2012: NIH case: exclusive rights in regulatory test data are absolute, even where there are drug shortages

In August 2, 2010, the National Institutes of Health (NIH) was asked to grant an open license to permit manufacture of Fabrazyme, a drug used to treat Fabry disease (more on the march-in case here: http://www.keionline.org/fabrazyme). On December 1, 2010, Francis S. Collins, Director of the NIH issued a determination in the case, rejecting the petition for the NIH to exercise its march-in rights, citing as support for the denial that granting march-in rights would not overcome other barriers, including the exclusive rights in test data.

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DG-Enterprise – data exclusivity prevents access to life saving drugs (in the EU), even in an emergency situation

On February 20, 2006, Martin Terberger, the Head of Unit for Pharmaceuticals in the European Commission Directorate-General for Enterprise and Industry, wrote to Greg Perry of the European Generic medicines Association (EGA). The letter was a follow-up to an inquiry from the EGA regarding “the question of data exclusivity under the European pharmaceutical legislation,” in cases where a government overrode the exclusive rights of a patent and granted a compulsory license, and/or in a case of a medical emergency.

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AIDS 2012: Former President Clinton and House Minority Leader Nancy Pelosi Speak at Closing Ceremony

The XIX International AIDS Conference, which saw over 24,000 participants, came to a close on Friday, July 27, 2012. A number of people living with HIV/AIDS, activists, the immediate past president and current president of the International AIDS Society (and 2008 Nobel Prize Winner in Medicine), House Minority Leader Nancy Pelosi (D-CA), and former President Bill Clinton were among the speakers.

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AIDS 2012: US Congress and the Global AIDS Epidemic

At the International AIDS Conference 2012, on July 25, 2012, former Senator Frist (R-TN) moderated a panel of four members of Congress on “The U.S. Congress and the Global AIDS Epidemic.” The four members of Congress included Congresswoman Barbara Lee (D-CA), Senator Marco Rubio (R-FL), Senator Chris Coons (D-DE) and Senator Mike Enzi (R-WY).

From left to right: Congresswoman Lee, Senator Rubio, former Senator Frist, Senator Coons and Senator Enzi

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KEI comment on SCCR 24

The final conclusions of SCCR 24 are available here.

I’m going to spend some time adding to this, but to have something out quick, here are few thoughts.

1. Disabilities.

The Good: sets the stage for diplomatic conference in 2013, which is now highly likely.
The Bad: Lots of brackets in the text, and EU bent on making the agreement unworkable, and the US and EU hold off on the “nature of the instrument” is a treaty discussion.

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SCCR24: India on Contribution of the SCCR to the implementation of the respective Development Agenda recommendations

INDIA: Thank you, Mr. Chairman. Indian Delegation joins the distinguished Delegations of Iran, Egypt, South Africa in supporting the statement by the Distinguished Delegate and leader of the Development Agenda Group, the Brazil Indian Delegate. The Development Agenda recommendations and goals have achieved recent success in the Beijing spirit when we included the paragraphs, the preamble of the new treaty. And from there we have been listing — participating in the norm setting activities, in the limitations and exceptions.

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Last day of SCCR 24 regarding education and research exceptions

Last day of SCCR 24 regarding education and research exceptions (or topic 3 for the WIPO Secretariat)

There are many issues including: the structure of the proposed working document and its title, will it include comments or only textual proposals? is it a stand alone document? or is it linked to other proposals? and how it will be adressed/mentioned/continued in the forthcoming conclusions of the SCCR. All delegations seem to agree that the proposed document on education and research is not quite ready. More after informals.

In their own words:
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