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Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

More notes on the USTR 2012 Special 301 List

The USTR's 2012 Special 301 list was published on April 30, 2012. Below are some comments about certain portions of the Special 301 Report that concern access to knowledge and access to medicines.

USTR cites the "TEAM" approach to access to medicines

USTR's 2012 Special 301 Report, focuses on largest developing country markets, and Canada

The 2012 USTR Special 301 Report was published on April 30, 2012. The report details USTR's unilateral standards for the granting and enforcement for a diverse set of intellectual property rights, and singles out countries that USTR claims do not meet those standards. The Report places the offending countries into different categories, including those on the “Priority Watch List,” the “Watch List” and those to have a “Special 306” review. According to USTR:

Senate HELP Committee proposes evaluation of Innovation Inducement Prizes, as alternative to product monopolies

In the United States Senate, the Committee on Health, Education, Labor and Pensions (HELP) is trying to move forward a bill titled the "Food and Drug Administration Safety and Innovation Act." Among other things, the bill would "amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, establish user-fee programs for generic drugs and biosimilars," and address a number of other topics, such as extend the legal monopoly on antibiotic drugs by 5 years.

Senate HELP Committee Markup of FDA Bills on Wednesday, April 25, 2012

On Wednesday, April 25, 2012 at 10:00 AM, the Senate Health, Education, Labor and Pensions (HELP) Committee will have an executive session to do a markup of FDA bills.

Views on the Report of the WHO Consultative Expert Working Group on Research and Development (CEWG)

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 (CEWG) entitled "Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination".

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:

Senator Harkin (D-IA) sends letter to President Obama supporting a WIPO treaty for the visually impaired

On Friday, March 30, 2012, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to President Obama supporting an international treaty for persons who are visually impaired or have other disabilities. The letter urges the Obama administration to achieve several goals in such a treaty, including robust minimum standards that do not diminish the rights provided for under U.S.

KEI letter to Steve Ricchetti, asking recusal in matters that involve former clients

On March 12, 2012, Tedmund Wan posted a note on Joe Biden's appointment of Steve Ricchetti, exploring potential conflicts of interest with the clients in a lobbying firm that he ran. On March 29, 2012, KEI formally asked Ricchetti to recuse himself in matters concerning his former clients. The letter follows.


29 March 2012

Steve Ricchetti
Counselor to Vice President Joe Biden
The White House

KEI Comments to USPTO on Genetic Diagnostic Testing

In response to a Federal Register notice seeking comments on genetic diagnostic testing, KEI submitted comments detailing several proposals with respect to patents on diagnostic technologies and also included notes regarding our position in the American Molecular Pathology v. Myriad Genetics litigation. In addition to the questions listed in Federal Register notice, we recommended that the USPTO address two additional questions:

The 2012 WIPO/Library of Congress International Copyright Training symposium for developing countries

This week WIPO and the Library of Congress are holding a week long symposium on International Copyright, with title:

Emerging Issues in Copyright and Related Rights for Developing
Countries and Countries with Economies in Transition
organized by
the World Intellectual Property Organization (WIPO)
in cooperation with
the United States Copyright Office, Library of Congress
Washington D.C., March 19 to 23, 2012

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.

Wyden files legislative amendments to require transparency in TPPA and Congressional approval for ACTA

On March 20, 2012, Senator Wyden (D-OR) filed two amendments to H.R. 3606, a bill known in its short form as "Jumpstart Our Business Startups" or JOBS Act, related to the Anti-Counterfeiting Trade Agreement (ACTA) and the Trans-Pacific Partnership Agreement (TPPA).

Who is Sally Susman, and why does she want poor people to pay higher prices for medicines?

Sally Susman of Pfizer leads the most lethal lobbying effort on drug patents and prices. She's also a big Obama campaign fundraiser.

For several years, Pfizer has been considered a hardliner among big pharma companies on international negotiations over intellectual property rights and drug pricing. This has not changed despite the company having had three CEOs in the past five years.

WTO Dispute Settlement: Ukraine files dispute against Australia (13 March 2012) on Tobacco Plain Packaging Bill 2011

The following information is taken directly from the World Trade Organization's dispute settlement web page which reports that on 13 March 2012, Ukraine requested consultations with Australia under the WTO's dispute settlement system with respect to Australia's Tobacco Plain Packaging Bill 2011 which the WTO website noted imposes "trademark restrictions and other plain packaging requirements on tobacco products".

KEI Notes From the Eleventh Round of TPPA negotiations in Melbourne, Australia


The eleventh round of negotiations for the Trans-Pacific Partnership Agreement (TPPA) took place in Melbourne, Australia from 1-9 March 2012. Stakeholders were given the opportunity to present at the stakeholder platform on 4 March, attend a reception on 6 March and the stakeholder briefing on 7 March.

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