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- W4297238971 abstract "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." @default.
- W4297238971 created "2022-09-28" @default.
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- W4297238971 date "2022-10-01" @default.
- W4297238971 modified "2023-09-30" @default.
- W4297238971 title "How a Dosage Regimen Patent for RRMS Treatment May Satisfy the Written Description Requirement—A Lesson from <i>Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.</i>" @default.
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- W4297238971 doi "https://doi.org/10.1089/blr.2022.29285.phc" @default.
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