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Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 1 of 12 PageID #: 1
`
`
`
`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
`
`attorneys, allege as follows:
`
`NATURE OF THE ACTION
`
`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
`
`‘348 Patent” collectively “the Patents-in-Suit”).
`
`PARTIES
`
`2.
`
`Plaintiff Hologic is a corporation organized and existing under the laws of the
`
`State of Delaware with a principal place of business at 250 Campus Drive, Marlborough,
`
`Massachusetts, 01752. Hologic is a leader in women’s health care including diagnostics,
`
`screening, and imaging, as well as medical intervention and treatment.
`
`3.
`
`Plaintiff Cytyc is a limited liability company organized and existing under the
`
`laws of the State of Delaware with a principal place of business at 250 Campus Drive,
`
`01:17936255.1
`
`
`
`
`
`
`
`
`
`
`
`Civil Action No.
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`v.
`
`
`
`
`
`
`Minerva Surgical, Inc., a Delaware
`corporation
`
`
`Defendant.
`
`MINERVA - EXHIBIT 1012
`
`

`
`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 2 of 12 PageID #: 2
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`
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`Marlborough, Massachusetts, 01752. Cytyc is a leader in designing, developing, and selling
`
`medical devices for the treatment of excessive or abnormal endometrial bleeding. Cytyc is a
`
`wholly owned subsidiary of Hologic and the owner by assignment of the ‘183, ‘898, and ‘348
`
`Patents.
`
`4.
`
`On information and belief, Defendant Minerva is a corporation organized and
`
`existing under the laws of the State of Delaware with a principal place of business at 101
`
`Saginaw Drive, Redwood City, CA, 94063.
`
`JURISDICTION AND VENUE
`
`5.
`
`This action arises under the Patent Laws of the United States, Title 35 of the
`
`United States Code.
`
`6.
`
`This Court has subject matter jurisdiction over the causes of action asserted herein
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`7.
`
`This Court has personal jurisdiction over the Defendant. On information and
`
`belief, Defendant has had systematic and continuous contacts with this District, regularly
`
`transacts business within this District, and regularly avails themselves of the benefits of this
`
`District. On information and belief, Defendant, directly or through intermediaries (including
`
`sales agents and others), use, offer for sale, sell, imports and/or distributes to others for such
`
`purposes, endometrial ablation products for the treatment of abnormal uterine bleeding, in the
`
`United States and this District.
`
`8.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391(b)–(c) as, among other
`
`reasons, Defendant is subject to personal jurisdiction in this District and a substantial part of the
`
`events giving rise to the claims occurred in this District.
`
`01:17936255.1
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`2
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`

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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 3 of 12 PageID #: 3
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`
`
`BACKGROUND
`
`9.
`
`Plaintiffs Hologic and Cytyc are leading developers, manufacturers, and suppliers
`
`of medical devices dedicated to helping medical care professionals deliver superior healthcare to
`
`their patients. One such medical product that Cytyc makes and distributes is the NovaSure®
`
`endometrial ablation system, a system designed to, among other things, remove the endometrial
`
`lining of the uterus and control abnormal uterine bleeding. The NovaSure® system has been used
`
`to treat more than two million woman since it was approved for use by the FDA in 2001. The
`
`novel design (e.g., using radiofrequency impedance-based technology allowing for fast
`
`treatment time with no hormonal pretreatment required) of the NovaSure® system allows
`
`medical care professionals to quickly, efficiently, and comfortably control abnormal uterine
`
`bleeding.
`
`10.
`
`Plaintiffs have made significant investments into the research, development, and
`
`testing of safe tissue ablation, including the technology embodied by the NovaSure® endometrial
`
`ablation system.
`
`11.
`
`12.
`
`Plaintiffs have made significant investments into bringing the product to market.
`
`To protect these investments, Cytyc applied for and obtained a number of patents,
`
`including the ‘183, ‘898, and ‘348 Patents.
`
`13.
`
`On information and belief, Defendant has been directly competing with Plaintiffs
`
`since at least August, 2015, by making, using, selling, offering to sell, and/or importing into the
`
`United States for subsequent sale or use the Minerva Endometrial Ablation Device. A true and
`
`correct copy of the Minerva Endometrial Ablation System Operator’s manual which can be
`
`obtained from the FDA website (http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140013d.pdf)
`
`01:17936255.1
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`3
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`

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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 4 of 12 PageID #: 4
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`
`
`or from Defendant’s website (http://www.minervasurgical.com/health-care-
`
`professionals/clinical-study-data/#downloadifu) is attached as Exhibit A.
`
`COUNT I
`
`(Defendant’s Infringement of the ‘183 Patent)
`
`14.
`
`Plaintiffs repeat and reallege each and every allegation set forth in the preceding
`
`paragraphs as if fully set forth herein.
`
`15.
`
`On March 29, 2005, the U.S. Patent and Trademark Office (“USPTO”) duly and
`
`legally issued the ‘183 Patent, entitled “System and Method for Detecting Perforations in a Body
`
`Cavity,” to Russel M. Sampson, Mike O’Hara, Csaba Truckai, and Dean T. Miller as inventors.
`
`A true and correct copy of the ‘183 Patent is attached as Exhibit B.
`
`16.
`
`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
`
`‘183 Patent.
`
`17.
`
`Plaintiffs have complied with the notice requirements of 35 U.S.C. § 287 with
`
`respect to products that they manufacture and sell under the ‘183 Patent.
`
`18.
`
`Defendant has had knowledge of the ‘183 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 ‘183 Patent.
`
`19.
`
`On information and belief, Defendant was aware that Plaintiffs’ NovaSure®
`
`system embodied the claimed invention of the ‘183 Patent and knew or should have known that
`
`Defendant’s products, including the Minerva Endometrial Ablation System, infringed one or
`
`more claims of the ‘183 Patent due to their substantially similar designs.
`
`01:17936255.1
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`4
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`

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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 5 of 12 PageID #: 5
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`
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`20.
`
`On information and belief, Defendant has infringed and continues to infringe,
`
`literally and/or through the doctrine of equivalents, the ‘183 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, services, methods, or processes that are covered by at
`
`least claims 1-7, 9, 11, and 13-15 of the ‘183 Patent. On information and belief, such devices
`
`include, but are not limited to, the Minerva Endometrial Ablation System.
`
`21.
`
`On information and belief, Defendant has indirectly infringed and continues to
`
`indirectly infringe the ‘183 Patent in violation of 35 U.S.C. § 271. On information and belief,
`
`Defendant’s customers directly infringe at least claims 1-7, 9, 11, and 13-15 of the ‘183 Patent
`
`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
`
`activities relating to the marketing, sales, support, and distribution of the Minerva Endometrial
`
`Ablation System, including, for example without limitation, providing through Defendant’s
`
`website video and print instructions to use the Minerva Endometrial Ablation System in a
`
`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
`
`the same to be especially made or especially adapted for use in the infringement of one or more
`
`claims of the ‘183 patent and not a staple article or commodity of commerce suitable for
`
`substantial non-infringing use.
`
`22.
`
`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.
`
`01:17936255.1
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`
`
`5
`
`

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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 6 of 12 PageID #: 6
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`
`
`23.
`
`As a result of Defendant’s infringement of the ‘183 Patent, Plaintiffs have
`
`suffered and continues to suffer damages.
`
`24.
`
`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
`
`enjoins such infringing acts.
`
`COUNT II
`
`(Defendant’s Infringement of the ‘898 Patent)
`
`25.
`
`Plaintiffs repeat and reallege each and every allegation set forth in the preceding
`
`paragraphs as if fully set forth herein.
`
`26.
`
`On April 7, 2015, the USPTO duly and legally issued the ‘898 Patent, entitled
`
`“Moisture Transport System for Contact Electrocoagulation” to Csaba Truckai, Russel M.
`
`Sampson, Stephanie Squarcia, Alfonso L. Ramirez, Estela Hilario, and David C. Auth as
`
`inventors. A true and correct copy of the ‘898 Patent is attached as Exhibit C.
`
`27.
`
`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
`
`‘898 Patent.
`
`28.
`
`Plaintiffs have complied with the notice requirements of 35 U.S.C. § 287 with
`
`respect to products that it manufactures and sells under the ‘898 Patent.
`
`29.
`
`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.
`
`30.
`
`On information and belief, Defendant was aware that Plaintiffs’ NovaSure®
`
`system embodied the claimed invention of the ‘898 Patent and knew or should have known that
`
`01:17936255.1
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`
`
`6
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`

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`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 7 of 12 PageID #: 7
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`
`
`Defendant’s products, including the Minerva Endometrial Ablation System, infringed one or
`
`more claims of the ‘898 Patent due to their substantially similar designs.
`
`31.
`
`On information and belief, Defendant has infringed and continues to infringe,
`
`literally and/or through the doctrine of equivalents, the ‘898 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, services, methods, or processes that are covered by at
`
`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.
`
`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,
`
`Defendant’s customers directly infringe at least claims 1-6, 8, and 14-16 of the ‘898 Patent by
`
`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
`
`made or especially adapted for use in the infringement of one or more claims of the ‘898 patent
`
`and not a staple article or commodity of commerce suitable for substantial noninfringing use.
`
`01:17936255.1
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`
`7
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`

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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.
`
`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.
`
`35.
`
`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.
`
`COUNT III
`
`(Defendant’s Infringement of the ‘348 Patent)
`
`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.
`
`Cytyc is the assignee and lawful owner of all right, title, and interest in and to the
`
`‘348 Patent.
`
`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.
`
`40.
`
`Defendant has had knowledge of the ‘348 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
`
`01:17936255.1
`
`
`
`8
`
`

`
`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 9 of 12 PageID #: 9
`
`
`
`importation of the Minerva Endometrial Ablation System would infringe one or more claims of
`
`the ‘348 Patent.
`
`41.
`
`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.
`
`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
`
`Endometrial Ablation System.
`
`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
`
`United States, the Minerva Endometrial Ablation System knowing the same to be especially
`
`01:17936255.1
`
`
`
`9
`
`

`
`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 10 of 12 PageID #: 10
`
`
`
`made or especially adapted for use in the infringement of one or more claims of the ‘348 patent
`
`and not a staple article or commodity of commerce suitable for substantial non-infringing use.
`
`44.
`
`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
`
`enjoins such infringing acts.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court grant the following relief:
`
`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
`
`infringement of one or more claims of the ‘183 Patent;
`
`2.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant’s infringement of the ‘183 Patent has been and continues
`
`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
`
`infringement of one or more claims of the ‘898 Patent;
`
`01:17936255.1
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`
`
`10
`
`

`
`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 11 of 12 PageID #: 11
`
`
`
`4.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant’s infringement of the ‘898 Patent has been and continues
`
`to be willful;
`
`5.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant has and continues to directly infringe and induce
`
`infringement of one or more claims of the ‘348 Patent;
`
`6.
`
`Judgment in favor of Plaintiffs Hologic and Cytyc, and against Defendant
`
`Minerva Surgical, Inc., that Defendant’s infringement of the ‘348 Patent has been and continues
`
`to be willful;
`
`7.
`
`A preliminary and permanent injunction against Defendant Minerva Surgical, Inc.
`
`for infringement of the Patents-in-Suit;
`
`8.
`
`Judgment awarding Plaintiffs Hologic and Cytyc damages adequate to
`
`compensate for Defendant Minerva Surgical, Inc.’s infringement of the Patents-in-Suit in an
`
`amount to be proven at trial, together with pre-judgment and post-judgment interest and costs, as
`
`fixed by the Court;
`
`9.
`
`Judgment enhancing the damages due to Defendant Minerva Surgical, Inc.’s
`
`willful infringement, pursuant to 35 U.S.C. § 284;
`
`10.
`
`Judgment declaring that this is an exceptional case under 35 U.S.C. § 285 and
`
`awarding Hologic and Cytyc their attorneys’ fees and costs incurred in prosecuting its claims;
`
`and
`
`
`01:17936255.1
`
`
`
`11.
`
`Such other relief as this Court deems just and proper.
`
`JURY DEMAND
`
`Plaintiffs demand a trial by jury in this action on all issues so triable.
`
`11
`
`

`
`Case 1:15-cv-01031-SLR Document 1 Filed 11/06/15 Page 12 of 12 PageID #: 12
`
`
`
`
`
`DATED: November 6, 2015
`
`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
`
`01:17936255.1
`
`
`
`12

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