Lilly three strikes in three years not out in Teva patent challenge

pharmafile | January 13, 2017 | News story | Medical Communications, Sales and Marketing Eli Lilly, Teva, generics, lilly, patent 

Eli Lilly has successfully won a major patent case against Teva Pharmaceuticals, with the case being decided at the US Court of Appeals and finding in favour of Lilly’s patents for the third such case in three years. The case was regarded Lilly’s third biggest selling drug, Alimta, a treatment used in patients suffering from non-small cell lung cancer (NSCLC) and mesothelioma. Teva were looking to take a chunk of Alimta’s market by introducing its generic as a competitor.

The ruling regards Lilly’s ‘vitamin regimen’ patent, a solution that Lilly discovered to the potential serious side-effects of taking its drug in treatment. Patients who will be treated with Alimta take folic acid and vitamin B12 prior to treatment, reducing the toxicity of the drug. The court ruled that Teva’s labelling upon its generic would display, according to chief judge Sharon Prost, “the requisite intent for inducement” for doctors to encourage patients to break the patent protection upon the vitamin patent.

The judgement upholds the prior decision made by a district court to rule in favour of Lilly, which was preceded by a case in 2014 against a different patent held on the medication and last year’s case upon the same patent. Lilly’s success will come as a relief, with the drug responsible for $1.74 billion in the first nine months of 2016.

This doesn’t mean that Lilly are entirely out of the woods, an inter partes review will take place mid-way through 2016 that could, again, challenge Lilly’s patent protection upon the drug. With the drug currently holding patents upon the drug up until 2022, Lilly will gain confidence in protecting sales from the drug until much closer to that year.

“We are pleased with today’s ruling by the Court of Appeals, affirming the earlier district court’s decisions, finding the Alimta vitamin regimen patent is valid and would be infringed,” said Michael J. Harrington, senior vice president and general counsel for Lilly. “The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection, which has been confirmed in every validity challenge to date. We continue to emphasize 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.”

Ben Hargreaves

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