Compulsory licensing: Noble or ignoble during COVID-19?

With the world battling with the novel coronavirus, there have been many substantial developments in the field of intellectual property (IP) and pharmaceuticals. New means to prevent, treat and mitigate Covid-19 are being researched for developing effective medical treatments as fast as possible. The development of such medical treatments to prevent and treat Covid-19 is far more important for developing countries, wherein complete lockdown of the entire economy for slowing down the transmission of disease could be disastrous in the long run.

Owing to the continuous efforts of the pharmaceutical companies, there is an indication that effective treatments for coronavirus may soon emerge; however, the questions arises whether people will be able to access them at affordable prices or not. Considering this fact, governments of various countries do not seem to support patent-based monopolies for lifesaving medical treatments. In other words, patent monopolies and exclusivities are hindering the governments to explore effective options to tackle the Covid-19 emergency situation across the globe.

To combat the current health crisis the governments have begun to adopt alternative measures to tackle the unprecedented situation of the Covid-19 pandemic. Accordingly, various countries are taking pre-emptive measures, such as compulsory patent licensing, to deal with the monopolies for lifesaving medical treatments. Although, the laws of various countries differ on how and under what circumstances a compulsory license should be issued, the basic premise of the measure being invoked at a time of great and urgent national need is the same across jurisdictions. Because of the urgency of this crisis, several countries have issued, or are in the process of issuing compulsory licenses (or their equivalent laws).

Israel, issued a compulsory license to import the generic version of AbbVie's Kaletra, a fixed-dose antiretroviral combination drug i.e. Kaletra (Lopinavir/Ritonavir) from India for treating coronavirus, which is generally prescribed for the treatment of HIV/AIDS. The license is granted under section 104 of the Israeli Patents Law to allow importation of the generic version of the drug. Germany and Canada have amended their patent protection laws to granting of compulsory licenses. In particular, Germany has passed a new legislation, Prevention and Control of Infectious Diseases in Humans Act, for issuance of compulsory license under the section 13(1) of the Patent Act of Germany. Similarly, Canada also passed a new law, COVID-19 Emergency Response Act, which empowers the government to issue a license at first without negotiating with the patent holder. Chile and Ecuador have each passed resolutions urging their governments to issue compulsory licenses to make it easier to obtain patented drugs to combat the Covid-19 crisis.

Brazil, also introduced a bill to allow the government to temporarily suspend the patent monopolies for medical products which may be used to prevent and treat Covid-19; however, such license shall be valid till the duration of emergency. Contrary to this, Interfarma, a trade group representing drug makers in Brazil, stated that compulsory license, a tool to override patent holders' rights to promote generic drug competition, does not foster the immediate transfer of knowledge to speed up production, rather, the same increases the risk of misallocation and inefficient use of resources or raw materials. Further, Interfarma, stated that compromising on the intellectual property protections can result in long lasting damage which would affect future innovations in almost all sectors of the economy and wither the ability to restore national health systems in any future crisis.

Moreover, it is important to note that all the WTO members agreed in the Doha Declaration on TRIPS and Public Health which affirms that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health". This system allows the exporting country to issue a compulsory license for the purpose of exports to an importing country. However, such importing country has to notify to the WTO about its insufficient manufacturing capacity. Due to the immediate need of a drug/cure for Covid-19, many countries might find themselves insufficient in terms of manufacturing capacities and thus, might seek other countries' help to produce sufficient supplies.

In view of the grim and urgent situation arising from the pandemic, a resolution for implementation of already inherent flexibilities in the TRIPS agreement was put forth in the World Health Assembly (WHA). India has co-sponsored this resolution, which calls for four key measures to be taken to combat the pandemic. These measures include fair distribution of health technologies, preference of the TRIPS flexibilities over any existing IP rights involving health technologies relevant for COVID19, vaccines for COVID19 and increased R&D and global data pool geared towards finding COVID19 health technologies.