Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

Both Sides Come Away with Wins in Amgen v. Sandoz

Today, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Consistent with the Federal Circuit’s previous characterization of the BPCIA as “a riddle wrapped in a mystery inside an enigma,” the Federal Circuit panel itself was fractured and the decision held something for both sides. In particular, while Sandoz was not required to provide its Abbreviated Biologics License Application (“aBLA”) to Amgen as the reference product sponsor, Sandoz’s commercial launch of its biosimilar filgrastim product (Zarxio) must be delayed until September 2, 2015.

Writing the majority opinion—joined in different parts by Judges Newman and Chen—Judge Lourie explained the Court’s holdings that:

1. Under 42 U.S.C. § 262(l)(2)(A)—which states that a biosimilar applicant “shall provide to the reference product sponsor” a copy of its aBLA—a biosimilar applicant may choose not to do so. That is, “shall” does not mean “must” in the context of this particular section of the statute. If a biosimilar applicant chooses not to provide its aBLA or other material outlined in the statute, the reference product sponsor’s recourse is limited to the statutory options of (a) filing a declaratory judgment action pursuant to 42 U.S.C. § 262(l)(9)(C) or (b) filing a patent infringement action under 35 U.S.C. § 271(e)(2)(C)(ii). The reference product sponsor cannot rely upon “any non-patent-based remedies for a failure to comply with paragraph (l)(2)(A),” such as the state law claims asserted by Amgen. (Joined by Judge Chen)
2. Under 42 U.S.C. § 262(l)(8)(A)—which provides that the biosimilar applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)”—a biosimilar applicant must provide at least 180 days of notice before the first commercial marketing of its product, and that mandatory notice can only be provided after the FDA approves (licenses) the biological product. That is, “shall” in this part of the statute does mean “must.” Because Sandoz only provided such notice on March 6, 2015, the same day the FDA approved its aBLA, Sandoz could not launch until September 2, 2015—180 days after such notice. (Joined by Judge Newman)

In view of its holdings above, the Federal Circuit affirmed the dismissal of Amgen’s unfair competition and conversion claims under California law, finding such claims either barred by its interpretation of the BPCIA or moot. The Federal Circuit also determined that Amgen’s appeal of the District Court’s denial of its motion for a preliminary injunction was moot given the resolution of the state law claims.

While this litigation will continue with regard to the contested patent, the present opinion already suggests that biosimilar applicants may have a greater number of strategic options when deciding how to proceed under the BPCIA. This may be perceived as a “win” for biosimilars in the near term. On the other hand, the opinion also indicates that reference product sponsors could effectively have longer exclusivity for many of their products (especially some of the older products), based on the Court’s interpretation of the 180-day notice period. As noted by the Court in passing, such advantages are likely to vary over time, as the nature of the particular biologics changes.

For more information on patent strategies under the Biosimilars Act, please contact our biosimilars team.