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Patents Genentech BPCIA

Goodwin

Are Reference Product Sponsors Asserting More Patents in BPCIA Litigation?

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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

Goodwin

Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

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​​​​​​​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

Goodwin

Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement

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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

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Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

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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

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Tanvex Answers Genentech’s Trastuzumab Complaint

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​​​​​​​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

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New BPCIA Complaint: Genentech Files Suit Against Tanvex Regarding its Proposed Herceptin Biosimilar

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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

Goodwin

New BPCIA Complaint: Genentech Seeks to Block Samsung Bioepis’s Proposed AVASTIN Biosimilar

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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

Goodwin

Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations

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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

Goodwin

District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

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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

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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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

Goodwin

Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019

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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

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Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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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

Goodwin

Biosimilar-Related Patent Litigation Updates

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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

Goodwin

Trastuzumab Patent Litigation Updates

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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

Goodwin

Genentech Settles Rituximab Patent Dispute with Celltrion and Teva

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On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an...more

Goodwin

New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar

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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

Goodwin

BPCIA Litigation Updates: Bevacizumab, Trastuzumab, Filgrastim

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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

Goodwin

Trastuzumab, Rituximab, and Bevacizumab Litigation Updates

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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

Jones Day

Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

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In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of...more

Goodwin

Amgen’s Motion to Dismiss Genentech’s Complaint in the Delaware Mvasi Litigation

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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

Morgan Lewis

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim

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Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act. Shortly after Amgen received US Food and Drug Administration (FDA)...more

Goodwin

IPR Updates

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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

Fish & Richardson

The Herceptin® Battle Moves into the District Court

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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

Goodwin

Genentech Opposes Transfer of Deleware MVASI™ (bevacizumab-awwb) Litigation to California

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We reported earlier on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents, and Amgen’s motion to transfer that complaint to the Central...more

Patterson Belknap Webb & Tyler LLP

Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California,...more

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