Lupin Copy of Kidney Drug Found Not to Infringe Otsuka Patents

Aug. 1, 2024, 5:22 PM UTC

Lupin Ltd.’s generic version of Jynarque doesn’t infringe two Otsuka Holdings Co. patents for the blockbuster kidney disease treatment, a federal judge in Delaware ruled while also canceling one of them.

Judge Richard G. Andrews found Lupin’s method of making Jynarque’s active ingredient, tolvaptan, doesn’t infringe US Patent Nos. 8,273,735 or 8,501,730 because it doesn’t meet the specific chemical requirements they outline, according to an opinion issued Wednesday in the US District Court for the District of Delaware.

The ruling invalidated as obvious the ‘735 patent, which covers a process for making benzazepine compounds or their salts and would’ve expired ...

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