As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council filed an amicus brief in support of Apotex’s petition. The brief is available here.
In its amicus brief, the Biosimilars Council takes the position that “the Court should grant the petition in Sandoz and hold that biosimilar applicants are never required to wait until license approval to provide a notice of commercial marketing with the failure to do so privately enforceable by a mandatory 180-day injunction,” and that if the Court does grant review in Sandoz, “it should consider granting the petition in this case as well, so that the Court can consider the various factual scenarios in which the notice issue arises.” The Biosimilars Council adds that “even if this Court decides to deny review in Sandoz, it should take up the first question presented in this case” – i.e., “Whether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes … must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A)” – so as “to provide much-needed certainty to current and potential biosimilar manufacturers.”
Stay tuned to the Big Molecule Watch for further updates.