We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more recently in March 2018. At the time of our last update, the ’213 patent had been at issue in six district court litigations, and had been the subject of ten filed IPR petitions,
District Court
Celltrion’s and Hospira’s Production of Infliximab Biosimilars Does Not Infringe Remicide®-Related Patent
In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine of equivalents claim made by Janssen Biotech (“Janssen”) with respect to a Remicide®-related patent would ensnare the prior art.
Janssen makes Remicade®, a biologic drug whose active ingredient is the monoclonal…
District Court Grants Genentech’s Motions to Dismiss Celltrion’s Declaratory Judgment Actions in Herceptin® and Rituxan®-Related Suits
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents relating to Herceptin® (trastuzumab) and Rituxan® (rituximab) are non-infringed, invalid, and/or unenforceable. In response, Genentech filed a motion to dismiss in both cases arguing that the case was statutorily barred under the BPCIA. On May…
Immunex Loses Battle Over Institution of Follow-on IPR Petitions
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. recently scored a victory in their ongoing dispute over a patent that Immunex Corporation claims covers Dupixent®, Sanofi and Regeneron’s anti-IL-4 antibody marketed for treatment of moderate-to-severe eczema. In February, the Patent Trial and Appeal Board (“the Board”) instituted two petitions for inter partes…
Genentech’s Carter ’213 Patent Asserted and Challenged
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to Carter. The ’213 patent, “Method for making humanized antibodies,” which Genentech has stated in SEC filings covers technology used in developing the breast cancer drug Herceptin® (trastuzumab), has since been asserted or is otherwise…
Amicus Brief Filed By Biopharmaceutical Companies in Support of Amgen’s Petition for Rehearing En Banc
On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s petition for rehearing en banc. We reported previously that on November 6, 2017, Amgen filed a petition for rehearing en banc of a Federal Circuit panel’s decision vacating a permanent injunction against…
Amgen Files Petition for Rehearing En Banc of Praluent® Written Description and Enablement Issues
In October, a Federal Circuit panel vacated a permanent injunction against Sanofi and Regeneron’s Praluent® and remanded the proceeding to the district court for a new trial on the defendants’ written description and enablement defenses.[i] The panel had held that the district court erred by (i) excluding the defendants’ evidence of written description and…
The Federal Circuit Affirms: The Apotex Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) Litigation
Several of the Federal Circuit’s initial decisions involving the Biologics Price Competition and Innovation Act (the “BPCIA”) focused on unpacking the contours of the statute. The Federal Circuit’s recently issued opinion in Amgen Inc. v. Apotex Inc., No. 2017-1010, Slip Op. Nov. 13, 2017, by contrast, involves standard principles of appellate review.
We previously…
Sanofi Files Suit Against Merck Sharp & Dohme Over Second NDA for Insulin Glargine Biologic: A Look at the Differences in Biosimilar Approval Pathways
On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of New Jersey against Merck Sharp & Dohme (“Merck”) for infringement of U.S Patent Nos. 7,476,652 and 7,713,930. The suit relates to Merck’s insulin glargine vial drug product, a proposed follow-on biologic of Sanofi’s Lantus.…
AbbVie Files BPCIA Suit Against Boehringer Ingelheim Over Humira® (Adalimumab)
Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware against Boehringer Ingelheim International GMBH, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim Fremont, Inc. (collectively “Boehringer Ingelheim” or “Defendant”) related to Boehringer Ingelheim’s adalimumab product, a proposed biosimilar to AbbVie’s…