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27 August 2015Americas

Eli Lilly hails US court’s Alimta ANDA infringement finding

US pharmaceutical company Eli Lilly has thwarted attempts by its competitors to market a generic version of its Alimta (pemetrexed) drug.

On Tuesday, August 25, the US District Court for the Southern District of Indiana ruled that Abbreviated New Drug Applications (ANDAs) filed by Teva Parenteral Medicines, Barr Laboratories and App Pharmaceuticals infringed Eli Lilly’s patent.

Alimta is used to stop the spread of cancer cells in the body. In 2014 it generated $2.7 billion in revenue.

The patent at the centre of the row is US number 7,772,209. It covers the administration of Alimta with two nutrients—folic acid and vitamin B12. Such ingredients protect patients from the side effects of the drug.

The patent is due to expire in May 2022.

Judge Tanya Walton Pratt, presiding over the case, said: “The court concludes that Eli Lilly has shown by a preponderance of the evidence that the asserted claims of the ‘209 pate nt would be infringed by the defendants’ ANDA products.”

Michael Harrington, general counsel for Eli Lilly, said: “We are pleased with the district court’s ruling on Alimta finding the vitamin regimen patent would be infringed.

“The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection. We continue to emphasise that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve,” he added.

Last year, Eli Lilly succeeded in fending off an attempt by Teva to invalidate the ‘209 patent.

Teva had claimed the patent was invalid on the grounds it was obvious. But the Indiana district court dismissed this claim, stating Teva had failed to provide “clear and convincing evidence” that the patent was obvious.


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7 February 2018   Teva sued Eli Lilly yesterday in a bid to protect its IP rights covering “breakthrough treatments for migraine headaches”.

More on this story

Americas
7 February 2018   Teva sued Eli Lilly yesterday in a bid to protect its IP rights covering “breakthrough treatments for migraine headaches”.