The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
8/28/2024
/ Denial of Rehearing ,
En Banc Review ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Medical Devices ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Safe Harbors ,
SCOTUS
Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up....more
The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more
In Sawstop Holding LLC v. Vidal the Federal Circuit confirmed what many practitioners suspected— the Patent and Trademark Office will only award a patent term adjustment to offset a delay caused by appellate review of a...more
Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is...more
8/6/2021
/ CAFC ,
Life Sciences ,
Mitsubishi ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Expiration ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
7/21/2021
/ 35 U.S.C. § 271(e)(1) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Research Tools ,
Safe Harbors