Moderna loses bid to invalidate vaccine delivery patents, teeing up potential infringement lawsuit

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There is a substantial risk that Arbutus Biopharma could sue Moderna over its COVID-19 vaccine, the mRNA specialist has warned. (Getty Images/William_Potter)

Moderna has suffered a blow in its patent feud with Arbutus Biopharma, exposing the mRNA specialist to a potential infringement suit on its megablockbuster COVID-19 vaccine.

The U.S. Court of Appeals for the Federal Circuit rejected Moderna's bid to invalidate two key Arbutus patents that could be linked to the delivery of Moderna's COVID-19 shot, documents filed Wednesday show. With a win on the docket, Arbutus could levy a patent infringement lawsuit against Moderna over its COVID-19 vaccine or demand that the company pay up royalties, Bloomberg Law previously reported. 

Before the ruling, an Arbutus victory had been "heavily favored," Jefferies analysts wrote in a note to clients earlier this year. 

Moderna's star is tightly tethered to its vaccine, which is the company's first marketed product and the second COVID-19 shot to pass muster in the U.S. 

In two opinions issued Wednesday, the court affirmed previous decisions by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) validating Arbutus' patents Nos. 8,058,069 and 9,364,435.

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Both patents pertain to lipid nanoparticles (LNPs), which are used to protect and deliver genetic material such as messenger RNA as it travels through the body. LNPs are used in both Moderna and Pfizer-BioNTech's mRNA-based shots. 

Looking to stave off litigation, Moderna has preemptively challenged three Arbutus LNP patents since 2018. 

The PTAB said that portions of the '435 patent were invalid but otherwise ruled in Arbutus' favor—a decision which the Court of Appeals has affirmed. 

A Moderna spokesperson said the company is "pleased" with the court's decision to invalidate certain claims of patent '435 but that it disagrees "with the remainder of the decisions maintaining certain other claims or not considering their validity because of a procedural issue."

The company is confident its COVID-19 vaccine is not covered in those claims, the spokesperson added. 

“Moderna is a pioneer of mRNA-based vaccines, and we have developed our own proprietary LNP-delivery technology,” she said. “This technology allows us to deliver on our mission of creating a new generation of transformative medicines for patients.”

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Arbutus did not immediately respond to Fierce Pharma's request for comment. 

Moderna has warned of a "substantial risk" that Arbutus could invoke its '069 patent in an infringement suit targeting its COVID-19 vaccine, Wednesday's court documents say. Shaun Ryan, Moderna's senior vice president and deputy general counsel, previously directed the court's attention to a series of public statements by Arbutus "regarding the alleged extensive scope of its patent coverage over virtually all lipid nanoparticle ("LNP") delivery systems."

Arbutus' update comes as Moderna's public-private partnership with the U.S. government also faces turbulence. Separate from its Arbutus' squabble, Moderna has butted heads with the National Institutes of Health over the provenance of its COVID-19 shot. 

Moderna's vaccine has raked in billions so far. During the company's third-quarter earnings report, Moderna slashed its previous estimate for 2021 pandemic vaccine sales from $20 billion to between $15 billion and $18 billion. It blamed shipping delays that have hamstrung rollouts as Moderna tries to deliver the shot to more countries.