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©Juan Carlos Tomasi

One essential fact is that there are entirely lawful and effective tools to overcome the barriers posed by patents and that hamper access to medicines.  There are provisions enshrined in international patent laws that allow countries to take specific steps if a patent is no longer providing the win-win situation where both the patent holder and society benefit from an invention.  

The main ones include:

Designing patent laws in a way that is favourable for access to medicines
Countries have the right to define, in accordance with their public health needs, what deserves a patent and what doesn’t – this is known as patentability criteria. Countries also have the right to authorise civil society groups or other actors to oppose a patent application before the patent is granted.  This process, known as a ‘pre-grant opposition’, is a crucial safeguard to ensure the national patent office grant patents only for inventions that meet the patentability criteria defined in the national patent law.

By having strict patentability criteria and allowing for patent oppositions, it is possible to find a balance between international obligations to grant patents for pharmaceutical products and the need to make drugs as affordable as possible.  

This is precisely what India did when it was obliged under international rules to amend its Patents Act in 2005. The new Indian patent law contains several crucially important features to prevent patents from being granted too easily, not least provisions that specifically prohibit patenting of known compounds or substances (so that patents are granted essentially for new molecules and not modifications of existing ones). The 2005 Indian Patents Act also includes the possibility of pre-grant opposition for any third party.


Overriding patents through compulsory licences
In order to serve health needs, countries can also override patents – in an entirely lawful manner - by issuing what is called a compulsory licence.  A compulsory licence allows country A to produce, or to import from country B, a more affordable generic version of a drug that is under patent in country A.  This can be done without the permission of the patent holder, who must nevertheless be paid royalties.

One example is Thailand.  Until recently, two patented AIDS drugs – efavirenz and lopinavir/ritonavir – were available in Thailand only from the patent holders, and at high prices. In late 2006 and early 2007, the Thai Ministry of Health issued compulsory licences authorising the governmental pharmaceutical organisation to import the drugs from Indian generic manufacturers, at a fraction of the price of the patented drugs, and allowing more patents to receive treatment under the universal health care system.  

Legal measures, but fiercely fought
All of these measures are perfectly legal under international law.  It is crucial to remember these are entirely lawful acts, and that their use is by no means limited to developing countries.  Recently, for example, both Italy and the United States have resorted to compulsory licences for health products.

Yet the use of these flexibilities by developing countries has often attracted a storm of controversy and criticism.  Wealthy countries such as the US or the European Commission have responded to these actions by threatening trade sanctions for example.  There have also been measures of retaliation by pharmaceutical companies, notably for instance when Novartis mounted a failed legal challenge to India’s new patent law, or when Abbott responded to Thailand’s compulsory licence on its antiretroviral medicine by withdrawing all its applications to register new drugs in the country.   

Last updated: January 2009