Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
Sanofi
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By Seth Cockrum Comments are off
On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron...
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Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes
By Caitlin M. Wilmot Comments are off
Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...
Tagged with: Abasaglar™, Biocon, Eli Lilly, FDA, Insulin glargine, Lantus®, Lusduna™, Merck, Mylan, Sanofi, Semglee™, trastuzumab
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By Andrew Storaska and Jennifer P. Nock Comments are off
Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. recently scored a victory in their ongoing dispute over a...
Tagged with: District Court, Dupixent®, Follow-on petitions, Genzyme, Immunex, IPR, PTAB, Regeneron, Sanofi
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By Nicole DeAbrantes Comments are off
On December 20, 2017, Bristol Myers Squibb Company, Bavarian Nordic, and Enzo Biochem, Inc. filed an amicus brief in support of Amgen’s...
Tagged with: Amgen, Amicus Brief, Bavarian Nordic, Bristol-Myers Squibb, District Court, En banc, Enzo Biochem, Federal Circuit, Inc., Praluent®, Regeneron, Sanofi
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Amgen Files Petition for Rehearing En Banc of Praluent® Written Description and Enablement Issues
By D. Lawson Allen Comments are off
In October, a Federal Circuit panel vacated a permanent injunction against Sanofi and Regeneron’s Praluent® and remanded the proceeding...
Tagged with: Amgen, District Court, Federal Circuit, Praluent®, Regeneron, Sanofi
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By Nicole DeAbrantes Comments are off
On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...
Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi
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By C. Nichole Gifford Comments are off
Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection...
Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi
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By Seth Cockrum and C. Nichole Gifford Comments are off
The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved. Last...
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