Humanitarian Uses of Patented Inventions
This note concerns two areas of policy concerning humanitarian uses of patents. (1), a recommended exception to patent rights for humanitarian uses, and (2), the licensing of patents for humanitarian uses. Both examples focus on access to essential medical technologies.
1. Exceptions to patent rights for humanitarian uses.
The following proposal was first developed within discussions of the MSF Expert Group on Intellectual Property, motivated in part by cases involving lack of access to HIV drugs in orphanages in Africa and Romania.
Humanitarian uses of medical technologies
(a) It shall not be an infringement to make, use, import or export a patented invention for purposes of providing medical treatment to a person who otherwise would not have access to that medical treatment because they could not afford a product of service using the patented invention, or the patented invention was not otherwise available to the person, if the following conditions apply:
- The product or service is necessary to provide medical treatment or care for a serious medical disease or condition,
- There is no reasonable alternative available to pay for or otherwise acquire the patented invention, within the foreseeable and medically relevant future,
- The use is temporary,
- Efforts are made to secure sustainable sources of funding to pay for the patented invention on reasonable terms and conditions,
- The patent owner is notified of such use, and
- Appropriate notice is given to the [Department of Health ..... ]
(b) The [Department of Health ....] shall issue regulations to implement this provision.
The humanitarian use exception is necessary to ensure that a government implements the obligations of Doha Declaration on TRIPS and Public Health, and respects human rights.
The most important global norms concerning exceptions to patent rights are those found in the WTO TRIPS Agreement.
Exceptions to the exclusive rights of a patent can be implemented as remunerative or non-remunerative exceptions. For cases where the exceptions are remunerative, the TRIPS provides three primary options -- Articles 30, 31 and 44. For cases where the exceptions are implemented as non-remuneration exceptions, the most important section of the TRIPS is Article 30, which presents a three-step-test that such an exception must satisify, if this Article is used. (The three step test does not apply to Articles 31 or 44.2, which generally involve remuneration).
STANDARDS CONCERNING THE AVAILABILITY, SCOPE AND USE OF INTELLECTUAL PROPERTY RIGHTS
SECTION 5: PATENTS
Article 30 Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
The relevant conditions are:
- Is the exception "limited"?
- Does the exception "unreasonably conflict with a normal exploitation of the patent"?
- Does the exception ""unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
A WTO considered a challenge to an exception to patents rights in DS114 "Canada - Pharmaceutical Patents," a dispute over the exception to rights that allowed generic drug manufacturers to use, make, import and export patented inventions, for purposes to preparing a regulatory filing that would allow the commercialization of a generic medicine immediately after the expiration of a patent term. The Canadian pharmaceuticals case established certain limits on the use of Article 30, but did allow an exception to be used for the import and export of patented products, and to specially address the need to lower the price of medicines to address public policy objectives. DS114 also addressed a challenge to an exception on the grounds that it was an illegal form of discrimination under Article 27 of the TRIPS.
Article 27 provides that "patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced." The European Union asserted the Canadian exception was discriminatory. The WTO distinquished between differential treatment and 'discrimination," and permitted the exception.
Since the 2000 DS114 WTO Case, the WTO has adopted the Doha Declaration on TRIPS and Public health, which greatly strengthens the case for an exception focused on humanitarian uses.
The relevant text for the Doha Declaration on TRIPS and Public Health is paragraph 4, and in particular, the statement that the TRIPS "can and should be interpreted and implemented in a manner support of WTO members' right to protect public health and, in particular, to promote access to medicines for all."
Declaration on the TRIPS agreement and public health|
DOHA WTO MINISTERIAL 2001: TRIPS
20 November 2001
Adopted on 14 November 2001
4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.
In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
Also important are the provisions of the Universal Declaration of Human Rights, and the various implementing treaties, including the International Covenant on Economic, Social and Cultural Rights. Particularly relevant are Article 12 and 15 of the International Covenant.
International Covenant on Economic, Social and Cultural Rights
Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966
entry into force 3 January 1976, in accordance with article 27
2. Licensing of Patents for Humanitarian Uses
A second set of issues concerning humanitarian uses of patented inventions concerns the voluntary licensing patent rights, for particular purposes, fields of use or geographic areas.
Beginning in the late 1990s, CPTech undertook a number of efforts to license NIH funded patents to the World Health Organization, UNAIDS or other international organizations to facilitate access to treatments for AIDS and other illnesses. See, for example:
- September 4, 1998 petition from Thai AIDS patent to DHHS Secretary Donna Shalala, for licensing of NIH patents on DDI.
- September 3, 1999 letter to Dr. Harold Varmus from Ralph Nader, James Love and Robert Weissman, and the October 19, 1999 response of Dr. Varmus, rejecting the proposal. Representative Jan Schakowsky made a similar request, which was also rejected.
- March 28, 2001 Letter to US Secretary of Health and Human Services Tommy Thompson, from from Ralph Nader, James Love, and Robert Weissman.
In 2001, Amy Kapczynski, then a law student at Yale, pressed Yale University to modify its licensing of patents on d4T in South Africa. Kapczynski later founded UAEM, an organization that continues to press Universities to license inventions to address humanitarian needs. As a result of the leadership of UAEM, a number of Universities have implemented or are considering licensing of patents for humanitarian uses, or concessionary pricing of products using such patents. (More here).
On January 24, 2003 Pharmacia offered to issue voluntary, non-exclusive licenses to the patent rights to its antiretroviral drug delavirdine (sold as Rescriptor in the US) to generic firms. According to the Pharmacia press release, the offer applied to "countries with a per capita Gross National Income of less than $1,200 or an HIV infection rate of more than 1 percent," and required a five percent royalty on all generic sales. Pfizer acquired Pharmacia in April 2003. Pfizer terminated the license offer in November 2003.
UNITAID Patent Pool
At the 2002 Barcelona AIDS conference, CPTech proposed a patent pool for HIV/AIDS and other essential medicines. Working with MSF, KEI proposed such a pool to UNITAID. Today UNITAID is creating a patent pool for AIDS, and asking patent owners to voluntarily license patents to that pool. (more from UNITAID here and from KEI here, here, here and here.)
Incentives to License Patents for Humanitarian Uses
KEI is interested enhancements to the incentives to license patents for humanitarian uses.
Recently, Barbados, Bolivia, Suriname and Bangladesh have proposed a set of incentives for the licensing of of patents for humanitarian uses, including for example, this proposal:
A Prize Fund to Support Innovation and Access for Donor Supported Markets, Linking Rewards for Innovation to the Competitive Supply of Products for HIV-AIDS, TB, Malaria and Other Diseases for Humanitarian Uses, Proposal by Barbados, Bolivia, Suriname and Bangladesh to the WHO Expert Working Group on Sustainable R&D Financing. April 15, 2009.
Another approach would involve concessions on patent fees. In the UK and in some other legal systems, patent fees are cut by 50 percent when patent owners grant a license of right to use an invention. KEI proposes a deep discount in fees for patents that are licensed to bona fide humanitarian purposes. One possible approach would be to amend the WIPO PCT to consider a global norm to provide such incentives.