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Bharat Biotech claimed that it was an ‘inadvertent’ mistake to not include ICMR in the patent filings. (Representative Image)
Hyderabad-based Bharat Biotech International (BBIL) said on Saturday that it has initiated a process to include the Indian Council of Medical Research (ICMR) as co-owner in the patent application for the Covid-19 vaccine Covaxin.
The company claimed that it was an ‘inadvertent’ mistake to not include ICMR in the patent filings.
After reports claimed that filings in patent offices in India, the US, and Europe did not mention ICMR or its scientists, but only BBIL and its scientists, the Hyderabad-based biotech company clarified late at night that in the ‘rush’ to develop vaccines and file appropriate patents, BBIL had missed adding ICMR’s name in the original filings.
“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 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,” the company said.
It added that the Covid-19 vaccine application was filed under the above circumstances and the BBIL-ICMR agreement copy (being a confidential document) was not accessible. “Hence ICMR was not included in the original application. Though this was purely unintentional, such mistakes are not uncommon for the patent office; therefore, patent law provides provisions to rectify such mistakes,” the company said.
BBIL said on Saturday that it has ‘great respect’ for ICMR and is thankful to ICMR for their continuous support on various projects. Therefore, as soon as this inadvertent mistake was noticed, BBIL started the process to rectify it by including ICMR as co-owner of the patent applications for the Covid-19 vaccine, it claimed.
“Necessary legal documents are being prepared for it and BBIL will file those documents in the patent office as soon as they are ready and signed. These actions are in accordance with the Memorandum of Understanding (MoU) signed between ICMR-NIV Pune and BBIL for the joint development of the Covid-19 vaccine in April 2020,” the company said.
In a Rajya Sabha response, then minister of state for the Ministry of Health and Family Welfare, Bharti Pravin Pawar, had said in July 2021 that the MoU between ICMR and BBIL included terms like collaboration for the development of a Covid-19 inactivated whole-cell vaccine and that ICMR would provide a well-characterised virus strain for vaccine development. ICMR would get a royalty payment of 5 per cent on net sales to be paid on a half-yearly basis, the minister had said. It was also agreed that the vaccine would come in the joint name of ICMR and BBIL, and ICMR’s logo would be on the product.
Further, in a February 2022 Rajya Sabha response, Pawar had informed that ICMR had received a royalty payment of Rs 171.74 crore till January 2022 from BBIL from sales of Covaxin. “ICMR has spent around Rs 35 crore in R&D of Covaxin,” the minister had said.
It is thus not clear why ICMR was not included in the original patent filings.
First Published: Jun 22 2024 | 11:26 PM IST
