Thursday, February 08, 2007

IP law versus nature and national interest!

The New York Times reports that Indonesia is negotiating to sell its avian flu virus to a U.S. vaccine company, and is halting shipments of the virus to World Health Organization. Follow the link in the title to read this article in full. A spokeswoman for the Indonesian government cited concerns that some company could research and then patent the flu's DNA, and that the country might lose access to any rights in either the flu strain or any resulting vaccine. The article reports that while the Indonesian government has signed a memorandum of understanding with Baxter, Inc., the agreement does not require this to be an exclusive relationship.

I feel certain that the thoughts of the Indonesian government, leading to their halt of shipments of flu strains to WHO, were influenced by the experience of India. The rush to patent living organisms began with the U. S. Supreme Court case, Diamond v. Chakrabarty, 447 U.S. 303(1980)Findlaw link. An Indian academic, article by Dinar Godrej at Findarticles, comments:

In 1980 a paradigm shifted. Or rather it collapsed altogether.

Ananda Chakrabarty won a US Supreme Court case allowing him to patent a bacterium he had genetically engineered to digest oil. Suddenly a legal construct that had been designed to protect inventors' ideas from appropriation jumped over the not inconsiderable fence that separates the inanimate world from the sentient and animate. This however didn't seem to exercise the presiding judge unduly. He declared that the 'relevant distinction is not between animate and inanimate things but whether living products could be seen as human-made inventions'.

And there's the nub. Reproduction aside, can human beings really claim to create life? Chakrabarty himself said that he 'simply shuffled genes, changing bacteria that already existed - it's like teaching your pet cat new tricks'.

Genetic engineering involves the juggling of pre-existing components of life. No new gene or genetic material is ever created, just different combinations. So if a genetically engineered organism reproduces, it does so of its own accord following a natural process. How then can it be owned?

In order to be patented an invention must fulfil three criteria -- it requires an inventive step (which is not obvious to someone skilled in the field), it must be novel and it must be useful. But patents on life usually fail the first two, if not all three. It would appear the criteria have been downgraded in many instances to simply possessing the technology to tamper with life and the ability to describe the extent of the tampering.

Chakrabarty's oil-chomping bacterium opened the floodgates in the US. Five years later the US Patent and Trademark Office allowed genetically modified (GM) plants, seeds and plant tissue to be patented. By 1987 animal patenting was permitted. Today human gene sequences, cell lines and stem cells are allowed (see over).

What all of this means is that corporate interests (and university research departments which are increasingly corporate funded) can corner life forms for the lifetime of a patent (usually 20 years) and have a monopoly over their exploitation.

2 What's fair game?

Patents on life actually represent ancient Western obsessions -- conquest and colonization. Except here science, in the deep pocket of corporate finance, seeks to subdue the natural world and venture boldly into the 'interior spaces' of genes and cell lines. (1) Human beings have no rights to their own genetic heritage -- after all, they did nothing to exploit their usefulness, claim some scientists.

On 26 June 2000, the world learnt that a draft of the entire human genome had been completed independently by two competing bodies. The publicly-funded Human Genome Project aimed to keep the data in the public domain, whilst the company Celera Genomics sought to license use of its data for a fat fee. (snip)

3 Biopiracy

Natural resources known to indigenous peoples for centuries are easy plums for the biotechnology companies to pick. A remedy from India, where I grew up, comes to mind. The neem tree's anti-bacterial and insecticidal properties had over 80 patents slapped on them by eager US and Japanese corps, although at least one has been overturned. But these properties aren't news to anyone. My mother would mix neem twigs and leaves in with her store of wheat to keep the bugs off. Neem soap has been going for years -- especially popular with pustular teenagers on the subcontinent. And a good chew on a revoltingly bitter neem twig substitutes for brushing one's teeth for many a poor Indian.

You can see a very nice website on the patenting of the Indian Neem tree products (among other things) by western biotech companies at TED Case Studies Number 665, 2002 (by Sara Hasan, at American University) here. They have a nice website explaining this incident and others of the collision between western intellectual property law and cultural rights of traditional groups. Here is an insightful explanation of the situation:
While the neem tree has been used in India for over 2000 years for various purposes such as pesticides, spermicides and toothbrushes, a US company has been suing Indian companies for producing the emulsion because they have a patent on the process. The dispute is over the rights of companies to conduct research and development by using patents against the interest of the people who live at the source of the resource. To what extent can multinational companies claim and patent resources from the develping countries, like India? The movement around the issue of the neem tree and trade-related aspects of intellectual property rights (TRIPS) represents a challenge to the developing countries.

A good bit of the material at this website is derived from The Third World Network article by Vandana Shiva The Neem Tree, a Casehistory of Biopiracy. in this, Shiva notes:
W R Grace's justification for patents, therefore, pivots on the claim that these modernised extraction processes constitute a genuine innovation:

'Although traditional knowledge inspired the research and development that led to these patented compositions and processes, they were considered sufficiently novel and different from the original product of nature and the traditional method of use to be patentable.'

'Azadirachtin, which was being destroyed during conventional processing of Neem Oil/Neem Cake is being additionally extracted in the form of Water Soluble Neem Extract and hence it is an add-on rather than a substitute to the current neem industry in India.'

In short, the processes are supposedly novel and an advance on Indian techniques. However, this novelty exists mainly in the context of the ignorance of the West. Over the 2,000 years that neem-based biopesticides and medicines have been used in India, many complex processes were developed to make them available for specific use, though the active ingredients were not given Latinised scientific names. Common knowledge and common use of neem was one of the primary reasons given by the Indian Central Insecticide Board for not registering neem products under the Insecticides Act, 1968. The Board argued that neem materials had been in extensive use in India for various purposes since time immemorial, without any known deleterious effects. The US EPA, on the other hand, does not accept the validity of traditional knowledge and has imposed a full series of safety tests upon Margosan-O.

The allegation that azadirachtin was being destroyed during traditional processing is inaccurate. The extracts were subject to degradation, but this was not a problem since farmers put such extracts to use as and when they needed them. The problem of stabilisation arose only when it needed to be packaged for a long time to be marketed commercially. Moreover, stabilisation and other advances attributable to modern laboratory technology had already been developed by Indian scientists in the 1960s and 1970s, well before US and Japanese companies expressed interest in them.

Related, helpful web resources on the collision between westernized concepts of intellectual property and traditional cultural property:

Article at International Center for Technology Assessment (a U.S. non-profit, bi-partisan group)

Lawfirm of Schwegman, Lundberg, Woessner and Kluth, "Bring Them Back Alive! Patents on Products of Nature." The author, patent lawyer Warren Woessner, comments that patent issuance on natural products is only the first step in the collision. He argues that the patenting and commercialization of cultural and natural property is not "genetic colionialism." He comments that, far from putting neem tree products out of the reach of Indian natives,
Colonialism implies that a Third World country is somehow robbed of its resources for the benefit of the developed countries. In the case of the neem tree, Grace built an extraction plant in India which thus far employs sixty Indians. In addition to the employment provided, the factories presumably are taxed, and purchases are made from local suppliers.

The recent neem patents (but only provided that Grace has obtained patents of some sort in India) leave the Indian farmer with two choices: continue to use the crude preparations or the old formulations as always, or pay a premium for the convenience of the new, more active stable formulation. The hypothetical Indian farmer can make that choice, based on his own balance of cost and benefit. Even if he cannot afford the new formulations, he is no worse off than before, since a patent cannot remove the tree or the old formulations from the public domain.

In addition, the farmer may have a new cash crop. ...

The Indian perspective is largely different, as may be seen at

Thimmakka Newsletter
and many articles by Dr. Shiva.

Apparently, the EU Patent office revoked the patent it gave the W.R. Grace Company in the neem tree link. Undoubtedly, this decision was affected by finding by the WTO and GATT, reported at Biotech Monitor, and Declaration of Berne, Article at WTO, TRIPS article at the WTO, and TRIPS summary. The beautiful illustration of a neem tree is from the World Book article on alternative pesticides link.

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