BioNTech and Pfizer challenge Moderna’s COVID-19 vaccine patent

Inter partes review challenges broad claims and monopolisation over mRNA tech amidst existing legal dispute | Alnylam set to appeal separate court ruling against Moderna.

BioNTech and Pfizer have filed an inter partes review before the US Patent and Trademark Office concerning the ongoing dispute against Moderna’s COVID-19 vaccine.

The pair challenged US patent number 10,933,127 concerning mRNA technology owned by Moderna.

Moderna acquired the patent during the pandemic with “unimaginably broad claims directed to a basic idea that was known long before the asserted priority date of 2015”, claimed the petition.

These claims focused on using mRNAs to make spike proteins of any betacoronaviruses, formulated in a broadly claimed lipid delivery system to trigger an immune response.

BioNTech and Pfizer alleged that Moderna had attempted to monopolise the entire field of mRNA technology.

As a result, the pair have requested the claims be found unpatentable and cancelled.

Dispute over mRNA innovation

BioNTech and Pfizer claimed that the mRNA discovery was first made in 1990 when scientists found that injecting mRNA encoding protein leads to the protein being made, which has important medical uses such as making mRNA vaccines.

The companies’ petition outlined that within three years, scientists demonstrated that mRNA vaccines carrying antigens delivered via lipid carriers can create strong protection from diseases.

Before 2015, scientists had worked to improve mRNA vaccines and these were discussed in writings, according to the petition.

The ‘127 patent started with nine basic applications filed by Moderna in 2015.

The petitioners outlined these applications didn’t have much detailed information but centred around the same concept.

In 2016, a more official application emerged, showing tests of mRNA vaccines for betacoronaviruses in animals, however, exactly how the mRNA was structured was not disclosed.

Moderna secured patent ‘127 in 2021.

Case background

This filing adds to several ongoing cases in multiple jurisdictions concerning the three biopharmas.

In August 2022, Moderna sued Pfizer and BioNTech, alleging the pair had copied Moderna’s patented technology when developing their COVID-19 vaccine, Comirnaty.

The suit, filed at the US District Court for the District of Massachusetts, claimed that Comirnaty infringed patents Moderna filed between 2010-2016 over the mRNA technology.

Simultaneously, Moderna filed a suit against the pair at the Regional Court of Düsseldorf in Germany.

In December 2022, Pfizer and BioNTech hit back at Moderna and accused it of rewriting history in a defence and counterclaim filing in the US.

The pair asked the Massachusetts court to dismiss Moderna’s suit and to issue an order that Moderna’s patents were invalid and not infringed.

The action claimed that Moderna had rewritten history to “eliminate the contributions of many brilliant and dedicated scientists and place itself in the single, starring role”.

It added: “Ignoring the contributions of all these others—including defendants’ scientists and those working for the National Institutes of Health—Moderna now alleges that it developed both the Moderna vaccine and the technology behind Pfizer and BioNTech’s vaccine, and that Moderna deserves credit for the hard work and creative experiments performed by an entire field of researchers in the years before COVID-19 emerged.

“Moderna avers that it alone—not BioNTech, not Pfizer, and not the US government holds critical patent rights to both parties’ COVID-19 vaccines,” said the filing.

In July 2023, Moderna filed two new patent infringement lawsuits against BioNTech and Pfizer at the High Court in Dublin and at the Brussels Commercial Court in Belgium over the mRNA vaccine tech.

Alnylam joins the fray

In a separate case, Alnylam Pharmaceuticals has suffered a setback in its own patent infringement lawsuit against Moderna, originally filed in March 2022.

The suit, filed in the US District Court for the District of Delaware, was in response to Moderna's alleged breach of five Alnylam patents and revolved around the lipid technology in Moderna’s Spikevax.

Alnylam then sued Moderna and Pfizer alleging infringement of patents that it says are essential to the mRNA-based COVID vaccines, in May 2023.

The Massachusetts biopharma accused Moderna of infringing three further patents, and Pfizer of infringing four, in two lawsuits filed May 26 in the US District Court for the District of Delaware.

Alnylam, founded in 2002, invented a “breakthrough” class of protonatable biodegradable lipids used to form lipid particles that carry and deliver RNA-based vaccines safely into the human body.

Last week, the Delaware Court made a clear decision that definitively defined specific claim terms in two of Alnylam's patents.

Following this development, Alnylam released a statement outlining “Alnylam and Moderna have jointly agreed to final judgement of non-infringement of two of Alnylam’s patents.”

However, “Alnylam respectfully disagrees with the Delaware Court’s ruling and intends to appeal the decision,” the statement continued.

Alnylam anticipates that its second legal action against Moderna for infringement will continue to move forward in the Delaware Court.

The court's decision on the claim terms does not affect Alnylam’s claim against Pfizer and the company will continue in its litigation against Pfizer.

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