By
Donald Zuhn —
In
January, the gene patenting debate returned to National Public Radio when
WBUR's "On Point" became the fourth NPR program to tackle the issue
since 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, in Association
for Molecular Pathology v. United States Patent and Trademark Office (see Patent Docs reports here
and here). The first discussion, involving Dr.
Hans Sauer, the Associate General Counsel for Intellectual Property for the
Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the
Practice of Law at American University's Washington College of Law; and Shobita
Parthasarathy, Co-Director of the Science, Technology and Public Policy Program
at the Ford School of Public Policy at the University of Michigan, occurred in
June on WAMU's "The Kojo Nnamdi Show" (see "Gene Patenting Debate Continues").
In August, Kevin Keenan, the Executive
Director of the American Civil Liberties Union (ACLU) for San Diego and
Imperial Counties; Stacey Taylor, a partner at DLA Piper; and Dr. Leonard
Deftos, Professor of Medicine in Residence at the University of California, San
Diego, and Adjunct Professor of Law at California Western School of Law, discussed
the subject on KPBS's "These Days" program (see "Gene Patenting Debate Continues – Round Two"). And last December, Patent Docs author Dr. Kevin Noonan, a partner at McDonnell Boehnen
Hulbert & Berghoff, and Daniel Ravicher, the Executive Director of the Public
Patent Foundation (PUBPAT), squared off in a third debate on the topic on NPR's
"Science Friday" (see
"Gene Patenting Debate Continues – Round Three").
In
the most recent discussion,
Dr. Sauer once again defended gene patenting, while one of the attorneys in the
AMP case, Chris Hansen, who is Senior
National Staff Counsel with the ACLU, argued against gene patenting. The debate was moderated by "On
Point" host Tom Ashbrook.
Dr.
Sauer began the conversation by noting that "DNA molecules with human
nucleotide sequences are patentable under the laws of almost all industrialized
countries today, and the law has been clear for a long time." Dr. Sauer
indicated that as with natural substances like plant chemicals and antibiotics,
patented genes had to be "transformed by human intervention into something that is
sufficiently different from the natural state to qualify as something new and
useful and man-made."
Demonstrating a grasp of the issue that has often appeared to elude other moderators, Mr. Ashbrook offered that "by the time [a gene has been]
patented, it's been extracted and isolated and purified and made something
different — it's not just the
handiwork of nature."
Mr. Ashbrook then asked Mr. Hansen to present his argument against the patenting
of genes. Mr. Hansen explained
that it has been a long standing principle that while "creations of
people" are patentable, "creations of nature," such as E=mc2,
gravity, gold, or iron (Mr. Hansen's examples), are not.
According to Mr. Hansen, "a few years ago, the Patent Office veered
off and stopped applying that principle, and then started patenting things were
in fact products of nature or laws of nature or abstract ideas, and one of the
places where they erred was in patenting the human gene." When asked about the practical problems
associated with gene patents, Mr. Hansen noted that he represented four
national associations of physicians and pathologists who are willing to offer
genetic testing to women throughout the country, but who were prohibited from doing
so by Myriad. He added that many
women cannot afford the test being offered by Myriad.
Mr.
Ashbrook then asked Dr. Sauer about the implications to the biotech industry if
the District Court were to rule for the plaintiffs in the AMP case. Dr. Sauer
responded that the ACLU's lawsuit was "shortsighted" because" in
trying to strike at these two particular patents and at this particular company
. . . they are striking at all patent holders in biotechnology." He noted that "patents on
isolated and purified DNA substances don't only protect genetic testing
technology, which is in the cross hairs in this lawsuit, . . . in many cases
gene patents protect not genetic tests, but they protect actual medicines and
actual therapeutics, which for their development require an investment of $1 to
$2 billion over the course of ten years to reach the marketplace."
Mr.
Hansen countered that "the fact that I represent most of the medical
establishment of this country . . . would suggest that cries from industry that
this [case] is going to hurt patients is probably misguided," adding that
"the truth is there are lot of expert geneticists around the country who
can do the testing that Myriad does, who can do it cheaper and even better, and
Myriad is preventing that from occurring." He also denied that a favorable decision for the plaintiffs
would adversely impact the patenting of therapeutics or therapeutic
methods. Mr. Ashbrook, however,
asked whether the biotech industry would develop such therapeutics or methods
"without the incentive of owning it and the profit motive imbedded in
that." Mr. Hansen replied
that "we know that the incentive here was not necessary for Myriad —
there were several other labs all over the country looking for the BRAC1 and
BRAC2 gene; they were all just about as close as Myriad was to finding
it."
With
respect to Mr. Hansen's assertion that Myriad would not allow other scientists
to look at the BRAC1 and BRAC2 genes, and instead had "locked them away
for Myriad only," Dr. Sauer noted that it was his understanding that Myriad had never asserted its
patents against scientists that do basic research, and further, that thousands
of papers on the BRAC1 and BRAC2 genes had been published in the scientific
literature since Myriad obtained the patents. Dr. Sauer also addressed Dr. Hansen's criticism of the cost
of Myriad's test by pointing out that a Duke University study had determined that
Myriad's test was in fact no more expensive than comparable tests that were either not
patented or not exclusively licensed.
While
Mr. Ashbrook acknowledged that Myriad's failure to assert the patents and the
thousands of published papers didn't "sound like a lock down," Mr.
Hansen argued that you had "to distinguish between clinical [work] and
research — there's unquestionably a total lock down on clinical testing." He also contended that Myriad
prohibited basic researchers from divulging BRAC1 and BRAC2 test results to
individuals participating in studies, so Myriad was "locking up some
degree of the research and locking up all of the clinical practice."
Moving
to the call-in portion of the program, Mr. Ashbrook took a call from a
researcher who thought gene patenting was "a bad idea." The caller then attempted to dispel the
three "myths" of gene patenting by arguing that gene patents are not
profitable, that they stifle innovation, and that gene patents are not
necessary for the protection of therapeutics. While conceding that "it is probably true that basic
research doesn't need to be motivated by patents," Dr. Sauer asserted
that "patents are critically necessary for . . . transforming the basic
discoveries . . . that are done in the universities and research institutions
in this country into real life products that benefit patients."
Noting
that Dan Ravicher of PUBPAT had stated that the goal of the AMP litigation was to invalidate all
gene patents, Mr. Ashbrook asked Mr. Hansen to discuss the likely impact of
such a result on therapeutic development.
Mr. Hansen replied that the invalidation of all gene patents would have
"a very positive impact," and contended that there would be "an
explosion of scientific interest in [previously patented genes]," and
"an explosion of new techniques, new treatments, [and] new drugs."
Taking
a break from listener calls, Mr. Ashbrook introduced Dr. Wendy Chung
to the program. Mr. Ashbrook noted
that Dr. Chung, who is the director of clinical genetics at Columbia University
and a plaintiff in the AMP case, was
also gene patent holder. In
response to the implication, Dr. Chung explained that for her, the biggest issue in the case was
not the validity of the patents themselves, but rather the exclusive licensing
of these patents. She argued that
there should be mechanisms by which universities and diagnostic companies
interested in developing genetic tests could deal with gene patents by securing
non-exclusive licenses. Detecting
that Dr. Chung's motivation for participating in the case differed from that of
the ACLU and PUBPAT, Mr. Ashbrook asked whether gene patents encouraged
innovation. Somewhat surprisingly,
Dr. Chung acknowledged that gene patents "act as a carrot" by
incentivizing public and private research. Noting that "it seems like you see both sides," Mr
Ashbrook asked Dr. Chung why she nevertheless agreed to be a plaintiff in the case, to which
she again responded that the problem was with the licensing, rather than the
issuance, of the BRAC1 and BRAC2 patents.
Mr. Ashbrook inquired as to whether there was a "middle
ground," and Dr. Chung suggested patent pools and non-exclusive licenses
as two alternatives to a prohibition on gene patenting.
On
the subject of licensing, Dr Sauer noted that a recent poll of BIO's members
indicated that exclusive licenses were generally preferred, particularly where
the licensed technology was going to be used in the development of a
therapeutic product, but that non-exclusive licenses were granted in some cases. As for Dr. Chung's "middle
ground," Mr. Hansen offered that "we're certainly open to virtually
any option that would change the current situation."
Mr. Hansen concluded the discussion by predicting that there would be "a vast increase in the amount of genetic research that takes place and a vast increase in the number of new tests and new drugs that are developed" if the plaintiffs in the AMP case receive a favorable decision from the District Court. However, Dr. Sauer suggested that if the District Court finds for the plaintiffs, "we will lose the significant incentive to develop products like recombinant human growth hormone, insulin, erythropoietin, and other new therapies that we haven't even thought of today for the benefit of patients who are still waiting [for such therapies]."
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