Tagged as: Sanofi

European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab)

On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent.  The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies.  This EPO decision follows a ruling in…

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Federal Circuit Affirms PTAB Finding that Dupixent® Immunex Patent is Obvious

As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex.  In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…

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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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