The Battle Over the COVID-19 Vaccine Continues

I recently wrote about the patent infringement lawsuit filed by Moderna against Pfizer/BioNTech over the COVID-19 vaccine. In its complaint filed in federal district court in Boston last August, Moderna alleged that Pfizer/BioNTech infringed three of Moderna’s patents in developing the Pfizer/BioNTech COVID-19 vaccine. Moderna seeks damages only for the time period after March 8, 2022, when Moderna announced that it would begin to enforce its patents after holding off doing so for 15 months while the pandemic was raging. The amount of money at stake is high. Pfizer/BioNTech sold over $26.4 billion of the vaccine in the first nine months of 2022; Moderna sold over $13.5 billion of its vaccine during the same time.

Pfizer/BioNTech filed an answer and counterclaims in December 2022. As is typical in patent infringement cases, Pfizer/BioNTech asserted counterclaims for a declaratory judgment of noninfringement and invalidity of each of Moderna’s patents. Pfizer/BioNTech alleges that it did not use Moderna’s patented technology in its vaccine but instead uses a different mRNA structure and different lipids in the delivery system. Pfizer/BioNTech claims that Moderna did not give credit to scientists at Pfizer/BioNTech and NIH who developed the underlying technology and that Pfizer/BioNTech had invented and patented aspects of the technology that Moderna used before it had obtained its patents. 

Pfizer/BioNTech also alleges counterclaims for a declaratory judgment that Pfizer/BioNTech had an implied license to practice Moderna’s patents and that Moderna’s patents were unenforceable against Pfizer/BioNTech because Moderna had waived its rights to assert infringement and had acquiesced in Pfizer/BioNTech’s use of the patents. These counterclaims were all based on Moderna’s announcement in October 2020 that it would not enforce its patents against infringers during the pandemic.

In its answer to Pfizer/BioNTech‘s counterclaims, filed on December 21, 2022, Moderna did not hold back. Moderna filed a very detailed answer, vigorously denying that Pfizer/BioNTech’s vaccine was independently developed and strongly emphasizing that Moderna was the first to develop the mRNA vaccine. Moderna states that Pfizer/BioNTech changed its vaccine formula after its phase I/II clinical trials, switching to a vaccine with the same modification as Moderna had made to its mRNA molecule for the same spike protein that Moderna had chosen to use. According to Moderna, this is why the only two mRNA vaccines that have been successful are its vaccine and Pfizer/BioNTech’s vaccine.

Moderna claims that Pfizer/BioNTech’s reference to work done by other scientists is an attempt to distract from the issue of infringement. Moderna also states that Pfizer/BioNTech’s patents did not originally cover the technology that Moderna used, but that Pfizer/BioNTech’s patent applications were amended after Moderna’s patent applications (which disclosed Moderna’s technology) had been published.

Moderna responded to Pfizer/BioNTech‘s allegations of waiver by pointing out that it had kept its promise not to enforce its patents against companies producing vaccines for low- and middle-income countries. Moderna alleges that it kept its promise not to enforce its patents during the pandemic while the goal was to disseminate vaccines as quickly as possible to stop the pandemic. In March 2022, when the vaccines became easily accessible in the U.S. and other wealthy countries, Moderna announced its decision to enforce its patents going forward but offered to license its patents to its competitors. Moderna alleges it never agreed not to sue infringers indefinitely. Pfizer/BioNTech, of course, declined to take a license. 

The questions of whether Pfizer/BioNTech’s vaccine infringes Moderna’s patents and of whether Pfizer/BioNTech copied Moderna’s technology or contributed to Moderna’s technology, will now be litigated.