National Workshop on December 8th & 9th 2006 Hyderabad

"Emerging Technologies and IPR Implications"

Dr Bala Ravi, Advisor, Biodiversity in the M S Swaminathan Research Foundation, Chennai, was the next speaker who made a presentation on "Emerging Technologies and IPR Implications".

He began by saying that holding this workshop was a good beginning to begin the debate on the KIA albeit a bit late. He also felt that this process will not be sufficient for sensitization of people involved about the implications of the KIA and that multiple approaches have to be followed, including media intervention. The following are the main points he made, divided into two sections - what is the IPR regime related to agriculture that exists in the country today and two, what are the implications flowing out of the KIA.

• In our country, we did not have any patent regime for a long time. During the British rule of the country, the colonial powers introduced their own law in India. After independence, we had our own laws to govern IPR issues like the Copyright Act and the Patents Act of 1970. At that time, the law said that any method in agriculture or horticulture is not patentable. Any processes for treatment of plants and animals for rendering them free of pests and diseases were also not patentable at that time. No life forms were patentable as per this Act. As per this version of the Act, the period for patents was seven years for chemical processes. And then, India went to sign international agreements like TRIPS [Trade Related Intellectual Property Rights].

• TRIPS identified eight different kinds of IPRs. Patents shall be made available to all inventions whether for products or processes in all fields of science and technology (agriculture is also a field of S&T), as per TRIPS. Under TRIPS, for agriculture, patents and Geographical Indications are important. All developing countries have been given ten years from 1995 in which to make their domestic laws compliant with the treaty. The first phase of five years ended by 1999. The second phase ended by end of 2004. WE are right now in the TRIPS regime with our own laws changed and modified to make them TRIPS-compliant. A first amendment to the Patents Act was made in 1999 followed by a second amendment in 2002 and a third one in 2005. India enacted the Plant Varieties Protection & Farmers' Rights Act in 2001 to make use of the sui generis clause of TRIPS.

• A Patent is a legal grant by the State to an inventor allowing right to exclude others from making, using, exercising and marketing his/her invention within a geographic territory for a stipulated period of time in lieu of disclosing the invention in a patent specification. You can license the invention out or sell it for a royalty and so on after obtaining a patent. You can deal with it as you would with moveable property.

• The three essential requirements of a patentable invention are Novelty (that something is not known to the world till that date), Inventiveness and Industrial Utility. Some important features of a patent include the fact that there is nothing like an international patent and each patent has to be obtained in a given country (once something is patented somewhere, you cannot copy it and try and obtain a patent elsewhere because it loses its novelty). A patent established in one country is not automatically applicable in other countries. However, extension of a patent from the country where it is first established to other countries can happen within 12 months. A patent automatically lapses after 20 years and also lapses when renewal fee is not paid. Further, a patent can be challenged any time from its grant/ establishment to its expiry.

• In the Indian Patents Act of 2005, after the last set of amendments have been made, the following are the exemptions: Any methods in agriculture and horticulture are not patentable. An invention, which in effect is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known components is not patentable. Plants and animals are not patentable in whole or any part thereof, except for micro-organisms. Such non-patentability applies to seeds, varieties, species and essentially biological processes for production and propagation of plants and animals (normal, natural process of reproduction). Discovery of any living things occurring in nature is also not patentable [even the patentability of micro-organisms requires that they be improved or modified but not be patented as taken from Nature].

• Patents are however allowed on chemical, bio-chemical, biotechnological and food processes; on products arising out of the above processes except for the exemptions mentioned above; on microbiological processes and products thereof as per the 2005 Act. Product patents allowed now in India will have implications for stronger monopolies building up on several fronts including in the pharma sector.

• Patent Act 2005 also has a Disclosure requirement which means that the source and geographical origin of the material mentioned in the patent application is required to be disclosed. Further, the subject matter material has to be deposited in an international repository authority under the Budapest Treaty [India joined the Treaty in 2003].

• It is also important to understand the differences between India's patent regime and the regime that exists elsewhere, especially the US of A. There are many countries which have gone above the de minimis requirements of the TRIPS. In the USA, it is said that everything under the Sun can be patented. New plants and animals which are even naturally occurring are patentable in the US. There are instances of plants not known to America being carried there and patented there. Biotechnological products such as transgenics or other genetically engineered plants and animals are patentable there. Components of life forms like cell lines, tissues, organs of plants and animals including human beings are patentable in the USA. Genomes and gene sequences of plants and animals are also patentable.

• Comparison of the patent regimes between India and America shows glaring differences. While plants and animals are patentable in the US, they are not in India. On plant varieties, USA grants patents while India has a sui generic system of allowing Plant Breeder Rights (in addition to rights to researchers and farmers). Our patent regime is generally what is minimally required under TRIPS obligations. India has a Plant Varieties Protection & Farmers' Rights Act as the sui generis law. Plant Breeders Rights are the main IPRs provided under this, even as Farmers' Rights are also included. These Farmers' Rights are not only about use, re-use, save, sow and exchange registered varieties but an express provision to register farmers' varieties also. Researchers' rights are also provided for on registered varieties in this Act. In other countries, there is only Researchers' Privilege.

• India also has a Geographical Indications Act, enacted in 1999. This is to preserve the distinction of identify of particular products, those products which can be conceived in the mind just by the mention of the name. This is an attributable association between a given quality, reputation and other qualities of a product and its origin or production or act of processing or preparation in a definable territory. Often times, these are traditional varieties developed by communities and grown by them in particular parts of the country and a reputation associated with such varieties or products. Examples of GI in India are Darjeeling tea, basmati rice, Mysore silk etc. This is an IPR that is not transferable. The community gets a collective IPR as custodians.

Subject matter                                                         IPR Regime in USA              IPR Regime in India

Plants including transgenics                                        Patentable                             Not patentable

Animals including transgenics                                     Patentable                             Not patentable

Plant varieties                                                            Patentable                             Sui generic

Organs, tissue or cell lines of plants & animals             Patentable                             Not patentable

Gene sequences of plants or animals                           Patentable                             Not patentable

Expressed Sequence Tags                                          Patentable                             Not patentable

Single nucleotide polymorphism                                   Patentable                             Not patentable

Collective IPR under GI                                                Not allowed                            Allowed

• Biopiracy as a phenomenon has increased in recent times - since the 1990s, after patenting of life forms has been allowed. Advances in biotechnology are also another reason for increased bio-piracy. You can take one leaf of a plant from one country to the other, extract the DNA and patent a gene there. Out of the 2 lakh patents that have been established the world over on genetic material, the share of developing countries is 6%. Five corporate biotech giants, including Monsanto, own more than 75% of proprietary biotechnologies. Our earlier fights over bio-piracy related to neem, basmati and turmeric have also shown us that some of these could be fought, but at a huge cost - very often, this is not affordable.

• Now, there are attempts to document traditional knowledge to determine novelty and to counter bio-piracy. It is said that this will prevent bio-piracy and not just countering a patent after it is established. Traditional Knowledge Digital Libraries are being set up and the Biological Diversity Act talks about establishing people's biodiversity registers. A relevant counterpoint is that such ready documentation actually allows for more bio-piracy. 35000 ayurvedic preparations are supposed to have been documented so far under TKDL.

• The Biological Diversity Act defines all forms of biodiversity in the country as the sovereign property of India. Under this a National Biodiversity Authority has been set up to ensure that no foreigner has access to any biological resource or knowledge associated therewith, occurring within the country for research, or commercial utilization or bio-surveys or bio-utilisation without the consent of the Authority. The Act further says that prior approval by the NBA is mandatory for applying for establishing any IPR based on Indian biodiversity or traditional knowledge, with an exception to plant varieties however.

• Coming specifically to the KIA and IPR implications, it should be recognized that the deal provides for great R&D and innovation potential in at least four areas of the KIA - agri-processing and marketing; biotechnology; water management and about a dozen niche areas identified. There is also a huge transfer of crop, animal and fish genetic resources involved in the Theme that covers Biotechnology.

• The Biotechnology collaborative research involves pigeonpea genomics, cDNA [chromosomal DNA libraries], QTLs, allele mining, genes concerned to resistance to biotic and abiotic factors, genomics of buffalo and goats, cell and stem cell lines of these animals, Indian finfish species and the genetic diversity there and so on. Much of this diversity has been generated and nourished by our farmers to suit different growing conditions and our material is rich in resistance to many biotic and abiotic stresses because of such selection and maintenance of diversity. All these material is now going to be shared amongst concerned American Universities and private laboratories.

• Such transfer of huge and very important genetic material is happening without specific Material Transfer Agreements in place. There is no mention at all in the KIA document about such MTAs. There is a high danger of eventual use of these materials by US public and private sector research bodies for creation of patents. Further, the USA has not ratified the Convention on Biological Diversity and does not recognize the sovereign rights of other countries over their biological resources. Material is already being taken from here by scientists and after the research is over, it is not as though everything can be brought back. You can't destroy everything that has been studied and created in the research. You end up leaving some material as well as lot of data. Genomics of pigeonpea for instance cannot be done by taking just one variety from here.

• It is obvious that the biotechnology research is likely to generate innovations patentable in the USA. The KIA document is however silent on potential ownership. Absence of MTAs creates more dangers. KIA is also silent about the third party use of material after the research project period.

• What is also relevant to note is the fact that India has fair human and institutional capacity to conduct its own research in all the areas shortlisted in the KIA, especially on the biotechnology front. Rice genomic sequencing that we did as part of an international project is a good example to show that we have the capacities to take up such research right here in the country. DBT is being increasingly strengthened to take up research on almost all these topics listed in the KIA - we have nearly 55 centres of excellence recognized by the Department of biotechnology. There is no dearth of excellent laboratories or human capacities in the country on many of these areas, within the public sector itself, provided network approach is taken. There is no need to give so much material to our scientists and send them abroad and learn from the Americans. Simple training and upgrading the skills of Indian scientists is understandable. However, the transfer of Indian resources in the name of joint research, without an MTA is a dangerous thing that is happening. Joint patents in such partnerships mean that sub-licensing can happen from one party to a third party without the partner in the patent being informed about it. In the US, the private sector has a strong hold over the research, unlike here in India. Even Universities do most of their research for private companies. The public sector bodies also sell their research to private companies.

The KIA document seems to have been put together in a great hurry. There are many inconsistencies within the proposal - for example, 14 universities from the US are supposed to be collaborating on this deal. However, just the biotechnology section lists out 19 such universities including one private company. Further, the proposals for research under 'emerging technologies' seem to be a collection of various ongoing research projects that are already happening in India. Like buffalo genomics undertaken by the IVRI.

Given all the above, the KIA on biotechnology with transfer of Indian biodiversity is a strategic blunder, Dr Bala Ravi concluded.

Before the discussions began, Ms Kavitha Kuruganti from CSA requested the participants not to go into their stand on IPRs in agriculture (just presume that most people in the workshop are against it at the philosophical, conceptual and practical levels) and kindly focus the discussions on how we counter the KIA and its IPR implications. Mr Vijay Jawandhia added that if we ensure straight line varieties for all crops for farmers, no IPR law is going to affect farmers. If such seeds are available, this discussion on IPRs may not be necessary at all, he said. While seed prices are constantly increasing as we shift from varieties to hybrids to GM hybrids, the market price of output is falling for farmers.

DISCUSSIONS AFTER THE PRESENTATIONS ON THEME 2 OF THE KIA

• Mr Sreedhar from Thanal pointed out that Dr Bala Ravi's presentation raised some serious lacunae and questions with serious implications, flowing out of the KIA. In short, this is regarding the sovereignty of the nation and the need to protect our resources at whatever cost. Have these questions and concerns been raised in any official forum either in the formulation of the KIA or in the past one year of implementation, he wanted to know. He felt that this is of particular interest given that an NGO like MSSRF works with the government, unlike many other organizations which are fighting the government from outside. He added that Dr Bala Ravi's presentation shows that the KIA is a clear case of robbery under the leadership of the present government. He wanted to know from Dr Bala Ravi what legal options and what political options exist for civil society to counter what is happening. Dr Uma Shankari asked a related question on whether the MSSRF backs Dr Ravi's anxieties about the deal. Mr Debjeet Sarangi repeated the question by asking what MSSRF's stand on the deal was, given that Dr Swaminathan is also the Honorary Advisor to the Board of the KIA.

• Dr Shambu Prasad had a question related to technological determinism. The earlier day, there was a comment about atomic science moving ahead despite resistance from people including atomic scientists on a variety of grounds. He felt that there is a parallel here in agriculture with transgenic science and technological determinism. One side of the coin could be the conspiracy part, but the other side is the belief of scientists with institutional reward mechanisms built around such technological determinism. How do we respond to this huge technological determinism mindset? He also referred to Dr Bala Ravi's reminder to everyone that the USA is not a signatory to the CBD. On the nuclear deal, the US is able to put pressure on us to sign the NPT but nowhere is India saying that the US should sign the CBD. Why are we as a country unable to ask this of the USA? Should we ask our parliamentarians and others to raise this as an issue?

• Dr M S Chari wanted to know why there were differences in the royalties charged, from country to country, as the case of 'Bollgard' Bt Cotton illustrates. He also referred to the origin of illegal Bt Cotton in the country. Breeders from public sector are moving out to join private companies and are coming with new lines and varieties without following any legal procedures laid down. It is as though they have just dreamt about which variety exists where and picked it up to make crossing and to come up with new hybrids. It is also claimed later on by the company that they do not know how the Bt ended up in the plant, because they were undertaking pure line selection. How can this be allowed in our country?

• Mr Dharmendar Malik of BKU observed that farmers are not being given what they are asking for [good market prices for their produce, for instance], whereas things that were not asked for are being imposed upon them forcibly [IPRs]. It seems as though this is a method to criminalize farmers and penalize them, more than anything else.

• Mr Udaya Shankar wanted to know whether there was involvement of Department of Biotechnology or institutions like CCMB when the KIA was formulated given that it is an interdisciplinary programme. What are the procedures and processes that are followed in arriving at such bilateral agreements, he wanted to know.

• Ms Usha pointed out that regulation for many reasons does not work, does not happen in our country. Whether it is related to a technology or whether it is related to IPR regime. Taking the example of Kani Tribes, she pointed out that things like benefit-sharing have actually divided the community into two factions. We will end up doing that with Geographical Indications and other IPRs too. Instead of this, why can't we think of ways to protect our resources and knowledge at the national level as a sovereign right?

• Dr Uma Shankari wanted to know whether we cannot have a non-monetised system of recognizing innovations in an IPR system. If we have a system like that, we can invite people to come and do collaborative research and only the genuinely interested will come to us, she argued.

• A participant from Chittoor (who is also a Planning Commission working group member related to horticulture) summed up Dr Ramanjaneyulu's presentation as his arguments on why we don't need the technology and another set of arguments on how regulatory systems are failing. He wanted to know whether we have the kind of power that it takes to say no,

• based on this. Should we fighting this KIA which is after all only a 116-crore-a-year, small project, compared to the thousands of crores of rupees we are spending on other things and even wasting? He felt that NGO representatives go here and there and acquire some knowledge and keep saying No to various things. As I farmer, I don't care if the urban consumer dies because of a technology I adopt, he said; in the first instance, it is the urban people who taught the farmers all the hazardous technologies. Now that their health is badly affected with chemicals in food and food production, they are talking about how farmers should shift to biotechnology, he observed. Most NGOs are not asking farmers what they want but are only concerned about what they are advocating for from an ideological perspective.

• Ms Kavitha Kuruganti reiterated her earlier point about the two levels at which the IPRs in agriculture issue plays out. Saying No to IPRs in agriculture is something that has already been stated by most groups, she felt. At another level are implications flowing out of the KIA. She asked the participants whether we can bring the discussion to strategies of countering rather than just on stands related to IPRs.

• Another participant also wanted the workshop to first clarify our own role and what we need to do from tomorrow to counter the KIA and its implications. What should we do and what do we want others to do, he asked. Since the agreement is silent on some crucial aspects, what has to be done now, who has to do it, how etc., he wanted to know from Dr Bala Ravi.

• Mr Shaik Anwar wanted to know from Dr Bala Ravi whether the legal space does not seem to be contradictory between the KIA and the PVPFR.

Dr Bala Ravi's responses to the points raised by the participants:

• MSSRF is an NGO and its footing is like any other NGO. Dr Swaminathan as an individual is however being asked by the government to be involved in various projects, discussions, working groups etc., as an Advisor or a Chairperson and so on. That is in his personal capacity and it has nothing to do with MSSRF, the NGO. He is the Chairperson of the Governing Board of the MSSRF, true. He accepts various roles that could be convenient to him if governments and other national, international and other agencies ask him to. For example, he is advisor to the West Bengal government, to Rajasthan government and so on. On the other hand, we [about 200 staff members] at the Foundation work on several programmes and projects like any other NGO. He also said that no one from the Foundation has been involved in any official discussions on the KIA as per his knowledge. "I have no comment on whether he has accepted an Honorary Advisor position on the KIA in his personal capacity. I did not know that he was an Honorary Advisor to the KIA until I came here, in fact. I did not go to the internet to check more on the KIA but mostly went with the material the organizers had sent me as the KIA proposal", he added. "I am here speaking on my behalf, as an individual who has expertise in this area".

• Coming to the legal and political ways in which the KIA [especially on the IPR front] can be countered, he had a few points to make. Parliamentarians, state legislators (especially given that Agriculture is also a state subject) etc. can be approached. States can move on their own depending on whether they [are made to] understand the gravity of the situation. In any case, biodiversity is a state subject too - the Central government does not own any biodiversity - finally, biodiversity belongs to the state and the panchayats. State governments can move on this in an appropriate manner, he said. Similarly, parliamentarians can be sensitized to move on this issue if civil society can give a factual briefing to them. Legal recourse is always possible - we can move a court asking how the KIA can move forward when we have a Biological Diversity Act in the country without MTAs and without the consent of the NBA.

• The very purpose of any IPR is to give an exclusivity in commercial gain - therefore, having a law in India that has non-monetised IPRs is not possible. Whatever the IPR is, it finally boils down to the financial benefit. Our present IPR system has come as a consequence of our joining the WTO and the requirement of TRIPS. The amendments made to our Patents Act was incremental to meet the requirements of the TRIPS. Each time, there was resistance and hue and cry raised. The parliament rejected the amendments twice in fact and a Joint Parliamentary Committee was also set up. The Act in its present stage is there with considerable public-state interaction only. If we raise enough public opinion, we can certainly change the law - that recourse is always open of course.

• On NPT and CBD and USA's stand on these treaties, he explained that it is your clout in the international community that finally matters on whether you can get another country to sign on the NPT while you yourself would not sign on the CBD. Even if the media thinks that we are equal partners, it is not so in reality. He reiterated the point he made in his presentation that many of the areas of collaboration are not warranted in the first instance.

• On differential royalties being charged in different countries: the Bt gene is not patentable as per the Indian law. Public sector bodies like CICR can easily develop their own Bt Cotton varieties since the Bt gene is in the public domain. As we know, Gujarat farmers are developing their own Bt cotton varieties. Why could not ICAR develop its Bt Cotton varieties? A senior technocrat responded to this by saying that he does not have the support of his superiors. Well, all business people have their business morality and protocols. Although there is no law, they do not want to displease a business opponent. These royalties are charged mostly based on the market value and not because of laws that have been applied. The market value can be different for the same product in different contexts. In China, the Chinese Academy of Sciences had developed its own Bt gene and their own Bt Cotton crop. This, they started selling at a very low price. If that is the case with the public sector selling seeds at a very low price, the private sector cannot sell at a high price. They had to cut down their royalty. Kavitha added to Dr Bala Ravi's point and said that royalty fixation was preceded by market surveys that assessed WTP [Willingness to Pay] by farmers and was based on the results of such surveys.

• Responding to the fact that the government seems to be giving things to farmers that they are not asking for, while denying what they are asking for, he said that the PVPFR went through a process of consultations and discussions with many farmers' organizations. It was first mooted in 1993 when P V Narsimha Rao was the Prime Minister and went through the Parliament and its Joint Parliamentary Committee when the Rajya Sabha rejected the then Bill. In 2001, the Parliament passed the Act after the JPC went state to state consulting various stakeholders. To say that this Act is not receiving public support is a disagreeable matter, he argued. "Our democracy has been functioning like that and if any activism is required, it has to be done at the right time. If civil society activism does not happen at the right time, you know that to re-do the law the effort required is manifold", he pointed out.

• Were the DBT and other stakeholders involved while formulating the DBT? Dr Ravi said that he was not familiar with the process adopted and cannot answer this.

• In terms of roles to be played, he felt that this workshop should bring out the details of what is objectionable about this deal in a priority order and create awareness about it in the public in general but policy makers in particular. We can consult legal experts on the possibility of getting a stay on this, he said. Even though this is supposed to be a collaborative research, the proposal only talks about the money that the government of India is putting in, not what the US government will put in. It is not clear what the USDA is going to do and what is its role. Despite such confusion, it is reported that scientists from here have begun going to the US, with materials and that the research has begun, especially under the Borlaug fellowships.

Dr Ramanjaneyulu's responses to the discussion points raised:

• Agricultural research establishment cannot seem to get out of a mindset that they have of promoting techno-centric, input-centric models. How do we make the establishment accountable for the technologies that they generate and promote in itself should take care of how do we get them out of this mould.

• On consultation processes that have been adopted for the KIA formulation, there seem to be no such processes, from the information we collected from within the ICAR. It seems to be a top-down approach. Somebody has decided somewhere that this is the way to go and it is just passed down. There are so many unresolved issues related to technologies and ramifications, IPRs, priority themes for research etc. In the SAU of Andhra Pradesh, from the day George Bush visited the campus to this day, several senior scientists and officials have been visiting the USA but there is no clarity about what is happening.

• To Mr Narayana Reddy's point on urban consumers now dictating technologies that farmers should adopt, Dr Ramanjaneyulu clarified that CSA is not looking at the issue from a consumer perspective - that the beginning point is the farmers and their livelihoods, their reality. In the case of Bt Cotton also, it is the farmers who are facing the problem. If there is really a technology that helps farmers and upholds farmers' rights, we are not going to resist it, he said. However, we are trying to foresee from the experiences that we have had with GR technologies earlier, the Bt Cotton and GM regulation so far and evidences from elsewhere. Our understanding on GE issues flows from that and our analysis shows clearly that this is not for farmers and their benefit, he said. He also pointed out that like in the case of GR, we cannot afford to take up only post-mortem exercises on it, especially in the case of GE by allowing it to come in only to discover foreseeable problems sooner or later. We need a meaningful dialogue based on the evidence and arguments we are presenting. It is not wise to just attribute some motives to us, he pointed out. • It is also worth noting that the establishment is not bothering anymore about facts and empirical evidence - the situation also seems to be beyond law and regulation. The seed pricing issue that the AP government is fighting is a good example for this in a country which has technically no patents on genes. And when laws of both countries apply, the issue becomes much more complicated. We cannot walk into this blindly given such complications.

• The most important question according to him was, how can we believe that farmers will benefit out of all the transgenic research that the public sector is planning to take up under the KIA if the past twenty five years of research on hybrids has not materialized only in small set of farmers adopting the public sector releases. Unless we change the systems that exist, you may come out with any technology, but it may not reach the farmers. You may develop a variety, you may release it, the scientist might get a patent and even a promotion but this does not necessarily mean that farmers benefit out of it.

Mr Vijay Jawandhia concluded the session with a few remarks from the Chair. 65% of Indians are farmers and they are the ones voting governments into power mostly. And it is the farmers who are committing suicides. Soon, whole families have to commit suicides. According to our Constitution, Agriculture is a state subject. However, all major decisions related to agriculture have been kept with the central government. How do we stir up the politics of this, especially with the regional parties which are getting stronger in the country than ever before? If can change the politics of this country, there is hope that human beings in this country will get to live with human dignity. Until then, there is no hope, he added.