Context: Recently, the United States has announced support for waiving intellectual property protection for Covid-19 vaccines.
Background

• In October 2020, India and South Africa had asked the WTO to waive certain conditions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement that could impede timely access to affordable medical products to combat Covid-19.
• The countries had asked the TRIPS Council to recommend a waiver on the implementation, application and enforcement of four sections in the second part of the agreement.
• These sections 1, 4, 5, and 7 pertain to copyright and related rights, industrial designs, patents, and the protection of undisclosed information.
• The proposal had said that developing countries “especially”, may face institutional and legal difficulties when using flexibilities available in the TRIPS Agreement.

Key Highlights

• The US will pursue “text-based negotiations” on the waiver at the World Trade Organization (WTO).
• The text-based negotiations involve negotiators exchanging texts with their preferred wording and then thrashing out a consensus on the working.
• All 164 WTO members must agree on the draft, and any one member can veto it.
• Meaning of intellectual property waiver for Covid-19 vaccines
• The IP waiver might open up space for production of Covid vaccines with emergency use authorisations (EUA).
• Most production is currently concentrated in high-income countries and production by middle-income countries has been happening through licensing or technology transfer agreements.
• The US support for an IP waiver stems from a proposal by India and South Africa in the WTO last year.
• The proposal had called for a waiver on all Covid interventions, including testing diagnostics and novel therapeutics.
• The countries including Canada, South Korea, and Bangladesh have shown interest in making Covid vaccines if they can get a patent waiver.

What are the deterrents for the waiver?

• The pharma companies including Pfizer and AstraZeneca had opposed the proposed waiver saying eliminating IP protections would undermine the global response to the pandemic.
• It could create confusion that could potentially undermine public confidence in vaccine safety and create a barrier to information sharing.
• The argument that these countries do not have the capacity to speedily produce vaccines goes against earlier moves towards a patents regime for generic drugs.

Reasons for demand to waive patents on Covid vaccines

• At present, only drug companies which own patents are authorised to manufacture Covid vaccines.
• The lifting of patent will allow the recipes to be shared and there will no longer be an embargo.
• Any company which possesses the required technology and infrastructure can produce vaccines after waiver of patent.
• It will lead to cheaper and more generic versions of Covid vaccines.
• It will also mean two things that vaccines will be more affordable and this will be a big step in overcoming vaccine shortage.
• The inequitable distribution of vaccines has opened up a glaring gap between developing and wealthier countries.

What are patents and IP rights?

• A patent represents a powerful intellectual property right, and is an exclusive monopoly granted by a government to an inventor for a limited, pre-specified time. It provides an enforceable legal right to prevent others from copying the invention.

Patents can be either process patents or product patents

• A product patent ensures that the rights to the final product is protected, and anyone other than the patent holder can be restrained from manufacturing it during a specified period, even if they were to use a different process.
• A process patent enables any person other than the patent holder to manufacture the patented product by modifying certain processes in the manufacturing exercise.

Patent regime in India

• India moved from product patenting to process patenting in the 1970s, which enabled India to become a significant producer of generic drugs at global scale, and allowed companies like Cipla to provide Africa with anti-HIV drugs in the 1990s.
• But due to obligations arising out of the TRIPS Agreement, India had to amend the Patents Act in 2005, and switch to a product patents regime across the pharma, chemicals, and biotech sectors.

By: Shubham Tiwari