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Indianapolis-based Eli Lilly and Co. has received another positive ruling in a potential patent infringement case. The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has ruled in favor of Lilly’s patent protection of a vitamin regimen for the drug Alimta to treat some lung cancers and mesothelioma.
“Based on the record before us, we conclude that petitioner has failed to demonstrate by a preponderance of the evidence that claims 1–22 of the ’209 patent are unpatentable,” the written decision said.
Alimta is Lilly’s third biggest-selling drug, accounting for $2.28 billion of the Indianapolis-based company’s $21.22 billion of revenue last year, a regulatory filing shows. Lilly has said it begins losing patent protection in 2021.
Lilly says the U.S. PTO review was initiated by Chicago-based Neptune Generics LLC and New Jersey-based Sandoz Inc., however the office says Lilly’s claims of the vitamin regimen patent are valid. The decision is in line with previous rulings from the U.S. Court for the Southern District of Indiana and, most recently, the U.S. Court of Appeals for the Federal Circuit.
“We are pleased with today’s ruling by the U.S. PTO finding the claims of the Alimta vitamin regimen patent are valid,” said Michael Harrington, senior vice president and general counsel for Lilly. “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. We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. These rights help support the development of the next generation of innovative medicines.”
Shares of Lilly closed up 69 cents, or 0.8 percent, at $87.65. They had traded as much as 2.4 percent higher after the ruling was released.
Lilly has faced several legal challenges to its right to avoid generic competition for Alimta, whose chemical name is pemetrexed.
It has said its vitamin regimen patents provide patent protection for Alimta through June 2021 in Japan and large European countries, and through May 2022 in the United States.