RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/161
3 November 1999
(99-4755)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b)
Communication from India
The following communication, dated 20 October 1999, has been received from the Permanent
Mission of India,
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I. INTRODUCTION
1. Patents are one of the seven intellectual property rights protected under TRIPS Agreement.  It
requires Member countries to make patents available for any inventions, whether product or
processes, in all fields of technology without discrimination, subject to the normal tests of novelty,
inventiveness and industrial applicability.  It also requires that patent be available and patent rights
enjoyable without discrimination as to the place of invention and whether products are imported orlocally produced.  Of course, patents and patents rights have a territorial application i.e.  patents
granted under a particular national law can be enfor ced only within the territorial jurisdiction of that
country.
2. There are some general exceptions to the basic rule on patentability contained in Article 27.
One is for inventions contrary to ordre public or morality.  This also includes inventions dangerous to
human, animal or plant life or health or which se riously prejudice the environment.  The use of this
exception is subject to the condition that the commercial exploitation of the invention must also be
prevented.  Secondly, Members  may exclude from patentability diagnostic, therapeutic and surgical
methods for the treatment of humans or animals.
3. A review of clause (b) of paragraph 3 of Article 27 of the TRIPS Agreement is due in the year
1999.  This part of the Article states as under:-
"Member may also exclude from patentability:
(b) Plants and animals other than microorganisms, and essentially biological processes
for the production of plants or animals other than non-biological and microbiological
processes.  However, Members shall provide for the protection of plant varieties
either by patents or by an effective sui generis  system or by any combination thereof.
The provisions of this subparagraph shall be reviewed four years after the entry into
force of the WTO Agreement."
4. The review could perhaps encompass three distinct but overlapping dimensions of
Article 27.3.  Firstly, it may be a subject of review whether and what form of exclusion from
patentability should apply to plants and animals per se (patenting of lifeforms).  Secondly, the review
could consider the effect of protection granted to microorganisms and non-biological and
microbiological processes (scope and definition of microorganisms).  Thirdly, it would be reviewedIP/C/W/161
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whether and what form of protection of plant varieties through sui generis  systems is an effective
form of protection (effectiveness of plant variety protection).
5. The TRIPS Council had initiated an information gathering exercise by inviting Members to
provide information on how the matters addressed in this provision were presently treated in theirnational laws.  Developed country Members were to provide this information as they are already
under an obligation to apply this provision, while others could provide information on a best
endeavour basis.  The information received was incomplete, as a majority of Members, having yet to
take on obligations under this provision, had no information to give.  The information received was
also incomplete as it related primarily to the way developed countries were treating implementation of
Article 27.3 (b) in their laws.  It is clear from the proposals made in the communication of Kenya on
behalf of the African Group in the Genera l Council (Document No. WT/GC/W/302) that the
information made available so far by Members does not represent the practices of the Membership.
The various proposals made by Members in the General Council regarding review of the TRIPS
Agreement, including the review of Article 27.3 (b), also show that the review of this Article is a
substantive review of the provisions in the Article and not a review of the operation of the Article.
Therefore, this paper discusses the three aspects of the review mentioned in paragraph 4 above.
II. PATENTING OF LIFEFORMS
6. Patenting of lifeforms may have at least two dimensions.  Firstly, there is the ethical question
of the extent of private ownership that could be extended to lifeforms.  The second dimension relates
to the use of the IPRs concept as understood in the industrialized world and its appropriateness in theface of the larger dimension of rights on knowledge,  their ownership, use, transfer and dissemination.
International IPR regimes recognize formal systems of knowledge only.  Informal systems e.g.  the
shrutis  and smritis  in the Indian tradition and grandmothers’ potions all over the world get scant
recognition.  To create systems that fail to address this issue can have severe adverse consequences on
mankind, some say even leading to our extinction.
7. Clearly, there is a case for re-examining the need to grant patents on lifeforms anywhere in
the world.  Until such systems are in place, it may be advisable to:-
(a) exclude patents on all lifeforms;If this is not possible, then:(b) exclude patents based on traditional/indigenous knowledge and essentially derived
products and processes from such knowledge; or at least:
(c) insist on disclosure of the country of origin of the biological resource and associated
knowledge, and obtain consent of the country providing the resource and knowledge,
to ensure equitable sharing of benefits.
III. MICRO-ORGANISMS
8. As regards micro-organisms, the discussion would focus on the scope of patentability of
micro-organisms and non-biological and microbiologi cal processes.  There are many grey areas in
defining the scope of patentable microorganisms and microbiological processes multilaterally.  The
WTO could consider various dimensions of this in these discussions.  The first is the difference
between discovery and invention – only the latter  should be patented.  For example, patent on
Steptomyces Vioaceus  a micro-organism accessed from the soil  in Hyderabad, India (Patent
No. 4992376), granted by US PTO in 1991, to Bristol Myer would not be a valid patent.  The second
dimension is the patentability criteria.  Article 27.1 provides that patents shall be available for anyIP/C/W/161
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inventions provided they are new, involve an inve ntive step and are capable of industrial application.
Thus the criteria of novelty, non-obviousness and usefulness have to be satisfied before the grant of
patent.  The third dimension is the coverage of micro-organisms under the Article.  The Article
requires patenting of microorganisms, non-biologi cal and microbiological processes.  This would
mean that perhaps a microorganism which is a manmade, genetically-engineered bacterium, wouldmeet the test of patentability.  Another question is the patentability of biological material such as cell
lines, enzymes, plasmids, cosmids and genes.  It appears that these will not qualify as inventions
unless there is human intervention involved and unless they fall in the category of micro-organisms.
In cases where the biological material is also a chemical, as in the case of artificial enzymes, they
could be patentable as chemicals.  As for other biological material, it is felt that since plants and
animals are excluded, parts would also be excluded.  Thus a gene cannot be patented except if it also
qualifies as a micro-organism that is patentable under the national law.  National laws varyconsiderably on this issue.  Therefore, it should be left to national policy to decide what are patentable
micro-organisms.
9. The Article clearly excludes essentially biological process for the production of plants and
animals.  It may be pertinent to note that micro-organisms or not, some inventions could be excludedfrom patentability for other reasons given in the TRIPS Agreement.  These reasons are given in
Article 27.2 of the Agreement and include ordre public, morality, human, animal or plant life or
health and environment.  Thus, many of the fears arising out of possible adverse consequences of
patenting of micro-organisms can be allayed through proper national laws using these exceptions and
through effective examination of patent applications in this area.  This is all the more reason whyscope of patentability of micro-organism s should be left to national policy.
IV. PLANT VARIETIES
10. Article 27.3(b) stipulates protection of plant varieties either by patents or by an effective
sui generis  system or by any combination thereof.  It is therefore  abundantly clear from a plain
reading of the language that patents are only one of the possible options available to countries for
providing protection of plant varieties.  Clea rly, other options available are: either a sui generis
system that is effective or any combination of these two.  Thus, we believe wide latitude has been
given to countries for developing an effective means of providing for protection of plant varieties.
Obviously, in devising such a system, a country may be expected to take into account its own public
policy objectives including developmental and technological objectives (clearly recognized in the
TRIPS Agreement) and also the obligations that the country has undertaken in the context of theTRIPS Agreement and other international Agreements.  In view of this, the TRIPS Agreement is right
in leaving it to the Member concerned to decide what system it would like to choose for providing
protection of plant varieties in accordance with its own legal system and practice.
11. The UPOV Convention is considered by some to provide one set of models.  The UPOV
Convention is derived from the need to protect the interests of plant breeders in industrialized
countries; it does not derive from the needs of users in developing countries.  However, the 1978 Act
of UPOV allows the recognition of farmers’ privilege to resow farm-saved seeds.  The FAO
Commission on Genetic Resources for Food and Agriculture is currently recasting its International
Undertaking on Genetic Resources for Food and Agriculture, 1983.  That could provide another set ofmodels.  Certain national or regional laws based on a combination of plant variety protection and the
conservation of biological diversity also could be used as effective models.  Thus there are various
ways to develop an effective sui generis  system of protection of plant  varieties.  There is no reason
why countries cannot develop their own models, which are effective sui generis  systems under the
TRIPS Agreement.
12. Some broad suggestions for creating a sui generis  system that is effective under the TRIPS
Agreement but also caters to environmental concerns could be discussed during the review.  OneIP/C/W/161
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suggestion could be to ensure that implementation of obligations under the Convention on Biological
Diversity regarding its preservation and its benefit sharing should not be considered a dilution of the
effectiveness of the system.  Another is to give full consideration to environmental and ethical
concerns about intellectual property rights on lifeforms as discussed above.  Still another is to ensure
that a system considered effective should also promote food security and health security.  It would beessential to ensure that preservation of farmers rights would not be considered as a dilution of
effectiveness of the system.  Finally, what is an effective sui generis  system may be best left to each
Member to evolve in its legal system and practice.
V. CONCLUSION
13. The paper is intended to identify the scope of the review of Article 27.3 (b) and highlight
some of the important suggestions made nationally as well as internationally in various discussions onthe subject that have taken place since the coming into force of the TRIPS Agreement.  It is neither
intended to be an exhaustive treatise of the concer ns on the review nor is it intended to limit the scope
of review to the suggestions mentioned therein.  The paper is intended to introduce the subject and
suggest a possible road map for the review.
14. In conclusion, it is submitted that developing countries like India cannot accept any further
strengthening of the protection provided to lifeforms at present.  Developing country laws in this area
are still being developed.  It may take some more time for developing countries to acquire experience
on the level of protection necessary and desirable as well as the exceptions and balances necessary for
ethical, social and economic needs of their peoples.  Perhaps it may be beneficial to wait till suchexperience is acquired before debating the extent of protection of intellectual property rights in this
area.  In fact, it may be ideal to exclude patent protection for lifeforms from all national laws until
such time.  Until then, it may also not be advisable for the WTO community to assess the
implementation of obligations in this area.
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