Nonprofits, Experts Urge U.S. to Wield Moderna Vaccine Patent to Increase Global Supply

A group of academics, policy experts and nonprofits has penned a letter to HHS and the National Institutes of Health (NIH) urging the government to draw up provisions that improve global access to Moderna’s COVID-19 vaccine as part of any patent-licensing agreement for the drugmaker.

The U.S. government-owned patent could serve as the catalyst for significantly ramping up supplies of Moderna’s mRNA-based vaccine, mRNA-1273, that could go toward the global vaccination effort, the group said. Because the patent is not yet licensed to Moderna, the government could and should impose specific conditions in a patent-licensing agreement that would help improve access to the vaccine around the globe, argued the group, which includes more than a dozen professors as well as several advocacy groups, including Public Citizen and PrEP4ALL.

Specifically, they want the government to require, as part of a licensing agreement, that Moderna share its vaccine production steps with other contract manufacturing organizations (CMOs) to enable scaled-up production. The groups noted that Moderna has so far only contracted with a single CMO, Lonza Group, to produce the drug substance required for its vaccine.

“Currently, at best, only 1 billion doses of mRNA-1273 will be produced in 2021, far short of global demand,” they said. “The U.S. government has not licensed the patent to Moderna. It is imperative that the NIH uses any licensing agreement to include provisions to help increase global access to this lifesaving technology, rather than just a monetary royalty.”

They also said that any patent-licensing deal should require that the drugmaker share its technology with the World Health Organization (WHO), claiming that Moderna has so far chosen not to share production know-how with manufacturers in developing countries.

Lastly, the group called for fair pricing as a condition of a patent license so that less wealthy nations can afford the vaccine. They alleged that the drugmaker is charging between $10 and $40 per dose despite the manufacturing cost amounting to less than $3, a price range that can box out low- and middle-income countries.

“Assertion of U.S. government-owned intellectual property to increase access to pharmaceutical products is not unprecedented,” they said. “In 2019, the federal government sued Gilead Sciences for its infringement of government-owned patents protecting the use of Truvada and Descovy for HIV pre-exposure prophylaxis (PrEP) — and per the complaint itself, is using that litigation to increase access to PrEP. That lawsuit is ongoing.”

Development of Moderna’s COVID-19 vaccine was aided by more than $2.5 billion in taxpayer dollars, according to the group.

Moderna did not immediately respond to a request for comment.

Read the letter here: www.fdanews.com/03-26-21-Moderna070Patent.pdf. — James Miessler