Combating biopiracy - the legal way

India's 10-year-long battle against the grant of a patent on the use of neem as a fungicide has finally been won at the European Patent Office (EPO). Neem's fungicidal properties are part of the 'Traditional Knowledge' (TK) base of this country. Nonetheless, the patent rights on a method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil had originally been granted by the EPO in September 1994 to the United States Department of Agriculture (USDA) and the New York-based multinational agribusiness corporation WR Grace.

In June 1995, a legal opposition to the grant of this patent was filed jointly by Dr Vandana Shiva, director of Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), Ms Magda Aelvoet of the Green Group in European Parliament and Ms Linda Bullard of International Federation of Organic Agriculture Movements (IFOAM). Their joint legal opposition claimed that the fungicidal properties of the Neem tree had been public knowledge in India for centuries thereby nullifying the novelty (one of the criteria for patentability) claimed to be involved in the aforesaid patented subject matter. Consequently, the EPO revoked the patent in May 2000. The MNC, however, appealed the patent revocation. It is against this appeal that the EPO has finally upheld its earlier decision, thereby revoking in its entirety the patent rights once and for all on March 8, 2005.

Unfortunately, this is not the only instance of such biopiracy of traditional Indian knowledge. Instead, several cases of biopiracy have come to the fore in the past as well. The patents granted for instance, on wound-healing properties of 'haldi', or on anti-diabetic properties of `karela', `jamun', and brinjal, are some such examples of blatant biopiracy of Indian TK that have generated considerable hue and cry in not-too-distant past.

What is biopiracy?

Biological diversity or biodiversity encompasses all species of plants, animals and micro-organisms and the variations between them, and the eco-systems of which they form a part. TK associated with such biological resources is an intangible component of the resource itself. Such knowledge has the potential of being translated into commercial benefits by providing leads for development of useful products and processes.

The commercial potential involved in biological resources and the associated TK has assumed enormous magnitude in the last couple of decades with the tremendous proliferation of the biotechnology industry. Given that most of the world's biodiversity-rich countries are developing countries located in the tropics, these nations should have been in a strong position to benefit substantially by trading in such bio-resources and the associated TK. Unfortunately, this is far from the case. More often than not it is the giant MNCs of the developed world who are instrumental in appropriation of the precious bio-resources and the allied TK of the South, without the prior informed consent (PIC) of the legitimate holders of such resources, thereby bypassing any benefit-sharing arrangement with them. The mounting profits emanating from the commercial exploitation of these prized resources of the South accrue solely to the corporate giants of the developed world, courtesy the exclusive patent protection obtained by suppressing the true source of the relevant bio-resource and/or TK. The country of origin of the concerned bio-resources and/or TK however remains deprived of its legitimate share of the profits generated out of them. Such unscrupulous business practices of the MNCs have come to be known as Biopiracy.

Thus, in a nutshell 'Biopiracy' refers to the ways that corporations - almost all from the developed world - claim ownership of, free ride on, or otherwise take unfair advantage of, the genetic resources and TK and technologies of developing countries. Biopirates are those responsible for one or both of the following acts: (i) the theft, misappropriation of, or unfair free-riding on, genetic resources and/or TK through the patent system; and (ii) the unauthorised and uncompensated collection for commercial ends of genetic resources and/or TK.

The case for international legal protection

While the neem victory should certainly be regarded as a breakthrough for the legitimate rights of the holders of TK - not only in India but throughout the South - the time, money and effort involved in the whole process of revocation (which in this particular case lasted for ten long years) does stand out as a cause of concern in following the same path in case of other similar cases of biopiracy in future. In fact, the way biopiracy has been assuming endemic proportions, the transaction costs involved in getting biopiracy patents examined and revoked in foreign patent offices on a case-by-case basis could turn out to be prohibitive for a developing country like India. Hence, the necessity for an internationally enforceable legal regime, which can ensure an effective protection for the rights of communities on their TK-based biological resources by prohibiting the unscrupulous biopiracy practices of the western MNCs.

Particularly, an effective legal safeguard against biopiracy assumes enormous importance for a country like India, which not only qualifies as one of the twelve megabiodiversity countries of the world, but also has in its possession an equally rich treasure of traditional and indigenous knowledge, both coded as well as informal.

It is not that the existing international treaties are completely negligent about the problem of biopiracy. The legitimate rights of the holders of TK have been clearly acknowledged in the UN Convention on Biological Diversity (CBD), which came into force in 1993 with the following three objectives: the conservation of biological diversity; the sustainable use of its components; and fair and equitable sharing of benefits arising out of the utilization of genetic resources.

The CBD seeks, among other things, to regulate access to genetic resources and associated TK, while at the same time ensuring their sustainable use. While facilitated access to genetic resources and allied TK is of importance to researchers and bio-prospectors, PIC by the providers of the genetic resources and/or TK as well as appropriate arrangements for fair and equitable benefit-sharing are critical issues for the biodiversity rich countries of the world in general and in particular, for the local and indigenous communities who have acted as the custodians of these precious resources for ages.

Notably, India, which is a contracting party to the CBD, has already enacted a legislation viz. 'The Biological Diversity Act, 2002' in line with the provisions of the CBD. This legislation attempts to address the basic concerns of access to and collection and utilization of biological resources and TK by foreigners and the sharing of benefits arising out of such access. It also contains provisions for creation of a regulatory body, called the National Biodiversity Authority (NBA). The Biodiversity Act provides that any person seeking any kind of intellectual property right (IPR) in or outside of India for any invention based on any biological resource or information on a biological resource obtained from India, is required to obtain prior permission of the NBA, which may determine benefit-sharing fees or royalty for the benefits arising out of the commercial utilization of such rights.

With such broad international efforts, why does something like the neem patents incident ever happen? Because, even if an invention is based on the use of some biological material and/or TK, the patent applicant has no obligation whatsoever under the TRIPS Agreement of the WTO to disclose in his patent application the geographical origin of that material and/or knowledge. Nor is there any compulsion on the patent applicant under TRIPS to provide evidence on PIC obtained from the legitimate holders of the bioresources and/or TK in question. Consequently, there is no provision under TRIPS to ensure equitable sharing of benefits between the patent holder and the resource-owner either. Notably, TRIPS is that international treaty, which provides the universal 'minimum' standards of protection for all IPRs, including patents, that as many as 148 (as of now) member countries of the WTO are bound to comply with in their respective national legislations.

The leeways available under TRIPS

However, it should be noted that the scope of Article 29 of TRIPS, which provides Conditions on Patent Applicants, is not 'exclusive', i.e. it does not prevent a Member from imposing additional conditions on the patent applicants than what are compulsory under this Article, provided such additional conditions are compatible with other provisions of the TRIPS Agreement.

Notably, India has already utilized this flexibility of TRIPS in the Patent (Amendment) Act, 2002. This Amendment has introduced a new obligation (in Section 10 (4) of the principal (1970) Act, which stipulates the requirements of a patent application) on the patent applicant to disclose the source and geographical origin of the biological material in the patent application, when used in an invention. Such a provision is perfectly compatible with TRIPS, since, it is not violating other provisions of this Agreement.

The Patents (Amendment) Act 2005, passed by the Parliament recently, has also introduced some important provisions in this regard. Take for instance, the provisions included in the context of pre-grant and post-grant opposition in the revised Section 25 of the principal (1970) Act under the heading: Opposition Proceedings to Grant of Patent. The revised Section 25(l), which deals with pre-grant opposition provides that:

Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent within the prescribed period on the grounds of - (a) patentability including novelty, inventive step and industrial applicability, or (b) non-disclosure or wrongful mentioning in complete specification, source and geographical origin of biological material used in the invention and anticipation of invention by the knowledge, oral or otherwise available within any local or indigenous community in India or elsewhere,

and the Controller shall if requested by such person for being heard, hear him and dispose of the representation in such manner and within such period as may be prescribed."

Section 25(3) dealing with post-grant opposition further stipulates that at any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner on certain specified grounds. The eleven grounds stipulated for such post-grant opposition include the following two grounds, e.g.,

• That the complete specification does not disclose or wrongfully mentions the source and geographical origin of biological material used for the invention;

• That the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere

The 2002 Amendment Act has furthermore introduced another provision (in Section 64(1) of the principal (1970) Act, dealing with revocation of patents), which allows revocation of a patent on grounds of:

• Non-disclosure or wrongful mentioning in the patent application of the source or the geographical origin of biological material used for the invention concerned

• Knowledge, oral or otherwise, available within any local or indigenous community in any country as anticipation of the invention concerned.

Notably, the aforesaid provision on revocation has been introduced by the lawmakers of the country by making use of another leeway available under the TRIPS Agreement. This is because TRIPS does not have any stipulation regarding the grounds for revocation of patents. The only obligation imposed by TRIPS on the Member countries pertaining to revocation or forfeiture of patents is that: "An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available." (Article 32 of TRIPS).

The rationale behind the Indian provisions

In order to comprehend the rationale behind the inclusion of the abovementioned TK-related provision as a ground for revocation of a patent one has to be aware of the basic criteria of a patentable 'invention'. According to Article 27.1 of TRIPS, in order to qualify as patentable an invention has to satisfy three criteria:

• Novelty
• Inventive step
• Industrial applicability.

It is in line with this stipulation of TRIPS that Section 2(j) of the Indian Patents Act (as par the amendment of 2002) has defined the term 'invention' to mean "a new product or process involving an inventive step and capable of industrial application".

The question that arises here is -if an invention is anticipated on the basis of a TK of any country then can it at all be regarded as 'novel'? The answer will definitely depend on how the term 'novelty' or newness is defined and interpreted. Since the TRIPS Agreement does not specify the definition of 'novelty', the members are free to define and interpret the term in their own ways.

As far as India is concerned, the inclusion of the aforesaid second ground for revocation of a patent in the Indian law clearly reveals that if some TK, oral or otherwise, is used for anticipating an 'invention' then the patented subject matter does not satisfy the criterion of 'novelty' according to the Indian interpretation of the term 'new'. Thus, the Indian Patent Act recognizes even the existence of oral or non-written TK as part of what is called 'prior art' in the terminology of the patent laws, and refuses to allow patenting of any 'invention' based on such 'prior art'.

'Novelty' requirement - a bone of contention

However, in the backdrop of the silence of TRIPS regarding the definition of 'novelty', significant differences are observed to exist in the national patent laws of different countries with regard to the concept of 'novelty'. For instance, the US Patent Law does not consider that the 'novelty' requirement has been lost when an invention has been divulged outside the United States by 'non-written' means such as public use and sale. Section 102 of the US law, which defines 'prior art', reads as follows:

Conditions of patentability: Novelty and loss of right to patent. A person shall be entitled to a patent unless:

A. The invention was known or used by others in this country or patented or described in a publication in this or a foreign country before the invention thereof by the applicant for patent.

- or -

B. The invention was patented or described in a trade publication in this or a foreign country or in public use or on sale in this country more than one year prior to the date of the application for patent in the United States.

Thus public use or sale in a foreign country does not constitute 'prior art' according to the US patent law. Only existence of a patent or a published description of the invention is considered to be part of 'prior art' in case of a foreign country. This is in sharp contrast with the definition of a 'new invention', which has been inserted in the Indian Patents Act by means of an amendment introduced in the 2005 Amendment Act. According to this latest addition, Section 2(l) of the principal Act now reads as below:

"new invention" means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e. the subject matter has not fallen in public domain or that it does not form part of the state of the art".

Thus unlike the US law, the Indian law does not discriminate between the home country and foreign country while determining the 'novelty' of an 'invention'. The aforesaid provision of the US law implies that a patent conferred by the US Patent Office, which involves, say, an act of biopiracy of an Indian TK, can be challenged by India only if some written proof of that knowledge can be produced, for want of which such biopiracy would continue. Although patents are supposed to be granted for new inventions, this denial or non-recognition of non-written 'prior art' elsewhere (in the US law) allows patents to be granted for existing knowledge and use in other countries. It is this glaring loophole of the US law, which opens the door for bio-piracy of the non-written TK of India and other countries of the South by the MNCs.

The earlier-discussed provisions included in the Indian Patents Act in conjunction with the PIC and benefit sharing requirements incorporated in the Biological Diversity Act 2002 create sufficient room for combating the biopiracy threats at the national level in India. Nevertheless, the problem remains that existence of a similar protective shield for Indian bioresources and TK cannot be guaranteed under the national patent laws of other countries. Because, notwithstanding the leeways available under TRIPS for such provisions (as have been introduced in Indian Patents Act), the Agreement does not make it obligatory for the member countries to include in their respective patent laws provisions aimed at protecting the bioresources and TK of the country of origin against biopiracy. However, the protection of these precious assets cannot be guaranteed until and unless certain compulsory provisions are included in TRIPS in this regard, which all the Member countries would be obliged to comply with.

The Current Scenario at the WTO

India and some other like-minded developing countries (e.g., Venezuela, Bolivia, Colombia, Ecuador, Nicaragua, Peru, Thailand, Cuba, Brazil, Pakistan etc.) have been fighting against biopiracy at the WTO for quite some time now. In various communications to the TRIPS Council of the WTO during the last few years, it has time and again been emphasized by this group of countries that the rights of the holders of TK to share benefits arising out of innovation based on their knowledge and the associated bio-resources should be recognized in the TRIPS Agreement. This, according to them, calls for harmonization of the provisions of TRIPS with those of CBD. It is apprehended by India and others that in the absence of clear provisions in TRIPS providing for a mutually supportive relationship of that Agreement with the Members' obligations under CBD, implementation of the TRIPS Agreement may allow for acts of bio-piracy and thus result in systemic conflicts with the Convention. With a view to avoiding such conflicts an amendment of the TRIPS Agreement to accommodate some essential elements of CBD is considered necessary by India and allies.

Hence, this group of countries has proposed in the WTO that the TRIPS Agreement should be amended in order to provide that Members shall require that an applicant for a patent relating to biological materials or to TK shall provide, as a condition to acquiring patent rights:

• disclosure of the source and country of origin of the biological resources and of the traditional knowledge used in the invention;
• evidence of prior informed consent through approval of authorities under the relevant national regimes; and
• evidence of fair and equitable benefit sharing under the national regime of the country of origin.

Even though the recognition of the subject under the Doha Ministerial Declaration was initially perceived to be a significant step forward in resolving the issue, the actual chain of developments on the matter in the TRIPS Council in the post-Doha era, has not given much scope for the India and allies to cheer. The principal resistance to the proposal of amendment of TRIPS for incorporating the new patent disclosure requirements to bring TRIPS in line with the CBD has come on behalf of the United States.

The US maintains that while the objectives of TRIPS and CBD are distinct, there is no conflict between them and that these agreements can and should be implemented in a mutually supportive manner. The US clings to the argument that the introduction of the proposed new patent disclosure requirements will not ensure the achievement of the objectives envisaged by CBD and may furthermore have significant negative consequences. For instance, it is argued that the new patent disclosure requirements would add new uncertainties in the patent system. Particularly where the sanctions for non-compliance include invalidation of a patent, this would create a "cloud" of uncertainty over the patent right by opening a new avenue for litigation and other uncertainties. These, according to the US, would undermine the role of the patent system in promoting innovation and technological development. Moreover, the US apprehends that the new patent disclosure requirements may also lead to significant administrative burdens for the patent offices of the Member countries, which, in turn, would result in additional costs. This, argues the US, would be the case particularly with respect to those requirements that would demand compliance with foreign laws.

In light of these concerns, the US is not convinced that the proposed new disclosure requirements in patent applications are an appropriate solution to the problem. Instead, it maintains that the CBD's objectives on access to biological resources and TK, and on benefit sharing, could best be achieved through establishment of separate national legal and other frameworks (such as contractual arrangements) outside the patent system that can more directly and effectively regulate conduct relevant to these issues. Upholding the view that the patent system has been and continues to be a highly effective tool for technological and economic development, the US has cautioned the WTO to be wary of upsetting the delicately balanced patent system, particularly when it is doubtful that any suggested changes will actually achieve their stated objectives.

India and allies, however, have not refrained from countering the arguments put forward by the US. As far as the apprehension of the US regarding the potential administrative and cost burden of the new disclosure requirement is concerned, India and others have argued that while there will be administrative implications and there may be cost implications for applicants as they are expected to at least employ all reasonable measures to determine the country of origin and source of the material to meet this obligation, it is not foreseen that administrative procedures and costs related to meeting the obligation would be in any way burdensome. They have also highlighted the fact that as a matter of patent law practice there are already a number of other disclosure requirements. Besides, there are already a number of countries that require such a disclosure of source and country of origin of biological resources and/or TK used in an invention.

Furthermore, bio-piracy, it is argued, is a global problem and more often than not, involves the acquisition of material in one country and seeking of a patent in another. This means that relying on national measures alone is not sufficient to address the bio-piracy problem. Hence, to ensure the effectiveness of the contemplated obligations on the applicants, a positive and mandatory obligation needs to be imposed on the Member countries of the WTO to require the disclosure by patent applicants in their territories of the source and country of origin of the biological resources and/or TK used in inventions. Such a positive and mandatory obligation, according to them, could be introduced into the TRIPS Agreement either by appropriately amending the existing provisions or by introducing a new article in the Agreement.

In a significant attempt towards expediting the process of resolution of this contentious issue, India along with other like-minded developing countries has submitted a 'Checklist of Issues' (by a communication dated 2 March 2004 (IP/C/W/420)) on the relationship between TRIPS and CBD. The basic purpose of the 'Checklist' (see the Box) is to facilitate more focused, structured and result-oriented discussions on the subject. While most of the Members have agreed that the 'Checklist of Issues' identified in the communication formed a good basis for further deliberations in the TRIPS Council on this matter, the US (this time along with Japan) has once again come forward to oppose the proposed checklist approach arguing that World Intellectual Property Organisation (WIPO) is a better forum for detailed discussion on these issues. Although India and allies are still deliberating through various communications with the TRIPS Council on the aegis of the framework drawn in the 'Checklist', the snail's pace of progress made in the last one year clearly reveals that even the 'Checklist' approach has not been quite successful in actually expediting the process by breaking the deadlock.

Considering the current stalemate in the TRIPS Council on the contentious issue it seems highly doubtful that the debate will be resolved sometime in the near future. What is beyond any doubt however, is that, given the strong resistance put forward by the US on the issue, it is not going to be an easy battle for the proponents of the new patent disclosure requirements to win. Nevertheless, India, along with the other like-minded developing countries, should leave no stones unturned to ensure an effective protection against the biopirates of the 'North'. What are at stake are not only the legitimate rights of the custodians of the TK and the associated bioresources of this country, but also the stupendous commercial and trade implications associated with such precious resources.