Patent Rules Rescinded

The U.S. Patent & Trademark Office (PTO) has withdrawn highly controversial rules drawn up by the George W. Bush Administration that would have forced companies to limit the size of their patent applications.

The regulations, which were published in August 2007, were aimed at reducing the time it takes PTO to grant or reject an application—currently about three years—and helping the office manage its growing backlog of unexamined applications.

GlaxoSmithKline (GSK) and other companies objected and asked a federal court to overturn the rules, arguing that they exceeded PTO's procedural rulemaking authority (C&EN, Dec. 17, 2007, page 19). The rules were put on hold during the legal fight and never took effect (C&EN, March 30, page 23 and April 21, 2008, page 38).

"These regulations have been highly unpopular from the outset and were not well received by the applicant community," says David Kappos, the recently appointed PTO director and undersecretary of commerce for intellectual property. "We hope to engage the applicant community more effectively on improvements that will help make PTO more efficient, responsive, and transparent to the public."

The rules would have limited the number of claims a filer could make about an invention and the number of times an applicant could make follow-up filings or request further examination of a patent application.

GSK asserted in its lawsuit that the rules would stifle innovation because drugmakers often modify their applications as they learn more about a medicine through clinical testing.

Sherry Knowles, senior vice president and chief intellectual patent counsel at GSK, says the company applauds PTO for withdrawing the rules, "which we believe would have harmed innovation across all industries and specifically would have deprived GSK and other manufacturers of the patent protection necessary to promote medical research and innovation."

The rules would have limited the ability of biotech applicants to secure full coverage of their inventions, says James C. Greenwood, president of the Biotechnology Industry Organization. "This action is a positive sign that the new Administration wants to work in a constructive manner with the patent applicant community to address the serious challenges facing PTO," he says.