Of possible interest

Recent blogs about the World Intellectual Property Organization (WIPO) meetings are available at http://keionline.org/wipo.

The US Secretary General High Level Panel on Access to Medicine. KEI submissions.

Request to NIH and Army to use government royalty free or march-in rights in the prostate cancer drug Xtandi.

Proposal for a WTO Agreement on the Supply of Public Goods.

Prices and patents on drugs, vaccines and diagnosis of hepatitis.

Innovation inducement prizes, possibly as an alternative to IPR monopolies to reward successful innovation.

Now is a good time to donate money to KEI

KEI Timelines, on a variety of topics.


Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

Misc notes on the new Wikileaks cables

These are some notes on some of the new Wikileaks cables. (Much more at http://keionline.org/wikileaks)

May 18, 2009. Pfizer meets asks US embassy to intervene in Philippines debate over drug prices. Embassy agrees to tell Philippines government that "imposition of price controls . . . would be unacceptable.."


Subject: Health Department Patent Remedies to Cut Drug Prices

¶1. (SBU) Summary: The Philippine Department of Health is close to

USG cable on WTO TRIPS Council meeting of October 25-26 2005, discussion on LDC extension of TRIPS


Cable subject: Wto Trips Council October 25-26 2005
Cable written Wed, 16 Nov 2005 09:17 UTC


  1. Zambian Ambassador introduced LDC proposal to extend transitional period for TRIPS Compliance by An additional 15 years. He stressed points concerning that resource and economic difficulties LDCs face and the costs of implementing TRIPS obligations. Tanzania, Uganda, Cambodia, Senegal, Lesotho all supported Zambia's statement.

Wikileaks on USTR negotiations with India Commerce Minister Anand Sharma

Among the cables recently published by Wilileaks is one written on November 24, 2009, detailing negotiations between USTR and Anand Sharma, the Cabinet Minister for Commerce and Industry of the Government of India. The complete cable is available here: http://wikileaks.org/cable/2009/11/09NEWDELHI2375.html

From Wikileaks, a US government cable on its involvement to shape Guatemala legislation on pharmaceutical IPR

August 28, 2011
From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)

Among the many new cables released by Wikileaks is this gem, a detailed account of the U.S. government pressure on the Guatemala legislature to shape legislation on pharmaceutical test data IPR.




E.O. 12958: DECL: 03/11/2010

Notes from the Wikileaks cables (from the US Department of State)

Posted August 27, 2011

These are some tools for searching the US Department of State cables released by Wikileaks.

A Wikileaks page on the cables is available here: http://wlcentral.org/cablegate

KEI recommends this site for searching the cables by key words:


You might also want to try:

Positive agenda on copyright, at the WIPO SCCR

As part of the American University hosted Global Congress on Intellectual Property and the public Interest, I participated in a panel on the positive agenda for intellectual property. These are notes from my talk.

Presentation by Manon Anne Ress, Knowledge Ecology International
August 26, 2011, at American University in Washington, DC

John LaMattian, former head of Pfizer R&D, says industry mergers have harmed R&D efforts

John L. LaMattina, the former President of Pfizer Global Research and Development, has just published an article in Nature that looks at the impact of drug company mergers and increased industry concentration on R&D. Among his conclusions: the "impact on the R&D of the organizations involved has been devastating."




The impact of mergers on pharmaceutical R&D

ADAP Financial Eligibility Criteria and ADAP Expenditures

AIDS Drug Assistance Programs (ADAP) serve low-income, underinsured or uninsured HIV-positive patients in the United States and its territories. General eligibility requirements may include residency, clinical eligibility based on specific CD4 counts, and income. Specific eligibility criteria for each ADAP is determined by each individual state.

ADAP waiting lists continue to grow; 9,217 individuals on waiting lists, 64% are African American or Hispanic

The number of patients sitting on AIDS Drug Assistance Programs (ADAP) wait lists, denied the life-saving treatment they need, have risen dramatically over the past two years. ADAPs are critical in providing HIV/AIDS treatment to low-income, uninsured, or underinsured patients within the United States and its territories. As noted in an earlier KEI blog, in January 2010, 361 individuals were on ADAP waitlists; that number grew to 7,873 across eleven states as of May 5, 2011 (a 2100% increase over less than sixteen months).

Approval, ownership, market structure, and placement on WHO EML for 100 new cancer NMEs on NCI alpha list

KEI research associate Paul Miano has written the following paper: Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines. KEI Research Note 2011:1,

A full copy of the paper is available in PDF format here.

The following is from the introduction (sans footnotes, which are in the PDF version):

Introduction and Summary

In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

  • All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
  • Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
  • One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.

Federal Circuit decision in AMP v. USPTO results in three-way split in reasoning; 2-1 decision finds isolated DNA patentable

It has been estimated that 1 out of every 8 women in the United States will develop invasive breast cancer during her lifetime. Although a diagnostic test exists to identify mutations on the BRCA1 and BRCA2 human genes, two genes associated with breast and ovarian cancer, many women are not afforded the opportunity to have testing done because Myriad Genetics holds exclusive rights over these genes.

WIPO General Assembly: Expectations loom over decisions on treaties for actors, reading disabled persons and genetic resources

The WIPO General Assembly meets from Monday, 26 September 2011 to Wednesday, 5 October 2011 and will take place at the International Conference Center Geneva (CICG), 17 rue de Varembé, 1211, Geneva.

The tentative schedule for 49th session of the WIPO General Assembly can be found here: http://www.wipo.int/edocs/mdocs/govbody/en/a_49/a_49_1_prov_2.pdf.

Medicines Patent Pool agreement with Gilead contains flexibilities including termination provisions and severability of licenses

On 12 July 2011, the Medicines Patent Pool (MPP) and Gilead announced an agreement for Gilead to license patents for tenofovir (TDF), emtricitabine (FTC), elvitegravir (EVG), cobisistat (COBI) and a four drug combination of these drugs. KEI's initial comments on the agreement are available here.

Decision for WIPO GA 49: Matters Concerning the IGC on IP and genetic resources, traditional knowledge and folklore

After ten years of deliberations, the 19th session (18-22 July 2011) of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC/GRTKF) submitted a Decision for approval to the WIPO General Assembly (26 September-5 October 2011) that could pave the way for the General Assembly in 2012 to convene a Diplomatic Conference on an international legal instrument(s) for the protection of genetic resources, traditional knowledge and traditional cultural expressions (TCEs).

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