`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`Hologic, Inc., a Delaware corporation; and
`Cytyc Surgical Products, LLC, a Delaware
`limited liability company,
`
`
`Plaintiffs,
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`For its Complaint against Minerva Surgical, Inc. (“Defendant”), Plaintiffs Hologic, Inc.
`
`(“Hologic”), and Cytyc Surgical Products, LLC (“Cytyc”; collectively “Plaintiffs”) by its
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`attorneys, allege as follows:
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`NATURE OF THE ACTION
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`1.
`
`In this action, Plaintiffs Hologic and Cytyc allege that Defendant infringes U.S.
`
`Patent Nos. 6,872,183 (“the ‘183 Patent”), 8,998,898 (“the ‘898 Patent”), and 9,095,348 (“the
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`‘348 Patent” collectively “the Patents-in-Suit”).
`
`PARTIES
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`2.
`
`Plaintiff Hologic is a corporation organized and existing under the laws of the
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`State of Delaware with a principal place of business at 250 Campus Drive, Marlborough,
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`Massachusetts, 01752. Hologic is a leader in women’s health care including diagnostics,
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`screening, and imaging, as well as medical intervention and treatment.
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`3.
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`Plaintiff Cytyc is a limited liability company organized and existing under the
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`laws of the State of Delaware with a principal place of business at 250 Campus Drive,
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`01:17936255.1
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`Civil Action No.
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`JURY TRIAL DEMANDED
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`
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`v.
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`
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`Minerva Surgical, Inc., a Delaware
`corporation
`
`
`Defendant.
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`MINERVA - EXHIBIT 1012
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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 2 of 12 PageID #: 2
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`Marlborough, Massachusetts, 01752. Cytyc is a leader in designing, developing, and selling
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`medical devices for the treatment of excessive or abnormal endometrial bleeding. Cytyc is a
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`wholly owned subsidiary of Hologic and the owner by assignment of the ‘183, ‘898, and ‘348
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`Patents.
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`4.
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`On information and belief, Defendant Minerva is a corporation organized and
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`existing under the laws of the State of Delaware with a principal place of business at 101
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`Saginaw Drive, Redwood City, CA, 94063.
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`JURISDICTION AND VENUE
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`5.
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`This action arises under the Patent Laws of the United States, Title 35 of the
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`United States Code.
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`6.
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`This Court has subject matter jurisdiction over the causes of action asserted herein
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`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`7.
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`This Court has personal jurisdiction over the Defendant. On information and
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`belief, Defendant has had systematic and continuous contacts with this District, regularly
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`transacts business within this District, and regularly avails themselves of the benefits of this
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`District. On information and belief, Defendant, directly or through intermediaries (including
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`sales agents and others), use, offer for sale, sell, imports and/or distributes to others for such
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`purposes, endometrial ablation products for the treatment of abnormal uterine bleeding, in the
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`United States and this District.
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`8.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b)–(c) as, among other
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`reasons, Defendant is subject to personal jurisdiction in this District and a substantial part of the
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`events giving rise to the claims occurred in this District.
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`BACKGROUND
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`9.
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`Plaintiffs Hologic and Cytyc are leading developers, manufacturers, and suppliers
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`of medical devices dedicated to helping medical care professionals deliver superior healthcare to
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`their patients. One such medical product that Cytyc makes and distributes is the NovaSure®
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`endometrial ablation system, a system designed to, among other things, remove the endometrial
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`lining of the uterus and control abnormal uterine bleeding. The NovaSure® system has been used
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`to treat more than two million woman since it was approved for use by the FDA in 2001. The
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`novel design (e.g., using radiofrequency impedance-based technology allowing for fast
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`treatment time with no hormonal pretreatment required) of the NovaSure® system allows
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`medical care professionals to quickly, efficiently, and comfortably control abnormal uterine
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`bleeding.
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`10.
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`Plaintiffs have made significant investments into the research, development, and
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`testing of safe tissue ablation, including the technology embodied by the NovaSure® endometrial
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`ablation system.
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`11.
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`12.
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`Plaintiffs have made significant investments into bringing the product to market.
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`To protect these investments, Cytyc applied for and obtained a number of patents,
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`including the ‘183, ‘898, and ‘348 Patents.
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`13.
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`On information and belief, Defendant has been directly competing with Plaintiffs
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`since at least August, 2015, by making, using, selling, offering to sell, and/or importing into the
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`United States for subsequent sale or use the Minerva Endometrial Ablation Device. A true and
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`correct copy of the Minerva Endometrial Ablation System Operator’s manual which can be
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`obtained from the FDA website (http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140013d.pdf)
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`or from Defendant’s website (http://www.minervasurgical.com/health-care-
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`professionals/clinical-study-data/#downloadifu) is attached as Exhibit A.
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`COUNT I
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`(Defendant’s Infringement of the ‘183 Patent)
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`14.
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`Plaintiffs repeat and reallege each and every allegation set forth in the preceding
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`paragraphs as if fully set forth herein.
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`15.
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`On March 29, 2005, the U.S. Patent and Trademark Office (“USPTO”) duly and
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`legally issued the ‘183 Patent, entitled “System and Method for Detecting Perforations in a Body
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`Cavity,” to Russel M. Sampson, Mike O’Hara, Csaba Truckai, and Dean T. Miller as inventors.
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`A true and correct copy of the ‘183 Patent is attached as Exhibit B.
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`16.
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`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
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`‘183 Patent.
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`17.
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`Plaintiffs have complied with the notice requirements of 35 U.S.C. § 287 with
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`respect to products that they manufacture and sell under the ‘183 Patent.
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`18.
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`Defendant has had knowledge of the ‘183 Patent since at least the filing of this
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`Complaint and knew or should have known that the sale, offer for sale, use, manufacture, and/or
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`importation of the Minerva Endometrial Ablation System would infringe one or more claims of
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`the ‘183 Patent.
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`19.
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`On information and belief, Defendant was aware that Plaintiffs’ NovaSure®
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`system embodied the claimed invention of the ‘183 Patent and knew or should have known that
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`Defendant’s products, including the Minerva Endometrial Ablation System, infringed one or
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`more claims of the ‘183 Patent due to their substantially similar designs.
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`20.
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`On information and belief, Defendant has infringed and continues to infringe,
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`literally and/or through the doctrine of equivalents, the ‘183 Patent in violation of
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`35 U.S.C. § 271 by making, using, selling, offering to sell, and/or importing into the United
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`States for subsequent sale or use products, services, methods, or processes that are covered by at
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`least claims 1-7, 9, 11, and 13-15 of the ‘183 Patent. On information and belief, such devices
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`include, but are not limited to, the Minerva Endometrial Ablation System.
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`21.
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`On information and belief, Defendant has indirectly infringed and continues to
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`indirectly infringe the ‘183 Patent in violation of 35 U.S.C. § 271. On information and belief,
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`Defendant’s customers directly infringe at least claims 1-7, 9, 11, and 13-15 of the ‘183 Patent
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`by practicing the claimed method. On information and belief, Defendant has knowingly induced
`
`infringement and has had a specific intent to induce infringement of the ‘183 Patent by their
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`activities relating to the marketing, sales, support, and distribution of the Minerva Endometrial
`
`Ablation System, including, for example without limitation, providing through Defendant’s
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`website video and print instructions to use the Minerva Endometrial Ablation System in a
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`manner that infringes one or more claims of the ‘183 Patent. On information and belief,
`
`Defendant has contributed to infringement by selling and/or offering to sell within the United
`
`States, or importing into the United States, the Minerva Endometrial Ablation System knowing
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`the same to be especially made or especially adapted for use in the infringement of one or more
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`claims of the ‘183 patent and not a staple article or commodity of commerce suitable for
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`substantial non-infringing use.
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`22.
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`On information and belief, Defendant’s infringement has been and continues to be
`
`willful, making this an exceptional case under 35 U.S.C. § 285 and entitling Plaintiffs to treble
`
`damages under 35 U.S.C. § 284.
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`23.
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`As a result of Defendant’s infringement of the ‘183 Patent, Plaintiffs have
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`suffered and continues to suffer damages.
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`24.
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`Defendant’s infringement of the ‘183 Patent has caused and will continue to cause
`
`Plaintiffs irreparable injury for which there is no adequate remedy at law, unless this Court
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`enjoins such infringing acts.
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`COUNT II
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`(Defendant’s Infringement of the ‘898 Patent)
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`25.
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`Plaintiffs repeat and reallege each and every allegation set forth in the preceding
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`paragraphs as if fully set forth herein.
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`26.
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`On April 7, 2015, the USPTO duly and legally issued the ‘898 Patent, entitled
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`“Moisture Transport System for Contact Electrocoagulation” to Csaba Truckai, Russel M.
`
`Sampson, Stephanie Squarcia, Alfonso L. Ramirez, Estela Hilario, and David C. Auth as
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`inventors. A true and correct copy of the ‘898 Patent is attached as Exhibit C.
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`27.
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`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
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`‘898 Patent.
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`28.
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`Plaintiffs have complied with the notice requirements of 35 U.S.C. § 287 with
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`respect to products that it manufactures and sells under the ‘898 Patent.
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`29.
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`Defendant has had knowledge of the ‘898 Patent since at least the filing of this
`
`complaint and knew or should have known that the sale, offer for sale, use, manufacture, and/or
`
`importation of the Minerva Endometrial Ablation System would infringe one or more claims of
`
`the ‘898 Patent.
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`30.
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`On information and belief, Defendant was aware that Plaintiffs’ NovaSure®
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`system embodied the claimed invention of the ‘898 Patent and knew or should have known that
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`Defendant’s products, including the Minerva Endometrial Ablation System, infringed one or
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`more claims of the ‘898 Patent due to their substantially similar designs.
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`31.
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`On information and belief, Defendant has infringed and continues to infringe,
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`literally and/or through the doctrine of equivalents, the ‘898 Patent in violation of
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`35 U.S.C. § 271 by making, using, selling, offering to sell, and/or importing into the United
`
`States for subsequent sale or use products, services, methods, or processes that are covered by at
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`least claims 1-6, 8, and 14-16 of the ‘898 Patent. On information and belief, such devices
`
`include, but are not limited to, the Minerva Endometrial Ablation System.
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`32.
`
`On information and belief, Defendant has indirectly infringed and continues to
`
`indirectly infringe the ‘898 Patent in violation of 35 U.S.C. § 271. On information and belief,
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`Defendant’s customers directly infringe at least claims 1-6, 8, and 14-16 of the ‘898 Patent by
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`practicing the claimed method. On information and belief, Defendant has knowingly induced
`
`infringement and have had a specific intent to induce infringement of the ‘898 Patent by their
`
`activities relating to the marketing, sales, support, and distribution of the Minerva Endometrial
`
`Ablation System, including, for example without limitation, providing video and print
`
`instructions to use the Minerva Endometrial Ablation System in a manner that infringes one or
`
`more claims of the ‘898 Patent. On information and belief, Defendant has contributed to
`
`infringement by selling and/or offering to sell within the United States, or importing into the
`
`United States, the Minerva Endometrial Ablation System knowing the same to be especially
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`made or especially adapted for use in the infringement of one or more claims of the ‘898 patent
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`and not a staple article or commodity of commerce suitable for substantial noninfringing use.
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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 8 of 12 PageID #: 8
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`33.
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`On information and belief, Defendant’s infringement has been and continues to be
`
`willful, making this an exceptional case under 35 U.S.C. § 285 and entitling Plaintiffs to treble
`
`damages under 35 U.S.C. § 284.
`
`34.
`
`As a result of Defendant’s infringement of the ‘898 Patent, Plaintiffs have
`
`suffered and continues to suffer damages.
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`35.
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`Defendant’s infringement of the ‘898 Patent has caused and will continue to cause
`
`Plaintiffs irreparable injury for which there is no adequate remedy at law, unless this Court
`
`enjoins such infringing acts.
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`COUNT III
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`(Defendant’s Infringement of the ‘348 Patent)
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`36.
`
`Plaintiffs repeat and reallege each and every allegation set forth in the preceding
`
`paragraphs as if fully set forth herein.
`
`37.
`
`On August 4, 2015, the USPTO duly and legally issued the ‘348 Patent, entitled
`
`“Moisture Transport System for Contact Electrocoagulation” to Csaba Truckai, Russel M.
`
`Sampson, Stephanie Squarcia, Alfonso L. Ramirez, and Estela Hilario as inventors. A true and
`
`correct copy of the ‘348 Patent is attached as Exhibit D.
`
`38.
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`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
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`‘348 Patent.
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`39.
`
`Plaintiffs have complied with the notice requirements of 35 U.S.C. § 287 with
`
`respect to products that it manufactures and sells under the ‘348 Patent.
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`40.
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`Defendant has had knowledge of the ‘348 Patent since at least the filing of this
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`complaint and knew or should have known that the sale, offer for sale, use, manufacture, and/or
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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 9 of 12 PageID #: 9
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`importation of the Minerva Endometrial Ablation System would infringe one or more claims of
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`the ‘348 Patent.
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`41.
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`On information and belief, Defendant was aware that Plaintiffs’ NovaSure®
`
`system embodied the claimed invention of the ‘348 Patent and knew or should have known that
`
`Defendant’s products, including the Minerva Endometrial Ablation System, infringed one or
`
`more claims of the ‘348 Patent due to their substantially similar designs.
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`42.
`
`On information and belief, Defendant has infringed and continues to infringe,
`
`literally and/or through the doctrine of equivalents, the ‘348 Patent in violation of 35 U.S.C.
`
`§ 271 by making, using, selling, offering to sell, and/or importing into the United States for
`
`subsequent sale or use products that are covered by at least claims 1, 3, and 8-10 of the ‘348
`
`Patent. On information and belief, such devices include, but are not limited to, the Minerva
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`Endometrial Ablation System.
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`43.
`
`On information and belief, Defendant has indirectly infringed and continues to
`
`indirectly infringe the ‘348 Patent in violation of 35 U.S.C. § 271. On information and belief,
`
`Defendant’s customers directly infringe at least claims 1, 3, and 8-10 of the ‘348 Patent by using
`
`the claimed apparatus. On information and belief, Defendant has knowingly induced
`
`infringement and have had a specific intent to induce infringement of the ‘348 Patent by their
`
`activities relating to the marketing, sales, support, and distribution of the Minerva Endometrial
`
`Ablation System, including, for example without limitation, providing video and print
`
`instructions to use the Minerva Endometrial Ablation System in a manner that infringes one or
`
`more claims of the ‘348 Patent. On information and belief, Defendant has contributed to
`
`infringement by selling and/or offering to sell within the United States, or importing into the
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`United States, the Minerva Endometrial Ablation System knowing the same to be especially
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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 10 of 12 PageID #: 10
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`made or especially adapted for use in the infringement of one or more claims of the ‘348 patent
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`and not a staple article or commodity of commerce suitable for substantial non-infringing use.
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`44.
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`On information and belief, Defendant’s infringement has been and continues to be
`
`willful, making this an exceptional case under 35 U.S.C. § 285 and entitling Plaintiffs to treble
`
`damages under 35 U.S.C. § 284.
`
`45.
`
`As a result of Defendant’s infringement of the ‘348 Patent, Plaintiffs have
`
`suffered and continues to suffer damages.
`
`46.
`
`Defendant’s infringement of the ‘348 Patent has caused and will continue to cause
`
`Plaintiffs irreparable injury for which there is no adequate remedy at law, unless this Court
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`enjoins such infringing acts.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court grant the following relief:
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`1.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant has and continues to directly infringe and induce
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`infringement of one or more claims of the ‘183 Patent;
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`2.
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`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
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`Minerva Surgical, Inc., that Defendant’s infringement of the ‘183 Patent has been and continues
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`to be willful;
`
`3.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant has and continues to directly infringe and induce
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`infringement of one or more claims of the ‘898 Patent;
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`4.
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`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
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`Minerva Surgical, Inc., that Defendant’s infringement of the ‘898 Patent has been and continues
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`to be willful;
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`5.
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`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant has and continues to directly infringe and induce
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`infringement of one or more claims of the ‘348 Patent;
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`6.
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`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
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`Minerva Surgical, Inc., that Defendant’s infringement of the ‘348 Patent has been and continues
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`to be willful;
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`7.
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`A preliminary and permanent injunction against Defendant Minerva Surgical, Inc.
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`for infringement of the Patents-in-Suit;
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`8.
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`Judgment awarding Plaintiffs Hologic and Cytyc damages adequate to
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`compensate for Defendant Minerva Surgical, Inc.’s infringement of the Patents-in-Suit in an
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`amount to be proven at trial, together with pre-judgment and post-judgment interest and costs, as
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`fixed by the Court;
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`9.
`
`Judgment enhancing the damages due to Defendant Minerva Surgical, Inc.’s
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`willful infringement, pursuant to 35 U.S.C. § 284;
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`10.
`
`Judgment declaring that this is an exceptional case under 35 U.S.C. § 285 and
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`awarding Hologic and Cytyc their attorneys’ fees and costs incurred in prosecuting its claims;
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`and
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`11.
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`Such other relief as this Court deems just and proper.
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`JURY DEMAND
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`Plaintiffs demand a trial by jury in this action on all issues so triable.
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`DATED: November 6, 2015
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`Of Counsel:
`
`Matthew M. Wolf
`Edward Han
`Marc A. Cohn
`ARNOLD & PORTER LLP
`601 Massachusetts Ave., NW
`Washington, DC 20001-3743
`Telephone: (202) 942-5000
`matthew.wolf@aporter.com
`edward.han@aporter.com
`marc.cohn@aporter.com
`
`
`YOUNG CONAWAY STARGATT & TAYLOR LLP
`/s/ Karen L. Pascale
`_____________________________
`Karen L. Pascale (#2903)
`Pilar G. Kraman (#5199)
`Rodney Square
`1000 North King Street
`Wilmington, Delaware 19801
`(302) 571-6600
`kpascale@ycst.com
`pkraman@ycst.com
`Attorneys for Plaintiffs, Hologic, Inc.
`and Cytyc Surgical Products, LLC
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