Erred in not crediting ICMR as co-inventor of Covaxin, says Bharat Biotech

Covaxin manufacturer Bharat Biotech said it had made an “inadvertent mistake” in not including ICMR scientists as ‘co-inventors’ in patent applications; it would include their names in fresh filings

Hyderabad-based Bharat Biotech International Limited (BBIL) and manufacturer of Covaxin, India’s first indigenous Covid-19 vaccine, said it had made an “inadvertent mistake” in not including scientists from the Indian Council of Medical Research (ICMR) as ‘co-inventors’ in patent applications filed in India and abroad to protect the intellectual property rights around the vaccine. It would include their names in fresh filings for patent purposes, it said in a statement late on Saturday.

“BBIL 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 has already started the process to rectify it by including ICMR as co-owner of the patent applications for Covid-19 vaccine. 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,” the company said.

The statement came on the day The Hindu reported, citing patent-linked documents, of the ICMR being uncredited as inventors. This was despite a statement by the Health Ministry in Parliament that the intellectual property rights of Covaxin were “jointly owned” by ICMR and BBIL. Other than that, ICMR’s role in the development of vaccine was widely publicised by the government as well as ICMR’s own leadership through multiple channels during the pandemic.

By way of explanation, the company, in its press statement, said that like other pharmaceutical companies working on Covid vaccines, it was faced with multiple challenges and “all organisations were in a rush” to develop vaccines and file the appropriate patents, prior to competitors or data being published in journals.

Bharat Biotech said it did not have “access” to its own agreement with ICMR that governed the terms of engagement between both entities regarding Covaxin as this was a “confidential document”. The Hindu reached out to BBIL to clarify this point but did not get a response till the time of going to press.

“Bharat Biotech’s Covid vaccine application was filed in above circumstances and since 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 statement said.

A day earlier, BBIL gave a different explanation to The Hindu on omitting ICMR’s name. BBIL had filed a patent for the “process” governing the manufacture of Covaxin. Moreover, the development of Covaxin was “fully funded” by Bharat Biotech and the ICMR had provided the strain and conducted clinical trials, a spokesperson reasoned in an email. “It is to be noted that while ICMR-NIV (National Institute of Virology) owns the animal challenge studies (pre-clinical trial data), Bharat Biotech owns the process development and new adjuvant (a chemical that strengthens a vaccine’s immune response) added to the vaccine,” the firm had said.