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EUROPEAN UNION

The European Union (EU) will remain on the Priority Watch List because it has not demonstrated any willingness to address certain IP-related concerns in a sufficient manner, despite encouragement by the United States including through the U.S.-EU Trans Atlantic Economic Partnership. At the conclusion of the 1999 Special 301 review, the United States initiated a WTO dispute settlement case against the EU, based on the apparent TRIPS deficiencies in EU Regulation 2081/92 ("GI Regulation"), which governs the protection of geographical indications (GIs) for agricultural products and foodstuffs in the EU. The regulation appears to discriminate against non-EC nationals and products, thereby violating WTO obligations to provide national treatment and most-favored-nation treatment. Further, the GI Regulation appears to deny trademark rights to owners of registered trademarks, rights that the EC is obliged to provide under the TRIPS Agreement. Despite over four years of consultations since June 1999, we were unable to resolve this matter, and so, in August 2003, we requested the establishment of a WTO dispute settlement panel to review the consistency of the EC's GI Regulation with WTO rules. That proceeding is on-going. In addition, lack of full implementation of the EU Biotechnology Directive, which obligates EU Member States to reform national laws and practices to affirmatively provide patent protection for a broad range of biotechnology inventions, by several EU member states continues to be a concern.

INDIA

While India has improved its IPR regime, protection of intellectual property in some areas remains weak due to inadequate laws and ineffective enforcement. India's 2002 patent law amendments (which became effective in May 2003) exempt subject matter such as biotechnological inventions, methods for agriculture and horticulture; processes for the treatment of humans, animals, or plants, and substances prepared by chemical processes from patent protection. Under the TRIPS Agreement, India has until January 1, 2005 to provide product patent protection, including for pharmaceuticals and agricultural chemicals. While the United States is encouraged by the Indian Government's recent statements concerning implementation of data exclusivity regulations, India has yet to implement the TRIPS obligation to protect confidential test data submitted by innovative pharmaceutical companies for market approval. India's Copyright Act has three overly broad exceptions, which together weaken protection of software. India is also in the process of revising its copyright law to implement the WIPO Internet treaties; we expect India to fully implement its obligations in this regard. Protection of foreign trademarks remains difficult due to procedural barriers and delays. Trademark owners must prove they have used their mark to avoid a counterclaim for registration cancellation due to non-use. Such proof can be difficult, given India's policy of discouraging foreign trademark use. Companies denied the right to import and sell products in India often are unable to demonstrate use of registered trademarks through local sale.

Piracy of copyrighted materials (particularly software, films, popular fiction and certain textbooks) remains a problem for U.S. and Indian rightholders. India has not adopted an optical disc law to deal with optical media piracy. Cable television piracy continues to be a significant problem, with estimates of tens of thousands of illegal systems in operation. The United States also has serious concerns about high levels of counterfeiting, particularly for medicines and auto parts. India's criminal IPR enforcement regime remains weak, and India needs sustained, centralized, coordinated enforcement of intellectual property rights, especially trademarks and copyrights. Its court system is extremely slow, and there are only a few reported convictions for copyright infringements resulting from raids. Industry reports significant weaknesses in India's border protection against counterfeit and pirated goods. India also needs to address the high volume of exports of domestically produced counterfeit goods.

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