KEI will host a conference call at 11:00 A.M. today to brief interested stakeholders and the press on issues related to NIH patent policy, including the recent decision in KEI’s Xtandi petition (additional background here: /xtandi), the grant of exclusive licenses on government-owned inventions (/nih-licenses), and transparency of decision-making at NIH more broadly.
For call-in information, please contact Zack Struver at email@example.com. Continue Reading
27 June 2016
KEI statement on exceptions and limitations to patent rights
In relation to limitations and exceptions, we recall Brazil’s prescient submission, document SCP/14/7 (tabled in January 2010) which called attention to the lack of policy coherence in a world where in certain international fora, countries endorse the use of compulsory licensing to promote access to medicines for all, and in separate fora, criticize developing countries for actually considering or issuing such compulsory licenses.
In the wake of the NIH’s letter to KEI declining to use the government’s rights in the federally-funded patents on Xtandi under the Bayh Dole Act, it is interesting to consider that even the Gates Foundation, hardly the anti-patent group, maintains certain programs and policies to ensure that Gates-funded inventions are used for charitable purposes, with limitations on pricing.
Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a doctor, an Army Reserve colonel, and the former top doctor for the Pentagon. There, he praised the central role of the Department of Defense in bringing important prostate cancer medicines to market, including Xtandi (referred to by its experimental name, MDV3100), an expensive prostate cancer drug that was funded from basic research through phase I and II clinical trials by taxpayer and charitable funds. Continue Reading
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
At the 32nd session (13 June 2016 – 1 July 2016) of the Human Rights Council, a bloc of countries known as the the Core Group (Brazil, Egypt, Indonesia, India, Senegal, South Africa and Thailand) have tabled a resolution on access to medicines “premised on the primacy of human rights over international trade, investment and intellectual property regimes.” The draft resolution complements the work of the United Nations High-Level Panel on Access to Medicines in reviewing and assessing “proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inven Continue Reading
Health Minister Alejandro Gaviria issued a declaration that it would be in the public interest for the government to lower the price of Novartis’ expensive leukemia drug, Gleevec (imatinib).
CONTACT: Andrew Goldman, +1 (202) 332-2670 or firstname.lastname@example.org
The following individuals are also available for comment:
- Andrea Carolina Reyes Rojas, Misión Salud: email@example.com
- Dr. Francisco Rossi, IFARMA: firstname.lastname@example.org
Washington, DC, June 17, 2016 — Colombian Minister of Health Alejandro Gaviria today issued Resolution 2475 of 2016, declaring that it would be in the public interest for the government of Colombia to lower the price of an expensive leukemia drug. The Ministry of Health describes this resolution as unprecedented in Colombia.
The drug, imatinib, is marketed as Glivec in Colombia by the Swiss pharmaceutical company Novartis at a price of approximately $15,000 per patient per year, nearly twice the average income of a Colombian resident. Glivec has generated over $47 billion in global revenue for Novartis. Continue Reading