Moderna again points at U.S. gov’t in COVID-19 vaccine patent lawsuit

A vial labelled with the Moderna coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration

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  • Moderna says U.S. government liable for patent infringement claims by Alnylam
  • Company made same argument in another lawsuit over vaccine tech, pointing to law with World War One-era roots

(Reuters) – Moderna Inc told a Delaware federal court Monday that it is immune from patent-infringement allegations over its COVID-19 vaccine because it supplied the shots for a U.S. government effort.

Alnylam Pharmaceuticals Inc is required under a longstanding federal law to sue the government directly over shots used in its nationwide vaccination effort, Moderna said in a motion to dismiss the lawsuit.

Moderna argued earlier this month that the law similarly insulates it from patent claims over its vaccine brought by Arbutus Biopharma Corp and Genevant Sciences GmbH.

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A spokesperson for Genevant said at the time that Moderna was “trying to shift responsibility for its patent infringement to the U.S. taxpayer” instead of responding to the claims. A judge has yet to rule on Moderna’s motion in that case.

An Alnylam spokesperson said Tuesday that its technology was “foundational” to the vaccines and has a “fiduciary duty to shareholders to seek fair compensation” for its use. It did not specifically respond to Moderna’s arguments.

The Food and Drug Administration declined to comment. Moderna, its attorneys, and the Department of Health and Human Services did not immediately respond to requests for comment.

Cambridge, Massachusetts-based Alnylam sued Moderna and Pfizer Inc in Delaware in March, seeking royalties for the lipid nanoparticle (LNP) technology their vaccines use to deliver genetic material known as mRNA.

Pfizer has not yet responded to Alnylam’s claims. The court on Monday extended Pfizer’s deadline for a response to Friday.

Moderna’s motion to partially dismiss Alnylam’s case cites a federal law known as Section 1498 that passes liability to the U.S. government when infringing products are made on its behalf.

The law was previously used to keep patent disputes from interfering with the supply of war materials during World War One. Moderna said a situation like the COVID-19 crisis is “exactly when Section 1498 is meant to apply.”

Moderna also told the court that its vaccines do not infringe any patents, “but that dispute is for later.”

Aziz Burgy, a patent partner at the law firm Axinn, Veltrop & Harkrider, said Tuesday that the court’s decision could have “broad implications” for future patent fights over essential drugs and vaccines. He said the success of Moderna’s argument could hinge on the degree of authority the U.S. government gave the company in their agreement.

Moderna on Monday cited part of the contract that says the Department of Defense and Department of Health and Human Services “authorize and consent to all use and manufacture” of “any invention described in and covered by a United States patent.”

Matthew Rizzolo, a patent partner at Ropes & Gray, said Moderna’s liability may also depend on whether the federal government was its only U.S. customer.

Moderna could theoretically be liable for sales to other parties in the United States even if it wins on its Section 1498 defense, Rizzolo said.

The case is Alnylam Pharmaceuticals Inc v. Moderna Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-00335.

For Moderna: Jane Love and Anne Brody of Gibson, Dunn & Crutcher

For Alnylam: William Gaede, Sarah Columbia and Ian Brooks of McDermott Will & Emery

Read more:

Moderna says U.S. on the hook in COVID-19 vaccine patent case

Alnylam files patent infringement lawsuits against Pfizer, Moderna

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Our Standards: The Thomson Reuters Trust Principles.

Blake Brittain

Thomson Reuters

Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at blake.brittain@thomsonreuters.com

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