Nick Papadimitriou rounds up worldwide
President Bush's clearance for government scientists to work with pre-exiting lines of embryonic stem cells lays bare the absurdity of the US patent laws.
Wisconsin University's Alumni Research Foundation (WARF) owns the US patent on all human and primate embryonic stem cells (ES cells), including methods for isolation. As government officials negotiated access to the cell lines, WARF insisted their patent would not impede research. However, the patent is so broad that US government scientists do not have the option of turning elsewhere for ES cell-lines.Not only does this scupper Bush's intention to allow scientists access to the ES cells worldwide, it also lines up WARF as the sole financial beneficiary of any medical applications that may ensue.
WARF is already suing Geron Corporation, with whom it previously held a contract granting exclusive rights to Geron to develop six cell types from ES cells. The relationship has soured following Geron's attempts to extend its rights to another 12 derivative cell types.
Furthermore, two non-US companies, Bresagen (Australia) and ES Cell International (Singapore) are prepared to give away cells to publicly funded scientists. In return they are asking for first rights to license therapeutics and medical procedures arising from the research. Bresagen claims its cells differ sufficiently from WARF's and justify a separate patent. But the Bresagen cells only differ in that they are a few days older.
Source: "Patent Laws May Determine Shape of Stem Cell Research" by Sheryl Gay Stolberg, The New York Times, Aug 17, 2001
A lawsuit worth $500m is being fought over royalties arising from patent rights to genetically modified human insulin.
GM human insulin, one of the first GM medicines, was developed in the late seventies by City of Hope biologists, funded by Genentech, who were a small start-up company at the time. The development brought huge wealth to both parties and fuelled Genentech's subsequent growth.
Now City of Hope accuses Genentech of cheating on them and stealing millions in royalties through violating the 1976 contract.
The contract gave Genentech the patents on the insulin, which had sales of $1.7bn last year. City of Hope stood to gain 2% from all sales resulting from the patents. However, precisely which product the patent covers, is open to dispute.
Genentech claims the agreement is limited to the proteins that the City of Hope biologists helped develop. City of Hope however, claims the contract is more far reaching and entitles them to royalties on 27 licensing agreements struck by Genentech with third parties.
Genentech have subsequently licensed to GlaxoSmithKline, among others. The settlement demanded by City of Hope could put Genentech in the red for one year.
Source: "Cancer Center, Drug Firm Fight Over Biotech Riches" by Denise Gellene, Los Angeles Times, Aug 28, 2001 http://www.latimes.com/business/la-082801patentstory
Industrialized countries are using bilateral treaties to gain a stronger monopoly over rights to biodiversity in the developing world. Third world governments are being forced beyond their commitments to WTO by bilateral trade and aggressive investment deals.
These so-called "TRIPS-plus" treaties enable western countries to bypass current WTO limits on patents on indigenous biodiversity.
The TRIPS (Trade Related Intellectual Property Rights) agreement does not go far enough for greedy countries, who are negotiating closed deals of their own, effectively tying the hands of developing nations into extreme commitments. Moreover, they are being kept secret and hence difficult to challenge.
So far, 23 TRIPS-plus agreements have been identified in a report issued by GRAIN, but this is just the tip of the iceberg. Some 150 nations in the developing world are affected. The proponents of these deals include the US, EU, Switzerland and Canada.
Henk Hobbelink, Coordinator at GRAIN, said "in country after country TRIPS-plus agreements undermine national decision making processes and hijack policy options for the South, having serious consequences for farmers, research and the public interest". They are "manipulative" and "undemocratic" and render the debate on patenting of life irrelevant and obsolete.
Source: ""TRIPS-plus" treaties leave WTO in the Dust", GRAIN July 27, 2001. Report available in English at www.grain.org/publications/trips-plus-en.cfm
TRIPS came under UN scrutiny again over the Protection of Human Rights. The UN Sub-committee on the promotion and protection of human rights resolved to call for action against biopiracy, more serious attention to human rights and a special review of how TRIPS affect indigenous people.
It urges all governments to put human rights before economic policies and calls them to integrate national and local policies that honor international human rights obligations.
Highlighting the international covenant requiring signatories to co-operate and protect economic, social and cultural rights, the UN resolves to gain "observer status" for UN High Commissioner for Human Rights at the World Trade Organisation. This will enable the ongoing review of the TRIPS agreement as well as analyse impacts on the rights of indigenous people.
Source: "Intellectual Property Rights and Human Rights." United Nations Sub-Commission on the Promotion and Protection of Human Rights, resolution 2001/21. Sent by GRAIN Spain http://www.unhchr.ch/Huridocda/huridoca.nsf/(symbol)/
The Canadian National Farmers Union (NFU) has initiated an unprecedented campaign to prevent intellectual copyrights being applied to the seed industry of the developing world. The NFU wants to prevent biotech companies from using patents to tighten their grip on the world's genetic resources.
NFU executive member, Terry Boehm said "It's highly unlikely [patenting] can be stopped in the North American context". But "TRIPS and plant breeders rights are privatizing the fundamental building blocks of nature and nature itself." NFU members agree the last thing farmers in the developing world need is more monocultures pushed on them by multinational corporations.
Source: "NFU fights seed patenting trend" by Adrian Ewins, Western Producer, Canada, July 5, 2001
A new report issued by the US watchdog Public Citizen challenges the US pharmaceutical industry's claim that drugs cost an average of $500m each to develop. This figure is used by industry to justify tight patent controls and high prices. Public Citizen points out that pharmaceutical companies "cherry-pick" choice research from publically funded labs. As a consequence R&D costs per drug are closer to $100m. According to an internal NIH document obtained by Public Citizen 50% of the research resulting in the top five drugs of 1995 was carried out in the public sector. That's how our public money is subsidising the corporations.
Source. www.publiccitizen.org, Aug 2001
As Britain edges closer to establishing its own national DNA databank, the opportunities for claiming broad patents rises and the British pharmaceutical industry is no strangers to claiming patents on the human genome. The British Medical Association [BMA] has called for international debate on gene patenting.
The European Patents Office implemented the current EC directive on patents on life [98/44/EC] in June 1999. The directive states that a gene cannot be patented if it forms part of the body. But it can, if it is isolated from the body. Several EU member states are challenging the directive on the grounds of ambiguity.
Professor Vivienne Nathanson, Head of Health Policy at the BMA insisted there is a desire for clear information. "The issues are very complex" she said. The BMA are particularly concerned that patents match the amount of innovative work done.
As the situation stands biotech companies can take out patents on work done at the public expense. Public labs solicit investor interest to spin-off research with little returns, given the rewards that follow. Such "spin-out" companies from public labs are routinely floated on the stock market.
Meanwhile, the UK government has set up a new commission to examine how gene patenting rules can be improved to take account of the worlds poor. The Commission on Intellectual Property Rights [CIPR] is to report in March 2002 and will investigate the exploitation of traditional knowledge, the impact of TRIPS, benefit sharing, human gene patenting and issues of consent.
Sources: "BMA calls for debate on gene patenting", BMA Press Release, Aug 6, 2001
Web page of UK Commission on Intellectual Property Rights, Aug 2001 http://www.iprcommission.org
In a scenario of true Frankenstein proportions, the European Patent Office (EPO) has granted a patent on genetically modified fish. The patent (EP 578 653) issued under the controversial 1998 EC directive was awarded to Canadian company Seabright. It covers Atlantic Salmon and any other fish carrying a gene for faster growth.
The Seabright patent application describes experiments that resulted in monstrous fish, eight times the normal size. Greenpeace has denounced the patent, stating the giant fish will become invasive species and cause havoc in the marine ecosystem. This mirrors concerns expressed repeatedly elsewhere in the scientific literature. They have called on the EU to immediately ban the release of these fish. Seabright, which has since become 'Genesis' ,claims to have 15 million genetically modified fish eggs for sale to fish farms around the world.
An application for the commer-cialization of the fish has been filed with the US Food and Drug Administration
Source: "Greenpeace Denounces The First Ever European Patent Granted For Genetically Modified Fish", Greenpeace International, Sept. 10, 2001.
Former director of the International Rice Research Institute (IRRI) and Nobel laureate M.S. Swaminathan criticized the logic and conduct of biotechnology companies.
Evoking the spirit of Gandhi, Swaminathan said biotechnology should be used to improve lives, not exclude those in most need. The industry should consider themselves as 'trustees' rather than 'owners'.
Swaminathan thinks biotech will come to depend on biodiversity and safeguarding biodiversity should be ensured so that future molecular breeding programs can succeed. He stated "What we need are bio-partnerships, not bio-piracy", adding " the present situation is not conducive to conservation".
Source: Innovation interview- M.S Swaminathan: "Partnerships not Piracy", Far Eastern Economic Review, Aug 23, 2001
Following protests by several international groups, the Indian Government looks set to pass a new bill granting farmers the right to sell their seeds and keep control over food production. The Plant Variety and Farmers Rights Bill has already been passed in India's lower house and will now be placed before her upper house for approval.
The bill, which allows farmers to sell seeds - a right formally reserved for seed companies and multinational seed giants - effectively prevents the monopolization of India's food supply.
Source: "Farmers Right to Sell Seeds Protected in New Legislation", The Hindu, India, Aug 22, 2001
The US Patent and Trademark Office (USPTO) has upheld three patents for hybrid strains of basmati rice awarded to US company RiceTec, despite attempts by the Indian government to have all the patents originally granted in 1997 quashed.
USPTO ruled to disallow RiceTec from calling the rice "basmati", but allows them to label it "a superior basmati rice", adding insult to injury! The Indian Government was furious.
Devinder Sharma, a New Dehli-based food expert is scathing of the government's failure to demand USPTO reject the patents.
The Indian Government delayed in recognizing India's claim to have basmati protected under geographical indication provisions at the WTO. India is claiming a victory in that RiceTec have been denied the use of the word "basmati" as a trade name.
Source: India Still Sifting Grain From "Basmati" Chaff, by Ranjit Devraj. Aug 22, 2001 Posted on Norfolk Genetic Information Network (ngin), http://www.ngin.org.uk
USPTO has granted five patents on amla (phyllanthus emblica), a tree that is widely grown and used in India. Amla is one of the three ingredients of triphala, a traditional ayurvedic formulation used for thousands of years. One of the patents, filed by Unilever Corporation, claims an invention using extracts of amla in a hair coloring preparation. Four further patents involving amla have been filed in the Japanese Patent Office.
Source. "Amla turns patenters' darling!" by M. Somasekhar, July 9, 2001 http://www.hinduonline.com/
Brazil's Sugar Cane EST Genome Project (SUCEST) has just handed over exclusive rights of access to CropDesign, a Belgian agbiotech company, in exchange for an undisclosed sum.
CropDesign intend to combine their bioinformatics expertise to select genes for entry into their TraitMillTM, a high throughput evaluation system, designed to put together sequences for 'superior crops'. Furthermore, CropDesign intend to commercialize their results outside Brazil.
Brazil grows 25% of the world's sugarcane and exports large quantities of rice, corn and wheat. Sugarcane is a close genetic relative of these other crops and any useful similarities identified from SUCEST could become the intellectual property of CropDesign.
Source "CropDesign and SUCEST in Functional Genomics Alliance, Atlas Venture News, Sept 4, 2001 http://www.atlasventure.com/news_content.asp?ne_id=420
Paris-based Curie Institute is challenging Myriad Genetics in the courts over the US company's Euro patent covering the BRCA1 gene.
Myriad Genetics was awarded the patent (EP 699 754) for BRCA 1 in January. This means that European users are obliged to pay $2,400 for Myriad's screening test for genetic disposition to breast cancer.
Myriad exercise its exclusive rights to carry out diagnostic tests on both BRCA 1&2 by insisting that all samples for testing be sent to the company labs in the US.
The patent covers all tests based on comparing sample sequences with the sequence it describes for BRCA1.
The Curie Institute intends to challenge the patent on grounds of lack of novelty and inadequate description. They also point out that the patent is based on "prior art" drawn from public genome databases and that the original patent application contained errors limiting its usefulness.
The French Government is officially supporting the challenge and intends to introduce legislation extending compulsory licensing to cover genetic tests.
Source: "French researchers take a stand against cancer gene patent", Butler & Goodman, Nature, Sept 17, 2001 p95
A huge potential conflict-of-interest issue is simmering on the West Coast of the United States.
US venture-capital firm Burrill has set up a scheme with University of California, San Francisco (UCSF) in a move calculated to cash in on university-based research.
The aim is to fund high-risk projects of the type usually by-passed for funding by public agencies. Burrill intend to hand out grants of up to $500,000 per project and would also help to establish start up companies alongside UCSF and other partners to exploit any commercial potential. Needless to say, a disproportionate part of revenues generated from patents will end up in Burrill's hands.
It is not all plain-sailing for Burrill however; UCSF faculty have accused Burrill and their own university administrators of reaching the agreement without their formal consent and have voiced concerns about implications for academic freedom. One faculty member is quoted as saying "this deal raises huge conflict -of-interest issues."
Source: "Venture Capital concerns Academics", Rex Dalton, Nature, Sept 17,2001, p95.
Widespread, untoward attention to Sarawak's native bintangor tree by US pharmaceutical companies intent on developing a new anti-HIV/AIDS drug has prompted NGOs to sound the alarm.
Mark Bujang of the Borneo Resources Institute says the East Malaysian state's natives are in danger of having their traditional knowledge of medicinal plants stolen by biopirates.
He points out that the concept of property rights is unfamiliar to them. The locals freely share in benefits from traditional knowledge passed down through generations. His institute wants to make sure a share of any profit arising from native wisdom goes to the people of Sarawak.
Meanwhile, the state-led Sarawak Biodiversity Centre (SBC) has initiated a project to record, in writing, the orally transmitted knowledge of the locals. This is because recognition skills are fast disappearing. Today's youngsters can often name 10-20 medicinal plants and animals whereas the previous generation knew hundreds of different species. Local populations would be free to keep any written records to themselves, thus assuring a share in any financial benefits arising from that knowledge.
The records will also help Malaysia's efforts to implement the International Convention of Biological Diversity, requiring countries to ensure benefits derived from research of native genetic resources are shared with indigenous peoples.
Source: "Bio-pirates stalk Borneo tribe's treasure trove", Patrick Chalmers, Sept 4, 2001.
In an interview published in the London Evening Standard, Sir John Sulston of the Human Genome Project launched a vitriolic attack on rival Craig Venter, president of Celera Genomics, and the privatization of the genome sequence. As well as chastising Venter for blurring the distinction between science and business, Sir John insists that the idea of exploiting the genome was "a morally wrong decision. Yes, I'll stick to that."
In a further comment that the interviewer could only describe as "something that seems initially wild," Sulston, while in no way condoning terrorism, says the following about the attack in the US:
Sulston: " I cannot help, in my heart of hearts, relating this to the way both American and European military industrial complexes are treating the rest of the world It is very clear to me that western policies are driving the world further and further apart in terms of rich and poor, and causing large groups of people in the world to have justifiable resentments."
Interviewer: "And the Venters of the world will make the world unfairer? The West's rich might get cancer cures, the Middle East's poor might not and that breeds further resentment?"
Sulston: "Exactly so, which is why I relate the two things..
Source: The Andrew Billen Interview, Evening Standard, Sept 19, 2001 p27.
Article first published October 2001