[A2k] WIPO study on Patents and the Public Domain

Thirukumaran Balasubramaniam thiru at keionline.org
Fri Nov 18 03:50:47 PST 2011


WIPO's study on Patents and the Public Domain can be found on the following link: 

http://wipo.int/edocs/mdocs/mdocs/en/cdip_8/cdip_8_inf_3.pdf

According to the secretariat, the "Patents and the Public Domain part of the study was prepared by Mr. Jeremy Phillips, Professorial Fellow, Queen Mary Intellectual Property Research Institute, University of London, London, United Kingdom. The Development Dimension: National Practices and Experiences part was prepared by:
A. Mr. McLean Sibanda, Chief Executive Officer, The Innovation Hub, Pretoria, South Africa;
B. Mr. Hossam El Saghir, Professor of Commercial Law and General Director of the, Regional Institute for Intellectual Property, Helwan University, and Attorney at Law, Cairo, Egypt;
C. Mr. Ernesto Rengifo García, Professor, Universidad Externado de Colombia, Bogota, Colombia;
D. Mrs. Olena Pavlina Orlyuk, Director, Scientific Research Institute of Intellectual Property, Kyiv, Ukraine; and
E. Mr. Calab Gabriel, Senior Partner, K&S Partners, Intellectual Property Attorneys, Gurgaon, National Capital Region, India."

The study is 121 pages long.

Here is an excerpt from the study:

"Information which must be disclosed for the benefit of the public at the expense of the party disclosing it should not be put to unfair use by competitors or free-riders who have incurred no cost in creating and verifying it.  This issue is one which touches not on the patent system itself but on those who use it, and it is provided for under international law:  it relates to what is often called “regulatory data”, information demanded by public authorities as proof of the efficacy, environmental impact or other characteristic of a new medicine or other chemical product.  Article 39(3) of the TRIPS Agreement,[1] which neutrally describes it under the heading “Undisclosed Information”, requires Members to provide that such regulatory data is either kept confidential or that its use be restricted so as to prevent unfair competition.  In theory this provision relates to all test data, whether it relates to a product which has been patented or not;  in practice its importance lies in the fact that manufacturers of generic and other equivalent products cannot make free use of the data furnished by the originator of the tested product.  While the obvious significance and potential importance of this information to the public domain, it should be understood that this provision of the TRIPS Agreement does not address public domain concerns.  There is no indication as to how long such regulatory data should be kept confidential or its use restricted;  this may result in the retention of regulatory data in a state of confidentiality long after any related patents and supplementary protection certificates have expired, with the result that the public is deprived of useful material which might save lives as well as be of commercial or technical value."


[90]           The TRIPS Agreement, Article 39(3): “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.  In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use”.


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org



Tel: +41 22 791 6727
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