USPTO Holds Public Hearing on Genetic Diagnostic Testing

On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, permitting stakeholders to present their views relating to DNA patents, exclusive licensing, patient health and genetic testing, particularly as they relate to secondary or confirmatory genetic diagnostic testing. Notes from the hearing and speaker statements are included below. KEI’s oral statement can be found here.

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Who USTR clears to see secret text for IPR negotiations? (Such as TPPA)

In a meeting with USTR on February 15, 2012, KEI, MSF, Oxfam and Public Citizen pressed USTR to release the negotiating text for the intellectual property rights chapter in the TPPA trade agreement negotiation. USTR said the negotiation had “unprecedented” transparency, but maintained the text needed to be secret from the general public. USTR also claimed than no one on its many advisory boards, who are cleared to see the negotiating text, were lobbyists.

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What we don’t know, and why, about incentives to stimulate biomedical R&D

This is an essay about strategic ignorance, as regards evidence relevant to policies that cost consumers and taxpayers billions of dollars.

The United States government grants 20 year patents on pharmaceutical drugs, and it also provides a growing number of other non-patent incentives and subsidies to stimulate R&D investments in new medicines. Are these incentives and subsidies necessary or cost effective? How would anyone know?

Here are some of the incentives we offer:

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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.
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Seven public health groups write to oppose the “Research Works Act”

On February 8, 2012, seven public health organisations submitted a letter to Rep. Darrell Issa (R-CA), Chairman of the Committee on Oversight and Government Reform and the other thirty-nine members of this committee opposing H.R. 3699, the “Research Works Act.” This bill, originally introduced on December 16, 2011 by Rep. Issa and Rep. Maloney (D-NY) would prohibit federal agencies from conditioning its federal grants on recipients making its published research results available to the public. Continue Reading

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US, France, Japan, South Africa, WIPO, ICC-BASCAP, Lilly, Microsoft and Pfizer co-sponsor Africa IP Forum in Cape Town

The United States Department of Commerce’s Commercial Law Development Program (CLDP) is the lead agency of a concerted effort involving the governments of France, Japan, South Africa and the United States, alongside the World Intellectual Property Organization (WIPO), Organisation Africaine de la Propriété Intellectuelle (OAPI), and the African Regional Intellectual Property Organization (ARIPO) to organize the inaugural “Africa Intellectual Property Forum: Intellectual Property, Regional Integration and Economic Gr Continue Reading

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2012: KEI asks Senator Leahy (D-VT) to demand greater transparency in the TPPA

On January 26, 2012, KEI sent a letter to Senator Patrick Leahy (D-VT), Chairman of the Judiciary Committee, calling for greater transparency in the Trans-Pacific Partnership Agreement (TPPA). The letter highlights the fact that the general public is kept in the dark regarding negotiating positions and the actual text while “cleared advisers” and corporate lobbyists have unequal access to information. It calls for Senator Leahy to urge the Obama Administration to release the negotiating text in order to allow full and effective public participation in our democratic society.

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