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US statement to SCP 18 on the United States proposal on Patents and Health

The following is the statement read today by USPTO during a meeting of the WIPO Standing Committee on the Law of Patent, on the agenda item for patents and health. I’ll provide more commentary later, but in general, this was seen an aggressive attack on a proposal for work by the Development Agenda Group (DAG), and on the notion that countries should grant compulsory licenses on patents to address concerns over access or affordability of drugs.

[Update: KEI wrote to USPTO about the submission: /node/1420]

The USPTO statement follows:

Obligations to fund R&D, under CEWG recommendation

The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.

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Statement of Sen. Bernard Sanders (I-VT) on the Mark-up of FDA Reauthorization Package

This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:

  • The proposal for a new extended monopoly for antibiotics and antifungal drugs is a “huge giveaway” that will lead to high prices and harm consumers.
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Senate HELP subcommittee hearings on S.1138, the HIV/AIDS prize fund

Update: the hearing web page is here: http://www.help.senate.gov/hearings/hearing/?id=2d5dda75-5056-9502-5d1a-2a40d8a92d51

On May 15, 2012, the Primary Health and Aging Subcommittee of the Senate HELP Committee will hold hearings on S.1138, the Prize Fund for HIV/AIDS.

COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS
Primary Health and Aging Subcommittee

HEARING NOTICE

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5 April 2012: World Health Organization’s Consultative Expert Working Group on R&D Financing releases its Report

On Thursday, 5 April 2012, the World Health Organization released the report of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination entitled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination”. The 218 page report will take some time to fully assess.

The report can be found here: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf

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Unanimous Supreme Court decision invalidates Prometheus diagnostic test patents and reverses Federal Circuit decision

In a major patent ruling today, the Supreme Court of the United States issued a unanimous decision in Mayo v. Prometheus Laboratories. The case, heard twice before the Federal Circuit (once before the Supreme Court’s ruling in Bilski and once after), has been closely followed because of its impacts on personalized medicine and potential implications for the Myriad Genetics case on the BRCA genes. The Supreme Court reversed the Court of Appeals for the Federal Circuit and held that Prometheus’ patents-at-issue were not eligible for patent protection.

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