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PATENTS ON LIFE FORMS SHOULD BE RE-EXAMINED, SAYS INDIA


by Someshwar Singh




Geneva, 27 Oct 99 -- Developing countries like India cannot accept
any further strengthening of the protection provided to life forms
before assessing, by experience, what is good for their peoples, India
has said in what is called 'a discussion paper' on the review of
Article 27.3 (b) of the TRIPS agreement.

The paper has been presented at the meeting of the TRIPS Council
last week, when the Council also prepared the report to the
General Council. That report, in a reference to the 'non-
violation' disputes on which there is at present a moratorium,
says that most members are in favour of recommending to the
Ministerial Conference an extension of the period referred to in
Article 64.2 of the Agreement, in order to allow the Council to
further examine the scope and modalities of "non-violation"
complaints under the TRIPS agreement.

The report says, without identifying, that one member (a
reference to the US) is not in a position to join the consensus
to that effect.

The report adds that some Members were of the view that in the
absence of a decision by the Ministerial Conference, under
Art.64.3, on this question, "there would be no scope for 'non-
violation' complaints under the TRIPS Agreement." Some other
Members were not in a position to share this view.

"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," the paper said.

It argued that perhaps it may be beneficial to wait till such
experience is acquired before debating the extent of protection
of IPRs in this area.

"In fact, it may be ideal to exclude patent protection for life
forms from all national laws till such time. Till then, it may
also not be advisable for the WTO community to assess the
implementation of obligations in this area," the paper has
suggested.

In a separate paper, also to the TRIPS Council, the United States
(without any direct reference or mention) has attempted to rebut
the Indian reasoning and arguments, and has highlighted the
benefits of providing protection for biotechnological inventions.

According to India, the mandated TRIPS review concerns "a
substantive review of the provisions in the Article and not a
review of the operation of the Article." This was clear from the
various proposals made by members to the General Council (in the
Seattle preparatory process) on the TRIPS review.

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 their
national 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 majority of members,
having yet to take on obligations under this provision, had no
information to give on implementation of Article 27.3 (b) in
their laws.

The relevant TRIPS provisions under review, says India, have
three dimensions. Firstly, whether and what form of exclusion
from patentability should apply to plants and animals per se
(patenting of life forms). Secondly,the review could consider the
effect of protection granted to micro-organisms and non-
biological and micro-biological processes (scope and definition
of micro-organisms).

Thirdly, whether and what form of protection of plant varieties
through sui generis systems is an effective form of protection
(effectiveness of plant variety protection).

Patenting of life forms, according to India, may have at least
two dimensions. Firstly, there is the ethical question of the
extent of private ownership that could be extended to life forms.
The second relates to the use of the IPRs concept, as understood
in the industrialized world, and its appropriateness in the face
of the larger dimension of rights on knowledge, their ownership,
use, transfer and dissemination.

International IPR regimes recognize formal systems of knowledge
only, India maintains. 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," the Indian paper warns.

India says there is clearly a case for re-examining the need to
grant patents on life forms anywhere in the world. Till such
systems are in place, it may be advisable to:

(a) exclude patent on all life forms; 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.

As regards micro-organisms (where there are significant
implications for biotechnology), India argues that it should be
left to national policy to decide what are patentable micro-
organisms.

"There are many grey areas in defining the scope of patentable
micro-organisms and non-biological and micro-biological processes
multilaterally. The WTO could consider various dimensions of this
in these discussions," India said.

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 any inventions
provided they are new, involve an inventive 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-organism under the
Article, which requires patenting of micro-organisms, non-
biological and micro-biological processes. This would mean that
perhaps a micro-organism which is man-made, genetically
engineered bacterium, would meet 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, India has said.

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 it also qualifies as
micro-organism that is patentable under the national law," the
Indian paper notes. "National laws vary considerably on this
issue. Therefore, it should be left to national policy to decide
what are patentable micro-organisms."

It adds that 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 excluded from patentability for other reasons given in
the TRIPS agreement and spelt out in Article 27.2 - and include
on grounds of 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 why scope of patentability of
microorganisms should be left to national policy.

On the question of protection of plant varieties (Article 27.3
b), the Indian paper noted that a wide latitude has been given
to countries - between the choice of patents or an effective sui
generis system or by any combination thereof.

"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 recognised
in the TRIPS agreement) and also the obligations that the country
has undertaken in the context of the TRIPS agreement and other
international agreements."

As to the choice of models, the Indian paper argues that what is
effective sui generis may be best left to each member to evolve
in its legal system and practice. It says there is no reason why
countries cannot develop their own models, which are effective
sui generis systems under TRIPS. At the same time, the Indian
paper counsels against the models provided by the UPOV
Convention.

"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."

Another set of models could be provided by the FAO Commission on
Genetic Resources for Food and Agriculture, which is currently
recasting its International Undertaking on Genetic Resources for
Food and Agriculture, 1983.

India also suggests that the review could also discuss the sui
generis system and its response to environmental concerns. One
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 (sui generis).

Another is to give full consideration to environmental and
ethical concerns about IPRs on life forms.

Equally important other considerations are whether the system
promotes food and health security.

It would be essential to ensure that preservation of farmers's
rights would not be considered as a dilution of effectiveness of
the system.

The United States of America, in its own submission, highlighted
the benefits of providing protection for biotechnological
inventions and countered most of the concerns raised above.

The USA "believes that an exception to patentability, authorized
by Article 27.3 (b), is unnecessary and, therefore, treats plants
and animals and non-biological and microbiological processes as
patentable subject matter under its patent law."

In fact, the US submission starts off by asserting that the
"United States strongly supports patent eligibility for
inventions in all fields of technology, including biotechnolgy."

The watershed in the US patent law as regards life forms was the
year 1980 when a new, man-made microorganism that could break
down oil was made patentable subject matter by a 5-4 decision of
the US Supreme Court.

Following that landmark decision, the U.S. Patent and Trademark
Office has consistently granted patents on such microorganisms,
including unicellular organisms, bacteria, yeast, fungi, and
other living organisms, and on non-biological and microbiological
processes. In addition, the U.S. PTO grants patents on both
plants and animals.

[Several patent experts have pointed out that the US-PTO accepts
as prior knowledge and state of art, thus excluding from grant
of patent, information published in scientific journals or local
traditional knowledge, but does not recognize traditional
knowledge abroad as 'prior knowledge'.]

In the field of agriculture, says the U.S. paper, biotechnology
is improving upon the long tradition of plant breeding to design
new plants that have improved characteristics (e.g. improved
yield and viability) by tapping the potential to transfer traits
through direct manipulation of the genome of a plant, instead of
only by trial and error through conventional plant breeding
techniques.

Similarly, pharmaceutical biotechnology is helping to improve
human and animal health by developing new pharmaceutical agents
and new methods for treating or curing disorders. Over 350 new
biotechnological pharmaceuticals and vaccines are in clinical
trials today and there a re hundreds more in the early
developmental stage.

The biotechnology industry, states the U.S. paper, has already
produced hundreds of highly accurate tools for diagnosing and
treating diseases and other physical afflictions.

On ethical questions, the U.S. says "some WTO members have
referred to unspecified moral and ethical consequences of
patenting life forms." As an example, it said, the grant of a
patent on a pharmaceutical product or process does not, in most
countries, give its owner the right to produce and market the
patented pharmaceutical or the pharmaceutical produced using the
patented process.

"A separate process is used to determine the safety and efficacy
of the pharmaceutical in question before approval for production,
sale and use is given. Similar approval processes are used in
many countries to review the safety and efficacy of agricultural
and industrial chemicals, cosmetics, and foodstuffs before they
can be marketed."

"Concerns a country might have about the safety and efficacy of
micro-biological products or non-biological or microbiological
processes are addressed in that way," according to the US paper.

On the question of protection for plant varieties, the US notes
that the UPOV 91 works to the benefit of all contracting parties.
"UPOV 91 Contracting Parties can limit rights, however, to permit
farmers to save seeds they harvest from their own plantings in
order to replant it in subsequent years on their own holdings.
The rights and obligations are balanced and work to the benefit
of all countries."

On the subject of relationship between the TRIPs and the
Convention on Biological Diversity, the U.S. notes that the two
have been in existence for the last five years but that none of
the discussions and papers so far have been able to identify "a
single inconsistency between the two agreements."

"It is time, therefore," says the United States, "to lay to rest
the allegation that the obligations of the two agreements are
inconsistent and concentrate on addressing any specific concerns
that WTO members that are also members states of the CBD might
have about the manner in which they might implement particular
obligations of either agreement so that they avoid any question
of conflict with obligations under the other agreement."

On the issue of protection for genetic resources and traditional
knowledge, the United States is clearly against suggestions that
patent applicants be required to identify in their applications
the source of any genetic materials or traditional knowledge used
in developing their claimed invention as a means of ensuring
benefit sharing.

"Such a system would be impractical and would not ensure that
those contributing such resources or knowledge would share in the
benefits that might follow from commercialization of the
invention."

The U.S. submission recalls that it is a longstanding principle
of international law, reaffirmed in the Preamble to the CBD (the
Biodiversity Convention which the U.S. has not ratified and is
only an observer) that countries have sovereign rights over the
biological resources within their territories.

"Among those rights is the right to determine who will be given
access to those resources, on what terms, and for what purposes.
Nothing in the TRIPs agreement alters those rights."

But, in the very next sentence, the U.S. says, "obligations, such
as national and most favoured nation treatment, contained in
other multilateral and bilateral agreements to which the party
granting access to genetic resources or knowledge would, of
course, have to be considered in establishing a legal regime for
granting access to such resources and knowledge."

The U.S. paper goes on to suggest that "the most effective means
for exercising those rights would appear to be to require that
parties seeking access to genetic resources or traditional
knowledge enter into a contract with the sovereign entity that
grants that access. Such contracts should spell out in detail the
terms and conditions under which the access is granted."

"Obviously, questions of jurisdiction of courts, conditions to
be included in contracts with any third parties licensed to make use
of resources or knowledge obtained should be spelled out. A
contract granting access also should define expressly terms that
are not clear on their face , such as genetic resources and
traditional knowledge," the paper added.

The U.S. believes that such clear rules help to avoid
misunderstanding and confusion. It adds that when faced with a
choice, the party seeking access could choose territory that is
least expensive!

"Where genetic resources or traditional knowledge can be obtained
from a number of sources, of course, the party seeking access
likely will seek the resources or knowledge from the territory
that provides the most favourable terms."

The U.S. paper also points out that insisting on information on
source of genetic resources or traditional knowledge in all
patent applications would be 'an onerous task' and would also
increase the cost of obtaining patents. That would have a greater
adverse effect on individual inventors, non-profit entities, and
small and medium-sized businesses, including those in developing
countries.

To make contract law most effective, the U.S. paper suggests an
education programme for those in control of genetic resources and
traditional knowledge. "Over time, such a programme might enable
them to develop their own patentable inventions or to otherwise
commercialise their resources and knowledge in a manner that can
improve their standard of living, if that is what they choose to
do."

On behalf of the African group, Kenya expressed 'full support'
to the Indian submission and highlighted some of the salient points
of Africa Group's position on Article 27.3 (b).

On the scope and nature of the review, Kenya said the mandated
review was one of substance of the sub-paragraph itself. This is
clear from the wording of the last sentence of Article 27.3 (b)
which reads, "The provisions of this sub-paragraph shall be
reviewed four years after the date of entry into force of the WTO
Agreement."

On the substance of the provisions, the Africa group said the
review should seek:

1. To clarify the criteria or rationale for deciding what can
and cannot be excluded from patentability in Article 27.3 (b).
This relates to the implicit distinction made between plants and
animals (which may be excluded from patentability) on the one
hand, and micro-organisms (which may not be excluded) on the
other.

Another distinction is made between "essentially biological
processes" (which may be excluded) and "micro-biological
processes" (which may not be excluded).

2. The review should confirm that the concept of "effective
protection" as it relates to the protection of plant varieties,
either by a patent, sui generis system or a combination thereof,
leaves the discretion to members to decide the effectiveness of
their implementing legislation in achieving their broad economic
objectives in a manner consistent with the TRIPs agreement.

Achieving such economic objectives requires an optimal
combination of instruments including those contained, for
instance, in the CBD and other available international
instruments. These objectives include preservation of biological
diversity, farmer's rights, the environment, as well as ensuring
food and health security. It is in this light that the African
Group views the need for harmony between the CBD and the TRIPs
agreement.

On the architecture of the agreement, Kenya said the African
group is concerned that deliberations on this subject may not be
as fruitful and comprehensive until developing countries have had
time to gain sufficient experience with the implementation of the
provisions, both of the agreement as a whole and of the
provisions of Article 27.3 (b) in particular. (SUNS4539)

The above article first appeared in the South-North
Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief
Editor.
[c] 1999, SUNS - All rights reserved. May not be reproduced, reprinted
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