Eli Lilly secures patent win against Dr Reddy’s

A US court handed victory to Eli Lilly late last week after finding that a drug for which Dr Reddy’s is seeking approval would infringe a patent covering cancer treatment Alimta (pemetrexed for injection).

On Friday, June 22, District Judge Tanya Walton Pratt of the US District Court for the Southern District of Indiana, Indianapolis Division held that the two products are equivalent.

The patent at issue, US number 7,772,209, covers a method of administering the chemotherapy drug pemetrexed disodium with folic acid and vitamin B12 to reduce the incidence of patient toxicity caused by Alimta. It expires in May 2022.

Dr Reddy’s had filed a New Drug Application with the Food and Drug Administration for pemetrexed ditromethamine in 2015 and, in February the following year, Eli Lilly sued Dr Reddy’s for patent infringement.

“Eli Lilly asserts, and the court agrees, that healthcare providers using the proposed Dr Reddy’s product will directly infringe under the doctrine of equivalents, and that Dr Reddy’s is liable as an indirect infringer,” said Pratt on Friday.

Michael Harrington, Eli Lilly’s senior vice president and general counsel, said that Eli Lilly’s research to discover the patented Alimta vitamin regimen deserves IP protection.

“We depend on strong and effective IP protection to support our investment in the next generation of breakthrough medicines,” he added.

In a separate decision earlier in June, the same district court ruled in favour of Eli Lilly against Hospira, granting Eli Lilly’s cross-motion for summary judgment and denying Hospira’s motion for summary judgment.

According to Eli Lilly, the two rulings mean that Dr Reddy’s and Hospira will be prevented from launching their alternative salt forms of pemetrexed until the patent expires.

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