There is an increasing trend towards the full publication of data resulting from clinical trials sponsored by the industry. This was the topic of a discussion between the Working Group of the American Chamber of Commerce in...more
On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more
After the butt-slide play, you might think that the sad sack Houston Astros could not sink even lower but I guess setting the Major League Baseball (MLB) record for the worst record for three straight years is not enough....more
Pharmaceutical and medical device companies have enough to worry about when it comes to enforcement risks....more
In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial...more
Originally published in BNA’s Patent, Trademark & Copyright Journal on 09/28/2012.
When is a clinical trial an invalidating public use of an invention? Courts have struggled with this question — one particularly...more