United States: Federal Circuit Interprets Statutory Requirements For Biosimilar Regulatory Pathway

Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015)

In a case of first impression, the U.S. Court of Appeals for the Federal Circuit has ruled that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) did not require a follow-on biologics or biosimilar applicant to disclose its application and manufacturing information to the reference product sponsor (RPS), but did require the applicant to provide a 180-day notice of marketing after its product was licensed by the U.S. Food and Drug Administration (FDA). Amgen Inc., v. Sandoz Inc., 2015 WL 4430108, Case No. 2015-1499 (Fed. Cir. July 21, 2015), (Lourie, J.) (Newman, J., concurring in part and dissenting in part) (Chen, J., dissenting in part).

BPCIA Statutory Landscape

The BPCIA, enacted in 2010, provides an abbreviated pathway for regulatory approval of biosimilar products that are "highly similar" to a previously approved "reference product" by allowing the follow-on product to rely in part on the approved license of the reference product. To balance innovation and price competition, a biosimilar application may not be submitted until four years after the reference product was first licensed, and may not be approved until 12 years after the reference product was licensed.

Additionally, the BPCIA established a patent-dispute-resolution regime related to biosimilars. This statutory regime includes (1) the biosimilar applicant granting the RPS access to its application and manufacturing information within 20 days of the FDA acceptance of the application; (2) an identification of patents and negotiation between the biosimilar applicant and RPS to formulate a list of patents (listed patents) subject to an immediate infringement action; and (3) at least 180 days' notice prior to the first marketing of the biosimilar, to allow the RPS to seek a preliminary injunction based on identified, but non-listed, patents. The BPCIA also provides that neither the applicant nor the RPS can bring an declaratory judgment suit on non-listed patents prior to receiving the notice of first marketing—but permits the RPS to seek declaratory relief if the applicant fails to abide by certain provisions of the patent-dispute-resolution regime.

Biosimilar Applicants Are Not Required to Produce Their Applications to the Reference Product Sponsor

In 2014, Sandoz filed a biosimilar application for filgrastim, identifying Amgen's Neupogen® product as the reference product. In July 2014, after the application was accepted by the FDA, but prior to approval, Sandoz notified Amgen that it planned to market its biosimilar product in early 2015, and that it was opting not to provide Amgen with access to its application or manufacturing information. Sandoz later provided additional notice of its intention to market the biosimilar product after the product was approved.

In October 2014, Amgen sued Sandoz for un-fair competition and conversion relating to alleged violations of the BPCIA. Specifically, Amgen alleged that Sandoz was required by the BPCIA to provide its application and manufacturing information within 20 days of the FDA's acceptance of its application and that Sandoz first marketing notice to Amgen was in-effective because it occurred prior to the FDA's approval of Sandoz's application. The U.S. District Court for the Northern District of California evaluated these allegations on the pleadings and found that Sandoz had not violated any terms of the BPCIA.

The Federal Circuit reviewed the district court's decision de novo and found that Sandoz had not violated the BPCIA. Accordingly, it upheld the district court's dismissal of Amgen's un-fair competition and conversion claims.

First, the Federal Circuit found that a biosimilar applicant is not required to provide its application and manufacturing information to the RPS under the BPCIA. Even though the statute states that an "applicant shall provide . . . the application submitted," when viewed in the context of the entire statutory regime, such language did not indicate that providing the application was mandatory. Importantly, the court noted that if providing the application and manufacturing information was mandatory, the statutory provision allowing the RPS to bring suit on any patent immediately in the event the applicant did not provide the application would be rendered meaningless.

Second, the court found that the 180-day notice is mandatory, and must be given after FDA approval to license the biosimilar is granted. Sandoz argued that this would impermissibly extend the statutory monopoly period of 12 years by a further 180 days. However, the Federal Circuit ruled that the statutory language clearly referred to notice of marketing of a "biological product licensed [by the FDA]," which required the product to be approved before notice could be given. Yet, because Sandoz had provided additional notice after its biosimilar was approved, the court held that Sandoz had met the BPCIA requirements and could market its product 180 days after this later notice.

Neither aspect of the Federal Circuit's decision was unanimous. Judge Pauline Newman wrote a dissenting opinion arguing that the language "shall provide" clearly indicated that the biosimilar applicant was required by the statute to provide the application and manufacturing information to the RPS if it wanted to take advantage of the abbreviated regulatory pathway. On the other hand, Judge Raymond T. Chen argued that the 180-day notice period was not mandatory. Instead, he opined that the 180-day notice period only makes sense in the larger BPCIA patent-dispute-resolution framework—and that if an applicant, like Sandoz, chose not to take part in that framework, they were not required to comply with the 180-day notice provision.

Federal Circuit Interprets Statutory Requirements For Biosimilar Regulatory Pathway

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