Court of Appeals Affirms District Court Decision Invalidating Minerva Surgical Patent

Rhea-AI Summary

Hologic, Inc. (NASDAQ: HOLX) announced that the U.S. Court of Appeals for the Federal Circuit upheld a 2021 ruling that invalidated a Minerva patent related to its NovaSure system. The court determined Minerva's patent was invalid due to a delay in filing after showcasing a prototype. This decision aligns with the previous district court judgment, which favored Hologic just before trial. In a related case, Minerva was ordered to pay Hologic over $7.4 million for infringing a Hologic patent. NovaSure, approved by the FDA in 2001, is a minimally invasive procedure for treating abnormal uterine bleeding, with a 77.7% efficacy rate and 92.8% patient satisfaction.

Positive

• The U.S. Court of Appeals affirmed the invalidation of Minerva's patent, strengthening Hologic's position.
• Hologic successfully defended its NovaSure system against infringement claims, avoiding potential legal liabilities.
• NovaSure has treated over 3 million women since its FDA approval in 2001, underscoring its market acceptance.

Negative

• None.

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Court of Appeals for the Federal Circuit unanimously affirmed a 2021 district court ruling that invalidated a Minerva patent asserted against Hologic. The appellate court ruled that Minerva’s patent is invalid because it waited more than a year to file a patent application after showing a prototype of the invention at a trade show.

“We are pleased with the U.S. Court of Appeals decision to invalidate Minerva’s patent. It confirms our belief from the beginning that Minerva’s lawsuit lacked merit,” said Essex Mitchell, President, Hologic GYN Surgical Solutions Division.

In 2017, Minerva alleged that Hologic’s NovaSure^® Advanced endometrial ablation system infringed a Minerva patent. In 2021, the district court issued a judgment in Hologic’s favor two weeks before trial, holding that Minerva’s patent is invalid.

Today’s affirmation by the U.S. Court of Appeals follows a prior decision against Minerva. In a separate matter between Hologic and Minerva, a Delaware district court found Minerva liable for infringing a Hologic patent. The U.S. Court of Appeals rejected Minerva’s arguments on appeal and as a result, Minerva had to pay Hologic more than $7.4 million.

About NovaSure

The FDA approved the NovaSure endometrial ablation procedure in 2001 as safe and effective for women who suffer from abnormal uterine bleeding (AUB). The procedure provides a minimally invasive treatment option for women seeking an alternative to hormones or hysterectomy to treat their AUB, and since its introduction, more than 3 million women have been treated. The procedure has an efficacy rate of 77.7% and a demonstrated 92.8% patient satisfaction rate at one-year follow-up of the pivotal clinical trial.¹

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic, NovaSure, The Science of Sure and associated logos are trademarks and/or registered trademarks of Hologic Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks and product names are the property of their respective owners.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

¹NovaSure Instructions for Use

Source: Hologic Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230217005046/en/

Media Contact:

Jane Mazur

Vice President, Communications

(+1) 508.263.8654

jane.mazur@hologic.com

Investor Contact:

Ryan Simon

Vice President, Investor Relations

(+1) 858.410.8514

ryan.simon@hologic.com

Source: Hologic Inc.

FAQ

What did the U.S. Court of Appeals decide regarding Hologic's patent dispute with Minerva?

The U.S. Court of Appeals upheld the invalidation of a Minerva patent as it was filed late after a prototype reveal.

What is the significance of the Hologic vs. Minerva legal case?

The case confirms Hologic's rights over their NovaSure system, protecting it from infringement claims.

How much did Minerva have to pay Hologic in related legal matters?

Minerva was ordered to pay Hologic over $7.4 million for infringing a Hologic patent.

What is the efficacy rate of Hologic's NovaSure system?

The NovaSure system has an efficacy rate of 77.7% for treating abnormal uterine bleeding.