New Internationalist

Pirates ahoy!

Issue 349

Micro-organisms, plants, animals, human genes - anything goes in the patenting free-for-all. Here are a few case studies.

Soybeans

The claims

A share of the multi-billion-dollar soybeans crop could make a patent-holder very happy indeed. A biotechnology company called Agracetus was awarded a patent in 1994 which covered all transgenic soybeans. Monsanto protested vigorously, alleging lack of novelty. But when Monsanto purchased Agracetus the complaints were dropped.

Currently Monsanto has an application lodged with the World Intellectual Property Organization (already granted in Australia) which claims gene sequences associated with high-yielding soybeans plants, all plants which have them, including those in the wild, and screening methods to identify the molecular marker of the sequences.

The fallout

Such broad patents stake out territory, blocking competition. Farmers sowing saved seeds could find themselves legally pursued by Monsanto as has often occurred. If the application is granted breeders of soybeans would be severely restricted. Ironically, the gene sequence originates from a wild Chinese species of soybeans. China, the genetic homeland of the crop, won’t receive a bean.

Hoodia

The claims

A succulent plant chewed by the San people of southern Africa to suppress hunger on long treks. South Africa’s Council for Scientific Research (CSIR) isolated the appetite-suppressing ingredient and promptly patented it. Phytopharm – a British biotech company – licensed it from CSIR, and then licensed it on to Pfizer (of Viagra fame) for $32 million. Pfizer hopes to put an anti-obesity drug on the market which could be worth $2 billion a year.

The fallout

The San were not best pleased with this result, especially as Phytopharm’s chief executive claimed they had ‘disappeared’ when mutterings of compensation for their traditional knowledge arose. They sued. A benefit-sharing agreement is now in the air with possible roles for the San to harvest the plant, educational scholarships and royalty payments. But such royalties are rarely above 1-2 per cent, if that. And if this is a victory, does that make patenting life OK? Whatever happened to life belonging to us all?

Oncomouse

The claims

Genetically engineered by the lab coats at Harvard University to be susceptible to cancer, the oncomouse was the first animal to be patented in the US in 1987. It and its offspring, who shared this susceptibility, were offered up to the medical establishment as experimental animals for cancer therapy research. The multinational DuPont snapped up the European patent in 1992, attempting to gain control over all animals produced using the oncomouse technique. DuPont also staked claims to any future anticancer products created using the animals.

The fallout

The European patent was contested by public groups on the grounds that it was contrary to morality, but the European Patent Office replied saying that interpreting morality was beyond its remit. They later took the position that any ‘invention’ that benefited humanity more than the suffering caused to the animal was morally acceptable. In November 2001 the patent was upheld ‘limited to transgenic rodents containing an additional cancer gene’. The battle in the Canadian courts lasted 15 years before a Canadian patent was granted in August 2000.

The bottom line is that this patent reduced animals to the level of machines. It changed traditional prohibitions on the patenting of breeds, especially those that offended morality. It opened the floodgates to further animal patents. Numerous transgenic animals are in the pipeline.

Milk, eggs and meat

The claims

With a plethora of obesity-related diseases plaguing the rich world, low-cholesterol animal products would rake in cash. The Johns Hopkins School of Medicine filed for a world patent covering animals genetically engineered to have increased muscle mass. The application was staggering in its breadth, claiming not only ownership of transgenic animals and how they are created, but also all their food products.

The fallout

The application was refused. Had it been granted it would have turned farmers into ‘renters’ of livestock, giving the patent holder control over the food items produced. Some biotechnology companies which specialize in livestock expect to charge royalties on offspring of ‘transgenic’ animals produced by them or to forbid farmers from allowing them to breed on farms. There are fears that a corporate assault on animal husbandry by the biotech industry will further reduce the genetic diversity of farm animals, which is already dwindling.

Iceland’s genetic history

The claims

By an act of government in January 2000, deCODE Genetics, a Delaware-based company, gained a 12-year monopoly on any commercial use of a database that linked individual health records with genetic data of the entire Icelandic population. Icelanders had to actively opt out of the database otherwise their details would go on by default. If their details were already recorded, then they could only opt out of providing further information – nothing already entered would be erased. By January 2002, over 20,000 (around 7 per cent of the total population) had chosen to opt out. The attraction of mapping the genome of isolated populations is that it may help identify small patentable variations in genes that show susceptibility to diseases. DeCODE attracted a cool $200 million from Swiss pharmaceutical company Hoffmann la Roche which hoped to develop drugs for diseases based on the genetic information. Icelanders would receive any such drugs for free.

The fallout

Mannvernd (‘human protection’ in Icelandic), a coalition of local scientists, doctors and concerned citizens, condemn the Act for providing no controls over how the information is used, for infringing privacy and human rights. Consent is also an issue – apart from the notorious opt-out measure, individual consent is meaningless when people are genetically closely related. With indigenous peoples in the Majority World, genomic information has landed up in US databases without any consent whatsoever, at the mercy of the highest bidder. The wider criticism of population genetics is that it can ignore the environmental causes of disease and create a demand for the ‘improvement’ of hereditary qualities; in other words, eugenics.

But the marriage of companies that peddle genetic data (bioinformatics) with Big Pharma has been barren so far – the wonder drugs haven’t materialized. Stock prices for bioinformatics firms have taken a dive in recent years. [http://www.mannvernd.is/]

Human genes and tests for them

The claims

Myriad Genetics, a Utah-based biotechnology company, developed a DNA test based on two genes – BRCA1 and BRCA2 – that helps to predict the risk of developing breast and ovarian cancer. Not content with patenting the test, the company moved quickly to ringfence the genes themselves. Over 25 patents have been slapped on the genes, proteins related to them and any further medical use of them. The company has stopped any testing for these genes by other labs in the US. It also insists comprehensive tests for the genes must be carried out only at its headquarters at $2,700 a pop – regardless of where in the world the patient may be located.

The fallout

The high price tag means testing in British Columbia, Canada, has dropped from around 100 families per year to 6. Myriad is under a boycott by Dutch, Belgium and German labs, as well as Canadian Health Authorities. Labs in Germany, the Netherlands, Belgium and Denmark have decided to flout Myriad’s patents by doing their own tests, whilst the French government is mounting a legal challenge with the European Patent Office. Clinical studies could be hampered because of Myriad’s controls over data.

Having bought the two genes, Myriad’s attempt to control diagnostic tests worldwide is prompting other biotech companies to follow suit. With drugs companies rushing for patents on genes, a similar situation may arise with drug development, to say nothing of the stifling of research on any patented genes. Companies could carve out monopolies around ‘their’ genes, marketing their own drugs at steep prices and controlling research for the lifetime of the patent.

Sources: This article is mainly based on the GRAIN briefing ‘Of Patents and Pirates – Patents on Life: the final assault on the commons’ July 2000 available at [http://www.grain.org/publications/pirates-en.cfm] Information on Myriad Genetics was sourced from ‘Your money or your life’ by Sylvia Pagán Westphal, New Scientist 13 July 2002. Updates came from: ‘Biopiracy + 10: Captain Hook Awards - 2002’, ETC Group Communiqué March/April 2002 ([http://www.etcgroup.org]); Mannvernd website; European Patent Office; ‘Bushmen victory over drug firms’ by Antony Barnett, The Observer 31 March 2002; Devlin Kuyek; [http://www.pixunlimited.co.uk/guardian/pdf/chickenpatent.pdf]

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