This month, Arbutus Biopharma and its licensee Genevant Sciences sued Pfizer and BioNTech for patent infringement over COVID-19 mRNA vaccine technology.
The lawsuit, filed April 4, claims that Comirnaty’s inventors infringed five Arbutus patents on lipid nanoparticle (LNP) technology, the vaccine’s delivery mechanism for mRNA. The plaintiffs say Pfizer and BioNTech should pay since Arbutus’s technology made their formulation possible.
Pfizer told BioSpace it is “confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.” BioNTech informed BioSpace of the litigation but declined to discuss legal strategy.
Patent experts following mRNA vaccines expected the legal action. “This is consistent with what we have been expecting all along,” said Villanova University law professor Ana Santos Rutschman. Arbutus has developed LNP delivery methods for years and licensed the technology to Acuitas.
Long Overdue
Over the past year, mRNA vaccination lawsuits have proliferated. Kevin Noonan, a biotech patent law attorney at McDonnell Boehnen Hulbert & Berghoff LLP, told BioSpace that many corporations avoided fighting over vaccine development intellectual property during the epidemic. During a global public health crisis, “it made perfect sense to wait.”
He added the worst of the epidemic appears to be past and the biotech sector is studying how to adapt mRNA vaccine technology to oncology, cardiovascular disease, and other fields.
Arbutus has targeted vaccine makers twice. Moderna sued Moderna in February 2022 for violation of six patents, three of which were also cited in the Pfizer complaint.
Moderna unusually argued that Arbutus should sue the U.S. government, which had ordered Moderna to create COVID-19 vaccinations. “Under Federal law, claims against U.S. Government-contracted suppliers must proceed against the Government in the U.S. Court of Federal Claims,” Moderna stated.
This argument failed. The court, Mitchell Goldberg, denied it late last year and again in March 2023 after the U.S. Department of Justice filed a “Statement of Interest” backing Moderna. Noonan said the rejections are good news for Arbutus, which would receive significantly less compensation in a U.S. Court of Federal Claims triumph than against Moderna.
Arbutus and Moderna declined BioSpace’s requests for comment.
Suits abound
Other companies have similar disputes. Alnylam Pharmaceuticals sued Pfizer and Moderna in March 2022 for violating one of their LNP patents. “Alnylam is seeking fair compensation for use of its technology based on patent claims to a broad class of biodegradable lipids invented over a decade ago,” the company said.
In August 2022, Moderna sued Pfizer and BioNTech for mRNA patent infringement. “We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger stated at the time. “Surprised by the litigation,” a Pfizer spokeswoman told Reuters. It countersued Moderna.
Experts said this litigation will go months and they don’t know what to expect. They note that plaintiffs in these instances are seeking compensation or royalties rather than injunctions, which are improbable due to the vaccines’ life-saving properties. Noonan predicted substantial settlements for several of these issues. That’s usually “the smartest thing for them to do.”
That hinges on the patents at the center of the claims being upheld. If the technology presented is an obvious extension of existing processes, patents may be invalidated. Noonan emphasized that the U.S. Patent and Trademark Office’s inter partes review can invalidate a patent, unlike the courts.
Moderna invalidated an Arbutus patent using this method. On Tuesday, the U.S. Court of Appeals for the Federal Circuit sided with Moderna in upholding an earlier finding that the invention was “anticipated” by an earlier Arbutus patent and invalid.
Rutschman believed Arbutus was the first patent battle loss.
Rutschman said companies interested in mRNA- or LNP-based technologies are watching such developments. “We are talking about technology that will address some of the biggest threats to public and individual health.”
It could also restructure this industry, with larger firms avoiding future disputes by partnering with or acquiring technology-owning enterprises. “Who else they need in their wheelhouse so they avoid these kinds of challenges,” Rutschman added. “I think some of these companies will consider going there soon.”