In a case that will have a profound effect on biotech and pharmaceutical companies, the U.S. Supreme Court on March 20, 2012 issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and addressed the question as to when medical diagnostic methods fulfill the patentable subject matter requirement of Section 101 in the Patent Code.
As held by the Supreme Court, claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of natural phenomena or laws of nature rather than correlations involving those laws. In addition, the U.S. Supreme Court clarified that the so called “machine or transformation test” articulated in Bilski v. Kappos is not a definitive test of patent eligibility.
As the U.S. Supreme Court has recently remanded Association for Molecular Pathology v. Myriad to the Federal Circuit for consideration in light the decision in Mayo v. Prometheus, the question of when are genes and gene fragments, methods of drug screening and medical diagnosis using genetic material and information patentable subject matter will again be addressed.
For more on the matter, you should really attend PLI’s next One Hour Briefing. On Wednesday, April 4th, at 1pm, PLI is hosting a One Hour Briefing entitled, “Prometheus: Implications of the U.S. Supreme Court’s Decision.” This briefing will be conducted by Keith J. McWha, partner in the law firm Day Pitney LLP, and Paul T. Martin Associate Director Intellectual Property and Assistant General Counsel at PTC Therapeutics Inc. Specific topics include:
- What are the consequences of the Court’s ruling on the patentability of process patent claims generally?
- How might this decision affect biotech and pharmaceutical patent claims such as dosage or method of use and naturally occurring therapeutics?
- What can be done to ensure that method claims for drug screening, diagnostics and dosing satisfy the Prometheus test for patentable subject matter?