- The Washington Times - Wednesday, March 15, 2000

The United States and Britain agreed yesterday to share data from a National Institutes of Health (NIH) project to decode the human genetic pattern, hammering shares in biotechnology companies hoping to profit from the sale of gene research.

The biotech fall prompted the technology-heavy Nasdaq Composite Index to fall 201 points to 4,707 yesterday, or 4.1 percent.

The two countries said they would share raw data, including the human DNA sequence and its variations, with scientists worldwide. Raw data identifies genes but does not describe their functions or their potential medical uses.

"To realize the full promise of this research, raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere," President Clinton and British Prime Minister Tony Blair said in a joint statement yesterday.

The human genome is a biological map laying out the sequence of the estimated 3.5 billion pairs of chemicals that make up the DNA in each human cell. Those chemical arrangements comprise the estimated 80,000 to 100,000 human genes, which in turn carry the instructions for all the body's processes.

A complete map would help scientists discover causes of disease and help them find treatments.

Gene-research companies reacted positively to the statement, saying they already make their data public knowledge though their stocks fell as much as 20 percent yesterday. But they say they own their discoveries based on that research and should be able to patent them.

Genes themselves cannot be patented, but their applications can be, according to the U.S. Patent and Trademark Office.

To be patentable, inventions or discoveries must meet three requirements: Novelty, usefulness and how they work. And although gene discoveries are new, just knowing they exist is neither useful in developing drugs nor instructive.

The federal government started the Human Genome Project at NIH 10 years ago to create a map of human genes. The project, which has laboratories worldwide, says it will have a rough draft of the human genome by June.

PE Corp.'s Rockville, Md.-based Celera Genomics Group is racing NIH to map the human genome first and sell drug makers and researchers genetic data and the technology to use it to create new drugs.

Celera has said it will be able to complete the sequencing of the human genome ahead of the NIH project for $200 million, as opposed to the $3 billion price tag for the federally funded effort.

Since it was created, the Human Genome Project has asked Celera and other genomics companies to share the names of new genes they discover, and the companies have complied.

Project officials were negotiating with Celera to give them more information until the talks fell through last week.

"Celera said it was going to contribute if they could get up to five years on some patents, but that fell apart last week," said Laura Kragie, chief scientific officer at BioMedWorks Inc., a biotechnology consulting firm based in Silver Spring, Md.

"Part of the problem is egos and Nobel prizes, and part of it is making money off the genes," she added.

Officials at Celera, headed by J. Craig Venter, did not return calls yesterday.

Celera's stock closed at $154 yesterday on the New York Stock Exchange, down 19 percent, or $35, from Monday.

Other companies working on sequencing and compiling genetic information databases said they were pleased with the U.S.-British accord because it reaffirms the importance of genes and patents, though their stocks dropped as well.

"It's the first time that they have gone on the record to mention support for human genetic information," said William A. Haseltine, founder and chief executive officer of Human Genome Sciences Inc., a Rockville company that researches genes and their medical uses.

Mr. Haseltine said the industry supports the release of raw genetic data "for the very simple reason that raw genomic data is not useful for science or for medicine." Genes disperse into small bits around the body and must be assembled to be used to make new drugs or discover what causes illnesses.

Roy Whitfield, CEO of Incyte Pharmaceuticals, a Palo Alto, Calif., company that researches gene information from how old genes are to how they are affected by drugs and diseases, compared the Human Genome Project to a phone book. He said the mapping of the human genome is like the Yellow Pages with phone numbers but no names and addresses.

"Just having the sequence really doesn't get you very far," he said.

The agreement sent stocks of genetic-research companies plummeting, with Incyte falling $53.50 to $143.50 and Human Genome Sciences $29.05 to $123.52 on Nasdaq yesterday.

Biotech and pharmaceutical companies across the board were hurt by the news, but analysts said investors overreacted.

"I think the perception had to do with patents, and investors thought that may nullify the intellectual property and patents the genomics companies have been filing, which is their main value," said Sushant Kumar, a biotechnology analyst with Mehta Partners in New York.

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