Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...
BPCIA
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By Spencer Johnson Comments are off
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to...
Tagged with: BLA, Boehringer Ingelheim, BPCIA, Celltrion, District Court, Genentech, Herceptin®, IPR, Litigation, Mylan, Pfizer, Samsung Bioepsis, Teva, trastuzumab
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By D. Lawson Allen Comments are off
On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central...
Tagged with: Amgen, Avastin®, bevacizumab, bevacizumab-awwb, BPCIA, Genentech, Mvasi
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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Aydin Harston and Andrew Storaska Comments are off
U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
Tagged with: BPCIA, EMA, FDA, Regulatory
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Celltrion and Teva File Declaratory Judgment Action Against Thirty–Eight Herceptin®-related Patents
By Seth Cockrum Comments are off
On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...
Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, IPR, News, Patent Dance, Roche, Teva, trastuzumab
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By Caitlin M. Wilmot Comments are off
On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
Tagged with: Amgen, Amgen v. Sandoz, BPCIA, FDA, Federal Circuit, filgrastim, Neupogen®, Sandoz
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By Benjamin R. Holt Comments are off
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...
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By Daniel McCallum Comments are off
Several of the Federal Circuit’s initial decisions involving the Biologics Price Competition and Innovation Act (the “BPCIA”) focused...
Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Federal Circuit, Legal, Litigation, Patent Dance
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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Aydin Harston and Andrew Storaska Comments are off
European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
Tagged with: BPCIA, EMA, FDA, Regulatory
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