Transcript Using FTA Side Letters and Congressional Letters to

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
[email protected]
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 patentregistration 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, followon 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.