Marys Medicine

Slg august.indt

‘Bio Piracy' — A
Discussion of Some
Important Cases
The article discusses the issue of large pharmaceutical companies patenting bio-resources that have been traditionally used by the indigenous people of a land.
Bio piracy is the appropriation of the to traditional knowledge,2 some of the an ancient Sanskrit text and a paper knowledge and genetic resources of important cases and instances of bio published in 1953 in the Journal of the farming and indigenous communities piracy are examined in this article.
Indian Medical Association.6 The patent by individuals or institutions seeking was finally revoked by the USPTO on 14 exclusive monopoly control (usually Controversial Cases Involving
August 1997 on grounds of established patents or plant breeders' rights) over Traditional Knowledge and
these resources and knowledge.
Neem patent The term, bio piracy has no usus Turmeric patent Neem (‘Azadirachta indica') is a tree loquendi in international conventions Turmeric (‘Curcuma longa') is a plant found primarily in India and other parts on the subject of genetic resources of the ginger family yielding saffron- of South and Southeast Asia. It is now and bio-diversity but is a colloquial coloured rhizomes used as a spice for planted across the tropics because of derivation arising from cases concerning flavouring Indian cooking. It also has its properties as a natural medicine, commercial exploitation of bio-diversity properties that make it an effective pesticide and fertiliser. Neem extracts in developing countries in Asia and ingredient in medicines, cosmetics and can be used against pests and fungal South America. The alleged piratical as a colour dye. As a medicine, it has diseases that attack food crops. Other appropriation of resources and knowledge traditionally been used to heal wounds applications of Neem include the oil could include the patenting of pre- extracted from its seeds which is used existing forms of knowledge possessed to treat colds and flu, and, mixed in by the indigenous communities, which In 1995, two researchers at the soap, is believed to offer low cost relief are, however, absent from the popular University of Mississippi Medical Centre4 from malaria, skin diseases and even public databases, and the commercial were granted a US patent on the ‘use monopolisation of such knowledge, in of turmeric in wound healing'.5 The a manner which is deleterious to the patent claims were based on the use In 1994, the European Patent Office interests of the indigenous communities.
(administered both orally and topically) (‘EPO') granted a process patent8 to the of turmeric, as a wound healing agent. US Corporation WR Grace and the US Quite understandably, the indigenous communities are piqued to find that the Department of Agriculture (‘USDA') over The Indian Council of Scientific and genie has been taken out of the bottle a method for controlling fungi on plants Industrial Research (‘CSIR') requested and there are no wishes being granted by the aid of ‘a hydrophobic extract of the US Patent and Trademark Office to the people who have preserved it for Neem oil'.9 (‘USPTO') to re-examine the patent. so long. They allege that the Western The argument made by CSIR was that pharmaceutical industry has, in many turmeric has been used in India for This patent was challenged by a group instances, not taken their consent, as thousands of years for healing wounds non-governmental facilitators, before going ahead with and rashes and, therefore, its medicinal (‘NGOs') in India and the European Union the commercial exploitation of the use was not novel. Novelty is as such, an in 1995.10 They submitted evidence to the traditional knowledge. While South bloc essential requirement for any patentable effect that the fungicidal effects of Neem countries wait for intellectual property invention. CSIR's claim was supported seed extracts were known to and used by laws to catch up on providing protection by documentary evidence that included Indian agriculturists for centuries and the The Singapore Law Gazette claimed invention was, therefore, void be contrary to the public interest and the Hoodia cactus (‘Hoodia Gordonii') of novelty or inventive step. morality because of the sacred nature of the to stave off hunger and thirst on their Ayahuasca tree throughout the Amazonia long hunting trips. Traditional use of After reviewing the evidence submitted region.14 Extensive and relatively recent Hoodia cactus is, however, not restricted by the NGOs, the EPO panel accepted ‘prior art' was presented by CIEL, and in to the San people only. The Haioms of that Neem had been used in India for November 1999, the USPTO rejected the northern Namibia still use Hoodia sap many years and the patented process patent agreeing that the patent should to treat allergic reactions in the eyes, for use of Neem extracts in fungicidal never have been issued.15 and to treat severe stomach pain, they treatment did not represent an inventive boil Hoodia pieces in water and drink step and the patent was revoked by the EPO in 2000, six years after its grant. Though the rejection represented a the brew. The Anikhwe of northern victory for the NGOs, the rejection Botswana feed children who ‘eat too Ayahuasca patent itself was made on the narrowest legal much' pieces of Hoodia to make them For generations, shamans of the ground under the statutory bar of 35 eat less. For decades, obese members indigenous tribes living in the Amazon USC § 102(b). The said section of the of the Khomani community of north- Basin have processed the bark of the US patent law prohibits, inter alia, the western South Africa had been eating Ayahuasca tree (‘Banisteriopsis caapi or issuance of a patent when the invention the Hoodia to slim down or to maintain B.caapi') to produce a ceremonial drink was patented or described in a printed a high energy level.18 known as ‘ayahuasca'. The shamans use publication more than one year prior to ayahuasca (which means ‘vine of the the date of patent application. Thus, the Scientists at the South African Council soul') in religious and healing ceremonies historical use of the Ayahuasca tree was for Scientific and Industrial Research to diagnose and treat illnesses and neither acknowledged nor established as (‘SACSIR') only recently came upon divine the future. What is remarkable prior art by the USPTO.
this traditional use of the Hoodia cactus and significant is that at least 72 different and began research on it to determine indigenous tribes of Amazonia, however Due to this legal technicality, the patentee its beneficial constituents.19 In 1995, widely separated by distance, language, appealed successfully and, in early SACSIR patented Hoodia's appetite- and cultural differences, all manifest 2001, the USPTO went against its earlier suppressing element and thereafter a detailed common knowledge of decision and decided that the patent for licensed the patent to the UK biotech ayahuasca and its use.11 the Da Vine variety of Ayahuasca was company, Phytopharm, in 1997. In 1998, valid, since at the time when the patent the pharmaceutical company Pfizer An American, Loren Miller, obtained a was challenged by CIEL, the US patent acquired the rights to develop and market patent from the USPTO in June 1986, law did not permit third party challenges the drug as a potential slimming drug which granted him monopoly rights over to patent claims.16 The US law has since and cure for obesity (a market reportedly an alleged variety of B.caapi that he called been amended and has introduced new worth more than £6bn annually), from ‘Da Vine'. The patent description stated rules on inter partes re-examination of Phytopharm for a reported payment of that the ‘plant was discovered growing in patents on the basis of prior art.17 £21m in royalty payments.20 a domestic garden in the Amazon rain-forest of South America'.12 The patentee After the validation of the Ayahuasca On hearing of the commercial claimed that Da Vine represented a patent by the USPTO, there have been a exploitation of the Hoodia, the normally new and distinct variety of B.caapi, number of protests by NGOs representing reclusive San threatened legal action primarily because of the colour of the tribes of the Amazon basin and various against the SACSIR on grounds of bio its flower.
other environmental organisations, but piracy. They claimed that their traditional to no avail, and the Ayahuasca tree is knowledge had been stolen and that The Co-ordinating Body of Indigenous now being commercially cultivated in SACSIR had failed to comply with the Organisations of the Amazon Basin and the US and Hawaii. rules of the Convention on Biological the Centre for International Environment Diversity, which requires the prior Law (‘CIEL') subsequently filed a re- Hoodia cactus patent informed consent of all stakeholders, examination request on the Da Vine including the original discoverers and patent.13 The request was based on the The San bushmen who live around the fact that the existing prior art included Kalahari Desert in southern Africa are one the Da Vine specie of the B.caapi plant of the world's oldest and most primitive Under pressure from environmental and that the granting of the patent would tribes. The San have traditionally eaten groups and representatives of various The Singapore Law Gazette African tribes, an understanding was An initial challenge was mounted against on novelty, inventiveness and usability, reached between the SACSIR and the the RiceTec patent by the Government of is not sufficiently sensitised to deal with San whereby the San were recognised as India's Agricultural and Processed Food cases of traditional knowledge. The the custodians of traditional knowledge Products Export Development Authority difficulty faced by patent examiners, associated with the Hoodia plant. (‘APEDA') on the grounds of lack of in a large part arises from the lack of Pursuant to this agreement, the San will novelty of the Basmati rice grain. This written prior art ie documented records receive a percentage of the future royalties challenge was, however, pre-empted by of traditional use of genetic resources. from the commercial exploitation of the the lawyers for RiceTec by deleting four Hoodia cactus.22 As for the San, although patent claims that dealt with the novelty In some cases of bio piracy, patents have they remain annoyed that they were of the hybrid rice grain. The remaining been granted for pseudo inventions due almost swindled, they can't help but be 16 claims which dealt with techniques to the lack of knowledge of their prior amused by the prospect of Westerners for production of the rice line outside use, while in other cases, the issue of using the Hoodia plant for slimming South Asia were continued by RiceTec. novelty is not as important an issue as to address the identity of the inventor(s). RiceTec's remaining patent claims were Basmati rice patent subsequently allowed by the USPTO Patent law has so far only benefited after deleting the term ‘Basmati' from Basmati rice is renowned for its length large pharmaceutical and life sciences the claims. However, this deletion was and aroma and has been traditionally companies in preserving the status quo. only superficial as the amended patent grown in South Asia, particularly in the It has been argued that patent law is granted by the USPTO, gave monopoly countries of India and Pakistan. Farmers inherently incapable of protecting such rights to RiceTec to market rice lines in both countries have, over centuries resources as it offers protection to new Bas-867, RT-1117 and RT-1121 which perfected the art of selection and farming inventions and only for a limited time were described as having ‘characteristics of basmati rice grain. Basmati rice exports period. It is highly speculative to assume similar or superior to those of good form an important part of the revenues of that indigenous communities would be quality Basmati rice'.26 these agriculture dependent economies.
ready to disclose their best kept secrets in exchange for the 20 odd years of The Basmati saga is not an isolated incident In September 1997, RiceTec, a Texas, of patenting of the rice grain. The US has exclusive profits. USA-based agri-business company, was been able to maintain a stronghold on the granted a US patent on a new variety of international rice business through effective Acknowledging the inadequacies in basmati rice line and grain, ostensibly use of its patent laws. By September 2000, patent law, efforts are being made at an obtained by ‘crossing a selected basmati 609 patents on rice genes had been international level to create appropriate seed with a semi-dwarf variety of long- granted and US corporations owned the legal mechanisms for protecting the grain American rice'.24 RiceTec claimed lion's share of these patents, holding 45% traditional knowledge of indigenous that it had invented a way to produce of the world's rice gene patents.27 tribes. Some headway has been made basmati rice in the US which was in these efforts with the use of national comparable to the best basmati grown in databases of traditional knowledge and India and Pakistan. It also claimed that genetic resources which are owned by rice plants thus bred were of semi-dwarf The above cases are illustrative of today's indigenous communities. It is hoped that variety and were substantially photo- reality that the pharmaceutical industry royalties from the licensing of such national insensitive and high-yielding.25 RiceTec's is looking towards natural bio-resources traditional knowledge databases can be patent encompassed 20 patent claims and their traditional use by indigenous used for the betterment of the shamans, that related to the process for their communities, in the field of medicine and who have nurtured ancient wisdom for breeding the new strain of the hybridised life science. When patent protection is the benefit of future generations. rice grain and the rice line itself. The granted to inventions based on traditional company subsequently began producing knowledge, it effectively starves the and marketing the Texan rice, calling it indigenous people of their livelihoods. TSMP Law Corporation International patent law, which is based The Singapore Law Gazette

Endnotes
8 European Patent No 0436257, see relating to inter partes examination in 37 CFR 1.902–1.997.
1 The Action Group on Erosion, 18 For more information on the Hoodia Technology and Concentration cactus, see http://www.botanic-art.
(formerly the Rural Advancement com/hoodia.htm. See http://www.
Foundation International) at http:// 10 The challenge to the Neem patent was made at the Munich office of the EPO 2 A World Intellectual Property by three groups: the EU Parliament's 20 See, the website of the international Green Party, Dr Vandana Shiva of the NGO — Grain for further details, at India-based Research Foundation for Intellectual Property and Genetic Science, Technology and Ecology 21 Article 8, Convention on Biological Resources, Traditional Knowledge and the International Federation of Diversity mandates approval of and Folklore was established in Organic Agriculture Movements. See knowledge holders prior to its September 2000 as an international article by Chakravarthi Raghavan: sustainable use and encourages forum for debate and dialogue ‘Neem Patent Revoked by European equitable sharing of the benefits concerning the interplay between Patent Office' at http://www.twnside.
arising from the utilisation of intellectual property and traditional such knowledge. The text of the knowledge, genetic resources and 11 Schultes and Raffauf, The Healing Convention is available at, http:// traditional cultural expressions Forest and also see, http://www.
(folklore). For more information on 12 US Plant Patent No 5,751.
22 As per Media Release by SACSIR, on the role of WIPO, see http://www.
13 See the re-examination request at: 22 March 2002 available at the CSIR 3 For more information on the benefits 23 Excerpt from press release from of turmeric, see http://www.herbal- Associated Press No 8/25/92.
15 See, Bio-Piracy in the Amazon; 24 US Patent No 5,663,484 dated 2 September 1997.
4 Das, Suman K and Hari Har P biopiracy/ayahuasca.htm; see also, 25 R Ramachandran, Challenging the (Jackson, MS).
Basmati Patent; in ‘The Frontline', 5 Patent No 5,401,504, granted on 28 Vol 17, Issue 10, 13–26 May 2000.
March 1995. For more information, 16 See, Leanne M Fecteau: ‘The 26 An excerpt from the RiceTec's patent Ayahuasca Patent Revocation: Raising description, taken from an article by 6 US patent law only recognises prior questions about current US patent Devinder Sharma: ‘Let Us Accept It, art that is in material written form. policy' Boston College Third World India Has Lost the Battle', at http:// Law Journal, 2001.
17 35 USC §§ 311–318 and rules 27 13 Alb LJ Sci & Tech 123. Viewpoint Ad Repeated Advertisement The Singapore Law Gazette

Source: http://www.lawgazette.com.sg/2004-8/feature1.pdf