A Delaware judge has denied Hologic’s request to halt the sale of Minerva Surgical’s Endometrial Ablation solution.

The U.S. District Court for the District of Delaware rejected Hologic’s motion for an injunction against the sale last Thursday, allowing Minerva to continue selling its Endometrial Ablation System (EAS). The denial is based on another decision handed down last month by the Federal Circuit Court of Appeals, upholding a decision by the U.S. Patent and Trademark Office to invalidate a patent of Hologic’s for the detection of perforations in the uterus during ablation procedures.

“The Court of Appeals, in a unanimous decision, agreed that the patent was invalid,” Vera Elson, a lead trial lawyer and a partner for Wilson Sonsini Goodrich & Rosati, who represented Minerva Surgical, told HCB News. “We informed the court, and the court denied the motion for an injunction, which means that Minerva is free to continue selling its product. The judge concluded it was very unlikely that decision would change.”

The debate over the validity of the patent dates back to 2015 when Hologic filed a patent infringement lawsuit against Minerva, alleging that the Minerva EAS infringed upon four U.S. patents owned by Hologic via their acquisition of CYTYC, a company that had previously acquired another company called Novacept in 2004. Minerva was established in 2008 by the founder of Novacept.

Two of the four patents were dropped prior to trial, because one expired and the other was invalidated by the U.S. Patent and Trademark Office as a result of Minerva filing for a post-grant review of the patent (PGR).

The first of the remaining two patents revolved around a method for detecting the existence of any perforations within the uterine wall lining prior to ablation. If any holes are found, then the procedure cannot move forward, as the delivery of energy from the ablation process would create heat that could seep through the hole and potentially damage nearby organs, such as the large intestine. Such damage would likely require major surgery a few days later.

Minerva filed an inter partes review (IPR) with the U.S. Patent and Trademark Office to review the validity of the patent, presenting evidence to show that similar methods had been patented before using various techniques and challenging the assertion by Hologic that inventing such a method required a skilled artisan with experience using uterine devices.

“When you file an IPR, you provide examples of what is called ‘prior art’ that demonstrate a party’s patent claims are not novel,” David Clapper, CEO of Minerva Surgical, told HCB News. “We provided the patent trademark office with several examples of inventors who disclosed intrauterine tests using flow, volume, pressure and other means to say that the claims of the Hologic patent were obvious, and someone who was skilled in the art with a bachelor’s degree and knew something about surgery could have figured out how to perform this method effectively and safely.”

Following the review, the U.S. Patent and Trademark Office agreed with Minerva and invalidated the patent in December 2017. Hologic appealed the decision to the federal court. A three-judge panel on April 19 unanimously upheld the U.S. Patent and Trademark Office’s choice to invalidate the patent, and ordered Hologic to pay Minerva’s costs for the appeal. It noted in its deliberation that the Federal Circuit was “not likely” to reconsider its decision and that the Supreme Court would likely not grant certiorari (further review) into the matter.

The second patent was part of an old line of patents and expired in November 2018. Following a ten-day trial in June, a Delaware jury vindicated Minerva of willful patent infringement and awarded Hologic $4.8 million for this and the first patent. Hologic is only entitled to damages based on Minerva’s sales up until the date of expiration of the patent on November 19, and no damages afterward, regardless of the outcome of any appeal.

While the court denied post-trial motions, including Hologic’s request for a permanent injunction, it did recognize the 2018 jury's decision for Minerva to pay Hologic in damages.

“We are pleased to report that a U.S. District Court in Delaware recently upheld a jury award of $4.8 million in damages for Minerva Surgical’s infringement of Hologic patent 9,095,348 related to endometrial ablation technology," said Hologic in a statement to HCB News. "In addition, the court awarded Hologic supplemental damages through patent expiration in an amount to be determined."

Post-trial motions, including that of the permanent injunction as well as for supplemental and post-judgment damages, were heard in late February.

Minerva is currently appealing the ruling for past damages.