New Delhi: Last month, after a news report first appeared about how Bharat Biotech International Limited (BBIL) had excluded the Indian Council of Medical Research (ICMR) from a patent application it had filed at the Indian Patent Office for Covaxin in 2020, the company announced that it would amend its paperwork to include the government body as a co-inventor of the vaccine against novel coronavirus.
BBIL’S statement came after The Hindu’s Jacob Koshy reported the omission of ICMR in the Hyderabad-based pharma firm’s patent application despite the government having said in a parliamentary reply on July 20, 2021 that the ICMR and BBIL jointly held Covaxin’s Intellectual Property (IP) rights.
While BBIL’s original application – bearing number 202041007559 – is still pending at the Indian Patent Office (IPO), a ‘search report’ prepared by the IPO for the World Intellectual Property Organisation (WIPO) has raised serious concerns about Covaxin’s patentability – i.e. eligibility for grant of a patent to BBIL.
The international application filed by BBIL with WIPO lists K.M. Ella – BBIL founder and chairman – and Deepak Kumar, also associated with BBIL, as inventors of Covaxin. There is no mention of ICMR in this application either.
The ‘search report’, more importantly, says many claims made in BBIL’s international application do not hold ground for ‘inventive steps’ and ‘novelty’ in the making of Covaxin.
‘Novelty’ and ‘inventiveness’ are criteria that must necessarily be fulfilled to obtain a grant for patent.
Whether this adverse report prepared by the Indian Patent Office for WIPO will also have any bearing on the former’s decision regarding the separate application that BBIL has filed in India, and whether the the Indian office would raise the same red flags, will only be clear when it ‘examines’ the documents that BBIL has submitted as part of the Indian application – a process that has not yet formally begun.
It is important to note that the claims made by BBIL in the WIPO application and the ones filed with the Indian Patent Office are exactly the same.
The application at the Indian Patent Office is still ‘awaiting request’ by BBIL for ‘examination’ of the documents.
Once a patent application is filed in India, the applicant has to request the patent controller at the IPO to perform an ‘examination’ or basic search of documents/application for grant of patentability. According to Indian patent laws, this has to be done within four years of the filing date.
BBIL’s application was filed on August 21, 2020, The deadline for such a request will expire soon, thus leaving the fate of the patent application unclear. Failure in complying with this deadline may result in the application being considered as ‘withdrawn’.
Adverse search report against international application
WIPO, where an international application is filed, administers the ‘Patent Cooperation Treaty’ or PCT – an international patent law treaty. The PCT has 157 countries that are party to it.
An international patent application filed under the PCT makes it possible for the applicant to get a patent for an invention in a large number of countries by filing a single “international” application instead of filing several separate national patent applications.
Once an application is filed with the PCT, WIPO designates the patent office of any country as an ‘International Search Authority’ (ISA).
The ISA then prepares a ‘search report’ by doing a ‘search’ of the documents annexed with the patent application and tries to evaluate the patentability – by assessing the ‘novelty’ and the ‘inventive steps’. It also goes through objections filed against the application which challenge the patentability.
Following this exercise, the ‘search report’ is sent to the applicant, and also released in the public domain. A favourable report helps the applicant in getting a patent granted in the offices of various countries which are a party to the PCT.
The report is not binding on any national patent office – they all remain free to make their own decision – but a favourable, or for that matter, unfavourable, report may influence the decision-making of any national patent office.
If the preliminary ‘search report’ is unfavourable, the applicant can make amendments in its international application to overcome the deficiencies. These are considered while making the final decision in what is termed as the ‘International Report on Patentability’.
For BBIL’s international application for Covaxin, WIPO designated the Indian Patent Office as the International Search Authority. The WIPO application for Covaxin, which seeks a patent for its ‘method for preparation’ bears publication number WO’642.
The International Search Authority’s preliminary report for Covaxin, issued on February 16, 2023, says all 26 claims made in the application to meet the criterion for ‘inventive steps’ are not established.
The ‘search report’ states that four out of 26 such claims ‘fall’ in the ‘realm of conventional wisdom’ in the making of a ‘pharmaceutical composition’ by someone who is already ‘skilled in the art’ or has ‘general knowledge in pertinent art’.
In other words, the report states that some of the ‘inventive steps’, which BBIL claimed it had come up with in making Covaxin, had already been known before the filing of the patent. Anyone who knew how to use those particular steps ‘and was considered skilled in the art’ or having ‘general knowledge in pertinent art’ could have used them to manufacture a particular pharmaceutical product.
Therefore, BBIL’s claims regarding these four inventive steps were inadequate, the report indicated.
The report also points out that at least 22 steps, which BBIL cited to back claims related to the ‘novelty’ of Covaxin, were not established. Only four other claims for novelty passed the muster.
Hence both the ‘novelty’ and ‘inventive steps’ are under question for the international application filed under the PCT before the WIPO, per the ‘search report’.
Whether BBIL has responded to this ‘search report’, and has amended its application to improve its claims, is not immediately known. The last status report of the international application was published on July 9, 2024. It says the second and the final ‘International Report on Patentability’ – which presumably would have considered BBIL’s amendments if at all they were made – has not yet been prepared.
Meanwhile, there has been complete silence from the ICMR on the adverse report at WIPO. Of course, the ICMR has not been registered as co-inventor of the vaccine in any of BBIL’s patent applications, including the international one. More on the role of ICMR later.
As mentioned earlier, the government had said in reply to a question in Parliament that BBIL and ICMR jointly owned the IP rights for Covaxin – something that BBIL didn’t incorporate in its patent applications even till the date of the publication of this piece.
BBIL’s withdrawal of patent applications in other jurisdictions
BBIL had filed applications for grant of patent in the US, Nigeria, Columbia, Brazil, South Africa and Europe, apart from India and the WIPO (international application). However, it ‘voluntarily abandoned’ or withdrew its application in Brazil, South Africa and Europe. The Wire, in an email sent to the BBIL on June 23 had asked why these applications were withdrawn. BBIL did not reply to the questions. Hence it is unclear whether they were withdrawn for fear of attracting adverse third party objections for these applications, or because the company decided it did not make business sense to pursue them.
For the European Patent Office (EPO) patent application, at least, it is clear that there were strong anonymous third party objections which challenged the patentability in the making of Covaxin. They can be read here and here.
Some of the third party comments had damning observations. One of the objections raised is that the ‘processes and technology’ used by BBIL for making Covaxin had been used by the same pharma firm itself for making vaccines for other diseases.
“Bharat Biotech International (BBIL) has not only used known processes and technology for producing the inactivated SARS-CoV2 virus to be used in the vaccine [Covaxin] composition, but in fact used technology that BBIL itself has disclosed/claimed for producing inactivated vaccines for other diseases,” those comments say.
These diseases include polio, rabies, rotavirus, Japanese encephalitis, chikungunya and zika, per a press release issued by BBIL on June 29, 2020. This, the additional third party comments allege, prove that BBIL’s Covaxin manufacturing technology lacks any new invention.
These comments also go on to highlight that the adjuvant – a product used in a vaccine to enhance its effect – used in Covaxin has already been used by BBIL in making another vaccine for which it had applied for a patent under the PCT.
BBIL’s promised rectification still awaited
On July 20, 2021, the Modi government’s minister of state for health told the Rajya Sabha that the IP for Covaxin was jointly owned by BBIL and ICMR. Given that BBIL’s August 2020 patent filing had excluded ICMR, this meant the government had either misled or lied to parliament or was not interested in defending the public investment made in developing the vaccine.
After The Hindu’s news report appeared, however, BBIL issued a statement on June 22, 2024.
“BBIL has great respect for ICMR and is thankful to ICMR for their continuous support on various projects therefore as soon as this inadvertent mistake was noticed, BBIL 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 BBIL will file those documents in Patent office as soon as those are ready and signed,” the company said in its statement.
Through this U-turn, the company may have hoped to put to rest any current uncertainty about ownership of the Covaxin patent going forward. However, its patent application and related documents publicly available at the Indian Patent Office website [accessed on July 9, 2024] do not indicate that the ‘rectified’ documents – which BBIL’s June 22 statement said would also include ICMR – have been filed so far.
It also emerges that the company’s patent applications for Covaxin filed in other global jurisdictions do not mention ICMR’s name either.
These applications had been filed in the United States, Nigeria, Colombia and WIPO, as well the three global jurisdictions where the company had withdrawn its application, mentioned above.
All these applications, which The Wire has reviewed, list K.M. Ella – BBIL founder and chairman – and Deepak Kumar, also associated with the BBIL, as inventors of Covaxin.
So far, there is no public indication that BBIL plans to include the ICMR as co-inventor in these global applications as well. The company has not made a public statement about this and has not replied to the queries sent by The Wire on June 23, 2024.
The Wire has reviewed all relevant documents related to the global and the Indian patent applications.
Also read: BHU’s Covaxin Safety Study: Cautious Interpretation of Results Needed
BBIL statement raises more questions than answers
BBIL’s June 22, 2024 statement said that the non-inclusion of ICMR in the patent application filed with the Indian Patent office was an ‘unintentional mistake’:
“Bharat Biotech was working on developing the COVID-19 vaccine as a top priority to ensure product availability at the earliest. The COVID vaccine development of BBIL was faced with multiple challenges and all organisations were in a rush to develop vaccines and file the appropriate patents, prior to any other entity or prior to any data being published in journals,” it said.
The statement blamed the mistake on the rush with which the vaccine was developed, and on the ‘confidentiality’ of the BBIL-ICMR agreement.
“A benefit of doubt [regarding the mistake] can be given though it is hard to believe because this was not simply any other product,” said Rajeshwari Hariharan, an advocate who specialises in intellectual property including patents and designs, among other things related to this field.
“[After all] it was a product made for the entire country and something as vital as a vaccine against Covid-19,” she added.
The BBIL statement also added: “Bharat Biotech’s COVID vaccine application was filed in the above circumstances [filed in a rush], and since BBIL-ICMR agreement copy, being a confidential document, was not accessible. Hence, ICMR was not included in the original application. Though this was purely unintentional, such mistakes are not uncommon for the patent office therefore Patent Law provides provisions to rectify such mistakes.”
Commenting on BBIL’s argument that the ICMR-BBIL agreement was ‘confidential’ and was not accessible to it, another intellectual property rights lawyer, who didn’t wish to be identified said, “This is bunkum, it’s not possible [that BBIL did not possess an agreement that it had signed].” The Wire had sought clarity from the BBIL on this point too in the questionnaire sent to the company that went unanswered.
Before announcing it’s U-turn on including ICMR in the Indian patent application, the BBIL spokesperson had told The Hindu that that the agreement between BBIL and ICMR regarding the patent was only for the ‘product’ (that is, the product called ‘Covaxin’) and not the ‘process’ (the method of manufacturing Covaxin).
Therefore, since the patent at the Indian office was filed only for process, the company was well within its rights to exclude ICMR, the spokesperson indicated.
In other words, the spokesperson appeared to suggest that the ‘process’ for making the vaccine was BBIL’s property and only the product ‘Covaxin’ was jointly developed with the ICMR’s National Institute of Virology (NIV). The NIV had isolated the virus and then given it to BBIL for mass production.
(Isolation of a virus involves growing a virus in large amounts in a lab derived from a sample of the natural form of the virus obtained from an infected person. The isolated virus, once inactivated to prevent it from causing further infection, is then converted into a vaccine formulation).
As per Indian patent law, two separate patents can be filed for ‘product’ and ‘the ‘process’ of manufacturing a product.
BBIL’s last statement does not provide clarity on how and why – if the agreement between ICMR and the company for intellectual property was only for the final ‘product’, and not the ‘process’, as it told The Hindu – the decision to exclude ICMR from the patent application was eventually reversed.
“[Moreover] the patent application was filed in 2020 and the rectification is coming in 2024. This, too, seems inexplicable,” Hariharan said.
Role of ICMR
BBIL’s patent applications in various jurisdictions, including India’s, have made no mention of ICMR.
Curiously, the ICMR itself never reacted to any of these omissions. The Wire wrote to the Council on May 2, 2024 asking why it had not objected. Despite several attempts to follow up, The Wire didn’t get any response.
Was ICMR caught unawares? This doesn’t seem feasible, says Hariharan.
“The ICMR has a special team whose only job is to look into patents for products founded or cofounded by it,” she told The Wire. Perhaps the ICMR administration didn’t realise that Covaxin is an important product, she added. “If this mistake was unintentional, then it was merely [a case of] administrative apathy [at ICMR]”, she said.
Moreover, the ICMR – a government funded institution – has a standard practice of making the Memorandums of Understanding (MoUs) public it signs with various companies and institutions. But despite attempts of transparency activists, the ICMR never did so with the agreement it signed with the BBIL.
