D. Ct. Ruling on Preliminary Injunction and 180-day Notice Issue in Amgen v. Apotex

Amgen v. Apotex (pegfilgrastim)  •  Biosimilar News  •  BPCIA and Related U.S. Statutes

We’ve been covering Amgen’s motion for a preliminary injunction in Amgen v. Apotex, where Amgen sought to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex notifies Amgen that its biosimilar application has received FDA approval and that Apotex intends to begin commercial marketing (see our post on the preliminary injunction hearing here).

The District Court today issued an order granting Amgen’s motion, making it the first post-Amgen v. Sandoz decision to interpret the BPCIA patent dispute resolution provisions.

In its order, the District Court focused on the word “shall” in the notice provision, which reads: “The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” 42 U.S.C. 262(l)(8)(A) (Op. 4, emphases added in opinion). The court stated that while “[t]he Federal Circuit addressed the meaning of ‘shall’ as used in § 262(l)(8)(A) in the [Amgen v.Sandoz case…[it] left some ambiguity which this Court must now address.” As the court summarized:

In Sandoz, the subsection (k) applicant submitted the abbreviated application allowed by the BCPIA, but did not provide the RPS with its aBLA or manufacturing process as contemplated by § 262(l)(2). Even though § 262(l)(2) contained the word ”shall,” the Federal Circuit, in a two-person majority, ruled that ”shall” in the context of  § 262(l)(2) is not mandatory. The court then stated that the word “shall” in the context of § 262(l)(8)(A) does mean ”mandatory.” “Paragraph (l)(8)(A) is a standalone notice provision in subsection (l), and Sandoz concedes as much. . . . The purpose of paragraph (l)(8)(A) is clear: requiring  notice of commercial marketing be given to allow the RPS a period of time to assess and act upon its patent rights.” However, the Sandoz decision was limited to situations where the subsection (k) applicant “completely fails to provide its aBLA and the required manufacturing information to the RPS by the statutory deadline …. Because the situation was not before it, the court did not address whether the notice provision of § 262(l)(8)(A) applies where the applicant, like Apotex, did share the information required by § 262(l)(2).

(Op. 4-5, citations omitted).

Apotex had argued that the notice provision is not mandatory where the applicant did comply with the information disclosure provision of § 262(l)(2). The court disagreed, in part by turning Judge Chen’s dissent in Amgen v. Sandoz, which Apotex had cited in support of its position, against it. The court held: “The scenario proposed by Apotex would result in confusion and uncertainty, as well as inconsistent results, depending on which route a subsection (k) applicant chooses to travel,” and, as Judge Chen wrote, “[n]othing in the statute supports this peculiar outcome.”

The 180-day notice, the court held, provides a “defined statutory window” after the biosimilar applicant receives FDA approval and there is a “fully crystallized controversy,” and that window “exists for all biosimilar products that obtain FDA licenses, regardless of whether the subsection (k) applicant complies with § 262(l)(2).”

The court also reiterated, without elaboration, the Federal Circuit’s somewhat puzzling opinion that a mandatory post-licensure notice requirement would not grant the RPS an additional 180 days of effective exclusivity, because “[t]hat extra 180 days will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products.”

In response to Apotex’s argument that § 262(l)(9) would be superfluous if the notice provision is mandatory, the court held that while (l)(9) enables an RPS to file a declaratory judgment action if the applicant fails to provide notice, “it is not an exclusive remedy.” Another available remedy, the court held, is “an injunction to compel compliance with the 180-day notice provision of § 262(l)(8)(A).”  The court added: “The BCPIA simply does not give the subsection (k) applicant the power to nullify the RPS’ statutory right to 180 days notice of approval prior to marketing based on whether or not the subsection (k) applicant complies with § 262(l)(2).”

Because the parties had stipulated that the other elements needed for issuance of a preliminary injunction are met, the court held that Amgen had a substantial likelihood of prevailing on the merits of its BPCIA claim, and ordered injunctive relief for Amgen.

Thus, “[i[f the FDA approves Apotex’s…[a]pplication for its pegfilgrastim product, Apotex must provide Amgen with at least 180 days notice before the date of the first commercial marketing of the biological product approved by the FDA….Apotex and those acting in concert with it are enjoined from any commercial marketing of its biosimilar pegfilgrastim product…until Apotex gives Amgen proper notice…and the 180-day notice period is exhausted.”

We do not expect this to be the end of the story.   Instead, we would expect Apotex to immediately appeal this decision to the Federal Circuit and to seek a stay of the district court order pending appeal.

Stay tuned for further developments here on the Big Molecule Watch.

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