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Federal court backs Lilly's patent exclusivity on Alimta drug delivery method

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Federal court backs Lilly's patent exclusivity on Alimta drug delivery method

Eli Lilly and Co. has notched another win in a multicase patent battle over a vitamin regimen delivered with the company's cancer therapy Alimta. A federal appeals court has ruled that other companies cannot market an alternative version before the patent expires in May 2022.

At issue is Lilly's chemotherapy treatment Alimta, which is no longer subject to patent. But Lilly has a remaining patent on a delivery method for the drug that injects the medicine along with certain vitamins and other additives that reduce the drug's side effects.

Alimta must be administered with folic acid and vitamin B12 to reduce harmful side effects, according to the drug's label. The drug is approved in combination with Merck & Co. Inc.'s Keytruda and platinum chemotherapy as an initial treatment for nonsquamous non-small cell lung cancer with a certain gene mutation that has spread.

Companies such as Dr. Reddy's Laboratories Ltd. and Hospira Inc. had challenged Lilly's ability to file a patent on the delivery method as they sought to create their own mixture of Alimta, or pemetrexed. The court challenges, which began in 2014, also question whether Lilly's rights would be infringed if the companies were to manufacture Alimta with the patented delivery method.

Several lower courts had previously ruled in Lilly's favor. The U.S. Court of Appeals for the Federal Circuit has now backed up the determination that the pharma giant's rights would, in fact, be infringed upon.

A previous case, ruled in April, found that Lilly could patent the delivery method.

If all remaining patent suits are resolved in Lilly's favor, the Alimta delivery method would remain exclusive through May 2022, the company said in an Aug. 9 news release.

"Lilly's extensive research to discover this patent deserves intellectual property protection, which has been confirmed in every challenge in the U.S. to date," said Michael Harrington, Lilly's senior vice president and general counsel.