Roche wins appeal to overturn $137M lab-testing patent infringement penalty

Roche is getting a second chance in a long-running legal battle against Meso Scale Diagnostics.

The Maryland-based company maintained for years that the diagnostics giant was infringing its patent rights, culminating in a 2019 jury ruling in Delaware district court in Meso’s favor. The ruling carried with it a fine of just over $137 million, which ballooned to more than $170 million once the presiding judge added interest.

This month, however, Roche put the ruling back under the microscope as it won an appeal (PDF) that overturned much of the 2019 decision and is likely to significantly shrink down the financial penalty.

The original battle stems from a series of patents relating to the technology behind electrochemiluminescence immunoassays. The patents were originally owned by Meso’s predecessor, IGEN International, which licensed the technology to Roche in a 2003 nonexclusive agreement.

In the meantime, IGEN sold the patents to diagnostic services provider BioVeris. When Roche acquired BioVeris in 2007, it folded the patents into its own portfolio of intellectual property and began selling the products without the field restrictions required by the previous agreement with IGEN.

That didn’t sit well with Meso, which in 2010 sued Roche for violating the field restrictions of the 2003 licensing agreement. That case was ultimately thrown out, but, in 2017, Roche took its own legal action against Meso, hoping for a conclusive ruling on its own rights to the patents.

Alas, that didn’t happen. Instead, Meso countersued for patent infringement, and the Delaware jury determined in 2019 that Meso still held the exclusive license to the patents. It concluded that Roche had directly infringed one patent claim and induced users of its Cobas analyzers to infringe three other claims—all of which the jury found was done willfully on Roche’s part.

In post-trial motions, the court declared that Roche hadn’t infringed three other patents because Meso had waived its right to a counterclaim on those counts by failing to do so in its initial response to Roche’s claim.

Both companies appealed the conclusions—and both took home at least partial wins this month. In Meso’s favor, the Delaware appeals court reversed the follow-up decision of non-infringement, allowing the company to potentially sue for infringement of those claims in the future.

Meanwhile, though the court upheld the finding of Roche’s direct infringement, it overturned the ruling that it had induced users to violate Meso’s patent rights, too, since Roche had been proven only to be negligent on those accounts rather than willfully intending to violate the patents.

As a result, the court vacated the $137 million damages ruling and called for a new trial to determine Roche’s penalty.

In an email to Fierce Medtech, Roche said it “appreciates the court’s verdict” but would provide no further comment.