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

HIF in the European Parliament

Today there will be a presentation at the European Parliament on the Health Impact Fund. Below are a few earlier KEI blogs about the HIF.

April 2011 report on negotiations for a WIPO copyright treaty for persons who are blind or have other disabilities

KEI Research Note 2011:1
April 7, 2011

Background and update on negotiations for a WIPO copyright treaty for persons who are blind or have other disabilities

Introduction

US provides misleading answer to WIPO questionnaire on export of accessible works under US law

Although domestic law in the US provides for certain exceptions and limitations from infringement of copyright for the production of accessible works for the visually impaired, as well as importation and exportation of these materials, the law is ambiguous and insufficient in allowing non-profit entities or government agencies to export these works.

KEI presentation to the WHO Consultive Expert Working Group on R&D

Attached below are two PDF files that were used in my presentation today at the 1st meeting of the World Health Organization (WHO). I did not following the text that closely. The WHO is making a video of all of the presentations, which will be made available later.

Federal Circuit hears oral arguments on patent eligibility of DNA claims

On Monday, April 4, 2011, a panel of three Federal Circuit judges heard oral arguments about the patentability of the BRCA 1/2 gene claims in American Molecular Pathology, et. al, v. U.S. Patent and Trademark Office, et. al.. The panel included Judge Lourie, Judge Bryson and Judge Moore. Gregory Castanias from Jones Day argued for Myriad's position, defending the DNA claims while Chris Hansen of the ACLU argued against the patentability of the claims. The U.S.

MEPs Marietje Schaake and Christian Engstrom submit question on appointment of Maria Martin-Prat to EU copyright post

70879-christian-engstrom-parti-pirate-suedois_250x350.jpg marietje-1.jpg On April 1, 2011, Marietje SCHAAKE and Christian ENGSTRÖM submitted a parliamentary question on the appointment of Maria Martin-Part as the new head of unit for copy

Maria Martin-Prat reported to replace Tilman Lueder as head of unit for copyright at European Commission

1257323036PS4picMARTINPRAT.JPGAccording to stories in the German and French press (links below), Tilman Lueder will be leaving his position as the head of union for copyright for the European Commission, for a new EC job in China. [The FT confirms Tilman is leaving, but suggests he will have a different assignment]. Tilman will reportedly be replaced by Maria Martin-Prat.

KEI to appeal USTR rejection of FOIA of Congressional Research Service (CRS) study of ACTA

USTR has rejected a KEI FOIA request for a Congressional Research Service study of ACTA that was done for Senate Ron Wyden. Senator Wyden shared the report with USTR. USTR acknowledges that it has possession of the document, but asserts it does not have control. Public Citizen has agreed to represent KEI in an appeal of the decision. Our administrative appeal was filed today.

March 23, 2011

FOIA Appeals Committee
Office of the Untied States Trade Representative
1724 F Street NW
Washington, DC 20508

Re: Freedom of Information Act Appeal

The production of generic drugs in India: A new trade agreement with the EU would hinder access to drugs in developing countries

On March 22, 2011, the British Medical Journal (BMJ) published the following guest editorial about the EU/India Free Trade Agreement negotiations.

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.

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