Compulsory licensing of medical patents

Background FAQ on Glivec (imatinib) compulsory license in Colombia

(More on Colombia here: http://keionline.org/colombia)

For more information, contact:
(U.S.) Andrew Goldman, KEI: andrew.goldman@keionline.org or +1 (202) 332-2670
(Colombia) Andrea Carolina Reyes Rojas, Misión Salud: subdireccion@mision-salud.org
(Colombia) Dr. Francisco Rossi, IFARMA: francisco_rossi@hotmail.com

Frequently Asked Questions

What is happening in Colombia with regard to imatinib?

Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents

When the United States federal government funds research that results in patents, it obtains rights, either directly or through contracts, to the patents. These rights are retained even when the patents are licensed to a third party, for example, to develop a commercial product like a drug or a vaccine. The rights include (1) a royalty free right in the patents "though out the world" to be practiced "for or on behalf of the United States," and (2) march-in rights in the patent.

Bicameral letter from 6 Senators and 6 members of the House to NIH

On March 28, 2016, six Senators and six members of the House of Represenatatives sent a letter to HHS Secretary Burwell and Director Collins at NIH, calling for an "open and transparent public hearing" to discuss the issues presented in the KEI/UACT request that HHS or NIH exercise their rights under the Bayh-Dole Act to break the patents on Xtandi, a $129,000/year federally-funded drug for metastatic prostate cancer that costs the United States 2-4x what other high income countries pay.

2016 Xtandi Petition

On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes of Health (NIH) and Department of Defense (DoD) asking that they exercise their authority under the Bayh-Dole Act to authorize the generic production of an expensive prostate cancer drug.

KEI and UACT asked that the NIH use either its royalty-free, non-exclusive license or march-in rights.

The Johnson & Johnson Acuvue Compulsory License

In April of 2010, District Judge Timothy J. Corrigan (M.D Florida, Jacksonville division) declined to grant a permanent injunction following a finding that the Johnson & Johnson’s ACUVUE®OASYS contact lens product infringed patents owned by CIBA Vision Corporation, providing another example of, in effect, a judicial compulsory license following the 2006 eBay v. MercExchange case; the judge wrote:

The CoreValve compulsory license on patent to treat aortic stenosis

On February 7, 2011, a federal judge in Delaware rejected a request for an injunction to prevent the continued infringement of United States Patent No.

Statement of the United States to WTO TRIPS Council on the Paragraph 6 System

The following statement was delivered by USTR at the WTO Council for TRIPS Annual Review of the Paragraph 6 System on Wednesday, 27 October 2010.

Statement of the United States
Agenda item F, Annual Review of the Paragraph 6 System
Topic 5

Mr. Chairman

We are pleased to be here today to participate in the annual review on the implementation of paragraph 6 of the Doha Declaration.

Remarks by UNAIDS Secretariat and on behalf of UNDP: Capacity building on the Paragraph 6 System and related TRIPS flexibilities

The following statement was delivered on Wednesday, 27 October 2010 by the UNAIDS Secretariat and on behalf of UNDP during the Annual Review of Paragraph 6.

World Trade Organization
Council for TRIPS – Regular Session
Annual Review of Paragraph 6
Doha Declaration on the TRIPS Agreement and Public Health
Agenda item 4 – Capacity building on the Paragraph 6 System and related TRIPS flexibilities
Remarks by UNAIDS Secretariat and on behalf of UNDP
27 October 2010


Mr Chair, Distinguished Delegates

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