New Delhi: Two days after it emerged that Bharat Biotech applied for patents as sole inventor of India’s first indigenously developed COVID-19 vaccine, Covaxin, without any mention of the Indian Council of Medical Research (ICMR), the Hyderabad-based vaccine maker has clarified that it is adding ICMR as a co-inventor in the filings.
Covaxin was developed from SARS-CoV-2 strain or COVID-19 virus isolated at the National Institute of Virology (NIV), which comes under the ICMR. The government health research agency also supported clinical development of the vaccine through assistance in conducting clinical trials.
Media reports earlier indicated that in its patent filings in India, the US and Europe, Bharat Biotech failed to give credit to ICMR scientists and officials.
Reacting to reports, the vaccine maker said in a statement issued late Saturday night that it was an “unintentional” omission.
“Bharat Biotech was working on developing the COVID-19 vaccine as a top priority to ensure product availability at the earliest. The Covid vaccine development of BBIL (Bharat Biotech International Limited) was faced with multiple challenges and all organisations were in a rush to develop vaccines and file the appropriate patents, prior to any other entity or prior to any data being published in journals,” it said.
It added that the company’s Covid vaccine application was “filed in above circumstances” and ICMR was not included in the original application since the “BBIL-ICMR agreement copy, being a confidential document, was not accessible”.
The Hyderabad-based vaccine maker stressed that though this was purely unintentional, such mistakes are not uncommon for the patent office and patent law has provisions to rectify such mistakes.
It added that it is thankful to ICMR for their continuous support on various projects and “as soon as this inadvertent mistake was noticed, BBIL has already started the process to rectify it by including ICMR as co-owner of the patent applications” for Covaxin.
“Necessary legal documents are being prepared for it and BBIL will file those documents in the patent office as soon as those are ready and signed. These actions are in accordance with the Memorandum of Understanding (MoU) signed between ICMR-NIV Pune and BBIL for joint development of COVID-19 vaccine in April 2020,” it added.
ThePrint reached ICMR Director General Dr Rajiv Bahl for comment but he was unavailable. ThePrint also reached Bharat Biotech for clarity on when it filed for patents for Covaxin in India, the US and Europe but had not received a response till the time of publication. This report will be updated if and when a response is received.
In July 2021, in response to a question in the Rajya Sabha, the then minister of state for health had informed the Upper House that an MoU between the ICMR and BBIL included terms like collaboration for the development of an inactivated whole cell COVID-19 vaccine and ICMR had provided a well characterised virus strain to the company for this purpose.
Parliament was also apprised that as per the MoU, ICMR was to receive five percent royalty on net sales to be paid on a half-yearly basis. Another term of the agreement, according to the reply, was that the vaccine would be in the joint name of Bharat Biotech and ICMR and the apex state-run health research agency’s logo would appear on the product label.
(Edited by Amrtansh Arora)
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