The world is turned upside down in the wake of COVID-19 with millions of people infected globally and nearly hundred thousand in India. Be it the government or healthcare professionals, everyone is tackling the pandemic in the best possible way. Since there hasn’t been any cure found to diminish the effect of Corona, pharmaceutical companies are partnering and forming alliances with each other or with research organizations to protect people from the deadliest pandemic of all times. Owing to the unprecedented demand of treatment, collaborations and solidarity are two important keys to fight with the global health crisis. For instance, AstraZeneca collaborated with the Oxford University’s Jenner Institute to distribute and manufacture the potential coronavirus vaccine known as ChAdox1 nCov-19. Sanofi and GSK also joined their forces to address the outbreak by complementing their expertise and resources. The organizations have been on their toes to combat the spread of this virus. Ramping up the production rate, distribution and supply to meet the requirement of proper access to medicines, vaccines, testing kits, respirators and ventilators are equally important concerns. As it is said that “Necessity is the mother of invention”, and where there is an Invention, the protection of it is mandatory and inevitable to recuperate the invested time and money. The encouragement of protecting intellectual property is proven to be an impediment when it comes to the management of global crises. Because if it is imperative for an inventor to monopolize the healthcare technology one has come up with, it is also important to ensure the access of it at affordable price during the tough times like this and with the protection against misuse of one’s intellectual property, it is hard for other manufacturers to step in and fill this void of lacking the access. Repurposing and restructuring of the existing molecules are two of the ways healthcare companies are approaching to help the population fight the COVID battle. hydroxychloroquine and chloroquine, originally indicated for malaria, were produced in bulk in recent past and are considered to be inexpensive and temporary defense tools to beat the coronavirus, reason being the drugs are out of patent protection edge. Though hydroxychloroquine hasn’t been found as very promising cure. Several budding molecules, clinically proven to be effective for other diseases, have shown positive results in treating the COVID-19 symptoms. For example, the influenza antiviral medicine Remdesivir, Favipiravir, Avigan® by Fujifim Toyama and anti-HIV combination Lopinavir/Ritonavir, Kaletra® by Abbvie. But again, patent protection is what hampers the accessibility of these treatment options. Although relaxation of patent rights by benevolent Abbvie has sheltered the generic players from patent infringement and which enabled Israel to issue a Compulsory License for importation of generic versions of Kaletra®. Patent protection of another promising molecule Remdesivir has put its innovator Gilead Science “at the edge of the knife situation” after it had been proved progressive in preventing the virus infection and reducing the recovery time of hospitalized patients with advanced COVID-19 and lung involvement. After successful completion of phase 3 clinical trials, Gilead can either expand its manufacturing capacity to make Remdesivir accessible globally with affordable cost which is next to impossible or it can allow third party organizations to step in to accelerate the mass production. According to the recent press release of Gilead, it has chosen to go with the latter option and has signed an agreement allowing the generic players like Cipla, Ferozsons, Hetero, Jubilant life sciences and Mylan to have non-exclusive voluntary license in order to expand the production capacity of Remdesivir and also, its distribution in 127 countries consisting of low-income, lower middle income, some upper middle and high income countries. The disadvantage of this agreement to Gilead is that it won’t get any royalty until the World Health Organization announces the end of Public Health Emergency or until the discovery and approval of an alternative treatment, whichever is earlier. However, the situation in the U.S. with regard to Remdesivir is quite different as it has already received USFDA Emergency Use Authorization (EMU) on May 1, 2020 backed by its early clinical data. Of all the segments, healthcare gets most affected by Intellectual Property because its protection dissuades the country to make its own population to use the essential treatment options at a reasonable price. There are norms available to promote openness and neglect IP hindrance with the intervention of the Government in countries like the UK, USA and India.

1)  Crown Use in UK

This possibility under UK patent law allows the Government to intervene and to provide qualified rights of selling the medicines in the time of emergency without the consent of the patent holder or exclusive licensee. Sometimes the Government would be needed to render the compensation to patent owners in return of loss of profit.

2)  Bayh-Dole Act in the United States

This legislation provides march-in rights to the Government when the invention arises from federal government funded research and the Government can further license the invention to other entities.

3)  Section 84, 92(3), 100 and 102 under Indian Patent Act (IPA),1970

Compulsory License (CL) can be obtained by any person interested by making an application to the controller after three years of grant of the patent under section 84 of IPA, 1970 if the product protected by patent is available at exorbitant price or the public demand is not being fulfilled or the patented invention is not worked in the territory of India. The chances of getting CL under section 84 are null for Remdesivir as the certificate of grant was issued recently in February, 2020. However, under section 92(3), in case of national emergency, extreme urgency and public non-commercial use which may arise during a public health crisis, the controller of the patent office without even hearing the patent holder can grant the approval for CL. Under section 100, the Central Government can use the patented invention and authorize the non-exclusive rights to third parties. Under section 102, when the Central Government is of the opinion that the invention protected by patent should be acquired for the public purpose, the rights of that invention are transferred to Government by notifying the applicant. Not only for medicines but also in case of masks, testing kits, and medical devices to preclude the spread of the virus, there occurs an imbalance between protection of rights and affordability. Unconventional times like COVID has indeed brought the innovator companies holding patents of N-95 masks, lifesaving vaccines and medicines in a difficult situation of whether to enforce the Intellectual Property Rights and gain the profit or to put the private profit at stake for the public good to confront the battle against deadliest virus and overcome the shortage. In conclusion, for the time being, intellectual property is not to be enforced strictly and open licensing is allowed but that is also going to benefit the company in terms of its goodwill and reputation in the market and towards the public at large. However there are many instances, where still string IP enforcement can be implied where there is a situation of counterfeit products or duplication with substandard quality.