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.

Poll

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

Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries

On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.

KEI comment on USTR's 2016 Special 301 report

The 2016 USTR Special 301 report is now available. (copy here). The report is 77 pages of complaints about intellectual property policies around the world, plus a number of other complaints, including those related to pricing and reimbursement of pharmaceutical drugs and medical devices, restrictions on data flows, standard setting, and government procurement.

On the one hand, USTR says it is supports "access to medicine for all."

Transparency of patents on medicines and other technologies

2016:1 KEI Briefing Note
Transparency of Patent Landscapes
April 25, 2016

At an April 12, 2016 WIPO seminar, Reed F. Beall and Amir Attaran presented a paper, “Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines,” which includes the following odd comment:

WHO releases program of work and progress report in advance of Consultative Expert Working Group on R&D (2-4 May 2016)

The World Health Organization (WHO) is convening an open-ended meeting of member states on the Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in Geneva, Switzerland at WHO headquarters from 2 May 2016 to 4 May 2016. The WHO has published the provisional agenda, the proposed program of work and progress report.

2015 Oct 16 version: RCEP draft text for investment chapter

(More KEI RCEP leaks here: http://keionline.org/rcep)

Attached below is the October 16, 2015 version of the investment chapter for the proposed Regional Comprehensive Economic Partnership, known as RCEP. This text is made public for the first time by KEI.

Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi

KEI submitted the attached letter to Secretary Burwell and Director Collins in support of the KEI/UACT petition that asked the NIH (or the Army) to use the federal government rights in the patents on the prostate cancer drug Xtandi, to remedy the excessive and discriminatory price in the United States. The letter calls attention to findings of an article from the the Journal of Oncology Pharmacy Practice, in which the authors conclude that a reduction in price would make Xtandi the most-cost effective option.

The text of the letter follows:

2015 Oct 15 version: RCEP IP Chapter

Attached here (in docx format) is the October 15, 2015 version of the draft intellectual property right chapter for the proposed Regional Comprehensive Economic Partnership (RCEP).

Global pharmaceutical sales, by region, 2013-2015

These estimates are published by Statista, here.

Statista-Global-Sales-2013-2015.png

KEI comment on WIPO report on patents landscape for the WHO essential medicines list

This is a comment on the WIPO- commissioned report on the patent landscape for the WHO essential medicines list, published on April 11th, 2016. The report is titled: Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines, by Reed F. Beall and Amir Attaran, both at the University of Ottawa, Canada. This is is the third collaboration between WIPO's Thomas (Tom) Bombelles (Head, Global Health, WIPO) and Attaran on the same topic -- the patenting of medicines in developing countries.

Obama Administration memo: "Background on TPP Biopharma Provisions" describes how TPP will raise drug prices

[First reported by Politico] On April 9, 2016, the Obama Administration sent a document to Congress defending the TPP against criticism from the pharmaceutical industry that they did not get enough from the deal.

CDIP 17: Asia Pacific and African Group raise concerns re: WIPO's position on the UN High-Level Panel on Access to Medicines

The World Intellectual Property Organization (WIPO) is convening its 17th session of the Committee on Intellectual Property and Development (CDIP17) from 11 April 2016 to 15 April 2016. The mandate of the Committee is to "develop a work-program for implementing the 45 adopted Development Agenda recommendations" and "monitor, assess, discuss and report on the implementation of all recommendations adopted" (Source: WIPO page on the Committee on Development And Intellectual Property).

The 2016 Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.

Draft, revised April 12, 2016.

2015:4 KEI Briefing Note: The Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.
April 12, 2016
James Love

This is a briefing note on the 2016 Tufts study titled: Innovation in the pharmaceutical industry: New estimates of R&D costs, co-authored by three industry consultants, Joseph A. DiMasi, Henry G. Grabowski and Ronald W. Hansen. [J.A. DiMasi et al. Journal of Health Economics 47 (2016)].

2016: Great Lakes Neuroscience and NIH exclusive license on MS/ALS patent

The following is the KEI comment to the NIH proposed exclusive license to Great Lakes Neuroscience for a patent on Multiple Sclerosis, Amyotrophic Lateral Sclerosis and certain other CNS Disorders. (PDF version here). KEI asks the NIH for certain information about the proposed license, and also asks the NIH to include provisions in the license that protect consumers in both the United States and developing countries.

For the United States, KEI asks that prices be:

7 April 2016: Keynote address of Minister Rob Davies (South Africa) to WIPO International Conference on IP and Development

On Thursday, 7 April 2016, Dr. Rob Davies, Minister of Trade and Industry of South Africa, delivered a keynote address at the World Intellectual Property Organization's (WIPO) International Conference on Intellectual Property and Development.

On compulsory licensing, in relation to voluntary licensing, the Minister remarked:

Incentives for R&D on new uses of existing drugs

The Fordham international IP conference just concluded a panel on patents for second uses of medical inventions, and the discussions illustrated once more the degree to which the patent system is poorly designed to address this issue.

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