[World Health Organization, Link] Summary: Intellectual property plays an important role both for the researching pharmaceutical industry, which relies heavily on intellectual property to protect its products, and for generic companies, which produce copies of existing medicines once patent protection expires. Beyond patent protection, trademarks are another form of intellectual property rights used to identify and market pharmaceutical products. Trade secrets and protection of clinical test data are other important elements of this industry. Consequently, how a national intellectual property system is set up is important when considering options for local production of pharmaceuticals in developing countries.
Using practical examples and patent landscapes, this report attempts to set out the various strategies and options available to facilitate local production. The report describes the options available to countries with a generic industry to design an intellectual property system that is favourable for local production and potentially for public health. The report highlights the importance of transparent and fair patent administration systems using the example of access to patent information. The report exemplifies how this can also support the use of certain pre-grant flexibilities to increase the space for local generic companies and facilitate local production. In this context, the questions of whether and how to examine patents are essential. Where countries decide to provide for substantive examination, they need to pay particular attention to what standards need to be followed to ensure implementation of pre-grant flexibilities in practice. Favourable interpretation of various provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to support local industry is important: simply writing flexibilities into legislation will not achieve their intended impact without a good understanding by local producers of patent laws and patent systems. Competent intellectual property professionals and a transparent, fair and efficient court system also need to be in place to allow such policies to flourish.
The existence of a patent does not mean local production is not possible. This report provides practical examples showing multiple ways that allowed for local production through cooperation and/or the use of TRIPS flexibilities. Collaboration by patent holders has increased over the past years. Licensing has become common in the area of HIV/AIDS, and we have also seen cooperation in the area of hepatitis C. In this context, implementing pre- and post-grant flexibilities and using them strengthens the negotiating position of local companies when they endeavour to enter into licensing and technology transfer deals.
This report provides patent information on a number of medicines to show that it is a simplification to describe a medicine as “under patent”. Patents are granted for national or regional jurisdictions, and the complete landscape often reveals countries where patents have not been filed or granted and thus where local production could take place if the technical problems associated with the production of affordable good-quality medicines can be overcome.
Local production depends on many conditions; the intellectual property environment is only one of these conditions and in itself will not be decisive. The mere absence of a patent in a country will not lead to local production of a medicine or ensure access to that medicine. The intellectual property system can, however, be used and designed to favour local pharmaceutical innovation and manufacturing. Local production does not necessarily lead to improved access and health outcomes, which require good-quality essential medicines to be produced and marketed at affordable prices.
