Augsburg, Bavaria, Germany - March 23, 2021: Vials with the Moderna Covid-19 vaccine are used at the corona vaccination centers worldwide.

No Take-Backs: Moderna’s Attempt to Renege on its Vaccine Patent Pledge

By Jorge L. Contreras

On October 8, 2020, Moderna, the maker of one of the first mRNA-based vaccines for COVID-19 and the recipient of billions of dollars of U.S. government funding, announced that it felt “a special obligation … to use our resources to bring this pandemic to an end as quickly as possible.” As a result, it publicly promised that “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.” Moderna broke that promise on August 26, 2022, when it sued Pfizer and BioNTech, the producers of a competing mRNA vaccine, for patent infringement in the U.S. and Germany. This post explains why Moderna’s lawsuits should fail given its irrevocable and continuing nonenforcement pledge.

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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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Doctor or nurse wearing PPE, N95 mask, face shield and personal protective gown standing beside the car/road screening for Covid-19 virus, Nasal swab Test.

COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies

By Joshua D. Sarnoff

In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.

In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.

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