Moderna hires patent lawsuit against Pfizer and BioNTech over mRNA Covid-19 vaccines

“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringe patents Moderna filed between 2010 and 2016 covering Moderna’s fundamental mRNA technology. This ground-breaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna’s permission, to create Comirnaty,” the press release says.

Pfizer said the lawsuits were unexpected.

“Pfizer/BioNTech has not yet fully reviewed the complaint, but we are surprised by the lawsuits given that the Pfizer/BioNTech COVID-1[ads1]9 vaccine was based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer. We remain confident in our intellectual rights support The Pfizer/BioNTech vaccine and will vigorously defend itself against the lawsuit’s allegations, Pfizer said in a written statement to CNN.

In a statement, BioNTech said it “will vigorously defend itself against all claims of patent infringement. BioNTech also values ​​and respects the valid and enforceable intellectual property rights of others and remains secure in its intellectual property.”

Moderna said in the release that it is not seeking to remove Pfizer’s vaccine from the market or prevent future sales of the vaccine, nor is it seeking compensation for sales under specific circumstances. The company says it will not seek a cut in Pfizer’s sales to the US government, and it will not seek money from sales to a list of 92 low- and middle-income countries that have had a tough time accessing the world’s supplies of covid- 19 vaccines. Nor will it claim compensation for activities before March 8, a date the company uses to mark the end of the pandemic.

What Moderna really wants is a cut of its competitor’s profits, said Christopher Morten, an intellectual property law expert at Columbia University.

“We have one of the two largest vaccine makers asking a court to award a portion of the competitor’s revenue. And that’s a very interesting kind of prospect for Moderna and its shareholders and for Pfizer and its shareholders,” Morten said in an interview with CNN .

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Moderna said it pledged in October 2020 not to enforce its Covid-19-related patents “while the pandemic continued”.

“In March 2022, as the collective fight against COVID-19 entered a new phase and the vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its promise. It made it clear that although they would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license if they asking for one for other markets. Pfizer and BioNTech have failed to do so.”

Moderna outlined specific cases where the company alleges Pfizer infringed the patents, saying the company moved forward with “a vaccine that has the same exact mRNA chemical modification of the vaccine as Spikevax. Moderna researchers began developing this chemical modification that avoids provoking a unwanted immune response when mRNA was introduced into the body in 2010 and were the first to validate it in human trials in 2015.”

Moderna also says “Pfizer and BioNTech copied Moderna’s approach to encode the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna researchers developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID -19 first appeared.”

Vaccines are key.  They also make some people very rich.

Legal experts said the lawsuit was a signal that Moderna was trying to control mRNA vaccine technology, despite the company’s assurances that it is not trying to limit access.

“Instead of thinking about mRNA technology as a global public good, and being the heroes of the Covid pandemic, you know, Moderna is just playing hardball,” Lawrence Gostin, a professor of global public health law at Georgetown University, said in an interview with CNN . “They played hardball with countries and negotiated their contracts. They played hardball with failing to transfer their technology to lower income countries. And now you know, Pfizer is suing, I can tell you one thing the consumer is not going to be the winner .”

In addition to the lawsuit against Pfizer, Moderna is also in a public dispute with the National Institutes of Health over intellectual property rights.

Moderna is also being sued by two biotech companies, Arbutus Biopharma and Alnylam Pharmaceuticals, for the same thing it claims Pfizer did – patent infringement. These companies claim that Moderna used technology they developed to create lipid nanoparticles that are key to delivering mRNA to cells.

Moderna defends itself in that case by saying that it has been given the right to infringe patents under a legal clause that enables the authorities to give up patent rights for companies that develop goods in public emergencies. Moderna’s legal brief was obtained by a Freedom of Information Act request filed by the nonprofit Knowledge Ecology International, or KEI.

James Love, director of KEI, said on the one hand that Moderna had made efforts to seek a narrow remedy for its complaints, to limit the impact the lawsuit could have on public health.

On the other hand, the fact of the lawsuit and the amount of money it seeks – treble damages – would almost certainly dissuade other companies from developing products with mRNA technology.

“It will have a chilling effect on all new mRNA products,” Love wrote in an email to CNN.

Moderna and Pfizer’s mRNA Covid-19 vaccines have been the backbone of the US vaccination strategy, with Pfizer making up the majority of doses administered.

As of Friday morning, 360 million doses of Pfizer’s Covid-19 vaccine have been administered in the United States and 229 million doses of Moderna’s.

The development of the mRNA vaccines for Covid-19 is considered one of the greatest achievements in modern science. In a race against time, researchers created and tested the shots in less than a year, sending the first doses to health care providers in December 2020.

A recent study estimated that Covid-19 vaccines saved almost 20 million lives in the first year they were used.

CNN’s Ben Tinker contributed to this report.

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