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1.INTRODUCTION :
A Patent is a set of exclusive rights granted by a state to an inventor or his assignee for a
fixed period of time in exchange for a disclosure of an invention.
The procedure for granting patents, the requirements placed on the patentee and the extent of
the exclusive rights vary widely between countries according to national laws and
international agreements. Typically, however, a patent application must include one or more
claims defining the invention which must be new, inventive, and useful or industrially
applicable. In many countries, certain subject areas are excluded from patents, such as
business methods and mental acts. The exclusive right granted to a patentee in most countries
is the right to prevent or exclude others from making, using, selling, offering to sell or
importing the invention.
Patent usually refers to a right granted to anyone who invents or discovers any new and
useful process, machine, article of manufacture, or composition of matter, or any new and
useful improvement thereof. The additional qualification utility patents is used in countries
such as the United States to distinguish them from other types of patents but should not be
confused with utility models granted by other countries. Examples of particular species of
patents for inventions include biological patents, business method patents, chemical patents
and software patents.
some other types of intellectual property rights are referred to as patents in some
jurisdictions: industrial design rights are called design patents in some jurisdictions (they
protect the visual design of objects that are not purely utilitarian), plant breeders' rights are
sometimes called plant patents, and utility models or Gebrauchsmuster are sometimes called
2.1 Etymology :
The word patent originates from the LATIN patere, which means "to lay open" (i.e., to make
available for public inspection), and more directly as a shortened version of the term letters
patent which originally denoted a royal decree granting exclusive rights to a person.
History of patent goes back to thousand-year back. Although we often think of information
modification as a new process, history of intellectual property goes back to some of the
farthest reaches of our recorded history. In fact, according to a scholar the book was one of
very fine commodities. Greece in the 5th century B.C. and its active book trade, for the first
example of buying & selling information.
"Encouragement was held out to all who should discover any new refinement in luxury, the
profits arising from which were secured to the inventor by patent for the space of a year."
………………….Sybaris (about 500 BC)1
The rise of this intellectual market coincided with a renewed acknowledgement within the
culture of existence of the individual creative self, as well as with the development of
commerce and urban societies. Previously, it had been not originality, but craftsmanship
within established forms, that have been valued; oral cultures like that of earlier Greek
societies had viewed creative works as collectively produced, and as entities to be imitated
and b other in every society. There were communities & persons who were only authorized to
make a particular product upon by others. Later on medieval era patent system was present in
some form or other in every society. There were communities & person to make a particular
product.
A number of international conventions on intellectual property have been adopted since last
century covering different areas of industrial property, copyright law and other specialized
matters (such as breeder’s right). The World Intellectual Property Organization (WIPO) &
UNIESCO are responsible for administering the main conventional force.
The TRIP negotiations were conducted within GATT and the provisions of the resulting
agreement are enforceable within the frame work of WTO – a forum without any tradition of
work in field of IPRs.
[Table No 1]
The 1984 Drug Price Competition and Patent Term Restoration Act (1984 amendments) was
enacted on September 24, 1984. This act gave the agency clear statutory authority for FDA
approval of pre- and post- 1962 generic drugs. It also provided for reduced cost of health care
with the use of generic drugs and for elimination of duplicative clinical trials. This act
included measures to assure continued development of new drugs through patent extension
and exclusivity granted to certain new drug applications (NDAs). The passage of the 1984
RKDF COLLEGE OF PHARMACY Page 7
amendments was a compromise to achieve balance between the innovator or pioneer drug
industry and the generic drug industry.
The act encouraged and awarded innovative new drug development while at the same time
made more drug products eligible for generic competition. Costly clinical trials that
established the safety and effectiveness of the drug would not need to be repeated in order for
a generic drug to enter the marketplace. Once information has been established about a drug,
there is no requirement for a second sponsor to prove the safety and efficacy a second time or
‘‘re-prove’’ an already established fact. The act that was passed was comprised of two parts,
Title I and Title II. Title I was the part of the act providing for increased eligibility of drug
products to be approved through ANDAs (abbreviated new drug applications) or generic
applications. Increased availability of generic drugs would lead to reduced costs of
healthcare. Title I also provided for exclusive marketing rights and patent protection for
innovator new drug applications and prohibits generic approval until expiration of the patents
listed in the Orange Book or expiration of the exclusive marketing rights. Title II of the 1984
Amendments was designed to promote development of new drugs and provided for up to five
years of patent extension to compensate for patent time lost due to the drug review process.
[Table no. 2]
[Table No. 2]
A person who makes inventive contribution A person who participates only in the
to at least one claim as claimed in the patent reduction of the invention without
application contributing anything to the final, complete
conception of the invention
A person who is the actual deviser of the Such persons who have helped in conducting
invention the experiments etc., without providing any
intellectual inputs
A person who contributes towards the Such persons who have helped in conducting
development of patentable features i.e. the experiments etc., without providing any
novelty, inventive step and industrial intellectual inputs
application .
Inventor to be able to identify a specific Then the person who does the routine work
component of the invention as his own idea. may be regarded as the “extended technical
He must be able to say that he contributed to arm” of the inventor
its conception.
[Table No. 3]
6. Copyright:
Copyright is a right given by the law to creators of literary, dramatic, musical and artistic
works and producers of cinematograph films and sound recordings. In fact, it is a bundle of
rights including, inter alia, rights of reproduction, communication to the public, adaptation
and translation of the work. There could be slight variations in the composition of the rights
depending on the work.
6.2 Procedure for registration of a work under the copyright act, 1957
Copyright comes into existence as soon as a work is created and no formality is required to
be completed for acquiring copyright. However, facilities exist for having the work registered
in the Register of Copyrights maintained in the Copyright Office of the Department of
Education. The entries made in the Register of Copyrights serve as prima-facie evidence in
the court of law. The Copyright Office has been set up to provide registration facilities to all
types of works and is headed by a Registrar of Copyrights and is located at B.2/W.3, C.R.
Barracks, Kasturba Gandhi Marg, New Delhi- 110 003, Tel: 338 4387.
[Table no 4]
An important part of the policy package was the passage of the Patents Act 1970 (effective
April, 1972). This legislation greatly weakened intellectual property protection in India,
particularly for pharmaceutical innovations. Pharmaceutical product innovations, as well
as those for food and agrochemicals, became unpatentable, allowing innovations
patented elsewhere to be freely copied and marketed in India. The statutory term was
shortened to 5 to 7 years on pharmaceutical process patents and automatic licensing was
put in place. As a result, the number of patents granted per year fell by three-quarters over
the following decade, from 3,923 in 1970-71 (of which 629 were to Indian applicants,
3,294 to foreign applicants) down to 1,019 in 1980-81 (349 Indian, 670 foreign) .
Although all inventors were affected by the weakened patent regime, it is clear that
foreigners, in particular, no longer found taking out a patent in India worthwhile.
Other aspects of the policy package set up to encourage the domestic production of
pharmaceuticals included restrictions on the import of finished formulations, high
tariff rates, ratio requirements (where imports of bulk drugs had to be matched by
purchases from domestic sources at a fixed ratio) and equity ceilings on foreign
participation. Further, the strict price control regulation which was introduced with the
1970 Drugs Price Control Order, while making the production of pharmaceuticals less
profitable for all firms selling in the Indian market, made it relatively less interesting
for foreign firms with market options elsewhere. Thus even the price control regime
PCT
1 RANBAXY 320 108 458 194 8.9 2.6
LABORATORIES
2 DR REDDY'S 315 27 113 39 8.3 5.3
LABORATORIES
3 ORCHID 149 17 47 11 4.3 2.8
CHEMICALS &
PHARMACEUTICALS
4 CADILA 148 17 67 23 6.8 3.9
HEALTHCARE
5 CIPLA 138 27 67 39 16.6 8.5
6 SUN 121 18 81 12 11.4 5.9
PHARMACEUTICAL
INDUSTRIES
[Table No. 5]
The Patent Amendment Act 2005 passed by the Parliament in its budget session of 2005
brings the Indian Patent Act in full conformity with the intellectual property system in all
respects. This replaced an ordinance promulgated on December 2004 to meet WTO
obligations. Some of the major amendments have been introduced in Sections 2 and 3 which
are as follows:
Section 2 of the Patent Act is the definition clause:
According to Section 2(j) invention means a new product or process involving an inventive
step and capable of industrial applications.
Inventive step means a feature of an invention that involves technical advance as compared
to existing knowledge or having economic significance or both and that makes the invention
not obvious to a person skilled in art.
Thus an invention in order to be patentable, should:
(i) involve an inventive step capable of industrial application;
(ii) which should involve technical advances as compared to the existing knowledge or
having economic significance or both; and
(iii) be not obvious to a person skilled in art.
Section 3 outlines various situations where an invention (properly so called) can yet be not
patentable. Section 3(d) of the Patents Act 1970 has been amended under the new Act to
prescribe a class of discovery which cannot be subject matter of patent; it reads as follows:
(d) mere discovery of a new form of 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
9.1 The amendment introduced by the Patents (Amendment) Act, 2005 and
the problems relating to it is as follows:
The definition of the term “Pharmaceutical substances” as given under the new act is too
broad and ambiguous. The amendment describes “Pharmaceutical substances” as “any new
entity involving one or more inventive steps”. The term “chemical” should have been added
so as to read as “any chemical entity”
The term “inventive step” has been modified under this definition broadens the existing
provision to the benefit of the paten holders and it provides for two criteria for meeting an
inventive step and hence is quite ambiguous. As the new amendment stands now, for meeting
the criteria of an inventive step the patentee will have to show that the invention includes a
“technical advance” or has economic significance or both. The provision should have
required the applicant to comply with both the requirements for meeting the inventive step
requirement. Otherwise it leads to the dilution of the inventive step requirement by the fact
that a patent could be granted on economic significance alone.
Section 3(d) of the Patents Act, 1970 has been amended under the new Act to read as follows
- “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.
11.3 RENEWAL
The patent is renewed every year from the date of patent.
11.10. Opposition:
An opposition is a process by which any party can oppose or resist the registration or grant of
a patent. The proceeding is presided over by the Controller of Patent. If the opposing party is
able to prove his opposition the patent is rejected. If the applicant is able to prove that the
opposition is frivolous and baseless then the opposition is rejected.
12.6 Filing :
Filling an international application, complying with the PCT formality requirements, in
one language, and pay one set of fees.
* The graph below shows the growth in the number of international applications filed since
1978.
.
The agreement on trade aspect of intellectual Property Rights (TRIPS) is an international
agreement administered by the World Trade Organization (WTO) that sets down minimum
standards for many forms of intellectual property (IP) regulation. It was negotiated at the end
of the Uruguay Round of the General Agreement on Tariffs and Trade(GATT 1994).
Specifically, TRIPS contains requirements that nations' laws must meet for: copyright rights,
including the rights of performers, producers of sound recordings and broadcasting
organizations; geographical indications, including appellations of origin; industrial designs;
integrated circuit layout-designs; patents; monopolies for the developers of new plant
varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also
specifies enforcement procedures, remedies, and dispute resolution procedures.
The TRIPS agreement introduced intellectual property law into the international trading
system for the first time and remains the most comprehensive international agreement on
intellectual property to date. In 2001, developing countries, concerned that developed
countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that
resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the
scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the
goal "to promote access to medicines for all.”
PUBLIC HEALTH,
5 2005 DECISION ON THE AMENDMENT OF THE TRIPS AGREEMENT,
6 DECEMBER 2005
6 2005 HONG KONG MINISTERIAL DECLARATION PARAGRAPH 40 ON
The new set of challenges stem from the deeper implications of the imminent product patent
regime. With the exception of a few, most Indian pharma companies are unfamiliar with the
Method of Evergreening:
Filing separate 20-year patents on multiple attributes of a single product. These patents can
cover aspects for everything from manufacturing process to tablet colour, or even a chemical
produced by the body when the drug is ingested and metabolized by the patient.
During the 1980's in Europe a drug's properties eligible for patenting were relatively
limited, including only the following :
*Primary uses
*Processes and intermediates
*Bulk forms
*Simple formulations
*Composition of matter
During the 1990's, however, it grew to nearly four times that of the earlier decade to include
patenting on additional aspects including the following:
Indeed, innovator companies no longer wait until the end of a product's patent life to begin
the evergreening process. In order to maximize revenues from their products, they begin
preparing strategies to extend patents and to put out generic competition at the outset of
product life cycles.
To evergreen their products, the innovator company will develop what are euphemistically
called "life-cycle management plans" composed not only of patent strategies, but an entire
range of practices aimed at limiting or delaying the entry of a generic product into the market.
Some of the evergreening strategies employed involve:
*Repeatedly creating line extensions and so-called "next generation" drugs, incorporating
minor, normally therapeutically insignificant, variations to a product and patenting it as a new
medication
*Switching from prescription-only to over-the-counter status
*Creating exclusive partnerships with chosen generics manufacturers prior to patent expiry to
allow time to create brand-name loyalty for the generic version while earning royalties on the
RKDF COLLEGE OF PHARMACY Page 47
product (Reports of originator companies buying up generic companies to eliminate
competition from lower-priced products are not infrequent)
*Defensive pricing strategies, whereby an Innovator company cuts the price of its product to
levels that allow it to compete healthily with equivalent generic versions
*Establishing a subsidiary generics unit to compete in the generics market before independent
generics companies are allowed to do so.
[TABLE NO. 7]
• Import : 4% of total.
Product patent is a dead sentence on indigenous pharmaceuticals. The blunder of singing the
Uruguay round ( as latter connected by some minister ) is an anti-people sell out. Any
product, to be patentable, needs the triple quantities of
a) Novelty (previously known to people )
b) Non obviousness ( containing sufficient innovativeness to merit protection )
c) Industrial applicability for usefulness.
By one broad stroke, all ayurvedic drugs, adivasi recipes, alternative native medicine,
naturopathy, magneto therapy & yoga therapy, from charaka and susruta and patanjali
downwards, familiar in various parts of india & therefore no novality at all, can be out of pale
of patent. Minimal changes which have nothing to do with the core of it, but impact glittering
appearance, attractive packing & glossy advertising magic, cannot be treated as establishing
novelty. Ultra-modern manipulation of ancient vintage Indian medicine cannot be fobbed off
as patentable mealy by using dazzling brand name baloney. Already American
pharmaceutical are taking patent for neem, tulsi & gooseberry.
Once patent protection is available, patent owning firms may choose either to export their
patented drugs to India, thereby replacing domestic production, or they may choose to
produce in India through a subsidiary or under license to India firms.
Concerns about global price difference, local, low cost production attractive as a way to
justify prices which are lower than those charged in developed country markets. Selling
prices are determined as a make-up on input costs. This means that there is a “transient
loophole”. An MNC may export the patented active ingredient to Indian subsidiary at a
artificially high transfer price & there by obtaining a controlled price for its formulation. This
would give patent owning MNCs an incentive to produce bulk drug inputs elsewhere & then
20. The Controversy Over Aids Medications and the Doha Declaration
The HIV/AIDS epidemic has caused many to question whether a stronger global patent
regime creates new obstacles to meeting public health emergencies.
TRIPS Agreement permits WTO member states to limit the exclusive rights of patent owners
where a national government needs to use the patent itself or where it is necessary to issue a
compulsory license to a third party, such as in a health emergency. While use by government
is permitted merely upon notice to the patent owner provided it is “considered on its
individual merits,” compulsory licenses may be granted only if “efforts to obtain a voluntary
The provisions became the subject of a contentious debate at a meeting of trade ministers in
Doha in November 2001. The debate resulted in a ministerial “Declaration on the TRIPS
Agreement and Public Health” that acknowledged, “Intellectual property protection is
important for the development of new medicines” but expressed “concerns about its effect on
prices.” The ministers recognized “the gravity of the public health problems afflicting many
developing and least developed countries, especially those resulting from HIV/AIDS,
tuberculosis, malaria and other epidemics” and affirmed “that the [TRIPS] Agreement does
not and should not prevent Members from taking measures to protect public health.”(The
Ministerial declaration stated: “Each Member has the right to grant compulsory licenses and
the freedom to determine the grounds on which such licenses are granted. The right to
determine what constitutes a national emergency…it being understood that public health
crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can
represent a national emergency or other circumstances of extreme urgency.”
The TRIPS Council was requested to resolve this issue before the
end of 2002. It was not, in fact, resolved until August 30, 2003 when WTO’s General Council
agreed that compulsory licenses could be issued for imports from another country where
“needed to address the public health problems” referenced in November 2002 Declaration,
namely situations involving “HIV/AIDS, tuberculosis, malaria and other epidemics.” Further,
the decision required that the importing country establish “that it has insufficient or no
manufacturing capabilities…for the product(s) in question…” and that “only the amount
necessary to meet the needs of the eligible importing” country could “be manufactured under
the license…” With regard to the question of royalties to be paid to the patent holder, the
decision reaffirmed that the exporting country was responsible to see that “adequate
remuneration” is paid “taking into account the economic value to the importing Member.
These limitations contained in the decision itself were supplemented with a statement of the
Council Chairman noting that the system “established by the Decision should be used in good
• A - US Patent
• RE - Reissued Patent
• Europe
• B1 - Patent
• PCT
Patent Act as bargaining chips & enable the individual inventors to license out their patent
and exchange for technical know how for financial privileges.
Patents Act as bargaining chips and enable the individual inventors to license out their patents
in exchange for technical know-how or for financial privileges.
Patent system encourages the disclosure of information instead of it being kept confidential
as a trade secret. Hence it contributes to the prior art in the particular field and enhances
scientific knowledge by using the information contained in the published patent documents.
They help in identifying the uncovered areas and initiate R&D in such areas.
Hence the patent system helps in ascertaining global technological trends in specific areas of
interest. Lastly, the patent system helps in identifying the possible competitors and their
strength in particular areas of interest.
Developing countries are having a hard time in implementing the TRIPs Agreement in the
area of pharmaceuticals. The transitional periods are running out and such countries are under
the continuous pressure of some countries (notably the United States) to grant a protection
broader than required under the Agreement.
Developing countries that are introducing patent protection for medicines are facing a number
of legal and administrative problems, and need to take decisions on how to deal with several
important issues in the framework of the TRIPS Agreement.
The implementation of the TRIPS Agreement in the patent field has given rise to increased
speculative litigation, particularly with an aim to expand the term of pre-existing patents.
Strategic litigation to compete out local companies has also increased.
Patent applications relating to new chemical entities are a small fraction of the total
applications made in the pharmaceutical field. The great majority correspond to processes,
particular formulations of a known active ingredient and, where admitted, new and second
Therefore, Indian companies can go either for collaboration or concentrate on producing and
marketing generic drugs. This futuristic conclusion is based on the realistic assumption
regarding poor research and market penetration strategies by the Indian companies.
The trickiest part is what position the Indian government should take. The issue is a political
–economic one, and has to be approached from both angles political –economic.