NEW YORK, November 11, 2011 – Baker Botts L.L.P. filed an amicus brief on behalf of Novartis Corporation in the U.S. Supreme Court in Prometheus v. Mayo Clinic (no. 10-1150), supporting the patent-eligibility of therapeutic and diagnostic processes under §101 of the Patent Act, 35 U.S.C. §101.
The case raises the basic question of whether therapeutic methods that are predicated on making correlations, such as between a drug’s metabolite levels and its safety and efficacy, are impermissibly directed to “laws of nature,” which the patent law considers to be fundamental tools of science that should be free to all to use.
The brief argues that therapeutic- and diagnostic-method claims generally do not preempt “laws of nature” because they invariably are directed to applications of such laws and implicate transformative events, features that comfortably place these claims within the broad scope of §101. Indeed, by facilitating the diagnosis and treatment of diseases and disorders, these types of claims are directed to one of the most important applications of all-- namely, enhancing the quality of, and even sustaining the very existence of, human life.
The brief is noteworthy in that it extends the argument beyond the realm of therapeutic methods (such as those at issue in Prometheus) to even embrace diagnostic methods, thereby attempting to remove the cloud of uncertainty created by Lab. Corp. v. Metabolite Labs., 126 S. Ct. 2926 (2006). That case concerned a method of diagnosing vitamin B deficiencies by correlating cobalamin and folate levels to such deficiencies. Although the appeal was dismissed, a dissent led by Justice Breyer would have exercised appellate jurisdiction and held the claim patent-ineligible for preempting a law of nature.
To view the amicus curiae brief, click here.
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