For decades, courts have construed the transitional phrase “consisting essentially of” to mean that the scope of a claim is limited to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA
As we previously reported, earlier this year the Federal Circuit affirmed a district court’s finding that Sandoz’s ZARXIO filgrastim biosimilar and proposed pegfilgrastim biosimilar do not infringe Amgen’s patents. The patents-at-issue were Amgen’s U.S. Patent Nos. 8,940,878 (“the ’878 patent”) and 6,162,427 (“the ’427 patent”). The ’872 patent is directed towards methods of purifying
On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron Pharmaceuticals (collectively “Sanofi”) against U.S. Patent No. 8,679,487 (“the ʼ487 patent”) assigned to Immunex Corporation (“Immunex”). Claim 1 of the ʼ487 patent is the only independent claim, and it is directed to “an isolated
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”) seeking declaratory judgment of non-infringement and invalidity of Amgen’s U.S. Patent No. 9,643,997 (“the ʼ997 patent”). The ʼ997 patent is directed to methods of purifying a protein expressed in a non-native limited solubility form in a non-mammalian
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,
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
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
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
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
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