QIAGEN comments on preliminary injunction and confirms intention to defend its U.S. intellectual property position
Venlo, The Netherlands and Hilden, Germany, September 10, 2016 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) commented on a decision issued late on Friday, September 9, by the U.S. District Court for the Northern District of California, San Francisco Division, in which the Court granted the motion for a preliminary injunction against the Company as part of patent litigation filed by a competitor. The lawsuit alleges infringement of U.S. Patent 7,566,537 by QIAGEN’s GeneReader NGS System.
“While we are disappointed and disagree with the Court’s decision, we believe our intellectual property position in next-generation sequencing is strong, and we are pursuing all legal means to get the current decision reviewed by the U.S. Court of Appeals for the Federal Circuit as soon as possible,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “The disputed intellectual property claim is related to a narrow step within the overall broad GeneReader NGS workflow. In addition, QIAGEN intends to accelerate the development already underway of an upgrade to the component under dispute to resume U.S. commercialization with a full workflow of at least comparable or even better performance. The issue in this case also applies only in the United States, so customers in all other regions of the world can continue to purchase and use the GeneReader NGS System.”
The latest decision comes as part of a long-standing intellectual property dispute involving differences of opinion with a competitor and complex litigation among several entities. These types of disagreements are common in the pharmaceutical and diagnostic industries, where new product launches can trigger legal actions by other parties to defend their positions.
“We are confident in QIAGEN’s ability to continue to develop our franchise with the first Sample to Insight solution designed to deliver actionable insights. Our value proposition for the GeneReader NGS System goes far beyond the sequencing workflow step, since this system focuses on the insights that can be generated from a complete workflow. We are working to further enhance the overall performance, capabilities and applications of this unique system," Mr. Schatz added.
No meaningful revenue contributions from the GeneReader NGS System were included in QIAGEN’s internal financial forecasts for 2016 due to the early launch stage and the start of commercialization only in December 2015. As a result of this court decision, which only applies to the U.S., and also in light of the forthcoming upgrade to the component under dispute that is not expected to fall under this decision, QIAGEN does not expect a material financial impact from this decision on its financial outlook for full-year 2016 nor currently anticipates any material changes to its internal financial projections for 2017.
A trial date in this case is scheduled for November 2017.
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), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of June 30, 2016, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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, 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. 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 (SEC).