|
||
|
PATENTS
ON LIFE FORMS SHOULD BE RE-EXAMINED, SAYS INDIA 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 or posted to any system or service without specific permission from SUNS. This limitation includes incorporation into a database, distribution via Usenet News, bulletin board systems, mailing lists, print media or broadcast. For information about reproduction or multi-user subscriptions please contact < suns@igc.org >
|
||
