Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules

Informed sources have revealed that Mark Dybul, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, is the brains behind an initiative to create global framework for the tiered pricing or in the Global Fund’s own words, “Equitable Access to Essential Medicines and Vaccines: Developing a Framework for Success”, enforced by the rules of the World Trade Organization. KEI has obtained this internal concept note prepared by the Global Fund which we understand is a work in progress.

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KEI Comments on Patient Assistance Programs as referenced in the 2014 Special 301 Review Hearing

Among the comments that KEI filed today in the 2014 Special 301 Review process were comments regarding pharmaceutical companies’ donation and patient assistance programs. An oft-cited claim by pharmaceutical companies and those lobbying on their behalf is that donations and patient assistance programs fully provide for those that cannot afford the high priced medications offered by the companies. Continue Reading

WIPO hosts Conference on Open Innovation: Collaborative Projects and the Future of Knowledge (22-23 January 2014)

The World Intellectual Property Organization (WIPO) will host a “Conference on Open Innovation: Collaborative Projects and the Future of Knowledge” on 22-23 January 2014 at its headquarters in Geneva, Switzerland.

The origins of this conference on open collaborative development models is predicated upon Recommendation 36 of the WIPO Development Agenda which states:

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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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WTO: Spotlight on the United States at the Trade Policy Review (December 2012)

On 18 December 2012 and 20 December 2012, the World Trade Organization (WTO) undertook a trade policy review of the United States of America. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The questions raised by WTO Members during the US TPR touched upon on compulsory licensing (including cases of judicial compulsory licensing following eBay v. MercExchange), copyright (Golan v. Holder), the Special 301 report and the Medicines Patent Pool. On 30 April 2013, the WTO released the records of the meeting including WT/TPR/M/275. Continue Reading

IPAB hearing on the Nexavar compulsory license, part 1, R&D costs

On January 16, the India Intellectual Property Appeals Board (IPAB) began a hearing on the merits of Bayer’s appeal of India’s first compulsory license.

The outcome of this trial, which focuses on the cancer drug Nexavar, is a matter of first impression for the IPAB, and is expected to set precedents on a wide range of issues, including the permissible grounds for granting compulsory licenses, the relationship between the India patent law and the TRIPS Agreement, and the setting of terms and conditions for the compulsory license, including the royalty rates.

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Wellcome Trust tells WHO it opposes R&D Treaty and the de-linkage of R&D costs from drug prices

At WHO deliberations (26 November 2012 to 28 November 2012) on charting a path forward following the recommendations of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), Bolivia, Colombia and Thailand reiterated their political commitment supporting a binding R&D treaty. Continue Reading

Update: WTO Trade Policy Review of Israel covers new developments on fair use, data exclusivity and parallel importation

UPDATE: On 3 December 2012, the secretariat of the World Trade Organization (WTO) released the minutes of Israel’s Trade Policy Review (WT/TPR/M/272) held on 30 October 2012 and 1 November 2012. According to the chair, Eduardo Munoz Gomez (Colombia), innovation was one of the salient points identified in the TPR noting that:

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