Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. et al., Case No. 2021-1070 (June 21, 2022), granting a petition for panel rehearing filed by Defendants-Appellants HEC Pharm Co., Ltd. and HEC Pharm USA Inc., vacating its own prior decision, and reversing the district court’s judgment of no invalidity for lack of written description.
Novartis’s U.S. Patent No. 9,187,405 discloses methods of treating relapsing-remitting multiple sclerosis, and Novartis markets a branded drug that purportedly practices the ’405 patent. HEC filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market a generic version of the drug. Novartis sued HEC for patent infringement. After a bench trial, the district court found that HEC’s ANDA infringes the claims of the ’405 patent and that the claims are not invalid for anticipation or for inadequate written description. HEC appealed. In an initial panel decision, the Federal Circuit affirmed (with Judge Moore dissenting), holding that the district court did not commit clear error in its written description finding. HEC petitioned for panel rehearing.
The Federal Circuit granted panel rehearing and issued a new decision reversing the district court (this time with Judge Linn dissenting). The Court’s decision focused on the adequacy of the ’405 patent’s written description of a negative limitation recited in all claims—namely, the absence of a loading dose. A “loading dose” is a higher-than-daily dose usually given as the first dose. The specification of the ’405 patent does not mention loading doses, or the absence thereof, and instead describes administering the drug at regular intervals. The Court explained that “[f]or negative claim limitations, like the no-loading-dose limitation …, there is adequate written description when, for example, ‘the specification describes a reason to exclude the relevant [element].’” After giving examples of the types of disclosures that would satisfy the written description requirement, the Court stated that it “cannot be met through simple disregard of the presence or absence of a limitation.” Noting the possibility that silence could be sufficient if a skilled artisan would understand the specification as inherently disclosing the negative limitation, the Court concluded the record here did not support such a finding. The Court held that the district court clearly erred in finding that the no-loading-dose limitation meets the written description requirement and reversed the district court’s judgment of no invalidity.
Coauthored by Rachel Zimmerman Scobie and Melissa Quirin