by April Breyer Menon | May 6, 2016
On May 6, 2016, Michelle K. Lee, the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO), announced a second update (May 2016 Update) to the Interim Guidance on Patent Subject Matter Eligibility...
by April Breyer Menon | Dec 12, 2015
Biologics and biosimilars together represent a rapidly growing component of the pharmaceutical marketplace, and the unique legal issues that accompany them demand careful strategic planning to successfully navigate proceedings in the myriad venues where disputes will...
by April Breyer Menon | Oct 22, 2015
On October 16, 2015, the Federal Circuit declined to rehear en banc its July decision interpreting key provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Download PDF
by April Breyer Menon | Sep 1, 2015
In its recent Amgen Inc. v. Sandoz Inc. decision, the Federal Circuit decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that the BPCIA does not require a biosimilar applicant...
by April Breyer Menon | Aug 25, 2015
Discussion of the various patent reform proposals to Inter Parties Review (IPR) practice that are currently before Congress, with an eye to IPR statistics, and equivalent statistics from post-grant Opposition proceedings before the European Patent Office (EPO)....
