On September 10, the 8th round of negotiations for the Trans-Pacific Partnership Trade Agreement (TPPA) – a controversial pact between the United States and eight countries in the Asia-Pacific region – will be taking place in Chicago. The meeting will include trade representatives from the U.S., Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam – and other stakeholders such as corporations with global interests.
The negotiations will consider inclusion of pre-grant opposition procedures, a process which allows interested parties to submit information to the patent examiner before deciding whether or not to approve a drug firm’s application for a patent. Global health advocates argue that the process facilitates increased access to affordable medicines in resource-poor countries, by allowing generic competition for drugs to treat diseases such as HIV and tuberculosis, among many others. In early 2011 India rejected a drug patent application for the Liponavir/Ritonavir drug combination – a second-line HIV therapy – allowing Indian generic drug manufacturers to provide the combo at a much lower price to those in need – a decision applauded by health advocates around the world.
“The TPPA is undermining access to affordable medicine,” said Matt Kavanagh, director of U.S. advocacy at Health Global Access Project (Health GAP), during a press briefing on the TPPA with experts who gathered for the Global Congress on Intellectual Property and the Public Interest last week in Washington, DC. Kavanagh said expanded intellectual property barriers to affordable medicines would limit AIDS and disease treatment in many countries. “We are finding it especially shocking that Obama is violating promises he made as a presidential candidate to break the stranglehold that a few big companies have on these lifesaving drugs – sadly we see the opposite happening in the TPPA negotiations right now.”
“Pre-grant opposition procedures that permit broad participation allow any person, including researchers, NGOs, health organizations, and market competitors to oppose a patent application by submitting information and analysis to patent examiners, under an adversarial administrative process,” according to an analysis of eliminating patent pre-grant opposition put out by Public Citizen, Health GAP, the Third World Network, and the Initiative for Medicines, Access and Knowledge (I-MAK).
Prior to TPPA negotiations held earlier in the year, a U.S. paper sent to the other TPPA countries was leaked that outlines the potential negative impacts of pre-grant negotiations and asks questions of countries with such policies currently in place. In an emailed comment to Science Speaks consistent with that paper, a spokesperson from the office of the U.S. Trade Representative wrote, “A lengthy or onerous formal pre-grant patent opposition system can place undue burdens on patent applicants and create additional costs for patent offices, thereby causing uncertainty and deterring innovators and enterprises that would otherwise bring innovative products and services to market. It is important to distinguish between pre-grant and post-grant review processes. As the Federal Trade Commission pointed out in a 2003 report, post-grant review ‘offers greater value to challengers’ than alternative processes, ‘with less opportunity for delay and harassment than pre-grant opposition.’”
The analysis of the leaked document by civil society organizations discounts these claims, stating it fails to take into account the fact that substandard patent applications are currently a persistent problem; that pre-grant opposition actually increases certainty for business decisions for both the innovator and generic companies by settling contested patent claims earlier in the process and therefore less expensively; and that frivolous and weak patent applications place undue administrative burdens on patent offices.
Earlier this month, a group of ten members of Congress wrote a letter to U.S. Trade Representative Ron Kirk expressing concerns about the negotiations taking place – and the importance of promoting trade policies that improve access to affordable medicines, especially in low-resource countries.
According to a Chicago Sun-Times blog post, thousands of demonstrators who are opposed to the TPPA as it stands are expected to protest in Chicago during the negotiation, starting with a rally in Grant Park on September 5. In addition to access to medicine, civil society groups will be speaking out on how the TPPA will impact labor rights, the environment, financial regulations and other social and economic justice issues.