Science in Society Archive

Biopiracy & Biopatents

Angela Ryan rounding up world-wide

Bushmen Knowledge Plunder

The Kung bushmen, who live around the Kalahari desert in South Africa, have used the Hoodia cactus for thousands of years to stave off hunger whilst on long hunting trips.

UK based company, Phytopharm, patented P57, the appetite suppressing ingredient in Hoodia, claiming it as the next big slimming aid. Phytopharm's share price rocketed as city traders expected rich returns from a drug that would revolutionize the slimming market, worth £6 billion. The company has since cashed in on the biopiracy and sold the rights to license the drug for $21m to Pfizer, the US pharma-ceutical giant. It will be ready in pill form within three years.

Phytopharm's self-proclaimed Buddhist chief executive, Richard Dixey, told the Financial Times, "we're doing what we can to pay back, but it's a really fraught problem… especially as the people who discovered the plant have disappeared".

The bushmen, who number 100,00 across South Africa, met with their lawyers at their annual gathering in Cape Town to plan a challenge against Phytopharm and Pfizer, demanding compensation.

Dixey replied that the South African Council for Scientific and Industrial Research (CSIR) approached him with the deal and told him the bushmen were extinct.

Dr Marthinus Horak, the man in charge of the CSIR project, claims he always intended to tell the bushmen about the deal, once the drug had been approved [and patented]. He said he didn't want to raise expectations with promises that couldn't be met. Apparently, CSIR is committed to sharing financial benefits through a variety of benefit-sharing programs. The Hoodia drug may be South Africa's first blockbuster drug where talk of 'benefit-sharing' kept strictly confidential by CSIR comes cheap.

The bushmen are expert botanists able to identify 300 different types of plants with different properties. They naturally fear more intellectual property plunders.

Source: "In Africa the Hoodia cactus keeps men alive. Now its secret is stolen to make us thin", By Antony Barnett, The Observer, June 17th 2001.

South Africa's Floral Heritage Sold Off

South Africa's National Botanical Institute (NBI) has sold the rights to develop new strains from national flora to US based company, Ball Horticultural. The unnamed government official who blew the whistle on the deal, which was signed two years ago, said "this effectively hands over South Africa's floral heritage to a US company in exchange for a pittance in royalties".

NBI will get royalties of between 2-10% on any products developed by Ball. In return, Ball will receive 90% of the profits and have the right to develop and patent any South African plant except trees, woody shrubs and succulents "unless specially requested by Ball".NBI staff are collecting plants to ship to America. The South African Department of Trade and Industry estimated the countries flower exports, which presently generate about $30m a year, could be worth $260m annually ten years from now. The Ball deal kills off any potential for local companies to develop the floriculture export industry.

Source: "Selling off the country's floral heritage", South-North develop-ment monitor, SUNS No 4874, April 11th 2001.

Dupont's Biopiracy Challenged

Greenpeace and Misereor (German Catholic Church Development Agency) have filed a joint legal objection at the European Patent Office against patent EP 744888, issued to Dupont Aug. 2001.

The patent covers all corn containing a total oil content at least 6%, where the oleic acid content is not less than 55%. By presenting one specific method of hybridization DuPont have successfully claimed intellectual property rights over all high oil content maize varieties throughout the entire food chain.

High oil content maize occurs naturally in Central and South America, where breeders and farmers have been cultivating it for hundreds of years. If the patent is upheld, farmers worldwide will suffer trade restrictions, license fees and loss of marketing rights.

Source: "Dupont claims patent monopoly over natural maize traits", Greenpeace press release, May 29th 2001 http://www.greenpeace.org

India Robbed Again

First it was the neem tree, then turmeric, now another Indian medicinal plant is the target of foreign patents. Ashwagandha [Withania somnifera] has been used for thousands of years in the Ayurvedic system as an aphrodisiac, diuretic and for restoring memory loss.

Officials at the Department of Science and Technology (DST) said "one thing which is very obvious is that Ashwagandaha is catching the attention of scientists, and more and more patents are being filed and granted on it by different patent offices around the world.

Seven American and four Japanese companies have filed or have been granted patents on Ashwagandha.

Source: Diverse Women for Diversity,Norfolk Genetic Information Network http://www.ngin.org.uk "After neem and turmeric, foreign firms patent Ashwagandha PTI" . New Delhi, May 15 2001.

No 'Collaborative' Deal

A prototype collaborative agreement between business, academia and government has collapsed due to concerns about the commercial application of publicly funded data and who controls the intellectual capital.

Since 1948, the residents of Framingham, MA, have provided researchers with valuable long-term epidemiological data, including patient histories and tissue samples, about causes of diseases such as stroke, arthritis and heart disease. The Framingham study (FS) was initiated and funded by US National Institutes of Health (NIH) and in 1971 Boston University (BU) became the administrator. Today, both share joint control over the data, which BU licenses to private firms [but provide freely to academics for use in drug development].

A private firm, Framingham Genomic Medicine (FGM) entered an agreement with BU and NIH to analyze and sell the data from the public health study. It raised $21 million to create a new digitized database of information, combined with information from 160 other health studies using FS participants. The company planned to sell access, and conduct linkage studies, similar to those being done by companies like Gemini, Genomics (Cambridge, UK) and deCODE Genetics (Reykjavic, Iceland), as well as bioinformatics tools to search for disease-related genes,

The deal is now off, as Boston University, despite having a 20% stake in FGM, does not want to loose control over the data. NIH officials demanded that the data be freely available to everyone, including potential competitors, a move that would preclude FGM from any intellectual capital. A NIH spokesperson said, "had the deal gone ahead it would have resulted in FGM using the data without contributing to the advancement of knowledge". Moreover, "the company was receiving data supported by public funds".

The Framingham agreement was considered a model for joint industry-academic-government projects using public health studies. It was thought a better, more cooperative, approach compared to the competition model, adopted by Celera in its race against federal agencies to sequence the human genome.

The interplay between government agencies and private firms that want to mine data from taxpayer-funded studies remains an important ethical consideration. Fred Lealey, CEO of FGM, said "there's no general consensus on relationships between companies, universities and government".

Source: "Collapse of Framingham Data deal highlights lack of cooperative model", By Eric Niler, Nat. Biotech. 19, Feb 2001 p 103

Patently Patenting People

A new study carried out by Greenpeace Germany and Kein Patent auf Leben! [No patents on Life!] reveals a startling increase in the number of patent applications on human genes, human cells, human cloning procedures, human embryos and human-animal chimeras.

The study looked at more than 1000 patent applications (1999-2000) and shows the extent to which human parts and embryos are being claimed by the private sector. At least 10 patent-applications include human embryos, over 30 describe methods in genetic engineering or cloning humans, 9 refer to human germ cell manipulation, over 60 cover human stem cells and 10 cover human-animal chimera embryos. In some cases several hundred human gene sequences are being claimed at once and the number of such patents is rising. Patents on humans include,

Source: "Patents on human genes, cells, on human cloning procedures, on human embryos and human-animal-chimeras", Florianne Keochline, Buleridge-Institute, www.blauen-institut.ch May 16th 2001.

European Court of Justice to Okay Patents on Life

The European Court of Justice is likely to okay Directive 98/44/EEC on patents on life. Francis Jacobs, the advocate general, proposed June 14th 2001 to dismiss the application for annulment submitted by the Netherlands and supported by Italy and Norway. In their application for annulment the Netherlands stated the Directive does not comply with the Convention on Biological Diversity and patenting of human genes violates human rights to dignity. The court usually follows the recommendation of the advocate general, meaning patents on plants, animals and humans will be widespread throughout Europe, leaving a chilling legacy for future generations.

A New Delhi based NGO, Forum for Biotechnology and Food Security, has decided to take out a patent on the unique configuration of genes and cell lines in Jacob's brain. They hope to block any proliferation of such ill-conceived thought.

Source: "ECJ likely to okay patenting life directive, Green Group EPA in the European Parliament", June 14, 2001; "Indian NGO to seek a patent on the advocate general of the European court of justice", New Delhi, India, June 16th 2001. See http://www.ngin.org.uk

Monsanto's Suing Campaign Backfires

Since winning the patent infringement case against Canadian farmer Percy Schmeiser Monsanto have launched an aggressive suing campaign against hundreds of farmers. The Federal Court of Canada ruled Schmeiser was liable for having Roundup Ready canola in his conventional fields and failing to notify Monsanto. Schmeiser's neighbour's GM canola crop cross-pollinated with his, leaving it contaminated. His case has just been accepted by Canada's Court of Appeals.

Many farmers' crops are testing positive for transgenic traits due to cross-pollination and increasing contamination problems. Seed companies are refusing farmers written guarantees that conventional seeds are GM free.

Farmers are outraged and fighting back. They are not replanting GM seed and are adamant that contamination is causing the test positives. Many sued farmers have testified to abandoning GM crops, claiming they are more expensive, yield less and require more herbicides.

One farmer, Mitchell Scruggs, goes even further and admits to saving Monsanto seeds in order to break even. As far as Scruggs is concerned, once he's paid for seed, it's his to do with as he pleases. He has founded 'Farmers Save Our Seed', better known as SOS. Hundreds of growers have phoned the organisation's toll-free number [1-877-727-6207].

The case against Scruggs involves the relationship between the Plant Variety Protection Act (PVPA) and utility patents. Although the PVPA protects the rights of creators of plants that reproduce sexually (with seeds) it includes an exception that honours farmers' century old practice of saving seed. Even if a utility patent protects the patent holder in terms of the first generation of seed, there is considerable question as to whether that same patent can extend to the progeny. Monsanto is also in violation of anti-trust laws by selling GM seeds in foreign markets, such as Argentina, for half the cost. The farmers are filing hundreds of counterclaims, asserting patent misuse and anti-trust violations against Monsanto.

Source: "Monsanto still suing Nelsons and other growers", Cropchoice, USA, by Robert Schubert, May 21st 2001; "Mississippi farmer fights for the right to save seed", Cropchoice April 6th 2001. See http://www.cropchoice.com

Monsanto Torpedoes Ag-Biotech

A new US patent, awarded Jan 2001, gives Monsanto exclusive rights over a method for identifying genetically modified plant cells that employ antibiotic resistance markers, which is used in practically all commercial GM crops.

Patent experts say the patent is a particularly sinister "submarine patent", a term used to refer to a patent claim widely used by competitors. Monsanto is now in position to demand license fees and royalties or deny access to the method altogether.

Professor John Barton, an intellectual property specialist at Stanford Law School, said "it raises very sharply the question of what we should do about patented research tools". Barton sees the new patent as only the most recent in a line of extremely broad patents covering biotech's most basic enabling tools.

Source: "Monsanto's submarine patent torpedoes Ag biotech", Rural Advancement Foundation Inter-national, Canada, April 27th 2001.

Mycogen-Monsanto Case Returns

The US federal Court of Appeals has ruled that Mycogen Plant Science is entitled to continue its patent infringement suit against Monsanto. The Mycogen patent covers a process for increasing the expression of Bacillus thuringensis (Bt) toxin in GM plants. The ruling is thought to be significant, as Mycogen believes that virtually every company developing Bt crops is violating its patent. It is unclear whether the company plans to go after everyone.

Source: "Court rules Mycogen can continue patent suit against Monsanto", <AgWeb.com> USA, June 5th 2001.

Japan Grants Academics Go-ahead for Profit

In March 2001 the Japanese government removed the ¥ 6 million (US $50,000) ceiling on the amount of money that researchers at public universities are allowed to earn from government-held patents based on their work. In Japan, practically all patents coming from public research are government-held. This signifies a major sea change in policy and is intended to encourage academics to be more active in pursuing commercial applications for their work. Since 1996, and the advent of extensive gene patenting, the number of patents granted on university based science has jumped almost five fold in Japan.

Source "Japan's academics get green light to make their fortunes", By David Gyranoski, Nature Vol 410 No 6828, p 504

Wellcome Shuts Out Celera

The Wellcome Trust has banned all its grant recipients from using Wellcome money to subscribe to the human genome sequence of Celera Genomics. Wellcome deny an out and out ban but their new policy document states "no trust funds may be used for the purpose of accessing Celera subscription services". Wellcome's director, Mike Dexter says "there is no evidence that Celera's database offers any scientific advantage".

Source: "No Wellcome money for Celera", by David Adam, London, Nature Vol 410 No 6827 p 397

Taq DNA polymerase Patent Revoked

The European Patent Office (EPO) has revoked Hoffmann-La Roche's 1997 patent for naturally occurring Taq DNA polymerase. EPO officials say the patent is invalid because it is not a novel invention and is based on previously published data.

Taq DNA polymerase comes from the bacterium Thermus aquaticus, which lives in hot springs. It is a thermally stable enzyme crucial to the polymerase chain reaction (PCR) process, a widely used research tool that amplifies DNA.

This is the second time a major Roche patent on PCR has been revoked. In 1999, a federal judge in San Francisco ruled Roche's US patent for native Taq invalid because it had been obtained with "intent to mislead".

Promega, a US based company that markets native Taq is responsible for disputing the patent and has been supported by three other companies, Bioline, New England Biolabs and Becton Dickinson. They claim the patent should not have been allowed in the first place and was only granted after years of lobbying by La Roche.

La Roche also holds an EPO patent for a recombinant version of Taq, which was created by inserting the Taq gene into another species of bacterium. Recombinant Taq now accounts a large portion of Roche's market. It too is being challenged by London based company, Bioline.

Source: "Patent ruling could cut PCR enzyme prices", By Rex Dexton, San Diego, Nature, Vol 411, 7th June 2001, p622.


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