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TRIPS compliance, what does it mean?
Possible talking point regarding clarification of USG position on TRIPS
compliance
1. The USA should admit that parallel imports do not violate the TRIPS
agreement, and that countries have the right to make national policy on
the issue of exhaustion of patent, copyright and trademark rights. The
USA should further admit that US patent law does not bar parallel
imports, and that US restrictions of parallel imports of pharmaceutical
drugs are based upon regulatory policy, not intellectual property
rights. Therefore, the US government should immediately stop
interfering with South African efforts to permit parallel imports of
pharmaceutical drugs.
2. With respect to compulsory licensing, the USG should state in clear
language its understanding of country obligations under the TRIPS. This
explanation should a good faith representation of the international law
as it is, rather than what PhRMA wants the law to be. Furthermore, the
USG statement on TRIPS and compulsory licensing should also address US
laws on compulsory licensing, including, for example, the Clean Air Act
(42 USC 7608), our laws on licensing atomic energy patents (42 USC
2183), public health purposes compulsory licensing under the Bayh-Dole
Act (35 USC 203), US government use (28 USC 1498), and the authority of
state governments to use patents under recent US Supreme Court decisions
(College Savings Bank V. Florida Prepaid Postsecondary Ed. Expense Bd.
98-149, and Florida Prepaid Postsecondary Ed.
Expense Bd. V. College Savings Bank 98-531). Is the USG asking South
Africa to abide by higher standards than exist in the USA? Also, if the
US government raises the issue of discrimination under Article 27.1 of
the TRIPS, please explain how this position is consistent with the US
Hatch/Waxman Act provisions on pharmaceutical patent extensions and
pharmaceutical research exemptions.
Jamie
--
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org