocol for the construction of article 69
and does not expressly lay down any principle for the
construction of claims. It does say what principle should
not be followed, namely the old English literalism, but
otherwise it says only that one should not go outside the
claims. It does however say that the object is to combine
a fair protection for the patentee with a reasonable degree
of certainty for third parties.
The House of Lords thus declared that the Catnic
principle of construction was therefore precisely in
accordance with the Protocol. It is intended to give the
patentee the full extent, but not more than the full extent,
of the monopoly which a reasonable person skilled in the
art, reading the claims in context, would think he was
intending to claim.
POSITION IN INDIA
In India, the doctrine of equivalents was discussed
in Ravi Kamal Bali vs Kala Tech And
Ors 2008(110)Bom LR 2167, Though the matter was
regarding an interim application for request of
submission of additional documents by the defendant, yet
in the order the Court observed that the counsel of the
plaintiff submitted that while considering the question of
infringement of patents, the Court ought to apply the
doctrine of equivalence by which a device is set to
infringe a claim if it "performs substantially the same
function in substantially the same way to obtain the same
result". The test is whether the Defendants product
appears to have taken the essence or what is sometimes
called the pith and marrow of the invention. Counsel for
the plaintiff further submitted that even under the Indian
Patent Act, 1970 while deciding the question of
infringement of patents, the Court ought to apply the
doctrine of equivalence under which the Court must
determine and distinguish the essential and nonessential
elements of the product. He submitted that it is not
necessary that the infringing goods must be identical in
every respect to the patented goods and it is sufficient if
it is found that what has been taken is the essence of the
invention.
Ravi Kamal Bali, the plaintiff, instituted an infringement
suit seeking an interim injunction inter alia restraining
Kala Tech, the defendant, from making, using, selling or
distributing tamper proof locks/seals falling within the
scope of the claims of the his patent bearing No. 162675
and patent of addition No. 178879. Ravi Kamal alleged
that the product of Kala Tech has similar constructional
and functional features to his patented invention. Arguing
further, Ravi Kamal contended that Kala Tech’s product
do the same work, in substantially the same way and
accomplishes substantially the same result thereby
contributing to the infringement. In response, Kala
Tech’s counsel while asserting on the differences in the
constructional and functional structure between the two
products, made a counter argument comparing the
inventive step between the plaintiff’s patent and the
patent of addition and the patents of plaintiff and
defendant, and submitted that when the only difference
between the plaintiff’s patent and the patent of addition is
the addition of ‘vanes’ in the patent of addition then the
defendant’s invention would also constitute a new
invention qua the invention that is patented as the
difference between the defendants invention and the
plaintiff’s patented invention is greater than the
difference between the patent of addition and the patent
itself.
The submission above equated a patent with a patent of
addition which was found erroneous by the Court on the
ground that this would obliterate the rights of a patentee.
The patent holders of the main invention and the patent
of addition being different in the instance of the patent
over the main invention being revoked may see the patent
of addition continuing for the remainder of the term for
the patent of the main invention, unless also applied for
and revoked simultaneously. However, the Court denied
the relief of an interim injunction justifying it on the
plaintiff’s act of seeking an ad interim injunction on a
representation which was incorrect in material aspect.
This case is important as it discusses Doctrine of
equivalents, an important legal principle under the patent
law regime covering indirect infringement. In addition to
literal infringement which is direct and unambiguous, an
indirect infringement takes place when insubstantial or
minor changes made to the patented product or process
causes it to fall outside the declared scope of the patent
i.e. patent claims, but, which in practical terms, remains a
duplicate of the patented product/process.

CONCLUSION

There seems to be many approaches towards dealing with

non – literal infringement across different jurisdictions.
Doctrine of equivalent and doctrine of Pith and Marrow
are two such. In India cases have been very few where
Doctrine of equivalents have been discussed. The debate
between the doctrine of equivalents and promissory
history estoppels will continue to come before the courts.
It is advisable that there should be a single approach to
tackle non literal infringement among all jurisdictions.
But in recent years, distinguished academics have
predicted the so-called “demise” of the doctrine of
equivalents.
Module 3
Patentability of Pharmaceutical under TRIPS
Philosophy: TRIPS attempts to strike a balance
The WTO’s Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) attempts to strike a
balance between the long term social objective of
providing incentives for future inventions and creation,
and the short term objective of allowing people to use
existing inventions and creations. The agreement covers
a wide range of subjects, from copyright and trademarks,
to integrated circuit designs and trade secrets. Patents for
pharmaceuticals and other products are only part of the
agreement.
The balance works in three ways:
 Invention and creativity in themselves should provide
social and technological benefits. Intellectual property
protection encourages inventors and creators because
they can expect to earn some future benefits from their
creativity. This encourages new inventions, such as new
drugs, whose development costs can sometimes be
extremely high, so private rights also bring social
benefits.
 The way intellectual property is protected can also
serve social goals. For example, patented inventions
have to be disclosed, allowing others to study the
invention even while its patent is being protected. This
helps technological progress and technology
dissemination and transfer. After a period, the
protection expires, which means that the invention
becomes available for others to use. All of this avoids
“re-inventing the wheel”.
 The TRIPS Agreement provides flexibility for
governments to fine tune the protection granted in order
to meet social goals. For patents, it allows governments
to make exceptions to patent holders’ rights such as in
national emergencies, anti-competitive practices, or if
the right-holder does not supply the invention, provided
certain conditions are fulfilled. For pharmaceutical
patents, the flexibility has been clarified and enhanced
by the 2001 Doha Declaration on TRIPS and Public
Health. The enhancement was put into practice in 2003
with a decision enabling countries that cannot make
medicines themselves, to import pharmaceuticals made
under compulsory licence. In 2005, members agreed to
make this decision a permanent amendment to the
TRIPS Agreement, which will take effect when two
thirds of members accept it.
What is the basic patent right?
Patents provide the patent owner with the legal means to
prevent others from making, using, or selling the new
invention for a limited period of time, subject to a
number of exceptions.
A patent is not a permit to put a product on the
market
A patent only gives an inventor the right to prevent
others from using the patented invention. It says nothing
about whether the product is safe for consumers and
whether it can be supplied. Patented pharmaceuticals still
have to go through rigorous testing and approval before
they can be put on the market.
Under TRIPS, what are member governments’
obligations on pharmaceutical patents?
Patenting: WTO members have to provide patent
protection for any invention, whether a product (such as
a medicine) or a process (such as a method of producing
the chemical ingredients for a medicine), while allowing
certain exceptions. Article 27.1. Patent protection has to
last at least 20 years from the date the patent application
was filed.
Non-discrimination: Members cannot discriminate
between different fields of technology in their patent
regimes. Nor can they discriminate between the place of
invention and whether products are imported or locally
produced. Article 27.1
Three criteria: To qualify for a patent, an invention has
to be new (“novelty”), it must be an “inventive step” (i.e.
it must not be obvious) and it must have “industrial
applicability” (it must be useful). Article 27.1
Disclosure: Details of the invention have to be described
in the application and therefore have to be made public.
Member governments have to require the patent applicant
to disclose details of the invention and they may also
require the applicant to reveal the best method for
carrying it out. Article 29.1
ELIGIBILITY FOR PATENTING
Governments can refuse to grant patents for three reasons
that may relate to public health:
 inventions whose commercial exploitation needs to be
prevented to protect human, animal or plant life or
health — Article 27.2
 diagnostic, therapeutic and surgical methods for
treating humans or animals — Article 27.3a
 certain plant and animal inventions — Article 27.3b.
Under the TRIPS Agreement, governments can make
limited exceptions to patent rights, provided certain
conditions are met. For example, the exceptions must
not “unreasonably” conflict with the “normal”
exploitation of the patent. Article 30.
RESEARCH EXCEPTION AND “BOLAR”
PROVISION
Many countries use this provision to advance science and
technology. They allow researchers to use a patented
invention for research, in order to understand the
invention more fully.
In addition, some countries allow manufacturers of
generic drugs to use the patented invention to obtain
marketing approval — for example from public health
authorities — without the patent owner’s permission and
before the patent protection expires. The generic
producers can then market their versions as soon as the
patent expires. This provision is sometimes called the
“regulatory exception” or “Bolar” provision. Article 30
This has been upheld as conforming with the TRIPS
Agreement in a WTO dispute ruling. In its report adopted
on 7 April 2000, a WTO dispute settlement panel said
Canadian law conforms with the TRIPS Agreement in
allowing manufacturers to do this. (The case was titled
“Canada — Patent Protection for Pharmaceutical
Products”)
ANTI-COMPETITIVE PRACTICES
The TRIPS Agreement says governments can also act to
prevent patent owners and other holders of intellectual
property rights from abusing intellectual property rights,
“unreasonably” restraining trade, or hampering the
international transfer of technology. Articles 8 and 40
COMPULSORY LICENSING Compulsory licensing is
when a government allows someone else to produce the
patented product or process without the consent of the
patent owner. In current public discussion, this is usually
associated with pharmaceuticals, but it could also apply
to patents in any field.
The agreement allows compulsory licensing as part of the
agreement’s overall attempt to strike a balance between
promoting access to existing drugs and promoting
research and development into new drugs. But the term
“compulsory licensing” does not appear in the TRIPS
Agreement. Instead, the phrase “other use without
authorization of the right holder” appears in the title of
Article 31. Compulsory licensing is only part of this
since “other use” includes use by governments for their
own purposes.
Compulsory licensing and government use of a patent
without the authorization of its owner can only be done
under a number of conditions aimed at protecting the
legitimate interests of the patent holder.
For example: Normally, the person or company applying
for a licence must have first attempted, unsuccessfully, to
obtain a voluntary licence from the right holder on
reasonable commercial terms — Article 31b. If a
compulsory licence is issued, adequate remuneration
must still be paid to the patent holder — Article 31h.
However, for “national emergencies”, “other
circumstances of extreme urgency” or “public
noncommercial use” (or “government use”) or
anticompetitive practices, there is no need to try for a
voluntary licence — Article 31b.
Compulsory licensing must meet certain additional
requirements. In particular, it cannot be given exclusively
to licensees (e.g. the patent-holder can continue to
produce), and usually it must be granted mainly to supply
the domestic market.
WHAT ARE THE GROUNDS FOR USING
COMPULSORY LICENSING?
The TRIPS Agreement does not specifically list the
reasons that might be used to justify compulsory
licensing. In Article 31, it does mention national
emergencies, other circumstances of extreme urgency
and anti-competitive practices — but only as grounds
when some of the normal requirements for compulsory
licensing do not apply, such as the need to try for a
voluntary licence first. Doha declaration 5(b) and (c)
PARALLEL IMPORTS, GREY IMPORTS AND
‘EXHAUSTION’ OF RIGHTS
Parallel or grey-market imports are not imports of
counterfeit products or illegal copies. These are products
marketed by the patent owner (or trademark- or
copyright-owner, etc) or with the patent owner’s
permission in one country and imported into another
country without the approval of the patent owner.
For example, suppose company A has a drug patented in
the Republic of Belladonna and the Kingdom of
Calamine, which it sells at a lower price in Calamine. If a
second company buys the drug in Calamine and imports
it into Belladonna at a price that is lower than company
A’s price, that would be a parallel or grey import.
The legal principle here is “exhaustion”, the idea that
once company A has sold a batch of its product (in this
case, in Calamine), its patent rights are exhausted on that
batch and it no longer has any rights over what happens
to that batch.
The TRIPS Agreement simply says that none of its
provisions, except those dealing with nondiscrimination
(“national treatment” and “most-favoured-nation
treatment”), can be used to address the issue of
exhaustion of intellectual property rights in a WTO
dispute. In other words, even if a country allows parallel
imports in a way that another country might think
violates the TRIPS Agreement, this cannot be raised as a
dispute in the WTO unless fundamental principles of
non-discrimination are involved. The Doha Declaration
clarifies that this means that members can choose how to
deal with exhaustion in a way that best fits their domestic
policy objectives. Article 6 and Doha declaration 5(d)
Patent Term Extension
India, though in a phase of rapid economic development,
still has the bane of poverty. In this country, around 22%
of the population is Below the Poverty Line, and hence
most of the nation’s policies are oriented towards the
poor. India’s IP Policy is no different, as the IP
legislature in India is mostly oriented towards giving the
general public an easy and inexpensive access to
medicines. Indian IP policy drafters have used every
flexibility in the Agreement on the Trade-Related Aspects
of Intellectual Property Rights (TRIPS), to which India is
a signatory, for this purpose.
The curious case of drug development
The process of development of the drugs to treat the
diseases and ailments is pretty much painstaking. A drug
regulatory authority, (e.g. The US Food and Drug
Administration-US FDA; Central Drugs Standard
Control Organization-CDSCO in India) monitors and
governs the testing of the New Chemical Entities (NCEs)
through pre-clinical and clinical trials to prove their
safety and efficacy to treat an ailment. Several NCEs fail
at some or the other stage, rendering all the money and
efforts in vain. The amount of money invested in each
NCE is of the order of billions of dollars. The time period
it takes for the development of the NCEs as approved
‘Drugs’ typically ranges from 10-15 years. The chances
of a candidate making it through this whole of the
process, to the desk of the pharmacy, are merely 2%. So,
in this precarious situation, the 20 years of patent
protection granted to the drug products is not sufficient to
recover the huge investment made in the R&D of the
product. So, the pharma companies usually demand the
extension of the protection of their monopoly over the
drug product. This Patent Term Extension (PTE) is
granted by the Patent Office of the region or country.
Now, these clinical trials generate data regarding the
therapeutic activity and safety of the drug. So, if a
generic player wants to launch the same drug, it will need
this data to prove that its generic version of the drug is
‘equivalent’ to the innovator’s product. Since the
innovator companies invest huge amounts of time,
money and efforts into generating this data, they demand
exclusivity of this data. This Clinical Trial Data
Exclusivity is under the discretion of the drug regulatory
authority and regardless of the existence of a valid patent
on the subject matter. If granted, it gives an additional
layer of protection to the innovator drug product.
In the following paragraphs, we will discuss the Patent
Term Extension and Clinical Trial Data Exclusivity
provisions present in the US and European, legislature, in
comparison with the Indian scenario. Several other
countries also provide these provisions, but we will limit
our discussion to these three jurisdictions.
Patent Term Extension
In the US, according to the Drug Price Competition and
Patent Term Restoration Act, or the Hatch-Waxman Act,
1984, the patent term can be extended up to 5 years,
however, the total patent term (including extension)
should not be more than 14 years after the date of
approval of the product by FDA. This period may be
extended by a period of another six months of Pediatric
Exclusivity.
The European Patent Office similarly provides an
extension of protection in this regards, by giving the
Supplementary Protection Certificate (SPC). The SPC
allows extending the Patent term by 5 years. however, the
total patent term (including extension) should not be
more than 15 years after the date of approval of the
product by the European Medicines Agency. Additional
6 months’ protection is given to medicinal preparation to
treat children (Pediatric Formulations). This extension is
not applicable to orphan drugs
Non-Patent Exclusivities:
The US FDA grants different types of Non-Patent
Exclusivities –
1. 5 years for a New Chemical Exclusivity (NCE) for
the Active Ingredient approved for the first time
2. 180 days exclusivity for the generic player who first
files and maintain an ANDA (Abbreviated New
Drug Application) with Paragraph IV certification,
which requires the applicant to prove either that he
will not be infringing the innovator’s patent or that
the innovator’s patent is invalid/not enforceable.
 3 years of New Clinical Study Exclusivity for
submission of “reports of new clinical investigations
(other than bioavailability studies) essential to the
approval of the application [or the supplemental
application] and conducted or sponsored by the
applicant”. For example, in case of preparation of a
drug previously approved, which differs in the route
of administration, drug delivery system, dosing
regimen, modification of the drug such as salt or
ester, which won’t affect the pharmacological
actions of the drug. The exclusivity period would
start from the date of NDA approval of the same
drug. This is for the Active Ingredient has been
approved before in another application.
1. 5 additional years in case of antibiotics that treat
some serious condition, for products that have
obtained Qualified Infectious Disease Products
(QIDP) designation under the Generating
Antibiotics Incentives Now (GAIN) Act.
2. 7 years for an orphan drug, i.e. the drug for the
treatment of the rare diseases
3. 6 months of Pediatric Exclusivity which gets added
to the existing Patents and exclusivities.
India
India has not, as of yet, implemented such provisions,
because-
1. Granting of the PTE and Non-Patent Exclusivities
would require the establishment of the Patent
Linkage system in effect, which is not there at
present, and India is not planning to do it in the near
future, because India has not, as of yet, entered into
any trade agreement which requires such provisions.
2. The TRIPS agreement also does not require
members to grant such benefits to the innovators,
this means that India is in no obligations to grant
PTE and Non-Patent Exclusivities. [8] Whatever
pressure is there on Indian policymakers to
implement such benefits, are there due to the Trade
Agreements like the Trans-Pacific Partnership
(TPP), Regional Comprehensive Economic
 Partnership (RCEP). These agreements constitute to
a new regime called as TRIPS Plus, which is lobbied
by the big pharma companies of the developed
countries. Currently, India is not signatory to any of
such agreements.
3. If at all these provisions are implemented, they
would severely delay the entry of generic versions
of the drugs into the market. India, being a
developing country, simply cannot afford granting
PTE and DE to every request, at the expense of
access to the poor.
4. On the same lines, the Indian Pharma sector is
largely thriving on the generic players, so the
industry is hardly affected by the absence of
provisions for PTE and DE.
These provisions have long been sought by the Big
Pharma lobby of the developed nations, by criticizing
India’s ‘weak’ IP policies. Companies like Bayer,
Novartis have tried to tweak with the legislature for the
same purpose. Several generic pharma companies and
access-to-medicines activists like Médecins Sans
Frontières (Doctors without Borders) have constantly
warned India about the effects of such provisions, saying
that India will no longer remain the ‘Pharmacy of the
world’.
Implementing these would be advantageous only to the
innovator companies, and millions will be stripped off
their right to live a healthy life. This is being sugarcoated
to say that these provisions will boost the trade and
innovation in India. On the other hand, if these provisions
are not introduced, India will be under constant pressure
to do so at the earliest, but it won’t kill anyone. Now it is
up to the policy makers whom they are going to put first.
Mail Box
Article 70-B of TRIPS Agreement
States that where a member does not make available (as
of the date of entry into WTO) patent protection to
pharmaceutical and agricultural chemical product, that
member shall provide as from the date of entry into WTO
Agreement a means by which application for patent foe
such invention may be filedthis is known as Mail
Boxing System
Further where Product is the subject, a patent application,
the member state (i.e. the mailbox), exclusive right shall
be granted for a period of five years after obtaining
marketing approval in the country or until product patent
is granted, or registered in member state.
Exclusive Marketing Rights
TRIPS Agreement which came into effect, ushered a new
era of IP law in India and developing world by
Introducing system of Product Patent and Exclusive
Marketing Rights.
The term EMR means the right to sell or distribute the
article or substance covered in a patent or patent
application in the country. EMR will be granted when
there is no system of product patent in country. Its only a
temporary arrangement which will cease to have effect
when product patent regime is introduced.
Loopholes in agreement
 Developing countries to have transition period of 5
years to adopt TRIPS
 Further 5 years if Product Patent not available.
What does ‘generic’ mean?
Dictionaries tend to define a “generic” as a product —
particularly a drug — that does not have a trademark. For
example, “paracetamol” is a chemical ingredient that is
found in many brandname painkillers and is often sold as
a (generic) medicine in its own right, without a
brandname. This is “generic from a trademark point of
view”.
Sometimes “generic” is also used to mean copies of
patented drugs or drugs whose patents have expired —
“generic from a patent point of view”. This is not
necessarily different since patented drugs are almost
always sold under a brandname or trademark. When
copies of patent drugs are made by other manufactures,
they are either sold under the name of the chemical
ingredient (making them clearly generic), or under
another brandname (which means they are still generics
from the point of view of patents).
Whether a drug is generic is one question. Whether it
infringes intellectual property rights and is pirated or
counterfeit is a separate question. Generic copies are
legal from the patent point of view when they are made
after the patent has expired or under voluntary or
compulsory licence — but pirated and counterfeit
products are by definition illegal.
Developing countries’ transition/Grace periods
GENERAL
Developing countries and economies in transition
from central planning did not have to apply most
provisions of the TRIPS Agreement until 1 January 2000.
The provisions they did have to apply deal with non-
discrimination. Article 65.2 and 65.3
Least-developed countries were given until 1 January
2006. Article 66.1. On 30 November 2005, members
agreed to extend the deadline to 1 July 2013, or to the
date a country is no longer “least-developed”, if that is
earlier.
For pharmaceutical patents this is extended to 2016 under
the Doha Declaration on TRIPS and Public Health.
Most new members who joined after the WTO was
created in 1995 have agreed to apply the TRIPS
Agreement as soon as they joined. Determined by each
new member’s terms of accession
PHARMACEUTICALS AND AGRICULTURAL
CHEMICALS
Some developing countries delayed patent protection for
pharmaceutical products (and agricultural chemicals)
until 1 January 2005.
This was allowed under provisions that say a developing
country that did not provide product patent protection in
a particular area of technology when the TRIPS
Agreement came into force (on 1 January 1995), has up
to 10 years to introduce the protection. Article 65.4
However, for pharmaceuticals and agricultural chemicals,
countries eligible to use this provision (i.e. countries that
did not provide protection on 1 January 1995) had two
obligations.
They had to allow inventors to file patent applications
from 1 January 1995, even though the decision on
whether or not to grant any patent itself need not be taken
until the end of this period — Article 70.8. This is
sometimes called the “mailbox” provision (a
metaphorical “mailbox” is created to receive and store
the applications). The date of filing is significant, which
is why the mailbox provisions were set up. It is used for
assessing whether the application meets the criteria for
patenting, including novelty (“newness”).
And if the government allowed the relevant
pharmaceutical or agricultural chemical product to be
marketed during the transition period, it had to — subject
to certain conditions — provide the patent applicant an
exclusive marketing right for the product for five years,
or until a decision on a product patent was taken,
whichever was shorter. Article 70.9
Which countries used the extra transition period
under Article 65.4, wholly or partially? The answer is
not entirely straightforward. Thirteen WTO members —
Argentina, Brazil, Cuba, Egypt, India, Kuwait, Morocco,
Pakistan, Paraguay, Tunisia, Turkey, United Arab
Emirates and Uruguay — notified “mailbox” systems to
the TRIPS Council, indicating that at the time they did
not grant patent protection to pharmaceutical products. It
is possible that a few other members should have notified
the WTO but did not do so.
TRIPS Plus-Free Trade Agreements
Despite the Doha Declaration, in recent years, many
developing countries have been coming under pressure to
enact or implement even tougher or more restrictive
conditions in their patent laws than are required by the
TRIPS Agreement – these are known as ‘TRIPS plus’
provisions. Countries are by no means obliged by
international law to do this, but many, such as Brazil,
China or Central American states have had no choice but
to adopt these, as part of trade agreements with the
United States or the European Union. These have a
disastrous impact on access to medicines.
Common examples of TRIPS plus provisions include
extending the term of a patent longer than the twenty-
year minimum, or introducing provisions that limit the
use of compulsory licences or that restrict generic
competition.
One of these provisions is known as data exclusivity.
This refers to exclusive rights, granted over the
pharmaceutical test data submitted by companies to drug
regulatory authorities for obtain market authorisation. It
means that information concerning a drug’s safety and
efficacy is kept confidential for a period of, say, five or
ten years.
If a generic manufacturer wants to register a drug in that
country, it is not allowed simply to show that their
product is therapeutically equivalent to the originator
product. Instead, it must either sit out the exclusivity
period, or take the route of repeating lengthy clinical
trials to demonstrate the safety and efficacy of the drug –
trials that have already been undertaken. This happens
even when the originator product is not patented. In
other words, data exclusivity is a backdoor way of
preventing competition, so that even when a medicine is
not protected by a patent, a pharmaceutical company will
receive a minimum period of market monopoly when
artificially high prices can be charged.
India’s Obligation to TRIPS and Implication of
Trips on Indian Pharmaceutical Industry
In 2005, in order to comply with the requirements of
TRIPS, the Indian government introduced product
patents on pharmaceuticals. For the previous three
decades, such patents had been forbidden, allowing India
to develop one of the most robust generic pharmaceutical
industries in the world
Pharmaceutical patents were first introduced to India by
the British. But in Patent Act 1970 changed the course
prohibiting product patents on medicines. At that
time drug prices in India were very high The 1970 Act
served as a big boost of growth in the domestic
pharmaceutical industry. Although the law permitted
process patents related to medicines, they were very
limited in scope. The law thus created significant space
for the entry of local pharmaceutical firms and they
started producing active pharmaceutical ingredients
(APIs) in the mid-1970s. Indian companies became
skilled in reverse engineering and developing new
processes for drug production. And gradually drug prices
were amongst the lowest in the world. In 1995, India
joined the WTO and the TRIPS Agreement. TRIPS
altered the terrain of international IP law. TRIPS had
more teeth than WIPO administered treaties as treaties
administered through the World Intellectual Property
Organization (WIPO) had no effective enforcement
mechanism, but the WTO incorporated a new dispute
settlement system, allowing for adjudication of TRIPS
disputes and for trade sanctions against countries found
to be in violation of the Agreement.
The Doha Ministerial Conference declaration on the
TRIPS agreement and public health recognized the
gravity of public health problems afflicting many less
developed countries. The declaration stressed the need
for the TRIPS agreement to be part of wider international
action to address these problems. It acknowledged the
concerns about its effects on prices. The Ministerial
Conference agreed that the TRIPS agreement should not
prevent members from taking measures to protect public
health. WTO members were under obligation to
implement TRIPS provision by 2000, 2005, or 2016,
depending on their level of development.
India was given an extended period of time to make its
patent regime complaint to TRIPS. Consequently India
passed the Patents Amendment Act, 2005 which came
into force on 1st January, 2005. Earlier India had allowed
for the manufacture of generic versions of many drugs.
Through this amendment it has now implemented a
product patent regime and product patents in the
pharmaceutical sector.
Few Changes after TRIPS in Indian Law
2005 Amendment : A number of changes were
introduced by the 2005 amendment
Compulsory Licence provisions
Mail Box Applications Pursuant to TRIPS obligation,
India amended its Patent Act in 1999 and inserted section
11A to provide that applications claiming pharmaceutical
inventions would be accepted and put away in mailbox
which would be examined in 2005. There is a provision
of issue of automatic compulsory licence in case of grant
of patent of those mail box application, provided the
generic companies have made a significant investment
and were producing and marketing the drug covered by
the mailbox application prior to 2005.[7]
92A PROVISION A new ground was introduced by
the 2005 amendment to enable export to countries with
inadequate manufacturing capabilities. Section 92A
‘Compulsory licence for export of patented
pharmaceutical products in certain exceptional
circumstances’ has been introduced which provides
that compulsory licence shall be available for
manufacture and export of patented pharmaceutical
product to any country having insufficient or no
manufacturing capacity in the pharmaceutical sector for
the concerned product to address public health problems,
provided compulsory licence has been granted by such
country or such country has, by notification or otherwise,
allowed importation of the patented pharmaceutical
products from India. 'pharmaceutical products' has been
explained as any patented product, or product
manufactured through a patented process, of the
pharmaceutical sector needed to address public health
problems and shall be inclusive of ingredients necessary
for their manufacture and diagnostic kits required for
their use.
As many countries today do not have manufacturing
capacities, Indian generic companies can provide those
countries in need with the medicinal requirements
provided they have not ‘opted out’ of it.
Case NOVARTIS AG VS UNION OF INDIA
Case HOFFMANN-LA ROCHE LTD. and ANR v
CIPLA LIMITED
Plaintiff were patent holders of the drug molecule,
medically termed as a Human Epidermal Growth Factor
Type-1/Epidermal Growth Factor Receptor (HER/EGFR)
inhibitor, popularly known as Erlotinib. This drug is
administered in the form of a tablet. The tablet
formulation of Erlotinib is sold by the plaintiff under the
trademark and name of Tarceva, which is registered in
the name of the plaintiff. It is averred that the drug
Erlotinib and its formulation Tarceva has been approved
by the U.S. Food and Drug Administration in the year
2004 and thereafter by the European Union in the year
2005.
The first Plaintiff is actively engaged in the manufacture,
marketing and sale of the innovative drug Tarceva in
various countries including India and it introduced
Tarceva in India sometime in April 2006.
The Defendant, CIPLA, is the second biggest
pharmaceutical company in India. In December 2007 and
January 2008, various news reports appeared in the print
as well as the electronic media about the defendants plans
to launch a generic version of Erlotinib in India and also
for exporting it to various countries. The Plaintiffs claim
their knowledge of the Defendants plans to infringe their
rights in the patent, from such reports. They have filed
the present action seeking permanent injunction and
damages. It was averred by the Plaintiffs that Erlotinib
was developed after long, sustained and substantial
research, and after incurring enormous expenditure for
the tests, mandatorily conducted to establish its efficacy
and safety. It was submitted that this innovation was duly
protected under the provisions of law and no person
except those authorized to exercise the legal rights
associated with the patented drug can be allowed or
permitted to copy/simulate and/or recreate it in any
manner or in any other name. They alleged that the
Defendant was following an illegal course to offer a
generic version of the patented drug; firstly, in an
unlawful manner by infringing the legal rights of the
plaintiffs, and secondly, in a manner that may pose a
serious hazard to the lives of the patients. They submitted
that they would suffer serious and irretrievable prejudice
in case the Defendant was not restrained as prayed for.
They further claimed that the actions of the Defendant
may cause a serious and grave hazard to the lives of the
cancer patients.
Along with other defences, Cipla contended that the
plaintiffs patent claim lack an inventive step. They
alleged that the patent was liable to be revoked as
Erlotinib, being a Quinazolin derivative, only sought to
improve from the existing prior art. It would be obvious
for a person skilled in the art that quinazolin compounds
are known to inhibit growth and proliferation of
mammalian cells and have been used in cancer treatment.
Various quinazolin derivatives are available in the market
for treatment of different types of cancer. The patented
compound of the Plaintiffs was a quinazolin derivative
used for the treatment of cancer therefore, a derivative of
a known compound and hence not patentable under
Section 3 (d) of the Act. It was next contended that the
patent did not reveal any obvious inventive step. In
support, the Defendant averred about existence of at least
three European patents, which date back to 1993 that
disclose quinazolin derivatives. One such patent discloses
the exact chemical structure contained in the Plaintiffs
patent except for one substitution, which was obvious to
any person skilled in the art. Apart from this, the
defendant alleged that the plaintiff has miserably failed in
proving that there was any improved efficacy of the said
drug and that no tables or comparative data were
provided in support of such claim. Drawing from the
summary of the invention in the patent specifications of
the plaintiff, the Defendant submitted that the Plaintiffs
had admitted that the Erlotinib was a quinazolin derivate.
It was alleged that in the absence of proven enhancement
in efficacy in terms of Section 3(d) no patent can even be
considered, let alone granted. The defendant alleged that
Erlotinib was just a derivative from Gefitinib of Astra
Zeneca for which patent was refused in India, on the
ground that the said product was already in prior use and
was in the public domain. Under such circumstances, the
Defendant submitted, the patent office ought not to have
granted a patent for Erlotinib. It alleged that the Plaintiffs
attempt to protect Erlotinib (which was nothing but a
derivative of Gefitinib), established that the plaintiff was
indulging in evergreening. Evergreening, it was
submitted is contrary to public policy, against the
statutory language employed in Section 3(d) of the Act
and in the context of the pharmaceutical industry against
national interests. The defendant placed reliance in this
regard on the ruling of the Madras High Court in
Novartis v. Union of India, 2007 (4) MLJ 1153, where
the Court extensively relied on legislative debates in this
regard.
The learned single judge after noticing the Novartis
judgment observed that even if non-obviousness of an
invention in the pharmaceutical or chemical industry
were established, the applicant should also prove that if
the invention claimed is the derivative of a known
substance, it does not fall within the excepted category,
in the Explanation to Section 3(d) as it comprehend a
discovery of significant enhancement in known efficacy
of such known substance.
On the issue of interlocutory injunctions it held that : (i)
In patent infringement actions, the courts should follow
the approach indicated in American Cyanamid, by
applying all factors; (ii) The courts should follow a rule
of caution, and not always presume that patents are valid,
especially if the defendant challenges it; (iii) The
standard applicable for a defendant challenging the patent
is whether it is a genuine one, as opposed to a vexatious
defense. Only in the case of the former will the court
hold that the defendant has an arguable case.
After going through the facts, it came to the conclusion
that plaintiff was not entitled to claim an ad interim
injunction. In the judgment the learned judge did observe
that though India entered into the TRIPS regime, and
amended her laws to fulfill her international obligations,
yet the court has to proceed and apply the laws of this
country, which oblige it to weigh all relevant factors.
In this background the Court cannot be unmindful of the
right of the general public to access life saving drugs
which are available and for which such access would be
denied if the injunction were granted. The degree of harm
in such eventuality is absolute; the chances of
improvement of life expectancy; even chances of
recovery in some cases would be snuffed out altogether,
if injunction were granted. Such injuries to third parties
are un-compensatable.
Roche’s appeal before Division Bench of the High Court
was also unsuccessful.
Till now the effects of the TRIPS compliance of the
developed countries have been primarily theoretical.
The developing countries need to use the TRIPS
flexibilities to tackle any difficult situation. India has
significantly changed the Patent Act to bring it in
conformity with the TRIPS agreement, but a lurking
fear remains that such overhaul of the patents Act may
make the prices of drugs outside the reach of the general
public. But it has to be kept in mind that there are
various provisions already engrafted in the Patents Act
like the detailed provisions of compulsory licencing
which can check misuse of patents. It is also to be
noticed that Indian courts till now have not felt bound
by the TRIPS in particular cases and have held that
domestic laws will take precedence over TRIPS in case
of any conflict.