ARTICLE | Regulation

Patent Office Snubbing Animal Data

May 31, 1994 7:00 AM UTC

WASHINGTON - There has been a shift in practice at the U.S. Patent and Trademark Office, making it much more difficult to use animal data to prove claims related to the efficacy of drugs and biologicals in humans, according to patent attorneys.

Examiners from Group 1800, the biotechnology patent group of the patent office, met last month to review policies on the allowance of animal data to substantiate claims for the utility of drugs and biologicals in humans, according to Charles Warren, deputy director of Group 1800. Warren denied that there has been a policy change, but acknowledged that a number of biotech patents recently have been rejected or limited by examiners who rejected animal data. "The cases are becoming a little more complex and people are over-claiming in terms of utility," he said...