By Kevin E. Noonan —
The AMA, ACLU, and some of their friends oppose the (Leahy-Smith) America Invents Act, and their reasons may not surprise you.
In separate letters Wednesday to Rep. Lamar Smith, Chairman of the House Judiciary Committee and Rep. John Conyers, the Ranking Member, both the American Civil Liberties Union (ACLU) and the American Medical Association (AMA) opposed H.R. 1249. While on first blush the basis of their opposition may be surprising (Rep. Debbie Wasserman Schultz's (D-FL) amendment contained as Section 27 of the Manager's Amendment that mandates the availability of "second opinion" genetic diagnostic testing), both groups have much bigger goals and aims than protecting the rights of Americans to a "second opinion." Despite the propaganda used by both groups (they even had Morley Safer believing it) of the importance of such "second opinions," what these groups are really after is a ban on human (or all) gene patenting. Whatever the flaws in the proposed "second opinion" amendment (see "Manager's Amendment (and Others) to H.R. 1249 — Second Opinions in Genetic Diagnostic Testing"), the gene patenting ban pursued by both groups, most recently in the Association of Molecular Pathology v. U.S. Patent and Trademark Office case, is an even worse prescription for the future of genetic diagnostics and other applications of genetic technology.
The ACLU's letter (also addressed to Rep. David Dreier, Chair, and Rep. Louise Slaughter, Ranking Member, of the House Rules Committee), from Laura W. Murphy, Director, Washington Legislative Office and Michael W. Macleod-Ball, Chief Legislative and Policy Counsel, raises as one basis for its opposition the specter that passage of H.R. 1249 containing Section 27 would indicate to courts Congressional approval of human gene patenting. This argument ignores the reality that Rep. Xavier Becerra (D-CA) has been introducing bills to do just that for several years, none of which has ever even come to a vote in committee. It also ignores 30 years of USPTO practice granting such patents in the face of political pressure not to do so; in this the ACLU may not be faulted, since the Department of Justice also has amnesia on this topic, so much so that Acting Solicitor General Kaytal argued to the Federal Circuit that the DOJ's position did not represent a sea change in policy (see "AMP v. USPTO: Oral Argument at the Federal Circuit").
The ACLU's letter does a remarkable job in misstating the holding of the Diamond v. Chakrabarty case, changing what the Court actually said, that "laws of nature, physical phenomena, and abstract ideas" are not patent eligible, to read "natural phenomena, products of nature and laws of nature," thus bringing "products of nature" within the patent-ineligible ambit. And it cites in support its signal victory before Judge Sweet, and in a footnote noting the Department of Justice's "about face" on the issue in (honestly, only partial) support of their position. The remainder of the letter contains characteristic inapt correlations between the number of Americans suffering from Alzheimer's disease, muscular dystrophy, and various cancers, and the purported "inhibitions on research, treatment, and scientific progress" occasioned by gene patenting, none of which has any empirical basis (and, indeed, the evidence is to the contrary, including the more than 8,000 scientific research papers on the BRCA genes since the patents invalidated by Judge Sweet were granted).
The "real solution," according to the ACLU and its supporters, would be to "allow hospitals and laboratories to develop and offer testing in the first instance," despite the evidence that no one has done so for the overwhelming (~80%) number of genes not patented. Finally, the ACLU makes sure the Members know that they have God, and many constituents, on their side, citing "patients and their advocates, health providers, scientific organizations, environmental activists and Christian organizations" as their supporters in opposing the bill. Those groups include Breast Cancer Action, the Center for Genetics and Society, Family Research Council Action, Friends of the Earth, International Center for Technology Assessment, National Women's Health Network, Our Bodies Ourselves, Southern Baptist Ethics and Religious Liberty Commission, and the United Methodist Church — General Board of Church and Society. In their letter (attached to the ACLU's letter), is reiterated the ACLU's position, that "patents on human genes present a barrier to second opinion genetic testing" because they "stop[] those labs from examining, testing, and working with patented genes." (Of course, the scientific evidence shows that the only thing gene patent holders stop is others charging for these services, but that goes unmentioned.) The remainder of the letter repeats most of the inaccuracies in the ACLU's letter, including the mis-citation to the Chakrabarty holding (in a passage taken almost word-for-word from the ALCU's letter), and including allegations of a rash of other ills from permitting gene patents (littered with phrases like "ownership and sole control over the fundamental building blocks of life" and "monopolistic gene patent holders").
Not wishing to burn any political bridges, the AMA's letter (from Executive Vice President and CEO Michael D. Maves, M.D., M.B.A.) terms Rep. Wasserman's amendment "well-intentioned by flawed," but nonetheless repeats the ACLU's accusation that passage of the amendment "may be misconstrued as authorizing, implicitly, the issuance of patents on human genes." The group goes on to render an incorrect legal opinion ("[g]enes are products of nature and have never been patent eligible") and falls into the Judge Sweet error (that patenting genes involves restrictions on the genetic information per se). The letter accurately states that the weakness of the proposed provision is that it is "marked by numerous exceptions" (since an outright ban would be easier to administer) and "would not establish a well-defined pathway for non-patent holders to follow in order to avoid lawsuits." Dr. Maves also asserts as a possible negative consequence that the provisions could "undermine the ability of physicians to provide optimal care for patients, and further inhibit the development of quality diagnostic tests and access to those tests by physicians and patients." While undoubtedly his (and his organization's) views, few of its members are involved with "the development of quality diagnostic tests" and, as consumers, like most Americans are most concerned with obtaining the best possible test at the lowest possible cost. It is hard to criticize Dr. Maves on this score but the facts are that such tests are not so easily developed that intellectual property protection does not influence investment. And with patents, the public gets the benefits of fixed terms and perpetual freedom to use after patent expiry, something also unmentioned in Dr. Maves' letter; the alternatives are not as favorable to "the development of quality diagnostic tests."
Although it is hard to support Section 27 (and opposition from the ACLU and AMA are not legitimate bases for such support), the provision itself (as with much of H.R. 1249 and its companion S.23) illustrates again how little the operation of the patent system is understood or appreciated even by those who cry the loudest about the need for innovation. For all its flaws (and for all they have been exaggerated by interests who want to eat their innovation cake and have it, too), the system was an important part of the resurgence of the American economy that resulted in a budget surplus at the end of the last century (however wantonly squandered). If indeed innovation is the only way for a return to prosperity, attacking the patent system for short-term, nearsighted gain (political or otherwise) is not the smart thing to do. It's time for Congress to wake up to that reality.
Patent Docs 
Leave a reply to EG Cancel reply