Are Covid Vaccines Patented ?

In the past two years, as the COVID-19epidemic continues, Moderna, the main mRNA vaccine company, has moved from acompany with annual revenue of only tens of millions of dollars to a companywith annual revenue of $20 billion, and there are three lines of synchronizeddevelopment around the patent issue of mRNA vaccine, all related to Moderna. So,are covid vaccines patented?

Line 1: mRNA vaccine IP exemption

India and South Africa were the first torequest a vaccine IPR exemption from the WTO after the 2020 COVID-19 outbreak.U.S. President Joe Biden expressed support for the exemption shortly aftertaking office (May 2021) and in doing so formally advanced the U.S. vaccinediplomacy strategy.

Line 2: Moderna's battle with the NIH overthe inventor of the mRNA patent

Moderna, the leading mRNA vaccine company,has actually been supported by the U.S. government until the COVID-19 outbreak,which began in 2015 when Moderna signed a basic collaboration agreement withthe National Institute of Allergy and Infectious Diseases (NIAID), a divisionof the NIH, to jointly develop a new vaccine, which involved, among otherthings, three inventor experts from the NIH on the patents at issue. NIH'sthree inventor experts. So, are covid vaccines patented?

In July 2021, Moderna made clear that itwould not name U.S. government scientists as co-inventors on patentapplications for the mRNA vaccine, and after months of negotiations between thetwo parties, Moderna said that the fact that NIH is an inventor on one patentrelated to our COVID-19 does not mean that they are an inventor on every patentapplication related to the vaccine. inventor. Instead, NIH believes that theseexperts played an important role in a key component of the vaccine: thecreation of the stable stinger protein. In that case, are covid vaccinespatented?

In fact, the reason behind this may have todo with the Biden administration's stated support for the vaccine IP exemption,as Moderna wanted to cut out as much government influence as possible on thepatent so that it would not be controlled by the government due to the presenceof government-affiliated inventors.

Line 3: Moderna's alleged infringement ofArbutu's LNP patent

While Moderna is circling the government onone side, it is also embroiled in a lawsuit over a patent infringement dispute.

Last October, Moderna launched aninvalidation reexamination IPR against Arbutus' three mRNA-essential lipidnanoparticle delivery system LNP technology patents without being subject to apatent infringement lawsuit, because there was a collaboration between the twoparties, and the LNP technology used earlier by Moderna was licensed to Arbutusby none other than Acuitas (remember that name. The LNP technology used byModerna in the early days was licensed to them by another company, Acuitas(remember that name, it's the new protagonist of this article), and Acuitas'technology was licensed from Arbutus. But then Arbutus terminated Acuitas'license.

Moderna then thought it would always beshrouded in the risk of infringement. But in the end, the reexamination of theinvalid IPR resulted in the invalidation of only one of the patents, while theother two remained valid. For this reason, Moderna initially appealed, askingfor a reversal of the IPR result and asking the court to help it avoid becomingembroiled in a patent lawsuit over the COVID-19 vaccine. In that case, arecovid vaccines patented?

However, on December 1 of last year, theU.S. Court of Appeals for the Federal Circuit denied Moderna's request and heldthat Arbutus' patent was valid.

So on February 28 of this year, Arbutuschose to sue Moderna for infringement of six of its U.S. patents. This was justone month after the COVID-19 vaccine received full approval from the federalpublic health agency for the vaccine.

However, no one expected that Arbutus,which had been dominating the patent landscape, would also become a defendantbecause of the LNP patent.

Just half a month after Arbutus suedModerna, on March 18, Acuitas, above, sued Arbutus in the District Court forthe Southern District of New York.

Acuitas asked the court to determine thatits licensing of its mRNA-LNPs technology to Pfizer and BioNTech for theCOVID-19 vaccine COMIRNATY does not infringe on Arbutus' nine patents. And thetwo COMIRNATY vaccines have produced 320 million doses.

According to the complaint, on November 23,2020 and October 12, 2021, Genenant, the company to which Arbutus has licensedits patents, sent letters to Pfizer arguing that the COMIRNATY it manufacturesand sells may infringe Arbutus' patents.