Big Molecule Watch
November 16, 2015

Apotex opposes Amgen’s motion for PI

On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex.  As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval.  Amgen has taken the position that section (l)(9)(B) of the BPCIA requires Apotex to provide notice of commercial marketing of its biosimilar product after FDA licensure of the product, and at least 180 days prior to the date of the first commercial marketing of the product.

In its opposition to Amgen’s motion, Apotex argues that Amgen v. Sandoz, in which the Federal Circuit required Sandoz to provide a 180-day notice of commercial marketing after FDA approval, “is directed to situations where the biosimilar applicant does not comply with the patent-dispute resolution process.”  Where the biosimilar applicant does comply with the patent dispute resolution provisions, as Apotex states it has done in this case, the 180-day notice of commercial marketing is not mandatory. In such a case, the reference product sponsor’s sole remedy for an applicant’s refusal to provide a 180-day notice of commercial marketing is provided for in § 262 (l)(9)(B), which enables the reference product sponsor (Amgen, in this case) to file a declaratory judgment action asserting any yet-unasserted patents it identified during the patent dance.

Apotex argues that Amgen’s reading of the notice provision, which would require notice of commercial marketing in every case, improperly “seeks to elevate a notice provision, which is otherwise interconnected with other parts of the statutory patent-dispute resolution process, into a de facto marketing exclusivity.” This reading, Apotex argues, finds no support in Amgen v. Sandoz or in the BPCIA.  Apotex points out that the Court in Amgen v. Sandoz “explicitly stated that its holding was limited to scenarios in which a biosimilar applicant elects not to follow the BPCIA pathway, and thus does not provide its aBLA to the RPS at the outset,” as the majority in that case wrote “where, as here, a subsection (k) applicant completely fails to provide its aBLA and the required manufacturing information to the RPS by the statutory deadline, the requirement of paragraph (l)(8)(A) is mandatory.”  Nor does the BPCIA support Amgen’s reading, Apotex claims, because the notice provided for in (l)(9)(A) would serve no purpose in a case such as this one, where the parties have agreed to immediately litigate “all of the unexpired patents from Amgen’s patent list.”  The notice of commercial marketing  under the BPCIA “only gives Amgen standing to seek a preliminary injunction based on patents from its patent list that have not yet been asserted,” thus, where there are no other patents to assert from Amgen’s patent list, “a mandatory notice of commercial marketing would serve no purpose except to give Amgen an improper 180-day exclusivity on top of the 12 years of exclusivity it has already enjoyed under the BPCIA.”

Finally, Apotex contends that Amgen has no right to seek injunctive relief to enforce the procedural provisions of the BPCIA.  “[T]he BPCIA contains no rights-creating language that would entitle Amgen to a private right of action to enforce the statute,” Apotex writes. “When the BPCIA addresses injunctive relief, it refers to patent-based injunctive relief, not injunctive relief based on the statute,” and thus Amgen’s motion for a preliminary injunction to enforce its reading of the notice provision of the BPCIA asks for a remedy “that the BPCIA does not provide.”

Apotex’s brief is available here.