In legislation passed last week, the House Judiciary Committee decided not to include special exemptions for university researchers from patent laws regulating genetically-altered animals because the courts already provide such protection.
Sponsored by Rep. Robert W. Kastenmeier (D-Wis.), the legislation originally would have enabled university researchers and small farmers to freely use patented animals for noncommercial purposes without having to fear lawsuits for patent infringement.
However, after some deliberation, the Judiciary Committee agreed to two amendments, one of which, sponsored by Rep. Carlos J. Moorhead (R-Ca.), would eliminate the exemption for researchers on the grounds that this was already protected by the courts and did not need to be further spelled out in the legislation. The full House is expected to approve the bill in September.
The other amendment, sponsored by Rep. Michael Synar (D-Ok.), would broaden the exemption for farmers, allowing them to market the patented animals and their offspring. They would still be prohibited, however, from marketing the sperm or embryo of these animals.
Harvard officials said that the bill would have little impact on the patent issued this spring to Andrus Professor of Genetics Philip Leder '56 since the genetically-altered mouse that Leder developed would not be used by farmers.
Leder was at the center of a national controversy this spring after Harvard received the exclusive marketing rights for the genetically-altered strain of mice he created to do cancer research. It was the world's first animal patent.
"The common practice is that research use in a non-commercial sense is never challenged," said Joyce Brinton, director of Harvard's Office for Patents, Copyrights and Licensing. Brinton said that Leder had already been offering his product to researchers at a rate well below the breeding costs of the mice.
Yet, perhaps most significant of all to the future of biotechnology research, Harvard officials and industry advocates say, was that the committee rejected by a 22-10 vote a third amendment, sponsored by Rep. Bruce Morrison (D-Conn.), which would have delayed the granting of animal patents for two years or until a federal regulatory agency was set up with the jurisdiction over such patenting.
Although the Morrison amendment would have keptLeder's patent intact, Harvard officials andbiotechnology advocates had opposed it on thegrounds that it would have unnecessarily hamperedresearch in the field.
"I was concerned that the moratorium woulddelay the development and implementation ofgenetically-altered animals and thereby create anenvironment of secrecy [inimical to research],"Leder said in an interview yesterday. "It wouldalso serve as an incentive to drive thedevelopment of biotechnology overseas."
Leder said he had not heard of the Kastenmeierbill and thus could not comment on the specificprovisions of it, but stressed that he has soughtall along to share his work with his fellowresearchers.
"Information regarding this has [already] beenwidely published," Leder said.
"The most significant aspect [of theKastenmeier bill] was the lack of success of thethird amendment," said Lisa J. Raines, director ofgovernmental relations for the Washington-basedIndustrial Biotechnology Association