At the global stage, India is one of the co-sponsors – with South Africa – of a World Trade Organisation agreement demanding a waiver on intellectual property rights for vaccines for the duration of the pandemic. India’s proposal has recently gained steam, after US President Joe Biden announced his support, with hopes that this might make it easier for many more countries to get access to Covid-19 vaccines.
At home, however, the Indian government is not only taking a different stance, it has even asked the Supreme Court to not even discuss or mention the use of the state’s power to override intellectual property rights for essential drugs or vaccines, claiming these could have “serious, severe and unintended adverse consequences in the countries efforts being made on global platform.”
Experts feel that the Centre’s stand against compulsory licensing – which the Supreme Court had floated as a tool it could use as part of its pandemic response – is not only contradictory to its position at international forums, it could end up jeopardising India’s efforts to ensure vaccine equity at the global level.
The weakness of India’s vaccination programme have come to the fore over the last month, as the brutal Covid-19 second wave exploded all over the country. Vaccination centres around the nation have faced shortages, and the current pace would not allow India to reach herd immunity by the end of the year.
Some, like Delhi Chief Minister Arvind Kejriwal, have demanded that the Centre invoke its powers to issue compulsory licenses so that vaccine production can be ramped up, with the aim of helping the states inoculate more people over a shorter period of time.
In simple terms, when a government invokes a compulsory license, it grants permission to a person to make or sell an invention or product without seeking permission from the patent holder. The question of compulsory licensing in India involves two important provisions under the Patents Act, 1970.
First is Section 92. Under this provision, the government can declare compulsory licensing for any patented invention in times of national or extreme emergency. Once a declaration is made, the controller general of patents can grant licenses to any applicant. The patent holder will be paid a royalty fixed by the controller general.
Section 100 of the Act, on the other hand, allows the Centre or others to use the invention for the purposes of the government, if deemed necessary. This would allow Indian companies to begin manufacturing while the royalty is negotiated. If the negotiations fail, it falls upon the High Court with the jurisdiction to fix a reasonable royalty.
The Supreme Court raised the matter in its wide-ranging case that is covering everything from oxygen allocations – on which it set up a National Task Force – to vaccine policy. However, the Centre said it was against compulsory licensing in its affidavit to the court. In communicating this position, the Centre has used convoluted language in its affidavit, making no clear distinction between essential drugs and vaccines.
While the section in the affidavit titled “Issue of compulsory license for vaccine and essential drugs (Remdesivir, Tocilizumab)” deals mostly with essential drugs, it concludes by saying:
“It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform using all its resources, good-will and good-offices though diplomatic and other channels.”
The Centre has asked the court to not to discuss exercise of statutory powers both for vaccines and essential drugs. But this line turns up in a section on compulsory licensing focusing on medicines. Experts feel the government’s stand should be assumed to apply to both essential drugs and vaccines.
This includes a statement in the affidavit saying in case a manufacturer applies for compulsory license under Section 92 of the Patents Act, it may be suitably considered by the government.
According to Shantanu Mukherjee, a New York- and India-qualified lawyer and the founder of Ronin Legal, a corporate law firm with a focus on healthcare, there seems to be a contradiction between India’s position at the World Trade Organisation over Covid-19 vaccines and its stand on compulsory licensing before the Supreme Court.
Mukherjee said that in October 2020, India and South Africa made a joint proposal before the WTO seeking a waiver on enforcing four types of intellectual property rights under the Trade Related Aspects of Intellectual Property Rights agreement. These are patents, industrial designs, copyrights and trade secrets or undisclosed information.
While at the WTO level India seeks a waiver on intellectual property rights, before the Supreme Court, the Centre has essentially said that it was at the moment not in favour of discussing statutory provisions to grant compulsory licenses, even though it added a caveat that if applications are made for such licenses, they may be considered.
“It was only four days ago that the United States came out in support of the Indian proposal,” Mukherjee pointed out. The waiver proposal has, as a result, picked up tremendous momentum. “Meanwhile, you have this affidavit that says compulsory licences can only be counter-productive at this stage, which undermines India’s argument before the WTO. This is not a good time for India, as the architect of this waiver proposal, to lose credibility on the global stage.”
Mukherjee added that he actually has sympathy for the larger idea expressed in the affidavit itself. At this time, with about 4000 people dying every day in India, due to Covid-19, the need is to get vaccines into India quickly, and imports, he said, are the quickest way. “And import negotiations – already hampered by disagreements with companies like Pfizer over indemnification and a lack of interest from a capacity-strapped Moderna – could become strained or even break down if there’s talk of compulsory licensing, which is probably the fear being expressed by the affidavit.”
Further, the lawyer said there were other complications in the compulsory licensing route such as transfer of proprietary technology and technical know-how , which he had dealt with in this piece in News18.
Murali Neelakantan, principal lawyer at Amicus and former global general counsel at Cipla, said that the Centre’s position that it would consider applications for compulsory licenses is startling. “You do not wait for an application,” he said. “The government should notify the patents under Section 92 and Section 100 of the Patents Act. Thereafter, such patents are open to use.”
Neelakantan said the Centre’s affidavit does not reveal on what basis it has taken its position on compulsory licensing. “Who are these experts you have relied on for this?” he asked. “You are jeopardising the diplomatic effort at WTO by taking a position domestically that you are not in favour of compulsory licensing.”
Position on Covaxin
In particular, the Centre’s position on Covaxin, the indigenously developed vaccine over which it has joint ownership with Bharat Biotech, has not been spelt out in clear terms.
In the affidavit, the Centre stated that efforts were being made to scale up production of Covaxin. “... support for one private industry and three public sector manufacturing facilities, is under consideration to make them ready with enhanced capacities to support augmented vaccine production over the next 6-8 months,” the document said.
These facilities include Bharat Biotech, Hyderabad, Indian Immunologicals, Hyderabad, Haffkine Biopharmaceuticals, Mumbai and Bharat Immunologicals and Biologicals, Bulandshahr. In all, Rs 200 crore has been allotted for this support.
Neelakantan pointed out that while there is the Centre’s position on compulsory licensing of other vaccines on one hand, what was inexplicable was the reluctance to grant licenses for Covaxin for which it has joint ownership. “There are several facilities in India which could produce Covaxin if the Centre grants licenses. They have not answered the question as to why the licenses are not being granted.”
The lawyer had earlier argued in Scroll.in that India should offer free licensing and technology transfer for Covaxin to the Global South and export the vaccine at an affordable price.