Moderna Therapeutics is best known for its receipt of emergency approval for its Coronavirus vaccine from the FDA. Although it quickly emerged as one of the leading manufacturers of the vaccine did you know that Moderna has the cleanest legal record?
Until recently, you couldn’t find evidence of any kind of violation or lawsuit, however, its development of new mRNA technology and delivery systems has brought about a volley of legal actions, stemming from Moderna protecting its patents, and outsiders claiming a share of the credit for doing the work that got them there.
Here are the 7 biggest lawsuits in Moderna’s company history.
1. Moderna lawsuit against Pfizer and BioNTech for patent infringement
In August of 2022, Moderna filed a patent infringement lawsuit against Pfizer and BioNTech, according to CNN. The plaintiff claims that the two companies developed a Covid-19 vaccine named Comiranty, which violates protections Moderna secured between 2010 and 2016, regarding its mRNA technology, used in the development of the vaccines.
Moderna claims credit for developing the technology resulting in the production of Spikevax and claims that Pfizer and BioNTech used components of the technology, copying elements to develop Comiranty without the permission of Moderna. Pfizer officials claim that the legal actions caught them by surprise and were not expected.
The defendants plan to “vigorously defend against the allegations of the lawsuit.” Moderna previously stated that it would not enforce patents related to the development of Covid-19 vaccines while the pandemic raged, but it has since had a change of heart. It’s not seeking to halt production of Comiranty, but it is asking for a cut of the profits from Pfizer and BioNTech.
Moderna is further asking for biotech companies to respect its patents for intellectual properties and request permission for use of technology in other markets via commercial licensing granted with permissions.
2. Are Pfizer and BioNTech fighting back against Moderna with a countersuit?
Reuters reports that Pfizer and BioNTech have no plans of settling with Moderna for alleged patent infringements over mRNA technology disputes. Instead, they’re answering allegations made in the 2022 lawsuit with a countersuit.
It seemed as though the major pharmaceutical companies were working together to develop life-saving vaccines to bring the horrors of the Covid-19 pandemic to manageable levels when millions were infected and losing their lives.
Pfizer and its German partner, BioNTech SE came out with a suit requesting a Boston-based federal court to rule Moderna’s patents invalid to dissolve allegations of patent infringement and dismiss the case against them.
Moderna claims that the mRNA technology used to develop the vaccines was a project they pioneered before the onset of the pandemic and they’re requesting their share of the profits.
Pfizer and its partner company stand to lose billions if Moderna wins its case. Prizer brought in an estimated $26.4 billion in vaccine sales for the products in dispute.
Moderna claims that Pfizer and BioNTech violated three of their patents when they developed Comiranty, a Covid-19 vaccine, and they’re seeking their cut of the profits. The case is ongoing but is only one of the many litigations in process currently.
3. Moderna loses its bid to shift the blame to the US Government
Moderna went to court in February of 2022, attempting to hide behind the US government when Arbutus filed a lawsuit against them for patent infringements.
Attorneys for Moderna presented the argument that the allegations of patent infringement should instead be aimed at the United States Government, under which the company worked on a contract. The early stages of the pandemic brought about confusion in the hurry to develop potentially life-saving measures against the outbreak.
Moderna claimed that all doses of the vaccine were provided “under a federal contract,” according to Fierce Pharma. They made a motion to have the lawsuit dismissed, and have the patents in question invalidated, but Mitchell Goldberg, U.S. District Judge, disagreed.
He stated that Moderna didn’t provide evidence for sufficient grounds that the government should be in the hot seat. He also upheld the pated legitimacy held by Arbutus and Genevant. Because of their loss in court, Moderna will square off with Arbutus Biopharma and Roivant’s Genevant Sciences as the lawsuit moves forward.
It will be up to Moderna to prove that they did not commit any of the six alleged patent infringements, or they may have to pay the price, which could amount to billions.
4. Arbutus and Roivant Genevant Science sue Moderna
A lawsuit filed in the US District Court for the District of Delaware in February of 2022 named Moderna as the defendant by Arbutus and Roivant’s Genvant Sciences. The two pharmaceutical companies claim that Moderna committed six patent infringements when they produced and sold its vaccine for Covid-19.
The plaintiffs claim that Moderna’s research in nucleic acid-lipid particles with lipid vesicles, along with compositions of the drugs manufactured and use methods violated their protections under patent law.
They’re seeking damages in an unspecified amount for the infringements. It’s estimated that the court case could take up to two years to reach a conclusion and/or settlement. Although the dollar amount is not discussed, the infringement of six patents carries a significant financial burden and if proven, the case could result in multiple millions of dollars in damages or more.
Genevant collaborates with multiple pharmaceutical companies in the efforts to develop mRNA vaccines and treatments to improve the physical health of the world and protect people from the threat of infectious diseases. The plaintiffs also seek royalties on sales and other uses of the products they claim infringed on patents, that are reasonable as reimbursement.
Although Moderna took steps to prevent legal action on Arbutus patents, the courts ruled that the plaintiffs have the legal right to pursue their case, according to Fierce Pharma.
5. Alnylam files lawsuit against Moderna
Pharmaceutical company Alnylam filed a lawsuit against Moderna in a Delaware federal court in early 2022. It claims that Alnylam secured patents in lipid nanoparticle delivery technology for the drug Onpattro, an RNAI-class treatment for polyneuropathy, approve in 2018.
The plaintiff alleges Modern’s LNP technology infringed on established patents and owes Alnylam royalties for producing and selling treatments using technologies based on Patent No. 11,246,933, which is a breakthrough treatment in cationic biodegradable lipids, paving the way for creating lipid nanoparticles to deliver vaccines in the mRNA class.
Moderna counters that its research team has worked on its proprietary LNPs for many years and that its work is unrelated to that of Alnylam. The lawsuit comes on the heels of a similar suit filed by Arbutus, and Moderna’s failed attempt to invalidate the patents for that company.
Alnylam’s research goes back over a decade and seeks royalties on the products that raked in over $17.7 billion with an additional $22 billion in sales expected for the current year.
6. Oxfam files SEC complaint against Moderna: Was Moderna hiding the facts?
Moderna is under the microscope for allegations that the company published “misleading statements and failing to disclose to shareholders and the SEC,” its part in patent disputes with the NIH, according to Oxfam America.
A whistleblower complained to the Securities and Exchange Commission on behalf of shareholders, alleging a lack of transparency about the ongoing patent disputes and burying “critical information from its investors.”
Moderna could not produce enough of the vaccine, and its unwillingness to share its mRNA technology with other pharmaceutical manufacturers placed it in the unique situation of deciding who lived or died, according to reports on the complaint.
The complaint further claims that Moderna held power with its potentially life-saving technology, but instead of sharing its findings, fought with the National Health Institute, declined to share the technology, and fought with the US government, choosing to quibble over patents.
Moderna generated reports with vague language and chose to avoid open disclosures of the ongoing patent battles. The actions to hide the disputes had the potential for damaging the value of Moderna stock, violating securities laws with its framing of the situation.
News about the investigation broke in late 2021 with Oxfam calling for an SEC investigation to keep the giant pharmaceutical company held to account for shareholders.
7. Was Moderna sued by the National Institutes of Health?
Headlines about a potential lawsuit from the National Institutes of Health vs. Moderna broke in November of 2021. Moderna applied for patents to secure the rights to its Covid-19 vaccine Spikevax.
The NIH claims that three of its leading federal scientists contributed to the development of the technology, however, Moderna failed to name them in its patent application.
Instead, the pharmaceutical company claimed they did not co-invent the mRNA and its compositions related to the development of the product.
The company stated on the patent document that it “reached the good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application,” according to Fierce Pharma.
The NIH claims that Kizzmekia Corbett, M.D., Barney Grahame, M.D., and John Mascola, M.D., should receive credit on the patent as co-inventors of the vaccine. Moderna counters that only one of the four patents refers to contributions made by NIH scientists in the ongoing fight over patent rights.
The federal government used taxpayer funding to sponsor research and development that helped pay the costs for Moderna to make the breakthrough discoveries in addition to supplying scientists to help with the groundwork. It’s a case with the potential to head to court, but as of yet, no official documents show it’s reached that status yet.
The implications for suing the US government over patent rights could become interesting should the NIH advance the case to a Federal Court.
The unique posturing of Moderna Pharmaceuticals
Investigating the legal history of the most prolific pharmaceutical companies in the world today yields hundreds of lawsuits and billions of dollars in settlement discoveries. Companies such as Johnson & Johnson, Pfizer, Novartis, Roche, Merck, Abbvie, and others have a tarnished history of being sued and paying out to settle legal disputes.
Moderna maintained a clean slate until the trouble began with patents involving its research and development of mRNA technologies leading to the production of the Covid-19 vaccine Spivax. It was among the few with a clean record until it disagreed with the National National Health Institute over credit for the intellectual property rights of mRNA technology.
Moderna deals with threats of lawsuits from the United States government regarding due credit for inventors. News about Governor Ron Desantis and his plans to request a Grand Jury investigation into the activities of Moderna and other pharmaceutical companies recently broke.
His statements question their ethics, morality, and the legality of their roles in handling the ongoing pandemic. The landscape is quickly changing, and the stellar legal record of Moderna has experienced a dramatic shift. Seven ongoing battles are currently raging over accusations of patent infringement.
No company is above the law
Moderna attempted to sidestep a lawsuit filed against them, claiming multiple patent infringements as they developed their version of mRNA technology and the delivery methods of its Spivax vaccine.
The company asked the court to invalidate patents held by other pharmaceutical companies. Instead, they sought to pass the liability for violations onto the National Institutes of Health. The judge dismissed Moderna’s motion for dismissal. He further ruled in favor of the defendants.
The result came as a ruling that opened up a torrent of potential litigations as Moderna has no legal protection from lawsuits. Moderna had no substantial evidence to implicate the government in any wrongdoing and will face its accusers in court.
Since that time, Moderna has been sued by other pharmaceutical companies, claiming patent infringement in multiple areas. The pharma giant has not yet settled any ongoing cases.
Moderna will continue to defend itself against various plaintiffs while taking Pfizer and BioNTech to court, claiming patent infringements. The world will likely witness a volatile and impactful time in the history of big Pharma over the next few years.
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