Idenix to appeal Norway District Court decision in Gilead’s favor

Dispute focuses on compounds useful in the treatment of the hepatitis C virus (HCV) and other flaviviridae infections

Lloyd Dunlap
CAMBRIDGE, Mass.—Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it intends to file an appeal to challenge the Oslo, Norway District Court's decision in a patent invalidity case concerning Idenix's co-owned Norwegian patent NO 330 755 that covers certain 2'-methyl-2'-fluoro nucleoside compounds useful in the treatment of the hepatitis C virus (HCV) and other flaviviridae infections.
 
Ten days ago, Idenix announced that it has filed patent infringement lawsuits against Gilead Sciences, Inc. and/or certain of its subsidiaries in each of three countries—France, Germany and the United Kingdom.
 
The lawsuits allege that Gilead infringes Idenix's recently granted, co-owned European patent EP 1 523 489 that covers 2'-methyl-2'-fluoro nucleosides for treating the hepatitis C virus. In these lawsuits, Idenix is seeking remedies with respect to Gilead's marketing and sales of drugs containing sofosbuvir, which Idenix believes infringes its European patent.
 
"We are pleased to have been granted this European patent, and today's filings further confirm Idenix's conviction in the strength of our intellectual property portfolio and the resolve we have to protect it," said Maria Stahl, senior vice president and general counsel at Idenix in a news release concerning the legal action. "Idenix has invested significant resources in nucleoside drug discovery and in building a valuable intellectual property portfolio and we will continue to vigorously defend it. These proceedings, along with the U.S. infringement actions we filed in December, are part of a concerted effort to safeguard these technologies."
 
In September 2012, Gilead Sciences Europe Ltd., a subsidiary of Gilead Sciences, Inc., filed a lawsuit in the Court claiming that Idenix's Norwegian patent NO 330 755 is invalid. Idenix subsequently filed a counter claim that a patent owned by Gilead covering similar subject matter (Norwegian patent NO 333 700) is invalid and unenforceable. On March 21, 2014, the Court determined that Idenix's patent is invalid and that Gilead's patent is valid.
 
"We intend to challenge this decision in proceedings in the Appeal Court in Oslo, as we maintain that our patent is valid and enforceable under Norwegian law," said Stahl.
 
Idenix has several ongoing litigation and administrative matters involving Gilead and/or certain of its subsidiaries. In December 2013, Idenix announced it filed two lawsuits against Gilead: a patent infringement lawsuit in the United States District Court in Boston, Massachusetts (Idenix U.S. Patents 6,914,054 and 7,608,597) and a separate patent infringement and interference lawsuit in the United States District Court in Wilmington, Delaware (Idenix U.S. Patent 7,608,600 and Gilead U.S. Patent 8,415,322).
 
In February 2012, the U.S. Patent and Trademark Office, or USPTO, initiated a patent interference between one of Idenix's co-owned patent applications and a patent owned by Gilead. In January 2014, the USPTO determined that Idenix is not entitled to priority of invention and judgment was entered in favor of Gilead. Idenix challenged this decision in the U.S. District Court for the District of Delaware.
 
In December 2013, the USPTO declared a second patent interference between Idenix's U.S. Patent 7,608,600 and Gilead's U.S. Patent Application 11/854,218, both related to the use of certain 2'-methyl, 2'-fluoro nucleoside compounds to treat HCV infections.
 
In August 2013, Idenix filed a request with the Chinese Patent Office's Patent Re-examination Board, or the PRB, to invalidate Gilead's Chinese Patent No. ZL.200480019148.4.
 
Gilead Sciences has also filed suit against Idenix in various jurisdictions outside the United States (Canada, Norway and Australia) to invalidate granted Idenix patents covering certain 2'-methyl-2'-fluoro nucleoside compounds and their use in treating HCV or other Flaviviridae viruses.
 
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection.
 
Source: Idenix Pharmaceuticals

Lloyd Dunlap

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