A Covid-19 vaccine based on the messenger RNA technology of CureVac has yet to successfully emerge from clinical trials, lagging well behind the mRNA shot from rival BioNTech that has landed authorizations and approvals across the world. But CureVac is now trying to secure a win in another forum: the German courts.
Tübingen, Germany-based CureVac contends that BioNTech’s vaccine infringes on key mRNA technology patents. On Tuesday, CureVac filed a lawsuit in German Regional Court in Düsseldorf, Germany, against BioNTech and two of its subsidiaries. CureVac said it is not seeking a stop to the manufacturing and distribution of the Covid vaccine that BioNTech is marketing with partner Pfizer under the brand name Comirnaty. But the company is seeking an unspecified amount of “fair compensation.”
“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,” CureVac said its statement announcing the lawsuit. “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.”
CureVac, founded in 2000, developed technology based on insight into mRNA biology and interactions with the immune system. It initially focused on developing mRNA vaccines for cancer and rabies. Like many vaccine developers, it switched gears to Covid-19 with the onset of the pandemic. But CureVac’s research has been stymied by delays and clinical trial setbacks. A year ago, while BioNTech and Pfizer were ramping up the distribution of their FDA-authorized vaccine, CureVac was grappling with clinical trial results showing just 47% efficacy—well below the efficacy rates reported for the BioNTech and Moderna vaccines. CureVac blamed the results on new viral variants circulating in the clinical trial population.
Aiming to take another run at an mRNA Covid vaccine, CureVac teamed up with GSK to develop a next-generation bivalent mRNA vaccine. But this vaccine now trails other vaccine developers as well. CureVac and GSK began a Phase 1 study in the spring. Nevertheless, CureVac contends that its early work as an mRNA pioneer—BioNTech was founded eight years after CureVac—contributed to Covid-19 vaccine development.
BioNTech responded to CureVac with its own statement that did not address specific patent infringement claims or even mention its rival by name. In the brief statement, BioNTech said it values and respects valid intellectual property rights.
“BioNTech’s work is original, and we will vigorously defend it against all allegations of patent infringement,” the company continued. “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.”
CureVac’s lawsuit is not the first patent infringement claim Comirnaty has faced. In March, Alnylam Pharmaceuticals sued both Moderna and Pfizer claiming their vaccines infringe on its lipid nanoparticle technology used to deliver RNA into cells. Like CureVac, Alnylam said it did not want to stop the production and distribution of Covid-19 vaccines. Alnylam is, however, seeking damages or other monetary relief, “no less than a reasonable royalty.”
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