By Steve Usdin
Contributing Editor

WASHINGTON - The U.S. Patent and Trademark Office is rejecting numerous biotechnology patent applications that fail to prove utility with data from animal or human trials, according to members of the American Intellectual Property Law Association Biotechnology Committee.

"Within the last two months the Patent Office has issued hundreds, if not thousands, of rejections in the chemical and biotechnology areas" because they were not supported by clinical trials, Albert Halluin, an attorney with Limbach & Limbach in San Francisco told BioCentury. The rejections started late last year, said Halluin, who formerly was vice president and chief patent counsel at Cetus Corp.

Allowances recanted

"In many, many cases where the applications have been previously allowed, the cases have been re-opened and rejected," according to Halluin. In the past the Patent Office generally restricted the requirement for clinical evidence to cancer treatments, but Halluin