Of possible interest

KEI requests that DHHS Inspector General investigate failure to disclose federal funding in Spinraza patents.

KEI objects to the U.S. Army grant of an exclusive license to Sanofi on U.S. Army-owned patents on a Zika Virus vaccine.

Research and testimony on transparency legislation.

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

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

Innovation inducement prizes 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?:

NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs

The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.

The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.

The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way.

Summary of Report of United Nations Secretary-General's High-Level Panel on Access to Medicines

On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]

KEI Statement on United Nations Secretary-General's High-Level Panel on Access to Medicines Report

On September 14, 2016, the United Nations Secretary-General's High-Level Panel on Access to Medicines issued its long-awaited report, which addressed the policy incoherencies between intellectual property, trade, human rights, innovation, and public health.

The report is available here: http://www.unsgaccessmeds.org/final-report/

Cancer Moonshot Blue Ribbon Panel Does Not Address Pricing, Alternative Funding Models

On September 7, 2016, the National Cancer Advisory Board Blue Ribbon Panel issued a draft report with recommendations directed to the Cancer Moonshot Task Force.

The draft included 10 interesting and useful recommendations (see A - J) related to cancer research, but none to address the pricing or affordability of products.

German Court Issues Compulsory License on HIV Drug Patent

A German patent court has ordered a compulsory license under Section 24 of the Patent Act, allowing Merck (US) to continue to market the HIV drug raltegravir (marketed as Isentress).

Commentary on Hillary Clinton's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs

Democratic presidential nominee Hillary Clinton has published a factsheet presenting, "Hillary's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs."

Today via Twitter, KEI Director James Love offered a six point commentary on Secretary Clinton's proposal to address drug price hikes:

KEI Briefing Note 2016:2: 2015-2016 Pharmaceutical Transparency Legislation

The attached briefing note analyzes transparency legislation that has been proposed in 14 states in 2015 and 2016. The bills would require various degrees of transparency for research and development (R&D) and marketing costs, as well as for drug prices and price changes.

Bloomberg: CVS Will Exclude Xtandi From Formulary in 2017

Bloomberg reported on August 2, 2016, that CVS Health announced that it plans to exclude 35 drugs from its formulary beginning in 2017, including Xtandi, bringing the total number of excluded drugs to 131.

Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs

The Associated Press recently released a chart from the Centers for Medicare and Medicaid Services' Office of the Actuary that outlines spending for the top 20 costliest drugs to Medicare in 2015 after reaching Medicare's catastrophic spending threshold: http://www.nytimes.com/aponline/2016/07/25/us/ap-us-medicare-pricey-drugs-glance.html.

UPDATE: The AP also released another story, on July 24, 2016, outlining the overall program costs of catastrophic spending and explaining various spending increases: http://www.nytimes.com/aponline/2016/07/24/us/politics/ap-us-medicare-pricey-drugs.html.

top-20-medicare-drugs-2015.png

Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiatives

20 July 2016
For Immediate Release

Contacts
Knowledge Ecology International: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670
Public Citizen: Peter Maybarduk, pmaybarduk@citizen.org, +1 (202) 588-7755

Public Health, Human Rights, and Faith Organizations Question State Department Pressure Against Global Access to Medicines Initiatives

Evidence shows pattern of interference in national and international efforts to improve access to affordable medicines, according to Doctors Without Borders (MSF USA), Knowledge Ecology International, Public Citizen, Oxfam, and other leading public interest groups.

Washington, DC — More than 50 public interest organizations and experts asked Secretary of State John Kerry today to explain evidence that the State Department recently pressured the United Nations and the governments of Colombia and India against taking action to improve access to affordable medicines, citing U.S. business interests and implying that relations with Washington would suffer.

Francis Gurry appoints Sylvie Forbin, lobbyist for Vivendi, as new head of copyright at WIPO

Francis Gurry has appointed the new Deputy Director General for the Copyright and Creative Industry Sector. She is Sylvie Forbin, a national of France, and most recently Senior Vice President for Public and European Affairs, for Vivendi. Here is the WIPO announcement: as PDF.

SCP24:WIPO patent committee adopts robust work program on patents and health, limitations and exceptions and quality of patents

On 30 June 2016, the 24th session of the WIPO Standing Committee on the Law of Patents (SCP) agreed to an ambitious work program on patents and health, exceptions and limitations to patent rights, quality of patents, transfer of technology and confidentiality of communications between clients and their patent advisors.

On patents and health, the Committee agreed to the following:

WIPO Marrakesh Treaty for the blind to come into force September 30, 2016, following ratification by Canada

On June 30, 2016, the WIPO Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled received its 20th ratification, from Canada, and this will bring the Treaty into force September 30, 2016. The WIPO announcement was here. WIPO Director General Francis Gurry made a statement about the Marrakesh Treaty's imminent entry into force in the video below:

Human Rights Council adopts watershed resolution on Access to Medicines

*(The author thanks Mirza Alas and Alexandre Gajardo for their notes of the 2nd round of informal consultations held on 22 June 2016 and Sophia Simon for transcribing the statements delegations made during the plenary discussions held on 1 July 2016.)

SCP 24 - A fruitful discussion?

30 June 2016

By Sophia Simon

The World Intellectual Property Organization’s (WIPO) Standing Committee on the Law of Patents (SCP) plays a significant role as the United Nation’s only dedicated, multilateral forum for the discussion on patents. The WIPO SCP convened for its 24th session in Geneva from 27 June 2016 to 30 June 2016.

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