Moderna gets win in COVID-19 patent dispute with Pfizer, BioNTech

Moderna gets win in COVID-19 patent dispute with Pfizer, BioNTech

Published: May 20, 2024

By Tristan Manalac

BioSpace

The European Patent Office has handed Moderna a victory in its patent dispute with Pfizer and BioNTech regarding its COVID-19 vaccine, according to The Financial Times which first reported the development on Friday.

In an oral decision, the European patent authority maintained the validity of Moderna’s patent ‘949 which describes and protects specific alterations to mRNA molecules designed to lower its immunogenicity, bypass the immune system and boost its translation in the body—as well as the potential uses of the modified mRNA.

The two companies have two months to appeal the decision, which Pfizer told The Financial Times it may pursue. BioNTech said that despite the verdict, it will “continue to vigorously defend our innovations against all allegations of patent infringement including this case.”

Moderna kicked off the protracted patent battle with Pfizer and BioNTech in August 2022, when it sued the partners alleging that they had infringed on protected mRNA technology to produce their COVID-19 vaccine Comirnaty.

The lawsuit focused on two specific parts of Comirnaty: its approach to encode the spike protein packaged inside of a lipid nanoparticle and the particular mRNA modification, which Moderna claims is exactly the same as its coronavirus shot Spikevax.

In August 2023, Pfizer and BioNTech took the fight to the U.S. Patent Trademark Office (PTO) asking for an inter partes review of Moderna’s patents, seeking to have them declared invalid. According to the partners, Moderna protections were too broad and tried to claim ownership of knowledge that existed before 2015—the priority date of Moderna’s patents.

Last month, the U.S. District Court for the District of Massachusetts gave Pfizer and BioNTech a temporary reprieve in the legal battle, granting the partners’ motion for a hold pending the results of the PTO’s review. Federal judge Richard Stearns said in his ruling that waiting for the board’s decision could simplify matters in the case.

Last week’s patent win for Moderna comes as COVID-19 revenues continue to crater. In its first-quarter 2024 earnings report, the biotech generated total revenue of $167 million, compared to $1.9 billion in the same period in 2023, due to reduced sales of its COVID-19 vaccine. Net product sales for Q1 were $167 million, a 91% decline compared to the same period last year.

Pfizer has also been hit with steep COVID-19 revenue declines, with the pharma earlier this month reporting a 20% year-over-year drop in its Q1 2024 report. In 2023, Pfizer saw a 42% revenue drop.

Source: BioSpace