Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the EU.” Insulin aspart Sanofi contains the active substance insulin aspart, a rapid-acting insulin, and received marketing…
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…
We have previously reported on the Amgen v. Sanofi Praulent® litigation, which has been ongoing since late 2014. After the parties stipulated to infringement, a jury in the District of Delaware found in favor of Amgen and the validity of its patents over its biologic drug Repatha® (evolucumab) in March…
On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab). After a jury found that two of the five asserted…
On February 25, 2019, a jury in the District of Delaware made findings related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab). The jury found Sanofi and Regeron failed to demonstrate that at least some claims of the…
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)…
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…
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…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a new trial regarding written description and enablement of the asserted claims of the patents-in-suit. On March 16, 2016, after a trial,…