Amgen Files Opposition to Apotex’s Petition for Certiorari

Amgen v. Apotex (pegfilgrastim)

On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an aBLA applicant to provide notice of commercial marketing only after it receives approval, as well as the Federal Circuit’s interpretation of that statute.

Amgen raises three procedural grounds for denying Apotex’s petition.  First, Amgen argues that Apotex’s appeal is moot in light of (a) the district court’s September 6, 2016 order granting a permanent injunction enjoining Apotex’s launch until 180 days after Apotex provides effective, post-licensure notice of commercial marketing, and (b) Apotex’s failure to appeal from that order.  Quoting a 1999 Supreme Court decision, Amgen asserts: “Generally, an appeal from the grant of a preliminary injunction becomes moot when the trial court enters a permanent injunction, because the former merges into the latter.”

Second, Amgen argues that review of Apotex’s appeal would be redundant in view of the pending Sandoz case, which Amgen calls the “elephant in the room.”  According to Amgen, if the Supreme Court grants the petitions in the Sandoz case, “then this case will add nothing new” and there will be no reason to address Apotex’s petition.  If the Supreme Court denied the Sandoz petitions, then, Amgen argues, the Court already “will have rejected the issues Apotex seeks to raise” about the interpretation of subsection (l)(8)(A).

Third, Amgen argues that Apotex’s petition presents a poor vehicle for review because “it presents no disagreement between the Federal Circuit panels across cases or a disagreement between the district court and the appellate court in this case.”

On the merits, Amgen asks the Court to decline to review Apotex’s first question presented, which concerns whether the notice of commercial marketing provision applies to aBLA applicants like Apotex who—unlike Sandoz—actually engaged in the patent dance.  Amgen asserts that, rather than challenging the holding in Sandoz that a notice of commercial marketing is mandatory, Apotex “simply wants the Court to create an extra-statutory exception for a specific subclass of Applicants, by conditioning the requirement of subparagraph 262(l)(8)(A) on an Applicant electing not to provide the Sponsor with the subparagraph 262(l)(2)(A) disclosure.”  According to Amgen, Apotex offers no basis in the statute or elsewhere for its reading of the statute, nor any basis for concluding that the Federal Circuit erred.

Amgen argues that the Court need not review Apotex’s second question presented, regarding whether effective notice can be provided before approval, because it is “the exact same question already presented in Sandoz’s pending petition” and Apotex fails to advance any new arguments that would warrant a different outcome than in Sandoz.  The fact that Apotex, unlike Sandoz, disclosed its aBLA and manufacturing information in accordance with subsection (l)(2)(A) makes no difference according to Amgen because the notice of commercial marketing provision of subsection (l)(8)(A) is mandatory for all applicants. Amgen contends that Apotex is only able to arrive at its position that providing notice of commercial marketing is not mandatory by misinterpreting subsection (l)(9)(B) as providing remedies, rather than simply a restoration of the RPS’s right to bring a declaratory judgment action that was temporarily limited   under subsection (l)(9)(A).  Amgen concludes its brief by reiterating its previous arguments that the Federal Circuit in Sandoz correctly held that notice of commercial marketing is effective only after FDA approval.

Apotex’s reply is expected the week of November 21. The case will be considered by the Supreme Court at its private conference on January 6, 2017, but it is possible that action will be deferred, especially if the Solicitor General’s brief in Sandoz v. Amgen has not yet been filed and teed up for consideration.

Stay tuned to Big Molecule Watch for additional coverage of the pending Supreme Court petitions and the merits of the Amgen v. Apotex litigation, which is now on appeal before the Federal Circuit.

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