On May 5, 2015, the Federal Circuit issued an Order preventing Sandoz from launching its biosimilar drug, ZarxioÒ in the United States, pending a decision on Amgen’s motion for a preliminary injunction. Despite being FDA approved on March 6, 2015, ZarxioÒ will now not enter the market until later this year, at the earliest.
This case has captured the attention of the pharmaceutical industry and the legal community alike, because reference product holder, Amgen, has asked the court to determine at least two issues that will shape litigation strategy in the nascent U.S. biosimilars market. The first is whether the notice and exchange procedure set out in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”)—also referred to as the “patent dance”—is mandatory. 42 U.S.C. § 262(l)(2)-(8). The second is whether biosimilar applicants must give reference product holders at least 180 days’ advance notice of first commercial marketing, on or after obtaining FDA approval. Id. at 262(l)(8)(A).
The district court, at first instance, found for Sandoz, determining both of these issues in the negative: Judge Seeborg of the Northern District of California found that the “patent dance” was optional, and that the 180-day advance notice could be given prior to obtaining FDA approval. Amgen Inc. v. Sandoz Inc., Civ. No. 3:14-cv-04741 (N.D. Cal.). Amgen promptly appealed, and the Federal Circuit agreed to an expedited briefing schedule. Amgen Inc. v. Sandoz Inc., No. 15-1499. Oral argument will be heard on June 3.
In the meantime, Amgen sought a preliminary injunction to preserve the status quo. Judge Seeborg denied this in his March 19 decision, and denied it again pending appeal on April
15. On April 17, Amgen filed an emergency motion at the Federal Circuit that the court granted, without giving reasons, on May 5.
Five Amicus Curiae briefs have been filed, and the briefing is now complete. Janssen Biotech, Abbvie, and the Biotechnology Industry Organization (“BIO”) have filed briefs in support of reversing or remanding the district court’s March 19 decision. Hospira and Celltrion, and the Generic Pharmaceutical Association have filed briefs in support of affirming this decision.
Sandoz’s application to market ZarxioÒ in the U.S. was the first to be filed under the new abbreviated approval pathway enacted under BPCIA. The FDA accepted Sandoz’ application on July 24, 2014 and approved it eight months later, on March 6, 2015.
ZarxioÒ was first approved in Europe in 2009, and is currently marketed in more than 40 countries worldwide. It is a “biosimilar” of Amgen’s reference product NeupogenÒ (filgrastim) that was FDA approved in 1991. NeupogenÒ and ZarxioÒ are immunostimulants that are produced by recombinant DNA technology. They are indicated to reduce the duration of neutropenia (a white blood cell disorder) and associated conditions.
While the pharmaceutical industry and the legal community await the decision of the Federal Circuit in the Amgen litigation, there are lessons to be learned. Biosimilar competition is increasing worldwide and it is now on our doorstep. More than 40 biosimilar drugs are currently approved in India, 19 are approved in Europe, eight in Australia, seven in Japan, three in Canada, and now one—ZarxioÒ, with at least three further applications pending (two filed by Apotex, and one by Hospira)—in the U.S. The FDA aims to review these applications within ten months.
One significant difference between the abbreviated approval pathway enacted under BPCIA, and the equivalent abbreviated pathway enacted under the Hatch-Waxman Act—which regulates the approval of small molecule (non-biologic) drugs—is that under BPCIA there is no provision for a 30-month stay of FDA approval should litigation be filed following the submission of an application to the FDA. This means that regardless of the Federal Circuit’s decision in the instant litigation—whether the court finds in favor of the reference product holder (Amgen) or the biosimilar applicant (Sandoz)—biosimilars litigation is a different beast. Any pre-action exchanges and negotiations, and then litigation, are likely to proceed quickly, and motions to enjoin market launch (to prevent or mitigate potential damages) are likely to be more frequent.
In the meantime, this decision by the Federal Circuit is set to be groundbreaking, not least because it will clarify the rights and obligations, and therefore, the litigation strategies of biosimilar applicants and reference product holders, under the recently enacted BPCIA.