Pfizer and BioNTech Sued for Patent Infringement Over mRNA Vaccine

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Pictured: The Statue of Justice/courtesy of iStock

Arbutus Biopharma and its licensee Genevant Sciences sued Pfizer and BioNTech for patent infringement earlier this month, intensifying an ongoing intellectual property battle over the technology underlying COVID-19 messenger RNA (mRNA) vaccines.

The lawsuit, filed April 4, alleges that the developers of Comirnaty have infringed on five Arbutus patents describing lipid nanoparticle (LNP) technology, the delivery system used by the vaccine to get mRNA into human cells. Pfizer and BioNTech couldn’t have produced their formulation without Arbutus’s technology, the plaintiffs claim, and so should pay compensation.

A spokesperson for Pfizer, which partnered with Canadian LNP company Acuitas Therapeutics last year, told BioSpace the company remains “confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.” A BioNTech spokesperson told BioSpace it is aware of the suit but would not comment on legal strategy.

News of the legal action comes as no surprise to patent experts watching the mRNA vaccine landscape. “This is consistent with what we have been expecting all along,” said Ana Santos Rutschman, a professor of law at Villanova University. Arbutus has been working on LNP delivery systems for years (and licensing the technology to companies such as Acuitas). 

A Long Time Coming

The litigation is part of a flurry of lawsuits to hit the mRNA vaccine space over the past year or so. Around the beginning of the pandemic, many firms avoided fighting over intellectual property related to vaccine development, Kevin Noonan, an attorney specializing in biotech patent law at McDonnell Boehnen Hulbert & Berghoff LLP, told BioSpace. Legal action would have been an impractical distraction, not to mention a poor look, during a worldwide public health crisis, so “it made perfect sense to wait.”

That’s no longer the case, he said, with the worst of the pandemic appearing to be over and the biotech industry considering how to apply the technology underpinning mRNA vaccines to oncology, cardiovascular disease and many other areas beyond infectious diseases.

This is the second time Arbutus has gone after a vaccine maker. In a lawsuit filed against Moderna in February 2022, the company alleged infringement of six patents (three of which were also cited in the lawsuit against Pfizer).

In an unusual move, Moderna attempted to persuade the court to dismiss the case on the grounds that Arbutus should instead sue the U.S. government, which had directed Moderna to develop COVID-19 vaccines. “Under Federal law, claims against U.S. Government-contracted suppliers must proceed against the Government in the U.S. Court of Federal Claims,” Moderna noted in a statement at the time.

This argument has so far been unsuccessful. The judge presiding over the case, Mitchell Goldberg, rejected it late last year—and again in March 2023 after the U.S. Department of Justice filed a “Statement of Interest” supporting Moderna’s position. The rejections are good news for Arbutus, which would stand to gain far less compensation in a victory in the U.S. Court of Federal Claims than in a win against Moderna, Noonan said.

Arbutus and Moderna did not respond to BioSpace’s requests for comment.

Lawsuits Galore

Other companies are involved in similar disputes. Pfizer and Moderna are also facing allegations of patent infringement from Alnylam Pharmaceuticals, which in March 2022 sued both companies over alleged violations of one of its own 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 stated at the time.

Moderna, meanwhile, filed its own suit against Pfizer and BioNTech in August 2022, alleging infringement of patents relating to mRNA technology. “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 said in a statement at the time. A Pfizer spokesperson told Reuters in a statement that the company was “surprised by the litigation.” It has since countersued Moderna.

These lawsuits will play out over many months, and experts note it’s too early to know exactly what to expect. However, they highlight that plaintiffs in these cases are requesting compensation or royalties rather than injunctions, which are unlikely to be granted given the life-saving nature of the vaccines in question. It’s probable, therefore, that many of these disputes will end in financial settlements, Noonan said. That’s nearly always “the most intelligent thing for them to do at the end of the day.”

Of course, that outcome depends on the patents at the heart of the allegations being upheld. Firms alleging infringement could instead find their patents invalidated—for example, if the technology described is deemed an obvious extension of existing techniques. While attempts to invalidate a patent through the courts are often unsuccessful, Noonan noted, there exists another route: requesting what’s known as an inter partes review through the U.S. Patent and Trademark Office.

Moderna has already successfully employed this approach to invalidate one of Arbutus’s patents. In a ruling handed down on Tuesday, the U.S. Court of Appeals for the Federal Circuit sided with Moderna in upholding an earlier judgement that the patent in question was “anticipated” by an earlier Arbutus patent and therefore invalid.

In that sense, “we have our first loser in the patent wars, and it’s Arbutus,” Rutschman said.

Such developments are being closely watched by companies interested in the applications of mRNA- or LNP-based technology, Rutschman said. “We are talking about applications of technology that will deal with some of the most important threats to both public and individual health.”

It could help restructure the playing field in this industry, too, with larger firms dodging future disputes by entering into partnerships with or acquiring companies that own the relevant technology. They’ll be asking “who else they need to have in their wheelhouse so they avoid these kinds of challenges,” Rutschman said. “I think that’s where some of these companies will consider going in the near-ish future.”

Catherine Offord is a freelance science journalist based in Barcelona. Reach her at coffordwrites@gmail.com or @ce_offord.

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