The United States Patent and Trademark Office (USPTO) has announced that four controversial patent regulations, which GlaxoSmithKline (GSK) has fought in the courts, have been dropped.

The regulations, which were drawn up by the Bush Administration in 2007, sought to make companies reduce the size of their patent applications, in order to speed up and improve the work of the USPTO and manage its growing backlog of unexamined applications. However, as he signed a Final Rule rescinding them last week, USPTO director and Under-Secretary for Intellectual Property David Kappos acknowledged that the proposed regulations had been “highly unpopular from the outset and were not well-received by the applicant community,” who felt that they would have exactly the opposite effect to that intended.

The USPTO “should incentivise innovation, develop rules that are responsive to its applicants’ needs and help bring their products and services to market,” said Mr Kappos.

Two of the controversial regulations, the Continuation Rule and the Request for Continued Examination (RCE) would have permitted an applicant to file only two continuation applications and one RCE request per application family as a matter of right. For a third or subsequent continuation application or RCE, the applicant would have had to make a case to the USPTO to show why the additional filing was needed.

A third regulation, the Claims Rule, would have permitted applicants to file five independent claims and 25 total claims per application. In order to file more, the applicant would have been required to supply the Office with specific information, details of which were outlined in a fourth regulation, termed the ESD Rule.

The regulations were published in the Federal Register in August 2007 for implementation that November, but they have never come into effect because, in fourth-quarter 2007, GSK and Dr Triantafyllos Tafas began court proceedings against the USPTO to stop the Claims and Continuation Rules from being introduced. The District Court of the Eastern District of Virginia upheld their case and acted to stop the Office from implementing them, but an appeal subsequently lodged by the agency was accepted by the Court of Appeals for the Federal Circuit. A rehearing was due to commence shortly but, with the rules now being dropped, the Office and GSK have asked the court to dismiss the suit.

Sherry Knowles, senior vice president and chief intellectual patent counsel at GSK, said the company applauded the Office “for its leadership” in deciding to withdraw these 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.”

She added that GSK looks forward to working with Mr Kappos and his colleagues “to ensure a patent law framework which promotes the investment that is essential to all innovation, and importantly, to discovering, developing and bringing lifesaving medicines to patients."

GSK and Dr Tafas were supported in their lawsuit by the American Intellectual Property Law Association (AIPLA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO). Jim Greenwood, chief executive of BIO, said the proposed rules were “controversial and harmful” and “would have limited the ability of biotechnology applicants to secure full coverage of their inventions.”

“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 the PTO, and BIO stands ready to work with Under Secretary Kappos and others at the PTO to do so,” he added.