FDAnews
www.fdanews.com/articles/208513-curevac-goes-after-biontech-claiming-patent-infringement-by-comirnatys-mrna-underpinnings

CureVac Goes After BioNTech Claiming Patent Infringement by Comirnaty’s mRNA Underpinnings

July 7, 2022

CureVac has filed a patent infringement lawsuit against BioNTech, claiming its messenger RNA (mRNA) technology was used without credit or compensation to create BioNTech’s and Pfizer’s Comirnaty, the world’s first approved COVID-19 vaccine and now the most widely used one.

Both mRNA-focused companies are based in Germany, thus CureVac filed its lawsuit in the German Regional Court in Düsseldorf against BioNTech SE and two of its subsidiaries, “seeking fair compensation for infringement of a portfolio of CureVac’s intellectual property rights,” CureVac said.

CureVac said it’s not seeking an injunction or intending to take legal action that impedes the production, sale or distribution of Comirnaty. But it does want to be paid.

“Over the last 22 years, CureVac developed proprietary foundational technology related to mRNA design, delivery and manufacturing that materially contributed to the development of safe and efficacious COVID-19 vaccines,” the company said, adding that its intellectual property portfolio protects “multiple inventions that are considered essential to the design and development of BioNTech’s SARS CoV-2 mRNA vaccine, among others.”

The patents relate to the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expression, as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines, the company said.

In response, BioNTech said that it “values and respects valid intellectual property rights,” but contended that no patents were infringed.

“BioNTech’s work is original, and we will vigorously defend it against all allegations of patent infringement,” the company said.

Comirnaty has been administered to more than one billion people globally, and BioNTech called it “one of the most successful drug launches in the history of medicine.”

CureVac has had a rough go of it in the COVID-19 vaccine space. The company had been working on its own mRNA-based COVID-19 vaccine, dubbed CVnCoV, but last year reported that the candidate showed only 47 percent efficacy against COVID-19 of any severity.

CureVac then halted development of CVnCoV, and Bayer dissolved its manufacturing deal with CureVac, which would have seen Bayer manufacture 160 million doses of CVnCoV in 2022 (DID, Oct. 18, 2021).

CureVac later disclosed that its advance supply deal for CVnCoV with the European Commission would be terminated.

This year, CureVac began a trial of a new vaccine candidate with partner GSK. — Suz Redfearn