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NIH Head Requests Gene Legislation

By Malcolm Galdwell
The Washington Post

WASHINGTON

National Institutes of Health Director Bernadine P. Healy has asked Congress to take up legislation clarifying when and how scientists should be allowed to receive patents on human genes.

The call follows the announcement, earlier this month, by the U.S. Patent and Trademark Office that it was initially rejecting an NI* application for patents on 2,400 human gene fragments that have been identified by federal researchers.

The Patent Office decision is not necessarily final. In fact, the office raised similar objections in more than 90 percent of the patents it reviews. But at a congressional hearing Tuesday, Healy said the Patent Office decision has raised enough questions to make congressional or federal action to change the way patents are issued for human genes "a matter of some urgency."

Healy's request to Congress follows her controversial decision earlier this year to file for patents on more than 2,000 human genes that NI* researchers have decoded.

The issue is not whether a patent can be issued on a human gene. Under patent law, a scientist who undertakes the difficult task of decoding the strands of DNA that make up the estimated 50,000 to 100,000 genes in the human body is allowed to receive a patent for his or her work, and receive royalties from the use of those genes if and when they are cloned and sold commercially.

What has not become clear, however, either under American or international patent law, is how to structure the patent system in order to best encourage the commercial development of drugs and therapies from human genes and assure the exchange of information among scientists.

For example, should the government be in the business of seeking patents for genes, or should it leave that to the private sector? More specifically, when should a patent be awarded?

Genes are hugely complicated structures. Typically, scientists have decoded them one fragment at a time, publishing at each step of the way. Often they have been able to decipher parts of a specific gene's structure long before they understand what exactly that gene does.

Should a patent be awarded on a gene before its sequence is fully decoded? And should it be awarded before a scientist discovers specifically what the gene does?

It was to generate a debate on some of these questions that the NI* decided last year to file for patents on thousands of gene fragments discovered by its scientists. Many were not complete gene sequences; nor in a majority of cases did the researchers understand what the genes did. But agency officials said they wanted to see how the Patent Office would respond.

The office has now ruled. In initially rejecting the applications, the Patent Office ruled that the NI* filing failed the requirement that the patent be "non-obvious," or unique. The Patent Office said that since even smaller fragments of the genes had been published in the scientific literature, the genes discovered by NI* were not the original discoveries.

This is precisely what NI* officials and some industry officials had feared. It means that if any company wanted to go to the extra trouble of decoding the full sequence of a gene, discover how it works, and make it into a drug, it could not receive a patent for its product and protect its investment because the Patent Office would consider that extra effort "obvious."

In order to encourage commercial development of human genes, Healy argued, Congress should consider clarifying this issue in a separate law, stipulating that "the prior publication of partial gene sequences not preclude a subsequent patent on the full genes and-or partial genes with known function." Several bills circulating in Congress also have suggested making this same change to the way the Patent Office considers applications for patents on human genes.