Source: Inside U.S. Trade
6 Jan 2015
Access to anti-retroviral drugs used to treat HIV would be roughly cut in half in Vietnam if the provisions in the current U.S. proposal on intellectual property (IP) for pharmaceuticals were the basis for a final Trans-Pacific Partnership (TPP) agreement, according to an unpublished draft study by academics from Australia and the United States.
The study, presented at a November conference in Sydney and published on the Internet, based its analysis on the highest level of IP protection advocated by the U.S. in the TPP IP text published by Wikileaks in October 2014.
If Vietnam were required to take on these obligations, the study estimates its government would only be able to provide anti-retroviral therapy to 30 percent of people in Vietnam living with HIV, down from its current treatment rate of 68 percent.
That conclusion was based on the study’s finding that the cost per person per year of anti-retroviral drugs would increase to $501 under the U.S. proposal from its current level of $127.
The study described the highest standard of protection for pharmaceuticals as requiring: patents for new uses and methods of using existing drugs; five-year patent-term extensions for new pharmaceuticals products; and five years of data protection for new drugs, plus an additional three years for new indications.
Low-income countries like Vietnam would initially be allowed to adhere to a lower standard for an unspecified period of time before transitioning to the higher level envisioned for all TPP countries.
The study used the assumption that the U.S. would seek five years of patent-term extension even though the October 2014 IP text does not specify a time frame for such extensions and states in Article QQ.E.14 that each party may provide for “conditions and limitations in implementing the obligations” on patent-term extensions.
Article QQ.E.16.2 requires that countries falling under the higher tier of IP protection provide three additional years of data exclusivity for new uses and methods of an existing drug where the regulatory authority requires additional clinical trial data.
Hazel Moir, an associate professor at Australian National University and one of the study’s authors, said in an e-mail that the “primary immediate issue of concern” for anti-retroviral drugs is not patent term extensions or data exclusivity, but rather the requirement that countries make patents available for new uses and a footnote that would lower the bar for patentability to anything that is not obvious to an expert.
She noted that these obligations do not appear to be part of the U.S. two-tier proposal and would therefore apply immediately to all countries. “These central issues have been largely overlooked in recent debate,” she said.
The other authors of the study are Brigitte Tenni of the University of Melbourne, Deborah Gleeson of La Trobe University, and Ruth Lopert of George Washington University. The study, described by the authors as an “early draft,” was presented at the Nov. 27-29 Asia-Pacific Innovation Conference at the University of Technology, Sydney.
Inside U.S. Trade – 12/26/2014, Vol. 32, No. 51