Dr.

Ram Manohar Lohiya, National Law University,

Lucknow

Academic Session
2019-2020

IPR IN PHARMA
Project on

Biotech Patenting in light of Indian Patent Regime and TRIPs

Submitted to: Submitted by:

Ms. Priya Anuraghini Stuti Sinha

150101168
 Table of Contents

INTRODUCTION......................................................................................................................... 3

INDIAN PATENT SYSTEM RELATED TO BIOTECHNOLOGY PATENTING .............. 4

Legal Provisions ........................................................................................................................ 4

Deposition of biological material ............................................................................................. 6

Sequence Listing........................................................................................................................ 7

TRIPS AND ITS IMPLICATIONS ON INDIAN BIOTECH PATENTING ......................... 7

CONCLUSION ............................................................................................................................. 9
INTRODUCTION
Biotechnology is a culmination of human intervention and natural processes. The term
“biotechnology” is defined broadly to include not only the traditional method of manufacturing
fermented products but also the genetic engineering and recombinant technology. 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. The requirements enshrined in the Venetian Statute such as utility, novelty
and non-obviousness 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. It will also 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 India’s current patent laws particularly relevant to
biotechnology inventions with the watershed judicial decisions for biotechnology patenting in
India.
INDIAN PATENT SYSTEM RELATED TO BIOTECHNOLOGY
PATENTING
Indian has taken a strict route as far as biotechnology patenting is concerned. India has adopted
rules like mandatory disclosure of biological material and prior approval of biodiversity board for
the grant of patent. There is though a huge debate on the benefit issues relating to Indian Patent
regime in Biotechnology.

Legal Provisions
The amendment in the Act came in 2002 to explicitly include biochemical, biotechnological and
microbiological processes within the definition of potentially patentable process. Where the
patentability of the Biotechnological innovations in India run on the principle of novelty,
inventiveness, and industrial application, there are a few exceptions to this given under Section 3
of the Act. Section 3 of the Act talks about the Non Patentable inventions in India under which
such inventions (Biotechnological/Biopharmaceutical) are barred from being patented which are,
(i) Immoral or against public order, harmful to human, animal or plant life or
harmful to environment.1
Inventions for which the primary or intended use or commercial exploitation is contrary
to public order or morality or which cause serious prejudice to human, animal or plant
life or health or to the environment are not patentable.2
(ii) Discovery of living things or non- living substances in nature3 or the mere
discovery of any new property or new use of a known substance4
Discoveries of living things or non-living substances occurring in nature are not
patentable subject matter. Thus, micro-organisms isolated from nature and DNA, RNA
or proteins isolated from living organisms are not patentable. Only genetically modified
micro-organisms and vaccines are patentable, subject to other requirements. Also, mere
discovery of any new property or new use of a known substance is not patentable.
Therefore, a second therapeutic effect of a known drug cannot be a ground for grant of
patent.

1
Section 3(b) of the Patents Act, 1970
2
https://www.iam-media.com/patenting-biotechnology-indian-scenario
3
Section 3 (c) of the Patents Act, 1970
4
Section 3 (d) of the Patents Act, 1970
 (iii) Plants and animals in whole or any parts thereof other than micro-organisms but
including seeds, varieties and species.5
There are various patents granted for the process of producing transgenic plants or
animals but the transgenic plants and animals are not considered as patentable subject
matter. In India, plants and varieties are provided protection under the provisions of the
Protection of Plants Varieties and Farmers Right Act, 2002.
With respect to the inventions relating to microorganism, the section specifically
excludes micro-organisms from the group of non-patentable invention. Micro-
organisms modified by human intervention are considered as a patentable subject
matter provided they meet the other prescribed patentability criteria. Whereas, naturally
occurring micro-organisms are specifically excluded from being patented under section
3(c) of the Indian Patents Act under which “discovery of any living thing or non-living
substance occurring in nature” is not an invention.6
(iv) Essentially biological processes for the production or propagation of plants and
animals.7
Since, a process consisting of technical or human intervention may not be regarded as
essentially biological process, patents may be granted for the process of producing
transgenic plants or animals. But any natural biological process to the same effect is
expressly barred by this section.
(v) 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.8
Section 3(i) precludes from patentability:
 any process for the medicinal, surgical, curative, prophylactic, diagnostic,
therapeutic or other treatment of human beings; or
 any treatment of animals which renders them free of disease or increases their
economic value (or that of their products).

5
Section 3 (j) of the Patents Act, 1970
6
http://www.asiaiplaw.com/article/41/857/
7
Section 3 (j) of the Patents Act, 1970
8
Section 3(i) of the Patents Act, 1970
 However, the act does not prevent patenting of pharmaceuticals and medical
devices. Thus, medicinal compounds, drugs, formulations, stents, surgical sutures
and staplers are patentable.
(vi) Methods of agriculture or horticulture.9
Methods of agriculture or horticulture are unpatentable. IPO has settled that processes
involving multiple steps, such as preparation of soil, sowing, applying manure and
fertilizers, irrigation, protection from pests and weeds, harvesting and storage come
under Agriculture and Horticulture and thus, cannot be patented.10
Also, in 9827/DELNP/2007 a method of reducing mycotoxin contamination of a plant
or harvested plant material that involved treatment of seeds with the chemicals before
sowing or during sowing in the field for the plant cultivation process was considered
unpatentable.
(vii) Traditional knowledge.11
An invention which is essentially traditional knowledge or which is an aggregation or
duplication of the known properties of a traditionally known component or components
is specifically excluded from patentability.

Deposition of biological material

An applicant must deposit the biological material mentioned in the specification if it is unavailable
to the public and cannot be described adequately as per the provisions of the act. 12 The material
must be deposited with an international depository authority under the Budapest Treaty. The
deposit must be made on the filing date of the patent application in India. A reference to the deposit
must be made in the specification within the prescribed period of three months from the filing date.
When the biological material is obtained in India, it is required that the permission from the
competent authority is submitted before grant of the patent.
The specification must include all available characteristics of the biological material that are
required for its correct identification. These include the name and address of the depository

9
Section 3(h) of the Patents Act, 1970
10
1785/KOLNP/2009
11
Section 3(p) of the Patents Act, 1970
12
Section 10 of the Patents Act, 1970
institution and the date and number of the deposit. The applicant must also disclose the source and
geographical origin of the biological material.

Sequence Listing
If a plant gene sequence has been claimed which is being used to transform other plant material,
the applicant must disclose the plant from which the gene sequence has been isolated as well as
the plant that is being transformed.
For genes, nucleotide sequences and polypeptide sequences, the applicant must mention the
sequence listing in the complete specification. The sequence listing must be submitted in electronic
form. A gene accession number must be mentioned for the gene.

Patents granted to Indian organizations during 1990-2002 were majorly granted in the area of
chemicals and pharmaceuticals. Patents granted in biotechnology were mostly overlapping patents
addressing other sectors (mainly pharmaceuticals). The main technological domains of patenting
activity in biotechnology were in microorganism compositions; macromolecular compounds; and
biocide and plant reproduction techniques. During 2003-04 also, pharmaceutical and chemical
sectors were the dominant areas of patenting activity. Biotechnology sector was also well
addressed with 48 patents granted during this period.

TRIPS AND ITS IMPLICATIONS ON INDIAN BIOTECH

PATENTING
Under TRIPS, the general prerequisites for patentability, namely, novelty, inventiveness and
industrial applicability (or utility) apply to biotechnology inventions as well. The rule is that the
biological material so obtained must be a result of a non-biological process. Non-biological
processes are defined as those where the hand of man had a part to play.

Where TRIPS bars the patentability13 of plants, animals and “essentially biological processes”, it
provides liberty to the members to grant patent to micro-organisms and non-biological as well as
micro-biological processes. Therefore, micro-organisms are patentable with regard to process of
their production and use.14 The ambiguous wording of this provision reflects the intention of the

13
Article 27.3 (b) of TRIPs
14
DESIDOC Bulletin of Information Technology, Vol. 27, No. 6, November 2007, pp. 31-39
drafters to accord liberty to the states to give suitable interpretations to these terms and provisions
in accordance with the conditions pertaining in those states. However, this freedom of
interpretation can be taken away at the time of mandatory review of this article.

Regarding review of Article 27.3(b) the member countries of WTO has submitted their
representations before TRIPS council and holds different views regarding aspects relating to
relations between TRIPS and CBD, IPR’s and Traditional Knowledge, patenting of
microorganisms and genetic sectors or life forms. The developing countries along with Least
Developed Countries had been successful in exercising pressure as a collective house upon
developed world or industrialized countries which was instrumental in incorporating the provisions
in Uruguay Round of multilateral trade negotiation.15

TRIPS calls for the availability of patents, whether for processes or products, in all fields of
technology. Article 27.3(b) of TRIPS incorporates minimal agreement that allows the exclusion of
plants and animals, and essentially biological processes for their production, from patent grant but
obliges the protection of microorganisms and microbiological or non-biological processes for their
production. While there is uncertainty on the definitions of certain terms such as ‘non-biological’
or ‘essentially biological’, clearly micro-organisms and microbiological processes are not
excluded from patent protection despite resistance from some developing countries. Even during
the TRIPS negotiations, the East Asian participants, notably Korea, Malaysia and Singapore, had
no objections to the patenting of microorganisms or microbiological processes as they already
allowed these in their national laws. However, some hold that there is considerable scope even in
defining ‘micro-organism’, confining this term to viruses, algae, bacteria, fungi and protozoa and
excluding genes and gene sequences. Others view the term as extending to genes and even to plants
and animals and call for its deletion from the text.

It is important to note that India is in compliance with the three universally recognized criteria of
patentability now incorporated into Article 27.1 of TRIPS, viz. novelty, non-obviousness and
industrial applicability or utility, which also apply to biotechnological inventions. Most
importantly, even under TRIPS discoveries of products found in nature do not constitute an

15
http://ssrn.com/abstract=1587584
invention and are thus excludable from patent grant. However, the distinction, relevant to
patentability, between the ‘discovery’ of something that exists in nature and the ‘invention’, or the
creation of something new involving a pre-determined degree of human effort or intervention, is,
in practice, difficult to make in the field of biotechnology. TRIPS gives no guidance on this, thus
giving a certain degree of flexibility to India and developing countries in formulating their laws to
avoid the patenting of products of nature specific details on scope of coverage, term of protection
and limitations to such protection. TRIPS in Article 28.2 extends the rights of process patentees to
the product directly obtained from the patented process. Thus patented microbiological processes
would give their owners product-patent-like rights over the products produced directly with the
use of these processes. TRIPS also calls for the reversal of the burden of proof in the case of
infringement of process patents, thus greatly strengthening the protection afforded to process
patents.

As far as the exclusion of rights if the products resulting from microbiological or other technical
processes are plants and animals are concerned, the answer is not clear. Nevertheless, even with a
minimalistic interpretation of these provisions, TRIPS obliges the grant of patents on
microorganisms, microbiological and non-biological processes and products thereof, while
excluding altogether only plants and animals and essentially biological processes for their
production. Again, plant varieties have to be given some form of effective protection. TRIPS also
allows adequate safeguards against abuse of the monopoly rights granted such as compulsory
licenses to third parties, use by government for public noncommercial use, price controls and
parallel imports.16

CONCLUSION
Patenting activity exhibited by India in this sector is a positive sign of innovation activities taking
place and the Indian patent regime has been so far compliant with TRIPs. Indian firms have
been able to obtain a number of patents in biotechnology during 1990-200, particularly in the
later period. However, there is a clear bar on re-engineering of patented products under TRIPs
which acts against the broadening of IPR. Since this broadening is beneficial for India keeping in

16
https://pdfs.semanticscholar.org/3e2a/882936f58afef5015f32ccfc4cc19b657db9.pdf
mind the condition of the country, TRIPs should provide some liberty to developing countries like
India in terms of granting patent to some re-engineered products as well.

The decision to be made regarding grant of patent in biotechnology is a tricky task and needs a lot
of expertise. It being a subject at a nascent stage in India, patenting of biological material in India
is still decided more often on a case-by-case basis. This is very subjective and makes it risky for
the investors to invest in R&D of Biotech inventions. TRIPs must address it with an appropriate
guidelines apart from the broad one of inventiveness, industrial use and non obviousness.