Supreme Court Grants Myriad’s Petition for Cert.

I feel a bit like Al Pacino in “The Godfather – Part 3” when he shouts, “Just when I thought I was out, they pull me back in!” (Repeated memorably by Silvio Dante in “The Sopranos”.) Now the Supreme Court has granted cert. to resolve one question: “Are human genes patentable?” In isolation, presumably, since I have been explaining to patent “civilians” for years that no one can patent a gene – or any other chemical – as it occurs in situ in the human body and then demand a royalty from anyone using the gene to live.

Of course, defining what the term “human gene” means will be a major part of the opinion. If you would like to see a cogent review of the steps necessary to obtain the ca. 100,000 bp BRCA1 gene (including introns and exons) AND then the steps needed to produce the mRNA and reverse transcribe it into “Myriad-made” BRCA1 cDNA having only about 5914 bp (and no introns), take a look at the amicus brief filed by Gilead on Oct. 29, 2010 (s. 2). It certainly impressed Judge Moore, who came close to splitting with Judge Lourie and finding that the isolated BRCA 1 gene (100K bp) is a patent-ineligible natural product, while the cDNA (eg, claim 2 of the ‘282 patent) is a non-naturally occurring product. Perhaps that is the ultimate holding that awaits us, but it could be worse.

The legal answer to this question will duck the broader question of whether or not any “genes” isolated and purified from any creature – plant or animal – are patent-ineligible natural products. Given the importance of this question to, say, agricultural biotechnology, it may not be long before the question presented is much, much broader.

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One Response to “Supreme Court Grants Myriad’s Petition for Cert.”

  1. From Paul Cole:

    What should be the criteria for the intervention of a non-specialist court of final appeal in a specialist legal area?

    Firstly that the non-specialist court has the skills to resolve the matter in dispute. Secondly that the existing state of the law amounts to a serious wrong. Thirdly that the non-specialist court has a reasonable chance of truly understanding the underlying technical facts and legal principles and of producing an opinion that is both correct in outcome and correctly reasoned (the Kalo case, for example, being a clear instance of a correct outcome based on reasoning that it is difficult to support). Fourthly that there is a reasonable chance of arriving at a new rule of law which is preferable to that which existed formerly. Fifthly that there is a reasonable chance that the new rule of law can be expressed in a way that meets the needs of those closely connected with the subject matter in dispute without major but unintended collateral damage in situations unforeseen when the opinion was written, especially by ill-advised and over-broad dicta.
    Although there have been outstanding decisions from the Supreme Court e.g. in Festo, its recent record in our field could most charitably be described as patchy. Did the opinion in Bilski leave the law in a clearer or a more uncertain state? Can anyone determine what the rule of law underlying Prometheus actually was?
    Is Myriad a case where intervention was justified? Two concurrent Federal Circuit decisions were well reasoned, have been generally welcomed in the profession and compelling reasons for disturbing them are difficult to discern. If it was a matter of legal certainty then refusing certiorari would have been the wiser course. An ill thought-out decision could be profoundly damaging to the chemical, pharmaceutical and biotechnology industries at least, could cut US law off from a century of legal thought concerning the patenting of new chemical entities and from international standard practice on this topic. In the present case, the decision to grant certiorari is not grounds for confidence but for the reverse.
    Coincidentally, the current edition of Scientific American carries a lengthy article by Shawn Otto warning of the dangers of science denial when carried into politics, warning that “When facts become opinions, the collective policymaking process of democracy begins to break down.” There appear to be real dangers of science denial being carried into law also, and the decision for certiorari in this case highlights the dangers of this happening. In appearing to support the wish of The Association for Molecular Pathology, Breast Cancer Action and Boston Women’s Health Book Collective, amongst others, that the public should have free access to the fruits of difficult and costly research, the Court has the appearance of embracing populism rather than rationality.
    [Comment also posted on the Patently-O blog]