For more than a year, Moderna and Pfizer have been dominating the COVID-19 vaccine market in what has been a peaceful reign for both companies. That was until Friday, when Moderna kicked off what will likely be the patent fight of the pandemic era.
Moderna has filed patent infringement lawsuits in the U.S. and Germany accusing Pfizer and its partner BioNTech of stepping on patents that Moderna says it filed between 2010 and 2016. Pfizer and BioNTech have reeled in tens of billions of dollars with their world-leading COVID-19 vaccine Comirnaty, so a win for Moderna in either case could be quite lucrative.
Moderna is seeking to "protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the COVID-19 pandemic," CEO Stéphane Bancel said in a statement. Moderna began working on the "foundational" mRNA platform way back in 2010, he added, which enabled it to develop its coronavirus vaccine Spikevax in "record time."
For its part, Pfizer says it has not "fully reviewed the complaint" but is "surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer." A company spokesperson told Fierce Pharma that Pfizer remains confident in its intellectual property and will "vigorously defend against the allegations of the lawsuit."
Moderna is not seeking to remove Pfizer and BioNTech’s vaccine from the market. It also isn't targeting Comirnaty sales in low- and middle-income countries covered by the global COVAX initiative.
But in developed markets, Moderna says it expects mRNA rivals to "respect its intellectual property rights and would consider a commercially reasonable license." Pfizer and BioNTech have "failed" to seek such a license, the company argues.
In its lawsuits, Moderna says Pfizer and BioNTech copied two "key features" of its patented technology.
For one, the company contends Pfizer and BioNTech started human testing of four candidates earlier in the pandemic. Some were free from any patent infringement concerns, but Moderna argues its rivals advanced a shot that has the "exact mRNA chemical modification" as Spikevax.
As a second complaint, Moderna says its rivals copied its knowledge in encoding a full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna says it worked on that technology during the outbreak of Middle East Respiratory Syndrome years back.
Reacting to the news, SVB Securities analysts said they expect Pfizer and BioNTech to "weaponize their own patent portfolio" in response to Moderna's lawsuit. The SVB team expects the disputes to take years to play out in court.
"While each case is unique, the history of [intellectual property] disputes among oligo companies suggests the most likely outcome would be modest royalties paid by both companies, with little net favorable impact for anyone but the law firms involved," the investment bank noted.
This is far from the first pandemic-related patent fight. In March, Alnylam Pharmaceuticals filed lawsuits accusing Pfizer and Moderna of violating a patent that covers a “breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles” for mRNA-based vaccines. Alnylam sought royalties from the sale of the leading COVID vaccines.
At the time, Moderna said that Alnylam's patent doesn’t apply to its COVID-19 vaccine and that the lawsuit “will fail.” Pfizer said that Alnylam was seeking to enforce intellectual property in “an effort to seek improper economic benefit.”
In July, German mRNA specialist CureVac sued Pfizer and BioNTech for infringement on a trio of patents. Pfizer and BioNTech argued that their vaccine is not manufactured using the methods protected under the three patents.
Separately, Arbutus Biopharma and Roivant’s Genevant Sciences sued Moderna for infringement back in February. Moderna argued that the two companies should have sued the U.S. government instead.