Biologics Price Competition & Innovation Act (BPCIA): Litigation Considerations | Practical Law

Biologics Price Competition & Innovation Act (BPCIA): Litigation Considerations | Practical Law

A Practice Note discussing strategic considerations when litigating a biosimilars case under the Biologics Price Competition & Innovation Act (BPCIA). It explains biologics, discusses the history and intent behind the BPCIA, the Food & Drug Administration's (FDA)'s Purple Book, biosimilar FDA regulatory approval and exclusivities, strategic pre-litigation and litigation considerations for both reference product sponsors and biosimilar applicants, and antitrust considerations in BPCIA settlements.

Biologics Price Competition & Innovation Act (BPCIA): Litigation Considerations

Practical Law Practice Note w-034-4767 (Approx. 17 pages)

Biologics Price Competition & Innovation Act (BPCIA): Litigation Considerations

by April Abele Isaacson, Kilpatrick Townsend & Stockton LLP, with Practical Law Intellectual Property & Technology
MaintainedUSA (National/Federal)
A Practice Note discussing strategic considerations when litigating a biosimilars case under the Biologics Price Competition & Innovation Act (BPCIA). It explains biologics, discusses the history and intent behind the BPCIA, the Food & Drug Administration's (FDA)'s Purple Book, biosimilar FDA regulatory approval and exclusivities, strategic pre-litigation and litigation considerations for both reference product sponsors and biosimilar applicants, and antitrust considerations in BPCIA settlements.