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1. Introduction
Biotechnology is a culmination of human intervention and natural processes. Biotechnology is
not new but exists since ancient times and its progress has been witnessed through many
centuries. The term biotechnology is defined broadly to include not only the old
biotechnology such as the traditional method of manufacturing fermented products but also
the new biotechnology represented by genetic engineering and recombinant technology.
In earlier days fermentation technology was used to produce and preserve goods for a long time.
Biotechnology proved itself to be in the field of miracles when it produced genetically modified
or non-natural living organisms. Genetic engineering is capable of manipulating living organisms
and making such organisms to perform and function in a way different from the natural ones.
Ever since a genetically engineered micro-organism was granted patent, the field of
biotechnology gained enormous significance and patents have been granted on genetically
engineered plant and human genetic material. Though evolution of patent law on biotechnology
dates back to seventh century, the global adoption of the patent system started in Venice as the
first patent law was enacted in 1494, which regarded as the foundation for the worlds patent
system. The requirements enshrined in the Venetian Statute such as utility, novelty and nonobviousness are still the basis of modern patent law around the world.
Earlier nobody thought that biotechnology could manipulate either plant or animal or human
being and therefore none thought of the need for evolving a comprehensive law on
biotechnology for regulation. However, as biotechnology has progressed in various generations
at different times and this field mandated a comprehensive legal framework for proper
regulation, TRIPS agreement provided protection and regulation of various biotechnology
inventions as well. Under the patent regime around the world the significance of biotechnology
and its inventions are recognized and protected. The biotech inventions could be patented
following the patentability criteria; however there exists complexity of manipulating of living
forms hence need special attention.
This paper will examine and analyze the effectiveness of TRIPS-level patent protection as an
incentive mechanism for enhanced biotechnology innovation in India and how to enhance patent
protection on novel biotechnology products by prosecuting the patent applications in an
articulate manner in the Indian Patent Office. The trend of filing biotechnological patents in India
has a steady growth as in 2008-09 the total filing was 1884, 2009-10 the total biotech application
is about 2700, however the highest filing recorded so far is 2774 in 2007.
2. Evolution of Indian Patents Act
British rulers enacted the first ever patent law in India the Act VI of 1856 on protection of
inventions based on the British patent law of 1852. After several modifications in 1859, 1872 and
1888, the consolidated Indian Patents and Designs Act, 1911was enacted and offered patent
protection to the inventions. In the light of changing socio-politico scenarios in India there were
moves to consolidate the patent law by bringing up a new legislation and the outcome is the
enactment of Patents Act 1970. The Patents Act 1970 highlights the invention that satisfies the
universally accepted requirements of patentability such as novelty, inventive step and industrial
application. The Patents Act 1970 had undergone several amendments in 1999, 2002 and finally
the Patents (Amendment) Act 2005 (hereinafter referred to as the Patents Act) with introduction
of product patents on substances capable of use as medicine, drug, or food could be obtained
when India completed implementation of TRIPS required amendments to its Act. Further
considerable changes have been made in the patenting procedure through the introduction of
Patent Rules, 2003 further amended in 2005 and 2006, resulting in new practice and procedure.
The Patents Act does not specify which are patentable, but it illustrates subject matters that are
not patentable. The Patents Act enacted in 1970 does not mention anything about biotechnology
invention. Judicial pronouncements in the US and EU and suitable intervention by judiciary led
to amendments of patent laws in these countries as efforts were made to grant patents to biotech
inventions. The same approach gained significance in India as well. Indias patent third laws
were amended in 2002 to explicitly include biochemical, biotechnological, and microbiological
processes within the definition of potentially patentable chemical processes. However, the formal
bio-guidance is the need of the hour as biotechnology is gaining momentum in India. The
requirement of submission of working of patents in India is another salient feature of the Indian
Patents Act.
This paper will discuss the effectiveness of patent protection to enhance biotechnology
innovation in India. The paper further overviews expanding biotechnology patenting activity in
India and Provisions of Indias current patent laws particularly relevant to biotechnology
inventions with the watershed judicial decisions for biotechnology patenting in India.
.
3. Biotechnology & Scope of Patent Law in India
Indian patent practice and jurisprudence with respect to the patenting of biological materials are
relatively new and thus not so well settled and/or uniform. There are several outstanding
deficiencies within the substantive law that needs addressing. Apart from narrow standards of
patentability, biotech products are faced with certain additional hurdles like mandatory disclosure
of biological material, prior approval from the Biodiversity Board and access & benefit issues
under the Indian Patent regime.
While TRIPS does not allow exclusion of inventions that are novel, non-obvious and industrially
applicable en masse, the Indian law has a long list of exceptions to patentability:
a. TRIPS consistent - naturally Occurring components, animate or inanimate from
biological material or their parts; process to obtain such components; isolation of live
material, genetically modified or transgenic organism, cell parts; process for the isolation
and modification; use/application of biological material;
b. TRIPS consistent - plants and animals as a whole or parts thereof; varieties of plants and
animals, seeds, essentially biological processes of propagation;
c. Criteria not found in TRIPS e.g., frivolous, simple combination of known elements;
Though inventions in this biotechnology category filed were mostly of the foreign origin but
there was considerable increase in Indian applications. Inventions were mostly in the field of
recombinant DNA molecule, recombinant vaccine, monoclonal antibodies, recombinant
therapeutic molecules, diagnostic kits, stem cells, recombinant vectors, Isolated Nucleic acid
encoding a gene, Method of preparation of recombinant hormones, DNA related inventions such
as preparing plasmids, vectors etc, bioleaching, biotransformation, biological treatment of waste,
gene and somatic cell therapy, pluripotent stem cells derived from regenerative tissue,
recombinant microbes expressing chimeric HIV protein, regulation of cell mediated immune
response, recombinant interleukin IL-18 inhibitors, plastid transformation vectors, Waste water
and sewage treatment using microorganism, conjugate vaccine against cholera and tetanus,
peptide based immunotherapy for atherosclerosis, mixed cell gene therapy, bone regeneration by
gene therapy and treatment of flower.
As, in other jurisdictions, in India too, the subject matter claimed as the invention, must be new,
non-obvious, industrially applicable and requires sufficient disclosure. When the existence of a
new compound or element in nature is discovered, one can not obtain a patent on it because the
form as it exists in nature is not new. Further to translate the discovery into a patentable subject
matter, the discovered component must be substantially changed through human intervention
into a form in which it does not occur in nature, or employed in a process resulting into technical
advancement and/or economic significance.
Following are some instances of non patentable subject matter per se; however fulfilling certain
criteria like functions the biotechnological inventions are patentable.
I. Non-patentable inventions
A. Ordre public and morality exception - Section 3 (b)- . As per the section an invention
would not be patentable if it is immoral or against public order, harmful to human,
animal or plant life or harmful to environment.
B. Discovery of living things or non living substances in nature - Section 3 (c)
C. Plants and animals in whole or any parts thereof other than micro-organisms but
including seeds, varieties and species - Section 3 (j)
D. Essentially biological processes for the production or propagation of plants and
animals Section 3 (j)
E. Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or
therapeutic or other treatment of human beings or animals to render them free of
disease or to increase their economic value or that of their products Section 3(i)
F. New use or new property of known substance Section 3(d)
G. Methods of agriculture or horticulture Section 3(h)
H. Traditional knowledge Section 3(p)
II. Patentable inventions
A. The MPPP regards claims to genetically modified Gene Sequence/Amino Acid
Sequence, a method of expressing the sequence, an antibody against the
protein/sequence, a kit containing such antibody/sequence as having a single
inventive concept and capable of being granted a patent
B. Gene sequences, DNA sequences without having disclosed their functions are not
patentable for lack of inventive step and industrial application
C. Living entities of artificial origin such as micro-organism, vaccines are patentable
D. Biological material such as rDNA, plasmids are patentable provided they are
produced by substantive human intervention
E. Processes for producing chemical and biological substances using microorganisms
including lower plants and animals are patentable
F. Modified Microorganism & process therefor
G. Process for modification/ isolation of microbes.
H. Isolated nucleic acids encoding gene, first time isolation of a molecule; novel
peptides, novel peptide analogs, proteins, vaccines, antibodies, recombinant:
DNA, RNA, Amino Acids, antibodies, primers, recombinant oligonucleotides and
primers, genes and process therefor; DNA related inventions such as preparing
plasmids, vectors etc.; composition/formulation thereof.
I. Cell lines-A cell line is patentable if artificially produced.
J. Hybridoma technology: patents are also allowed on hybridoma technology, but not on
protoplast fusion.
K. rDNA, cDNA, r-RNA, r-antibodies
a.
Expressed sequence tags, or ESTs, are small fragments of genetic
material
b.
obtained by reverse transcriptions of messenger RNA (mRNA) from
expressed
c.
genes. The gene sequence, or expressed sequence tags (ESTs), can be
patented if it
d.
has a use, such as if it works as a probe.
L.
M.
N.
O.
P.
Q.
R.
Bioprobes, biosensors
Diagnostic/Equipment kits, Research Tools
Methods of enzyme Purification.
Environment cleaning using biological materials such as solid or liquid waste
(industrial/domestic) treatment, water treatment, mitigation of air pollution, bioRemediation
Treatment of plants.
Further, MPPP provides that the processes for cloning human beings or animals, processes for
modifying the germ line, genetic identity of human beings or animals, uses of human or animal
embryos for any purpose are not patentable as they are against public order and morality.
During prosecution, the establishment of the biological function of a biotech invention, it is
preferable to include biological experimental data / efficacy data both in vitro as well as in vivo
to support the efficacy of a claimed invention over the prior art. Furthermore, an isolated but not
modified living entity is not substantially different from the form in which it existed in the nature
are non patentable under sec 3(c). However, mere isolation of a living thing or a part thereof
from its natural environment without a modification by genetic engineering or otherwise that
improves properties or increases efficacy of the claimed invention over the existing form or a
biological material or a part thereof is isolated in the desired form from its natural environment,
such material is no longer a living thing occurring in nature as envisaged in s. 3(c) of the Patents
Act. Additionally, quite often the material obtained by the process of isolation is in a raw state
and thus needs to be processed further e.g. purified by physical or chemical treatment to render it
industrially applicable. It can therefore be argued that the isolated material is not necessarily a
merely discovered living thing. First time isolation of a component from biological material is
patentable.
If sequences of biologics included with claims, to obtain broadest possible protection, it might
not be prudent to include such specific references to SEQ IDs in the main claim. However, in the
event that compliance with such a requirement is mandatory during the final stage of the
prosecution of an application, such a reference could then be merged in the main claim, as
broadly as possible in order to secure the eventual acceptance of such an application. The
specific sequence IDs of the genetic material being claimed must have been described
sufficiently in the accompanying description so as to enable a person skilled in the art to identify
and work upon such material (submission of SEQ ID in electronic as well as in form is also
mandatory). Otherwise, insufficient disclosure as well as enablement objections could be raised.
Additionally, the reference to more than one SEQ IDs requires establishing unequivocally that
more than one sequence of IDs is so correlated with another that they constitute a single
inventive concept.
A. Types of Objections Raised under First Examination Report
Objections relating to non compliance of criteria for patentability such as lack of novelty and/or
obviousness; community/folklore knowledge available, non-sufficient disclosure; noncompliance of Biological Diversity Act requirements; lack of functional aspects and information
required under Section 8 of the Act
B. Few Examples of Objections Raised Generally
A. Claims do not sufficiently define the invention;
B. Distinguishing features as compared to prior art given are not clear;
C. Disclosure is insufficient;
D. SEQ should be filed in electronic form;
E. Claims fall under section 3(i);
F. Claims fall under section 3(j).
G. Obtaining permission from NBA
e. Removing the fibroblasts cells from the culture to obtain a cell line
comprising essentially of epithelial cells.
D. Some examples of rejected claims in biotech inventions
1. Claims related to Methods for identifying tumors that are responsive to
treatment with anti-ErbB2 antibodies After determination that the patient
suffers from cancer (such as, Castration- Resistant Prostate CancerCRPC or ovarian cancer) that is positive for HER2 phosphorylation, the
patient will receive a loading dose of 840 mg of rhuMAb 2C4 on day 1
of cycle 1 (first 21-day treatment period), followed by 420 mg on day 1
of each subsequent 21-day cycle, as continuous intravenous infusion.
Applicant submitted that improvement lies in new amounts of rhuMAb
(420 and 840 mg) The controller refused the application under section
3(d) (new use of known substance) as being dosage and 3(i) method of
treatment that the said MAb are already known as described in the
description.
2. Invention related to a method for in vitro production of isolated
langerhans islets endocrine cells free from fibroblasts so as to be suitable
for transplantation. The process discloses the steps of culturing and
proliferation the cells and back and forth aspiration to separate fibroblast
from the cells, which will be capable of differentiating into insulin
producing, cells
The applicant argued the case on following grounds:
That the process is novel and has utility as fibroblast free langerhans islets are useful in the
enhanced production of insulin to control diabetes.
Kolkata High Court has already allowed patenting of a substance containing living organisms.
Indian Patent law does not bar the grant patent for such invention
The Controller refused the application under section 15 on the following grounds:
1. The end product of the process is nothing but a cluster of cells or piece of tissues of human
body.
2. The invention claimed is not patentable under section 3(I) as a method of treatment of human
being, since langerhans islets are freshly taken from the body of patient in order to treat them to
remove fibroblast so as to increase secretion of insulin.
3. The principles laid down in Kolkata High Court are not applicable as the end product of the
process of present invention are not commercial entity and cannot be passed on from one person
to another upon the transaction of purchase or sale.
6. Patentability of Biological Material(s)
(The Enablement Requirement in the Disclosure)
Mandatory disclosure is required in patent application of source and geographical origin of
biological material used in invention - Sec.10 (4) (d) of Indian Patents Act, 2005. In case of
patent applications involving biological material such as DNA, a recombinant vector, or cells or
invention related to genes that may not be described in such a way as to satisfy the enablement
and best mode requirements and if such material is not available to the public, submission and/or
deposition of biological material to an International Depository Authority (IDA) under the
Budapest treaty is required if adequate disclosure is not possible - Sec.10 (4) (ii). The disclosure
is mandatory if any specific material imparting the specific property is required to work the
invention.
In case the material such as proteins/peptides/amino acids prepared synthetically can substitute
the live material to work the invention appropriate submissions may help to overcome the
objection. The law also provides for pre-grant opposition and revocation of granted patents of
grounds of non-disclosure or wrongful disclosure of source or geographical origin of biological
resources and traditional knowledge - Sec. 25(1) & Sec. 64
The Microbial Type Culture Collection (MTCC) at the Institute of Microbial Technology
(IMTECH) in Chandigarh is the IDA in India. However the scope of this IDA is limited because
it is not equipped to accept deposits of cell lines, cyanobacteria, viruses etc. Biological deposits
of such materials would presumably need to be made in IDAs located outside of India, resulting
in increased cost and administrative complexity for domestic biotechnology firms.
National Biodiversity Authoritys prior approval is required for accessing biological material by
foreigners/NRIs (Sec. 3) as well as before seeking patent based on biological material and TK
obtained from India Sec 6(1) of Biodiversity Act 2002
7. Patentability of Micro-organism (s)
Guidelines were formulated for examination of the patent applications involving microorganisms from the point of view of substantial human intervention and utility.
Microbiological inventions include new products, processes, uses and compositions involving
biological materials. These inventions cover methods to isolate and obtain new organisms,
improve their character, modify them and find their new and improved uses.
Patenting of new micro-organisms is based on their differences with the characteristics & uses of
micro-organisms as available in the prior art. Known micro-organisms are restricted to new uses,
wherever patent law permits such a protection. The same is the case with genetically modified
micro-organisms. Genes and gene products are treated similar to chemical compositions.
In the Dimminaco AG vs. Controller of Patents, the Calcutta High Court held in 2002 that a
patent on a micro-organism is valid. The court ruled that the Act did not preclude a living end
product from being patented. As a result, a large number of patents have been granted to
microorganisms since then
Universally, as practiced by most patent offices, new micro-organisms isolated for the first time
from the natural surrounding can only be patented if they differ in character from the known
micro-organisms and find a new or improved use or function. Claims to micro-organisms have
been allowed on the grounds that they are the products of micro-biological processes.
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The government of India has granted the EPO &USPTO, access to its Traditional Knowledge
Digital Library (TKDL). The European Patent Office, for instance, has set aside its original
intention to grant patents in at least two cases, while 33 applications were withdrawn by the
applicants themselves. Council of Scientific & Industrial Research claims that around 400
applications pending in various other patent offices have also been similarly challenged. Loaded
with ancient medical knowledge, the online database contains translations of manuscripts and
textbooks in five languages (500-5000 year old texts on Ayurvedic cure & herbal remedies are
documented), including English. Access to the 30-million-page database helps to correctly
examine patent applications relating to traditional knowledge. With the TKDL, examiners have
improved access to background information at an early stage of patent examination. Prominent
cases of patent disputes include a US patent on the wound-healing properties of turmeric
(revoked in 1997) as well as an anti-fungal product from the Indian Neem tree (revoked in 2008).
Both herbal practices were evidence of traditional knowledge and the patents were rescinded. In
both instances, the Indian government needed to prove that the patented methods were not novel
and were based on traditional knowledge. The process to challenge the granted patents proved
lengthy and cumbersome as some traditional knowledge had only been documented in Sanskrit
or other ancient writings and thus required extensive translation. Agreements with regard to
TKDL with offices in Japan and New Zealand are round the corner.
A. Prior art & enablement
The TKDL allows examiners to compare patent applications with existing traditional
knowledge. New patent applications need to demonstrate significant improvements
and inventiveness compared to prior art in their field. If the medical use of an herb is
a traditional practice, and thereby public knowledge, it is considered prior art under
regulations.
If an applicant seeks to patent the medicinal use of an herb listed in the TKDL,
examiners conduct a thorough investigation. In some cases this leads to a reduction of
the scope of the patent or its refusal.
However, the patent applicant may still be granted a patent on a new method for
industrial-scale production of the active ingredient of the herb, for example, if this
process is new and inventive (example-jeevani, a medicine based on the traditional
medicinal knowledge, an extract of arogyappacha plant [Trichopus zeylanicusused] as
immunomodulator as well as for energy and vitality). There are about 6 patents
granted on jeevani and Tropical Botanical Garden and Research Institute (TBGRI),
the patent holder shared the royalty through ABS with the local tribe)
10. Biotech patent jurisprudence in India
A. Dimminaco A.G. v. Controller
In India there is no substantial case law development with regard to the biotechnology
inventions in India as the industry is in an infant stage. The leading biotechnology
patent law decision of the Indian courts is the A.G. v. Controller of Patents, Designs
& Trade Marks (in 2002), where for the first time, and utility of a biotech invention
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