New Delhi: A day after The Wire published a news story on July 10 regarding Covaxin’s patentability – highlighting the fact that Bharat Biotech International Ltd (BBIL) had yet to include the Indian Council of Medical Research (ICMR) in its patent application despite promising to do so in a June 22 statement – the Hyderabad-based pharma firm filed a revised application including the premier research institution of the country as co-owner.
As per the revised list of documents available at the Indian Patent Office (IPO)’s website, the BBIL wrote to the controller of patents at the patent office in Chennai on July 11, 2024 that it has ‘partially assigned’ its patent rights to the National Institute of Virology (NIV), the ICMR body that worked with the company on Covaxin.
The revised application includes a notarised assignment deed signed by BBIL, which says the “parties have mutually agreed that the BBIL will partially assign its Patent rights in the Patent application to NIV and NIV will be included in the Patent application as Co-applicant so that Patent Application is jointly owned by the BBIL and NIV in accordance with an MOU separately signed by the Parties.” (emphasis added)
The deed is undated, but the digital signature of the assignor (Bharat Biotech) and its witness records the date as July 11, 2024. For some reason, the deed filed has left the signature and witness from the NIV (assignee)’s side blank, i.e. unsigned.
The NIV had isolated the virus strain and given it to the BBIL for the mass production of Covaxin, the vaccine against the novel coronavirus. However, the revised patent application does not include any of the NIV’s scientists as co-inventors.
Incidentally, this revision comes almost four years after the filing of its patent application, and after The Hindu and The Wire highlighted the discrepancy between then-Union minister of state for health Bharati Pravin Pawar’s assurance to parliament on July 20, 2021 – that the BBIL and ICMR jointly owned the IP rights to Covaxin – and the fact that the BBIL had filed a patent application a year earlier without any mention of the ICMR or NIV.
Now, in its revised application, the BBIL has said the NIV would be included in this application as ‘co-applicant/co-owner’ and has requested the IPO to proceed with the application jointly in their name.
Section 50 of the Indian Patent Act covers the rights of the co-owners of a patent. It says, “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.” (emphasis added).
In the accompanying deed filed with this revised application, the BBIL has made it clear that adding the NIV’s name as co-applicant would not allow the latter to claim any monetary benefits – which the Modi government had presumably signed away in its original deal with the company.
Also read | Covaxin: Bharat Biotech U-Turn Means It Will Share IP With ICMR But Patent Office Questions Patentability
“By way of this Partial assignment of the Patent Rights, Assignee [the 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 deed states.
Incidentally, the ICMR never made the MoU it signed with the BBIL public despite several requests by civil society organisations – and notwithstanding its own standard practice of doing so with MoUs signed with other public or private institutions. Therefore, even four years after it was signed, details of the said agreement remain unknown.
Since the MoU is not in the public domain, it remains unclear whether there is ‘an agreement to the contrary [of provision of equal undivided share] is in force’, as mentioned in Section 50 of the Indian Patent Act. For the same reason, it remains unknown what are the benefits, or the limitations thereof, to the NIV as far as money is concerned.
In light of some of these unknowns, it becomes all the more necessary for the ICMR to put the MoU in the public domain, say legal and public health experts. The ICMR had dodged an RTI application that had demanded a copy of the MoU, leaning on section 8(1) of the RTI Act, which exempts certain information from being shared.
This was contrary to a Central Information Commission judgement in a case delivered in 2009, which had made it clear that if public resources are used to execute a project with a private entity, the information had to be provided to the RTI applicant.
According to the 2021 reply furnished in parliament, the ICMR had spent Rs 35 crore by way of conducting the phase-3 clinical trial of Covaxin and supporting the NIV in isolating the virus for the vaccine’s development.
The government had made it clear in another parliamentary reply furnished in February 2022 that it had earned Rs 171 crore till January 31, 2022, as per its agreement with the BBIL of sharing 5% of net sales.
According to the ICRA, a rating agency, the BBIL “witnessed substantial improvement in revenues to Rs 8,148.1 crore in FY2022 from Rs 1,501.2 crore in FY202, primarily on the back of ramp-up in Covaxin supplies in the domestic market…. GoI institutions remain the largest customer segment for BBIL, accounting for ~75% in FY2022 due to its high Covaxin supplies.”
The company sold the vaccine to the government at Rs 150 per dose. The price for private hospitals was initially set at Rs 1,200 per dose, but was reduced to Rs 225 in April 2022.
Unexplained delay
Given that the BBIL’s MoU with the NIV explicitly says the patent is to be jointly owned, it is not clear why the company chose not to include the latter’s name in the original application it filed with the IPO on August 21, 2020.
The BBIL issued a statement on June 22, 2024 in response to the The Hindu’s story, saying it couldn’t include the ICMR’s name in the application because it was filed in a rush; and also attributed the ‘mistake’ to the fact that the agreement it has signed with ICMR was ‘confidential’ – an explanation an IP lawyer termed ‘bunkum’ while speaking to The Wire.
The Wire had sought an explanation from the BBIL in an email sent on June 23, 2024. Till the publication of this piece, the BBIL has not responded.
The Wire’s July 10 story, titled ‘Bharat Biotech U-Turn Means It Will Share IP With ICMR But Patent Office Questions Patentability’, had also reported that the ICMR’s name was omitted not only from the BBIL’s Indian application for Covaxin, but also for the ones filed in patent offices at the US, Nigeria and Colombia.
Now, the deed between the NIV and the BBIL says that in all these global applications too, the name of the ICMR’s NIV would be included.
Incidentally, the BBIL had voluntarily abandoned its patent applications in Brazil, South Africa and Europe. The Wire, in the email sent to the BBIL on June 23, had asked why these applications were withdrawn. The BBIL did not reply.
Another issue The Wire’s piece had highlighted was that even though the BBIL had filed the Indian application on August 21, 2020, it had not ‘requested’ the patent office for the ‘examination of its documents’.
According to Indian patent laws, such a request had to be made within 48 months of filing the application – a deadline that would have expired in about a month’s time. Failure in abiding by this deadline may result in the application being considered as ‘withdrawn’.
BBIL filed the request for examination of documents with the Indian Patent Office on July 11 — a day after the earlier piece was published.
In the earlier piece, The Wire had highlighted the fact that even though the BBIL’s patent application at the IPO was pending, the same patent agency had given an adverse ‘preliminary search report’ to the World Intellectual Property Organisation (WIPO).
The BBIL had filed an international application with the WIPO. The search report, published in February 2023, had pointed out that all 26 claims related to ‘inventivity’ and 22 out of 26 claims related to the ‘novelty’ of the process of Covaxin’s making were not established, thus questioning the eligibility of a grant of patent to the BBIL.
The final report, which would have taken cognisance of the BBIL’s defence – if at all it was furnished – against the preliminary search report of the WIPO is pending.
The story has been updated on July 14 to correct the date of BBIL filing the request for examination of its documents submitted to the Indian Patent Office.
This is the second of three pieces on the patent for Covaxin. Read the first and third pieces.