Medical Technologies

2016: KEI comments on NIH proposal for exclusive licenses to Dedalus Pharma, LLC

On April 22nd, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Dedalus Pharma, LLC for the Development of Anti-CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic Myelogenous Leukemia. Below are the comments KEI submitted to the NIH on May 9th, 2016.

Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses


May 9, 2016

Andrew Burke, Ph.D.
Licensing and Patenting Manager,
Technology Transfer Center,
National Cancer Institute,

Delinkage

Some of our work on delinkage is now here: http://delinkage.org


De-linkage can be defined in the negative, by saying that the R&D funding should not be tied to the price of the product.

Progressive de-linkage means that governments implement reforms over time that sequentially and progressively move prices closer and closer to affordable generic prices, and reform incentives so they no longer rely upon high prices.

Some links to KEI work on delinkage:

Top WIPO PCT applicants for patents with cancer in specification or description

The March 10, 2013 search was: EN_AB:cancer OR EN_DE:cancer OR EN_CL:cancer

Noted that Roche owns Genentech.


Company Number of PCT patents
NOVARTIS AG 2286
ASTRAZENECA AB 2118
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA 1836
MERCK & CO., INC. 1190
GENENTECH, INC.

Sorafenib (Nexavar)

On February 14, 2012, KEI filed an affidavit in an India compulsory licensing case involving Bayer patents on cancer drug Sorafenib (Nexavar). The price for Nexavar in India is $47 per 200 milligram tablet. At a daily dose of 4 tablets, this comes to $5,637 per month, or more than $68 thousand per year. The per capita income in India was $1,330 in 2010.

Initial FDA approval

Date of FDA NDA application 21-923: Signed July 6, 2005. Received by FDA on July 8, 2005.
Date on FDA approval: December 20, 2005.

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):

Prices for Abbott's Norvir as a Standalone Product

We have 2010 and 2012 Surveys of Norvir prices.

Notes and data points for prices of orphan products

February 22, 2010., Matthew Herper, "The World's Most Expensive Drugs," Forbes.

Genzyme's web page on the cost of treatment.

Some data points on Fabrazyme prices.

2004 prices for Replagal

US NGO’s Call For George Washington University to Cease Industry-Sponsored Intellectual Property Training in India

On June 7, 2010 medicine access advocacy groups joined together in asking that George Washington University (GWU) put a stop to its industry-sponsored intellectual property (IP) summits and to take an academic, evidenced-based approach to conferences it conducts in India.

Indian NGOs confront GWU Law School efforts to push maximalist IPR norms in India

The ties between Universities and businesses are often complex and blurred. Private companies or trade associations fund research and seminars, and have consulting relationships with faculty members, trying to shape public policy and judicial decisions on a wide range of issues. A particularly interesting industry/university connection concerns something called the "India Project," that is associated with the George Washington University (GWU) Law School.

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