Member countries of the World Trade Organization (WTO) are under an obligation to ensure that their domestic intellectual property rights (IPR) laws conform to the requirements of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. When the pandemic hit the globe, India and South Africa piloted the proposal to waive key provisions of the TRIPS agreement on COVID-19 vaccines, drugs, therapeutics, and related technologies. The core idea is that IPRs such as patents should not become barriers in scaling up production of medical products essential to combat COVID-19. The TRIPS waiver proposal, now backed by the U.S., is essential because it would give immunity to member countries from a legal challenge at the WTO if their domestic IPR laws suspend or do not enforce IP protection on COVID-19 medical products.
Foot-dragging on compulsory licences
It is uncertain when the TRIPS waiver would be adopted, or what conditions it would be subjected to. Meanwhile, nothing stops India from using the existing flexibilities under the Patents Act of 1970, such as compulsory licences, which are consistent with the TRIPS agreement , to increase the supply of COVID-19 medical products. While issuing compulsory licences for COVID-19 vaccines in the absence of technology transfer is easier said than done, they can be used to augment the supply of drugs and other therapeutics. For instance, Natco, an Indian pharmaceutical company, has requested a compulsory licence under Section 92 of the Patents Act for Baricitinib, a COVID-19 drug. Incyte Holdings Corporation owns the patent for Baricitinib with a licence to Eli Lilly, an American drug company. Likewise, there are demands that compulsory licences be issued for drugs such as Remdesivir to augment supply. Natco’s application demonstrates that the option of issuing compulsory licences is available to the government. However, despite the nudging by the judiciary and others, the government inexplicably hasn’t made use of compulsory licences in the pandemic. This is ironic because India has historically played a leading role in mainstreaming TRIPS flexibilities like the compulsory licence at the WTO.
To make matters worse, the Central government, in an affidavit filed before the Supreme Court a few days ago, suggests that issuance of compulsory licences will not be effective. Specifically, the affidavit states that the main constraint in boosting the production of drugs like Remdesivir is the unavailability of raw materials and essential inputs. If that is the real bottleneck, and not IPR-related legal hurdles, why is India pushing for a TRIPS waiver at the WTO? After all, the TRIPS waiver is about overcoming legal impediments, not about addressing supply-side bottlenecks. The affidavit further states, “it is presumptuous to assume that the patent holder will not agree to more voluntary licences”. Thus, the government believes that voluntary licences, not compulsory licences, are the way forward to address shortage of COVID-19 medical products. Interestingly, those who oppose the TRIPS waiver at the WTO advance the same argument.
The first step in advocating for the removal of IPR-related impediments at the WTO is to make use of the existing lawful means, even if insufficient, to lift the obstacles that come in the way of manufacturing patented products domestically. Therefore, the government’s stand before the Supreme Court is not only contradictory with India’s position at the WTO but also severely undermines it. This would make the TRIPS waiver negotiations arduous. To make its TRIPS waiver stand convincing, the government needs to make aggressive use of Sections 92 and 100 of the Patents Act to license all patents necessary to make COVID-19 medical products, without waiting for a private party to apply for a licence. An assertive posture on compulsory licences would also have the advantage of forcing several pharmaceutical companies to offer licences voluntarily.
India’s development of Covaxin is a spectacular scientific achievement. Given the involvement of taxpayers’ money in the development of Covaxin, the government has a stake in its IPR. Thus, the government should not only transfer Covaxin’s technology to domestic pharmaceutical companies, to boost national supplies, but also offer it to foreign corporations. By unlocking its vaccine technical know-how to the world, India would demonstrate its resolve to walk the talk on the TRIPS waiver. Licensing Covaxin widely would enable India to live up to its reputation of being the ‘pharmacy of the world’ and also put pressure on developed countries to transfer their vaccine technology to developing countries. India must take a consistent stand on IPRs on COVID-19 medical products internationally and domestically.
Prabhash Ranjan is a Senior Assistant Professor at South Asian University’s Faculty of Legal Studies. Views are personal