As we reported earlier this year, Amgen filed a petition for rehearing en banc to the Federal Circuit, arguing that the panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with...more
July 1, 2021 In a development having significant ramifications for many biopharma companies, the Federal Circuit has denied Amgen’s petition for rehearing en banc a decision invalidating a genus patent covering its antibody...more
An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more
On petition for panel rehearing, the US Court of Appeals for the Federal Circuit stripped the phrase “applies only in exceptional cases and” from its previous opinion, but otherwise denied the petition. Amgen, Inc. v. Sandoz...more
Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...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
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
Earlier this month, the Federal Circuit vacated an injunction in the Amgen v. Sanofi litigation that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product in the United States until...more
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more