This article discusses how a treatment claim with a dosage regimen limitation may meet the written description requirement under Novartis I, 21 F.4th 1362 (Fed. Cir. 2022), and Novartis II, No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022). The disputed phrase in Novartis was "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen." Though, the daily dosage limitation was found valid in Novartis I, the no-loading-dose limitation was held invalid in Novartis II. These two Novartis decisions actually indicate what should be disclosed in the specification to make a treatment claim survive the written description challenge. This article proposes that for daily dosage limitations, a claim should not mention that the claimed dosage is effective. Instead, recitation of purposes of the treatment may be sufficient. Additionally, a specification must disclose the claimed dosage. In terms of RRMS (relapsing-remitting multiple sclerosis) treatment, a specification must describe animal models used for predicting therapeutic dosages administered to RRMS patients. Preferably, a way to predict human dosages through animal experiments should be explained. For no-loading-dose limitations, a specification must disclose when loading doses may be administered before the claimed regular dosage.
