NEW YORK – The California Institute of Technology has filed a lawsuit against Bio-Rad Laboratories for allegedly infringing a patent related to multiplex PCR technology, according to documents filed Tuesday with the US District Court for the Northern District of California, San Jose Division.
Caltech accused Bio-Rad of infringing US Patent No. 12,168,797, which covers methods, systems, compositions, and kits for the multiplexed detection of analytes in a sample, particularly where multiple analytes may be detected in a single sample volume by acquiring a cumulative measurement of at least one quantifiable component of a signal. Each signal or component of a signal can be used to construct a coding scheme that can then be used to determine the presence or absence of an analyte, according to the patent.
According to the suit, traditional methods of PCR multiplexing have been constrained by the need to tag each target with a distinct fluorophore, which requires tagging every target with a specific color. Those methods are also constrained by degeneracy, which occurs when multiple analytes are tagged with the same fluorophore, which results in "ambiguous fluorescence signals that do not uniquely identify a single analyte."
The innovation covered by the '797 patent removes both the one-target-one-color constraint and the degeneracy issue, enabling multiple targets to be identified even when they share the same fluorophore by encoding detected signals using both fluorescence intensity and a decoding matrix. The method "significantly expands the number of detectable targets per reaction, improving the efficiency, accuracy, and cost-effectiveness of molecular diagnostics," according to the lawsuit.
The lawsuit alleged that Hercules, California-based Bio-Rad markets and uses Caltech's multiplexing technologies without authorization and in violation of the university's exclusive rights. Bio-Rad allegedly integrated aspects of Caltech's patented technology into its QX600 Droplet Digital PCR System and its QX One Droplet Digital PCR System.
It also alleged that Bio-Rad's patent infringement has caused and will continue to cause significant economic harm to Caltech, "including by diminishing the value of Caltech's intellectual property portfolio."
The patent's provisional application was filed in 2012 and issued in December 2024.
Litigation between Caltech and Bio-Rad related to Caltech's high-definition PCR (HDPCR) technology has been ongoing. A group of Caltech researchers founded molecular diagnostics startup ChromaCode in 2012, and in 2015, Caltech granted ChromaCode an exclusive license to multiple patents related to HDPCR, including the '797 patent.
In September 2023, Bio-Rad threatened to enforce patents covering its competing multiplexing technologies against ChromaCode, who then filed a declaratory judgment action against Bio-Rad seeking a judgment of noninfringement regarding Bio-Rad's patents. In October 2023, ChromaCode then filed a complaint in the Central District of California that alleged Bio-Rad infringed certain Caltech and ChromaCode patents. Caltech subsequently joined the suit as a plaintiff.
In August 2024, the court consolidated ChromaCode's two cases into one case, and during discovery for that case Caltech produced the '797 patent to Bio-Rad in December. In the lawsuit filed this week, Caltech noted that the suit should proceed independently of the ChromaCode lawsuit because ChromaCode is not party to the present dispute and is not an exclusive licensee of the '797 patent.
The lawsuit alleged that "despite knowledge of the '797 patent and its relevance to Bio-Rad's QX600 system, Bio-Rad failed to obtain authorization and knowingly proceeded with its infringing activities."
Caltech requested that the court find that Bio-Rad directly infringed the '797 patent, enjoin Bio-Rad from making and selling its infringing products, and award Caltech a "reasonable" royalty for the patent infringement. It also requested monetary damages and a jury trial.
On deadline, Bio-Rad did not respond to a request for comment.