Peter Reichertz

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will...more The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be...more Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the...more In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating...more