New Delhi: A day before health minister J.P. Nadda was supposed to inform the parliament, on August 2, about the status of the Covaxin’s patent – an issue that became a controversy – Bharat Biotech Private Limited (BBIL) filed its second revised application with the Indian Patent Office (IPO), including National Institute of Virology (NIV) scientists as co-inventors, too.
This second revision came 21 days after the first revised application was filed on July 11 that mentioned NIV only as co-applicants/co-owners of the patent application. There was no mention of NIV scientists as ‘co-inventors’ in the July 11 (first revision) documents that BBIL filed with the IPO, as The Wire had reported then.
The co-ownership and co-inventorship of patents are different. The former grants rights, or partial rights, to all the parties involved, in terms of benefits that a grantee gets. This may not necessarily include them as co-inventors of the product, or the process of making the product.
All necessary documents and related forms, which ensured NIV-ICMR’s co-inventorship, including the revised deed, were filed on August 1 and 2, 2024, as per the IPO website. [The Wire last accessed the website on August 5, 2024].
The deed submitted on July 11 had not been signed by NIV. That correction has also been made in the deed signed on August 1 with signature of NIV director Naveen Kumar and a witness, Gajanan Sapkal – one of three NIV scientists mentioned as co-inventor, now. The other two NIV scientists are Pragya D. Yadav and Sreelekshmy Mohandas.
Nadda gave this information on August 2, 2024, replying to a supplementary question of Trinamool Congress’s Lok Sabha MP Saugata Ray. He had asked why no punitive action was taken against BBIL for not including NIV-ICMR in the patent application that it had filed four years ago – on August 21, 2020.
Nadda said the ICMR raised objections with the Hyderabad-based pharma company as soon as his ministry noticed the error. The health minister said in Parliament, “The moment we came to know about this [BBIL application excluding ICMR], we filed the objections.”
However, it remains inexplicable as to why the ICMR didn’t notice the error for four years.
“[The] ICMR has a special team whose only job is to look into patents for products founded or co-founded by it,” Rajeshwari Hariharan, an advocate who specialises in intellectual property rights, including patents and designs, among other things related to this field, had told The Wire earlier.
“The ICMR clearly didn’t take such an important product seriously,” she had said.
Coincidentally the BBIL filed its first revised application, mentioning NIV-ICMR only as a co-applicant on July 11, 2024 – one day after The Wire published a news report ‘Covaxin: Bharat Biotech U-Turn Means It Will Share IP With ICMR But Patent Office Questions Patentability’ on July 10. That news report said the company was yet to correct its patent application to include the name of NIV-ICMR as it had promised in its June 22 statement.
The BBIL’s June 22 statement came in response to a The Hindu’s story which had pointed out the omission of ICMR in the application.
Details Missing from Nadda’s reply
The health minister also referred to the memorandum of understanding (MoU) while answering Ray’s question. He said NIV-ICMR had isolated the virus for vaccine development and BBIL had developed the vaccine.
However, he failed to spell out some of the crucial details. For instance, the minister did not inform the parliament that NIV-ICMR will not get any monetary benefits out of the joint ownership of the application – something that the BBIL has said in the deed accompanying the revised application.
The deed states: “By way of this Partial assignment of the Patent Rights, Assignee [NIV] has not been granted any pecuniary rights [monetary benefits] in the Patent Application which will continue to be governed by the MOU separately signed by the parties.”
The MoU is not available in public domain.
Section 50 (i) of the Indian Patent Act states: “Where a patent is granted to two or more persons, each of those persons shall, unless an agreement to the contrary is in force, be entitled to an equal undivided share in the patent.”
The minister skipped telling the parliament whether indeed an agreement was in force which whether or not prevented NIV-ICMR in sharing these ‘equal and undivided’ benefits.
Section 50 (ii) of the Act states that when two or more persons/parties are registered as grantee or proprietor of one patent, each of those persons/parties are entitled to use the patent rights, including commercialisation, to their own benefit without accounting to the other person or persons/parties. The only exclusion to this provision is transfer of licence to any third party.
In other words, either of the two parties – BBIL and ICMR – can exercise the rights even without informing the other. Once again, there is only one exception to this – an agreement signed between the two parties that nullifies this provision.
Hence, the details of the MoU once again become important.
Neither the newly-appointed health minister clarified these necessary details in his answer, nor has ICMR, a government institution, shown any intention to make the MoU public. It even rejected an RTI application to this effect.
Also read: Bharat Biotech Files Revised Covaxin Patent, Stresses ICMR Will Not Get Monetary Benefit
Nadda also said in parliament that the government got Rs 172 crore as royalties from the BBIL after it invested Rs 30 crore in the pre-clinical and clinical research, including the three-phase trials.
The BBIL, according to ICRA, a rating agency, “witnessed substantial improvement in revenues to Rs 8,148.1 crore in FY2022 from Rs 1,501.2 crore in FY2021, primarily on the back of ramp-up in Covaxin supplies in the domestic market.”
Status of application with Indian Patent Office
As per the IPO website, the BBIL application is awaiting examination by the patent office. The request for examination was filed on July 11 – a day after publication of The Wire’s July 10 report. It stated the deadline for filing for such a request was going to expire in August this year.
The BBIL has also filed an international patent application with World Intellectual Property Organisation (WIPO) under what is known as ‘Patent Cooperation Treaty (PCT)’. It’s an international patent law treaty with 157 countries party to it.
Once the application is filed with the WIPO, it designates a patent office to look into the eligibility for patent and prepare a preliminary report. In the case of BBIL’s patent application for Covaxin, the Indian Patent Office had to do this job.
Now, Section 7 of the Indian Patent Act says any international patent application would be deemed as an Indian application too, if IPO had to do a preliminary investigation for the WIPO.
It’s is important to note here that as part of the WIPO inquiry, the Indian Patent Office had rejected all 26 arguments that BBIL used to claim ‘inventiveness’ for the process of making covaxin. As far as ‘novelty’ was concerned, only four out of 26 claims were robust, the IPO had noted in its prelim report for the international body.
The BBIL-NIV joint patent application filed with the Indian Patent office has claimed patentability on the same 26 claims that were made in the WIPO application
If the IPO’S preliminary report for WIPO and section 7 of the Act are read together, then it would be interesting to watch the decision of the Indian office and see if it would come up with similar observations that it did for the WIPO application.
BBIL patent applications for Covaxin are also pending in the US, Colombia and Nigeria. The company has withdrawn its patent applications filed in Europe, Brazil and South Africa.
The Wire had sent a set of questions to the BBIL on June 23, including asking for reasons for withdrawal. The company has chosen not to respond.
