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Qiagen Sues Bio-Rad Seeking Declaration of Non-Infringement of Digital PCR Patents

NEW YORK – Qiagen has filed a lawsuit against Bio-Rad in a US federal court seeking a ruling that it has not infringed several Bio-Rad patents related to digital PCR technology.

In a lawsuit filed on Wednesday in the US District Court for the District of Delaware, Qiagen stated that it is seeking declaratory judgment of non-infringement of US Patent Nos. RE41780 (reissue of US Patent No. 7,041,481); 10,782,226; 10,921,237; 11,073,468; and 11,237,096, all of which are either assigned to or licensed by Bio-Rad and relate to digital PCR or cell capture methods used in digital PCR.

Qiagen claims in its lawsuit that on May 27, 2021, Bio-Rad sent it a letter accusing Qiagen's QiAcuity Digital PCR system of infringing at least three of the patents, and stating that the system used Bio-Rad's patented technology without authorization.

Then, on Feb. 10, 2022, Bio-Rad sent Qiagen another letter "escalating the dispute" by reasserting the patents identified in the first letter and further claiming infringement of three more patents that had been recently issued, the lawsuit states.

Qiagen claims that since the initial letter, the companies have attempted to negotiate a resolution to the dispute. "However, it has become clear that the parties cannot resolve this issue without court assistance, and Qiagen believes further discussions would be futile in their current form," the lawsuit states. "Due to the imminent threat of a lawsuit being brought against it, Qiagen files suit in Delaware, the state in which Bio-Rad is incorporated."

Qiagen is seeking judgment that it has not infringed and does not infringe any claims of the Bio-Rad patents, and has not made, used, sold, offered for sale, or imported any products that infringe any of the patents' claims, directly or indirectly.

It is also seeking attorneys' fees, costs, and expenses and any other relief determined by the court.

The QiAcuity system, launched by Qiagen in early 2021, is one of five product portfolios expected to drive future growth for the firm. Qiagen has in particular found early success with the platform in municipal wastewater testing for the SARS-CoV-2 virus, having landed contracts for this application in 48 US states.

Bio-Rad was one of the first companies to commercialize digital PCR technology and has built a substantial patent portfolio around its trademarked Droplet Digital PCR (ddPCR) method. It currently markets the QX One ddPCR and QX200 ddPCR systems and has vigorously defended its patent estate, previously suing digital PCR startups Stilla Technologies and Dropworks.

In July 2021, Bio-Rad reached a settlement with Stilla, and in October it announced it had acquired Dropworks.