July 07, 2016

180-Day Advance Notice of First Commercial Marketing Is Mandatory For All Biosimilar Applicants

7 min

On July 5, 2016, the Federal Circuit issued a decision interpreting the provision of 180-day notice of first commercial marketing of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). Amgen Inc. v. Apotex Inc. (Amgen II), No. 2016-1308 (Fed. Cir. July 5, 2016). The Court held in an earlier decision that 42 U.S.C. § 262(l)(8)(A) is a standalone provision that is mandatory where the biosimilar applicant fails to participate in the so-called "patent dance," and the clock starts running on the 180-day notice only after FDA approval is obtained. Amgen Inc. v. Sandoz Inc. (Amgen I), 794 F.3d 1347 at 1357, 1359, 1360 (Fed. Cir. 2015). In Amgen II, the Court has now held that this provision is obligatory "regardless of whether the applicant" has participated in the patent dance. Amgen II, slip op. at 25.

Amgen I – The Neupogen® Decision

Amgen I presented issues of first impression relating to the interpretation of the BPCIA. Amgen I, 794 F.3d at 1350. In May 2014, Sandoz filed an abbreviated biologics license application ("aBLA") with the United States Food and Drug Administration ("FDA") seeking permission to market a biosimilar of Amgen's Neupogen® (filgrastim) product. Id. at 1352. Sandoz's aBLA was approved on March 6, 2015 for all approved uses of Amgen's Neupogen®. Id. at 1353. Sandoz had declined to participate in the patent dance and gave a second notice of commercial marketing once it obtained FDA licensure. Id. at 1353, 1358, 1359. The Court held that "where, as here, [an aBLA] applicant completely fails to provide its aBLA and the required manufacturing information to the [reference product sponsor ("RPS")] by the statutory deadline, the requirement of paragraph (l)(8)(A) is mandatory." Id. at 1360.

As to subsection 262(l)(8)(A), the Court found that an aBLA applicant "may only give effective notice of commercial marketing after the FDA has licensed its product." Id. at 1357. Once licensure has been obtained, "the product, its therapeutic uses, and its manufacturing processes are fixed," "the scope of the approved license is known and the marketing of the proposed biosimilar product is [presumably] imminent." Id. at 1358; see also Amgen II, slip op. at 12. The RPS can then "effectively determine whether, and on which patents, to seek a preliminary injunction from the court." Amgen I, 794 F.3d at 1358. "Requiring that a product be licensed before [the] notice of commercial marketing [is effective] ensures the existence of a fully crystallized controversy regarding the need for injunctive relief." Id.; see also Amgen II, slip op. at 12-13, 17-18. It also "provides a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to the launch of the biosimilar product." Amgen II, slip op. at 14 (citations omitted); see also Amgen I, 794 F.3d at 1360 ("The purpose of paragraph (l)(8)(A) is clear: requiring notice of commercial marketing be given to allow the RPS a period of time to assess and act upon its patent rights.").

Amgen II – The Neulasta® Decision

In Amgen II, Apotex filed an aBLA seeking permission to market a biosimilar of Amgen's Neulasta® (pegfilgrastim) product. Amgen II, slip op. at 11. Unlike Sandoz, Apotex participated in the patent dance, resulting in Amgen's filing an infringement action against Apotex on August 6, 2015. Id. at 11-12. After participating in the patent dance, Apotex informed Amgen that it would not provide the 180-day notice of first commercial marketing under 262(l)(8). Amgen Inc. v. Apotex Inc., No. 15 civ 61631, slip op. at 3-4, 8 (S.D. Fla., Dec. 9, 2015). Amgen then sought, and obtained, a preliminary injunction preventing Apotex from commercially marketing its product, "until Apotex gives Amgen proper notice, at least 180 days before first commercial marketing but not before its pegfiltrastim biosimilar product is licensed by the FDA, and the 180-day notice period is exhausted." Id. at 9. This preliminary injunction has now been affirmed by the Federal Circuit, which held that "an applicant must provide a reference product sponsor with 180 days' post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review." Amgen II, slip op. at 25.

In Amgen II, the Federal Circuit confirmed that the "purpose" of subsection 262(l)(8)(A) "is to ensure that, starting from when the applicant's product, uses and processes are fixed by the license, the necessary decision-making regarding further patent litigation is not conducted under time pressure that will impair its fairness and accuracy." Id. at 17 (citing Amgen I, 794 F.3d at 1358, 1360). "The 180-day period gives the reference product sponsor time to assess its infringement position for the final FDA-approved product as to yet-to-be-litigated patents. And if there is such litigation, it gives the parties and the district court the time for adjudicating such matters without the reliability-reducing rush that would attend requests for relief against immediate market entry that could cause irreparable injury." Id. at 19.

Jurisdiction for Granting a Preliminary Injunction

As to the grant of a preliminary injunction, the Federal Circuit found in Amgen II that 42 U.S.C. § 262(l)(9)(C) "addresses an applicant that does not even provide the first-step notice under [subsection] (2)(A)" of the patent dance. Id. at 8. In this circumstance, "the reference product sponsor, but not the applicant, may bring an action under 28 U.S.C. § 2201 for a declaratory judgment of 'infringement, validity or enforceability of any patent that claims the biological product or a use of the biological product,'" adding that "[t]he subject of such action is not limited by reference to any patent lists." Id. (citing 42 U.S.C. § 262(l)(9)(C)).

Where, instead, an aBLA applicant "does provide the (2)(A) notice," subsections 262(l)(9)(A) and (B) come into play. Id. Together, these subsections provide that "neither side may bring a declaratory-judgment action ... until after the (post-licensure) 180-day notice of commercial marketing under (8)(A) is received" (42 U.S.C. § 262(l)(9)(A)), and if such notice is not given, "the (9)(A) bar on declaratory-judgment actions is [then] lifted for the reference product sponsor, but not for the applicant," allowing the RPS "to bring a declaratory-judgment action on any patent on its [subsection] (3)(A) list as supplemented under [subsection] (7)." Id. at 8-9 (citing 42 U.S.C. § 262(l)(9)(B)).

An Open Question: Is 180-Day Advance Notice Possible Before Expiry of the 12-Year Exclusivity Period?

In Amgen I and II, Sandoz and Apotex both expressed concern that the Court's interpretation of subsection 262(l)(8)(A) "would effectively extend, by six months, the 12-year exclusivity period given to a reference product sponsor by § 262(k)(7)." Amgen II, slip op. at 16; see also Amgen I, 794 F.3d at 1357. The FDA has yet to issue guidance on whether it might tentatively approve an aBLA before expiry of the 12-year period. In the meantime, the Federal Circuit in Amgen II observed that "we have been pointed to no reason [why] 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. ... And we read [subsection] (8)(A) as allowing the 180-day notice of commercial marketing to be sent as soon as the license issues, even if it is not yet effective, because it is at the time of the license that 'the product, its therapeutic uses, and its manufacturing processes are fixed.'" Amgen II, slip op. at 17 (citing Amgen I, 794 F.3d at 1358).

Petition for Writ of Certiorari

The Amgen I decision is currently the subject of certiorari petitions to the Supreme Court by Amgen and Sandoz. On June 20, 2016, the Court deferred a decision on these petitions and requested the views of the Solicitor General. If the Court accepts certiorari, and Apotex decides to file a certiorari petition in Amgen II, the Supreme Court could consider consolidating these petitions. A decision on the Amgen I petitions is expected in the fall and may be influenced by the Federal Circuit's decision in Amgen II.