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

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


BioPharm International


CONCLUSION

Strong US patent laws have long fueled innovation in the biopharmaceutical industry and have helped establish US biopharmaceutical companies as leaders in the world. In today's increasingly global markets, innovation and the development of new, cutting-edge, life-saving medicines will depend on better international harmonization of patent laws and more effective protection for biopharmaceutical products, not just in the United States but also in foreign markets. Ultimately, patients and consumers all over the world stand to benefit from laws that create incentives for biopharmaceutical research and for innovation through higher patent standards. As the importance of markets such as China and India for US biopharmaceutical companies continues to rise, many US companies will take on the challenge of entering those markets, bringing newer and better medicines to patients. Much progress has been made toward better market conditions through implementation of the TRIPS agreement and other patent standards, creating some promise for more stable operating environments. However, achieving strong patent protections at a standard comparable to those existent in the United States will require continued efforts by both the US government and industry. Until those protections are achieved, the biopharmaceutical industry must stay abreast of developments and challenges, and should actively work with the US government to find innovative solutions to the challenge of balancing access to medicines with adequate and effective patent protection.

Paul Sharer, J.D., is a partner specializing in biotechnology and pharmaceutical patents issues within the Intellectual Property Group at Mayer, Brown, Rowe & Maw LLP, 1909 K Street NW, Washington, DC 20006, 202.263.3340, fax 202.263.5340,

Martina Simpkins, LL.M., is a senior international legal advisor in the Government and Global Trade Group at Mayer, Brown, Rowe & Maw LLP, 1909 K Street NW, Washington, DC 20006, 202.263.3323, fax 202.263.5340,

REFERENCES

1. The text of the TRIPS agreement is available at http:// http://www.wto.org/english/docs_e/legal_e/27-trips.pdf.

2. The concept of exhaustion of intellectual property rights influences the extent to which the distribution of goods can be controlled by the owner of a patent or other intellectual property right. Under the exhaustion concept, once the holder of an intellectual property right has sold a product, the holder cannot prohibit the subsequent sale of that product; the intellectual property right has been "exhausted." While the US legal system assumes that exhaustion occurs on a national basis (ie, the intellectual property right is exhausted only in the country where the product was sold), this issue has been very controversial in the international community. A system of regional exhaustion is currently in place in the European Union, where a sale in any member state leads to an exhaustion of the intellectual property right in all EU member states. Others have even advocated a regime of international exhaustion, in which a legitimate sale in any country would lead to exhaustion of the intellectual property right worldwide, leaving the holder of the right unable to control the global distribution of its product after the first sale. See also International Chamber of Commerce Commission on Intellectual and Industrial Property, Policy Statement: Exhaustion of Intellectual Property Rights, January 7, 2000, available at http:// http://www.iccwbo.org .

3. The text of the declaration is available at http:// http://www.wto.org/english/thewto_e/min01_e/mindecl_trips_e.htm.

4. The General Council Chairman's statement is available at http:// http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm.

5. The text of the relevant intellectual property chapter and side-letters is available at http:// http://www.ustr.gov/Trade_Sectors/Intellectual_Property/IP_Chapters_in_FTAs/Section_Index.html.

6. In a recent development, Brazil and India have joined forces to oppose the US position on the relationship among the TRIPS agreement, the Convention on Biodiversity, and the protection of traditional knowledge. While the US opposes proposals for new disclosure requirements that could add uncertainties to patent protections, Brazil and India have advocated such requirements.

7. PhRMA, Submission pursuant to Request for Public Comment: Identification of Countries Under Section 182 of the Trade Act of 1974, 70 Fed. Reg. No. 1, dated February 11, 2005.


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