The Corona virus crisis was declared as 'pandemic' by the World Health Organization (WHO) on March 11, 2020. While the 'Patent Rights' are awarded to inventors for protecting their inventions from unfair competition for a limited number of years, this 'pandemic' presents a scenario where the competition is between the humans and the virus rather than a competition between companies. It is important to mention herein, that during World War II, in order to expedite the production of penicillin, US government had asked companies and universities to scale up penicillin production so as to save thousands of soldiers. At the time, penicillin manufacturing companies never sued each other in the name of patent infringement.
One year into the declaration of pandemic, there are 10 Covid-19 vaccines approved for use all over the world. These vaccines include
- m RNA vaccines: Comirnaty (BNT162b2) of Pfizer, BioNTech; Fosun Pharma, Moderna COVID‑19 Vaccine (mRNA-1273) developed by Moderna, Barda, Niaid;
- adenovirus vaccine: COVID-19 Vaccine AstraZeneca (AZD1222); also known as Vaxzevria and Covishield;
- Sputnik V which is a recombinant adenovirus vaccine developed by Gamaleya Research Institute, Acellena Contract Drug Research and Development;
- COVID-19 Vaccine Janssen (JNJ-78436735; Ad26.COV2.S) a non-replicating viral vector developed by Johnson & Johnson of The Netherlands;
- CoronaVac & BBIBP-CorV which are inactivated vaccines from China;
- EpiVacCorona, a peptide vaccine developed by Russia;
- Convidicea (Ad5-nCoV) which is a Recombinant vaccine (adenovirus type 5 vector) developed by CanSino Biologics of China; and
- Covaxin (BBV152), an inactivated vaccine developed by Bharat Biotech & ICMR of India.
While the development in the area of vaccines is humongous, there are challenges that will be faced by least developed and developing countries in the distribution and accessibility of vaccines to their low income strata of population. In order to address this issue, on 2nd October 20201, India along with South Africa, reached out to World Trade Organization with a proposal asking for a waiver from the implementation of intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information in the field so that it does not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing, and supply of medical products essential to combat COVID-19.
REPRIEVE OR LICENSE
Mass vaccination of the human population is the only way to put an end to this pandemic. Apart from patents, other IP rights hinder developing countries with insufficient or no manufacturing capacity to comply with the requirements of Article 31bis of the TRIPS agreement and will lead to a cumbersome process for the import and export of pharmaceutical products. IP waiver/reprieve would help in putting together the vaccine components, setting up manufacturing facilities and producing vaccines in sufficient quantities to deliver to a wider population in shortest span of time thereby putting an end to this devastating pandemic.
Apart from waiving IP rights, companies can opt for increase in licensing deals in exchange for payment so that more and more companies can manufacture vaccines to cater the needs of a staggering population. It is also to be noted that World Health Organization is setting up a facility for companies to share their vaccine technology, skills and know-how as an effort to increase access to vaccines through technology transfer and local production.
MODERNA - LICENSING IP RIGHTS DURING COVID-19 PANDEMIC2
Moderna, a pioneer in the development of COVID-19 m RNA vaccine, in its press release issued on October 8, 2020, announced that it won't enforce its COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any IP barrier to vaccine development across countries during the pandemic period, upon request were willing to license their intellectual property for COVID-19 to others for the post pandemic period.
FUNDING FROM PUBLIC BODIES
India's indigenous COVAXIN, is in large measure a product of publicly funded research in India. With the limited set of production capacity with vaccine developers and their licensees, it will take several years to cater to the entire country's population. Owing to the devastating effect of COVID-19 on the country's economy, we cannot afford to prolong the vaccination by years. Considering the alarming fatalities caused by the second wave in India, it is pertinent for the WTO to reconsider the IPR waiver proposal so that the people of our nation do not have to wait indefinitely for vaccines.
US & WTO'S RATIFICATION
WTO's General Counsel took up the issue on temporary waiver for IP rights on COVID-19 vaccines, which was earlier proposed by India and South Africa. World Health Organization (WHO), in April 2021, asserted that only 0.2% out of 700 million vaccines globally administered had been given in low-income countries. The counter view of the big drug companies that opposed patent waivers, argued that vaccine making is difficult and the strong IP protection helped to provide incentive for the development of vaccines in record time. However, the WTO director Ngozi Okonjo-Iweala has suggested a compromise, laying out global action to increase vaccine access after a meeting with producers, governments, and others. It was suggested by WTO, to increase technology transfer to bring in new manufacturing capacity and to be transparent on contracts and pricing. The US trade representative, Katherine Tai, in May 2021, stated that "their administration believes strongly in Intellectual Property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines".
BESIDES IP, THE OTHER BOTTLENECKS
Besides availing IP waiver, there are other bottlenecks as pointed out by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) as 'real challenges' in scaling up production and distribution of Covid-19 vaccines. Challenges include trade barriers, supply chain bottlenecks, scarcity of raw materials used in vaccine preparation and above all the unwillingness of developed countries in sharing their vaccine doses to developing/poorer nations. Scarcity of raw materials required for vaccine production and dependence on specific suppliers are a huge roadblock in ramping up the vaccine production. For example, US had blocked exports of critical raw materials used in the production of some Covid-19 vaccines using regulations like the American Defence Production Act. Therefore in all, India that nurtures a huge generic industry, has ample production facility for manufacturing vaccines on its own, provided that it is backed by IP Waiver, technology transfer and know-how of vaccine development, unhindered raw material supply for vaccine production and facilities for scaling up the production and distribution to cater its humongous population.
Footnotes
1. https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
