United States: Supreme Court Decision Largely Favors Biosimilar Applicants

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues raised in Sandoz Inc. v. Amgen Inc. (No. 15-1039). The Court's unanimous decision was authored by Justice Thomas. Justice Breyer wrote a concurring opinion that invites the U.S. Food and Drug Administration (FDA) to "depart from" or "modify" the decision if it "determines that a different interpretation would better serve the statute's objectives."

With regard to the first step of the patent dance, the Court held that the requirement that a biosimilar applicant share its biosimilar application with the reference product sponsor (in this case, Amgen) is not enforceable by an injunction under federal law. The Court left open the possibility that an injunction might be available under state law (here, California law), but also advised the Federal Circuit to consider on remand whether any state law remedies are preempted by federal law. With regard to the premarketing notice requirement, the Court held that the biosimilar applicant does not have to wait for FDA approval before giving 180-day premarketing notice, meaning that once a biosimilar is approved, it could be marketed as long as there are no preliminary injunctions stemming from any still-pending patent litigation.

The ruling, therefore, vacated-in-part and reversed-in-part the Federal Circuit decision, and remanded to the Federal Circuit for consideration of the state law issues.

The Biosimilar Framework

Since 1991, Amgen has marketed filigrastim, a recombinantly produced human granulocyte colony-stimulating factor protein (C-CSF) under the brand name Neupogen®. Neupogen® is used in certain patients at risk of infection, such as those receiving chemotherapy. In May of 2014, Sandoz sought FDA approval of a biosimilar of Neupogen® (filgrasim-sndz or Zarxio®) under the BPCIA, by filing an abbreviated pathway application created by the BPCIA, such as an abbreviated Biologics Licensing Applications (aBLA) or subsection (k) application.

Similar to the Hatch-Waxman Act that governs traditional generic drugs, the BPCIA allows a biosimilar applicant to rely on the FDA's previous approval of the reference product (e.g., the original biologic product); such that the biosimilar applicant does not need to provide clinical data demonstrating the safety and efficacy of its product. As summarized by the Supreme Court, the biosimilar applicant need only "show that its product is 'highly similar' to the reference product and that there are no 'clinically meaningful differences' between the two in terms of 'safety, purity, and potency.'" Slip op. at 3 (quoting 42 U.S.C. §§ 262(I)(2)(A)(B)). As also recognized by the Court, a biosimilar application cannot be filed until the reference product has been approved for at least four years, and a biosimilar application cannot be approved until the reference product has been approved for at least 12 years. In this case, since Amgen's Neupogen® product had been approved for more than 12 years before the BPCIA was enacted, those time periods were not relevant.

Sandoz notified Amgen of its biosimilar application, but did not provide a copy to Amgen and did not follow any of the other patent dispute resolution procedures of the statute. As to premarketing notice, Sandoz first notified Amgen of its intent to commercially market Zarxio® in July of 2014, before it was approved, and gave notice again when it became the first approved biosimilar product on March 6, 2015.

Amgen sued Sandoz in the United States District Court for the Northern District of California alleging, among other things, violation of California's unfair competition laws and conversion based on Sandoz's alleged failure to comply with the BPCIA. The district court ruled in favor of Sandoz, and found no violation of the BPCIA to support Amgen's state law claims. The Federal Circuit affirmed the district court on the patent dance issue, but ruled that premarketing notice cannot be given until the FDA approves the biosimilar product.

The Biosimilar Patent Dance

Like the Hatch-Waxman Act, the BPCIA includes patent dispute resolution procedures, but the similarity ends there. The BPCIA lays out a multi-step, two-stage process that has been come to be known as the "biosimilar patent dance." The patent dance:

  • commences when the biosimilar applicant shares its biosimilar application with the reference product sponsor in accordance with 42 U.S.C. § 262(l)(2)(A),
  • continues with exchanges of lists of patents and validity/infringement contentions and negotiations of the patents to be litigated,
  • requires the reference product sponsor to assert the negotiated patents to avoid limitations on remedies, and
  • culminates with a last-chance opportunity to assert additional patents after the biosimilar applicant provides 180-day premarketing notice in accordance with 42 U.S.C. § 262(l)(8)(A).

Although Judge Lourie's majority opinion for the Federal Circuit described the statute as "a riddle wrapped in a mystery inside an enigma," Justice Thomas described it as providing "a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement."

The Supreme Court "agree[d] with the Federal Circuit that an injunction under federal law is not available to enforce § 262(l)(2)(A), though for slightly different reasons than those provided by the court below." In particular, the Court disagreed with the Federal Circuit's reading of 35 U.S.C. § 271(e)(2)(C)(ii) and the relevance of 35 U.S.C. § 271(e)(4) to the issue at hand, and determined instead that 42 U.S.C. § 262(l)(9)(C) is dispositive and sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application. The Court reasoned that "[t]he BPCIA's carefully crafted and detailed enforcement scheme provides strong evidence that Congress did not intend to authorize other remedies that it simply forgot to incorporate expressly." Slip op. at 12 (internal quotations omitted).

As noted above, however, the Court did not rule out the possibility that an injunction might be available under state law. On this point, the Court expressly declined to decide whether the application-sharing provision in 42 U.S.C. § 262(l)(2)(A) is "mandatory or conditional," explaining that "the nature of the BPCIA's requirements matters only for purposes of California's unfair competition law, which penalizes 'unlawful' conduct." Slip op. at 15. The Court found that the Federal Circuit "erred in attempting to answer that question by referring to the BPCIA alone." Id. Thus, the Court directed the Federal Circuit to determine on remand "whether California law would treat noncompliance with § 262(l)(2)(A) as 'unlawful,'" and "whether the BPCIA preempts any additional remedy available under state law for an applicant's failure to comply with § 262(l)(2)(A)." In forcing the Federal Circuit to look further at California's unfair competition laws, the Supreme Court left open whether Sandoz's decision to take a path at least technically permitted by a federal statute can be a violation of state law, and, thus, give rise to remedies not available under the BPCIA.

Premarketing Notice

On the premarketing notice issue, the Federal Circuit had read the reference in 42 U.S.C. § 262(l)(8)(A) to "the biological product licensed under subsection (k)" to mean that notice could not be given until the biosimilar product had been "licensed" (approved). The Supreme Court disagreed, finding that the phrase at issue "modifies 'commercial marketing' rather than 'notice.'" The Court emphasized that the statute only includes one timing requirement—that the applicant give notice "at least 180 days prior to marketing its biosimilar"—while the Federal Circuit imposed "two timing requirements"—that the applicant give notice "after the FDA licenses the biosimilar and at least 180 days before the applicant markets the biosimilar." In view of its interpretation, the Court held that a biosimilar applicant "may provide notice either before or after receiving FDA approval."

What's Next for Biosimilars?

Without going too far out on a limb, we believe it is unlikely that the Federal Circuit will find room for a state law-based injunction to enforce 42 U.S.C. § 262(l)(2)(A). Thus, we believe biosimilar applicants will continue to be able to choose how and when to address patent disputes. A biosimilar applicant who wants to resolve them early could share its application at the outset, to force the reference product sponsor to bring suit pursuant to the patent dance or face the limitations on remedies set forth in 35 U.S.C. § 271(e)(6)(B). A biosimilar applicant who wants to defer the patent issues could decide not to share its application, and perhaps challenge the patents in an inter partes review or post-grant review proceeding at the Patent Office, where it could take advantage of the lower burden of proof for invalidity. While a reference product sponsor could bring suit under 42 U.S.C. § 262(l)(9)(C) without having been given a copy of the biosimilar application, originators may prefer to postpone litigation until the biosimilar product is closer to approval, when the possible infringement issues will be more certain and when pending litigation could keep the biosimilar product off the market after approval.

As noted above, the Court's decision on the premarketing notice issue will mean that biosimilar products could be marketed as soon as they are approved, as long as there are no preliminary injunctions stemming from any still-pending patent litigation. This possibility might encourage biosimilar applicants to participate in the patent dance, to increase the likelihood that all patent disputes will be resolved by the time the product is approved.

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