CureVac files patent infringement lawsuit against BioNTech over COVID-19 vaccine mRNA tech

By Rachel Arthur contact

- Last updated on GMT

Pic:getty/williampotter
Pic:getty/williampotter

Related tags: CureVac, BioNTech, mRNA, COVID-19, Pfizer

CureVac has filed a lawsuit in a German regional court against BioNTech SE: seeking ‘fair compensation for infringement… of CureVac’s intellectual property rights’ regarding tech used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine. BioNTech, however, says it will 'vigorously defend' its work against all allegations of patent infringement.

CureVac – whose own first-generation mRNA COVID-19 vaccine was withdrawn from regulatory review last year in favor of developing a second-generation candidate – believes its tech played a fundamental part in fellow German mRNA specialist BioNTech’s creation of a vaccine against the virus.    

“The CureVac 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,”​ says CureVac in a statement released this morning. “These 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.”

Having been the first COVID-19 vaccine to be authorized, Pfizer and BioNTech now expect production to reach 4 billion doses this year: with the vaccine being distributed to some 179 countries worldwide.

CureVac highlights role as mRNA pioneer

CureVac has been developing its tech for the design, delivery and manufacturing of mRNA vaccines over the last 22 years: claiming this know-how ‘materially contributed to the development of safe and efficacious COVID-19 vaccines.’

CureVac’s own mRNA COVID-19 vaccine, CVnCoV, entered clinical trials in June 2020: only a matter of weeks behind Pfizer/BioNTech’s candidate.

However, it reported disappointing efficacy figures from trials (estimated at 48%), and although it persevered with applying for regulatory authorization in the EU it withdrew its application in October last year:​ noting that its second-generation vaccine created with GSK – which could have 10x higher immunogenicity – would be close to catching up by the time the first-generation candidate received a decision.

The second-generation candidate is currently in Phase 1 trials.

“CureVac considers the rapid development of these vaccines a tremendous achievement, with unprecedented positive impact for global public health. This achievement is based on decades of scientific research and innovation, supported by CureVac as the earliest pioneer in mRNA technology,”​ says the company.

“Accordingly, CureVac’s intellectual property rights need to be acknowledged and respected in the form of a fair compensation to reinvest into the further advancement of mRNA technology and the ongoing development of new classes of life saving medicines.”

CureVac has filed a 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, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, utilized in the manufacture and sale of Comirnaty, BioNTech and Pfizer’s mRNA COVID-19 vaccine’.

CureVac, however, highlights it is not seeking an injunction nor intending to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and Pfizer.

BioNTech: 'Our work is original'

A statement from BioNTech, issued today in response to the filing, reads: "BioNTech values and respects valid intellectual property rights. BioNTech's work is original, and we will vigorously defend it against all allegations of patent infringement.

"However, we are aware that it is not unusual that other companies in the pharmaceutical industry, having witnessed the success of Comirnaty, are now suggesting that the vaccine potentially infringes their intellectual property rights.

"Indeed, in 2020, BioNTech was able to rapidly and successfully create Comirnaty, the world’s first approved COVID-19 vaccine, which was a remarkable achievement by our co-founders and their teams. BioNTech’s innovations have enabled vaccination of more than one billion people worldwide, have prevented millions of severe disease cases, hospitalizations, and deaths, have through manufacturing innovations provided a path to potential local manufacturing of mRNA vaccines including Comirnaty in Africa, and have made Comirnaty one of the most successful drug launches in the history of medicine."

BioPharma-Reporter has contacted Pfizer for comment.

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