Blog September 2, 2015
BPCIA Dance Partners Request En Banc Rehearing and Amgen Seeks Temporary Injunction
- Person title
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.
Authors: Michael Amon, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Blog July 22, 2015
Amgen v. Sandoz: Federal Circuit Weighs In on the BPCIA Riddle
Blog June 18, 2015
Hot Topics Related to Biosimilars and the BPCIA
Blog February 9, 2015
The Dangers of Having Your Expert Not Devote Sufficient Time to Your Case
Blog December 4, 2023
Amended FRE 702 on Expert Testimony Effective December 1, 2023
Blog December 1, 2023
ITC Monthly Wrap-Up: November 2023
Blog November 27, 2023
Minnesota Patent Litigation Wrap-Up: Q3 2023
Blog November 15, 2023
ITC Monthly Wrap-Up: October 2023
Blog November 9, 2023
Legal Alert: FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book
Blog November 3, 2023
District of Delaware Finds Allergan Patents Invalid for Lack of Written Description and Obviousness-Type Double Patenting in Allergan v. MSN Labs
Blog October 31, 2023
Texas Patent Litigation Monthly Wrap-Up: October 2023
Blog October 30, 2023
District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA Infringement Suit
Blog October 11, 2023
ITC Monthly Wrap-Up: September 2023
Blog September 25, 2023
Federal Circuit Evaluates Enablement for Antibody Claims for the First Time Since Amgen v. Sanofi in Baxalta Inc. et al. v. Genentech, Inc.