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...
by April Breyer Menon | Mar 6, 2015
March 6, 2015 was a turning point for the emerging U.S. biosimilars market. The U.S. Food and Drug Administration (FDA) approved Sandoz’s application to market Zarxio®, the first biosimilar drug in the U.S. Zarxio® (approved as “filgrastim-sndz”) is a biosimilar of...
by April Breyer Menon | Jan 20, 2015
On January 20th, 2015 the Supreme Court of the United States in a 7-2 decision overturned the Federal Circuit’s de novo standard of review for claim construction decisions, holding “[w]hen reviewing a district court’s resolution of subsidiary factual matters made in...
by April Breyer Menon | Nov 12, 2014
Experiments with patented compounds or processes are sometimes necessary for Food and Drug Administration approval of a small-molecule drug, biologic, or medical device. The law exempts certain research and development activities using these patented compounds or...
by April Breyer Menon | Mar 24, 2014
Small interfering RNA (“siRNA”) therapy uses small molecules designed to pair with the sequence of messenger RNA that encodes disease-related proteins. The biotechnology industry has applied for and received hundreds of U.S. patents related to the nanoscale...