Compulsory Licencing of Patents and Access to Essential Medicines

THIS ARTICLE WAS WRITTEN BY BITTHAL SHARMA A STUDENT OF RAJIV GANDHI NATIONAL UNIVERSITY OF LAW (RGNUL)

What is a Patent?

A patent is an exclusive right for an invention which could be a product or a process. A Only the person who has got the patent registered has the right to use the invention for a limited period of time.[1] Products in the form of ball pen, telephone and an 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 owners permission. If a person does it so, he is liable for committing patent infringement.

Compulsory Licencing and Patents

A compulsory licence is a licence given by the government of a country to a person allowing him to use an invention without the patent owner’s permission.[2] This happens when the patent owner doesn’t uses the invention or uses it in an improper manner.There have been various instances of a government issuing compulsory licences 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 licences wherein certain conditions for the issuance of the licences are laid down[3]. Some of them include:

• Issuance of licence on the basis of merit
• The licence is supposed to be issued only after an initial attempt to obtain authorization with the owner has failed
• Compulsory licence is not exclusive
• It is not assignable
• Only a competent authority has the power to grant compulsory licence which is subject to judicial review[4]

Essential Medicines and Compulsory Licences

Recently, there has been intense debate over the topic whether compulsory licences 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 licencing 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 in order to have access to essential medicines.The ambiguous provisions given in the International legal framework makes the 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 licence only after the fulfilment of certain conditions while liberal and wide provisions such as Article 27 which provides for exceptions to patents. It allows issuing of compulsory licence in cases where members wish to protect public order and morality, including the protection of human life.[5]Article 27 allows a government to issue compulsory licence to a third party for manufacturing and importing of essential drugs in case of 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 patent in these countries by various pharmaceutical companies, access to them is very difficult for the people in other countries. Due to this, in the WTO Ministerial Conference in 2001 issued a ‘Declaration on the TRIPSAgreement and Public Health’ in Doha, Qatar.The declaration is an important step forward in the 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 pubic 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.[6]Paragraph 5 of the declaration expands upon the objective stating that each TRIPS member has the right to grant compulsory licences having the freedom to determine the grounds upon which they are granted.The members are free to determine which conditions constitute 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 licences 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 health of the population. In short, States not only have a duty to ensure that existing medicines areavailable within theirborders, they also have a responsibility to take reasonablemeasures to ensure that much-needed new medicines are developed and therebybecome available.[7]

Important Cases

• Natco v. Bayer

It is one of the landmark cases on compulsory licencing obtained in India in which Natco, a generic drug manufacturing company requested for a voluntary licence from Bayer. The request was denied by Bayer after which Natco filed an application for grant of compulsory licence. Natco finally received the licence from the Drug Controller General of India for manufacturing the drug.

• Germany: Raltegravir, Federal Court of Justice of Germany, X ZB 2/17

In the above case, the Federal Court of Justice allowed a compulsory licence under a patent for a pharmaceutical active ingredient for the first time ever. It was held by the German Court that public interest in such a licence may still exist where it concerns only a small group of patients.[8]

• United States v. South Africa

A legislation was introduced by South Africa which allowed the Health Minister to issue compulsory licences for pharmaceuticals. This action was interpreted by United States to be in violation of the spirit of Intellectual Property since it has continuously discouraged the use of compulsory licences for the promotion of scientific research and development. The issue was finally solved between the nations without the interference of the WTO.

[1]https://www.wipo.int/patents/en/

[2]Sara m. ford, Compulsory Licensing Provisions Under the Trips Agreement: Balancing Pills and Patents, AMU Int’l LR (2000).

[3]Ibid.

[4]Trips part ii, art. 31.

[5] trips part ii, sec.5, art. 27

[6]Richard Elliott, Patents, International Trade Law and Access to Essential Medicines, May 2002.

[7]Paul Hunt & Rajat Khosla, The Human Right to Medicines, 8 SUR – Int’l J. on Hum Rts. 99 (2008).

[8]at, http://patentblog.kluweriplaw.com/2017/10/24/raltegravir-federal-court-of-justice-of-germany-x-zb-217-11-july-2017/ (last accessed Feb.10).