Amgen Inc. et al. v. Apotex Inc. et al.

Docket No. 2016-1308

July 5, 2016

Update: Petition for a writ of certiorari denied (12/12/16)

Brief Summary: DC grant of preliminary injunction against Apotex regarding a biosimilar Neulasta® affirmed (“an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”)

Summary: Apotex appealed DC preliminary injunction against it with respect to its biosimilar application regarding Neulasta® under the Biologics Act. The DC agreed with Amgen that Apotex was required to notify Amgen of its FDA licensure and then wait 180 days to launch (Amgen v. Sandoz, FC 2015 (“We held…that the 180-day period runs from post-licensure notice.”) (“8A notice”)) The opinion provides a summary of the patent information exchange and litigation process under § 262(l) of the Biologics Act (“BA”), which begins when the applicant notifies the reference product sponsor of the FDA’s acceptance of the biosimilar application within 20 days of that event (section “2(A)”). Lists of patents are then exchanged under the rules provided in the BA. It also explains that the BA amended the infringement provision of the Patents Act regarding biosimilars such that “in two circumstances it is an ‘act of infringement’ for a person ‘to submit’ ‘an application seeking approval of a biological product’ if the purposes is to obtain approval ‘to engage in the commercial manufacture, use, or sale of a…biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” The two circumstances are, generally, where an applicant has or has not launched the Biologics Act (BA) information-exchange process (where the patent is identified by the reference product sponsor (here, Amgen) after notification under 2(A), or the applicant does not provide notice under 2(A) to begin the information exchange process). Where notice is not provided, “filing the biosimilar application is an act of infringement as to a patent that ‘could be identified pursuant to’ 3(A), i.e., a patent that the reference produce sponsor could identify as one it believes ‘could reasonably be asserted’ with respect to the biosimilar product at issue”. Section “271(e)(4) addresses remedies for such infringements”: injunctions and damages (subparagraphs (B) and (C), and under paragraph (D) a permanent injunction regarding “a patent in certain cases decided in the [BA’s] first-stage (paragraph (6)) litigation” (“the only remedies [under] paragraph (2)…except for attorney’s fees”). However, under paragraph (6), if the reference product sponsor is late in bringing the infringement action (more than 30 days after the scope of litigation has been determined under (4) or (5)), only a royalty is available. And if a patent the reference product sponsor should have included on its list ((3)(A) or (7)) “was not timely included”, it may not sue with respect to the product. Apotex argued that, here and unlike Sandoz (FC 2015), it “did launch the statutory processs for exchanging patent information and channeling patent litigation” and, therefore, “the commercial-marketing provision” (8(A) notice) “is not mandatory and may not be enforced by an injunction”, and it would “add[] 180 days to § 262(k)(7)’s 12-year exclusivitly period for reference product sponsors.” The FC panel explained that 8(A) “contains no words that make the applicability of its notice rule turn on whether the application took the earlier step of given the (2)(A) notice that begins the § 262(l) information-exchange process” (and under Amgen v. Sandoz (FC 2015), (8)(A) is “a standalone provision”). The FC panel also disagreed with Apotex’s argument regarding an extension of the 12-year exclusivity (even if that happens, “the result is consistent with § 262(k)” and “should occur less and less as time goes by” since “more of the reference products will be newer” and applicants are “entitled to file an application a mere four years after licensure of the reference product” (“the FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date”)). It also rejected Apotex’s argument that “paragraph (9) of § 262(l) makes a [DJ] action, discussed in (9)(B), the exclusive remedy for violations of (8)(A)” (no private enforceable right or “any statutory commitment” shown). Thus, the FC panel concluded that “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”

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