For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more
IPR Petitioners Must Be Permitted to Respond to Claim Constructions First Proposed in Patent Owner Response - In Axonics, Inc. v. Medtronic, Inc., Appeal No. 22-1532, the Federal Circuit held that where a patent owner in...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
Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have...more
IN RE CELLECT, LLC - Before Lourie, Dyk, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Obviousness-type double patenting analyses for patents with Patent Term Adjustments are based on the...more
Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more
The Federal Circuit recently decided two appeals, Novartis AG v. Ezra Ventures LLC (“Ezra”) and Novartis Pharms. Corp. v. Breckenridge Pharm. Inc. (“Breckenridge”) that both relate to the effect of obviousness-type double...more