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Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
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On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned...more
In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more
Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its...more
As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all...more
On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022,...more
The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku...more
As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under...more
As we previously reported, on June 3, 2022, Genentech filed a complaint against Tanvex in the U.S. District Court for the Southern District of Florida, alleging infringement of three patents under the BPCIA based on...more
Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05,...more
On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of the ‘264 patent,...more
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd....more
Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively,...more
Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of...more
On June 28, 2020, Genentech filed a complaint against Samsung Bioepis (Bioepis) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Bioepis’s submission of an aBLA for SB8, a...more
On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various...more
The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) claim construction (and inter partes review (IPR) decision invalidating claims for obviousness) in it recent Genentech, Inc. v. Iancu decision, and also...more
We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the...more
Following the oral argument two days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI...more
We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Today, a Federal Circuit panel (Judges Prost, Wallach, and...more
On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more
Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in...more
Last week, the Federal Circuit affirmed invalidation of claims to methods for reducing Protein A leaching in affinity column chromatographic methods important inter alia in purifying monoclonal antibodies, in Genentech, Inc....more
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more