International Patents and International Harmonization - Protection of intellectual property rights plays a key role in bilateral trade negotiations among international partners. - BioPharm


International Patents and International Harmonization
Protection of intellectual property rights plays a key role in bilateral trade negotiations among international partners.

BioPharm International

Overall, the problem of how developing and least-developed nations can provide their populations with appropriate access to life-saving patented medicines and biopharmaceutical products without undermining effective patent protection has still not been entirely resolved. Despite tough negotiations at the WTO level, little or no use has been made of the flexibilities in the TRIPS agreement that allow for compulsory licenses. Innovative biopharmaceutical companies have made various efforts to donate patented medicines to patients in developing nations while advocating the retention of intellectual property protections that are crucial to future innovation. At the same time, the global AIDS pandemic and the spread of other serious diseases have not slowed. The issue will likely continue to be at the forefront of any discussion regarding the TRIPS agreement and international biopharmaceutical patents.

Bilateral and Regional Trade Agreements

The protection of intellectual property rights has also played a key role in bilateral trade negotiations between the US government and its trading partners. The US government has consistently used bilateral and regional negotiations to improve intellectual property standards worldwide, and has pursued a policy of ensuring that bilateral trade agreements contain strong and effective patent protections. Patents for biopharmaceutical products are often at the center of these negotiations.

The North American Free Trade Agreement (NAFTA) provides strong intellectual property protections in its Chapter 17. In recent years, the US has also concluded bilateral free trade agreements (FTAs) containing strong intellectual property protections with Australia, Chile, Jordan, Morocco, and Singapore. An agreement with five Central American nations and the Dominican Republic has been signed and is awaiting implementation by the US Congress. The intellectual property chapters of these FTAs often provide for higher levels of protection in areas already covered by the TRIPS agreement. In a recent FTA with Australia, for example, the US government sought even better protection for biopharmaceutical patents, in particular with respect to non-tariff trade barriers such as Australia's Pharmaceutical Benefits Scheme.5

The US government is seeking similar high-level intellectual property protections in ongoing bilateral negotiations with Bahrain, Panama, and the five members of the South African Customs Union, and in additional negotiations with Andean nations and Thailand. Intellectual property protections are also key discussion points in negotiations toward a Free Trade Area of the Americas that would encompass all nations in North and South America, as well as in the Asia Pacific Economic Forum that includes 21 Pacific Rim countries. Bilateral, regional, and multilateral trade negotiations have, overall, been a key tool for the US government in its efforts to further strengthen and harmonize intellectual property protections for the biopharmaceutical industry worldwide.


In many countries around the world, certain problems are involved in implementing TRIPS-mandated standards into domestic law, and in enforcing existing domestic patent laws. Brazil, China, and India are all fast-growing economies with large markets and populations, and they have been of particular concern for research-based biopharmaceutical companies. These three countries also have substantial generic drug industries which are often able to exert a significant influence on commercial and industrial policy. In addition, Brazil and India have established themselves as leaders of a coalition of developing nations, often opposing US positions on stronger patent standards and enforcement.6


Some measures inconsistent with Brazil's obligations under TRIPS continue to be in effect. A 1999 amendment to Brazilian patent law gave the country's National Sanitary Supervision Agency (ANVISA) authority to review all patent applications for pharmaceuticals, and the agency has denied secondary-use patents to innovative companies despite approval from the Brazilian Patent Office. ANVISA's review authority has been a major factor in delaying patent applications. The agency's authority also discriminates against biopharmaceutical products, as other patented products are not subject to such reviews by regulatory authorities.

Another area of concern is Brazil's industrial property law that requires both domestic and simultaneous manufacture of every patent claim. Failure to adhere to this law can justify the issuance of a compulsory license. This requirement is in place despite TRIPS Article 27, which obligates member states to recognize that importing a product satisfies the requirement that a patent be "worked" in a member state. On a positive note, Brazil has not yet issued any compulsory licenses, although a relevant presidential decree governing the grant of compulsory licenses gives broad discretionary powers to government officials, and the Brazilian government has threatened the use of this decree in negotiations with the biopharmaceutical industry.

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