The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument focused on two issues of statutory construction: (1) whether the BPCIA requires biosimilar applicants to turn over their application and manufacturing information to the reference product sponsor (RPS), or whether instead it is “optional” at the discretion of the biosimilar applicant; and (2) whether biosimilar applicants can comply with the obligation to give Notice of Commercial Marketing as required by BPCIA by giving “notice” before FDA has even approved the product for commercial marketing.
On issue 1, Amgen argued that the statute at 42 USC 262(l)(2) states that the biosimilar applicant “shall” provide the application and manufacturing information to the RPS, and that use of the term “shall” should be construed as mandatory. Sandoz argued to the contrary – that the overall reading of the statute shows that the requirement to provide the application is required only if the biosimilar applicant elects to follow the patent dance procedure. According to Sandoz, the statute specifically contemplates biosimilar applicants electing not to choose that route and provides a specific and exclusive remedy if they elect not to do so...
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