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Ethicon Endo-Surgery, Inc. v. Covidien LP

United States District Court, D. Massachusetts

October 2, 2017

ETHICON ENDO-SURGERY, INC., et al., Plaintiffs and Counterclaim-Defendants,
v.
COVIDIEN LP, et al., Defendants and Counterclaim-Plaintiffs.

          ORDER ON MOTION FOR A PRELIMINARY INJUNCTION (DOC. NO. 38)

          Leo T. Sorokin United States District Judge

         Defendants and counterclaim-plaintiffs Covidien LP, Covidien Sales LLC, and Covidien AG (collectively, “Covidien”) have moved for a preliminary injunction barring plaintiffs and counterclaim-defendants Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC (collectively, “Ethicon”) from marketing and selling the Enseal® X1 Large Jaw device (“the X1”). Doc. No. 38. Ethicon opposed the motion, which is fully briefed and was the subject of a hearing on September 18, 2017. For the following reasons, Covidien's motion is DENIED.

         I. BACKGROUND

         Ethicon and Covidien produce and sell competing lines of advanced energy vessel sealing instruments. Such instruments are used in surgical procedures involving dissection of blood vessels or tissue. The devices permit surgeons to grasp a vessel or tissue between two jaws at one end of the instrument, apply energy to the vessel or tissue to form a seal and stop the blood flow through it, then cut the sealed tissue using a knife that moves along the length of the jaws. Generally speaking, Ethicon has been the market leader in the category of these devices using ultrasonic energy, and Covidien has been the market leader in the category using advanced bipolar (or radiofrequency) energy. The two companies are fierce, direct competitors, and this is not the first patent litigation between them. E.g., Covidien Sales LLC v. Ethicon Endo-Surgery, Inc., No. 3:14-cv-917, 2014 WL 5242872, at *1 (D. Conn. Oct. 15, 2014) (ruling on motion for preliminary injunction in patent infringement case by Covidien against Ethicon related to an advanced ultrasonic surgical device).

         The Covidien product most relevant in this case is the LigaSure Impact, which has been on the market for about a decade. The Impact accounted for more than $150 million in sales in 2016 - more than 30% of Covidien's advanced bipolar product sales in the United States for that year. Covidien attributes the success of the Impact, and the entire LigaSure line of products, to its “ability to provide a consistent and reliable vessel seal.” Doc. No. 39-1 at 10.[1] According to Covidien, the Impact's ability to deliver such a seal results from its incorporation of an invention protected by United States patent number 8, 241, 284 (“the ‘284 patent”). The ‘284 patent issued in August 2012, is assigned to Covidien, and is entitled “Vessel Sealer and Divider with Non-Conductive Stop Members.” Doc. No. 42-1.

         Only one claim of the ‘284 patent is at issue in Covidien's motion for a preliminary injunction.[2] That claim discloses:

         An endoscopic bipolar forceps, comprising:

an elongated shaft having opposing jaw members at a distal end thereof, the jaw members including a length and a periphery and movable relative to one another from a first position wherein the jaw members are disposed in spaced relation relative to one another to a second position wherein the jaw members cooperate to grasp tissue therebetween, the jaw members each including respective flat seal surfaces extending along a respective length thereof and adaptable to connect to a source of electrical energy such that the jaw members are capable of conducting energy through tissue held therebetween to effect a tissue seal;
a plurality of non-conductive stop members disposed along the length of at least one of the seal surfaces of at least one of the jaw members such that the plurality of non-conductive stop members are disposed along the same plane on the seal surface with respect to one another, the non-conductive stop members configured to maintain a uniform distance between the jaw members along the length thereof;
and a knife disposed in operative communication with at least one of the jaw members and translatable to sever tissue disposed between jaw members.

Id. at 23 (emphasis added). The critical limitations of the claim will be discussed in more depth below.

         This lawsuit arises from Ethicon's development and release of the X1, which launched commercially in March 2017. The X1's predecessor, the Enseal® G2 Super Jaw device (“the G2”), had neither succeeded in meaningfully competing with the LigaSure line of products nor enabled Ethicon to gain ground in the advanced bipolar market. The parties disagree about the reasons for the G2's lack of commercial success, a point which will be explored further below. They agree, however, that the X1 was developed to remedy the G2's shortcomings, and that it succeeded in doing so. In the first several months following the X1's launch, a number of hospitals that previously had used LigaSure products began purchasing X1s instead. The X1's performance in that time period surpassed Ethicon's projections, totaling $7.8 million in revenue and adding 366 new accounts (i.e., customers that had not purchased G2s). Doc. No. 79-21 at 3.

         The X1 and the G2 differ in several relevant ways. In place of the ridges or teeth running along the length of the G2's jaw, the X1 has six black bumps (three on each side of the knife channel) spaced along the bottom jaw, each rising .004 inches above the lower sealing surface. Instead of a single control causing the G2 to seal and cut in one action when activated by the surgeon, the X1 has separate sealing and cutting functions permitting surgeons to press one button to seal, then press another button to activate the knife if and when they wish to do so. In addition, the shape and contour of the portion of the device held in the surgeon's hand was modified in an effort to achieve better ergonomics with the X1. One important feature was not changed: both the G2 and the X1 have a steel pin positioned at the far end of the lower jaw, which contacts the upper sealing surface when the jaws are in the closed position and sets the gap between the jaws (which, on the X1, is .008 inches).

         The Impact has separate sealing and cutting functions, and has non-conductive spacers which set the gap between the upper and lower jaws. It has no steel pin.

         Ethicon began exploring prototypes for a successor to the G2 at least as early as 2013. Doc. No. 60-36. In 2015, Ethicon petitioned the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office, seeking inter partes review and arguing that various claims in the ‘284 patent were invalid. Doc. No. 42-6 at 3. That petition was denied. Id. In spring of 2016, when it was beginning to plan for the X1's launch, Ethicon notified Covidien of the impending release in an effort to resolve any patent disputes before the launch. Covidien agreed to mediation later that year, after Ethicon received pre-market approval for the X1 from the ...


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