NDLI: Managing Intellectual Property Rights Over Clinical Trial Data to Promote Access and Benefit Sharing in Public Health

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“Device for Mounting the Rear Shelf of a Car” : Intellectual Property Code, Art. L. 614(3) – Trèves SA v. Silac SAS, Simoldes Plasticos France SARL et Renault SAS

“Pipe Cleaning Nozzle II” (Rohrreinigungsdüse II) : Code of Civil Procedure, Sec. 253(2) No. 2; Patent Act, Secs. 9, 139

“Tube System” (Sondensystem) : Patent Act, Secs. 59, 61(1) second sentence, 101

“Right to Be Heard in Patent Examination Appeal” : Patent Act, Secs. 50, 159(2) – Haier Group v. The Commissioner of the Patent Office

“Novelty – All Elements Rule” : Patent Act, Sec. 29(1) – Tohr GmbH v. Rohm & Haas Co., Ltd.

“Misappropriation of Prior Art” : Patent Act Sec. 123(1)(vi) – Kato Mfg Co. Ltd. v. Tsukasa Machine Industry Co. Ltd.

“Aventis Pharma SA & Ors. v. Cipla Life Sciences” : Patents Act, No. 57 of 1978 (as amended) – Aventis Pharma SA & Ors. v. Cipla Life Sciences

“Seated Figure” : Council Regulation (EC) No. 6/2002 of 12 December 2001 on Community Designs, Arts. 4–9, 25(1)(b) and (e), 61 – Herbert Neuman, Andoni Galdeano del Sel, and Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM) v. José Manuel Baena Grupo, SA

Dev Gangjee: Relocating the Law of Geographical Indications

IIC - International Review of Intellectual Property and Competition Law : Volume 44, Issue 1, February 2013

Managing Intellectual Property Rights Over Clinical Trial Data to Promote Access and Benefit Sharing in Public Health

Content Provider	Springer Nature Link
Author	Andanda, Pamela
Copyright Year	2013
Abstract	The nature and scope of intellectual property protection, if any, which clinical trial data should receive in terms of Art. 39 of the TRIPS Agreement have been put back in the spotlight through recent events: First through suggestions by heads of the Dutch, French and UK regulatory authorities as well as the European Medicines Agency that such data should not be considered commercially confidential information. Secondly, courts in countries such as Argentina and Brazil have recently decided cases in which they had to balance rights over clinical trial data with competing public health priorities. Both courts decided that public health interests take priority over claims for exclusive rights over clinical trial data. These events raise pertinent ethical and legal concerns, which warrant considerations of strategies that can be used to manage intellectual property rights over clinical trial data with a view to fostering access and benefit sharing in public health. This paper draws lessons from these events and suggests possible options for strategic management of intellectual property rights over clinical trial data in order to cater to public health needs. The concept of access and benefit sharing, which has so far been debated in the fields of biodiversity and most recently in the human genome context is applied to public health with a view to initiating discussions on how it can inform decision making in the management of intellectual property rights over clinical trial data.
Starting Page	140
Ending Page	177
Page Count	38
File Format	PDF
ISSN	00189855
Journal	IIC - International Review of Intellectual Property and Competition Law
Volume Number	44
Issue Number	2
e-ISSN	21950237
Language	English
Publisher	Springer-Verlag
Publisher Date	2013-02-16
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	TRIPS Agreement Test data International IT and Media Law, Intellectual Property Law Intellectual property Clinical trials Public health Benefit sharing
Content Type	Text
Resource Type	Article
Subject	Political Science and International Relations Law

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9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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