http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent.html

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 sequencesófor
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 patentsófinancial and otherwiseócan 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.”

(The Science report is also available by subscription at http://www.sciencemag.orgOne-Fifth of Human Genes Have Been Patented0/cgi/content/full/310/5746/239.)