Blogs

NIH to taxpayers — we don't care about high prices in US for Xtandi.

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.

April 28, 2016 letter regarding US Senate Finance threats over compulsory license on Novartis cancer drug patents

Update: english translation of letter now available at end this blog.

Gates Foundation v. Teachscape: Restrictions on Patenting of Gates-Funded Inventions

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.

S. Ward Casscells, Pentagon Medical Chief, Praised Army Role in Xtandi Development

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.

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

Colombia Issues Public Interest Declaration To Lower Price of Glivec

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 andrew.goldman@keionline.org

The following individuals are also available for comment:

  • Andrea Carolina Reyes Rojas, Misión Salud: subdireccion@mision-salud.org
  • Dr. Francisco Rossi, IFARMA: francisco_rossi@hotmail.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.

Novartis complaints over public interest declaration debunked

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."

US Chamber of Commerce defends Swiss drug company charging excessive prices in Colombia

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David Hirschmann, US Chamber, claims efforts to curb high prices for cancer drugs are "a destructive course."

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.

Alfred Engelberg and Aaron Kesselheim in Nature on Bayh-Dole royalty free rights in patents, Xtandi case

Alfred Engelberg and Aaron Kesselheim have published an opinion article in Nature titled:

"Use the Bayh-Dole Act to lower drug prices for government healthcare programs," Nature Medicine 22, 576 (2016) doi:10.1038/nm0616-576, Published online 07 June 2016.
http://www.nature.com/nm/journal/v22/n6/abs/nm0616-576.html

Colombia Ministry of Health Announces that Negotiations With Novartis Have Failed; Declaration of Public Interest Imminent

Reports have emerged from a DNDi meeting in Rio de Janeiro, Brazil, that the Colombian Ministry of Health announced that negotiations with Novartis over the price of Glivec have failed, and that Minister Alejandro Gaviria will proceed with the formal declaration that a compulsory license for the patents on the drug is in the public interest.

US proposal to seek a "better understanding" of Switzerland's implementation of the Nagoya Protocol receives chilly reception

*The author thanks Professor Marc Perlman (Brown University) for his comprehensive notes on the IGC deliberations of 3 June 2016.

WIPO IGC30: Narrowing existing gaps relating to the protection of genetic resources?

By Sophia Simon

This week, the World Intellectual Property Organization (WIPO) is convening the 30th session of the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (GRTKF) from 30 May 2016 to 3 June 2016. The goal of this week’s session is to "[u]ndertake negotiations on [genetic resources] GRs with a focus on addressing unresolved issues" and to consider "options for a draft legal instrument." The Committee is chaired by Ian Goss (Australia).

WIPO IGC30: Clean and track-changed version of Facilitators' text on Intellectual Property and Genetic Resources

In October 2015 the General Assembly of the World Intellectual Property Organization (WIPO) renewed the mandate of the the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (GRTKF):

HAI/KEI intervention at the WHA69 on the Framework of Engagement with Non-State Actors

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The following is the intervention on behalf of Stichting Health Action International (HAI) at 69th World Health Assembly, Agenda Item 11.3 - Framework of engagement with non-State actors.

KEI worked with HAI on the statement, and the statement was delivered by Thiru Balasubramaniam


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