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The European Patent Office (EPO) has approved a restricted patent on the Harvard OncoMouse, dealing a setback to activists who fought for 9 years to bar EU patents on living organisms.
The EPO on July 6 limited the patent to mice; the original European patent, granted in 1992, extended the patent to all mammalian species with a transgenic oncogene. That patent had been restricted to just rodents in 2001.
The restricted patent protects any OncoMouse, whether created using methods discovered by the inventors or using other techniques. The cancer research tool, which was first recognized by a US patent in 1988 for a mouse containing the myc oncogene, has become a significant symbol for animal activists as well.
Harvard University Professor Philip Leder, who invented the original OncoMouse with Timothy Stewart (now a staff scientist at Genentech), praised the EPO decision to uphold the patent, even in its restricted state. Leder and Stewart sold the licensing rights to DuPont in 1999. "This is the organism that has the greatest utility," Leder told The Scientist. "I'm pleased to have the matter resolved."
For European academic scientists, the EPO decision means that research assisted by the OncoMouse can continue unabated. Dupont has issued 170 licenses for academic research, but charges a license fee for commercial uses, according to a statement.
Professor Pierre Chambon of France's National Institute for Health and Medical Research said that the original patent was too broad. "If you make recombinant E. coli and patent it, and then you try to patent all bacteria, it would be refused," he said. "[The EPO] restricted it because it was too large."
The patent decision, by the EPO Technical Board of Appeals, was the final ruling on multiple appeals by a group of European government departments and advocacy organizations, including Greenpeace and the British Union for the Abolition of Vivisection. Those groups have vowed to continue their campaign to prevent such patents.
"We wanted to say you can patent the process, but not the animal," Christoph Then, a campaigner for Greenpeace in Germany, told The Scientist. He expressed disappointment at the EPO decision, which was the group's last chance to lobby for European-wide government action; they can now only lobby within individual states.
With the end of its OncoMouse EPO campaign, Greenpeace hopes to stop the implementation of the 1998 European Biotechnology Directive, which allows for patents of any element of a living organism created in a lab. Germany is one of eight countries that have not yet implemented the 1998 directive. The European Commission referred the eight countries to the European Court of Justice a year ago, saying that their failure to implement the directive by 2000, as agreed in Parliament, held back the progress of biotechnology innovation.
Jan Creamer, chief executive of the UK National Anti-Vivisection Society, said that "patenting life should be wrong. You're not producing a product that will make a difference."
Chambon noted that the EPO usually bases patent decisions on the innovation, not on concerns for the welfare of animals, but that it was still fair to interpret the ruling as a statement that it's acceptable to patent living organisms. "If you decide that living things can be patented, it's fair to recognize the OncoMouse," he told The Scientist.
Nick Bassil, a partner in the UK patent firm Kilburn & Strode, said that although the OncoMouse case is significant to the activists, it's no longer significant for scientists. "This case established the principal of patenting higher life forms," he told The Scientist. "It was important, but [now] other patents have been granted."
In the United States, researchers funded by the National Institutes of Health (NIH) can use the OncoMouse free of charge, under a 1999 agreement between DuPont and NIH. Should the researchers collaborate with a private company, they will have to obtain a license from DuPont.
For other academic researchers, the definitions of the patent remain unclear, said Paul Clark, Harvard's outside patent attorney. "The patent law has no academic experimental use exemption," Clark said. "I don't know how far [the patent] extends. No one really knows."
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