[Pharm-policy] Gene test patents cause debate at HHS panel meeting

[Thiru Balasubramaniam]

Greg Aharonian
Internet Patent News Service
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    --  GENE TEST PATENTS DEBATED AT HHS PANEL MEETING: ACADEMIA VERSUS
BIO
 
Washington Fax
June 21, 2000 

                   Patenting of tests stirs debate at meeting
                     of HHS genetic testing advisory panel 

     Members of the Secretary's Advisory Committee on Genetic Testing
(SACGT) were subjected to bouts of strong opinion when discussion at
their June meeting turned to patenting policies and practices and their
effect on genetic testing. 

     While industry representatives strongly advised leaving the issue
in the hands of the Commerce Department's Patent and Trade Office (PTO),
academic forces called for access to the tests for research, and genetic
disease groups argued that patenting can lead to restrictions in
development of diagnostic and even therapeutic products. 

     Although committee members appeared perplexed and sometimes upset
over the influence the debate might have on genetic testing, other more
pressing business forced the group to forego any substantive debate of
their own on the issue. However, they did not explicitly remove it from
their agenda -- despite arguments from industry representatives, who
suggested they do so. 

     Not surprisingly, industry representatives reject proposals that
human genetic tests be handled differently from conventional patenting
procedures or, at least, that university-based researchers and
physicians be exempted from paying royalties or similar fees when they
use the tests on patients and their families; whereas, academic
researchers and patient advocacy groups typically see the issue in a
different light. 

     Charles Ludlam, vice president for governmental relations at the
Biotechnology Industry Organization (BIO), a biotech trade group,
bluntly urged the committee to leave patenting alone, saying such issues
lie within PTO jurisdiction, not with the Department of Health and Human
Services(HHS), which SACGT is chartered to advise.

     "PTO is setting high standards for approval," he said, referring to
patent applications covering partial or complete human gene sequences,
and recent PTO efforts to refine utility criteria for issuing such
patents.  "Patenting is not ownership; [patents] just prevent the
competition from stealing one's inventions. The biotechnology industry
needs to reassure investors that its inventions won't be stolen," said
Ludlam.

     However, several meeting participants disagreed with Ludlam's
assessment of patents. "This is an important discussion [for SACGT] to
bring balance to the legal and medical issues," said Michael Watson, who
directs clinical and medical cytogenetics testing at Washington
University in St. Louis. "Patent law is driven not by public interest,
and you should not disregard the role of HHS, which is needed here.
Monopolies are being developed, and labs are being told to stop doing
tests... Enforcement of gene patents can be against [the interests of]
health care." 

     Watson said several problems could arise from the zealous
enforcement of patents covering tests of human genetic disorders. For
instance, exerting control over diagnostic testing for genetic
disorders, particularly by restricting it to one site, which sometimes
happens, can impair the development of useful databases needed for
research into the disease and potential advances in its treatment. 
Moreover, such controls also can restrict training efforts, particularly
when testing for a specific genetic disease is carried out at a single
location. Yet, he pointed out, specialists with broad training in human
genetics already are in short supply and will be needed in greater
numbers in the years to come. 

     "Should human disease genes be subject to different rules?" asked
Ellen Wright Clayton, who specializes in law and pediatric medicine at
Vanderbilt University. "I don't argue that patents are bad per se, but
creating private property rights is not without costs."  One remedy to
consider is awarding "a part of royalties" to individuals whose DNA is
used for research and subsequent development of commercial products, she
said. "But this might only shift where the money goes and not solve
anything." A better plan would be to "give people who need the [genetic]
test some control over how it is used--grant royalty and decision-making
to the people who are affected." 

     Efforts to develop a genetic test for Canavan's disease, a
degenerative condition of the central nervous system that affects mainly
Ashkenazi (European descent) Jews, seemed to embark on such a track --
but then were derailed, according to Judith Tsipis, a vice president
with the National Tay-Sachs and Allied Diseases Association and director
of the genetic counseling program at Brandeis University in Waltham,
MA.  Back in 1987, a group of Canavan-affected families cooperated with
researchers, first at the University of Illinois, then at a hospital in
Miami, in efforts to study the disease and develop a screening test for
families carrying the gene that gives rise to it. "The early research
was ideal ... with a lot of cooperation...and no mention of patents,
licensing...and nothing to limit the use," she said. "It was a
partnership." 

     However, that partnership foundered after a patent for a broad
diagnostic method for Canavan's disease that also covered potential
therapies was awarded to the Florida researchers in 1997, Tsipis said. 
Members of the affected community "learned of plans to enforce the
patent when letters were sent out" the next year..."one week after
screening was designated the standard of care," she added. "The patent
restricts public access to the test and controls what labs can do it....
Some labs refused to sign the wretched contract, and some suspended
testing, and this has particularly affected members of the community who
contributed samples for the early work." What happens next is uncertain
as the patent holders and the affected community are seeking some
alternative to the current stalemate. Meanwhile, "access to testing is
restricted...and the patent also restricts access to research," she
said. 

     Nonetheless, Ludlam and other industry representatives who spoke
before SACGT, maintain that the patent system is a prerequisite for
bringing the private sector into the high-risk arena of human genetics
research, where the primary goals include the development of useful
diagnostic and therapeutic products. "Recommendations calling for new
regulatory hurdles will add to the costs of genetic testing," said Tom
Frank, medical director of Myriad Genetic Laboratories in Salt Lake
City.  Without protections such as patents, those restrictions "will
inhibit the development of new tests." 

     That the industry is in constant jeopardy in its efforts to develop
new tests and therapeutic products is not in doubt, BIO's Ludlam said. 
"Last March 14, billions of dollars evaporated in the biotech sector." 
That flash loss of cash resources followed a public statement by U.S.
President Bill Clinton and U.K. Prime Minister Tony Blair, who raised
questions about the legitimacy of patenting in the field of human
genetics. A subsequent clarification from Clinton, in which he deferred
to PTO authority on this issue, still has not restored the biotechnology
company evaluations that vanished practically overnight, Ludlam said. "I
don't know what research didn't happen because of this, but a lot was
curtailed or killed."