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ARTICLE | Company News

Fresenius, Teva, Eli Lilly cancer news

April 14, 2014 7:00 AM UTC

The U.S. District Court for the Southern District of Indiana found that eight claims of Lilly's U.S. Patent No. 7,772,209 regarding the co-administration of folic acid and vitamin B12 with cancer drug Alimta pemetrexed is valid and enforceable. In Eli Lilly and Company v. Teva Parenteral Medicines Inc., et al., the court found that "a POSA [person skilled in the art] would not have expected an increase in the antitumor activity of pemetrexed with the regimen covered under the '209 patent, and therefore supports a finding of non-obviousness." The court rejected the defendant's argument that previous preclinical mouse studies showed folic acid could modulate pemetrexed toxicity in mice, noting the drug's efficacy was only maintained at much higher doses of the drug than would have been tolerable to humans. Additionally, the court found that it would not have been obvious to apply to cancer patients the finding that co-administration of vitamin B12 and folic acid prevents B12 deficiency in rheumatoid arthritis patients on methotrexate.

Teva, APP Pharmaceuticals Inc., Barr Pharmaceuticals Inc., Pliva d.d., Accord Healthcare Inc. (Durham, N.C.) and Apotex Inc. (Toronto, Ontario) each submitted ANDAs to FDA for generic versions of Alimta. In 2010, Lilly filed suit in the U.S. District Court for the Southern District of Indiana alleging patent infringement. In 2012, Lilly filed similar suits in the same court against Accord and Apotex. The Accord and Apotex cases were consolidated and stayed, with the parties agreeing to be bound by the outcome of the Teva et al. litigation. The '209 patent expires in 2021, with pediatric exclusivity expiring in 2022. Alimta is approved in the U.S. and EU for first- and second-line therapy of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), maintenance therapy of advanced, non-squamous NSCLC following platinum-based first-line chemotherapy and malignant pleural mesothelioma. Alimta is an antifolate that inhibits thymidylate synthase, dihydrofolate reductase (DHFR) and glycinamide ribonucleotide formyltransferase (GARFT). Lilly recorded $1.2 billion in 2013 U.S. sales of Alimta. ...