Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the "patent dance" provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA's information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen's Abbreviated Biologic License Application (aBLA). This case is not the first to highlight the difficulties with a statutory scheme that requires fierce competitors to share highly confidential information, but may lead to the first decision on just how much information a biosimilar applicant has to disclose and to whom.