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]."