alimta

Lilly defeats Teva in US court over Alimta patent

pharmafile | August 26, 2015 | News story | Research and Development, Sales and Marketing Alimta, Eli Lilly, Teva Pharmaceutical, lung cancer 

Eli Lilly has won a case in a US federal court, in a battle over Teva’s attempt to create a generic version of Lilly’s lung cancer treatment Alimta.

Teva brought the case to court in an attempt to challenge Lilly’s patent, protecting Alimta (pemtrexed) in combination with a vitamin regimen (folic acid and vitamin B12), which is used to negate the drug’s side effects.

The ruling will effectively protect Lilly’s intellectual property patent until May 2022, when the patent for Alimta combined with the vitamins expires, although a separate patent for the Alimta compound runs out in 2017.

Teva had argued that the use of vitamins with Alimta was obvious, and did not require an additional patent. But in the initial case last year, the court decided that the significant scientific research undertaken by Lilly to test the combination was evidence that this was not necessarily true.

US district judge Tanya Walton Pratt said that although patients would decide to take the vitamins, they would be doing so at the instruction of their doctor, who in turn would be following the instructions of the patented method.

Pratt said that “the mere possibility that some patients might not follow their physician’s instructions” was not enough to rule in favour of Teva, and upheld the validity of the patent.

Commenting on the decision, Michael Harrington, senior vice president and general counsel for Lilly, says: “We are pleased with today’s District Court 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. These rights help support the development of the next generation of innovative medicines to treat unmet medical needs.” 

The Teva case is the latest in a series of legal battles for Lilly over Alimta, that have had mixed outcomes. Earlier this year, a German court upheld a challenge from Activis over the vitamin regimen, while the UK Court of Appeal ruled in March that Actavis would be infringing on Lilly’s patent if it were to produce a generic version of the drug.

Joel Levy

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