India’s drug regulator, the Central Drug Standards Control Organisation, approved two coronavirus vaccine candidates – Covishield and Covaxin – for “restricted use” in “emergency” situations. Covaxin is an indigenous vaccine candidate, developed by Bharat Biotech (Hyderabad), the Indian Council of Medical Research (Delhi) and the National Institute of Virology (Pune).
There are some important concerns about the safety and efficacy of Covaxin considering it was approved without the corresponding data from phase 3 clinical trials. In light of this, many independent experts have demanded that the government roll back Covaxin’s approval and wait for efficacy data.
The other candidate, Covishield, has been derived from an original developed by the British-Swedish drugmaker AstraZeneca. It’s phase 3 trials are currently underway in sites around the world. Preliminary reports from sites in the UK and Brazil have reported favourable results, but AstraZeneca has since been mired in multiple controversies over allegations that it has cherry-picked or fudged data to improve its market prospects.
AstraZeneca’s candidate vaccine has been approved for emergency use in the UK, Argentina, Dominican Republic, El Salvador, Mexico and Morocco. The EU is yet to follow but has preordered 400 million doses ahead of approval. However, the EU-AstraZeneca talks have been highly tense, with the block demanding that the company explain its erratic supply.
Against this background, the governments of developing countries – including of India – should prepare to issue compulsory licences for the COVID-19 vaccines.
Production capacity
Now is the time for India’s pharmaceutical industry to play a greater role in the global drug supply, pursuant to pharmaceutical security. India has already supplied lakhs of doses of Covishield as grants or gifts to Bhutan, Bangladesh, Maldives, Nepal, Myanmar, Seychelles, Sri Lanka and Morocco. Commercial exports are expected to follow soon.
Also read: India’s Gains From ‘Vaccine Diplomacy’ – if Any – Will Be Small, Transient and Pyrrhic
At this point, India must of course consider how many vaccine doses it can produce, what its own requirements are and what it can do to negotiate potential shortages.
Serum Institute of India, the Pune-based drugmaker that has a deal with AstraZeneca to manufacture Covishield in India, said it already has over 50 million doses ready and can produce 500 million more by July 2021. The Indian government plans to vaccinate three crore frontline and healthcare workers by July. India’s population is 1.38 billion and both Covaxin and Covishield are two-dose vaccine candidates. In addition, Serum Institute is a part of the WHO-backed Covax alliance set up to supply vaccines to low- and middle-income countries by the end of 2021, and has committed 100 million doses to this end, followed by 900 million more.
While Serum Institute’s production capacity is promising, it will have a tough time meeting both its national and international obligations. Time is an important factor here: the faster people are vaccinated, the closer we get to exiting the pandemic. At this juncture, the government of India should consider compulsory licencing of COVID-19 vaccines under its patent laws.
An employee in personal protective equipment (PPE) removes vials of AstraZeneca’s COVISHIELD, coronavirus disease (COVID-19) vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune, India, November 30, 2020. Photo: Reuters/Francis Mascarenhas/File Photo
Compulsory licencing
Patents are a form of intellectual property rights granted to individuals or companies for an invention deemed to be novel in nature and of some utilitarian value. The legal lifetime for patent protection is usually 20 years. In this time, the investor enjoys exclusive rights to exploit the patent’s intellectual contents while third parties are disallowed from doing so.
However, there is one way in which the controller general of the patent office can allow a third party to manufacture, use, sell and/or distribute a product that has been patented without having to obtain the consent of or a licence from the patent owner. The provisions for such an action, called compulsory licencing, are enshrined under chapter 16 of the Indian Patents Act 1970 and under section 31 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.
Pharmaceutical companies invest significant resources into researching, inventing and gaining approval for new medicines to treat known and emerging diseases. As such, the eventual prices of life-saving drugs can be quite high.
The University of Oxford, which developed the vaccine candidate that AstraZeneca has licenced in India under the name ‘Covishield’, has already patented the vaccine technology that Covishield uses. Last year, the university had also filed an application for another follow-on patent.
AstraZeneca and Serum Institute in turn entered into a licencing agreement to share the technology. Licencing agreements make for one way to commercialise intellectual property rights. From the point of view of the inventor, these agreements are collected under the term ‘voluntary licencing’.
Also read: How ICMR and Others Spun Covaxin’s Phase 1 Trial Results Out of Context
The concept of compulsory licencing complements this idea.
Under the Indian Patent Act, the government of India has the power to issue compulsory licences to any patents in force during a national emergency or to facilitate public non-commercial use. The government can also authorise specific companies to use an existing patent to save the state’s purposes.
India granted the first such licence in 2011 to a company called Natco Pharma, over a compound called sorafenib tosylate. In this case, Bayer Corp. was the inventor company and it marketed sorafenib tosylate under the name ‘Nexavar’, to help treat liver cancer. Bayer subsequently challenged the compulsory licence before the Intellectual Property Appellate Board, the Bombay high court and finally the Supreme Court of India. All appeals were dismissed.
The ongoing novel coronavirus pandemic certainly qualifies as a national emergency under section 92 of the Patents Act.
Compulsory licencing can thus be a powerful public health tool to work around concerns over an insufficient supply of important pharmaceutical products. While India currently doesn’t face a shortage of either of the two vaccine candidates, the government needs to be prepared nonetheless.
Men ride on a motorbike past a supply truck of India’s Serum Institute, the world’s largest maker of vaccines, in Pune, May 2020. Photo: Reuters/Euan Rocha
For example, a fire recently broke out at a Serum Institute facility in Maharashtra, killing five people and prompting a lot of questions over what might have happened had any Covishield doses been lost.
So should the need arise, the government can, under sections 92 and 92A, authorise leading pharmaceutical companies, other than Serum Institute, to produce Covishield and ensure India fulfils its national and international obligations as quickly as possible.
Also read: What Does Treating Covaxin and Covishield ‘Equally’ Entail?
The way ahead
A compulsory licence may not be the best way to deal with a pandemic because governments need to issue one on a case-by-case basis, and each government has to do so as well. However, it could be a powerful way out of the patent impasse – at least until the World Trade Organisation accepts the proposal of India and eight other countries to exempt member states from enforcing patents and other intellectual property rights for a limited period of time, on substances related to the treatment and elimination of COVID-19.
It’s notable that even the voluntary licences given to certain pharmaceutical companies are shrouded in secrecy, with opaque terms and conditions. Such exclusive licencing only encourages nationalism and does nothing to promote international collaboration – the need of the hour.
Shambhavi Sinha is a penultimate year B.B.A LL.B (Hons.) student at Symbiosis Law School, Pune.