- KEI statement: 21st meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines
- Dr. Elias Zerhouni defends Sanofi/Army proposed license on Zika patents, and KEI responds
- Maryland House of Delegates passes bill on prescription drug price gouging by vote of 137 to 4
- Leaked document: March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter
- Patients, Members of Congress Ask Chilean Government to Issue Compulsory Licenses on Prostate Cancer and HCV Drug Patents
- Leaked: Three documents from RCEP negotiations
- 14 March 2017 - Senate Finance Committee grills Robert Lighthizer (USTR nominee) on trade and IPR policies
- KEI Testifies in Maryland on Drug R&D Cost Transparency Bill (HB666/SB437)
- HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals' Spinraza
- KEI 10 March 2017 Comments on Army Exclusive License on Zika Virus Vaccine Patents to Sanofi
Knowledge Ecology International recently obtained extensive email correspondence between officials at the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Football League (NFL), which shed light on accusations of NFL attempts to control the NIH research agenda related to repeat concussion injuries in football players.
The records, which we received through FOIA, are available here:
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.
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.”
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/
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.
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).
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:
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 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.
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.
Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiativesSubmitted by Zack Struver on 20. July 2016 - 12:39
20 July 2016
For Immediate Release
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 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 patentsSubmitted by thiru on 7. July 2016 - 5:05
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 CanadaSubmitted by James Love on 5. July 2016 - 9:44
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:
*(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.)