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US Appeals Court upholds lower court's invalidation of Minerva patent against Hologic

by John R. Fischer, Senior Reporter | February 22, 2023
Business Affairs
A US Appeals Court has upheld a lower court's invalidation of a Minerva Surgical patent lawsuit against Hologic.
The U.S. Court of Appeals for the Federal Circuit has unanimously upheld a 2021 district court ruling invalidating a Minerva Surgical patent that had been asserted in a case against Hologic.

The case concerned endometrial ablation systems. Hologic launched its NovaSure Advanced endometrial ablation system in 2016 in Australia, Canada and Europe, and in 2017 in the U.S. Minerva gained premarket FDA approval for its own solution, the Minerva Endometrial Ablation System in July 2015, but did not launch the system until years later.

Designed to stop or reduce abnormal uterine bleeding, both systems utilize a moisture-permeable applicator head to destroy targeted cells in the uterine lining.

In a suit filed in San Francisco in 2017, Minerva said Hologic's solution infringed on its patent, but the district court in 2021 sided with Hologic and declared Minerva’s patent to be invalid. Minerva also sought an injunction to halt U.S. sales of the device but this was rejected as well.

The U.S. Court of Appeals for the Federal Circuit affirmed the 2021 court ruling on the grounds that Minerva waited more than a year to file a patent application after showing a prototype of the invention at a trade show.

The patent was originally filed by Csaba Truckai, who invented the device in the late 1990s and co-founded a company called Novacept, which was acquired by Cytyc. Cytyc was later acquired by Hologic.

Truckai founded Minerva Surgical in 2008.

Hologic received an altered patent in 2015 that added claims for the NovaSure System, with one pertaining to applicator heads generally, without regard for whether they are moisture permeable.

Hologic sued Minerva over this in a separate case filed in 2015 in Delaware. Minerva argued that the patent was invalid because the newly added claim did not match the solution’s written description, but Hologic argued that because Truckai assigned the original patent application, he and Minerva could not impeach the patent’s validity.

The District Court sided with Hologic in 2018, awarding it $4.8 million in damages. It dismissed another patent claim Hologic brought against Minerva for detecting the existence of perforations within the uterine wall lining prior to ablation, and denied, in 2019, Hologic’s injunction to halt the sale of Minerva's solution.

The Court of Appeals for the Federal Circuit affirmed the lower court’s decisions in this case as well.

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