The unsettling bio-catastrophe known as the COVID-19 epidemic has presented mankind with a slew of difficulties. The global COVID-19 panic is endangering human life, and governments are profoundly split over whether or not to support a temporary patent waiver on COVID-19 vaccinations and the granting of compulsory licencing.

Compulsory Licensing 一

The use of a patented product without the consent or authorization of the patent holder is known as compulsory licencing. The TRIPS agreement gives the government the authority to grant parties such rights or to utilise the patent itself. The Indian Patent Act, 1970, Sections 84–92, lays forth the pre-requisite criteria that must be met before a compulsory licence may be granted. The TRIPS Agreement's Article 31 permits the government to force local producers to produce a protected product without first obtaining permission from the patent owners. It also allows nations to engage in compulsory licencing in the event of a national emergency/extreme emergency or for "public non-commercial purpose." Article 31 bis also allows rich countries to export generic pharmaceuticals to developing countries that are unable to manufacture them.

The Benefits of Mandatory Licensing

Fearing that IP rights will obstruct timely delivery of medical items, India and South Africa submitted a petition to the World Trade Organization (WTO) seeking a waiver of patent duties.

Advocates for Compulsory Licensing argue that it is a good way to address the issues surrounding the production of COVID-19 vaccines and related equipment. They claim that issuing a mandatory licence will benefit both stakeholders and the general public. It will benefit stakeholders by not depriving them of any rights in which they have made significant investments, and it will also protect public health by ensuring the manufacture and delivery of vaccines. Another argument in favour of granting forced licences is that the right to health takes precedence over patent protection.

Why is it possible that mandatory licencing is a bad idea?

It is stated that while Covid-19 vaccines are new, their effectiveness and internal technological capabilities highlight the futility of requiring a forced licence. Furthermore, it is claimed that this approach is ineffectual since TRIPS provides for 'Adequate Remuneration' to be paid to patent holders under Article 31(h), but does not define "adequate" or the process of determining royalties. There is also a possibility of pharmaceutical corporations retaliating, which may seriously hurt the indigenous industry. Abbott withdrew and ceased marketing numerous medicines in Thailand after compulsory licencing of Abbott's HIV drug. In the case of Rakesh Malhotra v. Govt. of NCT India, the Delhi High Court stated that the best course of action is to urge firms to ramp up output on a war footing. They should be encouraged to give licences to other organisations on a voluntary basis.

Compulsory licences could only be issued if the government has a generic manufacturer ready to produce large quantities of generics and is technologically capable. Another potential stumbling block is the safeguarding of commercial secrets. Article 39 of the TRIPS Agreement mandates that members protect trade secrets against commercial use. Furthermore, giving patent exemptions may deter pharmaceutical firms from developing vaccines because they must invest much in research and development. Waivers like this give rivals a leg up on the competition when it comes to acquiring pricey technologies.

India on Compulsory Licensing 一

In a study titled "Review of IP Regime in India," the Commerce Standing Committee of Parliament stated that forced licencing may be considered in the event of national emergency. A three-judge panel of the Hon'ble Supreme Court has urged the government to investigate the idea of giving Compulsory Licenses in a Suo-moto case. According to the court, mandatory licences can be given with a sunset provision, indicating that the licence would expire once the epidemic is ended.

Experts were quick to point out their conflicting attitude after India's plea at the WTO. In a press statement issued on May 27, 2021, the NITI Ayog said that India does not intend to grant any compulsory licences for COVID-19 vaccines and that active participation from the businesses that originally created the vaccine is required. The spirit of India's National IPR Policy requires India to strike a balance between advocating its stance on access to medication and innovation.

As a result, it is important to meet vaccination requirements without jeopardising the innovation environment.