Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
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...more
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)...more
As we reported previously, 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)...more
In Amgen v. Sanofi, the Federal Circuit held that evidence that first came into existence after the priority date may be considered in determining whether a genus patent claim satisfies the written description requirement...more
In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more
We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while...more
For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more