QIAGEN receives positive court decision reaffirming an important QuantiFERON-TB patent

Rhea-AI Summary

QIAGEN (NYSE: QGEN) has secured a favorable ruling from the German Federal Patent Court in a patent dispute against SD Biosensor, validating a key patent for its QuantiFERON technology. The decision upholds QIAGEN's intellectual property rights for the German portion of European Patent EP 3 421 997, which protects important innovations in tuberculosis detection.

The ruling reinforces QIAGEN's QuantiFERON-TB Gold Plus position as the global standard for latent TB testing. The technology is part of a portfolio of over 120 patents and is recommended by major health organizations including WHO and CDC. The test offers superior accuracy and reliability compared to traditional skin testing methods for identifying individuals at risk of developing active tuberculosis.

Positive

• Court victory reinforcing patent protection for key QuantiFERON technology
• Strong IP portfolio with over 120 patents for QuantiFERON technology
• Product endorsement by major health organizations (WHO, CDC)

Negative

• None.

Insights

Patent Law Expert

The German Federal Patent Court's ruling represents a significant strategic victory for QIAGEN, extending well beyond mere legal validation. The upheld patent (EP 3 421 997) is part of QIAGEN's robust intellectual property fortress comprising over 120 QuantiFERON patents, effectively creating substantial barriers to entry in the TB testing market.

This legal triumph has three key implications for investors:

• Market dominance protection: The ruling safeguards QIAGEN's position in the lucrative TB testing market, where QuantiFERON-TB Gold Plus is already the global standard
• Revenue stream security: By preventing potential competitors like SD Biosensor from entering the market, QIAGEN can maintain its pricing power and market share
• Enhanced licensing potential: The validated patent strength could lead to additional licensing opportunities, creating new revenue streams

The decision's timing is particularly strategic as global health organizations, including WHO and CDC, increasingly recommend TB screening programs. With latent TB affecting approximately one-quarter of the world's population, this patent protection ensures QIAGEN's continued dominance in a growing market segment that represents a substantial recurring revenue opportunity.

VENLO, The Netherlands--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the German Federal Patent Court (Bundespatentgericht) has ruled in its favor in a patent dispute against SD Biosensor, reaffirming the validity of an important patent protecting key innovations in its QuantiFERON technology.

This ruling underscores the strength of QIAGEN’s QuantiFERON intellectual property portfolio and protects the scientific advancements that have made QuantiFERON-TB Gold Plus the global standard for latent TB testing.

“This decision involving an important patent for QuantiFERON reaffirms our ongoing commitment to delivering high-quality, science-driven solutions that improve health for patients around the world. QIAGEN will continue to invest heavily into novel solutions while also vigorously defending its innovations and investments,” said Thierry Bernard, CEO of QIAGEN.

The court’s decision upholds QIAGEN’s intellectual property rights involving the German part of European Patent EP 3 421 997, which protects key innovations in tuberculosis detection. Patents covering these innovations have been issued to QIAGEN in several other countries, and form part of a group of more than 120 patents currently issued for QuantiFERON.

QFT-TB Gold Plus offers superior accuracy, reliability, and ease of use compared to traditional skin testing methods and plays a key role in significantly improving TB control efforts globally. It is recommended by major health organizations worldwide, 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 tuberculosis.

Latent TB infection occurs when a person is infected with Mycobacterium tuberculosis but does not show symptoms. Unlike active TB, where the bacteria multiply and cause illness, in latent TB, the bacteria remain dormant in the body. People with latent TB do not feel sick and cannot spread the disease to others, but they are at risk of developing active TB if their immune system weakens. Screening and treatment of latent TB are crucial for preventing the progression to active TB and controlling the spread of the disease.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to 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 make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2024, QIAGEN employed more than 5,800 people in over 35 locations worldwide. Further information can be found at https://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered 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. To the extent that any of the statements contained herein relating to QIAGEN's products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has 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/20250204569595/en/

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 was the outcome of QIAGEN's (QGEN) patent dispute with SD Biosensor?

The German Federal Patent Court ruled in QIAGEN's favor, reaffirming the validity of their patent EP 3 421 997 protecting key innovations in QuantiFERON technology.

How many patents does QIAGEN (QGEN) hold for its QuantiFERON technology?

QIAGEN holds more than 120 patents for its QuantiFERON technology.

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

The World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) recommend QuantiFERON-TB Gold Plus for identifying individuals at risk of developing active tuberculosis.

What advantages does QIAGEN's QuantiFERON-TB Gold Plus offer over traditional testing methods?

QuantiFERON-TB Gold Plus offers superior accuracy, reliability, and ease of use compared to traditional skin testing methods for TB detection.