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TitlePatent Protection of Pharmacologically Active Metabolites: Theoretical and Technological Analysis on the Jurisprudence of Four Regions
Creator王立達
Wang, Richard Li-dar;Huang, Pei-Chen
Contributor法學院
Date2013
Date Issued10-Nov-2015 16:18:41 (UTC+8)
SummaryActive metabolite patents have been instrumental for brandname pharmaceutical companies to maintain their exclusivity even after the drug patents expire. This strategy obstructs market entry of generic medicine and reduces affordable drugs. The authors review jurisprudence from the United States, Europe, India, and Taiwan in search for practical solutions to confront this problem. Given the unique pharmacological value that active metabolites may possess, patent protection for those purified or synthesized in vitro should be preserved, but for those produced by metabolism should be declined. Except India, most countries under investigation comport with this dichotomy. Their jurisprudence may be subsumed into three possible solutions. The United States and the United Kingdom adopt the inherent anticipation doctrine; yet depriving artisan recognition of novelty analysis makes this doctrine highly controversial. The product of nature doctrine gravely suffers from incoherence and uncertainty in judging patentability. The non-practice theory, as articulated by Taiwan’s Intellectual Property (IP) Court, avoids these shortcomings. The unambiguity and sound rationale further support this theory to be the preferable solution among the three.
RelationSanta Clara High Technology Law Journal, Vol.29, No.3, pp.489-521
Typearticle
dc.contributor 法學院
dc.creator (作者) 王立達zh_TW
dc.creator (作者) Wang, Richard Li-dar;Huang, Pei-Chen
dc.date (日期) 2013
dc.date.accessioned 10-Nov-2015 16:18:41 (UTC+8)-
dc.date.available 10-Nov-2015 16:18:41 (UTC+8)-
dc.date.issued (上傳時間) 10-Nov-2015 16:18:41 (UTC+8)-
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/79385-
dc.description.abstract (摘要) Active metabolite patents have been instrumental for brandname pharmaceutical companies to maintain their exclusivity even after the drug patents expire. This strategy obstructs market entry of generic medicine and reduces affordable drugs. The authors review jurisprudence from the United States, Europe, India, and Taiwan in search for practical solutions to confront this problem. Given the unique pharmacological value that active metabolites may possess, patent protection for those purified or synthesized in vitro should be preserved, but for those produced by metabolism should be declined. Except India, most countries under investigation comport with this dichotomy. Their jurisprudence may be subsumed into three possible solutions. The United States and the United Kingdom adopt the inherent anticipation doctrine; yet depriving artisan recognition of novelty analysis makes this doctrine highly controversial. The product of nature doctrine gravely suffers from incoherence and uncertainty in judging patentability. The non-practice theory, as articulated by Taiwan’s Intellectual Property (IP) Court, avoids these shortcomings. The unambiguity and sound rationale further support this theory to be the preferable solution among the three.
dc.format.extent 280203 bytes-
dc.format.mimetype application/pdf-
dc.relation (關聯) Santa Clara High Technology Law Journal, Vol.29, No.3, pp.489-521
dc.title (題名) Patent Protection of Pharmacologically Active Metabolites: Theoretical and Technological Analysis on the Jurisprudence of Four Regions
dc.type (資料類型) articleen