On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...more
On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co.,...more
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
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
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
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
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
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis in the District of Delaware for patent...more
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid...more
Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar...more
More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month....more
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and...more
As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s...more
On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California. Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. ...more
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more
On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more