COVID-19 Data Exclusivity Drug Regulation Innovation Patent Trade Secret

Intellectual Property Rights in Covaxin – Part 3 (IP Rights over Clinical Drug Trials (CT) Data)


In Part I of this post, Anik and I argued that the government should waive the IPR in Covaxin in order to ensure that the vaccine can be rapidly accessed by the public. In Part II of this post, Swaraj and I explored the broader issue of IP ownership in outcomes of publicly funded research. In Part III, I analyse the opacity surrounding the clinical trial data generated during the Covaxin trial, which has not been publicly shared on grounds of IPR concerns.

Factual Background

Covaxin was granted approval in ‘clinical trial mode’ without phase 3 efficacy data and was approved for regular emergency use authorization only on March 11, 2021, even though administration of the vaccines had begun on 16th January, 2021.

The Union Health Ministry has outrightly denied RTI applications demanding data, evidence and other considerations based on which Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield were granted formal clearances for emergency use authorisation. Responding to an RTI filed by independent journalist Saurav Das, the Ministry refused to make the documents public, noting that the request is beyond the ambit of the RTI as the ‘sought information is exempted under Section 8(1)(d) and (e) of the Right to Information Act, 2005.’ In reply to the demand of another activist, Saket Gokhale, who sought to obtain information taken into consideration for the approval of Covaxin, the Central Drugs Standard Control Organisation (CDSCO) again refused under Sections 8(1)(d) and (e) of the RTI Act, noting that ‘disclosure would harm the competitive position of Bharat Biotech.’

Section 8(1)(d) exempts the disclosure of information to citizens if it includes information shared in “commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information.” Similarly, Section 8(1)(e) grants an exemption from disclosure when the “information (is) available to a person in his fiduciary relationship, unless the competent authority is satisfied that the larger public interest warrants the disclosure of such information.”

Nature and extent of protection over CT data in India

Prior to the introduction of a new drug in the market in India, it must undergo clinical trials, and the data generated during these trials must be submitted to the Drug Controller’s Office as per Rule 122-DA of the Drugs and Cosmetics Act 1940 and Rules, 1945. Apart from pre-clinical studies where the drug is tested on living organisms such as mice, rabbits, monkeys etc. to determine its safety and tolerability, the trial itself involves three distinct phases. The first phase entails testing the drug’s safety and tolerability on human beings in small groups of 20-100 healthy volunteers. The second phase explores the effectiveness and short-term side effects of the drug on human beings in a larger group of up to 300 patients. Finally, the third phase involves administration of the drug at multiple treatment centers to determine the therapeutic benefits of the drug prior to granting marketing approval to it.

These phases generate a gigantic amount of data, submitted to the Office of the Drug Controller, which is relevant to evaluate the safety, quality, efficacy, risks and benefits of the drug along with its composition, including physical and chemical characteristics. Companies rely on the costs incurred for development of drugs to claim both patent protection and protection over CT data, which ignores that recovery of their costs can often be catered to more than sufficiently via patent protection.

CT data may also constitute trade secrets in India, which are protected under contract law, or in the absence of a contract, under an equitable duty of confidence under common law. There is nothing in the Drugs and Cosmetics Act, 1940 and Rules, 1945 to prohibit the data submitted to the Drug Controller from being made available to any third party.

Further, India is obliged to comply with Article 39(3) of the TRIPS agreement which requires protection of test data against “unfair commercial use” which can be overridden “where necessary to protect the public.”

Larger Public Interest Warranting Disclosure

Both Sections 8(1)(d) and 8(1)(e) of the RTI Act, cited to exempt the information from disclosure via RTIs, can be overridden due to larger public interest involved as per the text of these Sections itself. Not many concerns come to mind which would be as compellingly within the ambit of public health and interest as vaccination amidst a deadly pandemic in a densely populated country with abject inequalities in access to medical infrastructure as India. This is significant since the right to receive medical care has been recognised by the Supreme Court in Chameli Singh v. State of UP, as part of the fundamental right to life under Article 21 of the Indian Constitution.

Further, it has been argued that under Article 39(3) of the TRIPS, a state is free to make non-commercial use of CT data or fair commercial uses of such data, for instance, to avoid health or safety risks that access to data can ameliorate. Non-commercial and fair uses of CT data for the promotion of research and science in the public interest would be aligned with the research exemptions embodied in the domestic patent laws of many jurisdictions (Section 47, Patent Act in India). Finally, when non-competitors like public interest organisations, universities, hospitals (such as Saket Gokhale and Saurav Das) demand disclosure for reviewing and verification of the reliability and completeness of data, such data can be disclosed without violating the TRIPS.

Even with respect to protection for undisclosed information, there have been statements by the heads of the Dutch, French and UK regulatory authorities as well as the European Medicines Agency (EMA) to the effect that CT data should not be considered confidential commercial information. They argue that not sharing this data publicly undermines the philanthropy of trial participants, most of whom would have agreed to partake in the trial with the motivation to contribute to medical knowledge.

Further, independent researchers who want to conduct a meta-analysis of the data for safety and efficacy studies cannot be characterized as illegal free riders. Confidentiality over CT data impedes possible uses of raw clinical data by researchers for the development of predictive models for patient orientation towards appropriate treatments.

Another compelling reason to disclose CT data is that history has shown us that confidentiality in this data can lead to bias in reporting the outcomes of trials, while depriving researchers of the opportunity of verification of claims. For instance, independent researchers could only gain access to additional clinical study reports for Tamiflu via a freedom of information request to the EMA. These reports revealed that serious adverse events were not reported in published papers and the manufacturer’s claims were not consistent with CT data. Incomplete reporting also hinders doctors from being able to come up with the best treatment for patients.

Conclusion

Refusal to share the CT data of Covaxin reveals the extraordinarily opaque functioning of the CDSCO. The Clinical Trials Registry Database makes some information publicly available regarding sponsors, ethics committees, regulatory clearance status etc. but this is far from ideal. Data regarding serious adverse events associated with clinical trials and specific drugs, Good Clinical Practice inspections at trial sites and the number of inspections by the CDSCO and are not publicly available. This is unlike other jurisdictions, for instance, the US FDA website provides convenient public access to details of warning letters issued by their regulatory agencies with information regarding the specific violations and deficiencies found, dates of inspections and further action to be taken to remedy the situation. There will not be a time as urgent as the pandemic to push for this level of transparency in India as well to inspire the faith of the public in the healthcare system.

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