On June 21, 2022, the Court of Appeals for the Federal Circuit (CAFC) granted a request for rehearing, vacated its prior decision, and reversed the district court’s decision that the patent claim was not invalid for inadequate written description.
Novartis Pharmaceuticals v. Accord Healthcare Inc., No. 2021-1070 (Fed. Cir. June 21, 2022).
We previously wrote about the prior CAFC panel decision (in our
January 11, 2022 post) that initially affirmed the district court’s decision that the asserted patent had sufficient written description for the negative claim limitation.
As we previously explained, the appeal involved a dispute in the Delaware District Court between Novartis, the owner U.S. Patent No. 9,187,405 directed towards the use of fingolimod hydrochloride in the treatment of relapsing remitting multiple sclerosis (RRMS), and HEC Pharm USA Inc., which sought to market a generic version of the drug. At issue was claim 1, which recited the administration of the drug for the treatment of RRMS “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” The specification describes the results of an experiment in rats that were administered the drug after being induced with a disease that mimics RRMS. The specification reports that disease relapse was completely inhibited in rats to which the drug was “administered daily at a dose of 0.3 mg/kg” or “administered p.o. at 0.3 mg/kg every 2nd or 3rd day or once a week.” It then described a prophetic human trial in which RRMS patients would receive 0.5, 1.25, or 2.5 mg per day for two to six months. No loading dose or lack of a loading dose was described.
HEC Pharm USA argued that the specification could not support a claim limitation requiring there be no “immediately preceding loading dose regimen” because “silence alone cannot serve as a basis” for a negative claim limitation under the written description requirement. It further argued that the finding of the district court to the contrary was inconsistent with its decision that a prior art abstract, which similarly failed to mention the presence or lack of a loading dose regimen, did not anticipate the claims.
The panel decision rejected both arguments. But, on rehearing, the CAFC reversed its position, in a 2-1 majority. Per the CAFC on rehearing, for negative limitations, such as those at issue here in the appeal, there is adequate written description when the specification, for example, describes a reason to exclude the limitation or otherwise the negative limitation would be inherent in the patent’s disclosure — the “common denominator” is the
disclosure of the negative limitation. If it were enough to simply remain silent in the specification, then every later-added negative limitation would be supported so long as the patent makes no mention of it.
Of particular note, the original panel consisted of Judges Moore, Linn and O’Malley, with Judges Linn and O’Malley in the majority and Judge Moore dissenting. Due to the retirement of Judge O’Malley, Judge Hughes joined the rehearing decision — with Judge Moore and Hughes now in the majority, and Judge Linn dissenting. To some degree, it shows the importance of panel make-up in the outcome.
