Sandoz, the generics arm of Novartis, has scored a victory in ongoing litigation with Amgen over its biosimilar to Amgen’s drug Neupogen (filgrastim), a drug for treating neutropenia (low white blood cell count). A federal appeals court dismissed Amgen’s state-law claims regarding notification requirements under patent-dispute resolution procedures under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which set the regulatory pathway for biosimilar approval in the US.

The case deals with Sandoz’s Zarxio (filgrastim-sndz), which was approved in March 2015 by the US Food and Drug Administration (FDA) and addresses the so-called “patent dance” provisions under the BPCIA, which sets the statutory framework for the exchange of patent and related information between the biosimilar applicant and the sponsor of the reference product. The dispute involved the BPCIA’s Section 262(l)(2)(A) requirement that within 20 days of the FDA accepting an applicant’s biologics license application, the applicant must provide the sponsor with its application and manufacturing information. The dispute also brought into question the interpretation of the 180-day exclusivity period under the BPCIA for when biosimilar developers should notify the maker of the originator biologic that they intend to market a biosimilar. The timing of the notice impacts the 180-day exclusivity period for the originator product and the timing of commercial launch of the biosimilar.

In June 2017, Sandoz received a favorable ruling from the US Supreme Court involving the interpretation of the 180-day notification requirements under the BPCIA for when biosimilars developers should notify the maker of the originator biologic that they intend to market a biosimilar. Amgen had argued that such notification would be required following FDA approval, but Sandoz had argued that such notification may occur earlier in development, asserting that the 180-day notification post approval amounted to 180 days of additional market exclusivity. The US Supreme Court ruled in favor of Sandoz on this issue.

In its ruling, the US Supreme Court also ruled that biosimilar applicants cannot be forced under federal law to engage in the BPCIA’s information-exchange framework, including through a federal injunction compelling compliance. The Court, however, left open the possibility of state remedies for a sponsor company to seek such an injunction, and remanded the case back to the United States Court of Appeals for the Federal Circuit to determine whether a state-law injunction is available.

In the most recent case with United States Court of Appeals for the Federal Circuit, Amgen argued that Sandoz had waived its preemption defense to its state-law claims, and that federal law did not preempt state-law remedies for applicants that fail to comply with the BPCIA’s information-sharing requirements. In turn, Sandoz argued that Amgen was not able to use such state-law claims. Specifically, Amgen argued that (1) Sandoz waived its preemption defense to its state law claims; (2) the BPCIA does not preempt state-law remedies for failure to comply with Section 262(l)(2)(A); and (3) failure to comply with Sec. 262(l)(2)(A) is both “unlawful” under California law and an act of conversion. Sandoz argued that (1) the US Supreme Court has discretion to address preemption; (2) both field and conflict preemption bar Amgen’s state-law claims; (3) Amgen’s state-law claims fail under California law; and (4) Amgen abandoned its conversion claim.

In its December 2017 ruling, the United States Court of Appeals for the Federal Circuit affirmed the dismissal of Amgen’s unfair competition and conversion claims, and that Amgen’s state-law claims are preempted on both field and conflict grounds.

Source: US Court of Appeals for the Federal Circuit (December 2017)