- KEI December 2, 2016 meeting on the delinkage of R&D costs from drug prices
- KEI Comments on NIH Proposed Exclusive License to Kite Pharma for Cancer Treatment
- Kite Pharma Press Releases & News Stories Related to Relationship with National Cancer Institute
- Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments
- 17 October 2016: USTR Ambassador Michael Froman's reflections on the United Nations High-Level Panel on Access to Medicines
- 56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries
- 5 October 2016: Statement of Knowledge Ecology International at inaugural Marrakesh Treaty Assembly
- KEI statement at WIPO GA 2013 on the Inter-governmental Committee (IGC) on genetic resources, traditional knowledge
- WIPO GA 2016: Statement by India on behalf of Asia Pacific Group - Report on the IGC
- WIPO General Assembly 2016: Statement of Knowledge Ecology International on the Report of the SCCR
I wanted to post a brief note about three separate mechanism to overcome patent monopolies in current US law. All are useful, in the right context, and all have some limits.
1. The Bayh-Dole March-In rights under 35 U.S.C. 203, as defined by 35 U.S.C. 201(f).
National Association of Manufacturers told USTR the EU position on LDC extension made a mockery of international trading systemSubmitted by thiru on 21. September 2016 - 14:36
On September 10, 2015, the National Association of Manufacturers (NAM), wrote to USTR expressing alarm at the European Union support of an indefinite extension of a WTO waiver of obligations to grant patents on pharmaceuticals for UN defined least developed countries (LDCs). In 2015, there were 954 million persons living in LDCs, with a per capita income of $964, according to the World Bank. The EU had aligned itself with health advocates trying to protect the bottom billion access to life saving medicines.
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: