As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions:
- Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its aBLA and/or related manufacturing information, which the statute says the applicant “shall provide”;
- Whether, where an applicant fails to provide information under § 262(l)(2)(A), the sponsor’s sole remedy is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii);
- Whether notice of commercial marketing given before FDA approval of an aBLA can be effective; and
- Whether it is improper to treat the notice of commercial marketing provisions under § 262(l)(8)(A) as a stand-alone requirement and as creating an injunctive remedy that delays all market entry of biosimilars by 180 days after approval.
BMW editors will be in attendance. Stay tuned for an update immediately following the arguments tomorrow.