“C” Will Always Follow “P”, Except When the BPCIA is the “BCPIA”, Says District Court in NEULASTA Decision

December 14, 2015

By Kurt R. Karst –  

Last week, the folks over at the Big Molecule Watch Blog broke the news that the U.S. District Court for Southern District of Florida (Judge James I. Cohn) ruled on a Motion for Preliminary Injunction (supplemented) filed by Amgen, Inc. and Amgen Manufacturing Limited (collectively “Amgen”) in litigation with Apotex Inc. and Apotex Corp. (collectively “Apotex”) over Apotex’s biosimilar version of Amgen’s NEULASTA (pegfilgrastim), approved under BLA 125031 (see our previous post here).  Amgen sought to enjoin Apotex from marketing its pegfilgrastim biosimilar biological product until 180 days after Apotex notifies Amgen of FDA licensure of the biosimilar application (referred to as a “Section 351(k) BLA” or as an “abbreviated BLA”, or “aBLA”).  In a December 9, 2015 Order, the court granted Amgen’s request.  Apotex immediately appealed the decision to the U.S. Court of Appeals for the Federal Circuit.  

The District Court’s decision is the first decision dealing with the 180-day notice of commercial marketing provision at PHS Act § 351(l)(8)(A) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) since the Federal Circuit ruled in a highly fractured July 21, 2015 decision (Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015)) that aBLA licensure is required before an “operative notice” of commercial marketing can be given (see our previous posts here and here).  (The Federal Circuit also ruled that the so-called “patent dance,” starting with the provisions at PHS Act § 351(l)(2), is not mandatory.)  In Sandoz, however, Sandoz did not partake in the patent dance.  Apotex decided otherwise and engaged Amgen in the dance.  Apotex, like Sandoz before it, provided what it argued was notice of commercial marketing, but that notice came before any aBLA licensure.  (And, in fact, Apotex’s application has not yet been licensed.)    

In his December 9, 2015 decision, Judge Cohn repeatedly refers to the BCPIA instead of the BPCIA.  This mix-up – and one that we have been guilty of as well (and perhaps the biologics counterpart to saying Wax-Hatchman instead of Hatch-Waxman) not only provides us with fodder for a cute headline – whereby commercial marketing notice (“C”) must always follow the patent dance (“P”) under the BPCIA (at least if a biosimilar applicant decides to go down that path) – but it also underscores how illusive the meaning is of the BPCIA’s patent dance and notice provisions.  

Amgen relied heavily on the company’s Preliminary Injunction papers in the Federal Circuit’s Sandoz decision.  “The Federal Circuit’s decision in [Sandoz] renders Apotex’s April 17, 2015 notice of commercial marketing ineffective, because that notice was given before FDA approval of Apotex’s application,” wrote Amgen.  “Apotex’s position is directly at odds with these statutory purposes.  If Apotex were correct and an Applicant could, at its whim, eliminate the notice period by ‘choosing’ not to provide notice under paragraph (l)(8)(A), then the ‘RPS would be left to guess . . . when commercial marketing would actually begin,’ [Sandoz, 794 F.3d at 1358], and would have to monitor public sources even to find out when FDA approves the Applicant’s aBLA, would have to sprint to court to seek a temporary restraining order just to secure time to seek a preliminary injunction, and would present the court far less than a ‘fully crystallized controversy’ and deprive the court of the ‘defined statutory window’ in which to ‘fairly assess the parties’ rights prior to the launch of the biosimilar product.’”  This would result in chaos, argued Amgen, instead of the ordered, timed process intended by Congress.

Apotex argued that notice is required only where an aBLA applicant fails to provide the reference product sponsor with a copy of its application and manufacturing information under PHS Act § 351(l)(2)(A).  But Amgen said that that’s not what the Federal Circuit said:

[T]he Federal Circuit’s holding [in Sandoz] that “paragraph (l)(8)(A) is mandatory” contains no exception for Applicants who comply with paragraph (l)(2)(A), and in fact the court clearly held that “Paragraph (l)(8)(A) is a standalone notice provision,” and that “nothing in paragraph (l)(8)(A) conditions the notice requirement on paragraph (l)(2)(A) or other provisions of subsection (l).”  Thus, Apotex’s provision of the disclosures called for by paragraph (l)(2)(A) does not drive the outcome here; Apotex must still give notice under paragraph (l)(8)(A) once FDA approves its aBLA.  Amgen is entitled to enforce that obligation, just as the Federal Circuit enforced it against Sandoz in granting an injunction pending appeal under Fed. R. App. P. 8A and then extending that injunction until September 2, 2015, precisely 180 days after Sandoz provided post-FDA-approval notice of commercial marketing under paragraph (l)(8)(A). [(Internal citation omitted)]

In his 9-page Order granting Amgen’s Motion for Preliminary Injunction, Judge Cohn came down squarely on the side of Amgen, rejecting each of the arguments proffered by Apotex:

Apotex would have this Court limit the Sandoz decision, and the mandatory nature of [PHS Act § 351(l)(8)(A)], to instances where the applicant did not comply with [§ 351(l)(2)] and make the notice provision of [§ 351(l)(8)(A)] optional in instances where the applicant did comply with [§ 351(l)(2)].  This scenario was addressed by Judge Chen in his dissent to the Sandoz decision: “While the result in the latter scenario comes from the plain language of the statute, not so with the former.  Nothing in the statute supports this peculiar outcome.”  This Court agrees.  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.  Nothing in the statute or the Sandoz decision leads to or supports such a result; neither the statute nor the Sandoz decision condition the 180 day notice provision of [§ 351(l)(8)(A)] upon a subsection (k) applicant’s compliance with [§ 351(l)(2)].

As noted above, Apotex immediately appealed Judge Cohn’s decision to the Federal Circuit.  Although Apotex may not have any better luck with that Court than the company had with the Florida District Court, we suspect the endgame here is to try and get the U.S. Supreme Court to take up the issue (if that Court does not take it up in a different appeal, perhaps an appeal of the Sandoz decision, or in one of the other pending cases where Judge Cohn's decision has already been submitted as supplemental authority).