Of possible interest

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?:

2016: KEI objections to NIH licenses to Vital Spark, Kalytera Therapeutics, CB1 receptor mediating compounds

More on NIH licensing at http://keionline.org/nih-licenses


May 4, 2016

Betty Tong, Ph.D.
Senior Licensing and Patenting Manager
Technology Advancement Office
National Institute of Diabetes and Digestive and Kidney Diseases
12A South Drive,
Bethesda, MD 20892
Via email: betty.tong@nih.gov

May 4, 2016

Dear Dr. Betty Tong,

Xtandi patient on Medicare — with supplement — pays $441.97 per month

Astellas has claimed that patients taking Xtandi face very small co-payments. One patient living in Arizona contacted KEI with proof that Astellas' claims just aren't true. The patient, who is on Medicare, provided a copy of a summary of his expenses for the first quarter of of 2016.

His monthly patient co-payment is $441.97 a month.

2016: NIH FOIA office withholds all records related to exclusive license on HER2+ breast cancer treatment technology

Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses

In response to a February request under the Freedom of Information Act (FOIA) for documents related to the grant of an exclusive patent license on a HER2+ breast cancer treatment technology, the National Institutes of Health (NIH) withheld in full all responsive records.

WHO CEWG 2016: Statement of Health Action International, Knowledge Ecology International and STOPAIDS

On Monday, 2 May 2016, the World Health Organization (WHO) convened the 2016 open-ended member states meeting of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). The 2016 CEWG is chaired by Bhanu Pratap Sharma, Secretary, Ministry of Health and Family Welfare, Government of India. The Vice-Chair is Tania Dussey- Cavassini, Vice-Director General, Ambassador for Global Health, Federal Office of Public Health, Switzerland.

Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D

On April 26, 2016, Congressman Lloyd Doggett (D-Texas) delivered the keynote address at a panel discussion on drug pricing at the Center for American Progress, where he addressed the Federal government’s role in subsidizing drug development, ensuring affordable access at reasonable prices for U.S. citizens, industry practices related to monopoly pricing, and legislative solutions to promote rational and affordable drug prices.

China: as PCT patent filings increase, GDP growth has decreased

The number of patents filed by China has accelerated over the last 15 years. According to WIPO, China represented just 1 percent of the fillings with the PCT in 2000. By 2015, China's share of PCT filing was 13.7 percent. We were interested to see how this increase in patent fillings related to China's growth in GDP.

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.

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