NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC.

Novartis owns U.S. Patent No. 9,187,405 relating to methods of treating relapsing-remitting multiple sclerosis (RRMS) using the immunosuppressant fingolimod, and markets a drug under the brand name Gilenya. HEC Pharm USA Inc. filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market a generic version of Gilenya. Novartis sued HEC, alleging that HEC’s ANDA infringes all claims of the ’405 patent. The district court found that HEC’s ANDA infringes and that the claims are not invalid for inadequate written description of the no-loading-dose or daily dosage limitations. HEC appeals. The district court found that because there is no recitation of a loading dose in the specification, the no-loading dose limitation is supported, but the CAFC finds that the district court’s finding was clearly erroneous. The CAFC notes that there is not a heightened standard for negative claim limitations – – rather, as with positive limitations, the disclosure must only reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date, and while silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure. The CAFC grants HEC’s petition for panel rehearing, vacates their own prior decision, and reverses the district court’s judgment that the claims of the ’405 patent are not invalid. Judge Linn dissents because in his view, the district court applied the correct standard and found ample support in the written description for the no-load limitation. 

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