Patenting life itself

String of nucleotidesBlueprint of human genes is public domain, specific therapies open to patent.

March 18, 2000

DECIPHERING the human genetic code, identifying and sequencing more than 100,000 genes that determine the body's development, is a formidable, complex task.

So too is the legal challenge to determine what is proprietary information that can be patented by gene research companies, and what genetic information should be public property.

In the balance is the discovery and treatment of myriad diseases and genetic disorders, a scientific breakthrough of unthinkable magnitude.

Four years ago, the leading industrial nations agreed to an informal program of complete, continuous release of information gathered by the international Human Genome Project. Tiny bits of new data on genes are released daily to the Internet by scientists.

This week, President Clinton and British Prime Minister Tony Blair committed to a broader program: free international access to the entire human genetic code when it is mapped.

The declaration shook the commercial genetic companies, which have bet tens of millions of dollars on discovering -- and patenting -- the genetic map before the Human Genome Project does. In the United States, 2,000 gene patents have been issued and another 7,000 applications are pending.

The problem is that many of these "patents" are for discoveries and maps, not for inventions or therapies that are typically patented. Many are simply protective filings, without any demonstrated therapeutic application, hoping that others will discover therapies and have to pay the patent-holder.

This is fundamentally wrong. The U.S. Patent Office erred 20 years ago when it allowed the first commercial patent for a specific human gene. It has tried to raise the bar for new genetic patents, but patent seekers have responded with broad claims of "theoretical" uses. Congress may have to intervene to toughen patent standards.

With 20 countries fully engaged in genetic research progams, the laws of one or two countries will not be controlling. France already prohibits patenting genes.

Protecting legitimate proprietary drugs and therapies is important. But it shouldn't thwart vital genetic research that is everyone's.

Pub Date: 3/18/00

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