Pooling patents for HIV drugs: A paradigm shift

Nirav Bhatt is an LLM candidate at Osgoode Hall Law School.

According to a report, AIDS, which is caused due to Human immunodeficiency virus (HIV) killed more than 25 million people worldwide from 1981 to 2006. Already, over six million people with HIV/AIDS are dying because they have no access to lifesaving medicines.  The current HIV drugs which are in market are available at prices that members of the developing countries can not afford. Therefore on one hand we have the Antiretroviral treatment which reduces both the mortality and the morbidity of HIV infection, but on the other hand, the routine access to antiretroviral medication is not available in some countries at lower costs. A possible answer to this problem is a patent pool. It is a one stop shop to answer the needs for HIV drugs at lower costs.

A patent pool is a consortium of at least two companies agreeing to cross-licence patents relating to a particular technology.  The creation of a patent pool can save patentees and licensees, both time and money. To address the issues of pooling HIV drug patents, UNITAID is promoting patent pools as a strong humanitarian case.

According to SciDev.Net – the Science and Development Network, UNITAID’s proposed patent pool would work by collecting patents held by the pharmaceutical companies and making them available to the developing world for drug production or research at the cost of an affordable licence fee or royalty. When a company creates a new drug, the patent protection prohibits other companies from producing and selling the drug or using it for research. Occasionally, the patent-holder may give other organizations access to its protected knowledge, but usually only in an extremely restricted capacity and at high cost — which puts low and middle income countries out of the running.  The UNITAID HIV patent pool would mean generics could be made immediately, and research could begin into new drug combinations and child-friendly formulations. Some pharmaceutical companies who are considering idea are Johnson and Johnson, Gilead, and Cipla who have been openly supportive, and Novartis and Merck are reportedly in talks with UNITAID. GlaxoSmithKline too haven’t ruled out joining the patent pool.

According to bmj.com, an international peer reviewed medical journal, the international medical aid organization Médecins Sans Frontières (MSF) is too calling on nine of the world’s largest drug companies to pool their patents on newer HIV drugs and to make them available in developing countries. The campaign is inviting the companies, which include Abbott Laboratories, GlaxoSmithKline, and Pfizer, to place the patents for a list of HIV drugs into a patent pool set up by UNITAID, that partners with organizations including the World Health Organization and UNAIDS to purchase drugs for developing countries.

However, it is to be seen if this is the appropriate solution; as few countries have issued compulsory licences to allow manufacturers to produce generic versions of patented drugs. This is in compliance with the TRIPS agreement of the WTO which imposes obligations on member countries with regards to grounds for granting and importing under compulsory licensing as well as compliant with the Doha Declaration on TRIPS & Public health. WTO members on 6 December, 2005 approved changes in TRIPS agreement, making a permanent decision on patents and public health originally adopted in 2003. This will now formally be built into the TRIPS Agreement when two thirds of the WTO’s members have accepted the change. Once two thirds formally accept it, the amendment will take effect in those members and will replace the 2003 waiver for them. While initially Canada, India, Norway and the EU had changed their laws and regulations in order to implement the waivers and to allow production exclusively for export under compulsory licence, Canada accepted the amendment to TRIPS agreement on 16th June 2009.

But if it comes to financial incentives, UNITAID still needs to come up with a solution for the companies to join as they are unlikely to do so from corporate goodwill alone. Due to the enormous profits that HIV drugs can bring, companies are unlikely to settle for less. In these circumstances, Article 31(f) of TRIPS requires that compulsory licenses be used “predominantly” for local markets. The royalties the patent holder receives by way of compulsory licensing are sufficient enough as they are either set by law or determined through some form of arbitration.

To conclude, the Doha declaration recognizes that there are flexibilities within the TRIPS agreement which can be used for public health purposes and particularly for purposes of taking measures to ensure access to medicines for all. Therefore it is to be seen how effectively it applies to ensuring access to HIV drugs. On the flip side, UNITAID’s proposal for a patent pool comes as the World Intellectual Property Organization (WIPO) is revitalized under new leadership. The new head, Francis Gurry, is trying to revive the organization’s development agenda. Therefore, UNITAID now need to make sure they successfully broker what could be a hugely important deal for the developing world.