QIAGEN commented on a decision issued late on 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.