This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
2/4/2025
/ Denial of Certiorari ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Regulatory Requirements ,
SCOTUS ,
Statutory Interpretation
Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more
12/30/2021
/ Clinical Trials ,
Hatch-Waxman ,
Obviousness ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
POSITA ,
Prior Art ,
Section 112 ,
Standard of Care ,
Written Descriptions
Since the Supreme Court’s ruling in TC Heartland, there has been increased litigation over appropriate venue in patent litigation, including Hatch-Waxman cases. 28 U.S.C. § 1400(b) provides that venue in patent infringement...more