CureVac Receives Positive Validity Decision from European Patent Office in Litigation Against BioNTech SE

Rhea-AI Summary

CureVac (NASDAQ:CVAC) has achieved a significant legal victory as the European Patent Office (EPO) largely dismissed BioNTech SE's opposition to CureVac's patent EP 3 708 668 B1, maintaining it in amended form. The patent covers CureVac's split poly-A tail technology, a foundational invention that enhances medical efficacy by improving protein expression in mRNA constructs.

This ruling marks a important milestone in the broader patent litigation between CureVac and BioNTech in Germany, which involves six intellectual property rights. An infringement hearing is scheduled for July 1, 2025, at the Regional Court Düsseldorf. If the court rules in CureVac's favor regarding infringement, it will trigger proceedings to assess damages.

Positive

• EPO validates CureVac's key mRNA patent against BioNTech's opposition
• Potential future damages if infringement is proven in court
• Strong intellectual property position with six patent rights in dispute

Negative

• Final outcome of patent infringement case remains uncertain until July 2025
• Patent maintained in amended form, potentially limiting its scope

Insights

Legal Expert (IP Specialist)

The European Patent Office's decision to uphold CureVac's patent EP 3 708 668 B1 with amendments represents a significant victory in the ongoing patent dispute with BioNTech. The patent protects CureVac's split poly-A tail technology, which enhances protein expression in mRNA constructs - potentially a critical component in mRNA-based vaccines.

This ruling effectively validates CureVac's claim as an early pioneer in fundamental mRNA technology. However, several important legal steps remain before any financial benefit materializes. The next critical phase occurs on July 1, 2025, when the Regional Court Düsseldorf will determine whether BioNTech's products actually infringe on this patent.

Patent litigation typically follows this two-step process: first establishing validity, then determining infringement. While CureVac has cleared the first hurdle, the infringement determination involves different legal standards and evidence. If infringement is established, the case would proceed to damage assessment, which could be substantial given BioNTech's COVID-19 vaccine revenue.

BioNTech still has several potential responses: appealing this validity decision, challenging the infringement determination, arguing for damages, or pursuing settlement negotiations. This represents just one patent in a six-patent dispute between the companies, indicating the complex nature of mRNA intellectual property rights.

Financial Analyst

This patent validity ruling represents a meaningful step forward in CureVac's litigation strategy but investors should moderate expectations about immediate financial impact. While clearing the patent validity hurdle improves CureVac's position, the company must still prove actual infringement at the July 2025 hearing - a separate legal challenge with its own uncertainties.

The financial implications remain speculative until we understand: (1) how the patent amendments affect the scope of protection, (2) whether the court will find BioNTech infringed the amended patent, and (3) how any potential damages would be calculated. With CureVac's current $640 million market capitalization against BioNTech's multi-billion COVID vaccine revenues, a favorable outcome could be significant - but remains distant and uncertain.

CureVac's pursuit of recognition and compensation for its early mRNA innovations represents a potential supplementary revenue stream beyond its pipeline development. However, patent litigation is notoriously unpredictable, lengthy, and expensive, with resolution likely years away.

The market appears to be assigning value to these litigation prospects, focusing instead on CureVac's ongoing operations and pipeline. While today's ruling incrementally improves the probability of future compensation, quantifying this potential upside remains challenging given the many remaining legal hurdles and the uncertain scope of the amended patent claims.

• European Patent Office largely dismisses opposition filed by BioNTech SE in April 2023 challenging validity of EP 3 708 668 B1 and maintains the patent in amended form

• A hearing on infringement of EP 3 708 668 B1 is scheduled for July 1, 2025, before the Regional Court Düsseldorf

• Confirming validity of patent in its amended form marks major milestone in broader patent litigation in Germany, recognizing CureVac's pioneering mRNA innovation

TÜBINGEN, GERMANY AND BOSTON, MA / ACCESS Newswire / March 27, 2025 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. Following today's hearing, the opposition division largely dismissed the opposition originally filed by BioNTech SE in April 2023 challenging the patent's validity and maintained the patent in amended form.

The ruling represents a major milestone in the ongoing patent dispute between CureVac and BioNTech in Germany, which involves a total of six intellectual property rights. Following today's ruling, the Regional Court Düsseldorf will decide whether the patent in its amended form has been infringed. An infringement hearing is scheduled for July 1, 2025. A positive infringement decision would trigger proceedings to assess damages in the same court.

"We welcome the decision of the EPO to uphold EP 3 708 668 B1 and remain confident that the patent is infringed in its amended form. Today's decision marks an important step on our path that we expect will lead to recognition of CureVac's major contribution to safe and efficacious COVID-19 vaccines as the earliest pioneer in mRNA technology," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "This effort is a multi-step process in Europe and the U.S. We remain determined to have our contributions to the field of mRNA technology acknowledged and fairly compensated, and to continue making advances that expand the frontiers of mRNA-based medicines."

EP 3 708 668 B1 describes a foundational invention of CureVac, called split poly-A tail technology, which enhances medical efficacy by improving expression of the protein encoded on an mRNA construct.

CureVac is represented in Germany by Oliver Jan Jüngst from Bird & Bird LLP and Andreas Graf von Stosch from Graf von Stosch Patentanwaltsgesellschaft and represented in the U.S. by Mark H. Izraelewicz from Marshall, Gerstein & Borun LLP and John M. Erbach from Spotts Fain, PC.

About CureVac
CureVac (Nasdaq:CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac's second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements CureVac
This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include statements regarding expectations of recognition of the company's contributions to mRNA technology and making advances to expand mRNA-based medicines. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," or "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

SOURCE: CureVac

View the original press release on ACCESS Newswire

FAQ

What is the significance of CureVac's patent victory against BioNTech?

The EPO's decision to maintain CureVac's patent EP 3 708 668 B1 validates their foundational mRNA technology and strengthens their position in the ongoing patent dispute with BioNTech involving six intellectual property rights.

When is the CVAC patent infringement hearing scheduled?

The patent infringement hearing is scheduled for July 1, 2025, at the Regional Court Düsseldorf.

What technology does CureVac's validated patent cover?

The patent covers split poly-A tail technology, which enhances medical efficacy by improving protein expression in mRNA constructs.

What happens if CVAC wins the patent infringement case against BioNTech?

If CureVac wins the infringement case, it will trigger proceedings to assess damages in the Regional Court Düsseldorf.