ASIA-PACIFIC

BI TECH NEWS

Indian Patent Law On

Biotechnological Inventions
Jayashree Watal*

the patenting of microorganisms and

Introduction microbiological processes. No such
he application of modern biotechnology to industry and agriculture is a provision is found in the Indian law.
T recent development, less than thirty years old. The biotechnology However, there are a number of
revolution has just begun to touch lives in the developing world. Amongst provisions, which taken together,
developing countries, India is one that has immense potential to utilize guide the Indian patent office in
biotechnology to its advantage to solve some of its most intractable problems accepting or rejecting applications
of productivity, health and environment. Yet India’s contribution so far to this for patents on biotechnological
area, in terms of basic research or commercial applications, has been marginal. inventions.
NGO activists in India have generally sided with some activists in the
industrialized world in opposing advancements in biotechnology, more What is an Invention?
particularly in agricultural biotechnology. This opposition extends in particular Under Section 2(j) of the Patents
to changing the intellectual property rights (IPRs) regime on biotechnological Act, 1970 "invention" has been
inventions – the slogan is No Patents on Life. The current patent law in India defined as any new and useful
dates back to the pre-biotechnology era and does not explicitly recognize or art, process, method or manner of
exclude the patenting of biotechnological inventions. However, the Trade- manufacture; machine, apparatus or
Related aspects of Intellectual Property Rights (TRIPS) Agreement, to which other article; substance produced by
India is a party as a member of the World Trade Organization (WTO), requires manufacture and includes any new
some level of protection of biotechnological inventions, including of plant and useful improvement of any of
varieties. India has to implement most of its TRIPS obligations by end of them. The terms "process" or "manu-
1999 and is currently in the process of drafting revised legislation. facture" or "substance" have not been
defined and therefore could be
presumed to include biotechnological

“ Amongst developing
countries, India is one that
Provisions of the Patents Act,
1970
Unlike the patent laws of most
processes. However, the practice
built up so far is that the manner of
manufacture must result in a non-
developed and even some developing
has immense potential to living substance. Thus, a process
countries, the current patent law in
of preparing a microorganism is
utilize biotechnology to its India, viz. the Patents Act, 1970, does
excluded from patenting in India,
not explicitly exclude or include any
advantage to solve some which is an extremely narrow and
biological matter. For instance, the
restricted view. India, like all other
of its most intractable European Patent Convention expli-
countries, grants patents for new,
problems of productivity, citly excludes the patenting of plant
useful and non-obvious inventions.
and animal varieties and essentially
health and environment. biological processes for their pro- Section 3 goes on to set out what

” duction, while it explicitly includes are not inventions under the law.

* The author represented India in the TRIPS negotiations in the Uruguay Round and is presently a visiting fellow at the Institute for
International Economics, Washington DC, USA. This paper partly draws upon Chapter V of the author’s forthcoming book: Intellectual
Property Rights in the World Trade Organization: The Way Forward for Developing Countries, Oxford University Press, New Delhi.

APBN • Vol. 4 • No. 4 • 2000 79

BTV4•4/part1 79 2/9/00, 9:13 AM

 “ The current patent law

in India dates back to

While the first three exclusions are
found in almost all patent laws, the
discovery of a new property or new
use for a known substance is now
Biotechnological Processes are
Included
Despite all these exclusion from
patentability, biotechnological pro-
patentable in almost all developed and cesses that do not result in living
the pre-biotechnology some developing countries. Indeed, organisms and are not agricultural or
the first patent given by the US on a horticultural methods or are not
era and does not living organism was based on the aimed at improving the economic
claim that a new property of the value of plants and animals, are
explicitly recognize or bacteria, that of eating oil spills, was patentable. In this narrow band of
discovered through novel and non- inclusions would fall processes that
exclude the patenting obvious process. Similarly, a method use living organisms to improve either
of agriculture or horticulture if new, industrial or environmental products.
of biotechnological useful and non-obvious would not
be excluded from patent grant in Indeed, from 1972 to 1990, a total
inventions. of 1049 process patents were filed on
most patent laws of the world.

Exclusions relevant to biotechnology

” Finally, although methods of medical
treatment are widely excluded from
patent enforcement, including in the
US, the Indian law extends this to
biotechnological inventions, of which
about 28.5% were filed by Indians.
These include processes for the
manufacture of vaccines and other
are inventions which are: methods that render plants and medicines, food additives and biogas
• frivolous or which claim anything animals free from disease or increase as well as for the treatment of
obviously contrary to well esta- their economic value or that of effluents and wastewater. However,
blished natural laws; their products. These last two are only six of these patents were cited,
certainly very broad exceptions that an indication of the low quality
• inventions whose primary or
would exclude all agricultural biotech- of these patents.1
intended use would be contrary
to law or morality or injurious to nological processes.

“
public health; What is Excluded from Patent
• the mere discovery of a scientific Grant? Unlike the patent
principle or the formulation of an In addition to excluding certain
abstract theory; inventions on the above-stated
laws of most developed
grounds, Section 5 of the Patents and even some developing
• the mere discovery of any new
Act, 1970 excludes the grant of
property or new use for a known
product patents for: countries, the current
substance or of a known process,
• substances intended for use or patent law in India, viz.
unless such known process results
capable of being used as food,
in a new product or employs at
medicine or drug;
the Patents Act, 1970,
least one new reactant;
does not explicitly
• substances prepared or produced by
• a method of agriculture or horti-
chemical processes. exclude or include any
culture and finally,
Claims for processes or methods biological matter.
• any process for the medical,
surgical, curative, prophylactic or
other treatment of human beings or
any process for a similar treatment
of manufacture for such substances
are, however, patentable. This, too,
has implications for biotechnologi-
cal inventions as these relate mostly
1
”
Taken from Karki, MMS and KC Garg
of animals or plants to render them (1993): "Patenting Activity in the Third
to food and pharmaceutical sectors.
free of disease or to increase their More importantly, as noted earlier, World — A Case Study of Biotechnology
economic value or that of their processes resulting in living organ- Patents Filed in India" in World Patent
products. isms are excluded. Information, Vol. 15, No. 3, pp. 165-170.

80 APBN • Vol. 4 • No. 4 • 2000

BTV4•4/part1 80 2/9/00, 9:13 AM

 ASIA-PACIFIC

BI TECH NEWS

Under Section 48, however, the or ‘essentially biological’, clearly organism’, confining this term to
rights of the process patentees extend micro-organisms and microbiological viruses, algae, bacteria, fungi and
only to the use of the process. The processes are not excluded from protozoa and excluding genes and
patentee has no ground to challenge patent protection despite resistance gene sequences. Others view the term
a product that was made using the from some developing countries. Even as extending to genes and even to
patented process outside the country during the TRIPS negotiations, the plants and animals and call for its
and then imported into the country East Asian participants, notably deletion from the text.
or, in the case of an identical product Korea, Malaysia and Singapore, had
It is important to note that India
produced in the country, to make the no objections to the patenting of
is in compliance with the three
defendant prove that he was not using microorganisms or microbiological
universally recognised criteria of
the patented process. processes as they already allowed
these in their national laws. However, patentability now incorporated into
TRIPS Requirements
India, however, has to amend its
patent law to meet its obligations
under the WTO TRIPS Agreement by
the end of 1999. TRIPS calls for the
availability of patents, whether for
“ While there is uncertainty on the definitions

of certain terms such as ‘non-biological’

processes or products, in all fields or ‘essentially biological’, clearly micro-organisms

of technology. However, at the time
of the negotiations on TRIPS in and microbiological processes are not
the Uruguay Round of multilateral
excluded from patent protection despite
trade negotiations, the US and the
EU differed on their approaches
to patenting of biotechnological
inventions. While the US believed
that ‘anything under the sun made by
resistance from some developing countries.
”
man’, except for human beings, was some hold that there is considerable Article 27.1 of TRIPS, viz. novelty,
patentable, the EU was grappling with scope even in defining ‘micro- non-obviousness and industrial
strong internal resistance to patents applicability or utility, which also

“
on living organisms. Since the debate apply to biotechnological inventions.
had not yet been settled in Europe, Most importantly, even under TRIPS
it was agreed to retain a minimal Even during the TRIPS discoveries of products found in
agreement while committing to revisit nature do not constitute an invention
this provision within four years from negotiations, the East Asian and are thus excludable from patent
the entry into force of TRIPS i.e. grant. However, the distinction,
participants, notably Korea, relevant to patentability, between the
by 1999.
Malaysia and Singapore, ‘discovery’ of something that exists
Article 27.3(b) of TRIPS incor- in nature and the ‘invention’, or the
porates this minimal agreement. It had no objections to the creation of something new involving
allows the exclusion of plants and a pre-determined degree of human
animals, and essentially biological patenting of microorganisms effort or intervention, is, in practice,
processes for their production, from difficult to make in the field of
patent grant but obliges the pro-
or microbiological processes
biotechnology. TRIPS gives no
tection of microorganisms and micro- as they already allowed these guidance on this, thus giving a certain
biological or non-biological processes degree of flexibility to India and
for their production. While there is in their national laws. developing countries in formulating
uncertainty on the definitions of their laws to avoid the patenting of
certain terms such as ‘non-biological’
” products of nature.

APBN • Vol. 4 • No. 4 • 2000 81

BTV4•4/part1 81 2/9/00, 9:13 AM

 Under 27.3(b) of TRIPS, if plants the burden of proof in the case of ments should be adequate to counter
are excluded from patent protection, infringement of process patents, thus any adverse effects on prices or on
at least an effective sui generis system greatly strengthening the protection access to technologies. However, it
must be put in place for the protection afforded to process patents. Can WTO must be noted that a policy of
of new plant varieties. In other words, members choose to exclude such cooperation may be better than
plant breeders’ rights (PBRs) are to rights if the products resulting from confrontation as sometimes patented
be protected despite the optional microbiological or other technical technologies cannot be worked
processes are plants and animals? The efficiently without the cooperation of
exclusion from the patenting of
answer is not clear. Nevertheless, even the right holder.
plants. Countries can also opt to give
both options for the protection of with a minimalistic interpretation of TRIPS obligations generally enter
plants. Unlike in the other subjects these provisions, TRIPS obliges the into force for developing countries by
under TRIPS, there is no mention grant of patents on microorganisms, 2000. However, countries that do not
of adherence to the pre-existing microbiological and non-biological allow product patents have been given
international convention or to any processes and products thereof, while time, under Article 65 of TRIPS, up
to 2005 to introduce such patents.
However, for pharmaceuticals and

“ In the case of microorganisms or other

biological material not treated as
agricultural chemicals, patent appli-
cations have to be accepted from 1995
onwards and exclusive marketing
rights, i.e. rights very similar to patent
rights, have to be granted for a period
of five years or until the grant or
pharmaceuticals or agricultural chemicals
rejection of a product patent. In the
case of microorganisms or other
India can take advantage
biological material not treated as
pharmaceuticals or agricultural
of the delayed introduction up to 2005.
chemicals India can take advantage
of the delayed introduction up to
India can also continue to exclude plants and 2005. However, process patentees will
have product-patent-like rights over
animals and only allow PBRs on plants. products directly obtained from
microbiological or non-biological

” processes from 2000 onwards. India

can also continue to exclude plants
and animals and only allow PBRs on
specific details on scope of coverage, excluding altogether only plants and plants. Is it possible that the TRIPS
term of protection and limitations to animals and essentially biological obligations will be revised soon as
such protection. processes for their production. Again, already envisaged in Article 27.3(b)?
plant varieties have to be given some
TRIPS in Article 28.2 extends Possibility of TRIPS Revision
form of effective protection.
the rights of process patentees to Built into Article 27.3(b) of TRIPS is
the product directly obtained from TRIPS also allows adequate a provision for this clause to be
the patented process. Thus patented safeguards against abuse of the reviewed four years after the date of
microbiological processes would give monopoly rights granted such as entry into force of the WTO i.e. any
their owners product-patent-like rights compulsory licenses to third parties, time after 1999. At the time of the
over the products produced directly use by government for public non- TRIPS negotiations this was a
with the use of these processes. commercial use, price controls and compromise, as the US wanted no
TRIPS also calls for the reversal of parallel imports. These policy instru- exclusions for biotechnological

82 APBN • Vol. 4 • No. 4 • 2000

BTV4•4/part1 82 2/9/00, 9:13 AM

 ASIA-PACIFIC

BI TECH NEWS

inventions, while the EC and many experts in the US and EU believe for plants and animals in the near
other developed and developing plant variety protection is appropriate future, India will need to patent
countries were comfortable with the for plant varieties while genes and microorganisms and microbiological
EPC language. It was expected that genetic processes should be granted processes and products directly
with the passing of the European patents, where eligible, thus pre- obtained therefrom. Sui generis plant
Biotechnology Directive that there serving farmers’ privilege to re-use variety protection can also take
would be united pressure on develop- saved seed. Moreover, as many advantage of the flexibility currently
ing countries from US, Europe and developing countries would only just allowed to include farmers’ privilege
Japan in the TRIPS Council in 1999 have changed their laws to implement and breeders’ exemption. However,
for accepting, under Article 27.3 (b), this provision of TRIPS, it may be new technological advances may
the patentability of all eligible considered premature to review this make farmers’ privilege redundant
biotechnological inventions, including so early. and local innovative breeders may
plants and animals. Some research- themselves demand the limiting of
One more reason for such caution
based agricultural biotechnology breeders’ exemption. Some develop-
could be the preparations being
companies in the US are particularly ing countries have already seen the
made by developing countries to
interested in plant patents as they wisdom of going on to the next
demand changes in TRIPS. Given the
argue that breeders’ rights, with stage of granting patents for plants,
controversy on the grant of patents
breeders’ exemption and farmers’ genes and animals and many others
based on indigenous knowledge, a
privilege, are not sufficient to recoup may do so, once domestic research
suggestion has been made that
their investment on R&D. While capabilities in biotechnology improve.
developing countries demand that
farmers’ privilege to use saved seed India should also do so once it gains
the US and other countries that
may, to some extent, be restricted by confidence that IPRs can be used to
follow such a system, undertake an
the use of hybrids or in the future, encourage domestic innovation in this
obligation under TRIPS to amend
possibly by using other Genetic Use crucial technology.
their patent laws to allow for prior
Restriction Technologies (GURTs),

“
knowledge of an invention revealed
breeders cannot legally or technically
by public sale or otherwise. Others
be protected under plant variety While farmers’ privilege
go further and suggest that patent
protection laws that permit other
applicants who base their inventions to use saved seed may, to
breeders to derive new varieties from
the protected one. Today, genetically on traditional knowledge should
name the indigenous community as some extent, be restricted
engineered crops make up a large
portion of agricultural production in co-inventor. Another suggestion is
by the use of hybrids or in
developed countries and is projected that genes, even if patented, upon
to grow even more rapidly, replacing isolation, remain free for use by all. the future, possibly by
traditional varieties. Demandeurs for strengthened IPR
protection may have reason to fear using other Genetic Use
However, developed countries, further weakening of the TRIPS text Restriction Technologies
backed by the international business in any premature review. For some
community, are reluctant to re-open time to come, India can expect the (GURTs), breeders cannot
the debate on Article 27.3(b). One TRIPS text on biotechnological
reason could be that some view this inventions to remain unchanged.
legally or technically be
as risky as it would endanger the protected under plant
advances already made in Europe in Conclusion
this area, even while the public debate At present India grants only process variety protection laws that
has not been fully settled there. Others patents for certain biotechnological
inventions. However, India’s ad- permit other breeders to
may believe that the wording of
TRIPS can be subject to as broad herence to the WTO will entail derive new varieties from
an interpretation under WTO dis- changes in its patent law by 2000.
putes as given in the recent European Although there is no need for India the protected one.
Biotechnology directive. Some to go beyond TRIPS and grant patents

”
APBN • Vol. 4 • No. 4 • 2000 83

BTV4•4/part1 83 2/9/00, 9:13 AM