Saturday, October 15, 2005

One-Fifth of Human Genes Have Been Patented, Study Reveals

Stefan Lovgren for National Geographic News
October 13, 2005

A new study shows that 20 percent of human genes have been patented in the United States, primarily by private firms and universities.

The study, which is reported this week in the journal Science, is the first time that a detailed map has been created to match patents to specific physical locations on the human genome.
Researchers can patent genes because they are potentially valuable research tools, useful in diagnostic tests or to discover and produce new drugs.

"It might come as a surprise to many people that in the U.S. patent system human DNA is treated like other natural chemical products," said Fiona Murray, a business and science professor at the Massachusetts Institute of Technology in Cambridge, and a co-author of the study.

"An isolated DNA sequence can be patented in the same manner that a new medicine, purified from a plant, could be patented if an inventor identifies a [new] application."

Hot Spots

Gene patents were central to the biotech boom of the 1980s and 1990s. The earliest gene patents were obtained around 1978 on the gene for human growth hormone.

The human genome project and the introduction of rapid sequencing techniques brought a deluge of new genetic information and many new patents. Yet there has been little comprehensive research about the extent of gene patenting.

The new study reveals that more than 4,000 genes, or 20 percent of the almost 24,000 human genes, have been claimed in U.S. patents.

Of the patented genes, about 63 percent are assigned to private firms and 28 percent are assigned to universities.

The top patent assignee is Incyte, a Palo Alto, California-based drug company whose patents cover 2,000 human genes.

"Gene patents give their owners property rights over gene sequences—for example in a diagnostic test, as a test for the efficacy of a new drug, or in the production of therapeutic proteins," Murray said.

"While this does not quite boil down to [the patent holders] owning our genes … these rights exclude us from using our genes for those purposes that are covered in the patent," she said.
Specific regions of the human genome are "hot spots" of patent activity. Some genes have up to 20 patents asserting rights to how those genes can be used.

"Basically those genes that people think are relevant in disease, such as Alzheimer's or cancer, are more likely to be patented than genes which are something of a mystery," Murray said.

Patent Maze

The effect of gene patenting on research and investment has been the subject of great debate.
Advocates argue that gene patents, like all patents, promote the disclosure and dissemination of ideas by making important uses of gene sequences publicly known.

Patents also provide important incentives to investors who would otherwise be reluctant to invest in ideas that could be copied by competitors.

But critics caution that patents that are very broad can obstruct future innovations by preventing researchers from looking for alternative uses for a patented gene.

"You can find dozens of ways to heat a room besides the Franklin stove, but there's only one gene to make human growth hormone," said Robert Cook-Deegan, director of Duke University's Center for Genome Ethics, Law, and Policy.

"If one institution owns all the rights, it may work well to introduce a new product, but it may also block other uses, including research," he said.

In cases where there are a lot of patents surrounding one area of research, the scientific costs of gene patents—financial and otherwise—can be extremely high.

"Our data raise a number of concerns about gene patents, particularly for heavily patented genes," Murray said. "We worry about the costs to society if scientists—academic and industry—have to walk through a complex maze of patents in order to make more progress in their research."