Washington Editor

A new federal rule issued last week was intended to make the patent examination process more efficient for the government, but the U.S. Patent and Trademark Office (PTO) could wind up spending more time reviewing detailed documents from applicants, said a representative of the biotechnology industry.

Most certainly, said Lila Feisee, managing director of intellectual property for the Biotechnology Industry Organization (BIO), the new rule will force biotech firms and universities to change the way they file patents, which will result in more time and money spent by those organizations.

Under the new rule, which takes effect Nov. 1, patent applicants will be limited to filing two new continuing applications and one request for continued examination (RCE) as a matter of right. Each application may contain up to 25 claims, with no more than five being independent.

Patent applications must submit justification for any third or subsequent continuing application or any second or subsequent RCE in an application family.

Applicants must file a petition with those subsequent applications, or RCEs, showing why the amendment, argument or evidence sought to be entered could not have been submitted previously.

Currently, Feisee said, patent applicants can file an unlimited number of continuing applications and RCEs.

But the government argued that the volume of continuing examination and RCE filings is having a "crippling effect" on the PTO's ability to examine new applications.

The new rule was needed, the PTO asserted in an Aug. 21 Federal Register notice, to "reduce the large and growing backlog of unexamined applications while maintaining or improving the quality of issued patents."

Continued examination filings increased from 11.4 percent of overall patent filings in 1980 to 29.4 percent in 2006, the patent office stated.

The new rule, the government said, will allow the PTO to apply patent examining resources "otherwise consumed" by continuing applications and RCEs to the examination of new applications "and thereby reduce the backlog of unexamined applications."

But Feisee argued that the rule's complex requirements will be burdensome and costly for applicants, particularly those in the drug and biological industries, and ultimately, taxing for government patent reviewers.

The process for submitting justification with each continuing application and RCE subsequent to those allowed under the rule will be arduous and nerve racking for biotech firms, she noted, especially for smaller companies.

Plus, Feisee added, if a firm overlooks something in its justification, the company could be accused of intentionally deceiving the government, which could result in a charge of inequitable conduct and lead to the organization losing its patent.

The translation of the rule's justification requirements is "very subjective," she said.

Feisee also predicted that the rules ultimately will lead to the PTO being inundated with appeals from patent applicants.

The rule also exacerbates the fact that laws surrounding the biotechnology industry are in an unsettled state.

Various bills affecting the biological industry are pending before Congress, including legislation about follow-on biologicals, reauthorization of the Prescription Drug User Fee Act and provisions that could affect inequitable conduct under patent laws.

Roque El-Hayek, an intellectual property lawyer at Wolf, Greenfield & Sacks in Boston, said only time will tell if the government's new rule will be more efficient or increase the burden on all involved.

But, he said, in light of the rule and the Nov. 1 effective date, biotech firms and other patent applicants should seriously rethink their strategies for filing continuing applications and RCEs.

El-Hayek advised applicants who already have filed at least one RCE for a patent to file again before the Nov. 1 deadline.

"That way, it won't be counted against you," he said.