Skip to Content Skip to Search

GlaxoSmithKline and U.S. Patent and Trademark Office file a motion to dismiss litigation over Final Regulations

GlaxoSmithKline (GSK) and Prosensa, the Dutch based biopharmaceutical company focusing on RNA modulating therapeutics, today announced that they have entered into an exclusive worldwide collaboration for the development and commercialisation of RNA based therapeutics for Duchenne Muscular Dystrophy (DMD). DMD is a severely debilitating childhood neuromuscular disease that affects one in 3,500 newborn boys.

Issued: Thursday, 8th October 2009, Philadelphia, PA

GlaxoSmithKline [NYSE: GSK] today announced that it has reached agreement with the United States Patent and Trademark Office (USPTO) to join the USPTO’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 USPTO will file a joint motion with the U.S. Court of Appeals for the Federal Circuit to dismiss the litigation and to vacate the previous decision in this case by the U.S. District Court for the Eastern District of Virginia.  The USPTO 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 USPTO, 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 USPTO from implementing them on the basis that they were substantive in nature and exceeded the USPTO’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.  

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

Enquiries:

UK Media enquiries:

Philip Thomson

(020) 8047 5502

Stephen Rea

(020) 8047 5502

Alexandra Harrison

(020) 8047 5502

Gwenan White

(020) 8047 5502

Claire Brough

(020) 8047 5502

US Media enquiries:

Nancy Pekarek

(919) 483 2839

Mary Anne Rhyne

(919) 483 2839

Kevin Colgan

(919) 483 2839

Sarah Alspach

(919) 483 2839

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

Sally Ferguson

(020) 8047 5543

Gary Davies

(020) 8047 5503

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

Jen Hill Baxter

(215) 751 7002

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS