Biotechnology Law Report
ISSN / EISSN: 0730031X / 15578704
Published by: Mary Ann Liebert Inc
Total articles ≅ 4,784
Latest articles in this journal
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29291.cip
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29292.sjz
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29288.st
In the era of smart health care, artificial intelligence technology has penetrated the medical field, resulting in a number of new inventions with “disease diagnosis methods” as their content and “artificial intelligence algorithm” as their method. These new inventions represent “intelligent” disease diagnosis. In China, patent applications for such inventions have been published and even been granted. Therefore, it is necessary to analyze the patentability of “intelligent” disease diagnosis methods and further demonstrate the extent to which China's attempts to grant such patents are in line with international patent granting trends. When dealing with such patent applications in the future, China may try to confirm the patentability of such objects by setting typical cases in the patent examination guidelines, so as to eliminate uncertainty as to the current legal status of such inventions. In a patent examination, it can declare China's higher protection for artificial intelligence patents in the medical field by conducting more substantive examination on them, so as to gain an advantage in the international patent competition.
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29289.cip
Biotechnology Law Report, Volume 41, pp 240-250; https://doi.org/10.1089/blr.2022.29285.phc
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.
Biotechnology Law Report, Volume 41, pp 258-261; https://doi.org/10.1089/blr.2022.29283.cip
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29282.cip
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29286.sjz
Biotechnology Law Report; https://doi.org/10.1089/blr.2022.29281.cmh