Using FTA Side Letters and Congressional Letters to Authorize Waiver of Data Exclusivity and Linkage Professor Brook K. Baker Northeastern U. School of Law Program on Human Rights and the Global Economy Health GAP (Global Access Project) CPTech - Next Steps and Strategies on Bilateral Free Trade Agreements Nov. 16, 2006

First and Foremost: Avoid TRIPS-plus FTAs Avoiding TRIPS-plus text in FTAs is far superior to trying to mitigate its impact after-the-fact.

Option Two: Easing the Pain Seek to limit the dangers of data exclusivity and linkage: –Definition new chemical entity –Use-it-or-lose-it clauses –No extra 3 years for new uses/formulations Seek to clarify and move Doha-flexibility assurances from side letters to footnotes and text.

Using the TPA Bipartisan Trade Promotion Authority Act of 2002, § 2101(b)(4): “The principal negotiating objectives of the United States regarding trade-related intellectual property are: (C) to respect the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial conference at Doha, Qatar on November 14, 2001.”

Using the Side Letters Understanding Regarding Certain Public Health Measures: –“The obligations of the [Patent Chapter] of the Agreement do not affect a party’s ability to take necessary measures to protect public health by promoting access to medicines for all, in particular concerning cases such as* HIV/AIDS, tuberculosis, malaria, and other epidemic as well as circumstances of extreme urgency or national emergency.” –“[The Patent Chapter] does not prevent the effective utilization of the [Aug. 30] TRIPS/health solution.” –“[T]he references [in this Understanding] include [the Article] ‘Measures Related to Certain Regulated Products.”

Plain Meaning On its face, the Side Letter permits FTA parties –to promote access to medicines for a non-exclusive list of conditions –to utilize, among other measures, the TRIPS/health solution, which permits importation of a medicine whether or not it is patent protected in the importing country, and –to interpret the data exclusivity and patent- registration linkage terms so as to promote access to medicines and to utilize TRIPS-compliant flexibilities.

Using the USTR Letter to Congressman Levin, July 19, 2004 “If circumstances ever arise in which a drug is produced under a compulsory license, and it is necessary to approve that drug to protect public health or effectively utilize the TRIPS/health solution, the data protection provisions in the FTA would not stand in the way.” Page 5. If a circumstance arose [concerning a non-patented product], such as an epidemic or national emergency, that could only be addressing by granting a second entrant marketing approval notwithstanding the data protection rights of the originator of the data, the FTYA would not stand in the way.” Page 6.

Plain Meaning Data protection provisions in the FTA, including data exclusivity and linkage, will not stand in way of registering a follow-on drug where it is necessary to approve the drug to protect public health. Note: even though the USTR has on occasion referenced the right of the generic company to conduct its own clinical trials, such trials are unethical under national and international standards.

Implication for Existing US FTA Parties There is clear legislative, side letter, and Congressional correspondence authority for clarifying by means of legislation, regulations, or regulatory practice, that –A compulsory license grants an automatic waiver of data exclusivity and linkage –A right of reference must be granted for a non-patented product where that product need be registered in order to protect public health

Testing the FTA Doha Flexibilities Even though FTA Parties face pressure from the U.S. in the implementation/ certification phase, Parties are free to and should authorize exceptions to improvidently granted data exclusivity and linkage provisions. Alternatively, as administrative practice when issuing compulsory licenses, Parties should clarify that D.E. and linkage are waived. Likewise, by administrative practice, they should register non-patent-infringing, follow- on drugs to meet public health needs.

Conclusion Negotiating TRIPS-plus data exclusivity and linkage is a very bad idea. The ambiguities, omissions, and weak authority of the Side Letters are highly undesirable. Nonetheless, there is ample authority to permit waiver of data exclusivity and linkage so as to permit registration of follow-on products via reliance on previously filed data or on the fact of prior registration.