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...