The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved. Last week, on May 1, 2017, Sanofi, Genzyme, and Regeneron voluntarily dismissed their Declaratory Judgment Complaint in the District of Massachusetts (Civ. No. 17-cv-10465). The dismissal, however, does not resolve the underlying patent infringement dispute, which is
Litigation
Supreme Court Hears Oral Argument in Its First Biosimilar Case
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…
The Patent Dance Goes on for Genentech and Amgen Over Bevacizumab (Avastin®)
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.…
Litigation Spotlight: The Infliximab (Remicade®) Litigation
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…
Briefing Completed in Supreme Court’s First Biosimilar Case
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…
Immunex Files Patent Infringement Suit Over Dupixent® (Dupilumab) and Seeks to Dismiss or Transfer Sanofi and Regeneron’s Prior DJ Complaint
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 and Regeneron Seek Declaratory Judgment that Dupixent® (Dupilumab) Does Not Infringe Amgen’s Patent
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,…
Samsung Bioepsis, Biogen, and Fujifilm Invalidate Humira® Patents in UK
Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.
On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once…
Complaint in Genentech v. Amgen Dismissed Without Prejudice
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…
Genentech Sues Amgen Over BPCIA Disclosures for Avastin® (bevacizumab)
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…