The chief of the U.S. Patent and Trademark Office has pledged quick action to resolve biotech industry distress caused by the PTO's decisions to reject patent applications that are not supported by human clinical data to demonstrate utility.

After listening to a full day of grievances from the industry last week in San Diego, Bruce Lehman, assistant secretary of commerce and commissioner of patents and trademarks, told BioCentury that he plans to address the industry's concerns.

"We are going to fix it, absolutely," he said. "I want our customers to be satisfied."

The U.S. patent system has always required that inventions have utility to be patentable. But over the past four years, the PTO has interpreted that requirement as demanding clinical data for biotech products.

Top of agenda

The utility issue is at the top of the Biotechnology Industry Organization's non-legislative agenda - unless it gets pushed into second place by reasonable pricing clauses in CRADAs, said Charles Ludlam, vice president of government affairs.