Month: November 2012

It was a papal conclave save for the plume of white smoke. At 17h04 on Thursday, 15 November 2012, the board of the Global Fund to Fight AIDS, Tuberculosis and Malaria announced that Dr Mark Dybul would be the organization’s next Executive Director following a process marked by opacity and secrecy that would do the Vatican proud. Dybul (former United States Global AIDS Coordinator) beat a field of three other candidates that included, Monique Barbut (France), Robert Greenhill (Canada) and Barbara Stocking (United Kingdom of Great Britain and Northern Ireland). Continue Reading →

On 12 November 2012, Ecuador issued a compulsory license on abacavir/lamivudine. (attached here) This follows the issuance of Ecuador’s first compulsory license in 2009 on ritonavir/lopinavir. Continue Reading →

Earlier this year, in the case In re K-Dur, the Court of Appeals for the Third Circuit found that reverse settlement agreements, also known as “pay-for delay” arrangements, were prima facie evidence of anticompetitive behavior. The court noted that the presumption that such payments are unreasonable restraints of trade can be rebutted by a showing that the payment either offered a pro-competitive benefit or that the payment was for a purpose other than delayed entry into the market of generics. Continue Reading →

Mark Rohrbaugh has written to Krista Cox to acknowledge the October 25, 2012 march-in petition. According to Rohrbaugh, the petition has be delegated to NIH’s Office of Technology Transfer (OTT), and “NIH has begun to review the issues you have brought to our attention.” Rohrbaugh closes by saying “We expect to respond to your request by the end of the year.” Continue Reading →

On 7 November 2012, Brazil delivered the following intervention under agenda item M, “Intellectual Property and Innovation”.

Statement by Brazil. TRIPS Council.
“Intellectual Property and Innovation”.

Thank you Chairman,

When Brazil asked for an item on “Intellectual Property and Innovation” to be included in the agenda of this session of the TRIPS Council, together with the US delegation, its primary intention was to help set the stage for a debate, without prejudging any outcome whatsoever.

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On 6 November 2012, India delivered the following intervention under agenda item J, “Tenth Annual Review under Paragraph 2 of the Decision on the Implementation of Article 66.2 of the TRIPS Agreement”.

TENTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT

Intervention on Agenda item J: Art 66.2

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On 7 November 2012, India delivered the following intervention under agenda item M, “Intellectual Property and Innovation”.

We thank the delegations of Brazil and the United States for tabling an agenda item on “Intellectual Property and Innovation” which we understand is a standalone item.

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On 6 November 2012, the United States delivered the following intervention under agenda item F, “Review under Paragraph 8 of the Decision on the Implementation of Paragraph 8 of the Doha Declaration on the TRIPS Agreement and Public Health”.

F. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

• Thank you, Mr. Chairman, and the Secretariat, for the report on the status of notifications of acceptance of the 2005 Protocol Amending the TRIPS Agreement.

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On 7 November 2012, the United States of America delivered the following intervention under agenda item M, “Intellectual Property and Innovation”.

M. INTELLECTUAL PROPERTY AND INNOVATION

• Thank you, Mr. Chair.

• The United States is pleased to join with Brazil in sponsoring this item on the agenda.

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The US Food and Drug Administration (FDA) publishes the “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations” in both an annual paper bound edition and web-based searchable database (available here). As part of a larger effort to expand access to government data, the FDA provides monthly updates of the underlying data here.

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