Clinton Urges Public Access to Genetic Code

President Clinton said Thursday that researchers and the public--not just a small group of drug and biotech companies--should have ready access to the human genetic code, which is widely considered the key to a whole new generation of drugs and medical treatments.

“We’ve got to get the basic information out to everybody who might find some particular use for it,” the president said in an Oval Office interview with three news organizations. “To me, it’s pretty clear what the policy ought to be.”

Clinton’s remarks, his first about how the soon-to-be-deciphered code should be used, came as industry is flooding the Patent and Trademark Office with thousands of applications to patent portions of the genetic code and policymakers wrestle with whether to limit the scope of what can be patented.

Critics, including some of the government’s own top scientists, warn that without limits, public access could be sharply restricted--to the detriment of research, medical care and innovation.

Debate over access and patents has heated up in recent months as the job of deciphering the human genetic code, a goal that once seemed reachable only a decade or more from now, suddenly appears to be on the verge of completion.

In the interview, Clinton distanced himself from the most strident voices in the gene patenting debate, coming from those who oppose almost all patents on human genetic material. Companies should be able to patent particular uses of the code, the president said, to protect the huge investments that will be required to exploit the new knowledge.

And he refused to take sides in a narrower dispute over whether rules recently proposed by the patent office for patenting genetic material would adequately protect public access to the code.

But his words seemed likely to be taken as support for those who fear that without more stringent limits than those proposed by the patent office the genetic code could be split up among dozens of commercial interests, with companies claiming large and overlapping pieces and fighting over the contested portions.

In endorsing broad public access, the president cited support of the academic and scientific communities. He said that gene patents should only be issued for narrow, clearly defined genetic discoveries or inventions.

“Most scientists and researchers believe the basic information ought to be as broadly shared as possible . . . ,” Clinton said. “Then, when people develop something that has specific use or commercial benefit . . . , that ought to be patentable.”

Some companies and organizations have sought to patent small pieces of the genetic code with only the thinnest of information about how those pieces function or how they could be used.

Reached Thursday night, an industry spokesman refused to comment directly on the president’s remarks but said worries that patents would limit public access to the genetic code were overblown.

“The patent system is the best way to make sure that the information developed by inventors is published and made available to researchers,” said Chuck Ludlam, vice president of the Biotechnology Industry Organization in Washington. “Academic researchers are totally free to take patented genomic material and conduct any kind of research they want as long as it is not commercial.”

Issues of access and control of the genetic code are coming to a sudden head largely because a group of private companies--including Celera Genomics Group, Incyte Pharmaceutical Inc. and Human Genome Sciences--have entered the fray with new computer technology that is allowing them to complete the deciphering process quickly and patent parts of the code that seem to have commercial potential.

In doing so, the companies so far have kept most of their findings to themselves. By contrast, the publicly financed Human Genome Project is making its results immediately available to researchers by posting them on the Internet.

Most observers believe that the scope of the patents that companies will be able to win on those portions of the code that the genome project has deciphered and released is limited. While they can seek patent protections for new tests, drugs or treatments based on those parts of the code, they cannot control the underlying code itself.

However, observers said that as things now stand companies may well be able to get extremely broad patents on those parts of the code that they, rather than the public project, decipher first. How broad those patents should be is where the debate now focuses, and on that issue the president came down on the side of narrowness.

“I think the patenting should be for specific discoveries and developments that have a clear and definable benefit . . . ,” Clinton said.

The effort to decipher the code is widely considered to be at the heart of a revolution in biology and medicine that is often compared in cost, ambition and technological daring to the splitting of the atom or sending the first man to the moon.

The code, carried by a person’s DNA molecules, determines what traits are passed from parents to child and how every cell in the body works. Tiny variations are thought to cause or at least contribute to a vast array of diseases. And understanding their operation could provide the key to new treatments and drugs.