[co-author: Alex Pechette]

The repercussions of Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016) (“Apotex”), continue as BPCIA litigants submit letters to their respective judges addressing the Federal Circuit’s latest ruling on the Act’s notice of commercial marketing provision 42 U.S.C. § 262 (l)(8)(A) and the available remedies for its violation. In an earlier case (Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015)), the Federal Circuit “held that the commercial-marketing provision is mandatory, . . . and that an injunction was proper to enforce the provision against . . . a biosimilar-product applicant that had entirely skipped the statutory process of information exchange and patent-litigation channeling.” Apotex, Slip Op. at 3 (summarizing Sandoz) (emphasis added). In an effort to avoid this ruling—which some believe improperly extends the 12-year exclusivity period of the reference product by another six months—other biosimilar applicants argued that Sandoz was limited to its facts, and that its holding should not apply to applicants who do engage in the “statutory process” (more commonly referred to as the “patent dance”). Last Tuesday, however, the Federal Circuit in Apotex rejected this argument, requiring Apotex to give Amgen notice of commercial marketing pursuant to § 262(l)(8)(A) even though Apotex had engaged in the “patent dance.” In the days following this decision, judges overseeing other BPCIA litigation began receiving letters from the litigants, arguing that their cases are either controlled by or distinguishable from Apotex.

Amgen v. Hospira (Case No. 15-839 in the District of Delaware) has exhibited the most activity, with Hospira writing first on July 6th, Amgen responding on July 7th, and Hospira replying on July 11th. In its July 6th letter, Hospira emphasized that its pending motion to dismiss (D.I. 15) is based on a different argument than that advanced by Apotex and rejected by the Federal Circuit. In particular, Hospira argued that “the [BPCIA] does not provide a private right of action to enforce the 180-day notice of commercial marketing in 42 U.S.C. § 262(l)(8)(A).” (D.I. 62 at 1.) This difference is significant, according to Hospira, because “[a]lthough the Federal Circuit found that Amgen was entitled to an injunction, it did so without ever considering whether there is a private right of action to enforce compliance with paragraph (8)(A).” (Id.) As such, the argument goes, “the specific issue of whether paragraph (8)(A) provides a private right of action as set forth in Hospira’s motion papers is still open for [the Hospira] Court to decide.” (Id. at 2.) Amgen responded the next day, asserting that “Hospira understates the significance of the Apotex decision” and arguing the Federal Circuit’s holding in Apotex “compels a finding here that the BPCIA provides a private right of action to enforce the 180-day notice of commercial marketing as required in 42 U.S.C. § 262(l)(8)(A).”    (D.I. 63 at 1.) The crux of Amgen’s argument was that although Apotex did not argue “‘that (8)(A) creates no privately enforceable right,’ . . . the Federal Circuit confirmed that the court’s ‘equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.’” (Id. (quoting Apotex, Slip Op. at 21).)  Hospira fired back, asserting that “Amgen’s letter mischaracterizes the recent Amgen v. Apotex decision and Hospira’s motion to dismiss,” and reiterating that “the Federal Circuit explicitly acknowledged that the private right of action issue was not raised by Apotex.” (D.I. 65 at 1.) Hospira further noted that “the panel opinion did not even cite to the controlling Supreme Court precedent” on “rights-creating language,” and therefore “the Apotex decision does not address the basis for Hospira’s pending motion to dismiss, which is ripe for decision.” (Id.) Although not mentioned by the parties, it is possible that the FDA could extrapolate from the Federal Circuit’s opinion in Apotex to independently enforce the 180 day notice requirement by issuing biosimilar licenses that go into effect 180 days in the future. (See, e.g., Apotex at 17, noting that there is “no reason that the FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date.”)

In Janssen v. Celltrion (Case No. 15-cv-10698 in the District of Massachusetts), the parties submitted a joint status letter to Judge Wolf on July 6th informing him that they would meet and confer on July 7th to determine whether further briefing on Janssen’s motion for an injunction would be necessary to address Apotex. The meet and confer went well for Janssen—on July 11th, the parties stipulated that Celltrion would not sell its proposed biosimilar version of Janssen’s Remicade® in the United States before October 3, 2016, which is 180 days after Celltrion gave Janssen post-licensure notice of commercial marketing. (D.I. 206; D.I. 207.) This moots the issues implicated by the Apotex ruling.

In Amgen v. Sandoz II (Case No. 2:16-cv-01276 in the District of New Jersey), Amgen wrote to Judge Chesler explaining that “Apotex . . . rejects Sandoz’s argument that ‘the only remedies for non-compliance with the BPCIA requirements—including, but not limited to the notice of commercial marketing—are the ability to initiate declaratory judgment actions of patent infringement in accordance with section 2[6]2(l)(9).’” (D.I. 49 at 1-2 (quoting Sandoz Reply Br. (D.I. 45) at 10) (emphasis and brackets in original).) Amgen thus argued that Apotex confirmed Amgen’s ability to file an action seeking a declaratory judgment that Sandoz’s reading of the BPCIA was wrong – and thus Apotex was another reason that Sandoz’s pending motion to dismiss should be denied. Sandoz replied on July 12th, reminding the court than Amgen’s letter addressed only one of the multiple grounds upon which Sandoz based its motion to dismiss. (D.I. 50.) Sandoz also argued that Apotex is inapposite because that case exclusively focused on the notice provision of (8)(A), which is not at issue in the Amgen v. Sandoz II litigation. Finally, Sandoz argued that the Apotex decision “strengthens Sandoz’s position that non-compliance with the BPCIA exchange process is not a violation of the BPCIA” because the opinion reconfirmed the holding in Amgen v. Sandoz (Fed. Cir. 2015) that a biosimilar applicant can opt out of the “patent dance” information exchange. (Id.)

Lastly, in Immunex v. Sandoz (Case No. 16-1118 in the District of New Jersey), the plaintiffs Immunex and Amgen implored Magistrate Judge Clark to reject Sandoz’s proposed Confidentiality Order which, according to plaintiffs, would “allow Sandoz to deny all opposing in-house counsel—even those charged with directly supervising the litigation—from access to information about the communications between Sandoz and the FDA.” (D.I. 78 at 1 (emphasis in original).) Plaintiffs argued that “[t]hose communications are core to a range of issues in this lawsuit—including (but not limited to) the date by which the FDA might approve Sandoz’s application, which would in turn trigger Sandoz’s statutory right to announce its intent to launch its competing product.” (Id. at 2.)  (citing Apotex).) That is, in part based on the ruling in Apotex, plaintiffs wanted their in-house counsel to be privy to the potential date on which the biosimilar would be licensed, since that date would now indisputably trigger the 180 day window for commercial notice.  According to the plaintiffs, in-house counsel managing the litigation could then prepare for a preliminary injunction motion precluding Sandoz from marketing before the 180 day window closed.

We will continue to monitor these cases as they develop and provide updates.