Compulsory Licensing of Patents and Access to Essential Medicines
What is a Patent?
A patent is an exclusive right for an invention that could be a product or a process. Only the person who has got the patent registered has the right to use the invention for a limited period. Products in the form of ball pen, the telephone, and the electronic iron come under the ambit of 'inventions' which has been previously patented by their respective inventors. A person cannot make use of the invention without the patent owner's permission. If a person does it so, he is liable for committing patent infringement.
Compulsory Licensing and Patents
A compulsory license is a license given by the government of a country to a person allowing him to use an invention without the patent owner's permission. This happens when the patent owner doesn't use the invention or uses it improperly. There have been various instances of a government issuing compulsory licenses to another entity for optimum and adequate use of the invention without the permission of the owner. Article 31 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) deal with compulsory licenses wherein certain conditions for the issuance of the licenses are laid down. Some of them include:
- Issuance of license based on merit
- The license is supposed to be issued only after an initial attempt to obtain authorization with the owner has failed
- A compulsory license is not exclusive
- It is not assignable
Only a competent authority has the power to grant compulsory license which is subject to judicial review
Essential Medicines and Compulsory Licenses
Recently, there has been intense debate over the topic of whether compulsory licenses should be issued for access to life-saving drugs without which millions of people may succumb to threatening diseases. This has resulted in a tussle between the developed and developing countries where the former want the compulsory licensing norm to be narrow and strict as this would help in the proliferation of more patents in the future whereas the latter countries want a lenient and liberal norm to have access to essential medicines. The ambiguous provisions given in the International legal framework makes things even more complicated. The provisions in TRIPS are both narrow and wide giving way to a rather contrasting framework. Certain narrow provisions such as Article 31 provides for the issuance of compulsory license only after the fulfillment of certain conditions while liberal and wide provisions such as Article 27 which provides for exceptions to patents. It allows the issuing of compulsory license in cases where members wish to protect public order and morality, including the protection of human life. Article 27 allows a government to issue a compulsory license to a third party for the manufacturing and importing of essential drugs in case of an outbreak of a life-threatening disease to save human life. Moreover, Article 7 of the agreement that the use of Intellectual Property Rights should be in a manner conducive to social and economic welfare, and to balance rights and obligations.
The Effect of Doha Declaration on Public Health
Despite the right to medicines being of the most essential human rights, around 2 billion people still lack access to essential medicines, mostly in underdeveloped and developing countries which makes these countries dependent on the developed countries for the supply of these medicines. But since most of the newly developed medicines are protected by patents in these countries by various pharmaceutical companies, access to them is very difficult for the people in other countries. Due to this, the WTO Ministerial Conference in 2001 issued a 'Declaration on the TRIPS Agreement and Public Health' in Doha, Qatar. The declaration is an important step forward in access to essential medicines for the countries not having access to them due to patent protection. The Doha Agreement states that the TRIPS agreement does not and should not prevent countries from taking measures to protect public health and that it should be interpreted in a way that supports countries' right to protect public health and also to promote access to medicines.Paragraph 5 of the declaration expands upon the objective stating that each TRIPS member has the right to grant compulsory licenses having the freedom to determine the grounds upon which they are granted. The members are free to determine which conditions constitute a national emergency or any other exigency. The most relevant provision of the Doha declaration is Paragraph 6 of the document which states that the ministerial committee recognizes that the WTO members with insufficient or almost no manufacturing capacities in the pharmaceutical sector face many challenges in their use of compulsory licenses under the TRIPS agreement. The declaration imposes a positive obligation on the developed states to make available the essential life-saving drugs in countries that don't have access to them and can't afford them for the protection of the health of the population. In short, States not only have a duty to ensure that existing medicines are available within their borders, they also have a responsibility to take reasonable measures to ensure that much-needed new medicines are developed and thereby become available.
Author: Bitthal Sharma, student of Rajiv Gandhi National University of Law (RGNUL), intern at Global Patent Filing. In case of any queries please contact/write back to us at email@example.com.