Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after licensure of a biosimilar product by the FDA. It argues that the Federal Circuit’s decisions in Amgen v. Sandoz and Amgen v. Apotex grant exclusivity windfalls to Reference Product Sponsors (RPSs), even where no patent rights remain. In response to the Federal Circuit’s statements in the Sandoz case that the FDA can issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date, Mylan argues that this reasoning is speculative, as nothing authorizes the FDA to grant pre-effective date licensure for biosimilar applications, and the FDA has issued no plans to develop any such regulations or guidance.
Mylan also argues that Congress drafted the BPCIA to allow aBLA applicants to control the timing of the two stages of patent litigation, and to choose to resolve all patent conflicts with an RPS prior to the expiration of the 12-year statutory exclusivity period. However, according to Mylan, the Federal Circuit’s decisions now require any second-stage patent litigation to occur after licensure by the FDA. Mylan argues that this result thwarts Congressional intent to allow an RPS and aBLA applicant to fully litigate and resolve patent disputes in time for a successful aBLA applicant to launch at the end of the statutory 12-year exclusivity period.
Finally, Mylan argues that the Federal Circuit has effectively granted an extra-statutory, private right of action allowing an RPS to compel an aBLA applicant’s commercial marketing notice, and that the right to an automatic 180-day post-licensure injunction imposes an “automatic injunction without [a court] considering the merits or equities.”
Stay tuned to Big Molecule Watch for continuing developments.