On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247. Boehringer Ingelheim seeks an interpretation of “strength” to
More Posts
Claim Construction Arguments in Appeal Forfeited if Not Raised Before the Board
Venue Considerations for Hatch-Waxman and BPCIA Litigation
Still No Same Party Joinder and Joinder of New Issues through 35 U.S.C. § 315(c)
IPR Parties Joined under 315(c) Have Full Rights to Appeal
USPTO Rulemaking for Post-Grant Proceedings Open for Public Comments
The § 315(b) Time-Bar and a New Real-Party-In-Interest
The Federal Circuit’s Determination That Administrative Patent Judges are Unconstitutionally Appointed
State Sovereign Immunity Does Not Apply in IPRs
Precedential Opinion Panel to Decide “Printed Publication” Requirements at Institution Stage
Subscribe: Subscribe via RSS
Firm/Org