It is no doubt that India was one of the worst hit countries of the second wave of the COVID-19 pandemic. Poor policy decisions and ineffective rules on the part of the government coupled with a disregard for the lockdown rules by the citizens proved to be a recipe for disaster. The second wave struck India during a strong and concerted vaccine drive by the government for all healthcare professionals, all citizens over 60 years of age and later, all citizens over 45 years of age.
Soon after, the country began facing an acute shortage of vaccines, an inevitable situation considering the population. The herculean task of vaccinating a population of 130 crore warrants not only foresight, but also an active effort and quick decision and policymaking on the part of the government.
This is where the provisions of the Patents Act, 1970 come into the picture. At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely:
(a) That the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
(b) that the patented invention is not available to the public at a reasonably affordable price, or
(c) that the patented invention is not worked in the territory of India.
As per Section 84, any person who is interested or already the holder of the license under the Patent can make a request to the Controller for grant of compulsory license on expiry of the three years, when the above conditions are fulfilled.
However compulsory licenses may also be granted, when –
- Section 92 A- For exports, under exceptional circumstances.
- Section 92A- In case of national emergency, extreme urgency of public non-commercial use by notification of the Central Government
- Section 92 A (1) – To a country which has insufficient or no manufacturing power in the pharmaceutical sector to address public health.
With the onset of the COVID-19 pandemic, came a lot of public declarations and innovative methods to tackle the hurdles posed by IP. This includes COVID-19 technology access pool1 and the medicines patent pool2, both of which were not instrumental in tackling the position of the much stronger pharma lobby. In response to this, several companies like our very own Serum Institute of India have entered into a licensing agreement with AstraZeneca, to manufacture their vaccine under the name 'Covishield' in India.
The government, in their Press Release dated May 27, 2021 has attempted to clarify certain "myths" on the government control over the vaccines.3 One such question addressed by the Government was the Centre's contributions in ramping up domestic production of vaccines. Under its brief response, it is clear that all efforts to induce talks between other companies (3 other companies specifically) and Bharat Biotech have been specifically undertaken under the supervision of the Government. Additionally, it is under watchful eye of the government that the Sputnik vaccine will now be manufactured by the 6 companies coordinated by Dr. Reddy's. From the government's explanation, it is clear that any and all efforts towards ramping up the domestic production of the vaccines is taken either directly by the government or by the concerned companies under the watchful eye of the Government.
In response to the comments on the invocation of Section 84 of the Patents Act, 1970, the Government has deemed the same to be an unattractive option due to the multi-faceted approach required to manufacture the vaccines. Including, but not limited to the active partnership, training of human resources, sourcing of raw materials and highest levels of bio-safety labs.
The Government's stance downplays its own stance before the World Trade Organization (WTO) regarding the IP waivers.4 Even with the free flow of information regarding the underlying technology to the components of the different vaccines around the world, India will have to make specific policy decision to ensure the manufacturing of the required number of doses. In fact, in its Press Release, the Niti Aayog has attempted to place the blame on vaccine manufacturers in India to not enter to licensing agreements themselves with Moderna who has already released a statement that no company will be 'sued' for manufacturing their vaccines.
Despite the Supreme Court's opinion that the "present circumstances warrant the Government's examination of its extraordinary powers". These powers, as per the Supreme Courts orders, could also mean negotiations with concerned stakeholders. The observations of the Supreme Court in the Order dated 30th April 20215 is reproduced below:
"This Court is further of the opinion that prima facie the present circumstance warrants the government's examination of its the extraordinary powers, meant to be used in extreme situations, such as the current pandemic, for fixing drug prices, be it vaccines, or patented formulations, having regard to the provisions of the Drugs and Cosmetics Act, 1940 and other provisions. We are cognizant that invocation of the above provisions, if any, is ultimately a policy decision of the Central Government and may encompass negotiations with the concerned stakeholders. We hope that the Central Government will adopt a route that best serves the public interest."
Despite requesting IP waivers from other countries, India has refrained from ensuring the widespread production of its own home-grown vaccine. The two most widely administered vaccines in India, Covaxin and Covishield, are being manufactured only by two companies across India, despite there being an acute shortage of vaccines in India. The onus is therefore on the government to ensure that the manufacturing of the vaccines in India procured whether home-grown procured under valid licensing agreements are manufactured on a wide-scale, especially if the current manufacturing capabilities are proven to be inadequate to meet the needs of India's population. For this purpose, the government needs to make sufficient use of the necessary tools at their disposal and trust their own authorities under the Patent Act, 1970 to be able to sufficiently handle the task at hand.
3. Press Release of Niti Aayog dated May 27, 2021.
4. Waiver from Certain Provisions of the TRIPs Agreement for the Prevention, Containment and Treatment of COVID-19, World Trade Organisation, 21st May 2021, See: https://www.keionline.org/wp-content/uploads/W669Rev1.pdf
5. Order dated 30th April 2021 passed by the Supreme Court in Suo Motu Writ Petition (Civil) No. 3 of 2021.
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