U.S. District Court denies injunction against NovaSure ADVANCED device
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As many are aware, shortly after the launch of NovaSure ADVANCED in April 2017, Minerva filed a lawsuit claiming that ADVANCED infringes one of its patents and in August 2017, asked the court to issue an injunction to stop sales of our product on a preliminary basis, before a trial on the merits in 2019. The court has denied this injunction, substantially on the merits of Minerva’s infringement allegations, but also in the interest of the women we serve. The below provides context for this decision and can be used to address concerns raised by customers who may be aware of this issue or question claims re: NovaSure ADVANCED.
News You Can Use:  U.S. District Court asserts that Minerva’s request to stop sales of NovaSure ADVANCED does not meet the requirements

On January 5th, the U.S. District Court for the Northern District of California denied Minerva Surgical, Inc.’s request for an injunction against sales of Hologic’s NovaSure ADVANCED device because it failed to show a likelihood of succeeding in the patent infringement case. Additionally, Judge James Donato said stopping the sales of NovaSure ADVANCED would limit women’s access to a 6mm device. Underscoring and influencing the court’s decision is commentary in the record from Minerva’s CEO describing the NovaSure ADVANCED device as embodying “a very well thought out and well-designed change...(that produces) a real advantage” for patients.

Furthermore, the court denied Minerva’s claims that the ADVANCED device caused the company to make price cuts as any evidence of price erosion was unfounded. This news further supports Hologic’s ongoing commitment to providing safe, effective, and minimally invasive solutions for women, designed with the patient in mind.

The story was picked up by Bloomberg Law (see below):
Minerva Fails in Bid to Stop Sales of Hologic Device
By Dana A. Elfin | January 8, 2018 5:48PM ET
  • Minerva Surgical sought to stop Hologic from selling competing endometrial ablation device
  • Facts show Hologic's device is more effective than other available options, court says 
Medical device maker Minerva Surgical, Inc. failed to convince a federal court to stop Hologic, Inc. from selling an endometrial ablation device that competes with Minerva's system.

Minerva isn't entitled to an injunction barring sales of Hologic's new NovaSure Advanced device because it couldn't demonstrate it was likely to succeed in the patent infringement case, Judge James Donato of the U.S. District Court for the Northern District of California said in a Jan. 5 ruling.

In a blow to Minerva and its EAS device, Donato said stopping sales of Hologic's Advanced would limit women's access to a device offering women “a greater degree of effectiveness and comfort than other options on the market.” The ruling leaves Minerva's EAS competing with the NovaSure Advanced device, which Hologic began distributing in February 2017.

Endometrial ablation devices treat abnormally heavy menstrual bleeding by destroying the uterine lining.

Minerva alleged Hologic's sales of its Advanced device infringe U.S. Patent No. 9,186,208 covering systems for endometrial ablation and asked the court to enjoin sales of the device. Minerva argued sales of the Advanced device have forced it to cut its price for Minerva EAS but the court said Minerva's evidence for price erosion was to scant to support its arguments.

Michael J. Watts, Hologic's vice president of investor relations and corporate communications, told Bloomberg Law Jan. 8 the company doesn't comment on ongoing legal matters. Watts said the company hasn't made sales figures for Novasure Advanced available.

Bloomberg Law contacted Minerva for comment on the ruling but no one from the company was available to respond. Wilson Sonsini Goodrich & Rosati represented Minerva. Founded in 2008, the company is based in Redwood City, Calif.

Arnold & Porter Kaye Scholer LLP represented Marlborough, Mass.-based Hologic and subsidiary Cytyc Surgical Products LLC.

The case is Minerva Surgical, Inc. v. Hologic, Inc., 2018 BL 4222, N.D. Cal., No. 3:17-cv-02013-JD, 1/5/18.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bloomberglaw.com
To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com
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