• Aug 14 2019
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  • Category: CAFC Updates

Sanofi appeals from the District Court’s judgment holding, after a bench trial, certain claims U.S. Patent 8,927,592 (relating to the compound cabazitaxel and methods of using it. Which Sanofi markets under the trade name Jevtana® to treat certain drug-resistant prostate cancers) invalid as obvious. Fresenius cross-appeals from the same judgment holding claims 1 and 2 of U.S. Patent 5,847,170 not invalid as obvious. Fresenius filed Abbreviated New Drug Applications (“ANDAs”) to market generic versions of cabazitaxel prior to the expiration of the ’592 and ’170 patents, prompting Sanofi to sue for infringement. While the district court case was pending, the Patent Trial and Appeal Board instituted inter partes review of the ’592 patent and held claims 1–5 and 7–30 unpatentable as obvious. Sanofi filed a statutory disclaimer of those claims in the Patent Office and so informed the district court. The CAFC finds that Sanofi’s disclaimer mooted any controversy over them, and that at the time the district court entered final judgment, the relief requested was both speculative and immaterial to possible future defenses, and Defendants thus failed to demonstrate an Article III case or controversy. Because there was no case or controversy with respect to the relevant claims of the ’592 patent when the district court issued its decision, the CAFCvacates the court’s decision concerning those claims. The CAFC further concludes that the district court did not clearly err in its assessment of the prior art references or in finding that they would not have motivated a skilled artisan to modify docetaxel to obtain cabazitaxel, and therefore affirms the court’s judgment that the ’170 patent is not invalid as obvious.

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