(2004; 110 pages)
II.1.4 Research and the Early Working Exceptions
Article 30 of the TRIPS Agreement establishes the general bases for exceptions to the exclusive rights envisaged under the Agreement.25 The rule is that exceptions to the patent rights must be limited; should not unreasonably conflict with the normal exploitation of the patent; and should not unreasonably prejudice the legitimate interests of the patent holder, taking into account the legitimate interests of third parties. Although not explicitly mentioned in the Agreement, the research and experimentation and early working exceptions are the two widely accepted exceptions under article 30 with implications for public health. In some countries, such as the United States, these exceptions have traditionally been judicially determined while in others, such as Japan, they are statutory rights.
25 For these rights see article 28 of TRIPS.
The research and experimental use exception is aimed at ensuring that scientific research aimed at generating new knowledge is fostered and is not impeded by patents. It is a longstanding exception which is justified on the basis that one of the main aims of patent laws is to facilitate the dissemination of knowledge, promote innovation and thereby facilitate the advancement of science. The exception is useful in fostering pharmaceutical technological progress by exempting experimentation acts for purposes such inventing around the initial invention, improving on the invention or for the purposes of evaluating the invention and determining if it works.26
26 See Correa (2000), p. 66.
The early working exception, on the other hand, relates to a situation where a potential competitor uses an invention without the authorization of the patent holder to undertake acts necessary for obtaining regulatory approval and registration of a generic product before the expiry of the patent term. The exception is intended to ensure that generic versions of the product are available on the market immediately or within a reasonable time of the expiry of the patent.27 The actual implementation of the exception differs from country to country. Under the 1984 United States Drug Price Competition and Patent Term Restoration Act, the United States introduced this type of provision while also allowing patent holders an extended period of protection.28 Other countries such as Kenya, on the other hand, provide for the early working exception to generic manufacturers without extending the life of the patent.29
27 Lettington and Musungu (2000), p.65.
28 Ackiron (1991), p. 157.
29 See section 21(3) (e) "The Industrial Property Act", Kenya Gazette Supplement No. 60 (Acts No. 3) 3 August 2001.