The TRIPS Agreement introduced global minimum standards for protecting and enforcing nearly all forms of intellectual property rights, including those for pharmaceuticals. The Agreement’s 73 Articles cover basic principles, standards and use of patents, enforcement, dispute settlement and a range of other subjects. The key requirements for pharmaceuticals are described below and summarized in Box 2.
Members must provide patent protection for a minimum of 20 years from the filing date of a patent application, for any invention, including of a pharmaceutical product or process. The invention must fulfil the criteria of novelty, inventive step and usefulness (subject to certain exceptions - see Box 2).
TRIPS specifies the rights conferred on a patent owner, but allows for limited exceptions and compulsory licensing, subject to specified conditions. The Agreement also contains provisions on: protection of undisclosed information (including test data); actions to address anti-competitive practices; protection of trademarks (relevant to generic substitution and combating counterfeit drugs); and enforcement.
TRIPS provides transitional periods during which countries are required to bring their national legislation and practices into conformity with its provisions. The latest dates for WTO Members were/are: 1996 for developed countries; 2000 for developing countries (as a general rule); 2005 for developing countries who had not introduced patents before joining the WTO; and 2006 for least-developed countries.
TRIPS specifically recognizes the economic, financial, administrative and technological constraints of the least-developed countries. It therefore provides the possibility for further extension of the transitional period.