Chacko, Sunil; Sambuc, Henri-Philippe --- "Blockbusters, Traditional Knowledge and Intellectual Property" [2003] IndigLawB 7; (2003) 5(22) Indigenous Law Bulletin 12

Blockbusters, Traditional Knowledge and Intellectual Property

by Sunil Chacko and Henri-Philippe Sambuc

Each year, when medicines like Taxol rake in over $1 billion, few ask why providers of original knowledge of biodiversity, often from remote regions or local tribes, are left out of a stake for their contribution to the development of many modern medicines. Legal acrimony and public unrest over the disputed claim is not so unusual nowadays. The Namibia / South Africa based San tribe threatened to sue Pfizer and its partners over the Hoodia cactus that the tribe has used for centuries to cut hunger during extended hunts, and which the pharmaceutical companies are testing as an anti-obesity substance.

Likewise, the patenting by corporations of the Maca plant, that has had traditional use as a food crop and natural enhancer of sexual function, led to massive demonstrations by Indigenous people in Peru. Similar examples are abundant for a number of other medicines in oncology, cardiology, neurology and metabolic diseases. Claims to intellectual property rights are increasingly becoming the source of highly charged disputes as global powerhouses from both sides of the spectrum – promoters and protesters – gather momentum.

The Taxol molecule originates from the pacific yew tree bark, and is one of the most powerful and widely used anti-cancer drugs available today. Isolated at a small non-profit entity in North Carolina for a US government research project, the semi-synthetic version of the naturally occurring molecule is manufactured and marketed by Bristol-Myers Squibb. These research projects are carried out in well equipped, modern research and development facilities, and those biological substances or their synthetic equivalent find their way to the millions of patients who need them. There is no question that researchers add immense scientific value during product development. Creating this scientific value requires an enormous amount of money, time and human resources, and the failure rate in drug development is very high. Obviously, the results deserve to be legally protected. The issue here is whether the traditional knowledge practitioners who provided the original leads for many blockbuster drugs have also contributed scientific value to naturally occurring substances.

Recently, the US Food and Drug Administration granted approval for a drug against a particularly severe leukemia. The drug has its roots in a traditional medicine in China augmented by additional research by a US company. What this illustrates is the fact that much traditional knowledge has indeed been tried, practiced and preserved over generations in many parts of the world. The quality of data and format of data collection may widely differ, but nevertheless it is valuable knowledge and clinical findings accumulated over centuries. Clinical trials for modern medicines today are typically done during 10 – 15 years of research. Yet, the value of research within traditional knowledge is quietly buried in a murky world and not properly recognised.

In addition, for modern medicine, the legal framework has fostered the creation of financial wealth. For instance, the Orphan Drug Act[1] signed into law in the US on 4 January 1983, has led to multiples of the expected rates of return on medical research, and many biotechnology startup companies have flourished. The Act provides marketing exclusivity, tax incentives and research grants to companies that develop drugs, vaccines or medical devices for rare diseases affecting less than 200,000 people, or where there is no reasonable expectation that the sales of the drug treatment will recover costs, even if more than 200,000 people are affected. In the US alone, about 25 million people suffer from an estimated 6,000 rare disorders meeting the definition of orphan diseases.[2]

Unfortunately vital legal frameworks and financial resources are missing in traditional medicine. With profit margins for blockbuster drugs being as high as 40 percent in the pharmaceutical industry, not even a small fraction of the annual profit of $400 million is for those who have nurtured the traditional knowledge from which the medicine is derived.

Morally unacceptable reasons are hidden behind the wrongful legal ones invoked to justify bio-piracy. Beyond this is the racism underpinning the belief that useful scientific knowledge is generated only in laboratories, otherwise it is not science. Usually bio-pirates justify this situation by applying to traditional knowledge the following legal principles of the patent system:

• If knowledge happens to be in the public domain it is nobody’s property and is free game for anyone;
• Because there is no novelty it cannot be protected; and
• Intellectual property is limited in time.

All of this is wrong and misleading because these three arguments are related to the patent system, and not to the intellectual property principles defined in the Convention establishing the World Intellectual Property Organisation, signed at Stockholm on 14 July 1967.[3] Under the Convention, commercial secrets and trademarks can be in the public domain, do not have to be new and are not limited in time, yet they are intellectual property rights that are protected. Furthermore, under the Convention ownership of intellectual property rights is not limited to individuals, but can be held by larger groups or communities.

The intellectual property general principles expressed in the Convention can accommodate national and international protection of traditional knowledge, in accordance with the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement (the ‘TRIPS’ Agreement).[4] Further, traditional knowledge is most often protected by customary laws, which are to some extent internationally protected by states.

The World Health Organisation estimates that the worldwide natural products market itself is $60 billion in size. But there is no estimate of the market potential for medicines derived from traditional knowledge used in modern medicine. A basic grasp of the situation has been left vacant for long, despite the many traditional systems of medicine such as Ayurveda,[5] Unani,[6] and homeopathy that have contributed to worldwide health care, and increasingly to eco-healing tourism for substance abuse patients.

Millions depend on these systems and swear by them, especially for chronic diseases. Only those sitting at the end of the medical pharmaceutical chain reap the formal legal protection and the monetary benefits, while original contributors are left with no financial resources, and punished collectively by governmental inefficiency. Without resources how can traditional medicine practitioners acquire modern equipment, laboratories and attend international scientific conferences to present their clinical findings necessary for their knowledge to be more scientifically acceptable? Within the current intellectual property right (the ‘IPR’) reality, where can they find such resources?

The idea of intellectual property rights was never meant to protect only financial monopoly rights. Therefore, it is vital to promote a new convention in today’s IPR structure, to be inclusive of the fact that there are indeed age-old scientific contributions and knowledge from uses of biological specimens that are leading to new medical treatments.

The bio-disputes, often between haves and representatives of have-nots, hamper fantastic potential for medical breakthroughs, and sustainable development based on the recognition of the equality of diverse intellectual creativity. A new convention based on market and intellectual property principles can be a part of a remedy to this long-standing conflict mired, economically inefficient and inequitable situation.

Dr Sunil Chacko is a health sciences industry analyst and public health physician who was trained at the Harvard and Columbia Universities, and is the executive director of the Fondation Science et Conscience in Geneva. Henri-Philippe Sambuc is an attorney at the Geneva Bar, the author of the forthcoming book, Savoirs traditionnels et propriété intellectuelle : la nouvelle frontière (Traditional knowledge and intellectual property: the new frontier ), and president of the Fondation Science et Conscience. Contact: [e-mail], [e-mail]

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[1] Pub L No 97-414.

[2] Figures provided by the US National Organisation for Rare Disorders.

[3] Convention establishing the World Intellectual Property Organisation, opened for signature 14 July 1967, 828 UNTS 3 (entered into force 26 April 1970).

[4] Agreement on trade-related aspects of intellectual property rights, opened for signature 15 April 1994, 1869 UNTS 299, 33 ILM 1197 (entered into force 1 January 1995) (‘TRIPS’). Product patent has been made compulsory by the TRIPS Agreement for the vast majority of states in the world.

[5] A traditional medical system that originated in India in which there is extensive usage of natural products as remedies, and mind-body linkages are emphasised.

[6] A traditional medical system that originated in the Middle East involving abundant usage of herbs as drugs.