By Kevin E. Noonan --
Darwin, Mendel, Watson and Crick -- a good case can be made that these four men make up the basis of modern biology as a science (as opposed to natural history). As such, their contributions to human understanding, of ourselves and the natural world around us, will be remembered for the rest of human history.
The same, unfortunately, cannot be said for the amicus brief filed by Professor Watson (at right) in the Myriad case. With the respect he is eminently due, the best that can be said is that he falls into many of the same legal, philosophical, and logical traps that others have on the subject (illustrating once again that genius rarely translates over distinct disciplines (Goethe and Count Rumford being exceptions) and that law, like science, can have subtleties that are not for the faint of heart or uninitiated.
Professor Watson makes three arguments, two of which are wrong and the third fraught with difficult consequences beyond his experience. The first argument is that human genes should not be patented because DNA is a unique molecule different from other chemicals and should be treated as such; this is a variant of Judge Sweet's view that DNA is different because it is the "physical embodiment of genetic information." While this characterization describes a gene's significance it does not change its fundamental nature as a chemical compound under patent law. Fortunately, Professor Watson applies his argument only to human genes, which limits its applicability and potential for legal mischief. However, the argument is a policy one outside the scope of the judiciary's purview. Neither the Federal Circuit nor the Supreme Court has the role of making the types of policy decisions urged by Professor Watson in his brief. This limitation was recognized by the Chief Justice in National Federation of Independent Businesses v. Sebelius (the healthcare case), where he stated "Members of this Court are vested with the authority to interpret the law; we possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation's elected leaders, who can be thrown out of office if the people disagree with them." If U.S. patent law is to be changed to preclude patenting of isolated DNA molecules, this is a matter for Congress. And it must be noted that Congressman Xavier Becerra has introduced several bills to do just that, and during Congresses actively engaged in patent reform. But these bills have gone no where; indeed, even the portion of the Leahy-Smith America Invents Act having to do with patenting inventions comprising the human body (codifying the Weldon Amendment) were introduced and passed with assurance from its sponsors that the provisions were not intended to affect patenting of human DNA.
Professor Watson's second argument is that human genetic information should not be "controlled by legal monopolies" or the private property of any company. Of course, a proper understanding of the matter is that human genetic information is not patented, and never has been. All the DNA sequences in all the "gene patents" in all the world do not preclude an investigator from using the sequence information freely; indeed, insofar as the efforts of companies like Celera were actively involved in the Human Genome Project (and they were) and submitted patent applications containing human gene sequence information (and they did) these companies performed precisely the academic and scientific service Professor Watson espouses and the patent system promotes: disclosure of the information to be used freely by others. It is true, as Professor Watson writes, that some at the time (including Sir John Shulston and Professor Watson himself) thought patenting ill-advised. But the inaccuracies regarding the effects of such patents evidenced by the brief and Professor Watson's apparent lack of experience with how biotechnology companies protect their intellectual property (and use it for funding) steal some of the force from these arguments.
The brief does raise a valid issue in its final portion: the potential for the development of a "patent thicket" of sequences that could prevent easy commercialization of genetic diagnostics. However, as frequently happens, the timeframe for robust genetic diagnostics (the future) and the timeframe for protecting human genes with patents (the past) are subject to shorter and shorter periods of overlap, so that the patents Professor Watson decries will not be in force when the genetic technologies are commercially available. (There may be other patent impediments to be sure, but gene patents are not one of them.) It is also the case that prototypical patent claims for human genes are simply not infringed by the types of genetic diagnostic testing that concerns Professor Watson in his brief (see the amicus brief filed by Dr. Holman, and the amici brief by Drs. Holman and Cook-Deegan). And the remedy the Professor recommends, compulsory licensing, is simply inconsistent with the extent of investment that has been and can be expected to be required to actually get commercial embodiment of such test to patients, which is Professor Watson's professed purpose.
There is one portion of the brief, a footnote really, where Professor Watson sees clearly, and in a single sentence provides an apt synopsis for the sorry state of affairs that has led to this situation:
I have also read the Supreme Court's decision in Mayo v. Prometheus, although its opaqueness must leave many attorneys wondering if it adds anything at all to the issues of whether human genes ought to be patented.