On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running battle between Sandoz and Amgen over Sandoz's attempt to market a biosimilar filgrastim (Zarxio) product.

In a case of first impression, a divided Federal Circuit panel addressed whether: i) a biosimilar applicant may elect not to disclose its abbreviated biologics license application (aBLA) and manufacturing information to the reference product sponsor (RPS) under the Biologics Price Competition and Innovation Act (BPCIA); ii) when notice of commercial marketing must be given to the RPS; and iii) whether, in the case of non-aBLA disclosure, notice is mandatory.

The appeal was taken from a decision by the U.S. District Court for the Northern District of California¹ which:

1. dismissed, with prejudice, Amgen's state law claims of unfair competition and conversion because Sandoz did not violate the information-disclosure² and notice-of commercial-marketing provisions³ of the BPCIA;
2. granted judgment on the pleadings to Sandoz on its counterclaims seeking a declaratory judgment that it correctly interpreted the BPCIA; and
3. denied Amgen's motion for a preliminary injunction based on its state law claims.⁴

Important BPCIA clarifications emerged from the majority opinion by Judge Alan D. Lourie. The first clarification addressed whether a biosimilar applicant may elect not to disclose its aBLA and manufacturing information to the RPS, subject only to the remedies and consequences set forth in 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e)(2)(C)(ii) (e.g., to being sued for infringement).⁵ 42 U.S.C. § 262(l)(2)(A) recites that not "later than 20 days after [the U.S. Food and Drug Administration (FDA) accepts the aBLA] . . . the applicant shall provide to the [RPS] a copy of [the aBLA], and such other information that describes the process or processes used to manufacture the biological product . . ."

Amgen argued that Sandoz's disclosure of the aBLA and related manufacturing processes was mandatory under the BPCIA. While noting that the disclosure portion of the statute, if read in isolation, could appear to require disclosure, the Federal Circuit determined that the disclosure provision "cannot be read in isolation."⁶ The BPCIA "explicitly contemplates that [an applicant] might fail to disclose the required information by the statutory deadline . . . [and] specifically sets forth the consequence . . . [that] the RPS may bring an infringement action . . ."⁷ Buttressing its statutory interpretation, the Federal Circuit also noted that once the RPS "brings an infringement suit . . . it can access the required information through discovery."⁸ "Because Sandoz took a path expressly contemplated by the BPCIA, it did not violate the BPCIA by not disclosing its aBLA and the manufacturing information by the statutory deadline."⁹

Next, the Federal Circuit addressed the notice of commercial marketing provisions of the BPCIA, specifically whether the 180-day commercial marketing notice to the RPS can only be given after a follow-on biological product is licensed by the FDA.¹⁰ Noting that the statutory language "compels such an interpretation" that "notice, to be effective under the statute, must be given only after the product is licensed by the FDA,"¹¹ the Federal Circuit agreed with Amgen: "An . . . [aBLA] applicant may only give notice of commercial marketing after the FDA has licensed its product."¹² "Requiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief" and "provides a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to launch of the biosimilar product."¹³ "We therefore conclude that [the aBLA applicant] . . . may only give effective notice of commercial marketing after the FDA has licensed its product."¹⁴

The Federal Circuit also concluded that the notice provision was mandatory for section (k) applicants who fail to provide their aBLAs and manufacturing information to the RPS by the statutory deadline. "We conclude that it is." ^15,16 Finding that the notice of commercial marketing paragraph "is a standalone notice provision . . ."¹⁷ the court concluded 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 [notice-of-commercial-marketing requirement] is mandatory."¹⁸

The Federal Circuit thus affirmed the dismissal of Amgen's state law claims, vacated the judgment on Sandoz's counterclaims interpreting the BPCIA, directed the district court to enter judgment on those counterclaims consistent with the Federal Circuit's opinion, and remanded to the district court for further proceedings. The Federal Circuit further extended the injunction of the sale of Sandoz's filgrastim biosimilar product to September 2, 2015, i.e., 180 days from Sandoz's approval and subsequent commercial marketing notice date to Amgen on March 6, 2015.¹⁹

Conclusion

BPCIA law continues to evolve. The complexity of the BPCIA and the issues that can arise under the act are underscored by the fact that Judges Pauline Newman and Raymond Chen each dissented from different parts of the decision.

¹ Amgen Inc. v. Sandoz Inc., No. 14-cv-04741, 2015 WL 1264756 (N.D. Cal. Mar. 19, 2015).

² See 42 U.S.C. § 262(l)(2)(A).

³ See 42 U.S.C. § 262(l)(8)(A).

⁴ Amgen at 3.

⁵ Id. at 13.

⁶ Id. at 12.

⁷ Id. at 12-13.

⁸ Id. at 14.

⁹ Id. at 15.

¹⁰ See 42 U.S.C. § 262(l)(8)(A).

¹¹ Amgen at 15.

¹² Id. at 16.

¹³ Id. at 17.

¹⁴ Id. at 18. While the Federal Circuit agreed with Sandoz that requiring the 180-day notice to the RPS only after a product is licensed has the practical effect of "an additional 180 days of market exclusion," the court noted that this "will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products."

¹⁵ Id. at 19.

¹⁶ "The subsection (k) applicant shall provide notice to the reference products sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)." 42 U.S.C. § 262(l)(8)(A). (Emphasis added.)

¹⁷ Amgen at 20.

¹⁸ Id.

¹⁹ Amgen at 7, 21.