(The Hindu) India’s first indigenously developed coronavirus vaccine, Covaxin, was a joint collaboration between the Indian Council of Medical Research (ICMR) and the Hyderabad-based Bharat Biotech International Limited (BBIL), with intellectual property (IP) rights jointly shared between the two organisations. That is what the public record states.
However, filings by the BBIL at patent offices in India, the United States and Europe suggest that only its scientists and personnel are credited as ‘inventors’ of the vaccine with no mention of ICMR scientists.
The Hindu has viewed documents detailing these patent applications. If BBIL personnel, credited in applications as Deepak Kumar and Krishna Murthy Ella — are indeed the only inventors, it contradicts a statement by the Union Health Ministry in the Rajya Sabha, which claimed that the IP rights are “jointly owned”.
In response to a question in the Rajya Sabha in July 2021 by Congress president Mallikarjun Kharge, who demanded details of the agreement between the ICMR and the BBIL for the development of Covaxin, the then Minister of State (Health Ministry) Bharati Pravin Pawar laid out a detailed response.
The Minister’s statement said the ICMR would provide a “well characterised” virus strain for vaccine development; the BBIL would develop the final vaccine formulation; and, the latter would be given a “non-exclusive” licence to commercialise the product within two years.
It was explicitly mentioned that the “…intellectual property over the product would be jointly owned by the ICMR and the BBIL”. The ICMR would also receive as royalty 5% of net sales to be remitted half-yearly.
The ICMR said that while it had not funded the BBIL for Covaxin development, one of its institutes — the ICMR-National Institute of Virology (NIV), Pune — had spent “funds for Covaxin development.” It also funded phase-3 clinical trials of Covaxin at 25 locations, involving 25,800 participants. In all, the ICMR spent ₹35 crore for developing Covaxin.
As of January 2022 — as per an update by the government to the Rajya Sabha — the ICMR received ₹171 crore as royalty for Covaxin. Ms. Pawar’s response to Parliament, however, did not elaborate on the sharing of patent rights.
The BBIL has had several research collaborations with public research bodies such as the Council of Scientific and Industrial Research (CSIR) and the ICMR itself. It has listed scientists from all institutions as ‘inventors’ in patent applications.
A BBIL spokesperson told The Hindu that the patent filed by Bharat Biotech was only for “process development” and specific to the making of the vaccine. It also covered the use of an adjuvant (an ingredient used in vaccines to elicit a stronger response) that was licensed from the Kansas-based ViroVax and added to Covaxin.
India’s patent laws allow both product and process patents. Product patents grant an inventor a monopoly over, say, a drug. Process patents bar competitors from making a similar drug using the same sequence of steps.