Before the Uruguay Round and TRIPS, pharmaceutical patents and other intellectual property rights on drugs were widely recognized among major industrialized countries, but not in many developing countries. As there were no international standards on the scope of patent protection, countries had very different regulations on IP protection according to their own needs. In the pharmaceutical sector, some 40 countries did not provide patent protection for pharmaceutical products. Patents were simply not available for pharmaceutical inventions in these countries, which implied that no one could claim an intellectual property right on such products. As a result, copies of medicines protected by a patent in other countries were widely available, usually at a lower price than the original patented drug. The copies were either manufactured by local companies or imported, without having to ask the patent holders' permission. This practice is now coming to an end. Copies of patented drugs will remain on the market but it will no longer be possible to manufacture and market copies of new patented medicines in those 40 countries, unless the original manufacturer has chosen not to seek any patent protection there.
Under the TRIPS Agreement, all WTO Members have to make patents available for pharmaceutical inventions in their countries1. A company that has invented a new pharmaceutical product or process has, since 1 January 1995, been able to apply for at least a 20-year patent protection in any WTO Member country. The inclusion of pharmaceutical patents in the new WTO/GATT rules has the potential to exacerbate the problem of access to drugs in developing countries, by limiting or even disabling direct competition (generics) to new medicines until the relevant patents expire (unless licences are granted).
1Taking into account the transitional periods allowed to developing and least-developed countries by the TRIPS Agreement.