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
On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). ...more
On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...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
This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool. SUSVIMO, which provides continuous administration of the anti-VEGF (vascular...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 January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the...more
On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press...more
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and...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
On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...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
On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc. That proposed consent judgment and permanent...more
As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab),...more
In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar...more
Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and...more