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US federal judge rules that Teva’s mometasone furoate nasal spray does not infringe on Merck’s patent

On November 14, 2016, Judge Sue Robinson of the US District Court for the District of Delaware issued a ruling upholding Merck’s US patent 6,127,353 but finding that Teva’s mometasone nasal spray ANDA does not infringe the claims of that patent. Merck filed suit against Teva in July 2014 after Teva submitted an ANDA for the product to the FDA.

Much of the discussion in the opinion deals with the competence of Merck and Teva’s experts in characterizing crystals of mometasone furoate monohydrate.

In 2012, a judge in the US District Court for the District of New Jersey also upheld the ‘353 patent and ruled that Apotex’s ANDA for mometasone furoate nasal spray did not infringe the patent.

Read the US District Court opinion.

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published on November 17, 2016

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