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Posted on Wed, Jun. 03, 2009

Patenting human genes thwarts research, scientists say

Robert S. Boyd | McClatchy Newspapers

last updated: June 03, 2009 03:12:06 PM

WASHINGTON - Rapid advances in biology and genetics are raising fresh 
concerns about the spreading practice of patenting human genes.

The U.S. Patent and Trademark Office has granted patents to at least 
4,382 human genes, including genes related to Alzheimer's, asthma, 
cancer, muscular dystrophy and other serious diseases.

"Twenty percent of the human genes are currently patented,'' said 
Christopher Hansen, an attorney for the American Civil Liberties 
Union, which filed a suit last month challenging six patents on two 
genes that are connected to tests for breast and ovarian cancer.

A gene patent gives its owner the exclusive right, for up to 20 
years, to control its use for medical research, diagnosis or 
treatment.

"A gene patent holder has the right to prevent anyone from studying, 
testing or even looking at a gene,'' the ACLU lawsuit protests. "As a 
result, scientific research and genetic testing has been delayed, 
limited or even shut down due to concerns about gene patents.''

Patent holders reply that they have a constitutionally guaranteed 
right to protect their inventions in order to pay the heavy costs of 
genetic research and development.

Though gene patents are lawful, many scientists, health professionals 
and patients' organizations object that the patents are stifling 
research and interfering with patient care.

"Patents are meant to protect inventions, not things that exist in 
nature like genes in the human body,'' Hansen said.

"Questionable patents are too easily obtained and are too difficult 
to challenge,'' the Senate Committee on the Judiciary declared last 
month. "An industry has developed in which firms use patents not as a 
basis for producing and selling goods but, instead, primarily for 
obtaining license fees.''

The patent war is being waged on several fronts.

Congress is weighing legislation that would make it easier to 
challenge patents. The National Institutes of Health released a 
136-page draft report on the problem this spring. The National 
Academy of Sciences and the Federal Trade Commission have held 
multiple hearings.

The ACLU suit was filed in federal district court in Manhattan on 
behalf of the American College of Medical Genetics, the College of 
American Pathologists, other research organizations and individual 
patients. The defendants are Myriad Genetics, a pharmaceutical firm 
in Salt Lake City, and the University of Utah Research Foundation, 
which sponsored the research.

The patents give Myriad Genetics the exclusive right to test women 
for mutations in two genes, known as BRCA-1 and BRCA-2, which may 
indicate a genetic susceptibility to breast or ovarian cancer. A 
woman who tests positive might decide to have her breasts or ovaries 
removed.

"The effect of the patents has been to stifle clinical practice and 
research on the genetic predisposition to breast and/or ovarian 
cancer,'' the ACLU said. "The public, and in particular women, have 
suffered unnecessarily as a result.''

In response to news media queries, Myriad Genetics said it thought 
that its patents were valid and that it intended to defend them 
vigorously.

The House of Representatives and the Senate are considering bills 
that would, among other things, make it easier to challenge existing 
patents. The Senate Judiciary Committee approved its bill May 12. The 
House Committee on the Judiciary has held hearings but hasn't yet 
approved its version. If it passes, the bill would be the first major 
change in patent law in more than 50 years.

Patents have a venerable history. The U.S. Constitution (Article 1, 
Section 8) provided for a system of patents in order to encourage 
innovation and industrial progress. The goal was to reward inventors 
for their discoveries and prevent competitors from using their work 
without paying for licenses.

However, no patents on living things were granted until 1980, when 
the Supreme Court, by a vote of 5-4, approved a patent on a microbe 
that had been modified to dissolve oil spills.

The court's decision opened the floodgates. More than 3 million 
gene-related patent applications have since been filed with the U.S. 
Patent and Trademark Office.

Multiple patents have been issued on different parts of a single 
gene, creating a "traffic jam'' blocking investigators from working 
with that gene.

Fiona Murray, a professor of management at the Massachusetts 
Institute of Technology in Cambridge, reported a "significant 
decrease in the rate of follow-on research after patents on gene 
sequences have been filed and granted.''

The Patent Office estimated that about 52,800 patents have been 
granted related to genes, fragments of genes, genetic processes and 
bits of DNA as small as a single letter change in the genetic code.