The NIH patent license agreement with the UNITAID supported Medicines Patent Pool for patents on darunavir

KEI Statement on NIH license of darunavir to the Medicines Patent Pool.

“The announcement today by the White House that the NIH is providing a royalty free license for patents on darunavir to the Medicines Patent Pool is a welcome political statement that the Obama Administration recognizes the importance of a competitive supply of low cost generic medicines in the struggle to make AIDS treatment sustainable. The involvement of NIH Director Francis Collins provides a signal to other patent owners that the time is now to embrace a policy of open licensing of patents to the Medicines Patent Pool. There is much more the NIH can do, and much more other patent owners can do. This is the beginning of a campaign to obtain licenses voluntarily. The alternatives to the success of voluntary measures are confronting the challenges of obtaining non-voluntary licenses, or shrinking the number of persons who will receive treatment. I think everyone recognizes the stake are very high.” James Love, Director, Knowledge Ecology International.

30 September 2010

Background:

The National Institutes of Health as part of the United States Public Health Service (PHS) within the US Department of Health and Human Services (HHS) granted the Medicines Patent Pool a royalty-free nonexclusive license related to the NIH’s method of treatment patents relating to the protease inhibitor darunavir. The scope of this license applies to “low and middle-income countries, as defined by the World Bank”. The following is a walkthrough the licensing agreement entered in between the US PHS and the Medicines Patent Pool.

The Patent License Agreement is a 20 page document which consists of a cover page, a six page Agreement, a Signature page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Licensed Products, Processes, Territory, Field of Use and Termination) and Appendix C (Development Plan).

The cover page lists he license application number is: License Application Number: A-373-2010, designates the licensee as ‘Medicines Patent Pool Foundation’. The additional remarks on the cover pages state:

This license agreement will provide complete rights to use the patents on a worldwide basis and to sell products covered therein in low and middle income countries. It is equivalent to an internal commercial use license agreement in all countries where the patents are actually pending or have issued, specifically the United States, Canada, Australia, Japan and member states of the European Patent Office.

Public Benefit(s): Make and develop antiretrovirals for use in low and middle-income countries

The patents covered by the Patent License Agreement include the following:

The first patent listed under the licensed agreement 7,470,506 is listed under the FDA Orange Book under the active ingredient darunavir ethanolate for the “treatment of human immunodeficiency virus (HIV) infection in adult patent patients, and treatment of human immunodeficiency virus (HIV) in pediatric patients 6 years of age and older. The patent listed under the Orange Book expires on 23 June 2019.

In the background section of the license agreement, it is noted that:

1.2 By assignment of rights from PHS employees and license from other inventors, HHS, on behalf of the Government, owns or controls intellectual property rights claimed in any United States or foreign patent applications or patents corresponding to the assigned inventions. HHS also owns any tangible embodiments of these inventions actually reduced to practice by PHS.

1.3 The Secretary of HHS has delegated to PHS the authority to enter into this Agreement for the licensing of rights to these inventions under 35 U.S.C. §§200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. §3710a, and the regulations governing the licensing of Government-owned inventions, 37 C.F.R. Part 404.

1.4 PHS desires to transfer these inventions to the private sector through commercial research licenses to facilitate the commercial development of products and processes for public use and benefit.

1.5 Licensee desires to acquire the rights to use certain of these inventions in order to develop processes, methods, or marketable products for public use and benefit.

In terms of definitions, the Licensing Agreement states:

2.2 “Government” means the government of the United States of America.

2.3 “Licensed Patent Rights” shall mean:

(a) U.S. patent applications and patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;

(b) to the extent that the following contain one or more claims directed to the invention or inventions claimed in 2.3(a):

• (i) continuations-in-part of 2.3(a);
• (ii) all divisions and continuations of these continuations-in-part;
• (iii) all patents issuing from these continuations-in-part, divisions, and continuations; and
• (iv) any reissues, reexaminations, and extensions of these patents;

(c) to the extent that the following contain one or more claims directed to the invention or inventions claimed in 2.3(a): all counterpart foreign applications and patents to 2.3(a) and 2.3(b), including those listed in Appendix A; and

(d) Licensed Patent Rights shall not include 2.3(b) or 2.3(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter of a claim in 2.3(a).

2.4 “Licensed Products” means tangible materials which, in the course of manufacture, use, sale, or importation would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

2.5 “Licensed Processes” means processes which, in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

2.6 “Licensed Territory” means the geographical area identified in Appendix B.

2.7 “Licensed Fields of Use” means the field of use identified in Appendix B.

The Licensing Agreement states the following regarding Grant of Rights:

GRANT OF RIGHTS

3.1 PHS hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a royalty-free nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make, have made, and to use, but not to sell the Licensed Products and Licensed Processes in the Licensed Fields of Use for the purposes of supplying the Licensed Products in low and middle-income countries, as defined by the World Bank. PHS represents that PHS has the legal right, title and interest in the Licensed Patent Rights to enter into this Agreement.

3.2 This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of PHS other than the Licensed Patent Rights regardless of whether such patents are dominant or subordinate to the Licensed Patent Rights.

3.3 PHS acknowledges that information relating to the Licensed Patent Rights may be of assistance to Licensee in its commercialization efforts. Accordingly, PHS shall consider reasonable requests by Licensee for access to the inventors of the Licensed Patent Rights.

A key provision regarding performance states:

5.2 Licensee agrees not to use the Licensed Products for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46. Licensee agrees not to use the Licensed Products for research involving human subjects or clinical trials outside of the United States without notifying PHS, in writing, of this research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to PHS of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of this research or trials.

Annex B of the Licensing Agreement provides the following data:

I. Licensed Territory:

(a) United States, Canada, Australia, Japan, Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, and Sweden.

II. Licensed Fields of Use:

(a) Treatment and prevention of medical conditions affecting humans

III. Termination:

(a) This Agreement shall expire, on a country-by-country basis within the Licensed Territory, on the last to expire patent containing a valid claim, unless previously terminated under Article 7.