All national patent laws contain exceptions to the exclusive rights granted by a patent, with the content and scope of those exceptions varying widely. Some exceptions are particularly relevant for the health area.
All of the exceptions considered below are recognized in some fashion in many developed countries. Outright exceptions to the exclusive rights of a patent (which operate without the need of a specific authorization by a court or administrator, and in favour of any third party) may be extremely important in fostering innovation, promoting the diffusion of technologies, or facilitating access at the lowest possible prices to health-related goods.
Article 30 of the TRIPs Agreement treats the exceptions issue only in general terms119 and leaves WTO Member states with considerable freedom to define the nature and extent of exceptions to the exclusive rights of patent owners. Comparative law reveals different types of exceptions that may be provided for within the scope of Article 30. However, national practice is not a blank cheque, and any particular exception may be challenged before WTO tribunals.
119 Exceptions to exclusive patent rights must meet three conditions: they should be limited, not unreasonably conflict with the normal exploitation of the patent, and not unreasonably prejudice the legitimate interests of the patent owner. These conditions are to be applied taking into account the legitimate interests of third parties.
Conversely, the boundaries of Article 30 may be affected by new state practice which may result from the wholesale adoption of certain practices by many developing countries or their regional organizations. Such a strategy would not save any given practice that constituted a clear violation of the TRIPs Agreement, but it might produce a differential approach in any judicial review where the violation was not clear.