[Ip-health] KEI comments on inconsistencies between USTR proposal for the TPPA and current US law
krista.cox at keionline.org
Wed Aug 31 10:23:27 PDT 2011
Full paper available for download at: http://keionline.org/node/1216
KEI comments on inconsistencies between USTR proposal for the TPPA and
current US law
As KEI has discussed previously, USTR's proposal for the IP chapter  of
the Trans-Pacific Partnership Agreement (TPPA) raises numerous concerns for
human rights , access to medicines , and access to information, among
other issues. Not only would USTR's proposal greatly impact those living in
the countries of the TPPA negotiating partners--currently Australia, Brunei,
Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam--but many
provisions of its February 10, 2011 text would be inconsistent with U.S.
law, requiring changes to our domestic laws.
On Tuesday, KEI provided additional comments to USTR, several focusing on
the inconsistencies between the leaked USTR's proposal on IPR and existing
US legal norms and legislative proposals.
* USTR's proposal would give copyright holders the right to prohibit
importation of their works, effectively banning parallel importation despite
the fact that this is an unsettled area of US law.
* The provisions related to technological provision measures (TPM) would
create a separate cause of action for circumvention of a TPM from any
underlying copyright infringement.
* Civil remedies under the USTR proposal for violations of TPM provisions
goes beyond what is required under the DMCA
* Limitations and exceptions to the TPM provisions are potentially drawn
more narrowly and may make new exceptions more difficult to obtain
* USTR would require the granting and enforcement of surgical methods. In
the US, we do not enforce these patents against medical practitioners, and
the TRIPS permits its members to eliminate patents on "diagnostic,
therapeutic and surgical methods for the treatment of humans or animals."
* The USTR proposal requires patents be granted on "any new forms, uses, or
methods of using a known product" even where there is no enhancement of the
efficacy of the product. This is bad public policy, and would change US
legal norms for granting patents.
* The term for data protection for pharmaceutical products is an area that
is not well settled in the US. President Obama's 2012 budget proposal
requests seven years of protection for biologic products, while some members
of congress are pushing for twelve years of protection for biologic products
in the TPPA. USTR has not indicated if it will retain the flexibilities of
the May 10, 2007 agreement as regard test data protection.
* Depending on the manner in which the provisions are read, USTR potentially
ignores the large number of provisions in US law which eliminate the
possibility of injunctions, even in cases of infringement
* USTR's aggressive damage provisions provide for measures leading to higher
damages and fail to take into account the numerous limitations on damages
currently provided for by US law
* The provisions would presume attorney's fees in trademark cases, flipping
the current presumption
* Depending on the way USTR's proposal is read, the TPPA could limit the
ability of the US Government to import goods that are infringing
Enforcement in the Digital Environment:
* USTR would expand the definition of "service provider," thereby expanding
* The TPPA proposal fails to incorporate important privacy safeguards which
are contained in the DMCA
* Concerns exist regarding whether USTR's proposal may impact US drug
Areas Potentially Impeding Legislative Reform Efforts:
* The need to address the problem of orphan works is widely recognized and
the TPPA language fails to include limitations on damages for cases
involving orphan works
* We have concerns that USTR's proposal may limit reform in the area of data
protection for pharmaceutical products such as the bill introduced in 2010
that would eliminate exclusive rights on test data where such repetition
would violate medical ethics
Considering the large number of inconsistencies between the US proposal for
the TPPA and current US law, USTR's decision to keep these texts secret is
inexcusable. We note that USTR proposed several provisions in ACTA that were
similarly inconsistent with US law and prompted Senator Wyden to request the
an analysis of these inconsistencies  from the Congressional Research
Service. KEI's April 2010 research note on ACTA and inconsistencies with US
law as they relate to injunctions and damages is available here . The
fact that many of these mistakes are replicated in the TPPA is highly
concerning and given the impact that the proposals, if accepted, will have
on our domestic law, we urge USTR to make these documents public.
As we have noted previously, the lack of access to information also quite
unequal as some corporate interests have special access to information about
the negotiations not made available to the general public. Industry
representatives who sit on Industry Trade Advisory Committees (ITAC) such as
the ITAC on Intelelctual Property Rights or ITAC on Chemical,
Pharmaceuticals, Health Science Products and Services, for example, are
heavily represented by large private trade associations and pharmaceutical
companies. This set up allows industry to have greater access to information
and shape the negotiating positions to conform to their private interests
while the general public is not afforded the same opportunities.
Our full paper analyzing these inconsistencies is attached below.
Knowledge Ecology International
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