QIAGEN takes legal action to defend QuantiFERON intellectual property and protect innovations in latent tuberculosis testing

Rhea-AI Summary

QIAGEN (NYSE: QGEN) has filed a patent infringement lawsuit against bioMérieux (EPA: BIM) in the German Unified Patent Court, specifically concerning European Patent EP 2 276 883 B2 related to its QuantiFERON technology. The legal action aims to protect innovations in the QuantiFERON-TB Gold Plus test, which is important for tuberculosis detection worldwide.

The company recently succeeded in defending another QuantiFERON-related patent against SD Biosensor in Germany. QuantiFERON-TB Gold Plus (QFT-Plus) is endorsed by the WHO and CDC for identifying individuals at risk of developing active TB, offering more reliable and objective results compared to traditional skin tests.

Positive

• Strong patent portfolio demonstrated through successful legal defense
• Product endorsed by major health organizations (WHO, CDC)
• Market leadership in TB testing technology

Negative

• Ongoing legal expenses for patent protection
• Competitive pressure in TB testing market requiring legal defense

Insights

Intellectual Property Legal Expert

QIAGEN's patent infringement lawsuit against bioMérieux represents a significant legal development in the diagnostic testing space. The complaint filed with Germany's Unified Patent Court specifically concerns European Patent EP 2 276 883 B2, which protects key innovations in their QuantiFERON-TB Gold Plus technology.

What makes this case particularly noteworthy is QIAGEN's recent successful defense of another QuantiFERON-related patent against SD Biosensor in Germany. This pattern of aggressive intellectual property protection suggests the company is implementing a comprehensive legal strategy to maintain market exclusivity for its TB testing technology.

The choice to file in Germany's UPC is strategic - this relatively new court system provides a streamlined approach to patent enforcement across multiple European jurisdictions. A favorable ruling could provide QIAGEN with powerful remedies including pan-European injunctions against bioMérieux's potentially infringing products.

For investors, patent litigation outcomes can significantly impact competitive positioning in the diagnostics market. Successful enforcement would protect QIAGEN's revenue stream from its QuantiFERON technology while potentially limiting market access for competitors developing similar technologies.

Medical Diagnostics Analyst

The QuantiFERON-TB Gold Plus (QFT-Plus) technology at the center of this legal dispute represents a critical advancement in tuberculosis testing. Unlike traditional skin tests that require subjective interpretation, QFT-Plus provides more reliable and objective results through blood-based interferon-gamma release assay (IGRA) technology.

This testing approach has earned endorsements from the WHO and CDC specifically because it addresses limitations in conventional TB screening. The technology's ability to accurately identify latent TB infection is particularly valuable given that approximately one-quarter of the world's population carries latent TB, with 5-10% of these cases potentially progressing to active, contagious TB without intervention.

The competitive implications are substantial. By protecting its proprietary technology through litigation, QIAGEN is defending its position in a specialized diagnostic market where technical differentiation drives adoption. The company's willingness to pursue litigation against bioMérieux, another major diagnostics player, underscores the commercial value of these testing innovations and their importance to QIAGEN's infectious disease portfolio.

For global TB control efforts, maintaining innovation incentives through patent protection could drive continued advancements in testing methodologies, though it may also impact broader access considerations depending on licensing practices.

• QIAGEN files lawsuit against bioMérieux with German Unified Patent Court to protect key innovations in its QuantiFERON technology

• QuantiFERON-TB Gold Plus plays a critical role in fighting the spread of TB worldwide

VENLO, The Netherlands--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has filed a complaint against bioMérieux S.A. (EPA: BIM) for patent infringement, reinforcing its commitment to protecting the scientific advancements behind its proprietary QuantiFERON technology.

The complaint, filed in the Local Division of the Court of First Instance of the Unified Patent Court (UPC) in Duesseldorf, Germany, concerns European Patent EP 2 276 883 B2. This patent, which is one of many held by QIAGEN protecting the QuantiFERON technology, covers important innovations in QuantiFERON-TB Gold Plus that is used worldwide for TB detection.

“Protecting our intellectual property is essential to ensuring continued innovation in infectious disease diagnostics,” said Thierry Bernard, CEO of QIAGEN. “QuantiFERON has transformed latent tuberculosis testing, and we will always take the necessary legal steps to defend our proprietary technologies against infringement.”

This legal action follows QIAGEN’s recent success in defending another QuantiFERON-related patent against an invalidity challenge by SD Biosensor in Germany, further demonstrating the strength of QIAGEN’s patent portfolio.

As a leader in molecular diagnostics, QIAGEN continues to defend its intellectual property to ensure that investments in innovation remain secure and that customers worldwide have access to trusted, high-quality testing solutions.

QuantiFERON-TB Gold Plus (QFT-Plus) is widely recommended by leading health organizations, including the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), for identifying individuals at risk of developing active TB. Unlike traditional skin tests, QFT-Plus provides more reliable and objective results, supporting global TB control efforts.

Latent TB infection occurs when the Mycobacterium tuberculosis bacteria remains dormant in the body without causing symptoms. While not contagious, latent TB can progress to active TB, which is a major public health concern. Effective screening and treatment of latent TB are critical for preventing the spread of tuberculosis worldwide.

For more information about QuantiFERON technology and QIAGEN’s commitment to TB diagnostics, visit https://www.qiagen.com/us/applications/tb-management.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Corporate

View source version on businesswire.com: https://www.businesswire.com/news/home/20250302561465/en/

Contacts QIAGEN:

Investor Relations

John Gilardi, +49 2103 29 11711

Domenica Martorana, +49 2103 29 11244

e-mail: ir@QIAGEN.com

Public Relations

Thomas Theuringer, +49 2103 29 11826

Lisa Specht, +49 2103 29 14181

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What is the patent infringement lawsuit filed by QIAGEN against bioMérieux about?

QIAGEN filed a lawsuit concerning European Patent EP 2 276 883 B2, protecting innovations in QuantiFERON-TB Gold Plus technology used for tuberculosis detection.

How does QGEN's QuantiFERON-TB Gold Plus test differ from traditional TB testing methods?

QuantiFERON-TB Gold Plus provides more reliable and objective results compared to traditional skin tests for TB detection.

Which major health organizations recommend QIAGEN's QuantiFERON-TB Gold Plus?

The World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) recommend QuantiFERON-TB Gold Plus for TB risk screening.

What recent legal victory did QGEN achieve regarding its QuantiFERON patent?

QIAGEN successfully defended a QuantiFERON-related patent against an invalidity challenge by SD Biosensor in Germany.