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.
Vivendi-SFR lobbyist nominated to WIPO by Hervé Le CrosnierOn July 14, 2016, the former Vivendi-SFR lobbyist Sylvie Forbin was named Deputy Director General of the WIPO “Culture and Creative Industries Sector” (the World Intellectual Property Organization is a United Nations agency). Incidentally the new name of the Sector, “Copyright and Creative Industries,” is revealing of her future professional activities.
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 initiatives
20 July 2016
For Immediate Release
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 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:
*(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.)
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.
On Wednesday morning, 29 June 2016, Nigeria, on behalf of the African Group, presented a revised proposal (SCP/24/4) for a WIPO work program on Patents and Health at the Standing Committee on the Law of Patents (SCP). The African Group proposal is a welcome breath of fresh air in the patent committee; the proposal aims to make WIPO more responsive to recent developments including: 1) "Challenges to public health ....
29 June 2016
World Intellectual Property Organization (WIPO)
Standing Committee on the Law of Patents (24th session)
Statement of Knowledge Ecology International: Patents and Health
Briefing Call on National Institutes of Health (NIH) patent policies, 29 June 2016, 11:00 A.M. (EST)
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: http://keionline.org/xtandi), the grant of exclusive licenses on government-owned inventions (http://keionline.org/nih-licenses), and transparency of decision-making at NIH more broadly.
For call-in information, please contact Zack Struver at firstname.lastname@example.org.
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.
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.
Human Rights Council heats up during informal talks on the primacy of human rights over international trade and IP regimes
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
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 email@example.com
The following individuals are also available for comment:
- Andrea Carolina Reyes Rojas, Misión Salud: firstname.lastname@example.org
- Dr. Francisco Rossi, IFARMA: email@example.com
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.
More on this dispute at http://keionline.org/colombia
In response to the recent announcement from Colombia's Ministry of Health that a public interest declaration regarding imatinib will be issued in a matter of days, Novartis issued a statement that criticized the forthcoming action, saying, "We have consistently said that Declarations of Public Interest can be important and legitimate tools to be used only in exceptional circumstances," and saying "this is simply not the case in Colombia."
The US Chamber of Commerce might consider renaming itself the US/Swiss Chamber of Commerce, after their most recent attack on the Colombia Minister of Health (MoH) announcement that a "Declaration of Public Interest" would be issued for the patents on the cancer drug imatinib, held by the Swiss company Novartis. In the US Chamber's defense of the Swiss drug company, they don't mention the fact that Novartis has earned about $48 billion from sales of imatinib (sold by Novartis under the brand names Gleevec or Glivec) since the drug was put on the market, including more than $380 million per month in 2015.