Washington, D.C. – The United States Supreme Court will hear an important patent infringement case this term that will determine the scope of patent rights in certain medical methods. Patent lawyers for Prometheus Laboratories, Inc. of San Diego, California filed a patent infringement suit against Mayo Collaborative Services, doing business as Mayo Medical Laboratories of Rochester, Minnesota, alleging that Mayo infringed patent no. 6,355,623, Method of treating IBD/Crohn’s disease and related conditions wherein drug metabolite levels in host blood cells determine subsequent dosage and patent no. 6,680,302, Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders which have been issued by the US Patent Office.
The patents at issue involve claims over an observed correlation between certain blood tests and patient health, specifically the correlation between the level of certain drug metabolites in the patient’s blood and the patient’s symptoms of gastrointestinal disease. As characterized by Mayo in its brief to the Supreme Court, the inventors did not “invent” these correlations; rather, they simply observed the correlations in a patient population. Based on the patents, Prometheus brought a blood test product called Pro-Predict to the market. The level of metabolite in the patient’s blood can give the treating physician information relevant to adjusting the patient’s dose of certain medications. Mayo improved upon Prometheus’s blood test product and later released its own competing product. Patent attorneys for Prometheus then initiated this lawsuit, alleging that Mayo had infringed its patents. Mayo has attempted to defend the suit by arguing that Prometheus’s patent claims were not patent-eligible under 35 U.S.C. § 101. The Court of Appeals for the Federal Circuit has twice ruled in Prometheus’s favor.
The oral argument is scheduled for December 7, 2011 at the United States Supreme Court. The briefs can be found on the American Bar Association’s preview page for the case. A number of amicus curiae briefs have been filed as well. Notably, the American Medical Association filed an amicus brief in support of Mayo.
Practice Tip: In 2010, the U.S. Supreme Court decided Bilski v. Kappos, which examined § 101 and held the machine-or-transformation test is not the sole test for determining patent eligibility, but is rather “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.” The decision in this case may clarify the Bilski holding.