May 29, 2024

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The Legal System

From Saving the World to Fighting Over IP: Moderna and Pfizer/BioNTech

From Saving the World to Fighting Over IP: Moderna and Pfizer/BioNTech

One of the most amazing accomplishments in the field of biotechnology has been the development and distribution of a vaccine against SARS-CoV-2 (COVID 19). The numbers tell the story.

The time from when the coronavirus’ RNA sequence, identified by China, was published on January 11, 2020 to the date that clinical trials in the U.S. began in March 2020 was 66 days. From the date the RNA sequence was published to the date that a vaccine was first administered to the public, on December 11, 2020, was 11 months. Within a year of the date the RNA sequence was published, both Moderna and Pfizer/BioNTech were providing thousands of doses of mRNA vaccines to people around the world. The mRNA vaccines were extremely effective – they provided about 94-95% protection against severe illness, hospitalization, and death. These vaccines are now available to anyone over the age of six months. In the world’s wealthiest countries, and in much of the rest of the world, vaccine availability is no longer a factor getting vaccinated.

Within the first year of the mRNA vaccines becoming available, 45% of the world’s population was fully vaccinated. As of today, 67.9% of the world’s population has had at least one dose of the vaccine; more than 12.89 billon doses of vaccine have been administered. As of today, 68% of the U.S. population is fully vaccinated, and an additional 12% of the population has received at least one dose of the vaccine. Thus, over 262 million people in the U.S. have received at least one dose.

COVID-19 is a terrible virus. It has caused at least 6.6 million deaths throughout the world, including at least 1.1 million in the U.S.  But COVID-19 is terrible for another reason: it has caused long term symptoms in what is believed to be about 23% of people who have had COVID. The CDC has estimated that as of February 2022, based on an antibody study, 60% of the U.S. population, or almost 200 million people, had had COVID-19.

However, the vaccines have been an incredible success. It is estimated that the vaccines prevented 14.4 to 19.8 million deaths worldwide during 2021, the first year the vaccines were administered. The vaccines changed the course of the pandemic and they have put us in a much better position when we have to face the next pandemic.

The next chapter in this story is about the intellectual property behind the vaccines. Moderna believes that it is a pioneer in the field of messenger RNA (mRNA) technology, which utilizes the body’s own cell machinery to produce proteins to prevent disease. Moderna was founded in 2010 for the sole purpose of developing mRNA medicines. In fact, the name “Moderna” was chosen based on “modified mRNA.” Moderna states that it figured out how to utilize mRNA medicines, which had never been done before, and spent billions of dollars to develop an mRNA platform to deliver those medicines to humans.

Moderna believes that its extensive and ongoing research into an mRNA vaccine for the coronavirus that caused Middle East Respiratory Syndrome (MERS) made it especially well situated in early 2020 to quickly develop an mRNA vaccine for COVID-19. Moderna also believes that its competitors, Pfizer and BioNTech, utilized Moderna’s technology to develop their own mRNA vaccine, and that these companies have received substantial profits from the sale of their vaccine.

In October 2020, when the COVID-19 pandemic was killing thousands of people a day and the world was desperate for a vaccine, Moderna announced that it would not enforce its patents against infringers during the pandemic so that the vaccines could be disseminated as fast as possible and the pandemic could be stopped as soon as possible. In March of this year, however, as the vaccines became widely available in the U.S. and the wealthy countries, Moderna announced that it expected its competitors to respect Moderna’s intellectual property and that it would offer patent licenses on reasonable terms to those who asked. Apparently, Pfizer and BioNTech did not ask.

On August 26, 2022, Moderna sued Pfizer and BioNTech for patent infringement in the district court in Massachusetts. Moderna’s lawsuit is unusual, however, in that the complaint expressly states that Moderna is not seeking: (1) to enjoin the defendants’ product or the sale of their vaccine; (2) to recover damages for the period prior to March 8, 2022, the day after Moderna announced that it would enforce its patents; or (3) to recover damages for the defendants’ sales of their vaccine in low- and middle-income countries.

In its complaint, Moderna alleges that it was a startup company founded by scientists who were investigating mRNA medicines, an unproven technology, and that it worked diligently for almost 10 years to develop the technology. According to the complaint, Moderna has been working on a specific problem with mRNA medicines: how to prevent the human immune system from attacking the mRNA. Moderna solved this problem by modifying the mRNA molecules by replacing one compound with another compound. Moderna also determined how to deliver an mRNA molecule into human cells using a lipid nanoparticle.

Moderna further alleges that in 2014, in response to the appearance of MERS, it focused on developing mRNA vaccines against infectious diseases. In 2015, Moderna developed an mRNA vaccine for MERS, using the mRNA that coded for the entire spike protein (the large protein on the viral surface that helps a coronavirus penetrate the cell it is attacking), contained in a lipid nanoparticle. In 2017, Moderna began working with the National Institutes of Health (NIH) to further develop the MERS vaccine. In 2011 and 2016, Moderna filed several patents on its mRNA technology and vaccines, which issued in 2020 and 2021.

Moderna alleges that in early 2020, after COVID-19 emerged, it made the decision to concentrate all of its resources on developing an mRNA vaccine for COVID-19, using its existing knowledge and experience with coronaviruses and its mRNA vaccine for MERS. Because Moderna had already developed its mRNA platform, it was able to develop a COVID-19 vaccine very fast. On March 16, 2020, within two months of COVID-19’s RNA sequence being published, Moderna had a COVID-19 mRNA vaccine that was entering clinical trials with NIH. Moderna’s vaccine was the first vaccine to enter clinical trials in the U.S. The FDA granted emergency use authorization for Moderna’s COVID-19 vaccine on December 18, 2020, just 11 months after the RNA sequence had been published.

Moderna alleges that Pfizer and BioNTech did not have Moderna’s experience with either coronaviruses or mRNA vaccines. It alleges that the defendants investigated various vaccine candidates, including some that did not use Moderna’s mRNA technology, but chose to pursue an mRNA vaccine that did use Moderna’s technology. Moderna alleges that in using the modified mRNA molecule that Moderna had developed and in using the entire spike protein as Moderna had done, the defendants developed their own vaccine much more quickly than they could have otherwise. In doing so, Moderna claims that Pfizer and BioNTech infringed three of Moderna’s mRNA patents.

Moderna seeks monetary damages, including a reasonable royalty and lost profits, from the defendants, alleging that it should be compensated for the technology that it invested in and patented. Moderna contends that the monetary compensation will allow it to reinvest in its mRNA technology, and to move forward with its work in developing mRNA products to prevent and treat diseases like HIV, autoimmune diseases, cardiovascular diseases, and rare cancers.  Moderna also seeks enhanced damages for willful infringement and attorneys’ fees.

Pfizer and BioNTech have stated that they did not use Moderna’s patented inventions, and that they will fully defend the case.  If the litigation proceeds, the defendants will probably challenge Moderna’s patents, as is typical in patent litigation. Alternatively, the case may eventually settle with the defendants taking a license. In the meantime, they should get back to doing what they do best, research and development.