Russia had offered India to supply 3,00,000-4,00,000 injections of remdesivir. This has triggered an alarm in the U.S., which is already upset with Moscow over unlicensed production of the drug. Any exports could invoke stringent U.S. penalties against Russia and even India. So the Indian government was trying to procure them directly from the U.S. as a consequence of this patent issues. However, exports of remdesivir, which the Russian government had offered, have run into trouble, with the California-based Gilead Sciences Inc., which developed the drug, invoking the U.S. licensing laws. The Russian side has now conveyed that the drug may not be sent to India unless the issue is resolved.
Gilead has signed non-exclusive voluntary licensing agreements with 10 manufacturers based in India, Egypt and Pakistan for remdesivir production, of which seven are Indian companies, but none with Russia. Demand for the drug has grown worldwide, despite a recommendation from the World Health Organization against its use. Gilead said on Monday said it will provide technical assistance to its seven Indian licensees so they can expand production capacity and donate active pharmaceutical ingredients (API). Last week, the Centre had announced that India’s monthly production capacity was being increased from 38 lakh vials to 74 lakh vials. The company said that it will donate at least 4,50,000 vials of the drug, under the brand name Veklury, to the government of India.
So, what was preventing other countries to export such injections like remdesivir?
On October 2 last year, India and South Africa submitted a joint petition to the World Trade Organization (WTO), requesting a temporary suspension of rules under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for implementation, application, and enforcement of Sections 1 (copyright), 4 (industrial designs), 5 (patents), and 7 (undisclosed information) of Part II of TRIPS […] in relation to prevention, containment or treatment of COVID-19 (emphasis inserted). They expect the waiver to continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.
Low- and medium-income countries (LMICs) either have to manufacture vaccines themselves, or import from countries with strong generics industry. In consultation with many LMICs, ISA decided to request a waiver from IPRs from the TRIPS council, to rely on their generic manufacturers to supply vaccine to low-income countries, without facing any infringement risk. However, ISA faced insurmountable opposition to their request.
TRIPS — Trade-Related Aspects of Intellectual Property Rights
The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated during the 1986-94 Uruguay Round, introduced intellectual property rules into the multilateral trading system for the first time. TRIPS is the most comprehensive multilateral agreement on intellectual property (IP). It plays a central role in facilitating trade in knowledge and creativity, in resolving trade disputes over IP, and in assuring WTO members the latitude to achieve their domestic policy objectives. It frames the IP system in terms of innovation, technology transfer and public welfare. The Agreement is a legal recognition of the significance of links between IP and trade and the need for a balanced IP system.
Types of intellectual property under TRIPS Agreement are Copyright and related rights, Trademarks, including service marks Geographical indications Industrial designs Patents Layout-designs (topographies) of integrated circuits, Undisclosed information, including trade secrets.
The TRIPS Agreement covers five broad areas:
- How general provisions and basic principles of the multilateral trading system apply to international intellectual property
- What the minimum standards of protection are for intellectual property rights that members should provide
- Which procedures members should provide for the enforcement of those rights in their own territories
- How to settle disputes on intellectual property between members of the WTO
- Special transitional arrangements for the implementation of TRIPS provisions.
India has implemented Article 31 of TRIPS, dealing with compulsory licensing of patents. It mandates that if patent holders: (i) do not fulfil consumer’s needs for the product, (ii) do not supply it at affordable price, or (iii) do not work the invention in India, then after three years from patent grant, the controller can grant compulsory licence of such a patent to interested manufacturers. To effectuate the Doha Declaration on public health, the TRIPS council introduced the Waiver of IPR under Article 31 . Under this, member states can issue compulsory licences predominantly to export medicines to needy countries, after fulfilling additional requirements. Implementing countries find these additional conditions onerous, involving amending their national legislation, seeking importing country’s approval, importing country seeking TRIPS council approval with exact units of the drug, and exporting country negotiating with patent owners for reasonable royalty, among others.
These developments have forced India and other LMICs to adopt emergency measures provided under Article 73 of TRIPS agreement. Under that, the WTO member countries could take any action necessary for protecting its essential security interests, in times of emergency in international relations. Under this article, India could suspend its obligations towards other member countries and their vaccine manufacturers and take any measure it deems fit to make vaccine available for its citizens, including suspending IPRs and instituting compulsory licensing of patents and the know-how
With growing pressure on the U.S. — both at home and abroad —to support an Indian and South African initiative at the World Trade Organisation (WTO) that will waive intellectual property rights temporarily to address COVID-19 related medical shortages, United States Trade Representative (USTR) Katherine Tai met with the heads of vaccine manufacturers, Pfizer and AstraZeneca, and discussed the role of developing countries in addressing global gaps in vaccine production and distribution.