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29 November 2013Patents

US reveals changes in TPP drug policy

The US government has said it is now advocating a “differential” approach to policies on patenting drugs as part of continuing trade negotiations with Pacific countries.

Following talks with the 11 remaining parties under the Trans Pacific Partnership (TPP), the US is trying to “identify ways to tailor potential flexibilities based on countries’ existing laws and international obligations”.

The statement, released on November 27 by the Office of the US Trade Representative (USTR), comes a week after the 12 TPP parties, which also include Australia, Canada and Japan, met in Salt Lake City to try to make progress with the TPP.

Those talks followed Wikileaks’ release of a secret chapter on IP earlier this month. The document has provisions that will make it easier for pharmaceutical companies to obtain patents, including in developing countries; have such patents for more than 20 years; and increase their ability to limit access to scientific data necessary for others to develop new medicines.

Since the IP chapter’s release, the provisions on pharmaceutical products have provoked significant controversy among doctors groups such as Medicins Sans Frontières, with much of the anger vented at the US, seen as the lead negotiator.

Writing in the  Guardian, another critic, Mark Weisbrot, director of the US-based think-tank Centre for Economic and Policy Research, said the policies would have negative effects.

“All of these measures will help raise the price of medicines and health care, which will strain public health systems and price some people out of the market for important medicines,” he said.

It is unclear whether the US has changed tack in response to such criticism, but the USTR’s statement does say that the government has listened to “helpful, in-depth feedback from our TPP partners” on the ideas covering drug patents.

Explaining the new approach, the USTR said: “We believe the best approach to pharmaceutical IPR issues in the TPP would be one that offers countries flexibility based on their individual circumstances.

“This flexible approach is based on precedent: Previous US trade agreements covered by the May 10, 2007 bipartisan agreement. Under May 10, developing free trade agreement partners (like Peru) were offered greater flexibility relative to more developed trade agreement partners (like Korea). In TPP, we are seeking to pursue a similar idea, using previous agreements – like those with Peru, Australia, Chile, Korea, and Singapore – as benchmarks, but keeping an open mind as to how these standards can be tailored to reflect the situations of individual partners.”

From this statement, one can surmise that the US is proposing that wealthier countries in the TPP be required to join the standards of richer nations such as Australia, South Korea, and Singapore, and poorer countries with the likes of Peru, said Sean Flynn, associate director of the Washington College of Law, who was writing on the academic-run blog infojustice.org.

“The Peru agreement makes certain patent extensions optional and provides for more flexibility to override data exclusivity rules that can grant registration monopolies without a patent,” he said.

Other policy changes outlined by the USTR include new backing for opposition procedures that would be available before a patent is granted.

“Reflecting input from stakeholders,” the statement said, “the US now supports patent pre-grant opposition procedures. These procedures, available in some countries, allow third parties to formally object to a patent at the initial application phase.”

Flynn said that this position confirms the one taken against such opposition procedures in the leaked proposals and previously in 2011.

“Until now, the USTR had refused to confirm that it had offered those proposals in fact. But each of those texts showed that the USTR was taking a new position not included in any prior free trade agreement negotiation that would ban the US and other counties from instituting administrative procedures to allow interested parties to challenge patent applications before the patent was granted — so called pre-grant oppositions.”

The USTR also explained the government’s stance on patent protection for biologic medicines.

“In the TPP negotiations, opinions vary on the best term of patent protection for biologics.  Standards also vary across the TPP region. Some TPP countries currently have no data protection for biologic drugs. Some have 5 years. Others have 8. Traditionally, the US approach to trade negotiations has been to base proposals on existing US law, where the current standard is 12 years.”

As negotiations continue, South Korea is rumoured to be joining the talks.

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Copyright
14 November 2013   A highly secretive document outlining how a proposed trade agreement between nations in the Pacific region could affect IP rights has been made public.