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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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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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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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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