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CAFC Updates


By January 4, 2022No Comments

Novartis markets a daily dose of fingolimod hydrochloride under the brand name Gilenya to treat relapsing remitting multiple sclerosis. HEC filed an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of U.S. Patent No. 9,187,405. After a four-day bench trial, the district court found that the ’405 patent is not invalid and that HEC’s ANDA infringes. HEC appealed, arguing that the district court erred in finding that the ’405 claims do not fail the written description requirement of 35 U.S.C. § 112(a) with respect to the 0.5 mg daily dose limitation and the no-loading-dose negative limitation. With respect to the daily dose limitation, the CAFC is not convinced by HEC’s argument that the Prophetic Trial does not provide sufficient written description, noting that the disclosure need only clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed, and to accept HEC’s argument would require them to ignore the perspective of the person of ordinary skill in the art and require literal description of every limitation, in violation of CAFC precedent. The CAFC also rejects HEC’s argument that “blaze marks” directing a skilled artisan to the recited daily dose are absent from the ’405 patent, because even if blaze marks were required in this case, the Prophetic Trial and 0.5–30 mg/day dosage range would provide a skilled artisan more than sufficient guidance to direct them to the claimed 0.5 mg/day dose. With respect to the negative limitation, the CAFC is unconvinced by HEC’s argument there is no written description because the ’405 specification contains no recitation of a loading dose “or its potential benefits or disadvantages at all,” and that the district court’s finding of written description of the negative limitation within the ’405 specification contradicts the district court’s finding that certain prior art, which is similarly silent as to loading doses, does not anticipate the claims. While HEC asserts that it is well-settled law that silence alone cannot serve as a basis for a negative limitation, HEC identifies no case that actually supports that proposition and attempts to create a new heightened written description standard for negative limitations contrary to the CAFC’s written description jurisprudence. The CAFC finds that in determining that there is adequate written description of the negative limitation, the district court correctly and carefully conducted an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art as required by CAFC precedent. Because the CAFC does not discern any clear error in the district court’s decision, they affirm. Judge Moore, dissents because in his view the majority dramatically expands a patentee’s ability to add, years after filing a patent application, negative claim limitations that have zero support in the written description, noting that while the negative limitation need not be recited in the specification in haec verba, there must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion: disadvantages, alternatives, inconsistencies, just something.

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