By Donald Zuhn —

Gene
patenting has been a hotly debated topic for at least the past three years.  The subject moved back to the
forefront when Chicago-Kent College of Professor of
Law Lori Andrews and the late Michael Critchton published an article in the November 11, 2006 issue of Parade magazine, in which the two
advocated for a Genetic Bill of Rights that would have included a prohibition on gene
patents (see "Gene Patenting in
the News Again").  The anti-gene patent baton was next
passed to Rep. Xavier Becerra (D-CA), who in February 2007 introduced a bill
(H.R. 977)
in the House that would have prohibited patents from being granted for "a
nucleotide sequence, or its functions or correlations, or the naturally
occurring products it specifies" (see
"The Continuing Threat to Human Gene Patenting").  And the debate was renewed last May
when a group of patients, physicians, academic researchers, and medical
societies filed suit against the U.S. Patent and Trademark Office and Myriad
Genetics, among others, over several patents claiming human BRCA1 and BRC2
genes and methods for detecting mutations in these genes to diagnose a
predisposition to breast and ovarian cancer (see "Association for
Molecular Pathology v. U.S. Patent and Trademark Office").

In
a recent article in Science Progress
entitled "Do Gene Patents Hurt Research?"
Timothy Caulfield, the Canada Research Chair in Health Law and Policy and a
Professor in the Faculty of Law and School of Public Health at the University
of Alberta, added his voice to the discussion.  Mr. Caulfield begins the article by asking what the controversy is all
about, and responds that:

While the concerns associated with gene
patents are varied, one has had the most policy traction:  the idea that patents on sequences of
genetic information hurt research, especially upstream, basic research.  The worry is that patents will hurt
science by making it difficult to acquire the rights to all necessary research
inputs.  Research will slow, become
more inefficient and expensive — or researchers will simply avoid doing
research on patented, yet scientifically valuable, genes.

While
Mr. Caulfield (at right) acknowledges that "[a]t first blush, all this [anti-gene
patenting] policy activity seems to make sense:  a logical response to a profound social problem [i.e., the
impact of patent tickets or the anti-commons on research]," he quickly
concludes that there is one hitch — in particular, that "[t]here is little evidence
that the problem exists." 
Thus, he writes that while "[t]here is lots of social angst,"
there is "no good data showing a widespread patent thicket/anti-commons
phenomenon."

In
support of his conclusion, Mr. Caulfield points to a 2007 study by the American
Association for the Advancement of Science, which found "very little
evidence of an 'anticommons problem'"; a 2005 study for the National
Academy of Sciences, which found that only 1% of scientists surveyed reported
suffering a project delay of more than one month due to patents; his own 2009
study of the Canadian genetic research community, which revealed "lots of
researcher concern about gene patents, but little evidence that they are
actually having a detrimental impact on the research environment"; and
Prof. Chris Holman's 2007 paper on the impact of gene patents on innovation and
access ("The Impact of Human Gene Patents on Innovation and Access:  A Survey of Human Gene Patent
Litigation").

Instead of a patent thicket/anti-commons problem,
Mr. Caulfield finds that:

While the apparent disconnect between
policy concern and evidence is a significant dilemma on its own, I think there
is a bigger problem.  By focusing
on gene patents, we seem to be downplaying other concerns associated with the
commercialization ethos that increasingly permeates the research environment.

Thus,
he asserts that the real problem is "[c]ommercialization pressure, not
patenting," adding that "at the current time, we need to recognize
that despite all the noise, there is still no solid evidence that gene patents
hurt basic research."  Mr.
Caulfield does not discount the possibility that such
evidence may be generated in the future.  But he insists
that "arguments for reform must be based on an honest assessment of
available evidence — not on assertions that conflict with the facts."  Thus, he sees a need for "more methodologically
robust research on the true benefits and harms of patents," which he
believes "will allow for a more informed debate on the fundamental patent
tradeoff:  that is, the granting of
a limited-term monopoly for the benefit of society."

For
additional information on this and other related topics, please see:

•
"Gene Patenting Debate Continues – Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical
Research Fails to Support Gene Patenting Ban," October 22, 2009
• "Gene
Patenting Debate Continues – Round Two," August 4, 2009
• "The
Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods,
Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene
Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S.
Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and
the Wisdom of Judge Lourie," April 12, 2009
•
"Genetic Diagnostic Testing: The "Anti-Commons" Revisited?"
March 25, 2009
• "Science Article
Should Help Allay Gene Patenting Fears," December 17, 2008
•
"The Continuing Threat to Human Gene Patenting," October 16, 2007
•
"Science Fiction in The New York
Times," February 13, 2007
•
"The Continuing Value of Biotech Patenting," February 4, 2007
•
"Anti-Patent (Sullivan?) Malice by The
New York Times," January 29, 2007.
•
"In Support of Gene Patents," December 6, 2006
•
"Gene Patenting in the News Again," December 5, 2006