Search Results for: "genentech v celltrion trastuzumab"

Briefing completed in trastuzumab IPR appeals

On October 15, 2019, Genentech filed reply briefs in support of its Federal Circuit appeals from the PTAB’s final written decisions of unpatentability of the challenged claims of U.S. Patent Nos. 7,846,441 and 7,892,549, which are directed to methods of treating HER2+ cancer with trastuzumab (Cases Nos. 19-1263, 19-1265, 19-1267…

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Biosimilar-Related Patent Litigation Updates

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 filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…

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FDA Approves Celltrion's Trastuzumab Biosimilar

Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label.  Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This marks the seventh biosimilar the FDA has approved…

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BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

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BPCIA Litigations

The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products.  For additional details, please consult the links below or some of our prior BPCIA litigation coverage. # Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal 1 Amgen v….

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New BPCIA Litigations Regarding Celltrion's Trastuzumab and Rituximab Biosimilars

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. According to the complaint, Celltrion and Teva seek a declaratory judgment of non-infringement, invalidity, and/or unenforceability of 38…

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