Tagged as: Sanofi

Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection).  Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market.  SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product.  SEMGLEE will be available in vials and pre-filled pens.  The lead…

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PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid

As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection).  On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…

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Motion For Summary Judgement of Invalidity Denied in Praluent® Litigation

On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…

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Litigation Update:  Sanofi’s Summary Judgment Motion Denied, Immunex Renews Its Motion to Stay Pending IPR in DUPIXENT Patent Litigation

Following up on our previous coverage of Immunex’s patent infringement suit against Sanofi related to Immunex’s Dupixent® (dupilumab) biologic, Judge Otero recently denied Sanofi’s motion for summary judgement of invalidity based on indefiniteness of the claim terms “competes” and “binding affinity (Ka).” Sanofi criticized Immunex’s ’487 patent for failing to…

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Sanofi Opposes Amgen’s Petition for Rehearing En Banc in Praluent® Litigation

As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written…

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