Moderna filed patent infringement actions, on August 26, 2022, against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
Moderna claimed that the COMIRNATY® vaccine infringes the patents covering its mRNA-1273 vaccine. According to the US court claim document seen by IP STARS, Moderna is relying on three patents (US patent numbers 10,898,574, 10,702,600, and 10,933,127) filed between 2011 and 2016, before its collaboration with the US medical research agency, National Institutes of Health (NIH).
BioNTech said it will “vigorously defend against all allegations of patent infringement”.
We have not yet confirmed the details of the German case. Updates on this case will be published here.
Among other relief, the company is seeking an award of damages for the sales and activities in the US and outside the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC) on or after March 8, 2022. Sales under US government contracts are also excluded.
The lawsuit came on the day Pfizer and BioNTech announced its regulatory application in Europe for an updated booster vaccine covering the Omicron variants. Moderna is not seeking an injunction to block or remove the COMIRNATY® vaccine from the market. Read its press release here.
After defending two patents at the PTAB, Arbutus Biopharma Corporation and its partner have hit back at Moderna with a patent infringement action in the US District Court for the District of Delaware (see here and here). Arbutus claimed that Moderna’s vaccine infringes its lipid nanoparticle (LNP) technology patent. Alnylam Pharmaceuticals also launched patent infringement proceedings against Moderna in the US.
According to Public Citizen, a US NGO, Moderna and the NIH had a dispute over naming three NIH scientists as co-inventors in its recent patent applications. The New York Times reported in December 2021 that both parties were discussing settlement.
Legal scholars have already started commenting on the case, with many saying that Moderna’s pledge, in October 2020, not to enforce its patents during the pandemic may come into play during the litigation. The company updated the pledge in March 2022, effectively warning COVID-19 vaccine manufacturers using mRNA technology. The World Health Organisation has cautioned against the perception that the pandemic is over.
In a press release on March 7, 2022, Moderna said: “In non-AMC 92 countries, vaccine supply is no longer a barrier to access. In these countries, the Company expects those using Moderna-patented technologies will respect the Company’s intellectual property. Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms.”
Jorge L Contreras, an IP professor at the University of Utah, believes there are “compelling legal and policy reasons” for Moderna’s action to fail. “Moderna’s existing 2020 patent pledge prevents it from prosecuting a patent infringement suit against Pfizer and BioNTech,” says Contreras in an opinion piece. He explained: “The reason that Moderna’s attempt to renege on its 2020 patent pledge is so important is its potentially damaging effect on the integrity of the much larger patent pledging ecosystem.”
As expected, the validity of the patents will be tested. Moderna says the ’574 patent, which covers the use of modified mRNA in a LNP formulation, is the foundation of its mRNA platform. St. John's University’s IP professor Jeremy Sheff commented: “It's a huge risk for Moderna to litigate the validity of its broad foundational patents, such as its '574 patent, with a big player like Pfizer. Pfizer's play is to use that invalidity risk to extract a license not only for this vaccine, but for other mRNA therapeutics too.”
This dispute also raises public policy issues, especially the role of government and publicly-funded institutions, in healthcare. Public Citizen has written about these issues. Moderna says its collaboration with the NIH started in 2017, and the patents asserted in this case were filed before that year. However, according to Washington and Lee University’s law professor Christopher B Seaman, there might be arguments over inventorship and ownership in this dispute. Seaman said on Twitter: “At a minimum, I expect Pfizer will investigate possible co-inventorship by federal researchers for the 3 patents-in-suit through discovery.”
Moderna’s lawsuit is not the first COVID-19 patent case against Pfizer and/or BioNTech. Allele Biotechnology sued both companies in 2020 but the dispute later settled (see here). Alnylam Pharmaceuticals sued Pfizer in the US in March 2022 while CureVac sued BioNTech in Germany in July 2022.
The IP landscape for mRNA modification and/or delivery systems is very complex and will continue to expand. There are several patent owners and users, including small biotech companies and research institutions, and the licensing landscape is even more difficult to ascertain.
According to the available literature, Moderna, CureVac, BioNTech and Arbutus Biopharma are among the key biotech companies with patent portfolios covering mRNA technologies, and the top patenting jurisdictions for mRNA COVID-19 vaccines are the US, Germany, and Canada.
To learn more, please see the research paper published by the WTO here, the series by UK law firm Bristows here and US law firm Rothwell Figg Ernst & Manbeck here, the EPO’s insight into vaccine technologies here, and Medicines Patent Pool’s VaxPaL database.
Life sciences and pharmaceutical companies now see mRNA as a viable technology for treating or preventing diseases. Users of this technology would find it helpful if these disputes are fully litigated in the patent offices and/or courts so that the essential patents can be confirmed as early as possible.
Just like we saw with CRISPR–Cas9 technology, mRNA stakeholders will be looking to defend and/or strengthen their legal positions in this space. We expect to see more legal actions and ad hoc licensing deals.
Time will tell if this dispute proceeds to trial and expands to other non-AMC jurisdictions or settles out of court.
Patent stars Amy Wigmore, Emily Whelan, and William Lee of WilmerHale are among the lawyers leading Moderna’s litigation against Pfizer and BioNTech. WilmerHale also represented the company in its Federal Circuit appeal in 2021 against the PTAB decisions.
Pfizer and BioNTech
We do not yet have details of their legal representatives. However, we know Williams & Connolly and Noonan Lance Boyer & Banach acted for Pfizer while Paul Hastings acted for BioNTech in the case brought by Allele Biotechnology in 2020.
We know the law firms that normally act for the parties in this dispute, but we cannot disclose them because of confidentiality and the fact that we have not yet received official confirmation.
*Follow our live coverage of the mRNA COVID-19 patent cases, including updates on this case, here.