What was the tussle over Covaxin IPR?

Sub: Science and tech

Sec: Intellectual Property Rights

Covaxin:

Covaxin (development name, BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology.
On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use, as the first Indian-developed covid vaccine to be approved.
By 31 January 2022, Covaxin had been granted emergency use approval in 13 countries.

Admission of Patent Filing Error by Bharat Biotech:

Bharat Biotech International Limited (BBIL) admitted to an error in its patent filings for Covaxin.
Scientists from the Indian Council of Medical Research (ICMR) were not included as co-inventors.
BBIL is one of India’s leading biotechnology companies.

Rights Governing Vaccine Patents:

India’s patent laws cover both product and process patents.
Product patents grant a monopoly over a drug, while process patents prevent competitors from using the same production steps.
BBIL patented the process of making Covaxin from virus strains provided by ICMR-NIV (National Institute of Virology).
Creating a vaccine on an industrial scale requires specialized facilities beyond lab capabilities.
Covaxin is an inactivated coronavirus vaccine with an added adjuvant to increase potency.
Companies strive to protect their processes to maintain a temporary monopoly and profits.
Patents are only granted after regulatory authorities confirm the novelty or inventiveness of the process.
BBIL has not yet been granted these patents.
For details of IPR

Roles of BBIL and ICMR:

BBIL had collaborated with the ICMR-NIV for all the steps in developing a vaccine.
An agreement outlining each entity’s responsibilities, including ICMR’s role in testing and funding.
- Beyond transferring the strains and making vaccines, ICMR would also test these vaccines on animals and then on people to establish that the vaccine worked as intended.
ICMR funded clinical trials and was to receive 5% of royalties from Covaxin sales.
Joint intellectual property rights were expected, as stated in Parliament.
BBIL initially distinguished between rights over vaccine making and data from clinical trials.
BBIL later acknowledged the mistake and committed to amending patent applications to include ICMR personnel.

Importance of Being Cited as an Inventor:

Intellectual Property Rights (IPR) cover various aspects of product invention.
The development of pharmaceutical products often involves multiple entities.
BBIL had a technology licensing agreement with Virovax for the adjuvant.
Being listed as an inventor affects the sharing of IPR, royalties, and product usage.
Omitting inventors in patent filings can lead to rejection of applications, particularly in the U.S.

Source: TH