[A big thanks to Swaraj for his inputs on the post.]
The Exclusion of ICMR from the Patent Application
Last weekend, a series of unusual developments regarding the Covaxin patent (Patent Application Number: 202041007559) generated significant buzz. Notably, in The Hindu, Jacob Koshy published back-to-back articles, with the first one appearing on June 22, 2024 (read here (paywalled)). In this article, Koshy reveals that Bharat Biotech (BBIL) filed a patent application for Covaxin without listing the Indian Council of Medical Research (ICMR) as a co-patentee or inventor. This is despite the Health Ministry’s assertion in the Rajya Sabha (pdf) that the intellectual property rights over Covaxin are “jointly owned” by ICMR and BBIL, according to their Memorandum of Understanding (MoU). However, the patent application’s Form 1 (pdf) clearly shows that only Deepak Kumar and Krishna Murthy Ella (Chairman and Founder of BBIL), are named as inventors. From what can be gathered online, it appears that Deepak Kumar was working with the Ella Foundation. This is also indicated as his address in the Form 1. (There doesn’t seem to be any clear information available regarding his affiliation with BBIL or ICMR, so maybe he was working under a contractual relationship?)
In the Rajya Sabha, the Health Minister stated that ICMR would provide a characterized virus strain for vaccine development, and BBIL would develop and commercialize the vaccine within two years under a non-exclusive license. The intellectual property would be jointly owned by ICMR and BBIL, with ICMR receiving a 5% royalty on net sales, paid semi-annually. Additionally, ICMR clarified that although BBIL did not receive direct funding from them for Covaxin development, their institute, the ICMR-National Institute of Virology (NIV) in Pune, allocated funds for the vaccine’s development.
As per the Hindu report, Patent filings by BBIL in India, the United States, and Europe indicate that no ICMR scientists have been listed as the ‘inventors’ of the vaccine. This omission drew significant attention, and when asked for comments, a BBIL spokesperson told The Hindu that their patent covers only the “process development” for making Covaxin, which includes an adjuvant licensed from ViroVax in Kansas. According to Indian patent laws, both product and process patents are permissible, and BBIL has applied for the process patent for Covaxin.
The strain used was procured from NIV, which also conducted variant testing. While ICMR/NIV carried out animal trials, BBIL developed the process and incorporated the new adjuvant. BBIL’s stated reasoning to the Hindu for not listing ICMR scientists as inventors was based on the absence of joint funding, suggesting that their role in process development and innovation warranted sole inventor credit for BBIL.
The Subsequent Backing Out by BBIL
Even more intriguing is the twist in this episode: in a subsequent piece published on the 23rd (read here (paywalled)) after this news broke, BBIL abruptly reversed course, labelling it an “inadvertent mistake” and pledging to correct it. Access their official statement here (I was not able to find anything on their website and the press release is from their Twitter handle). What captured attention more than the mere reversal was the change in BBIL’s rationale for excluding ICMR from the initial application. According to their official statement, BBIL filed its COVID-19 vaccine application in a rush, as all organizations were scrambling to develop vaccines and file patents before competitors could publish data in journals. Due to the confidentiality of the BBIL-ICMR agreement, which was not readily accessible, ICMR was unintentionally omitted.
Some Matters of Concern
In this sequence of events, two significant procedural issues come to light that merit discussion:
- Patent Examination: Better Late than Never?
Firstly, a perhaps procedural, or perhaps substantive question – depending on the answer – that arises is what was the purpose behind filing this application? The application appears to have been submitted in August 2020. According to the Patent Rules, there is a 48-month window to request an examination. With July 2024 fast approaching, they are nearing the end of this period, and it appears from online documentation that they have not yet filed a request for examination.
- Foreign Filings: What Does ‘Voluntary Abandonment’ Reflect?
On its own, this does not necessarily indicate any reason for raising eyebrows. However – another aspect of this episode involves BBIL’s filing of Form 3 (pdf), i.e. Section 8 disclosures, with the Patent Office, indicating the withdrawal of its application from 3 significant jurisdictions – Brazil, South Africa, and Europe.
The likely reason for this action is an anonymous PCT third-party observation (access pdfs here and here). The document reviewed certain clinical trial records related to the vaccine’s development. It compared these trials to previously created vaccines, asserting a lack of novelty and inventive step in the new vaccine. This prompts the question of whether it was the fear of potential rejection due to third-party observations the reason for withdrawing the three applications? Adding to the intrigue is the PCT International Search Report (pdf), which suggests that the Covaxin patent application is anticipated by prior art!
The discrepancies in not crediting ICMR as a co-inventor of Covaxin despite their involvement, along with BBIL’s contradictory explanations and acknowledgement of this omission, as well as discrepancies in the patent filings themselves, raise numerous questions. Hopefully, clear answers will emerge soon to address these issues and clarify the roles and credits involved in the development of Covaxin.