GlaxoSmithKline has reached agreement with the United States Patent and Trademark Office (US PTO) to join the US PTO's motion to dismiss its litigation over Final Regulations published in August 2007 (Triantafyllos Tafas and SmithKline Beecham Corporation, SmithKline Beecham PLC and Glaxo Group Limited vs. David J Kappos and the United States Patent and Trademark Office). GSK and the US PTO will file a joint motion with the US Court of Appeals for the Federal Circuit to dismiss the litigation and to vacate the previous decision in this case by the US District Court for the Eastern District of Virginia. The US PTO is withdrawing all regulations under dispute.
"We applaud the Patent and Trademark 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," said Sherry Knowles, senior vice president and chief Intellectual Patent Counsel, GlaxoSmithKline. "We look forward to working with David Kappos, the recently appointed director of the US PTO, and others at the Patent and Trademark Office 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."
In October 2007, GSK filed and was granted a motion to preliminarily enjoin the PTO from implementing new rules related to patent applications. Those rules were due to become effective in November 2007. In April 2008, the district court ruled on the merits of GSK's and co-plaintiff Tafas's challenge and permanently enjoined the US PTO from implementing them on the basis that they were substantive in nature and exceeded the US PTO's procedural rulemaking authority. In March 2009, on appeal, a divided panel of the Federal Circuit affirmed that judgment in part, and reversed it in part. In July 2009, the Federal Circuit vacated the divided-panel decision and agreed to hear the matter en banc.
The withdrawal of the Final Regulations means that the patent system that had been in place before this litigation will remain in place.