A decision by a U.S. appeals court could pave the way for cheaper generic drugs forms of Eli Lilly and Co’s Gemzar cancer drug to be launched in the United States beginning in mid-November.
Many industry analysts have expected Gemzar to lose U.S. marketing exclusivity in mid-November, when protection on the blockbuster drug’s basic chemical patent lapses. But Lilly has contended that Gemzar — approved to treat ovarian, lung, breast and pancreatic cancer — should not lose exclusivity until mid-2013 because it is protected until then by a separate patent involving the method it is administered.
But a panel of judges from the U.S. Court of Appeals for the Federal Circuit on Wednesday sided with a Michigan federal district court that last August ruled the method-of-use patent was invalid.
“We strongly disagree with the ruling,” Lilly said in a statement, adding it believes the method-of-use patent should remain in effect another three years.
The lawsuit was originally filed by Lilly in Michigan against Sun Pharmaceuticals Industries Ltd of India, which planned to launch a generic form of Gemzar.
Lilly said it will consider “all possible legal options” in fighting the decision, including a request for a further review of the matter by all members of the Washington, D.C.-based appeals court.
In the meantime, Lilly said it expects Gemzar to retain market exclusivity until November 15, and consequently the company will not need to modify its full-year 2010 earnings forecast.
Global sales of Gemzar, which is already facing generic competition in many overseas markets, fell 17 percent to $293 million in the second quarter. It is approved to treat ovarian, lung, breast and pancreatic cancer.
Lilly shares slipped 1.2 percent to close at $35.67 on the New York Stock Exchange. (Reporting by Ransdell Pierson; Editing by Richard Chang)
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