international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

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Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

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Vial and syringe.

4 Things to Know About Intellectual Property, Patent Pledges, and COVID-19 Vaccines

By Chloe Reichel

High-profile commentators have argued recently that vaccine scarcity needn’t exist. If vaccine manufacturers simply shared their patents with other pharmaceutical companies, supply would quickly ramp up. 

Others have pointed out that numerous bottlenecks exist in the manufacturing process, from the glass vials that hold the vaccine, to the lipids that encase the vaccine’s active ingredient, mRNA.

And even if these bottlenecks didn’t exist, the intellectual property argument may be a straw man.    

In fact, this past October, Moderna made a gesture toward opening access to its intellectual property, by pledging that it would not enforce its patents against “those making vaccines intended to combat the pandemic.” That month, Jorge L. Contreras, a Presidential Scholar and Professor of Law at the University of Utah, covered the patent pledge and its potential implications for Bill of Health.

We checked in with Contreras to ask about the implications of Moderna’s patent pledge now that its vaccine has been proven safe and effective. Here are the highlights from the conversation:

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Vaccine.

Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check

By Caranina (Nina) Colpaert

As pharma races to develop a COVID-19 vaccine, researchers and governments are working in parallel to pinpoint strategies to secure its widespread access.

To that end, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.

In the European Union (EU), however, compulsory licensing is not as self-evident as it might seem. This blog post focuses on four specific challenges that come with compulsory licensing in the EU and potential alternative solutions.

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Researcher works at a lab bench

Deconstructing Moderna’s COVID-19 Patent Pledge

By Jorge L. Contreras, JD

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.”

It also expressed willingness to license its intellectual property for COVID-19 vaccines to others after the pandemic. In making this pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

Moderna holds seven issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine is potentially enormous. As of this writing, the U.S. government has committed approximately $1.5 billion to acquire 100 million doses of Moderna’s vaccine if it proves to be safe and effective (with an option for 100 million more), and the Canadian government has agreed to purchase 20 million doses for an undisclosed amount.

In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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