Moderna Is Suing Rival Covid-19 Vaccine Manufacturers Pfizer And Biontech

Posted by Manish Kumar August 27, 2022
moderna and pfizer

The legal dispute over who owns important inventions employed in mRNA technology represents the biggest legal conflict to date.

Using patented mRNA technology used in the Cambridge company’s COVID-19 vaccines, Moderna filed litigation on Friday against its two main rivals, Pfizer and BioNTech.

All three businesses are involved in separate legal battles over patents pertaining to the technology, but Moderna’s case is the most well-known to date in the complicated legal battle over who is the rightful owner of crucial mRNA vaccine technologies. There won’t be a resolution for many years.

Moderna is the David in this case, according to Kevin Noonan, a biotechnology patent attorney with the Chicago law firm McDonnell Boehnen Hulbert & Berghoff who is not involved in the legal dispute.

On the premise that messenger RNA, or mRNA, might be utilised to transmit genetic instructions to cells so they can produce proteins, Moderna was established in 2010. The COVID vaccines, which used mRNA to trick cells into momentarily producing coronavirus proteins, proved to be more quickly designed and produced than conventional vaccines.

By the end of the year, it is anticipated that the two mRNA COVID-19 vaccines would have sold more than $107 billion worldwide, with Pfizer and BioNTech accounting for roughly two-thirds of those sales. If Moderna ultimately wins, even a negligible royalty share may significantly increase the billions of dollars in earnings it has already made from vaccine sales.

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According to Moderna’s chief legal officer, Shannon Thyme Klinger, “We believe that Pfizer and BioNTech illegally copied Moderna’s ideas and they have continued to utilise them without authorization.”

The New York-based business and BioNTech, its German development partner on the COVID vaccine, have not had enough time to thoroughly analyse the case, according to a Pfizer representative, but the companies “are shocked by the litigation.”

Their vaccine “was created by both BioNTech and Pfizer and was based on BioNTech’s unique mRNA technology,” the representative added.

The collision, according to specialists who study the subject of mRNA intently, was inevitable.

Mansoor Amiji, a professor of pharmaceutical sciences and chemical engineering at Northeastern University, said: “We’re seeing a lot of litigation linked to mRNA vaccines right now, so I wasn’t shocked about this particular lawsuit.”

According to Moderna, it is not its intention to have the vaccine sold by its rivals taken off the market.

The business promised that during the pandemic it would not prosecute its COVID-19 vaccine-related patents in October 2020. However, the business announced on Friday that in March “the global struggle against COVID-19 entered a new phase and vaccine supply was no longer an obstacle to access in many regions of the world,” paving the way for legal action against Pfizer and BioNTech.

For COVID vaccinations, “I think the implications are going to be very minimal,” according to University of Illinois law professor and biotechnology patent specialist Jacob Sherkow. “From now on, it will be about booster shots.” Sherkow continued, however, that the case might have larger repercussions for other mRNA vaccines and treatments.

Moderna CEO Stéphane Bancel said in a statement, “We are bringing these cases to defend the breakthrough mRNA technology platform that we pioneered, invested billions of dollars in developing, and patented over the decade prior to the COVID-19 epidemic.

Although Moderna had multiple early stage clinical trials ongoing, there were no licenced treatments or vaccinations based on mRNA technology when the pandemic started. Based on its prior work on an experimental vaccine for another coronavirus that causes Middle East Respiratory Syndrome, or MERS, the company quickly moved to create a vaccine for COVID-19 in January 2020.

Pfizer and BioNTech were collaborating at the time on an influenza mRNA vaccine, but the firms didn’t announce their plans for a COVID vaccine until that March. Pfizer and BioNTech allegedly “copied two critical aspects” from Moderna’s COVID vaccine, according to Moderna.

The first allegation of infringement centres on a chemical alteration Moderna made to its mRNA to enable it avoid immune system identification. Without these adjustments, the mRNA molecule itself is vulnerable to immune system attack and destruction, which prevents the vaccine from instructing the immune system to inhibit the coronavirus.

The chemical modification trick was discovered in 2005 at the University of Pennsylvania by Drew Weissman and Katalin Karikó, who are both currently employed with BioNTech. Moderna claims that it created the exact chemical change utilised in the COVID vaccinations and holds the patent for it. Moderna is taking a risk by suing over the patent, but the Chicago attorney Noonan said that if it succeeds, it might pay off handsomely “not only for the COVID vaccine, but for pretty much any RNA vaccine.”

Regarding the COVID vaccine’s overall design, two patents are the focus of the second alleged violation. The vaccines from Pfizer and BioNTech are comparable to Moderna’s in that they both use lipid nanoparticles, which resemble tiny bubbles, to protect and carry the mRNA into human cells. They also both encode a full-length spike protein from the coronavirus in an mRNA molecule. According to Moderna, this strategy was initially created for its MERS vaccine.

Additional cases have been filed about lipid nanoparticles. Alnylam Pharmaceuticals, located in Cambridge, filed a lawsuit against Moderna and Pfizer in March over a crucial component found in the firms’ lipid nanoparticles. Arbutus Biopharma, based in Pennsylvania, and its subsidiary Genevant Sciences are suing Moderna for violating a patent on lipid nanoparticles. And the tiny Canadian company Acuitas Therapeutics, whose lipid nanoparticle technology was licenced to Pfizer, has filed a lawsuit against Arbutus and Genevant.

The National Institutes of Health, whose experts worked on the early development of the COVID vaccine, including animal testing, has also been at odds with Moderna. According to the NIH, its scientists were left out of a crucial patent application for the COVID vaccination. Moderna argued that the patented work was created by its very own scientists. Earlier patents submitted between 2010 and 2016 are the core of the company’s case against Pfizer and BioNTech.

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