As we’ve covered previously (here and here), Amgen has moved for a preliminary injunction to prevent Apotex from launching its biosimilar version of Amgen’s Neulasta until at least 180 days after FDA licensure of Apotex’s product.
In its reply to Apotex’s opposition to its motion for a preliminary injunction, Amgen reiterates its position that the Federal Circuit’s opinion in Amgen v. Sandoz decides this issue squarely in Amgen’s favor. The opinion, Amgen argues, is clear: “an Applicant must give 180 days’ notice before first commercial marketing of its biosimilar product, and may give that notice only after FDA approval.” According to Amgen, Apotex’s challenge to Amgen’s invocation of Amgen v. Sandoz “attempts to manufacture uncertainty by seizing on the phrasing of” the Federal Circuit’s statement that where, as in Sandoz’s case, “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.” Amgen argues that this statement was only meant to address Sandoz’s argument that an applicant can opt out of the entire patent dance by opting out at the first step, (l)(2)(A). According to Amgen, the court’s statement that the notice requirement is mandatory for applicants that “completely fail” to comply with (l)(2)(A) was only meant to “ma[ke] clear that notice is mandatory [for] all Applicants, even those–like Sandoz–who do not comply with paragraph (l)(2)(A).” But, Amgen emphasizes, “[t]he majority did not…hold, state, or even imply…the converse proposition, that an Applicant that does provide its aBLA is exempt from giving notice under paragraph (l)(8)(A).”
Amgen further argues that paragraph (l)(9)(B), which Apotex points to as providing the sole remedy for an applicant’s non-compliance with the notice provision, is not a remedial provision. Amgen focuses on the fact that the court “noted that the BPCIA violation triggering a paragraph (l)(9)(C) declaratory judgment…was ‘precisely’ an act of infringement under 35 U.S.C. § 271(e)(2)(C)(ii),” while for the (l)(8) notice provision, “[t]here is no parallel….No provision in the Patent Act ties patent infringement to a failure to provide paragraph (l)(8)(A) notice or expressly limits available remedies for a failure to provide that notice.”
Even if the Federal Circuit had not decided this issue, Amgen argues, Apotex would still be wrong, because if Apotex’s interpretation is allowed, “chaos” and uncertainty would ensue: “[If] an Applicant could ‘elect’ not to give 180 days’ notice of commercial marketing, three things would be indisputably true:  No applicant would give notice” (so as to avoid a preliminary injunction of their product launch), “ Faced with the exigent launch of a biosimilar competitor and the ensuing irreparable harm, the RPS would not seek a declaratory judgment; it would run to court with a temporary restraining order” and a patent infringement suit, and “ The ensuing chaotic motion practice would rob the RPS, the court, and the public of the ‘defined statutory window during which the court and the parties can fairly assess the parties’ rights prior to the launch of the biosimilar product.”
Finally, Amgen argues that the notice provision serves a purpose even if, as in this case, the parties agree to litigate all of the patents listed by the RPS in the first wave of the BPCIA litigation. The purpose of the notice provision, Amgen argues, is to afford the RPS the ability to seek a preliminary injunction on any patents that issue or are acquired after the first wave of litigation. Because Amgen may still acquire later patents to assert in a second wave of litigation, notice from Apotex is required to enable Amgen to seek a preliminary injunction based on those later patents, as envisioned by the BPCIA.
We will continue to monitor developments on this issue, and will post updates here on the Big Molecule Watch.