Moderna Sues Pfizer for Copying Patented Technology in their Vaccine

When the COVID-19 pandemic began, scientists raced to create a vaccine that could keep people safe and return the world to normalcy. During one of the worst spikes in coronavirus deaths in the entire pandemic, Pfizer was given Emergency Use Authorization by the FDA on December 11, 2021, for its vaccine for people 16 years of age and up. On January 31, Moderna was also given this authorization, but only for adults. In a departure from the solidarity shown throughout much of the pandemic, Moderna announced on August 26 that it would be suing Pfizer and BioNtech, their rival drugmakers, for patent infringement on the COVID-19 vaccine. “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 during a press release.

These vaccines were developed with unprecedented speed; many drugs take years or decades to receive approval, but Pfizer and Moderna’s products took less than a year. There were many causes of this, such as years of prior research on similar viruses and the overlapping timelines of phases in the testing stage, but chief among them was cooperation in the scientific community. Moderna suspects that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents of Moderna from 2010 and 2016. These patents cover the messenger RNA (mRNA) technology crucial to Moderna’s COVID-19 vaccine Spikevax. This clash of companies, however, was seemingly inevitable. Despite the mRNA vaccine research that Moderna led in the decade prior to the pandemic, over 100 million more Pfizer/BioNTech doses have been administered in comparison to Moderna. Now that case numbers and mortality rates have declined, Moderna is looking to get a larger cut of the profits.

Vaccines activate the immune system’s production of memory cells and antibodies so that in case of an infection, the body will be able to recognize and destroy the virus. Most vaccines use a “deactivated” form of the virus, often a protein. Instead of directly introducing a viral protein into the body, mRNA vaccines introduce mRNA, a type of genetic material that is produced through transcription, the process by which DNA is copied into RNA. RNA encodes a particular set of amino acids, which are the building blocks of protein. In COVID-19 vaccines, mRNA acts as a blueprint by which human cells produce viral proteins on their own. This causes some of our cells to display this protein, called the spike protein, on their surface, prompting an immune response.

The use of mRNA in vaccines has been studied before for the flu, Zika, rabies, and cytomegalovirus (CMV), a common virus that can infect people of all ages, but typically does not cause symptoms. The only mRNA vaccine to reach full approval in the United States is the one that protects against COVID-19. For many decades, scientists have been working through technical challenges in the development of mRNA vaccines. A main one was ensuring that the mRNA would be taken up by cells and only degraded until after it was used to produce proteins. To solve this problem, Moderna coated the mRNA molecules with lipids to provide protection and structure, a technology they claimed Pfizer and BioNTech copied.

Moderna also believes that Pfizer and BioNTech have copied a second feature of Moderna’s patents. In the clinical testing phase, Pfizer and BioNTech had four vaccine options, none of which stepped on Moderna’s intellectual property. Ultimately, Pfizer decided to move forward with a vaccine that has the same chemical modifications as Spikevax. This chemical modification, which evades stimulating a potentially harmful immune response, was first developed by Moderna in 2010 and later validated in 2015.

In October of 2020, Moderna stated that they would not enforce any COVID-19 related patents during the continuation of the pandemic. Later in March 2022, when vaccine supply was no longer a problem, Moderna updated their original statement, saying that they would not enforce patents in low and middle-income countries, but expected companies to respect their intellectual property. Ria Bhaskar, an associate engineer at Pfizer, believes that this unity should remain intact: “I believe that such companies should put aside their corporate differences and rather work together.”

Moderna has made it clear that it is not trying to remove Comirnaty from the market but rather, seek monetary damages. Bhaskar expressed her disapproval of Moderna’s lawsuit, saying, “At this moment, the priorities for these companies should be to combat COVID-19, ensure vaccines are available to all, and carry the world out of this health crisis.”

The COVID-19 pandemic was a time where the world was united against a common enemy. It was a time of helping each other, and of leniency for the good of others. This lawsuit creates a divide between that time and now. It acknowledges that the world is healing, but is still broken in the ways that it was before.