TPP: Waxman letter to USTR opposing 12 year term of biologics exclusivity

In a 6 December 2013 letter, Representative Henry Waxman wrote to USTR Ambassador Michael Froman opposing USTR’s proposal of a term of 12 years of exclusivity for biologics in the Trans Pacific Partnership (TPP). The letter notes,

[w]hile I have worked closely with Senator Hatch on important health issues, including the generic drug law that we co-authored in 1984, I strongly disagreed that the United States should be proposing twelve years of exclusivity.

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Areas where USTR has shown some flexibility on the TPP IPR Chapter

USTR recently asked KEI if there were areas in the IP Chapter where we approved of the positions taken by USTR, and the answer is, yes. Given how critical we have been about the text, I will mention a few here.

USTR now “supports a more flexible approach under which partners could retain reasonable patent pre-grant opposition procedures.” This is welcome, and useful.

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Vatican criticizes Trans Pacific Partnership: Holy See statement to 9th WTO Ministerial Conference in Bali

The 9th Ministerial Conference of the World Trade Organization (WTO) is taking place in Bali, Indonesia from 3-6 December 2013. At the Ministerial, H.E. Archbishop, Silvano M. Tomasi, Apostolic Nuncio, Permanent Observer of the Holy See to the United Nations and Other International Organizations in Geneva delivered a withering critique of the Trans Pacific Partnership and the Transatlantic Trade and Investment Partnership. Continue Reading

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Rich, and not rich, in the TPP, as regards certain IPR obligations involving medical technologies

On November 28, 2013, I wrote a blog about the problems in using the World Bank’s definition of high income, in the specifc context of a proposal by the United States to use this as a measure of which countries in the TPP should have lower standards for intellectual property rights on medical inventions. (See: https://www.keionline.org/node/1834).

Here a different metric is presented, based upon relative incomes, benchmarked against the five highest income countries in the TPP with a population of more than 1 million persons.

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2009: Sign-on Letter – Against life + 70 year copyright term in the TPP

This is sign-on letter — Against life + 70 year copyright term in the TPP. See end of letter for details on how to sign.

<-------------------begin letter----------- December 9, 2013 Dear TPP negotiators, In a December 7-10 meeting in Singapore you will be asked to endorse a binding obligation to grant copyright protection for 70 years after the death of an author. We urge you to reject the life + 70 year term for copyright. Continue Reading

TPP: Senator Hatch to USTR, 12 years of IPR for Biologics test data, no restrictions on cross border data flows

In a December 2, 2013 letter, Senator Orrin Hatch wrote to USTR’s Michael Froman, suggesting TPP exclude any countries that do not meet “high levels of ambition.” According to Hatch, these high ambitions include agreeing to 12 years of exclusive rights for IPR in biologic drug test data, and the elimination of barriers to cross border data flows (a privacy issue). A copy of the Hatch letter is attached below.

The timing of the Hatch letter is designed to pressure countries meeting in Singapore on December 7-10 in the TPP negotiation, on these two contentious issues.

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The World Bank definition of “high income” has slipped, in relative terms, compared to high income countries in general

The United States has proposed that some (but no means all) IPR obligations involving medicines be modified for countries with incomes below the amount the World Bank defines as “high.” The threshold to be considered a high income country was $12,616 in per capita income for 2012, and is adjusted every year. In contrast, the US per capita income was $50,124 in 2012. (More data here)

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