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...
by April Breyer Menon | Apr 6, 2015
It has been five years to the month since the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law, and March 2015 was the busiest month to date for the emerging U.S. biosimilars market. Currently worth approximately $1 billion a year...
