Tag Archives: Safe Harbor

Federal Circuit Interprets Two Important Infringement Provisions

In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important sections of the infringement statute, 35 USC § 271. In one portion of its decision, the court adopted a literal interpretation of § 271(g), holding that the statute only … Continue reading this entry

Patent Safe Harbor Applies To Supplemental New Drug Applications

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

Federal Circuit Extends Safe Harbor To Post-Approval Drug Testing

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