Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World Biosimilar Congress in San Diego, California, on Wednesday, May 24, 2017. The 30-minute session covered: (1) the BPCIA’s “patent dance”; (2) what’s at stake in Sandoz v. Amgen, and the potential outcomes and practical implications of the
Introduction and Background
The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the parties participated in the patent dance. As a result, important issues regarding the interpretation of the Biologics Price Competition and Innovation Act (the “BPCIA”) were raised, including whether a biosimilar applicant (“(k) applicant”) must give 180-days’ notice to the reference
The Supreme Court heard oral arguments on Wednesday in its first biosimilar case. On a petition filed in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039, and a cross-petition filed in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195, the Court was asked to interpret two provisions of
Genentech filed suit against Amgen this past February when a dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®. Genentech accused Amgen of violating sections (l)(2)(A) and (l)(1)(c) of the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C.
Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and only two of those products are commercially available to patients in the United States – Sandoz’s Zarxio® (a filgrastim biosimilar to Amgen’s Neupogen®) and Celltrion and Hospira’s Inflectra® (an infliximab biosimilar to
As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz, Inc. v. Amgen, Inc., et al., Case No. 2015-1039 and on Amgen’s cross-petition in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195. On January 25, 2017, the Supreme
Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint without prejudice on March 1, 2017 for lack of subject matter jurisdiction in light of Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). As discussed in our earlier post (which raised the
On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262. A dispute arose between the parties during the first step of the “patent dance” for Amgen’s bevacizumab product (ABP 215), a proposed biosimilar to Genentech’s Avastin®.
Amgen announced in November 2016, that
The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”). On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039 and on Amgen’s conditional cross-petition for certiorari
Introduction
The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products. By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept