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
As we previously reported, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. filed a Declaratory Judgment Complaint against Amgen, Inc. and Immunex Corporation in the United States District Court for the District of Massachusetts on March 20, 2017, preemptively seeking a determination that Sanofi and Regeneron’s Dupixent® (dupilumab) product does not infringe U.S.
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. (collectively “Plaintiffs”) filed a Complaint in the United States District Court for the District of Massachusetts seeking a declaratory judgment from the Court that the development, manufacturing, sale, and promotion of Dupixent® (dupilumab) does not infringe U.S. Patent No. 8,679,487 (“the ’487 patent”). The ‘487 patent,
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
Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”). An IPR provides a mechanism for challenging the patentability of one or more claims of an issued patent through an administrative “trial” conducted by three Administrative Patent Judges from the United States Patent and Trademark Office’s
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