Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty

Pfizer and BioNTech aren’t playing sitting duck in the COVID-19 vaccine patent litigation that German mRNA specialist CureVac has brought.

After joining forces to develop the massively successful COVID shot, Comirnaty, Pfizer and BioNTech are now facing what they call “threats of a groundless patent infringement suit by a company, CureVac, who has been unable to bring to market any product to help in the fight against COVID-19,” the partners said in a complaint filed Monday in the U.S. District Court for the District of Massachusetts.

Pfizer and BioNTech allege there is “an actual, immediate, substantial and justiciable controversy” at play over whether Comirnaty has infringed or will infringe the trio of patents covered in CureVac’s lawsuit. Now, the partners want the Massachusetts court to rule against the infringement charges and prevent CureVac from pursuing further infringement claims, according to the court filings.

Further, the companies allege that CureVac, following its high-profile COVID-19 vaccine flop last year, is making an “attempt to profit from the success of BioNTech and Pfizer through threats of patent infringement.”

CureVac announced it was suing Pfizer and BioNTech in a Dusseldorf, Germany, court earlier this month.

"There’s a piece of IP which we think has been used. That’s OK. We’re not against using it, especially in a pandemic," CureVac CEO Franz-Werner Haas said in a recent interview with Fierce Pharma. "We just want to have this piece of contribution to be recognized."

If CureVac were to prevail over Pfizer and BioNTech in court, the mRNA specialist could be looking at a major payout, a Berenberg Capital Markets analyst wrote in a note to clients earlier this month.

According to analyst Zhiqiang Shu, $20 billion of Pfizer and BioNTech’s COVID-19 vaccine revenue could be subject to the suit,. The Berenberg team figures there’s a $500 million “potential upside” for CureVac based on a royalty rate of 2% to 3% in an “optimistic scenario.”

The case revolves around three patents, known as ’312, ’278 and ’493.

The ’312 patent describes a “method for producing a stabilized mRNA molecule encoding a polypeptide, wherein the stabilized mRNA molecule encoding the polypeptide comprises a coding sequence that has an increased guanine/cytosine (G/C) content relative to the original coding sequence encoding the polypeptide,” the court filing states.

The ’278 patent describes the composition of an RNA molecule used to prevent infectious disease. And ’493, for its part, refers to the vaccine’s inclusion of the SARS-CoV-2 spike protein, plus a lipid nanoparticle carrier used to deliver the shot.

Against claims of infringement on the ’312 patent, Pfizer and BioNTech argue that Comirnaty is not manufactured using a method that comprises “synthesizing a stabilized mRNA molecule encoding a polypeptide, wherein the stabilized mRNA molecule encoding the polypeptide comprises a coding sequence that has an increased guanine/cyosine (G/C) content relative to the original coding sequence encoding the polypeptide.”

Therefore, the court should rule that the partners’ production, use, offer to sell and sale of Comirnaty in the U.S. does not violate any claim of the ’312 patent, Pfizer and BioNTech argue.

The partners made similar arguments against infringement of the ’278 and ’493 patents.

When CureVac sued Pfizer and BioNTech, CureVac promised not to scuttle production, sale or distribution of Comirnaty. Instead, the Tubingen, Germany-based company is seeking recognition and compensation for the technology it claims it developed.

Meanwhile, this isn’t Pfizer and BioNTech’s first brush with patent infringement claims against Comirnaty. Back in October 2020, San Diego’s Allele Biotechnology and Pharmaceutical sued the partners for allegedly using its mNeonGreen fluorescent protein to test their vaccine. Pfizer and BioNTech resolved the case earlier this year.

In addition, in March Alnylam sued Pfizer and also the other mRNA COVID vaccine manufacturer, Moderna, claiming that more than a decade ago it invented the delivery technology that both companies used in their respective coronavirus shots.

During Pfizer's most recent earnings call in May, the company stuck by its predictions of $32 billion in Comirnaty sales for the year, plus another $22 billion in revenues from the company’s oral COVID antiviral, Paxlovid. That estimate followed first quarter COVID-19 vaccine sales of $13.2 billion, fueled in part by global uptake of pediatric and booster doses, Pfizer said at the time.