Eli Lilly and Company has triumphed over a patent case in London's Court of Appeal involving its lung cancer drug Alimta. The win boosts prospects for the drug's future sales and deals a blow to Actavis, Lilly's generic challenger.
The decision reverses a verdict handed down in 2014 by the English High Court and will be applicable as well in Spain, Italy and France because of a legal system supporting corresponding declarations. In 2014, Alimta was the biggest-selling product for Lilly, generating $2.79 billion in sales.
According to the appeals court in London, Actavis' plan of marketing certain salt forms as alternatives to Alimta once the basic patent for the drug expires at the end of the year will indirectly infringe another patent from Lilly. This other patent is valid until 2021 and covers the administration of vitamin B12 and folic acid, two nutrients given to patients during treatment with Alimta to help keep side effects at bay.
Pleased with the ruling, Michael J. Harrington, general counsel and senior vice president for Lilly, said that the ruling confirms the vitamin regimen patent they hold for Alimta would be infringed if generic pemetrexed was introduced to the UK market before June 2021.
"We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve." he added, pointing out that intellectual property rights are necessary to assure market exclusivity needed for supporting the development of the next-generation medicines that will treat medical needs currently unmet.
In a prior ruling, Lilly's vitamin regimen patents were also upheld by the European Patent Office's Opposition Division. An appeal has been filed for this ruling, but is pending before the EPO's Technical Board of Appeal.
In Germany, however, Lilly had to concede to Actavis after an appeal court decided in March that the distribution of generic pemetrexed after December 2015 will not infringe one of Lilly's patents. Lilly has requested that it be allowed to file an appeal for this court decision.
In the United States, Alimta was approved by the Food and Drug Administration in 2009 as treatment and maintenance therapy for metastatic or locally advanced non-squamous non-small cell lung cancer in patients whose disease hasn't progressed after undergoing four cycles of platinum-based first-line chemotherapy. In 2004, the drug was approved for treating malignant pleural mesothelioma in combination with cisplatin.
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