Whose Vaccine Is It, Anyway

On March 11, 2020, the world woke up to the declaration of pandemic by the World Health Organization (WHO) due to the virus outbreak in Wuhan. The race commenced to find a cure or vaccine for the virus called Coronavirus Disease 2019 or COVID-19 caused by SARS-CoV-2, the genetic sequence of which was disclosed on January 10, 2020.  While the race to develop covid cures, vaccines and diagnostic technologies are on, so are the murmurs of invoking compulsory licensing (CL) under Patents Act which is now before the  Supreme Court of India.  But is CL feasible?

Patents are territorial intellectual property rights.  The Indian Patent Law mandates 5 forms of compulsory licensing (CL) under the following 3 trigger situations :

• ‘March in’ rights by Indian government to access the pending or granted patents :

– on notification by government in circumstances of national emergency under S. 92,

– use by government under S.100,

– Acquisition by government under S.102 for public purpose.

• Where the government of other country allows importation of pharma products from India, enabling third parties to access the Indian patents for export to that country under S.92A.
• Where a third party who has been refused a voluntary license by the patent owner approaches Patent Controller under S. 84 on the grounds that reasonable requirements of the public are not met at reasonable price.

The only Indian patent is for the drug Remdesivir of Gilead Sciences filed in 2015 and granted in February 2020, effective in the treatment of ‘filoviridae virus infections’, including coronaviruses, as well as Ebola, Cueva and Marburg viruses.

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While Covishield and Covaxin have received the drug controller’s approval, the former is produced by Serum Institute under sublicense from AstraZeneca which has an exclusive license from Oxford University Innovation Ltd.  While the government may consider ‘march in’ rights in Remdesivir there is no scope of this for the Covishield vaccine.

Patent(s) for Covaxin is pending.  Developed by Hyderabad-based Bharat Biotech, in collaboration with Indian Council of Medical Research, Delhi and its subsidiary the National Institute of Virology at Pune, Covaxin was issued emergency drug controller’s approval on January 3, 2021.  There are new vaccines such as SputnikV to be manufactured by Panacea Biotech, vaccines from Zydus Cadila and BiologicalE in the pipeline.

The heavy investment in R&D and drug approval is usually recouped through pricing and tightly managed patent portfolios.  The present situation begs a different approach given the unprecedented pandemic.

While Serum Institute initially offered differential pricing to the Central and state governments, Bharat Biotech provided the first 1.65 million doses at no cost to the government, another 5.5 million doses are priced at Rs 206 per dose. For the private market, each dose of Covaxin costs Rs 295 rupees (US$ 4) which is the cheapest as compared to US$ 26–US$ 40 for Moderna, and US$ 37 for Pfizer/BioNTech. Government has capped Covaxin at Rs 250 per dose for private market.  

On April 16, 2021, additional funding of Rs 65 crores was announced to Bharat Biotech and Haffkine Institute for an additional 70,000,000 Covaxin doses by July, 2021. The need of the hour is access to covid related technology either through a global patent pool or WTO’s suspension of IP rights to deal collectively against the ever-mutating Covid virus.

India and South Africa have placed a proposal before the WTO under Article IX:3 and IX:4 of the WTO Agreement, asking for a temporary waiver of patent obligations under the TRIPS Agreement for the COVID-19 vaccines. While 57 WTO members have backed the proposal, it has been opposed by United States, EU, the UK and Canada.

Will CL provide the public with greater access to Covid technologies? No.  Since it will be limited to patents filed in India and it takes time to identify companies with proper facilities. India has challenges that are beyond the scope of S.92 ‘march in’ rights.

One hopes that the collective wisdom of the WTO will prevail to accept the India-S.Africa proposal.  The pandemic is not an opportunity to mint money but a race against time to save lives by developing covid technologies and vaccines to curb the ever-mutating Covid virus that has caused so many deaths and economic mayhem globally.

The author is a an advocate and a licensed patent agent. Views expressed are personal.