Lilly beats back challenge to Alimta patent
The US District Court for the Southern District of Indiana has upheld a patent covering Eli Lilly’s second biggest drug Alimta (pemetrexed disodium), after a challenge by Teva’s US pharmaceutical arm.
Judge Tanya Walton Pratt found on March 31 that Teva failed to show by “clear and convincing evidence” that Lilly’s 7,772,209 patent is invalid for obviousness, obviousness-type double patenting, inadequate description or lack of enablement.
Lilly launched the case after a group of companies, including Teva, filed Abbreviated New Drug Applications with the US Food and Drug Administration for approval to make and sell pemetrexed disodium products covered under the ‘209 patent.
The patent describes a method of administering chemotherapy drug pemetrexed with folic acid and vitamin B12 to reduce the incidence of toxicity. It is due to expire on May 24, 2022, while the compound patent will expire on January 24, 2017; both including paediatric exclusivity.
Alimta is used in the treatment of nonsquamous cell non-small cell lung cancer. In 2013 it generated $2.7 billion in revenues.
Michael Harrington, senior vice president and general counsel for Lilly, said: “We are pleased with the district court’s ruling on Alimta’s vitamin dosage regimen patent and are confident that the patent is valid and enforceable.
“The significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves IP protection. We continue to emphasise that protection of IP rights is extremely important to the biopharmaceutical industry and the patients we serve.”
Teva did not immediately respond to a request for comment.
