Posts Tagged: "FDCA"

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, providing twelve years of market exclusivity to pioneer biologics… Like the Hatch-Waxman Act, the BPCIA also sets out a process for identifying disputes over patent infringement and managing any ensuing litigation once an applicant seeks a biosimilar license… To streamline the first wave of litigation, the BPCIA mandates that following the biosimilar applicant’s receipt of the RPS’s detailed statement on infringement, the parties negotiate in good faith to select patents for litigation from the lists initially provided by the RPS and the biosimilar applicant. [§ 262(l)(4)].