This preliminary WIPO Study prepared for the 13th Session of the WIPO Standing Committee on the Law of Patents (SCP) which took place from 23 to 27 March 2009, while making a useful contribution, falls far short of expectation in terms of advancing the understanding of the subject and moving debate forward. There is no doubt that the study, as most of the others prepared for the same session, breaks from WIPO’s past. It discusses many key issues and makes statements, which only recently would have been considered alarming in WIPO. Paragraphs 3, 9, 31, 33, 36, 37, 59, 63, 72, 73, 90, 95, 96, 97 and 102 are just some examples of interesting and useful lines of discussion. The key failing of the study is the failure to bring to the attention of WIPO Member States a representative picture of the literature on the subject and some of the pertinent discussions such as on how exclusions from patentability and exceptions and limitations to patent rights should be addressed in patent harmonisation or their importance for development. Literature on these issues from a development and IP perspective is essentially ignored, and it is hard to believe that this was inadvertent or that such literature was beyond the scope of the study. It is perhaps for that reason that WIPO Member States decided, at the end of of the 13th Session, that further work on this subject should be commissioned out.

Exclusions from Patentability, Exceptions and Limitations and Development in the TRIPS Era

The importance of the exclusions from patentability and exceptions and limitations as mechanisms to address the development needs and concerns, especially for developing countries and least-developed countries (LDCs), has been highlighted in numerous studies, reports, journal articles, books and other publications. In the era of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) their importance, especially for development, can not be gainsaid. Indeed, in the last ten years their importance has been popularised by the use of the phrase “TRIPS Flexibilities”.

It is therefore sad that the WIPO study virtually ignores all the key literature on development and exclusions from patentability as well as exceptions and limitations, literature that would have significantly enriched the study and underscored to WIPO Member States and other stakeholders the importance of this subject in WIPO’s patent agenda. Examples of such literature include the work of scholars such as Carlos Correa (see e.g., Correa on the Research Exemption) and practitioners such as Christopher Garrison (see e.g., Garrison on exceptions to patent rights in developing countries), the work of the World Health Organization (WHO) (see e.g., both the work on essential medicines and the work of the CIPIH), the work of the UK Commission on IP, among others.

The further study anticipated on this topic will only be useful if it is truly representative of the range of views on the various issues that arise with respect to exclusions from patentability and exceptions and limitations and, in particular, if it takes into account the importance of this subject for development in the post-TRIPS era.

Patent Law Harmonisation and Exclusions from Patentability and Exceptions and Limitations

While the subject of exclusions from patentability and exceptions and limitations to patent rights has been discussed in WIPO in various contexts, including in the context of the WIPO Development Agenda, the most important discussion on the subject has been in the context of the proposed Substantive Patent Law Treaty (SPLT). In the SPLT discussion developing countries argued strongly that these issues had to be addressed in the treaty while developed countries argued that these issues should not be included in any package. In this context, I had the opportunity to discuss the subject in the context of the SPLT at the WIPO Open Forum on the SPLT in March 2006. (See the paper I presented on that occasion on the WIPO Website).

Beyond the SPLT discussion, there is also the broader discussion, similar to the discussion in the copyright area, on whether there is a case for a set of international minimum exceptions and limitations to patent rights. For example, it has been argued that in light of the international nature of research a minimum global standard on the research exemption would be an important booster for cross-border innovation and research activities.

The recent debate regarding the seizure of pharmaceuticals is transit, based on alleged claims of patent infringement, suggest that another area where international action may be urgently required is to create limitations and exceptions that assure international “freedom of transit”. Indeed, such a minimum standard has been set with respect to freedom of transportation in the Chicago Convention which enjoys near universal membership and is discussed in the WIPO study in paragraphs 82 and 83.