Litigation-Related Issues Under the Biologics Price Competition and Innovation Act
The chapter summarizes the pertinent provisions of the Biologics Price Competition and Innovation Act (“the Act”) that relate to patent issues, including the so-called patent dance, the two waves of litigation, and due to its significance to biosimilar practice, inter partes review.
The chapter first examines the statutory framework of the Act that governs the contemplated exchange of confidential-information between the sponsor and biosimilar applicant resulting in the list of patents to be litigated—the infamous patent dance. It also discusses the two distinct waves of litigation that the Act envisioned, and the 180-day notice of commercialization that triggers the second wave. Also provided are suggestions for both sponsors and applicants on preparing for litigation under the Act. The chapter then reviews the leading cases that have addressed the workings of the Act including the information exchange process, the patent dance, discovery, and remedies. Significantly, the Supreme Court ruled that information exchange and patent dance provisions are optional, and the 180-day notice of commercialization can be given at any time after FDA filing. Certain ramifications of the decision are explored in the cases discussed. The chapter concludes with a discussion of Hatch-Waxman safe harbor, which is applicable to biologics/biosimilars and unchanged under the Act, and inter partes review, which will continue to play a significant role in biosimilars’ attempts to avoid district court litigation for their proposed products.
KeywordsHatch-Waxman Act Infringement Patent dance Patents Litigation Inter Partes Review BPCIA
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