Last Thursday, December 3, the U.S. district court for the Southern District of Florida heard oral arguments on Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed in previous posts (here, here, and here), Amgen is seeking a preliminary injunction to prevent Apotex from launching its proposed biosimilar pegfilgrastim product until at least 180 days after FDA licensure of Apotex’s product, at which point Apotex can provide the 180-day notice of commercial marketing that Amgen argues is required under BPCIA subparagraph (l)(8)(A).
Amgen’s basic argument is that the Federal Circuit’s decision in Amgen v. Sandoz answered for all BPCIA cases the question of whether the notice provision is mandatory, and answered it “directly[,] without qualification,” when it wrote: “A question exists, however, concerning whether the ‘shall’ provision in paragraph (l)(8)(A) is mandatory. We conclude that it is.” And, Amgen argued, the Federal Circuit furthermore explained the reason for mandating compliance with the notice provision: notice is required in order to have a “fully crystallized controversy” and a statutory window during which the RPS can seek a preliminary injunction with the clarity of such a fully crystallized controversy.
Amgen suggested that under Apotex’s interpretation, where notice is not required, “chaos” would ensue: the RPS would run to court seeking a TRO that would require an expedited “full-blown evidentiary hearing” on complicated biotechnology patents. Instead of an orderly 6-month window for litigation of a preliminary injunction motion, Amgen argued, these inefficient and chaotic “fire drills” would be the default norm in BPCIA cases.
According to Amgen, only after FDA approval will the controversy be sufficiently crystallized to permit an orderly and efficient adjudication of a motion for preliminary injunction. Before that point, the indications and labeling for the biosimilar product might change, the manufacturing processes for the biosimilar might change, and the patent landscape might change. Amgen noted that the facts of this case illustrate how the patent landscape might change: one of the patents asserted against Apotex was issued just around 10 months ago, and another asserted patent will likely drop out of the case unless FDA finds that for safety reasons Apotex cannot carve out from its biosimilar product label a patent-protected indication approved for Amgen’s reference product Neulasta.
Amgen characterized Apotex’s arguments as misconstruing a sentence from the Federal Circuit opinion in Amgen v. Sandoz, which reads: “We therefore conclude that, 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.” According to Amgen, Apotex takes this sentence to mean its converse: that if a biosimilar applicant does not “completely fail” to provide its aBLA and manufacturing information by the statutory deadline, the notice requirement is not mandatory. Amgen argued that properly interpreted, this sentence just sets out the “general proposition” that the notice provision is mandatory, and expressly clarifies that this general proposition applies as well to the specific facts of Amgen v. Sandoz. The “completely fails” language, Amgen argued, was only a specific application of the general proposition, included to reject with greater particularity Sandoz’s contention that because it had completely opted out of the patent dance provisions, the notice provision did not apply.
Amgen also argued that, contrary to Apotex’s warnings, interpreting the notice provision to be mandatory would not render superfluous subparagraph (l)(9)(B), which provides that if an applicant provides its aBLA and manufacturing information under (l)(2)(A), then a subsequent failure of the applicant to comply with the patent dance–including a failure to comply with the notice provision–enables the RPS to bring a declaratory judgment action. Amgen analogized this to a speed limit: just because consequences are provided for non-compliance does not render the limit optional. Moreover, Amgen argued, (l)(9)(B) would not be superfluous if notice is mandatory, because that provision could kick in if there is a dispute as to whether the applicant provided “proper” notice or “failed” by, for example, serving notice on someone who was not an appropriate representative for the RPS. Amgen also noted that the (l)(9)(B) provision says only that the patent owner “may” bring a declaratory judgment action, and that nothing in the BPCIA or 35 U.S.C. 271 makes this the “exclusive” remedy for noncompliance. The non-exclusive nature of this remedy, Amgen argued, counsels in favor of courts fashioning injunctive relief to remedy noncompliance with the notice provision, as the Federal Circuit did in Amgen v. Sandoz.
Apotex argued in response that this case was about “consequences,” and that the BPCIA provides the clear consequence for an applicant’s noncompliance with the notice provision of (l)(8)(A). The remedy provided by Congress in the BPCIA, Apotex contends, is to bring a declaratory judgment action and then to bring a patent-based injunction claim if desired. It did not, Apotex emphasized, provide for the extraordinary relief of a preliminary injunction without requiring such an injunction to be grounded by patent claims.
Apotex argued that Amgen has misinterpreted the “completely fails” language from the Federal Circuit opinion: rather than being a specific application of a general proposition, the Federal Circuit was addressing a gap in the statutory scheme of consequences. The BPCIA, Apotex points out, provides a consequence if the biosimilar applicant fails to provide its biosimilar application and manufacturing information under the first step of the patent dance, (l)(2)(A): under (l)(9)(C), the RPS can bring an immediate action for patent infringement. The BPCIA also provides a consequence for when the biosimilar applicant does provide its biosimilar application and manufacturing information, but then “subsequently fails” to follow the rest of the patent dance steps: under (l)(9)(B), the RPS can bring a declaratory judgment action for patent infringement. But, Apotex explained, the BPCIA does not provide for a situation like Sandoz’s, where the biosimilar applicant failed completely to follow any step of the patent dance, beginning with the first step, (l)(2)(A). In that case, there was no “subsequent failure” to follow the patent dance; there was a complete failure to comply with any step of the patent dance. Because the BPCIA did not address the consequences for this “complete” failure, Apotex argued, the Federal Circuit fashioned an injunctive remedy to prevent Sandoz from launching until 180 days after it provided post-FDA-licensure notice. But here, Apotex contended, Apotex has complied with (l)(2)(A), and any failure to provide notice under (l)(8)(A) would be a “subsequent failure,” for which the express remedy provided under the BPCIA is the RPS’s ability to bring a declaratory judgment action.
As we’ve noted in a previous post, several cases are currently litigating this question of the BPCIA 180-day notice provision, and it will be interesting to see whether last week’s arguments move the parties closer to reaching the first post-Amgen v. Sandoz decision on the issue. Stay tuned.