Roche Wins Appeal to Overturn $137M Lab-Testing Patent Infringement Penalty

Roche, a biotech company based in Maryland, has been in a legal battle against competitor Meso Scale Diagnostics for infringing its patent rights.

The battle is rooted in a series of patents on 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. Meanwhile, IGEN sold the patents to diagnostic services provider BioVeris.

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Roche acquired BioVeris and folded the patents into its own portfolio of intellectual property in 2007. It started selling the products without the field restrictions required in the 2003 licensing agreement with IGEN. Meso didn’t appreciate this and sued Roche in 2010 for violating the aforementioned restrictions, but the case was thrown out.

In 2017, Roche commenced legal action against Meso, hoping for a conclusive ruling on its own rights to the patents, and Meso countersued for patent infringement. The Delaware jury determined in 2019 that Meso still held the exclusive license to the patents, concluding that Roche had directly infringed one patent claim and induced users of its Cobas analyzers to infringe three other claims willfully. The firm was fined more than $137 million, which amounted to $170 million with interest.

In April 2022, Roche reanalyzed the ruling after winning an appeal that overturned most of the decision in 2019, which will likely reduce the financial penalty. In post-trial motions, the court stated that the firm 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 decisions and took home partial wins. The Delaware appeals court reversed the follow-up decision of non-infringement in Meso’s favor. This allows it to potentially sue for infringement of those claims in the future.

The court also upheld the finding of Roche’s direct infringement and overturned the ruling that it had induced users to violate Meso’s patent rights, because it proved to be negligent rather than willful in its violation of patents. The court voided the financial penalty and called for a new trial to determine the firm’s fine. Thus, it no longer has to pay the $137 million fine and will have another chance in court to mitigate the damages.