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Why is it a big mistake to link funding of R&D costs with drug prices?:

UN Rapporteur for the Right to Health asked to intervene in the TPP negotiation

The following groups and individuals have written to Anand Grover, the Special Rapporteur for the United Nations on the right of everyone to the enjoyment of the highest attainable standard of health, to lodge a complaint about the Trans Pacific Partnership (TPP). The TPP is a regional free trade agreement being negotiated by the governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States.

Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1,500 per dose

(Following discussions with Ed Silverman of Pharmalot, this blog was updated at 12 pm on March 22, to add some suggestions as to how to reform the Orphan Drug Act).

This note concerns an increase in the price of hydroxyprogesterone caproate, from $10 to $20 per dose to $1,500 per dose. (Several injections are needed). Long used off label to prevent premature births, the drug will be sold by KV Pharmaceuticals, under a newly granted right under a statutory monopoly, at 150 times the price of the generic product using the trade name Makena.

MEP Franciso Sosa Wagner poses question about support for WIPO treaty for persons who are blind or have other disabilities

Francisco SOSA WAGNER, a Member of the European Parliament (MEP) from Spain, has submitted a question to the European Commission on the WIPO negotiations for a treaty for persons who are blind or have other disabilities.

David Hammerstein has provided the following translation into English:

Patents and Doctors, and the USTR TPP text

The recently obtained US draft text for the intellectual property rights chapter for the Trans-Pacific Partnership Agreement (TPP) contains provisions that go far beyond the requirements of international agreements as well as the standards of US law itself. One particular area of concern involves the broad definition of patent eligible subject matter that fails to provide for any exception from patentability for surgical methods or procedures. Nor does the draft language contain any exception for the enforcement of surgical method patents.

The complete Feb 10, 2011 text of the US proposal for the TPP IPR chapter

KEI has obtained the February 10, 2011 US government draft of the intellectual property chapter of the Trans-Pacific Partnership Agreement (TPP).

United States Patent and Trademark Office’s "Humanitarian Pilot Proposal." Comments by KEI, MSF, Oxfam, PC and UAEM

The USPTO is considering a pilot program to consider the benefits of providing a voucher for certain accelerated reviews of patent applications, as a reward for licensing patents for humanitarian uses. On March 2, 2011, Anne Guha provided a very useful summary of public comments on the proposal, which is available here:

Interview with David Hammerstein regarding negotiations on WIPO treaty for persons who are blind or have other disabilities

David Hammerstein is a former Member of the European Parliament from Spain. He now works for the Trans-Atlantic Consumer Dialogue (TACD). Among other things, he is an advocate for a new WIPO copyright treaty for persons who are blind or have other disabilities. The following is an interview with David, carried out from March 3 to March 6 by email.

David Hammerstein at SCCR 19

Intervention of Brazil to the WTO TRIPS Council (March 2011) providing details about the Brazilian HIV treatment program

On Tuesday, 1 March 2011, Brazil made the following intervention at the WTO Council for TRIPS during discussions of the paragraph 6 system.

Mr. Chairman,
Brazil welcomes the opportunity for this follow-up to the review on the implementation of the paragraph 6 system. Our aim here is to assess whether this system is indeed an expeditious solution for countries lacking manufacturing capacity and to address any shortcomings for the system’s effective operation.

Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System

On September 20, 2010, the PTO published "Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System" in the Federal Register (75 Fed. Reg. 57261, available here):

Michel Barnier tells the European Blind Union the EU does not support a treaty for persons with disabilities

Michel_Barnier_200x202.jpgOn March 2, 2011, Michel Barnier, the EC Commissioner for Internal Market and Services, wrote to Dan Pescod of the European Blind Union, to defend the European Commission decision to back a soft alternative to a treaty at WIPO. (More context, including the text of all of the proposals at WIPO, here.

Response of WHO to KEI letter regarding McKinsey, vaccine policy and competing interests

On 20 February 2011, Dr. Keiji Fukuda, Assistant Director-General - Health Security and Environment, World Health Organization, responded to KEI's letter (16 February 2011) regarding McKinsey, vaccine policy and competing interests. Here is the response in full (email contacts have been redacted).

From: "Fukuda, Keiji"
Date: February 20, 2011 4:14:05 PM GMT+01:00
To: "Thiru Balasubramaniam"

Seven being considered for new US Register of Copyrights

Apparently it is now down to seven final candidates to be the new US Register of Copyrights. These include two employees of the Copyright Office (Carson and Kasunic), a lawyer in private practice (Fries), a full time professor (Brauneis), a professor/USPTO negotiator (Hughes), a trade negotiator (McCoy), and a representative of a trade association (Perlmutter). By gender, the finalists are two women, and five men.

They are, in alphabetical order:

Robert Brauneis

WBU suspends participation in WIPO & EU Stakeholder discussions, pending agreement at WIPO on legal framework

On February 26, 2011, the World Blind Union issued a statement announcing it would "suspend participation in the WIPO Stakeholder Platform and EU Stakeholder Dialogue projects, pending agreement at WIPO on a proper binding legal framework." [See full statement below]. The WBU statement is expected to dramatically change the environment for considering a new WIPO treaty for persons who are blind or have other disabilities.

38 groups (including KEI) ask Congress to make CRS reports public

Congressional Research Service reports are prepared in response to requests from members of congress. For decades, right to know groups have been asking that they be available online. The CRS describes itself as follows:

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