Through the United States Trade Representative (USTR) and in close consultation with the biopharmaceutical industry, the US government has worked consistently for stronger and more harmonized international patent protections for innovative industries, both at the global level as well as in regional and bilateral negotiations with US trading partners. Various domestic trade laws are tools at the disposal of the US government to protect US patents from infringement. This article highlights the efforts in international patent harmonization and explores some of the ever-changing challenges that face the US biopharmaceutical industry.
MULTILATERAL AND BILATERAL TRADE AGREEMENTSWTO TRIPS Agreement: Overview
TRIPS attempts to strike a balance between the long-term objective of providing incentives for future inventions and creations, and the short-term objective of allowing people to use existing inventions and creations. The agreement covers a wide range of intellectual property rights, from copyrights and related rights, trademarks, integrated circuit designs, geographical indications, and trade secrets to patents. The preamble of the agreement lays out its general goals as reducing distortions and impediments to international trade, promoting effective and adequate protection of intellectual property rights, and ensuring that measures and procedures to enforce intellectual property rights do not themselves become barriers to international trade.
Certain general provisions of the agreement apply to all forms of intellectual property rights, from copyrights to patents. These include the fundamental rules of international trade on nationals, and on most-favored-nation treatment of foreign nationals, contained in Articles 3 and 4, respectively. The national-treatment clause generally forbids discrimination between a member's own nationals and the nationals of other TRIPS members, with respect to the protection and enforcement of intellectual property rights. The most-favored-nation clause forbids discrimination between nationals of other TRIPS members, thereby affording all foreign nationals operating in a member state the same level of protection. An additional important general provision, Article 6, makes it clear that exhaustion of intellectual property rights is outside the scope of the TRIPS agreement.2
The substantive patent provisions of the TRIPS agreement first and foremost require member countries to make patents available for any inventions, whether product or process, in all fields of technology, provided that the inventions are new, involve an inventive step, and are capable of industrial application. As stipulated in Article 27, patents must also be available without discrimination as to the place of invention, the field of technology, and whether products are imported or locally produced. This important core provision presented a major step forward in international patent protection for the pharmaceutical industry in particular, as many nations had excluded pharmaceuticals and biopharmaceuticals from all patent protection prior to binding themselves to the standards of the TRIPS agreement. Countries where patent protection for pharmaceuticals was only recently introduced as a result of the TRIPS agreement include Argentina, Brazil, Guatemala, India, Morocco, and Turkey.