The Story Till Now
On one hand, COVID-19 cases are rising yet again to everyone’s surprise, and on the other, the surprises from the Covaxin patent application don’t seem to stop. In late June this year, I wrote (here) about how Bharat Biotech (BBIL) filed a patent application for Covaxin without listing the Indian Council of Medical Research (ICMR) as a co-patentee or inventor, despite the Health Ministry asserting that the intellectual property rights over Covaxin are “jointly owned” by ICMR and BBIL. BBIL then did a quick about-face on this application and issued a clarification on June 22 that they would be refiling with proper credits to ICMR. If these events weren’t bizarre enough, what followed afterwards was no better. Two revisions in the patent applications have occurred since then, and this post analyses the events and their implications on the Covaxin patent.
What All Has Happened Afterwards?
Seven new documents have come up since the previous post documents were uploaded on the IPO’s website which reflects this change.
The First Revision (11 July 2024)
When it comes to the revised patent application, BBIL took its time in submitting it. Despite having promised to do so on June 22, BBIL filed a revised application on July 11. The Assignment Deed can be accessed here and the Revised Form 6 here. According to these revised documents, Form 6 now classifies NIV and BBIL as ‘Co-applicant/Co-owner’. Moreover, BBIL ‘partially assigned’ its patent rights to the National Institute of Virology (NIV). NIV is the arm of ICMR that worked with BBIL on Covaxin.
The Second Revision (1 and 2 August 2024)
The latest development is another revision to these documents by BBIL, as reflected in the two new documents filed on August 1 and 2, 2024, as shown in the screengrab before. This second set of revisions includes making the NIV scientists ‘co-inventors’ (mentioned in the revised Form-8 (pdf)). In the July 11 draft, only NIV was mentioned as a co-inventor, and the scientists were not specifically named. Interestingly, almost four years have passed since the original application was filed (i.e., August 21, 2020), and it is only now that such significant amendments to the applications and the submission of important documents from the applicants are being made!
Coincidentally or not, this revision has occurred suspiciously close to when the Minister of Health was scheduled to answer questions in Parliament regarding the Covaxin patent. On August 2, 2024, in response to a question, he informed Lok Sabha that the ICMR had objected to BBIL as soon as his ministry identified the error. However, it is fascinating how the error went unnoticed for four years! Another interesting factor is that media houses, especially Jacob Koshy who wrote about this in The Hindu (here and here), seemed to have noticed this inconsistency much earlier, followed by the clarification from BBIL.
One of the most crucial points is that the Assignment Deed clearly states that NIV will not receive any monetary benefits from the joint ownership of the application. This is concerning from the commercial perspective of the patent, especially given that the minister revealed on August 2 that ICMR had invested approximately Rs 35 crore in developing Covaxin! However, the pecuniary aspect is not left completely unaddressed. The memorandum of understanding (MoU) between the two parties becomes particularly important here, as the Assignment Deed indicates that the financial aspects of the transaction will be determined by the MoU, which unfortunately is not publicly available.
Is PIL the Panacea?
An article by The Wire makes a compelling argument for making such an MoU available. Section 50(i) of the Indian Patent Act states that when a patent is granted to multiple persons, each person is entitled to an equal undivided share unless there is an agreement to the contrary. Additionally, Section 50(ii) allows each of these persons to use the patent rights, including commercialisation, for their own benefit without accounting to the others, with the only exception being the transfer of a license to a third party. However, Section 50(ii) will not apply if an agreement between the parties is in force, which could impact how these provisions are applied.
While this contention is valid, a PIL seeking the disclosure of the MoU was rejected, as claimed by The Wire. This raises the question of whether an RTI request should be filed to access such documents. The RTI authority is likely to consider Section 8(1)(d) of the Right to Information Act, 2005, which exempts information “including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party,” or whether it will fall under the exception where the RTI authority may allow disclosure if “satisfied that larger public interest warrants the disclosure of such information.” Clearly, the former has prevailed over the latter. Preliminary searches for cases where the disclosure of MOUs has been requested from the government often reveal rejections for such disclosures.
International Patent Applications by BBIL (Yet Again)
International patent applications are also reflected in the documents for various countries (US, Colombia, and Nigeria currently). As mentioned in the previous post on this issue, BBIL had withdrawn its applications in Europe, Brazil, and South Africa (possibly due to prior art anticipations?) but has now decided to pursue patents in three other nations. The Wire also suggests that since BBIL submitted an international patent application to WIPO, with the report created by the IPO itself, the outcomes for the domestic and international applications are likely to be aligned.
The examination of the application remains pending, and it remains to be seen how many more surprises this situation might bring before it is resolved!
Readers are invited to share their thoughts and comments on this below!