by April Breyer Menon | Jul 21, 2015
On July 21, 2015, the Federal Circuit issued an opinion addressing two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that 42 U.S.C. § 262(l)(2)(A) does not require a biosimilar...
by April Breyer Menon | Jun 23, 2015
In recent years the Federal Circuit, in reviewing both litigation and prosecution decisions, has revived the doctrine of written description under 35 U.S.C. § 112. The court has applied the doctrine to biotechnology patents—specifically those claiming genuses of...
by April Breyer Menon | Jun 12, 2015
On June 12, 2015, the Federal Circuit issued an opinion holding that claims directed to a method of detecting paternally inherited cell-free fetal DNA (“cffDNA”) in maternal plasma or serum are not patent eligible subject matter under 35 U.S.C. § 101. Ariosa...
by April Breyer Menon | May 14, 2015
On May 13, 2015, a divided Federal Circuit panel, on remand from the United States Supreme Court, affirmed a district court finding of no direct infringement under 35 U.S.C. § 271(a), because a defendant did not perform all steps of the asserted method claims, and the...
by April Breyer Menon | May 12, 2015
On May 5, 2015, the Federal Circuit issued an Order preventing Sandoz from launching its biosimilar drug, Zarxio® in the United States, pending a decision on Amgen’s motion for a preliminary injunction. Despite being FDA approved on March 6, 2015, Zarxio® will now not...
