Lilly Wins U.S. Patent Challenges to Its Alimta Cancer Drug

By Susan Decker and Tatiana Darie, Bloomberg News

Eli Lilly & Co. won a challenge to the validity of a patent that keeps generic versions of its $2 billion lung cancer drug Alimta off the U.S. market until 2022.

The Patent Trial and Appeal Board rejected arguments by companies including Teva Pharmaceutical Industries Ltd., Novartis AG’s Sandoz unit and Neptune Generics LLC that the patent didn’t cover anything new. The board issued a number of opinions encompassing a total of 12 challenges to the same patent.

Alimta generated $2.3 billion in sales last year, making it the company’s third-biggest seller behind the Humalog insulin drug and Cialis for erectile dysfunction, Indianapolis-based Lilly said Jan. 31. Lilly rose as much as 2.5 percent to $89.09 on the news in New York trading.

The patent is for a way to administer the active ingredient in Alimta with certain vitamins to limit toxic side effects. The patent on the main compound, the chemotherapy drug pemetrexed disodium, expired in January.

“The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection, which has been confirmed in every validity challenge to date,” Lilly General Counsel Michael Harrington said in a statement.

In January, the U.S. Court of Appeals for the Federal Circuit in Washington rejected arguments by generic-drug makers including Teva that the patent didn’t cover a new idea. The same court may review this decision as well.

In this decision, the three-judge Patent Trial and Appeal Board looked at different invalidity arguments and used a different legal standard.

Israel-based Teva and Sandoz, two of the world’s largest generic-drug companies, are seeking to sell a low-cost version of Alimta. Also challenging the patent were generic-drug makers Wockhardt Ltd. and Apotex Inc. Neptune Generics, which has no regulatory approval for drugs, is backed by Burford Capital Ltd., a U.K.-based company that offers financing for litigation.

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