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

TRIPS allows for three important exceptions to the rule of patentability: (1) TRIPS excludes inventions contrary to ordre public or morality, (2) TRIPS excludes diagnostic, therapeutic, and surgical methods for the treatment of humans and animals, and (3) TRIPS members may exclude plants and animals other than microorganisms, as well as essentially biological processes for the production of plants, other than non-biological and microbiological processes. If members decide to exempt plant varieties from patentability, they must provide an alternative effective system of protection. The exclusive patent product rights conferred by TRIPS include the rights to make, use, offer for sale, sell, and import the product. Process patent rights must give exclusive rights not only over the process but over products obtained directly by the process. Patent owners may also assign patent rights and conclude licensing contracts. The term of protection for patents is 20 years, originating from the filing date.

With respect to the limitations of patent rights, TRIPS allows member states to provide for limited exceptions to the exclusive rights conferred by a patent, provided these do not unreasonably conflict with the normal exploitation of the patent or prejudice the interests of the patent owner. In addition, the TRIPS agreement does allow for compulsory licensing and government use without authorization of the patent holder, subject to certain conditions listed in Article 31. The extent to which compulsory licensing of life-saving patented medicines is permitted and considered acceptable under Article 31 of the TRIPS agreement has been the subject of much controversy among WTO members. The TRIPS agreement further contains general principles regarding the procedure to enforce intellectual property rights, including provisions on civil and administrative procedures and remedies. Disputes among WTO members with respect to their obligations under the agreement are subject to the WTO dispute-settlement procedures.

TRIPS Controversy: Access to Medicines

Striking the right balance between protecting patents and providing patients in developing countries with access to life-saving medicines has been a great challenge in the face of the worldwide AIDS pandemic and other devastating diseases such as malaria and tuberculosis. Biopharmaceutical companies are at the center of this debate. As global trade negotiations increasingly focused on the relationship between trade and development, the issue of providing access to medicines through the use of compulsory licensing came to the forefront at the 2001 WTO Ministerial Meeting in Doha, Qatar, where WTO members adopted the "Declaration on the TRIPS Agreement and Public Health."3 This declaration recognized the right of member states to grant compulsory licenses in cases of national emergency, or other circumstances of extreme urgency, such as public health crises relating to HIV/AIDS, malaria, tuberculosis, and similar pandemics.

One major issue not addressed by the declaration was that many developing and least-developed countries lack sufficient biopharmaceutical manufacturing facilities to produce drugs based on a compulsory license granted in the nation where the public health crisis occurs. It is, therefore, unclear whether countries with sufficient manufacturing capacity — and nations with strong generic drug industries, such as India and Brazil — could provide patented, life-saving medicines to poor nations without violating the TRIPS agreement. An interim agreement was reached prior to the 2003 WTO Ministerial Meeting in Cancun, Mexico, allowing WTO members to export pharmaceutical products made under compulsory licenses to certain criteria. At the request of the US and other western governments, this decision was accompanied by an oral statement from the WTO General Council Chairman emphasizing that the decision would be used in good faith, would be used only to deal with public health problems, and would not be used for industrial or commercial policy objectives.4 The format of this agreement, specifically the decision in combination with an oral statement, was the result of intense negotiations between the US government and other WTO members. The US government made it clear that it could accept the decision only in conjunction with the Chairman's statement. While this solution had seemed to lay the issue to rest at the time, it subsequently resulted in renewed controversy, leading up to the December 2005 WTO Ministerial Meeting in Hong Kong. Member states are currently negotiating whether the 2003 decision should be included in the TRIPS agreement. The US government has urged that the Chairman's oral statement also become part of TRIPS, while developing nations such as Brazil have strongly opposed that option.

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