[Ip-health] IUT: U.S. Generic Drug Industry Wants TPP To Include May 10 Standards

Peter Maybarduk pmaybarduk at citizen.org
Fri Mar 25 07:22:31 PDT 2011

Inside U.S. Trade - 03/25/2011 
U.S. Generic Drug Industry Wants TPP To Include May 10 Standards 
Posted: March 24, 2011 

The Generic Pharmaceutical Association (GPhA) last week pushed the Office of the U.S. Trade Representative to include intellectual property provisions found in the U.S.-Peru free trade agreement that limited patent protections for brand name pharmaceuticals in a final Trans-Pacific Partnership (TPP) deal.
In a March 18 letter to Assistant USTR for Intellectual Property Stan McCoy, GPhA argued that it is "essential" that USTR bases any patent provisions on the so-called May 10 agreement, which changed patent provisions in trade deals with Peru, Panama, and Colombia in ways opposed by the U.S. pharmaceutical industry.
USTR has yet to determine how it will approach these three issues in its IPR proposal for TPP. A leaked copy of the U.S. draft text, which was tabled earlier this year, has placeholders for these controversial patent issues.
GPhA argues in its letter that failure to adopt these May 10 standards in the TPP will cause harm to the generic pharmaceutical industry because it will take longer for generic companies to be able to develop and market generic versions of brand name drugs.
For example, the May 10 agreement made the granting of patent term extensions optional, whereas the U.S.-Peru FTA originally made the granting of such extensions mandatory. These extensions are meant to compensate for delays in a country's drug agency approval process.
The May 10 agreement also makes it optional for countries to pursue a patent linkage system. Such a system would require government regulators to investigate and confirm that a generic drug seeking marketing approval does not infringe an existing patent claim.
Public health advocates argue that patent linkage is unreasonable for a developing country, which might not have the resources to investigate patent infringement prior to the manufacture of generic drugs. Making these measures mandatory would have the effect of hurting U.S. exports of generic drugs and U.S. jobs in that sector as well as delaying access to cheaper medicines, the letter argues.
Despite this appeal, USTR has signaled to stakeholders that it is open to more stringent patent protections found in the Korea FTA (Inside U.S. Trade, Feb. 11).


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