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Bio-Rad, 10x Genomics Claim Single-Cell Patent Fight Victories on Different Fronts

NEW YORK – Bio-Rad Laboratories and 10x Genomics have traded blows in their fight over intellectual property related to single-cell technologies. Over the last week, in separate cases, each company has secured a favorable ruling from a judge.

On July 9, Judge Richard Andrews of the US District Court for the District of Delaware upheld a $24 million jury award to Bio-Rad for patent infringement.

And on July 12, a judge overseeing a US International Trade Commission (ITC) case between the companies made an initial determination (ID) that Bio-Rad imported microfluidics products to the US that infringed upon patents held by 10x.

The intellectual property fight over single-cell technologies has also expanded to include other firms: in May, 10x sued sample preparation firm Celsee, alleging patent infringement.

Bio-Rad has been duking it out with 10x over single-cell patents since at least 2015, when Bio-Rad sued 10x for patent infringement. Becton Dickinson has also sued 10x for patent infringement. The Bio-Rad case went to trial and in November 2018 the jury found 10x had infringed three Bio-Rad patents, awarding $23,930,718 in damages.

Judge Andrew's decision to uphold the jury verdict and award came in response to a post-trial request from 10x to overturn the verdict or, failing that, give it a new trial.

Bio-Rad has also requested the court issue a permanent injunction against 10x, which could hamper 10x's ability to sell instruments and reagents.

In an email, 10x said "we believe there are significant errors in the verdict and the damages and plan to appeal this."

The firm added that its customers have written to the court to explain the importance of 10x's products to their scientific research. "We believe that the public interest considerations require that these researchers be able to keep using our tools for their important work," 10x said.

And even if the court does issue an injunction, 10x said it has developed a novel microfluidic chip and "is thoughtfully transitioning customers to that new product so that research can continue uninterrupted."

Jeffries analyst Brandon Couillard said the judge's decision was a "key milestone" for Bio-Rad. "This is [Bio-Rad's] first major legal victory to asser its broad ddPCR IP estate," he said in an analyst note. "We think it could give [the firm] a lot of leverage to maximize future value capture, which could potentially include a royalty deal with 10x."

Not just on the defensive, 10x has pursued claims against Bio-Rad and struck a blow when ITC administrative law judge (ALJ) Dee Lord found that Bio-Rad imported microfluidic systems and components that infringed claims of 10x's US Patent Nos. 9,689,024; 9,695,468; and 9,856,530. Lord determined that Bio-Rad's products did not infringe US Patent No. 9,644,204.

According to documents obtained by GenomeWeb, 10x initiated its ITC complaint against 10x in January 2018. Prior to that, Bio-Rad had submitted a complaint against 10x to ITC in July 2017. In September 2018, an ITC ALJ made an initial determination that 10x had imported microfluidic chips that infringed Bio-Rad patents. Whether there is any overlap between the cases is unclear.

ITC cases involve trial proceedings, but do not award monetary damages; instead they offer the possibility of relief against infringement in the form of exclusion orders that direct "Customs to stop infringing imports from entering the United States," according to the ITC website. ITC may also issue cease and desist orders.

Before an exclusion or cease and desist order goes into effect, ITC must review the ALJ's determination. In December 2018, ITC said it would review in part the ID in Bio-Rad's case. In June, ITC said it would extend the target date for its investigation to August 15.  The commission has not yet said whether it will review the ID in 10x's case.

10x said it expected the ITC to "issue an exclusion order which will prohibit the importation of Bio-Rad products that infringe the 10x patents."

At the time of publication, Bio-Rad had not yet responded to request for comment.

Meantime, 10x has sued Celsee, formerly known as DeNovo Sciences, for patent infringement in federal court, also in the District of Delaware. Based in Ann Arbor, Michigan, Celsee makes the Genesis single cell isolation system.

In its complaint, 10x alleged that the Genesis system "willfully" infringes upon its US Patent Nos. 10,155,981; 10,240,197; 10,227,648; 10,273,541; and 10,280,459. 10x also accused Celsee of false advertising concerning the Genesis system's cell capture rate. It is seeking treble damages for willful infringement, injunctive relief, as well as costs and attorneys' fees.

On July 1, Celsee filed a motion to dismiss the suit.

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