Hyderabad-based Bharat Biotech International Limited, the manufacturer of Covaxin, said on Saturday that it had made an “inadvertent mistake” in failing to credit the Indian Council of Medical Research as a “co-owner” in patent applications for India’s first indigenous Covid-19 vaccine.
This came after The Hindu reported that the medical research body had not been acknowledged as co-inventors of the vaccine in patent-linked documents filed in India, the United States and Europe – despite the Union health ministry’s claims that the intellectual property rights to Covaxin were “jointly owned”.
In a statement, Bharat Biotech said that the Indian Council of Medical Research will be credited as a co-owner of Covaxin in fresh patent filings, the company clarified.
“[Bharat Biotech] has great respect for ICMR [Indian Council of Medical Research] and is thankful to ICMR for their continuous support on various projects,” the company’s statement read. “Therefore, as soon as this inadvertent mistake was noticed, [Bharat Biotech] 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 [Bharat Biotech] will file those documents in the Patent office as soon as those are ready and signed.”
The company also said that it had faced several challenges during the vaccine’s development and that “all organisations were in a rush” to file the appropriate patents before their competitors or the publication of their own data.
The company also said that it did not have access to its agreement with the Indian Council of Medical Research, which is a confidential document.
“Bharat Biotech’s Covid vaccine application was filed in above circumstances…Hence ICMR was not included in the original application,” the company said. “Such mistakes are not uncommon for the Patent office therefore Patent Law provides provisions to rectify such mistakes.”
However, The Hindu reported that the company had initially provided a different explanation about the Indian Council of Medical Research being excluded from patent applications.
“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 newspaper had quoted from a statement provided by Bharat Biotech.
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