Questions of Compulsory patent licensing in times of Covid-19

Girish Somawarpet Nagraj

IP Expert - India IP SME Helpdesk

Global chaos set in 2020 with the onset of the COVID pandemic. Governments federal and state have struggled yet toiled on war footing to address health and economic concerns the world over. Focusing on India- it has been reported that while the government and citizenry relaxed owing to tiding over the first wave relatively unharmed, the second wave caught them unaware.

With the coming of the second wave and the devastation it has struck, the citizenry moved from vaccine hesitancy to vaccine hankering, while the government moved from vaccine opulence to vaccine sparsity. In all this chaos the role of vaccines in mitigating fatality has been recognised and endorsed world-over with more and more anti-vaxers jumping ships onto the vaccination camp.

This need for large number of vaccines has triggered the debate on licensing vaccine patents to developing countries to enable diffusion of knowledge to increase vaccination production capacities. One of the mechanisms floated around is by issuing compulsory patent licenses. Now, can India issue compulsory licenses to help diffusion of vaccine manufacture? The answer is no and yes. No, since compulsory licenses can be issued to inventions which have been granted patent rights in India. In case of the current COVID scenario , many inventions are new and have not yet been granted patent protection or have not yet been filed in India thus making them ineligible for compulsory licenses. The answer is yes, since Indian government still has powers under Indian Patent Act to license patent applications (not yet granted patent rights) for its own use.

India and South Africa floated the idea of intellectual property waiver or “TRIPS waiver” (Trade-Related Aspects of Intellectual Property Rights) at World trade Organization (WTO) last year. This was initially opposed by European Union and United States of America, however the present dire need to increase vaccine production has now mellowed their stance on transfer of intellectual property rights.  However, there are still legal bottlenecks in India’s patent legislation which must be deliberated upon to enable local pharmaceutical industries to produce vaccines.

Compulsory licenses (CL) envisaged under  Patents Act of 1970 are seen as the legal tools available to broaden vaccine manufacturing by granting intellectual property licenses to Indian manufacturers. Compulsory licenses are issued under section 84 and section 92 under the patents act. CL’s can be granted any time after three years following grant of the patent if the invention is not available in the Indian market at a reasonable prize or the invention is not being worked in India and in times of national or extreme emergencies.

The primary criteria for grant of compulsory licenses under sections 84 & 92 is that that the patent be granted. If we solely consider the case of Oxford/Astra Zeneca vaccine patents, the patent concerned are  WO2012172277 which India granted in the year 2019 and other patent application  (WO2018215766A1 )which had been filed internationally in the year 2017 under the Patent Cooperation Treaty (PCT) with India as one of the many designated states and has still not entered the Indian national phase.

Any international patent (PCT) application has two phases.  An international phase and the other the national phase.  International phase consists of the patent application being initially searched & examined for its unity of invention, novelty, and obviousness. Once searched and examined which takes up to 30 months for the date of filing the patent application, the owner can bring forth the said patent into the national phase where the Indian Patent Office examines and grants the patent to the owner.

In the case of inventions related to the present crisis, many product and process inventions have yet to enter the national phase in India. As discussed, an invention having secured or granted patent rights being the fundamental criteria for issuance of CLs under section 84 & 92, the present COVID related inventions do not seem to meet the criteria’s laid out.

Though compulsory license may be ineffective, the central government has another tool in its tool kit. The Patents Act under section 100 further empowers the central government to issue authorization licenses to use the invention for its own purposes irrespective of the invention being granted patent rights or in the pre-grant phase (application phase).The Bombay high court in Garware-Wall Ropes Ltd. vs A.I. Chopra And Anr. has laid down that that the central government can use this power to grant patent utilization licenses to third parties subject to payment of royalties to the patentee.

Section 100 does provide the necessary legal basis for issuing licenses to patent applications (not available under section 84 & 92) and granted patents for use by the government, however, the provisions does not address situations of international patent filing where  national phase (Indian) has yet not been triggered. There seems to be a chink in the legislation to address situations akin to the present crisis where inventions are yet to be filled or enter in India.

Concluding, it must be kept in mind that patents are a small cog of the whole process of vaccine production. Technology & knowledge transfer, logistics, physical infrastructure are far bigger hurdles to cross over than brawl over intellectual property licenses. CLs in India are not common and only one CL has ever been issued for Bayer’s cancer drug Nexaver. In the present situation, negotiations with individual vaccine manufacturers might fasten the process of vaccine manufacture and distribution rather than  get tangled in the web of CLs negotiations and legalese.