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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KEI Statement at USPTO Public Hearing on Genetic Diagnostic Testing

On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, pursuant to a Congressional mandate that was part of the America Invents Act. This mandate directed the USPTO to evaluate several questions related to genetic diagnostic testing, particularly with regard to second opinion or confirmatory genetic testing. USPTO will deliver its final report to Congress in June. Notes from the public hearing are available in a separate blog post.

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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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February 22 noon Washington, DC meeting to discuss international negotiations on copyright (With international call-in)

On Wednesday February 22, 2012, from 12:30pm to 2:30pm, KEI will host a roundtable discussion on international copyright negotiations. The location of the meeting will be 1621 Connecticut Ave, NW, Suite 500, Washington, DC 20009. There will be an opportunity to participate by telephone, via toll free calls in many countries. (To register or for details on call-in, email manon.ress@keionline.org. If you want to try to join by skype, we will do our best.)

The topics to be discussed are the following International copyright negotiations:

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KEI files affidavit in India compulsory licensing case involving Bayer patents on cancer drug Sorafenib (Nexavar)

KEI has provided an affidavit in an India compulsory licensing dispute involving Natco and Bayer, for patents on the cancer drug sorafenib (sold by Bayer under the brand name Nexavar).

bayer_logo.gifThe Bayer price for sorafenib/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. In 2010, per capita income in India was $1,330.

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U.S. Dept of Commerce asked to review Africa Intellectual Property Forum compliance w/ Executive Order 13155

Health GAP, KEI, Oxfam, Public Citizen, Universities Allied for Essential Medicines and Professor Susan Sell have written Cameron Forbes Kerry, the General Counsel for the U.S. Department of Commerce, asking Kerry to “review work on the Africa Intellectual Property Forum, currently scheduled for April 3-5, 2012 in Cape Town, South Africa, to see if the sponsorship of the event violates Executive Order 13155, on Access to HIV/AIDS Pharmaceuticals and Medical Technologies.” Executive Order 13155 was issued by President Clinton on May 10, 2000 after an extensive review of U.S. Continue Reading

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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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