On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application and … Continue reading this entry
In a decision issued August 3, 2012 in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., the Federal Circuit held that the safe harbor provisions of 35 USC § 271(e)(1) can shield the defendants from liability for patent infringement arising out of their use of patented methods to satisfy FDA testing requirements for their approved products. … Continue reading this entry
At first glance, the Federal Circuit decision in Cybersource Corp. v. Retail Decisions, Inc. may not be of much interest to those in the pharmaceutical field. The patent at issue relates to a “method and system for detecting fraud in a credit card transaction” and the question before the court was whether various computer-related claim limitations … Continue reading this entry
On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite … Continue reading this entry
The Federal Circuit decided for the second time that the personalized medicine claims at issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services satisfy the requirements for patent-eligibility set forth in 35 U.S.C. ¬ß 101, even under the Supreme Court's decision in Bilski v. Kappos. In so doing, the court followed a two-part analysis that provides a framework for analyzing other method claims that may raise similar issues.
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