Amgen v. Sandoz Update -- Amgen's Continuing Efforts to Obtain Preliminary Injunction

Amgen is once again seeking a preliminary injunction in the Amgen v. Sandoz case, this time at the Federal Circuit while that Court resolves the issues on appeal from the District Court. Sandoz has only agreed to stay off the market until May 11, 2015. Therefore, this may be Amgen's last opportunity to forestall the launch of the first biosimilar drug product in the U.S.

As background, in 2014, Sandoz became the first company to file a BLA pursuant to the Biologics Price Competition and Innovation Act's ("BPCIA") abbreviated pathway found at 42 U.S.C. § 262(k). This application was for approval to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) drug. However, despite availing itself of this pathway for FDA approval, Sandoz refused to participate in the patent resolution component (the disclosure and information exchange provisions, also known affectionately as the "patent dance"), alleging that it was not a mandatory component. Amgen disagreed, but was disadvantaged without access to Sandoz's application and manufacturer information as contemplated by the BPCIA. Amgen's material U.S. patents on filgrastim had already expired, but it was in possession of approximately 400 other patents that could cover the manufacturing of the biosimilar drug. Nevertheless, without access to Sandoz's information, Amgen could not definitely identify which patents would be implicated. Therefore, it filed suit on October 24, 2014, requesting in part an injunction to prevent Sandoz from marketing ZarxioTM. Amgen followed this up with a preliminary injunction in District Court to prevent Sandoz from entering the market before the issues can be resolved by the Court.

United States District Judge Seeborg of the Northern District of California denied Amgen's motion for a preliminary injunction, ruling that the disclosure and notice provisions of the BPCIA were not mandatory. The Court entered final judgment on March 25, and two days later Amgen filed an appeal with the U.S. Court of Appeals for the Federal Circuit. Amgen also sought another preliminary injunction from the District Court pending appeal, or in the alternative, an injunction lasting until the Federal Circuit can rule on the appeal of such an order. Not surprisingly, the Court denied the motion on both grounds on April 15, 2015.

Two days later, on April 17, 2015, Amgen filed an emergency motion for an injunction pending appeal pursuant to Fed. R. App. P. 8(a). To grant this motion, the Federal Circuit will need to determine "(1) whether the movant has made a strong showing of likelihood of success on the merits; (2) whether the movant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceedings; and (4) where the public interest lies." Amgen asserted that it will likely succeed on the merits because the District Court erred in its interpretation of the BPCIA. Instead of balancing the interests of an applicant and a reference product sponsor ("RPS"), Amgen argued, the District Court's interpretation vitiates the benefits afforded to the RPS. This balance includes that, on the one hand, the applicants and public will benefit from the use of the RPS's data, to which it previously had a permanent and exclusive right. On the other hand, the RPS and the public benefit from the preservation of the patent system. According to Amgen, by converting the provisions of the BPCIA from mandatory to optional, the District Court "toppled the statutory balance in favor of the Applicant and allowed Applicants to game the system." Amgen also argued that the District Court erred in allowing Sandoz to give its 180-day notice of first commercial marketing before the FDA has licensed the biological product.

Amgen also alleged that the District Court's finding that the evidence was highly speculative was in error. The Court "based [its decision on the] as-yet unproven premise that Sandoz has infringed a valid patent belonging to Amgen." Instead, Amgen pointed out that the harm "arises independently from Sandoz's product entering the market on a biological license it secured without have compiled with the Patents provision of the BPCIA." Amgen also alleges that there will be price erosion absent an injunction, because (in part) it would be difficult to raise prices back to current levels because of the Medicare reimbursement rules. Amgen also believed that there will be a loss of goodwill and harm to customer relationships. Finally, Amgen asserted that, in balancing the equities, the Court should side with it, because any harm to Sandoz is its own doing. And, there is a strong public interest in encouraging investment in drug development.

Sandoz filed its opposition on April 24, 2015. Sandoz pointed out the unique nature of Amgen's request -- an injunction motion pending appeal without a claim of patent infringement. Instead, according to Sandoz, the motion is based solely on the supposed violation of the procedures of the BPCIA. Sandoz also focused on the California state law claims found in Amgen's pleadings at the lower Court, even though Amgen did not highlight these claims in its motion.

With regard to the required factors, it is not surprising that Sandoz disagreed that Amgen has shown a strong likelihood of success on appeal. Sandoz has maintained throughout that the "shall" language of the BPCIA with regard to the requisite disclosures and patent dance is only mandatory to the extent that both parties wish to partake of the patent resolution provisions. If one party does not so wish to do so, the statute provides the appropriate recourse -- in this case, Amgen was allowed to file an immediate declaratory judgement action. Also, Sandoz maintained that the 180-day notice of commercial marketing can occur at any time, and to hold differently would provide a RPS with a de facto extension of exclusivity. The remaining factors are too speculative, according to Sandoz. First, Amgen cannot show any purported harm, because any harm is "based on the as-yet unproven premise that Sandoz has infringed a valid patent belonging to Amgen." In addition, Sandoz pointed out that any price erosion was "highly uncertain." This also purportedly negates the goodwill harm asserted by Amgen. Moreover, Sandoz questioned Amgen's assertion of harm, because of Amgen's own decision to delay suing Sandoz until October 2014. Finally, the balance of hardships favors Sandoz, it argued, because any delay would cut into Sandoz's "head start" over two other biosimilar applicants who expect to receive approval in 2015 or early 2016, and besides, Amgen has already enjoyed a 24-year exclusivity period.

The Federal Circuit put Amgen's appeal on its calendar for June 3, 2015. Obviously, the Court will need to decide the present motion before that date to prevent Sandoz from launching in mid-May. The briefing for the appeal should be complete in the next week. We will continue to monitor the situation and provide any updates as warranted.