The Research Exemption to Patent Rights - Towards a Minimum Global Standard?

The Research Exemption to Patent Rights - Towards a Minimum Global Standard?

Geraldine Soon is an exchange student at Osgoode Hall and is taking the Patent Law course.

At the Standing Commmittee on the Law of Patents’ (SCLP) 13th session in March 2009, the World Intellectual Property Organization (WIPO)’s secretariat established a preliminary study on the “exceptions from patentable subject matter and limitations to the rights, inter alia research exemption and compulsory licenses”. The 47-page report highlighted and reiterated the importance of imposing exceptions and limitations onto patent rights: in an ideal world, the granting of exclusive patent rights would incentivize innovation and further knowledge; unfortunately, that is not always the case, and State governments have found the need to impose exceptions on these patent rights to further policy objectives and the welfare of society.

However, it is disappointing to note that apart from the comprehensive analysis on matters of interpretation of international agreements regulating the exceptions to patent rights, the report failed to address two main concerns that have cropped up in recent years in patent literature: 1) the limited and less-than-effective usage of exceptions and limitations on patent rights by developing countries; and 2) that the lack of a uniform formulation of the “research exemption” has impeded the very objective of the having a research exemption – to foster innovation.

The primary international agreement on the regulation of exceptions and limitations to patent rights is the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Article 30 of TRIPS provides that members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

It does not take a great measure of imagination to realize the very general nature of this formulation. Its generality becomes more apparent if one were to look at the history of the drafting of the provision on exceptions to patent rights in the TRIPS agreement, where a non-exhaustive list of specific exceptions to patent rights was suggested in the draft dated July 23, 1990 (see page 7 of Carlos Correa, “The International Dimension of the Research Exemption” http://sippi.aaas.org/Pubs/Correa_International%20Exception.pdf).

It is widely accepted that one of the exceptions to exclusive patent rights is the “research exemption”, and many jurisdictions have enacted laws accommodating this exception. However, the generality of Article 30 of TRIPS has resulted in the many varying formulations of the “research exemption” amongst the different countries.  In the cases of developing countries, some have formulated the exemption as being for the purpose of experimental purposes, some for scientific purposes, and some for technological research. Some require that the experimental purposes be done for non-profit, and some contain the implicit allowance for the research to be done for commercial purposes (in the case of technological research). Some even have research exemptions based not on the nature of the research, but on how it impacts the normal interest of the patent holder.

The variations go on. The question is: Has the multiplicity of formulations on the research exemption, as a result of the generality of Article 30 of TRIPS, hurt the potential for research output in developing countries?

At the national level, most of these developing countries had the patents system thrust upon them. Most have had little guidance as to how to best go about maximizing the benefits of the TRIPS agreement. Countries like India and China arguably have huge scientific and technological research potential, but have not formulated an optimal research exemption for themselves that would allow them to maximize this potential. In fact, this was the motivating factor behind Brazil’s proposal to the SCLP in January 2010 to establish a framework whereby detailed information on exceptions to patent rights in all jurisdictions, as well as information on experiences in implementing such exceptions and the impacts on development, would be compiled and made available to every jurisdiction.

At the international level, the lack of a uniform formulation of the research exemption could have an adverse effect on research – which would, of course, be a complete irony. The international nature of research suggests that barriers could arise as a result of the varying formulations of the research exemption in different countries - they could hinder transnational research activities and innovation.

Perhaps, at its 15th session, the SCLP and member countries of the WIPO should consider setting an international standard for the research exemption to exclusive patent rights.