Mayo Collaborative Services v. Prometheus Laboratories Inc.
To help clients understand and prepare for the potential impact of Mayo v. Prometheus, Banner & Witcoff offers the following content as a resource to monitor and analyze developments in the case.
Background
On December 7, 2011, the U.S. Supreme Court heard arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. involving whether certain types of medical methods are patent-eligible subject matter. The patents at issue claim methods for optimizing patient treatment in which the level of a certain drug metabolite is measured to identify a need to increase or decrease dosage levels. The district court ruled the claims were invalid, finding the inventors’ discovery was no more than “a natural body process . . . preexisting in the patient population.” The Federal Circuit reversed, holding the claims patent-eligible because they involve a physical transformation and thus are not merely an abstract idea or law of nature. The Supreme Court remanded the case to the Federal Circuit in light of its decision in Bilski v. Kappos, after which the Federal Circuit again ruled in favor of Prometheus.
At oral argument before the Supreme Court, several themes were apparent. Both the court and the parties struggled to separate the gatekeeping role of Section 101 against the novelty and obvious requirements.
The parties also focused on the relative merits of applying Section 101 rigidly to regulate eligibility versus addressing patentability by enforcing the requirements for novelty under Section 102 and nonobviousness under Section 103. Mayo urged that Section 101 is an important gatekeeper that allows doctors to make judgments without fear of being sued for patent infringement.
On March 20, 2012, the U.S. Supreme Court issued its ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc., striking down patent claims directed to methods of optimizing patient treatment in which the level of a certain drug metabolite is measured to identify a need to increase or decrease dosage levels. Please click here to view the decision.
On March 21, 2012, the USPTO issued a memo to examiners regarding the Mayo v. Prometheus decision. Please click here to view the memo.
On April 19, 2012, Lisa M. Hemmendinger, Ph.D., and Paul M. Rivard of Banner & Witcoff; Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy for the USPTO; Hans Saurer, Ph.D., Deputy General Counsel for Biotechnology Industry Organization, led a panel discussion that provided analysis and insight on the U.S. Supreme Court’s decision in Mayo v. Prometheus.
Important Dates
March 26, 2012 – Supreme Court Decision is Issued
December 7, 2011 – Supreme Court Oral Argument
Court Documents
U.S. Supreme Court Decision – March 26, 2012
Court of Appeals for the Federal Circuit Decision – December 17, 2010
Court of Appeals for the Federal Circuit Decision – September 16, 2009
Media
Banner & Witcoff attorneys are available to answer questions and discuss the Mayo v. Prometheus case. Media inquiries should be directed to Colleen Strasser at (312) 463-5465 or cstrasser@bannerwitcoff.com
related news
03.22.2012 | Paul M. Rivard discusses the Mayo v. Prometheus decision in BNA, BioWorld and the San Diego Business Journal
03.20.2012 | Patent Law Update: Mayo v. Prometheus
06.21.2011 | Patent Law Update: Mayo v. Prometheus
01.04.2011 | Robert H. Resis comments on the Prometheus v. Mayo decision in the Chicago Daily Law Bulletin
11.23.2009 | Sarah Kagan authors a guest column on Prometheus Laboratories, Inc. v Mayo Collaborative Services
related library documents
04.19.2012 | Practical Implications of Mayo v. Prometheus; Banner & Witcoff and BNA Webinar. 04/19/2012. (Hemmendinger, Lisa M.; Rivard, Paul M.)
03.20.2012 | Supreme Court Rules Prometheus Personalized Medicine Claims Not Patent-Eligible; Banner & Witcoff IP Alert. 03/20/2012. (Rivard, Paul M.)
