Original Article
Journal of Commercial Biotechnology (2009) 15, 44–58. doi:10.1057/jcb.2008.37; published online 14 October 2008
Pharmaceutical patents after KSR: What is not obvious?
Jason Lief1 and Peter Schuyler2
Correspondence: Jason Lief, McDermott Will & Emery LLP, 340 Madison Avenue, New York, NY 10173, USA. E-mail: jlief@mwe.com
1is a partner at McDermott Will & Emery LLP in the New York office. His practice focuses on patent litigation and counselling. He has successfully represented clients in major patent litigations, including Hatch-Waxman cases involving billion-dollar pharmaceutical products. He has tried patent infringement, validity, and enforceability issues before US federal judges and juries, conducted direct and cross-examinations of inventors and technical experts at trial, argued before the US Court of Appeals for the Federal Circuit and handled all aspects of discovery, including foreign court appearances pursuant to the Hague Convention.
2is a partner in the law firm of McDermott Will & Emery LLP. His practice focuses on all aspects of intellectual property law, including patent litigation and the counselling of clients on the protection, enforcement, and licensing of intellectual property rights. He received a bachelor's degree in Mechanical Engineering from the Polytechnic University and a law degree from the Fordham University.
Received 3 September 2008; Revised 3 September 2008; Published online 14 October 2008.
Abstract
The Supreme Court recently revisited the question of patent validity based upon obviousness in KSR Int'l v Teleflex, Inc. The court rejected the Federal Circuit's rigid application of the 'Teaching, Suggestion, Motivation' test in determining the obviousness of patent claims, and reasserted its precedent regarding obviousness, beginning with the seminal 1852 HotchKiss decision. The decision arguably makes it easier to invalidate patents for obviousness. This paper analyzes the effect of KSR on the state of the law concerning the obviousness of pharmaceutical and biotechnology patents in the Federal Circuit and District Courts.
Keywords:
pharmaceutical, patent, validity, invention, obviousness
