On July 21, 2015, the Federal Circuit panel issued its opinion in Amgen Inc. v. Sandoz Inc. (2015-1499) providing its interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The majority held (1) the “patent dance” provision of section (l)(2)(A) was not mandatory for subsection (k) applicants and (2) biosimilar applicants may only give effective notice of intent to commercially market after the FDA has licensed the product. As a consequence of that decision, Sandoz would be able to begin marketing its biosimilar product ZARXIO® on September 2, 2015. However, the panel deciding this issue of first impression was fractured, resulting in separate opinions from Judges Lourie, Newman, and Chen.
On August 20, 2015, both parties filed cross-petitions seeking en banc review of the panel’s decision. Amgen contests the panel’s holding that the patent dance is optional. Amgen, noting the fractured panel’s decision, agrees with Judge Newman’s dissent which states “the BPCIA ‘leaves no uncertainty as to which of its provisions are mandatory and which are permissive,’ and paragraph (l)(2)(A) is mandatory.” Amgen Petition at 5. Amgen maintains the majority erred in deciding paragraph (l)(2)(A) is permissive and that the “full Court should hear this issue en banc to correct that error.” Id. at 15.
Sandoz, for its part, takes issue with the panel’s ruling concerning the notice period. Sandoz states “the majority thus effectively granted 180 days of exclusivity for all biological products beyond what Congress expressly provided in the BPCIA. In doing so, the majority ignored the only remedy provided by Congress in the BPCIA – the right to initiate patent litigation – and instead created a new automatic injunction remedy.” Sandoz Petition at 1.
Yesterday, Amgen filed an emergency motion for a temporary injunction pending en banc consideration and review to “preserve the status quo.” Amgen requests the Court issue an injunction preventing Sandoz from marketing, selling, offering for sale or importing into the U.S. its ZARXIO® biosimilar product beyond September 2, 2015 through the full pendency of this appeal. Amgen alleges “Sandoz’s [ZARXIO®] launch will fundamentally and permanently alter the market, causing irreparable harm to Amgen if the en banc Court ultimately decides the issues in favor of Amgen.” Amgen Emergency Motion at 3.
Given Sandoz is poised to launch its biosimilar next Wednesday, September 2, we expect a decision from the Court regarding the temporary injunction within the week. The deadline for both parties to respond to the rehearing petitions is September 8. We will continue to monitor these developments and provide updates.