Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more
We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, protected under the Hatch-Waxman safe harbor? While courts have reached different...more
Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more