Tuesday, January 27, 2009

Amicus Briefs Filed in Prometheus v. Mayo, an Important Case for Biotechnology and the Future of Personalized Medicine

I have explained in several previous posts (on this blog and on Patently-O) why Prometheus v. Mayo is an important case for biotechnology, with particularly important implications for future innovation in diagnostics and personalized medicine. In Prometheus, the district court invalidated personalized medicine claims under 35 USC 101as patent-ineligible, based on its finding that a correlation between the level of non-naturally occurring drug breakdown products in a patient's body and the optimal drug dosage is an unpatentable “natural phenomenon.” In my view, the district court erred in characterizing a non-naturally drug breakdown product, and the interaction of those breakdown products with the human body, as natural phenomena. If not corrected, this erroneous interpretation of Section 101 could have a profound detrimental impact on patenting and innovation in the life sciences, particular with respect to new technologies relating to preventive and personalized medicine. A copy of Prometheus’s appellant brief is provided here.

Last week, I filed an amicus brief in Prometheus on behalf of myself and several other concerned patent law professors (Law Profs Brief). The brief supports neither party, and ventures no opinion on the ultimate patentability of the claims, but does argue that the rationale set forth by the district court for invalidating the Prometheus claims is incorrect and potentially harmful. It also argues that Bilski has not rendered moot the distinction between natural and non-natural phenomena, and that Bilski’s machine-transformation test will likely prove insufficient and appropriate for many patent claims arising out of the life sciences. It also points out the potential for unintended consequences and uncertainty with respect to a host of claims relating to biotech and pharma, and particularly with respect to the burgeoning field of personalized medicine. It also distinguishes the claims at issue from the oft-discussed claim 13 from LabCorp v. Metabolite, which relates to a correlation involving naturally occurring metabolites as opposed to non-naturally occurring drug breakdown products. Law Profs ask the Federal Circuit to reverse the district court on its determination that the correlation between the level of drug breakdown products in the human body and the optimal dosage of the drug is an unpatentable “natural phenomenon.”

The Biotechnology Industry Organization (BIO Brief) has also filed a brief supporting neither party, but like Law Profs arguing that the district court erred in its application of section 101 to invalidate Prometheus claims.

The American Intellectual Property Law Association (AIPLA Brief) has filed a brief in support of Prometheus, likewise arguing for a reversal of the district court’s judgment that the claims are invalid under Section 101.

I understand that Myriad also filed a brief in support of Prometheus, but I have only seen a draft and cannot definitely confirm that it was filed. As a leading diagnostics company, Myriad obviously has a major stake in the outcome of this case. The draft I saw argued that patents on the inventions claimed in Prometheus and LabCorp are critical for ensuring innovation in diagnostics and personalized medicine.

Law Profs, BIO and AIPLA all join with Prometheus in arguing that the district court erred in characterizing this correlation between a non-naturally occurring drug breakdown product and optimal drug dosage as a natural phenomenon. They also all make the point that if not reversed, the district court's misapplication of Section 101 could have profound unintended negative consequences on future innovation and biotechnology, with particular emphasis placed on the effect on personalized medicine. Law Profs and BIO argue that the Bilski machine-transformation test is not well-suited for determining patent eligibility for inventions arising in the life sciences. BIO and AIPLA argue that in any event, the Prometheus claims satisfy both the machine and transformation prongs of the Bilski test. They also fault the district court for improperly focusing on individual claim elements, rather than the patentability of the claim as a whole, and note the potential for abuse if courts disregard claim limitations as mere “insubstantial post-solution activity.”