The Research and Experimentation Exceptions in Patent Law: Jurisdictional Variations and WIPO Development Agenda


by Evans Misati, Kiyoshi Adachi

UNCTAD-ICTSD Project on IPRs and Sustainable Development Series • Policy Brief

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Research and Experimentation Exceptions in Patent Law 0.51 MB

The UNCTAD - ICTSD project on IPRs and Sustainable Development is pleased to announce the availability of Policy Brief 7, entitled “The Research and Experimentation Exceptions in Patent Law: Jurisdictional Variations and the WIPO Development Agenda” by Evans Misati and Kiyoshi Adachi.

Recommendation 22 of the World Intellectual Property Organization (WIPO) Development Agenda stipulates that WIPO should address potential flexibilities, limitations, and exceptions to intellectual property rights in its norm-setting activities.

Against this background, exceptions to patent rights have been the subject of increased attention in intellectual property discussions and processes in recent years.

One important exception to patent rights that has traditionally been recognized in many countries’ laws and jurisprudence is the use of a patented product or process, without the consent of the patent holder, for certain research and experiments. Both society and scientists have a legitimate interest in being able to use patent disclosure to support the advancement of science and technology, and inventors ought to be able to freely experiment using the patented invention or process to come up with better products or processes.

The research exception has also taken on particular importance in the light of the global consensus reached in WHO’s 2008 Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which specifically recognizes that a research exception could help to address public health needs in developing countries.

There has been, however, a great deal of debate on exactly what research and experimentation activities (hereafter “research activities”) should fall under such an exception. In practice, the scope and coverage of the research exception have varied from country to country.

This Policy Brief examines the practice of countries with respect to the research exception and a related exception that has an impact on a specific type of research, the regulatory review (“Bolar”) exception. After looking at the practice of various jurisdictions, the Policy Brief attempts to extract some lessons.

The main objective of the Policy Brief is to suggest the possible parameters of policy interventions that may be adopted, at the national and international level, by countries that wish to codify exceptions for certain research activities in a manner that will make patent law work more effectively for innovation, better adapt to local technological conditions, and increase the benefits of the patent system for the society at large.

Since its launch in 2001, the UNCTAD-ICTSD Project on IPRs and Sustainable Development has sought to achieve a better understanding of the development implications of IPRs; facilitate informed participation in ongoing multilateral, regional and bilateral negotiations, as well as to assist countries in designing and implementing appropriate IP laws and policies which take into consideration their economic and social needs and are supportive of their development objectives.

For further information, please contact Ahmed Abdel Latif at [email protected]

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