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EU and US Approaches to Delayed Access to Generic Drugs by Enforcement of a Patent or SPC Procured by Fraud

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dc.contributor.author Knade-Plaskacz, Agnieszka
dc.date.accessioned 2017-01-19T07:51:01Z
dc.date.available 2017-01-19T07:51:01Z
dc.date.issued 2016-10-13
dc.identifier.citation Comparative Law Review, Vol. 20, pp. 117-132
dc.identifier.issn 0866-9449
dc.identifier.other doi:10.12775/CLR.2015.014
dc.identifier.uri http://repozytorium.umk.pl/handle/item/3993
dc.description.abstract This article examines the impact of pharmaceutical patent protection on the introduction of generic drugs on the market. Basing itself on the Court of Justice of the European Union (CJEU) AstraZeneca case and US case law it examines, in particular, the way in which pharmaceutical companies may have created artificial barriers to entry for the market launch of generic drugs, so as to maintain market dominance by way of “life cycle management strategies”. Moreover, it compares the different ways, in which the EU and US have chosen to address the problem of the abuse of regulatory procedures by fraud with its purpose of delaying generic drug approvals. It also seeks to answer the question of whether the existence of a legal entitlement to a patent under the rules of patent law excludes competition-law liability.
dc.description.abstract This article examines the impact of pharmaceutical patent protection on the introduction of generic drugs on the market. Basing itself on the Court of Justice of the European Union (CJEU) AstraZeneca case and US case law it examines, in particular, the way in which pharmaceutical companies may have created artificial barriers to entry for the market launch of generic drugs, so as to maintain market dominance by way of “life cycle management strategies”. Moreover, it compares the different ways, in which the EU and US have chosen to address the problem of the abuse of regulatory procedures by fraud with its purpose of delaying generic drug approvals. It also seeks to answer the question of whether the existence of a legal entitlement to a patent under the rules of patent law excludes competition-law liability.
dc.language.iso eng
dc.rights Attribution-NoDerivs 3.0 Poland
dc.rights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by-nd/3.0/pl/
dc.subject abuse of regulatory procedure
dc.subject intellectual property law
dc.subject antitrust law
dc.subject generic drugs
dc.title EU and US Approaches to Delayed Access to Generic Drugs by Enforcement of a Patent or SPC Procured by Fraud
dc.type info:eu-repo/semantics/article


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