Patent Act:Biopiracy Of Traditional
Indian Products - An Overview
By Divya Bhargava
14 May, 2009
Each time someone claims a bit of India as their own - and in these times of Patent wars, we're fighting claims to about 40 products all over the world - the country goes into a tailspin. Anger, Confusion, Desperation and Determination to Fight It Out (one more time) do urgent rounds of Government offices, Agricultural bodies and NGOs. Perhaps rightly so, since Basmati, Neem and Haldi have never been too far from an Indian's life, and the idea that Someone Else may acquire the right to own, trade and market it, is more than a bit jolting.
Warning the world against " Scientific and Technological Colonialism " India offered to help all Developing Countries in protecting their wealth of Traditional knowledge with Patents so that it is not exploited by the West for making money.
One of the main objectives of the patents system is to develop new knowledge for prosperity of mankind which is getting diluted day by day. It is instead helping monopolisation of new knowledge for exploiting mankind. The need of the hour is to grant patents in a way that serves public interest. Our traditional knowledge is the result of hard work of our ancestors. It should be used for the benefit of humanity. But in this competitive world of patents, it needs to be protected. The grant of patents on non-patentable knowledge which is either a part of the traditional knowledge of the developing world or a minor variation thereof has been causing great concern to the developing world”
What is Bio Piracy?
“Bio piracy ‘refers to the use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products and processes that have been used over centuries in non-industrialized culture”.
Until and unless the very own traditional knowledge of our is protected, the country would have to fight for patents claimed by other countries as in the case of Haldi, Neem and Basmati . Creation of the TKDL, which targets Ayurveda in the first phase, would go a long way in this goal of protecting the country's traditional knowledge. It would help fusion of country's traditional knowledge with modern science. Government has taken a very effective move by setting up of an inter-ministerial access policy committee for TKDL to decide on accessing the data stored in the library. The West had claimed many of inventions which were known to India in the past as its own . What can be done is that all the Experts in all these areas like science, music, dance should try to find out what has been available in the past in the country in order to protect its patenting. Whenever there is an effort to protect the traditional knowledge, an opposition is faced by India . "Our medicines will be available to the world for the welfare of people." But now the world is a big threat to Indian pharmaceutical industry which discourages Indians for new inventions and discoveries as we do not know when our very own original invention can be claimed for patents.
India was the first to raise the fundamental issue at the World Intellectual Property Rights Organisation (WIPO) as to why the traditional knowledge-based system should not be treated at par with the industry-based system. In order to prove our stand on the patent rights claimed by west on our traditional knowledge, there is a need for vast human resources and various departments should be involved for the purpose. In 1995, two U.S. based Indians were granted U.S. Patent 5,401,504 on Use of Turmeric in Wound Healing, (popularly known as the Turmeric patent), which was assigned to the University of Mississippi Medical Centre, U.S. The invention claimed under the patent was the use of turmeric at the site of an injury and/or its oral intake to promote the healing of a wound. What more can be humiliating than this? US granting patents to US based Indians and trying to show India that they are giving it only to Indians but what has to be seen behind the iron screen is the cunningness of Americans that this patents are US based and will be useful only for America and not for Indians.
IPRs over Products of Biodiversity:-
1. Hill turmeric :-
The news was greeted with disbelief and surprise by most people in India . From time immemorial Turmeric has been traditionally used in India for its many special properties in wound-healing. For instance, it is used as a blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also used as an essential ingredient in cooking many Indian dishes. How could someone obtain a patent - i.e., an exclusive right to sell and distribute something that was so commonly known - was the disturbing question? This gave a striking blow to India . The biggest challenge before India was to prove its stand in the US courts.
The claimed subject matter was the use of "turmeric powder and its administration", both oral as well as topical, for wound healing. As per the requirements of U.S. law, it was necessary to find adequate evidence in the form of printed and published information that would establish that the manner of use of turmeric as in the claimed invention, was known before the patent was claimed and, therefore, the patent was invalid. Despite the fact that the use of turmeric was known to every Indian household for ages, finding published information on the use of turmeric powder through oral as well as topical route for wound healing was a difficult task. We were fortunate enough that after an extensive researches 32 references were located, some of which were more than 100 years old, and in the languages of Sanskrit, Urdu and Hindi. The USPTO revoked the patent, stating that the claims made in the patent were obvious and anticipated, and agreeing that the use of turmeric was an old art of healing wounds. The patent on the "use of turmeric in wound healing" is but one of the many examples of how patents are being sought over various aspects of biological resources and products derived from the same. What complicates matters in such patents is that the various useful properties and knowledge regarding biological resources is already known to many communities of the world in such circumstances proving our case over our traditional knowledge becomes difficult.
In the field of pharmaceutical research, indigenous knowledge contributes towards the identification of the material in developing the drug, and often provides information of its precise uses in treating particular illnesses, its means of preparation and its dosage. Some of the other recent examples of patents granted over "inventions" based on biological resources pertain to: Adivasi with Phyllanthus, traditionally used for jaundice: there is a need for alternative protection regimes for such knowledge.
i) Composition of Jamun, bitter-gourd, Gur-mar and Eggplant for treatment in diabetes.
ii) Various products obtained from the neem tree.
iii) Varieties of basmati which have the characteristics of growing in temperate climate in the absence of sunlight.
iv)Composition of Methi as a tonic to bring down blood glucose levels.
v) Compositions comprising of kala jeera or kalonji for increasing immune functions, and in the treatment of Diabetes, Hepatitis, and Asthma.
The basic logic behind patents is to promote innovation, by ensuring that the "inventor" would have the exclusive right to sell and distribute the "product" s/he has "invented". Patents, by definition , cannot be granted over something that is obvious; that is known or anticipated by prior use; that is a product of nature, and not a product of human creativity. However, laws of different countries vary in the criteria used for assessment of the degree of human innovation that is required for qualifying for a patent. In the turmeric case, it was possible for the CSIR to establish that the patent claim was not "new". However, it may not be possible to establish this in each case.
In the basmati patent, the Government of India has challenged only three of the 20 claims granted to the patent holder, Ricetec; the reason being that there was enough evidence on record only to challenge these. What was being challenged were only claims regarding certain characteristics of basmati (specifically starch index, aroma, and grain dimensions); and what was not claimed was the novelty which is also very important since the properties of each of the ingredients in the composition, and sometimes the composition itself, is not "novel". Another issue for consideration is that while in the case of turmeric , the use was commonly held knowledge, there would be many instances when use/s of a specific plant or herb is known only to a particular community or tribe or individual. " Patenting " products developed from such biological material poses further challenges. Though in effect, the turmeric case was a "success story", it also revealed a variety of "problem areas" in challenging what was obvious to people in India , based on the laws of a foreign jurisdiction.
Currently, the problem which is faced by many developing countries are that there is no requirement under patent laws of most countries for the holder of the patent, or any intellectual property rights for that matter, to share the benefits with those who had collected, preserved or initially identified the biological material as potentially worthy of investigation. The TRIPS Agreement that seeks to harmonise the Intellectual Property laws of various countries does not mandate this either.
India and other developing countries have emphasised in various communications to the World Trade Organisation (WTO) that the rights of holders of traditional knowledge to share benefits arising out of innovation on the basis of their knowledge and the biological resources nurtured by them, should be recognised. They have also have recommended that applications for patents should mandatorily disclose the source of origin of the biological resource and knowledge pertaining to it, so as to facilitate benefit sharing with the originators of the knowledge and resource. The United States has strongly opposed this as a "legal and administrative nightmare". This kind of a stand by the U.S. would only lead to greater misappropriation of biological resources and knowledge pertaining to the same.
US Patent on Neem :-
After a victory in turmeric case its another victory for India over its patent rights to use Neem. Signing by non-governmental organisations (NGOS) in both India and abroad forced the revocation of a patent granted jointly to the US Department of Agriculture (USDA) and the US chemical major W.R. Grace on a fungicide formation from the seeds of Neem. The fight was triggered off by a petition filed by three others before the European Patent Office. It culminated on May 11 when a four-member team of the EPO revoked the patent.
The legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP) who is currently the environmental minister of Belgium . The petition filed had categorically stated that "the US/Grace patent did not satisfy the basic requirements for a patent." The decision taken by the EPO has been appreciated across the globe by scientists and entrepreneurs alike. It has proved that the civil society can channel its efforts to effectively prevent biopiracy from developing nations. Indian Minister for Science and Technology said that It is highly appropriate that the EPO has held that the patent amounted to Biopiracy and has endorsed that the process for which the patent had been obtained was actually in use in India since time immemorial." As Indian farmers and indigenous communities strive to better the yields with traditional knowledge the MNCS might be there right behind them, ready to "steal" the product or process, introduce a non-existent novelty and then stamp a patent on it. Without the knowledge of Indian communities of the medicinal and insecticidal properties of Neem, it would just have been another tree to Grace.
It looks like that the west is behind Indian traditional knowledge, again and again its making every product its patent victim. Its now turn for Atta chakkis. Hundreds of wheat exporters may fall into the trap being laid by a Nebraska-based company, ConAgra. The US Patent Office has granted patent rights to ConAgra Inc for the “method for producing an Atta flour”. It is clear from the declaration made by ConAgra that patent rights is not claimed over any novel innovation in the plant or machinery needed for processing flour, but on the very traditional method for producing Atta. Monsanto's infamous patent on Indian wheat (EP0445929B1) claims to have “invented” wheat plants derived from a traditional Indian variety, and products made with the soft milling traits that the traditional Indian wheat provides. Monsanto has repeated the biopiracy pattern earlier attempted by Ricetec, which had claimed to have invented Indian Basmati. With Greenpeace, RFTSE is now preparing a challenge against Monsanto's biopiracy of Indian wheat.
The first statement in Monsanto's patent remarks “This invention relates to plants and to products derived therefrom”. In this case, the plant is essentially derived from the traditional Indian wheats which Indian farmers have collectively evolved and conserved over millennia. Monsanto is claiming as its inventions the traits of Indian wheat evolved for India's food culture and cuisine, based on ‘rotis' and ‘chapattis'. The patent is thus a piracy not just of millennia of breeding by Indian farmers but also of millennia of innovation in food qualities.” Making India 's Food, Culture and Economy Invisible. Such false claims are made throughout the patent. Nearly 600 million Indians use soft milling low gluten wheat as a staple in the form of ‘chapatis or rotis'. For thousands of years, we have eaten wheats appropriate to our food culture. The alternative is available on a very wide scale in India in our daily food. This is the alternative Monsanto is attempting to pirate. Monsanto's claim covers wheat plants derived from Indian wheat varieties and products made from soft milling wheats.
In the west, because it is eaten as bread, wheat has been selected for high elasticity and high water absorption, so that it is able to rise. Indian wheats are bred for chapattis and have low water absorption and low elasticity. Monsanto's claim is clearly not novel. This is a clear case of piracy of India 's indigenous knowledge of breeding and cooking. The patent needs to be revoked because to classify this as an invention is misleading and laughable. It also needs to be revoked because with an exclusive right to grow wheat with low gluten, Monsanto could extend these rights to India under the Patent Cooperation Treaty (PCT) and then charge royalties from farmers growing traditional wheat varieties! Even if the patent is not recognised in India , Monsanto's biopiracy patent in Europe and USA prevents India from deriving benefits from the growing market in US and Europe chemical free, low gluten wheat products.
At present also 60% of Indian population is involved in agriculture. The roots of India lie in age old traditional agricultural occupation. Farming for Indians is not only a source of income – it is a source of culture and identity. Since the late 1990s however, Indian governmental officials have wilfully compromised this sentiment for the ‘bright lights' associated with the West Patents on seeds are a necessary aspect of the corporate deployment of GM seeds and crops. When combined with the ecological risks of genetically engineered seeds like Bt. cotton, seed patents create a context of total control over the seed sector, and hence over our food and agriculture. From time immemorial, farmers have sown seeds, harvested crops, saved part of the harvest for seeds, exchanged seeds with neighbours. Every ritual in India is associated with seeds. We can see various varities of seeds in our country – thousands of rices, hundreds of wheats, oilseeds such as linseed, sesame, groundnut, coconut, pulses including gahat, narrangi, rajma, urad, moong, masur, tur, vegetables and fruits.
The main motive behind genetically modified seeds which can be introduced by developed countries is to rule the developing nations. If this is implemented the consequences will be far more dangerous then expected. The poor farmers have to buy its own seeds from west, we cannot innovate or invest any other hybrid variety of seeds, poor economy, and various forms of genetic diseases. One of the greatest losses to our society has been the destruction of our indigenous seeds, in order to promote HYV and GM seeds. They have been destroyed, making way for HYV and GM seeds sold by big companies. India is seeing a mad race of companies to grow more GM crops such as maize, mustard, sugarcane, sorghum, pigeonpea, chickpea, rice, tomato, brinjal, potato, banana, papaya, cauliflower, oilseeds, castor, soyabean and medicinal plants. GM seeds are being promoted by World Bank, FAO and CGIAR (Consultative Group on International Agricultural Research which is totally dominated by the US and big companies).it is very easy for the GM seeds registered in the US to find their way to India even while other countries such as EU, Australia, New Zealand, parts of Brazil and some states even in the US, like Vermont and parts of California, are banning them! Everyone agrees to the fact that implementation of GM crops will cause irreparable damage to wild-life, biodiversity and can adversely affect organic and conventional seed through cross-contamination and the major concern is that so far no proper tests have been done to show their side-effects on man and beast.
Monsanto and other large producers of GM seed are desperate to get into India as they are being forced out of other countries. In India , too, we will have to protest and push out these MNC monsters and their deadly GM seeds, chemical poisons and deadly toxins. Maybe we can take a lesson from Argentina , Bolivia and Venezuela to form our own black market for seeds. Its high time that Indian government think about our farmers and age old agricultural occupation and stop pursuing its deadly motives and interests.
Scope Of Patentability:-
This is a core component of the patents system. The definitions of 'patentable invention' and 'patentable pharmaceutical substance' in particular have to be carefully framed to ensure that only subject matter of basic research are patented. Since the patents system prevents third parties from the acts of making, using, offering for sale, selling, or importing products for these purposes without the owner's consent, it is important to carefully frame the patentability as otherwise the system will deprive effective competition in new products by other industrial enterprises. This scenario will be against public interest. The public health policy and laws, national drug policy and the patents system are intensely co-related. This aspect should have been kept in view while implementing the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in amending the Patents Act 1970.
Need to Define Patentability :-
In the absence of a proper definition of patentable invention, it is seen that the patent authorities in India is granting patent to everybody whether the said inventor and its innovation or invention falls within the ambit of the patent definition provided in the Patent Act or not. Now the question is whom should be blamed? It would be improper to blame the Patent Authorities alone for grant of such patents. The real blame lies with the broad-based provision on patentability stipulated in the amended Patents Act 1970. The crucial issue is to whom the patent should be given. The government must get its act together and refer the matter of 'scope of patentability' covering definition of patentable invention, patentable pharmaceutical substance and even patenting of micro-organism to the concerned Parliamentary Committee so that time is not lost in amending our Patents Act. Patentability should be for a true invention.
Section 91 of the Patents Act 1970 provides for licensing of related patents based on conditions stated therein. These available possibilities are sufficient and could be suitably availed by the industry. The government should not bend down in front of multinational corporations to further liberalize the scope of patentability. Though India signed the Trade Related Intellectual Property Rights (TRIPS) agreement in 1995 , which commits a country to listing products/inventions it wants A comprehensive inventory of India's traditional wealth, whether it's the Alphonso mango, Kolhapuri chappals or Kanjeevaram saris, is yet to be documented.
There's hope yet. India is now trying to protect its IPRs through legislation within the country, but it isn't enough. “We need an umbrella legislation which will cover the entire landscape of traditional knowledge,” Informal groups, however, have been acting as patent watchdogs...
It is difficult to digest as how can scientists in US files patent rights over traditional Indian products by just adding a few minor innovations? The problem lies in the fact that the IPR system, under the World Trade Organisation (WTO), is designed for inventions which are ‘formal', such as those carried out in universities and laboratories, or as part of industrial R&D. As of now, the WTO does not recognise technology innovations by farmers, artisans or grassroot innovators, which happen in an informal setup. These form a large part of India 's traditional knowledge. Additionally, the IPR system is oriented around the concept of private ownership and industrial innovation.
Judgements by Courts:-
1. Bayer corporation v/s Union Of India :-Bayer was granted for Nexavar,a liver and kidney cancer drug. The firm became aware that Cipla had also filed an application for approval to market the same product in a generic version .Bayer sued to stop Cipla from marketing their drugs.
Verdict :-The court directed the Drug Controller General of India not to give marketing authorisation to Cipla .The court appreciated the necessity of protecting patent rights even if the impunged product was not in the Indian market.
2. F. Hoffman La Roche v/s Cipla :-Roche filed a patent infringement suit against Cipla after it locally launched Erlotinib. Cipla filed a counter claim challenging Roche's patent. The pricing of Tarcera came into focus as well as that it was not manufactured locally.
Verdict :-In its Interim Order ,the Delhi High Court has allowed Cipla to continue selling its generic version. However it also directed Cipla to maintain accounts of sales, which would be relevant to calculate damage to Roche, in case the latter eventually wins the case.
3. BMS v/s Hetero Drugs:- Bristol Myers Squibb(BMS) holds a patent for Dasatinib in India . It sued Hetero Drugs when it found that Hetero was seeking marketing approval to generic drug makers for drugs that have already been granted patents in India . This was prevented Hetero from manufacturing or selling its generic version. This case is a score for pro-patents groups .It also raises the question-can a linkage be made between india's patent office and DCGI, which is mandated by the Drugs and Cosmetics Act to check only for safety and efficacy?
The Way Ahead (The Legal Position):-
Geographical Indication is a form of Intellectual Property Right (IPR) included along with other. IPR forms like patents and copyrights, in the Trade Related Intellectual Property Rights.(TRIPs) chapter of GATT/ WTO .This clause found in Articles 22 23, 24 of Section 3 deals with the protection of goods that are geographically indicated.. The patent system was introduced during the 19th century with a view to promoting basic inventions, enabling disclosure of inventions for further research and dissemination of the fruits of new research for the benefit of the public. The patents system has acquired a unique position in the industrial economy of each country. It is a system which has to be carefully used to ensure that exploitation of the consumer does not take place through creation of absolute monopolies over new products. The interests of the patent holders and consumers have to be balanced to ensure achievement of objectives and smooth working of the patents system.
1. Geographical Indications Bill
India has developed a multi-pronged approach to tackle IPR disputes. Under this, a product will be defined by a geographical area where it is traditionally found. If the Bill becomes an Act, it will also evolve product standards, provide cataloguing and classification and enforce discipline. However, the problem arises is that the WTO does not recongnise geographical indications for products other than wines and spirit. Though India has put in a proposal to include other products like Kanjeevaram silk, Alphonso mango and Darjeeling tea under this, the WTO is yet to respond to it. Once this legislation is passed, we can state that basmati is from a particular geographical area and another country cannot patent it.
2. Plant Varieties Bill
This will enable farmers or plant breeders to register their own innovations and traditional knowledge, so they cannot be patented elsewhere. This will definitely ease a lot of farmers problems.
3. Traditional Knowledge Digital Library
The inclusion of the Digital Library in the intellectual property regime will enhance the quality of patent examination, and the problem of granting patents based traditional knowledge will stand resolved.
It has taken India five years to draft these Bills. Though these efforts have are being criticized but one has to see that everything has its pro's and con's so where its lagging it will also offer some protection for our traditional property. The next battle is to convince the WTO about restructuring TRIPS to address the peculiarity of countries like India which have enormous traditional common wealth.
After five years of the enactment of the Geographic Indications of Goods (Registration and Protection) Act that came into effect from September 2003, only nine products have been accorded the Geographical Indicator (GI) status while another two are due to get the status from the Registrar of GIs in India . Official sources told Business Line here though innumerable agricultural, natural and manufactured products ranging from basmati rice, Darjeeling tea, Kanchipuram silk saree, Alphonso mango, Nagpur orange, Kolhapuri chappal to Bikaneri bhujia could form GIs, the registration is not compulsory as it only provides legal protection to Indian GIs.
Now its India 's priority to get its rights over traditional knowledge. The patenting laws will not resolve all issues. India has to keep in its mind that it has to fight battles always and follow Might is Right. Gone are the days when Indians used to succumb to west pressures. The free India knows how to claim for its rights without hurting sentiments of others. India has always thought for world welfare but not at its own risk and cost.
References :-( Internet and Patent Act)
1. Bussiness Portal of India (last visited the website on 13 th July 2009 )
2. Patent Traditional Products to Patent Them-Murali Manohar Joshi (last visited the website on 13 th July 2009 )
3. Basmati- Patent is not the Central Issue-Suman Sahai ( www.genecampaign.org/basmati patent-is-not-the-central-issue)last visited the website on 13 th July 2009 )
4. Victory on Basmati-Amit Sen Gupta ( www.pd.cpim.org/2001/sept02)last visited the website on 13 th July 2009 )
5. The Indian Seed Act and Patent Act-sowing the seeds of dictatorship-Vandana Shiva.( www.india.indymedia.org/en/2005)last visited the website on 13 th July 2009 )
6. Biopiracy and Traditional Knowledge-R.V Anuradha (Lawyer and Legal Consultant- www.hinduonnet.com)last visited the website on 13 th July 2009 )
7. Seeds of our Destruction-Srilata Swaminathan (article-last visited the website on 13 th July 2009 )
8. Financial Express-( www.financialexpress.com/news/conagra-gets-us-patent-for-atta)last visited the website on 13 th July 2009 )
9. Ask Questions-(Yahoo.com) last visited the website on 13 th July 2009 )
10. Patent Amendment Act 2005-An Overview-Author Parikshit (article) (legalserviceindia.com)
11. To Patent or not Patent-Express Pharma (online website)
12. Sanctuary Asia-Article published-Author-Dr.Vandana Shiva (Founder of the Research Foundation for Science and Technology and Ecology)( www.santuaryasia.com)last visited the website on 13 th July 2009 )
13. Intellectual Property Law in India – P.S. Narayana's
14. Patent Act, 2005 and Patent Act, 1970