Speculating on Species?

0 Comments | Insight on the News, Dec 14, 1998 | by Rachel A. Roemhildt

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. "What makes us valuable to a company is that we have patented various technologies," he explains.

Peddling products envisioned in the patents has been risky business during the 1990s. But companies that have survived say their industry is poised for explosive sales growth, and through mergers have been able to assert and consolidate control over components of medicine and agribusiness. Monsanto Co., for example, holds key patents on new genetic material in farm seeds and is positioning itself to dominate markets for some major crops.

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It may sound like a script inspired by Greek mythology, but scientists have applied to patent a process for making chimeras, creatures that are part human, part animal.

Jeremy Rifkin, president of the Foundation on Economic Trends, and Stuart Newman, professor of cell biology and anatomy at New York Medical College, applied in December for the patent to challenge government policy. If successful, Rifkin and Newman would use their patent to prevent the creation of chimeras for 20 years, giving Congress time to draft legislation addressing the issue.

"We would like to see a situation where there is public discussion about this," says Newman, "and we would like to see the legislatures at the national and international levels saying that organisms, particularly with human tissue, are not simple compositions of matter and are not inventions."

According to Steven Kunin, deputy assistant commissioner for patent policy and projects for the U.S. Patent and Trademark Office, life forms can be patented if human intervention isolates or genetically alters them. Naturally occurring discoveries of nature cannot be patented.

In 1978, the Patent Office rejected an application submitted by Ananda Chakrabarty to patent a microorganism genetically engineered to consume oil spills in the ocean. In 1980, however, in a 5-4 decision, the Supreme Court ruled that living organisms, excluding humans, could be patented as long as they met patent requirements.

Humans cannot be patented because the 13th Amendment to the Constitution prohibits slavery. Currently, animals with some human genes are patented and used in medical research. But there isn't a ratio of human genes to animal genes that sets a distinguishable line.

If the patent is not granted, Rifkin plans to take the issue to the courts or Congress. On average, it takes 22 to 24 months for a ruling, which means a decision on the chimera application is expected by December 1999.