US patents which encompass traditional biodiversity-related knowledge of indigenous and local communities in developing countries continue to be granted and challenged. One reason is that the US patent system fails to recognise 'prior art' -- the body of knowledge against which novelty and nonobviousness of an alleged invention is determined -- if it occurs outside of US territory. Below are some updates on what is being done about this in the context of the CIEL-contested US patent on ayahuasca, a plant from the Amazon, and a new US patent covering the use of bitter gourd, brinjal and other plants for control of diabetes, as challenged by the Indian government and nongovernment organisations. AUTHOR: David Downes TITLE: CIEL Asks US Patent and Trademark Office to Boost Recognition of Traditional Knowledge PUBLICATION: Submitted by the author to BIO-IPR DATE: 3 August 1999 CIEL ASKS US PATENT AND TRADEMARK OFFICE TO BOOST RECOGNITION OF TRADITIONAL KNOWLEDGE Center for International Environmental Law August 1999 On March 30, CIEL challenged the US patent on the ayahuasca vine, on behalf of the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), the Coalition for Amazonian Peoples and Their Environment (Amazon Coalition). The United States Patent and Trademark Office (PTO) is now reexamining that patent. Meanwhile, on August 2 CIEL filed comments with the PTO calling for changes in the procedures for identifying prior art during the examination of a patent application. The comments were also supported by COICA, the Amazon Coalition, and the Indigenous Environmental Network North American Indigenous Peoples Biodiversity Project. Traditional and informal knowledge developed and maintained by indigenous and local communities is a significant "prior art" resource for innovation, particularly in pharmaceutical and other technologies based upon biological diversity and biological resources. Such prior art is relevant in determining whether patent applications in such fields of technology describe inventions that meet the requirements for patenting of novelty and non-obviousness. As illustrated by the ayahuasca and turmeric patents, PTO's current approach leads to problems in identifying such prior art and ensuring that patenting requirements are met. In our comments, CIEL recommends improvements that the PTO could make to procedures and practices, within the framework of existing law. (The PTO is currently considering changes in its regulations, but no changes in legislation.) These proposed changes would significantly enhance the ability of patent examiners to assemble and review the prior art relevant to an application. At the same time, they would enhance recognition of the contributions of indigenous peoples and non-Western cultures to universal knowledge, enhance incentives for the conservation of traditional knowledge systems and associated biodiversity, and encourage equitable sharing of benefits between the users of traditional knowledge and those who have created and maintained it. Of course, these changes would not fully address widespread concerns, but they would be a step in the right direction. Under the United States Constitution, the underlying mission of intellectual property law is "[t]o promote the progress of science and useful arts." One of the ways that patent law promotes this goal is through the disclosure to the public of the basis for an invention (patent applications become publicly available if the patent is granted). The proper acknowledgment of "prior art" - that is, discoveries by others in the same field of technology to which the invention is an addition is valuable both as a resource for future innovators and as recognition accorded to the predecessors whose intellectual labors made the invention possible. In this context, disclosure of traditional knowledge that forms part of the prior art "promotes the progress of science and useful arts" by according recognition to knowledge created by cultures whose contributions have often been unrecognized and undervalued. Creating positive incentives to maintain these knowledge systems in turn can create an incentive for the knowledge holders to continue the traditional practices by which they have maintained high levels of biodiversity in their homelands over many generations. Indeed, the Convention on Biological Diversity recognizes this linkage - it requires governments to take steps to respect, preserve and maintain indigenous and local peoples' traditional knowledge, innovations and practices, and encourage equitable sharing of the benefits from its use. A copy of CIEL's comments (warning - a highly technical document, in Word format, of 138 KB) can be obtained by request from Kris Genovese at CIEL, cielkg(at)igc.org. For more information, please contact Glenn Wiser or David Downes at CIEL. David Downes, Senior Attorney Center for International Environmental Law (CIEL) 1367 Connecticut Ave., N.W., Ste. 300 Washington, D.C. 20036 U.S.A. Tel: +1 (202) 785-8700 Fax: +1 (202) 785-8701 E-Mail: ddownes(at)igc.apc.org WWW: http://www.econet.apc.org/ciel/ AUTHOR: Nidhi Nath Srinivas TITLE: 'Opposing patents is not government's job' : Jyoti Sagar IN: Economics Times (New Delhi) DATE: 29 July 1999 URL: http://www.economictimes.com/290799/29opin03.htm 'OPPOSING PATENTS IS NOT GOVERNMENT?S JOB? : JYOTI SAGAR Economic Times / Nidhi Nath Srinivas / 29 July 1999 The Indian government last week announced its intention to examine the implications of the patents on karela, jamun and brinjal and how to challenge them. As India is yet to file its protest against the basmati patent after more than 18 months of technical and legal analysis, mounting a fresh offensive is hardly likely to be easy. Jyoti Sagar, senior partner of Kumaran and Sagar, India?s attorneys in the basmati case, however, believes it is not for the government to oppose such patents. In a conversation with Nidhi Nath Srinivas he explains why. [Q] Should India approach the US Patent Office for revoking the patents obtained for products based on bitter gourd, jamun, and brinjal? [A] US Patent No 5,900,240 (May 4, 1999) has been issued for a herbal composition comprising a mixture of at least two herbs selected from Momordica charantia (Bitter gourd), Syzygium cumini (Jamun), Gymnema sylvestre, (gur-mar) and Solanum melongena (brinjal) for use as hypoglycemic agent. Any person can challenge a patent of the above nature in the US by citing documents published before the date of filing of the case. [Q] Does India need institutionalised procedures for opposing such patents? [A] Patents are private rights granted to individuals or companies, and opposing patents is usually left to the aggrieved individuals, companies or organisations. Even in developed countries, there are no government-sponsored or institutionalised procedures for opposing patent applications. While granting patents, officers overseas check the printed publications available with them to find out whether the invention before them is novel and non-obvious. Prior public use of the invention in the same country would be a bar to the grant of a patent. But they have no access to traditional knowledge or customary practices on any country, including India. Prior use in any country outside of USA does not bar the grant of a patent in USA. The law is the same in India. [Q] Would the creation of a database of traditional practices help? [A] Definitely. What we need is to develop a database of the traditional knowledge and customary practices prevalent in India, especially those relating to Indian systems of medicine. Such a database can be made available to the patent offices abroad, particularly in the US, Japan and Europe, so that the chances of our traditional knowledge being made subject matter of patents are significantly reduced. [Q] How can we ensure that India is alert to future infringement of its rights? [A] In many of the cases what one is trying to prevent is the creation of a patent monopoly in respect of a subject which is largely in public domain. For example, in the Haldi case while the US patent was revoked, it does not mean grant of patent or similar rights to any Indian organisation. Some foreign patents may arouse a sense of national indignation even though commercial interests are not affected. One could, therefore, see the need for a Patent Watch Cell, which could keep a watch on patents being applied for or obtained in important jurisdictions. [Q] India?s patent office needs immediate upgradation and centralisation. Do see a way out of hurdles such as these? [A] Yes, technical, financial and human resources are required to correct a fairly grim situation. There are about 30,000 applications pending for examination. In addition, already about 3,000 black box applications have been filed and more will get filed in the next five years. All these will surface for examination after January 1, 2005. More than 13,000 applications have also been filed in overseas patent offices under the Patent Cooperation Treaty since December 8, 1998, in which India is designated as one of the countries where patent protection will be sought. When these applications enter the national phase for examination, there will be a substantial increase in the workload of the examiners. Add to that the increase in applications consequent upon TRIPS implementation and the work load of dealing with Exclusive Marketing Rights. But the number of examiners is inadequate: only 32 as on 30 December 98. AUTHOR: Vandana Shiva TITLE: Biopiracy: need to change Western IPR systems IN: The Hindu (New Delhi) DATE: 28 July 1999 URL: http://www.hinduonline.com/today/stories/05281349.htm BIOPIRACY: NEED TO CHANGE WESTERN IPR SYSTEMS The Hindu / Vandana Shiva / 28 July 1999 The patents on the anti-diabetic properties of 'karela', 'jamun', and brinjal once again highlight the problem of biopiracy - the patenting of indigenous biodiversity-related knowledge. U.S. Patent No. 5,900,240 was granted recently to Cromak Research Inc., based in New Jersey. The assignees are two non-resident Indians, Onkar S. Tomer and Kripanath Borah, and their colleague, Peter Gloniski. The use of 'karela', 'jamun' and brinjal for control of diabetes is common knowledge and everyday practice in India. Their use in the treatment of diabetes is documented in authoritative treatises such as the "Wealth of India', the "Compendium of Indian Medicinal Plants' and the "Treatise on Indian Medicinal Plants'. This indigenous knowledge and use consists of "prior art'. No patent should be given where prior art exists, since patents are supposed to be granted only for new inventions on the basis of novelty and non-obviousness. These criteria establish inventiveness, and patents are exclusive rights granted for inventions. The claim to the use of 'karela' or 'jamun' for anti-diabetic treatment as an invention is false since such use has been known and documented widely in India. Biopiracy and patenting of indigenous knowledge is a double theft because first it allows theft of creativity and innovation, and secondly, the exclusive rights established by patents on stolen knowledge and steal economic options of everyday survival on the basis of our indigenous biodiversity and indigenous knowledge. Overtime, the patents can be used to create monopolies and make everyday products highly priced. If there were only one or two cases of such false claims to invention on the basis of biopiracy, they could be called an error. However, biopiracy is an epidemic. 'Neem', 'haldi', pepper, 'harar', 'bahera', 'amla', mustard, basmati, ginger, castor, `'aramla', 'amaltas' and now 'karela' and 'jamun'..... The problem is not, as was made out to be in the case of turmeric, an error made by a patent clerk. The problem is deep and systemic. And it calls for a systemic change, not a case by case challenge. If a patent system which is supposed to reward inventiveness and creativity systematically rewards piracy, if a patent system fails to honestly apply criteria of novelty and non-obviousness in the granting of patents related to indigenous knowledge then the system is flawed, and it needs to be changed. It cannot be the basis of granting patents or establishing exclusive marketing rights. The problem of biopiracy is a result of Western style IPR systems, not the absence of such IPR systems in India. Therefore, the implementation of TRIPs, which is based on the U.S. style patent regimes, should be immediately stopped and its review started. The promotion of piracy is not an aberration in the U.S. patent law. It is intrinsic to it. The U.S. laws were originally designed to pirate or borrow industrial innovations from England. Patents originally functioned as import franchises or import monopolies. Patents were given for salt manufacturers, for operating steamboats even though these were not invented in the U.S. Later, the recognition and stimulation of inventiveness was added as an objective, and the criteria of novelty, non- obviousness and utility were developed as a test for inventiveness. However, the earlier objectives of creating U.S. monopolies based on free import of knowledge from other countries have survived and the U.S. continues to import knowledge which it then converts to "intellectual property'. Article 102 of the U.S. Patent Law, which defines prior art, does not recognise technologies and methods in use in other countries as prior art. If knowledge is new for the U.S., it is novel, event if it is part of an ancient tradition of other cultures and countries. This was categorically stated in the Connecticut Patent Law which treated invention as "bringing in the supply of goods from foreign ports' that is not yet of use among us. 'Prior art' and 'Prior use' in other countries were, therefore, systematically ignored in the U.S. laws on monopolies granted on the basis of claims to invention. The same assumption of ignorance as invention is enshrined in the U.S. Patent Act of 1952. Section 102 of the Act treats as a 'prior art' use in the U.S. and publications in foreign countries. Use in foreign countries is not recognised as 'prior art'. Section 102 of the U.S. law which defines 'prior art' reads as follows:- 35 USC 102: 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. Use in a foreign country therefore does not constitute 'prior art' in U.S. patent law. Since patents are granted for new inventions, denial or non- recognition of 'prior art' elsewhere allows patents to be granted for existing knowledge and use in other countries. This is the basis of biopiracy or knowledge of Indian knowledge systems, and indigenous uses of biological resources being patented. The U.S. style patent laws can only pirate indigenous knowledge. They cannot recognise or protect it. The survival of an anachronistic Art. 102 thus enables the U.S. to pirate knowledge freely from other countries, patent it, and then fiercely protect this stolen knowledge as "intellectual property'. Knowledge flows freely into the U.S. but is prevented from flowing freely out of the U.S. If biopiracy has to stop, then the U.S. patent laws must change, and Article 102 must be redrafted to recognise prior art of other countries. This is especially important given that the U.S. patent laws have been globalised through the TRIPs agreement of the WTO. In 1999, Article 27.3 (b) of the TRIPs agreement is supposed to come up for review. This is the article that most directly impacts indigenous knowledge, since it relates to living resources and biodiversity. In 2000 A.D. countries can also call for an amendment of TRIPs as a whole. Since TRIPs is based on the assumption that the U.S. style IPR systems are "strong' and should be implemented worldwide, and since in reality the U.S. system is inherently flawed in dealing with indigenous knowledge and is "weak' in the context of biopiracy, the review and amendment of TRIPs should begin with an examination of the deficiencies and weakness of Western style intellectual property rights systems. A globalised IPR regime which denies the knowledge and innovations of the Third World, which allows such innovations to be treated as inventions in the U.S., which legalises monopolistic exclusive rights by granting of patents based on everyday, common place indigenous knowledge is a regime which needs overhaul and amendment. Instead of being pressured, as India has been, to implement a perverse IPR system, through TRIPs, India should lead a campaign in the WTO for review and amendment of the system. Meantime, India and other Third World countries should freeze the implementation of TRIPs. While TRIPs implementation is frozen for starting a process of review, we should make domestic laws which protect our indigenous knowledge as the common property of the people of India, and as a national heritage. The implementation of the Convention on Biological Diversity (CBD), enables us to do this. Since the CBD is also an international treaty, protecting indigenous knowledge via a Biodiversity Act does not violate our international obligations. In fact, removing the inconsistencies between TRIPs and CBD should be important part of the international campaign for the review and amendment of TRIPs. Amending TRIPs and U.S. patent laws is the challenge we must take up. The problem is not our IPR systems but the Western style IPR regimes which systematically enable piracy of indigenous knowledge and practices through patents. The review of TRIPs should be used to start amending these deficient systems. Some commentators have suggested that biopiracy happens because our knowledge is not documented. That is far from true. Indigenous knowledge in India has been systematically documented, and this in fact has made piracy easier. And even the folk knowledge orally held by local communities deserves to be recognised as collective, cumulative innovation. The ignorance of such knowledge in the U.S. should not be allowed to treat piracy as invention. Piracy of indigenous knowledge will continue till patent laws directly address this issue, exclude, patents on indigenous knowledge and trivial modifications of it, and create sui generis systems for the protection of collective, cumulative innovation. The protection of diverse knowledge systems requires a diversity of IPR systems, including systems which do not reduce knowledge and innovation to private property for monopolistic profits. Systems of common property in knowledge need to be evolved for preserving the integrity of indigenous knowledge systems on the basis of which our every day survival is based. Since neither TRIPs, nor the U.S. patent law have scope for recognising knowledge as a "commons', or recognising the collective, cumulative innovation embodied in indigenous knowledge systems, if indigenous knowledge has to be protected, then TRIPs and U.S. patent laws must change. Nothing less than an overhaul of Western style IPR systems with their intrinsic weaknesses will stop the epidemic of biopiracy. And if biopiracy is not stopped, the every day survival of ordinary Indians will be threatened, as over time our indigenous knowledge and resources will be used to make patented commodities for global trade. Global corporate profits will grow at the cost of the food rights, health rights and knowledge rights of one billion Indians, two thirds of whom are too poor to meet their needs through the global market place. India should lose no time in starting the movement for amendment of TRIPs and U.S. patent laws. Our survival itself is at stake.