Genetic Information Does Not Belong in Patent Office

IT'S a good thing Isaac Newton didn't have a lawyer. He might have tried to patent his law of gravity.

That sounds silly. But is it any sillier than the persistent effort of the United States National Institutes of Health (NIH) to patent parts of the human genome? That's the genetic information within cells that specifies the body's development, form, and function.

Research biologists who want to keep the flow of basic research information open and unrestricted say "no, they're equally silly." But NIH officials claim a crucial distinction between a basic natural law and the equally basic natural human genetic code. The former is a cosmic heritage that no one can "own." The latter contains commercially valuable information that can be obtained only through proprietary research.

In short, there's a lot of money to be made by those who can develop products - especially medicines - based on the properties of specific human genes. NIH says it is filing for patents to protect the interests of American industry and encourage development of such products.

The trouble is NIH isn't trying to patent specific genes it has identified and whose functions it has defined. It is trying to patent so-called genetic markers that delineate specific portions of the genome whose function and potential usefulness is unknown. It's like a sketchy map with landmarks such as a distinctive hill or cliff that tells you how to find specific areas within territory that has yet to be fully explored.

In biochemical terms, these genetic markers are fragments of DNA molecules. Genetic information is encoded in the DNA structure. It can take a sequence of thousands of DNA subunits to encode a single gene. However, the marker that specifies where that gene is located along the DNA molecule typically contains a sequence of only about 400 of these molecular building blocks.

Critics charge that NIH is trying to lay claim to unexplored genome territory. Britain's Medical Research Council has responded by filing patent applications of its own. It fed scientists' concerns about censorship by keeping its genetic marker sequences secret until the applications were filed.

Wrangling over this issue has soured the climate for the international effort to decode the genome. Nobel laureate James D. Watson resigned as director of the NIH National Center for Human Genome Research over the issue. France has called for a treaty outlawing the patenting of the genetic markers and the larger unexplored genetic sequences they identify.

Ross Sibson, who heads one of the Medical Research Council projects, spoke for many fellow scientists when he said it's hard to see "how you can exercise legal right over something about which you essentially know nothing." The US Patent and Trademark Office supported this view when it sent back the NIH patent applications last month. NIH now is revising its claims to meet Patent Office requirements. If it persists, the whole issue is likely to wind up in court.

Meanwhile, research identifying genetic markers zips along in Britain, France, and Japan. If everyone patents what they know, industrial scientists trying to use basic genetic information to develop products will be caught in a thicket of fragmented proprietary rights.

This isn't an issue for the Patent Office or the courts to decide. Congress should amend US law to keep genetic information in the public domain. And countries pursuing this research should negotiate a treaty to outlaw the patenting of genetic sequences of unknown utility.

Where would astronauts be if they had to get permission to use the law of gravity?

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