The new field of biotechnology, which will shape the future of food and medicine, is keeping the Patent Office busy. But some scientists fear the lure of profit is undermining scientific ethics.
Of the 237,045 applications received by the U.S. Patent and Trademark Office in fiscal 1997, 10,500 were in the field of biotechnology, making it and computer science the most active areas for invention.
Biotechnology means the "manipulation of a living species for a beneficial or commercial purpose," explains Sonia Guterman, a patent attorney from Boston with a doctorate in molecular biology. It covers everything from immunology to antibodies to gene therapy to genetically altered, or "transgenic" animals.
The first transgenic animal patented -- popularly known as "the mouse that went to Harvard" -- was altered to develop tumors for cancer research. Since then, the Patent Office has approved applications for animals given genes related to human diseases as well as for research. Now scientists talk about "tailoring" pigs, sheep and cows to make organs and medicine for humans.
As of September, the Patent Office had received 1,502 applications for transgenic animal patents and approved more than 90 -- 78 mice, three rabbits, two rats, a sheep, nematode, cow, bird, fish, pig, guinea pig and an abalone. Under U.S. law, once genes with known functions are isolated, they can be patented if they have potential for treating diseases or creating products. So far, researchers and companies have laid claim to more than 1,800 genes.
A patentholder can exclude others from using the invention for 20 years unless permission is granted, often in exchange for royalties. Speculators aren't supposed to be able to stake claims on genes without a specific purpose, but the intended application can be theoretical rather than immediately practical. And if a different use arises in the future, the patent covers it.
The Mayo Foundation for Medical Education and Research in Rochester, Minn., has patented several generelated discoveries involving a range of ailments, including Lyme disease, infections that often afflict AIDS patients and white blood cells that play a role in asthma. In another era, prominent medical and research institutions were expected to freely share their discoveries for the benefit of all, says Imran Nasrullah of Mayo's Office of Technology Transfer. But in a competitive market and a time of tight government funding, Mayo counts on the financial return from patents and joint ventures with private entrepreneurs to fund ongoing research. …