- Keywords > country case studies
- Keywords > innovation and intellectual property
- Keywords > Intellectual Property Rights (IPR)
- Keywords > patent information
- Keywords > patent system
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2003; 40 pages)
Each country must be able to design and operate its patent system in its own best national interest, using the flexibilities of the TRIPS Agreement. This principle was re-endorsed by the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which stated that the TRIPS Agreement "does not and should not prevent Members from taking measures to protect public health".
Patents were designed to ensure that the public benefits from innovations, but it is very clear that people in developing countries are currently not getting their part of the patent bargain. On the contrary: in many countries, patents hamper the public's access to life-saving medicines - in other words, profits are being put before public health.
This trend may be worsened by WIPO's ongoing negotiations aiming at developing a 'Substantive Patent Law Treaty', a global treaty that is very likely to be based on patent standards used in wealthy countries. This may lead to a system where any new medicine put on the market is patented worldwide.
Industrialised countries are also concluding bilateral agreements with developing and least developed countries to prevent them from using the Doha Declaration safeguards. Similarly, the US is trying to further limit the freedom of countries to grant compulsory licenses for public health reasons through ongoing negotiations on the Free Trade Area of the Americas (FTAA) Agreement.
As shown in the patent table, not all medicines are patented everywhere. But finding out whether a drug is patented in a particular country currently varies between being difficult and impossible. The World Health Organization (WHO) and WIPO urgently need to set up a user-friendly, public database providing comprehensive and transparent data on pharmaceutical patents of key medicines. This information should be accompanied with clear advice to countries on how to overcome patent barriers to medicines, and with technical assistance in doing so.
Drug patents that need not be granted are being granted in developing countries right now. This is true for example for "new" uses of existing compounds. The TRIPS Agreement defines the minimum intellectual property protection standards Members must adhere to, but there is no reason for countries to expand patent protection beyond that. In fact, patentability requirements in developing countries should be amended to keep the number of patents granted to an absolute minimum.
Even when a drug is patented, there are ways of overcoming this obstacle.
Patents that have been granted in developing countries may not be valid. Patents are already being challenged in some countries, for instance in Thailand. Countries should put in place appropriate checks and balances to revoke patents if necessary. To assist them, WHO and WIPO should provide data about essential drug patents that have been invalidated.
If patent holders are not willing to ensure equitable drug prices for poor countries or grant licenses voluntarily, governments must act. They can improve access to affordable medicines for their people by issuing a compulsory license for a patented drug or by making government use of a patent.
However, keeping the number of drug patents to an absolute minimum has advantages over the politically sensitive negotiations that currently precede issuing a compulsory license.
The patent system is a public policy tool: patents are contracts between their owners and society. Countries will come to test the flexibility of the TRIPS Agreement as they implement the Doha Declaration: the next few years will show whether ensuring that TRIPS is interpreted and implemented "in a manner supportive of WTO Members' right...to promote access to medicines to all" is feasible in practice. If this turns out not to be the case, the TRIPS agreement will need to be challenged.
"I am revolted when I hear claims that patent rights do not constitute a barrier to treatment here in South Africa. I have seen young women and men die from an AIDS-related brain tumour provoking unbearable headaches. I have seen children covered with scars due to AIDS-related dermatitis, unable to sleep for the pain. I knew that all of them could have been helped with antiretroviral therapy, but the cost of the patented drugs was the only barrier."
Dr Eric Goemaere, MSF, Khayelitsha, South Africa