The Dangers of the Indian Government’s Flirtation with U.S. Pharma and the Risks for India’s Coherent, Pro-Public Health IP Policy

 Posted by on October 6, 2014  Comments Off on The Dangers of the Indian Government’s Flirtation with U.S. Pharma and the Risks for India’s Coherent, Pro-Public Health IP Policy
Oct 062014
 

BrookBaker[Cross posted from Equilibri.net] U.S. business interests and government officials are trying to sell the idea that heightened intellectual property protections in India are essential to foreign investment, innovation, and achievement of public health goals.

Instead, heightened intellectual property rights will make India consumers captive to Big Pharma’s extortionate pricing….

Unfortunately, the joint communiqué issued at the end of Prime Minister Modi’s US visit shows deference by the US and Indian governments to Big Pharma’s pressure… Continue reading »

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Sep 172014
 

BrookBakerGilead has just released the text of its hepatitis C license.  Although there has been some praise for Gilead offering expanded generic access in 91 countries where over 100 million people living with hepatitis C live, there has also been mounting criticism over its exclusion of 51 middle-income countries with 49 million infected.

This paper closely analyzes the license to see what its impact might be, paying close attention to its definition of covered patent rights and illusory mechanisms that might eventually allow supply in some excluded territories.   Continue reading »

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Gilead’s Proposed Hepatitis C Medicines License: How Badly Will it Miss the Target?

 Posted by on September 12, 2014  Comments Off on Gilead’s Proposed Hepatitis C Medicines License: How Badly Will it Miss the Target?
Sep 122014
 

BrookBakerGilead has been busy building positive publicity for its proposed license on two new direct-acting oral antivirals used to treat infections with the hepatitis C virus (HCV), sofosbuvir (Sovaldi®) and ledipasvir, that will allow Indian generic manufacturers to produce and sell individual versions and a combination of the two medicines in a subset of low- and middle-income countries (LMICs). News stories have been uncritically positive so far about the still-secret license, and Gilead is quite coy with respect to key details. Health reporters and hep C activists should raise pointed questions about the scope and impact of the proposed license during Gilead’s press conference, now scheduled for 3:00 p.m. September 15, 2014 in India. Continue reading »

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MSF victorious in overcoming registration barrier to important 2d line treatment of DR-TB, but patent barrier may last a little bit longer

 Posted by on July 2, 2014  Comments Off on MSF victorious in overcoming registration barrier to important 2d line treatment of DR-TB, but patent barrier may last a little bit longer
Jul 022014
 

BrookBakerMédecins Sans Frontières has obtained an important but long-delayed victory in a a challenge to the refusal of the Medicines Control Council in South Africa to issue section 21 permission allowing the temporary importation and patient use of a generic version of a key, tuberculosis medicine, linezolid.  Linezolid can be effectively used as a treatment of drug-resistant tuberculosis, but the private sector cost of taking one pill a day for two years was approximately $49,000 when the medicine was sourced from the brand-name patent holder, Pfizer, at $65/pill.  Generic versions of linezolid are manufactured in India by Hetero at significantly reduced cost of only $8/pill. Continue reading »

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Released Text of GF Equitable Access Initiative Still Problemmatic

 Posted by on May 16, 2014  Comments Off on Released Text of GF Equitable Access Initiative Still Problemmatic
May 162014
 

englishMark Dybul, Executive Director of the Global Fund has written an email responding to a letter from 220 civil society organizations demanding that the Global Fund abandon its “tiered-pricing” proposal.

His response:

“Thank you for your letter. Dialogue is healthy and we appreciate the opportunity to engage. Of course there has not been time to consult with other organizations, but because you mention the world health assembly, I thought it might be useful to send a rapid response from me alone.

We have greatly appreciated the constructive feedback and adjusted the language and approach to be clear that this effort is not about tiered pricing. Continue reading »

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Civil Society to the Global Fund: Abandon the Tiered-Pricing Initiative

 Posted by on May 13, 2014  Comments Off on Civil Society to the Global Fund: Abandon the Tiered-Pricing Initiative
May 132014
 

BrookBakerBelow is a communication sent by Civil Society Organizations to Mark Dybul and others calling for the abandonment of the Global Fund’s misguided tiered-pricing initiative.  The CS letter is attached.

Dear Dr. Dybul, Dr. Chan, and Executive Directors of Proposed Convening Partners (UNITAID, UNICEF, World Bank, UNDP and GAVI):

Attached is a letter from 220 non-governmental organizations from around the globe opposing the proposed Blue-Ribbon Task Force to Develop a Global Framework on Tiered-Pricing.  The letter address a third-draft concept note on this initiative dated March 18, 2014.  In this letter, we urge the Global Fund and proposed partners to: Continue reading »

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Analysis of the ViiV/Medicines Patent Pool Dolutegravir Patent Licenses

 Posted by on April 23, 2014  Comments Off on Analysis of the ViiV/Medicines Patent Pool Dolutegravir Patent Licenses
Apr 232014
 

BrookBakerThis paper provides a detailed analysis of the effective geographical scope of the recently announced adult and pediatric between the Medicines Patent Pool and ViiV Healthcare covering dolutegravir. an important integrase inhibitor.  In addition to providing a comprehensive analysis of the effective geographical scope of the licenses, taking into account both the formally licensed territory and territories where ViiV patent rights would not be violated by sales of dolutegravir, the paper also analyses other key aspects of the licensing agreement. Continue reading »

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Mar 282014
 

BrookBakerProfessor Brook K. Baker, Northeastern U. School of Law
Policy Analyst Health GAP
Full Paper – PDF

On or about March 18, 2014, a third draft of the renamed “equitable access” proposal was released by Mark Dybul, Executive Director of the Global Fund, to partners for further input.  If anything, this third draft, the text of which is attached , is worse than the previous two drafts: Continue reading »

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Health GAP Response to PhRMA Submission for the Special 301 Review

 Posted by on March 8, 2014  Comments Off on Health GAP Response to PhRMA Submission for the Special 301 Review
Mar 082014
 

BrookBaker[Brook Baker and Matt Kavanagh] Health GAP submits these comments in response to written and oral submissions made by PhRMA and other trade associations attacking India’s intellectual property regime, particularly its issuance of a compulsory license on a Bayer cancer medicine and the adoption of section 3(d) to the Indian Amended Patents Act and its Supreme Court decision thereunder denying a patent on a Novartis medicine. The referenced submissions by opponents to the India IP regime can be found at http://www.keionline.org/ustr/Special301. Continue reading »

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US’s “New” Proposed TPP Intellectual Property Chapter Still Requires Patents on Medicinal Forms With “Distinguishing Features”

 Posted by on February 7, 2014  Comments Off on US’s “New” Proposed TPP Intellectual Property Chapter Still Requires Patents on Medicinal Forms With “Distinguishing Features”
Feb 072014
 

BrookBakerThe US has evergreened its patent proposal requiring patents on new forms of known/existing medicines by requiring patents on medicines with “distinguishing features.”  This is the wine of old IP maximalism – an elixir for Big Pharma – in a new bottle.

IP, health and trade activists expressed outrage in early 2011 when the proposed US IP Chapter for the Trans-Pacific Partnership Agreement was first leaked.  Particularly concerning was the language of section 8.1, addressing standards of patentability. Continue reading »

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Note on Reported Gilead Licenses for Hepatitis C Medicine

 Posted by on February 6, 2014  Comments Off on Note on Reported Gilead Licenses for Hepatitis C Medicine
Feb 062014
 

BrookBakerGilead is reported to be in talks to issue voluntary licenses to Indian generic manufacturers for the production of sofosbuvir, an important new drug to fight hepatitis C.

If the intended territorial scope of licenses is only 60 countries, it will be far less than what Gilead first offered through it voluntary licenses for ARVs and much more limited than the licensed territory negotiated with the Medicines Patent Pool.  Moreover, if the territories are limited to sub-Saharan Africa, India, and low-income countries, it will miss key countries with with very high HEP C burdens, e.g., Egypt. Continue reading »

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US PhRMA Bares its Fangs – South Africa Patent Law Reform and Access to Medicine at Risk Yet Again

 Posted by on January 18, 2014  Comments Off on US PhRMA Bares its Fangs – South Africa Patent Law Reform and Access to Medicine at Risk Yet Again
Jan 182014
 

BrookBakerPhRMA (Pharmaceutical Researchers and Manufacturers of America) is putting $350,000 on the table to stop proposed patent law reform in South Africa and instead to lobby for even more monopoly protections for medicines.  Why would a pharmaceutical association from the US be so interested in an African country that comprises only a tiny fraction of global pharmaceutical sales?  Why, after having faced universal public scorn for having sued the Nelson Mandela government 1998-2001 to stop earlier, completely lawful access-to-medicines reforms, would the industry once again risk humiliating publicity and an all-but-certain defeat?  More particularly, when every reform that South Africa is proposing is completely lawful under international intellectual property law, most particularly the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), why would PhRMA choose to a clandestine, public-relations and think-tank strategy not only to derail the propose reform, but advocate for even stronger monopoly protections? Continue reading »

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