terumo et. al. v. lepu medical technology et. al

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  • 7/29/2019 Terumo et. al. v. Lepu Medical Technology et. al.

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    Eric I. Abraham

    Christina Saveriano

    HILL WALLACK LLP202 Carnegie Center

    Princeton, New Jersey 08540

    Telephone: 609.924.0808Facsimile: [email protected]

    ADDITIONAL COUNSEL

    LISTED ON SIGNATURE PAGE

    Attorneys for Plaintiffs

    TERUMO CORPORATION

    TERUMO MEDICAL CORPORATION

    IN THE UNITED STATES DISTRICT COURT

    FOR THE DISTRICT OF NEW JERSEY

    TERUMO CORPORATION and TERUMO

    MEDICAL CORPORATION,

    Plaintiffs,

    v.

    LEPU MEDICAL TECHNOLOGY (BEIJING)

    CO. and VASCULAR SOLUTIONS, INC.,

    Defendants.

    Civil Action No. ______________________

    COMPLAINT FOR PATENT AND

    TRADEMARK INFRINGEMENT

    DEMAND FOR JURY TRIAL

    COMPLAINT AND JURY DEMAND

    Plaintiffs Terumo Corporation and Terumo Medical Corporation (Terumo Medical)

    (collectively, Terumo) allege as follows against Defendants Lepu Medical Technology

    (Beijing) Co. (Lepu) and Vascular Solutions, Inc. (Vascular):

    mailto:[email protected]:[email protected]:[email protected]
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    NATURE OF THE ACTION

    1. This is an action for patent infringement under the United States patent laws,35 U.S.C. 100 et seq., of United States Patent No. 7,498,477 (the 477 patent), and for

    trademark infringement under the Lanham Act, 15 U.S.C. 1051 et seq., of the TR Band

    mark.

    PARTIES

    2. Plaintiff Terumo Corporation (in Japanese, Terumo Kabushiki Kaisha) is aJapanese corporation with its principal place of business at 44-1, 2-Chome, Hatagaya, Shibuya-

    ku, Tokyo, 151-0072, Japan. Terumo Corporation is one of Japans leading suppliers of health

    care products. Terumo Corporation is the owner by assignment of the 477 patent. Terumo

    Corporation is also the owner of the TR Band markand has filed a use-based application for

    registration of the TR Band markwith the United States Patent and Trademark Office.

    3. Plaintiff Terumo Medical is a Delaware corporation with its principal place ofbusiness at 2101 Cottontail Lane, Somerset, New Jersey, 08873. Terumo Medical is a wholly-

    owned subsidiary of Terumo Americas Holding, Inc., which also has its principal place of

    business in Somerset, New Jersey, and which in turn is a wholly-owned subsidiary of Terumo

    Corporation. Terumo Medical offers a diverse portfolio of medical devices, supplies, and

    accessories for the United States health care industry. Terumo Medical is an exclusive licensee

    underthe 477 patent in the United States because Terumo Medical has the right to market and

    sell Terumos patented TR Band device in the United States to the exclusion of others.

    Terumo Medical also has permission from Terumo Corporation to use the TRBand mark in

    the United States, and owns the 510(k) Premarketing Approval for the TR Band device in the

    United States.

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    4. Terumo is informed and believes, and on that basis alleges, that Defendant Lepuis a Chinese corporation with its principal place of business at Beikong Building, 3rd Floor, No.

    10 Baifuquan Road, Changping District, Beijing 102200, China. Terumo is informed and

    believes, and on that basis alleges, that Lepu is the developer and manufacturer of the infringing

    R-Band radial hemostasis compression device.

    5. Terumo is informed and believes, and on that basis alleges, that DefendantVascular is a Minnesota corporation with its principal place of business at 6464 Sycamore Court,

    Minneapolis, Minnesota, 55441. Terumo is informed and believes, and on that basis alleges, that

    Vascular is the exclusive distributor of the infringing R-Band device in the United States under

    an agreement with Lepu.

    JURISDICTION

    6. The Court has subject matter jurisdiction under 28 U.S.C. 1331 (federalquestion), 28 U.S.C. 1338(a) (patent and trademark actions), and 15 U.S.C. 1121 (actions

    arising under the Lanham Act).

    7. Terumo is informed and believes, and on that basis alleges, that the Court haspersonal jurisdiction over Lepu and Vascular with respect to this Complaint because each of

    them has committed and continues to commit acts of infringement in violation of 35 U.S.C.

    271(a), 35 U.S.C. 271(b), and/or 15 U.S.C. 1125(a), including at least by advertising,

    marketing, using, and offering for sale the R-Band device within the District of New Jersey, and

    purposefully manufacturing, shipping, and selling the R-Band device with the knowledge or

    understanding that it will be used, offered for sale, and sold in this District. Further, Terumo is

    informed and believes, and on that basis alleges, that Lepu and Vascular each maintain

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    continuous and systematic general business contacts with this District and derive substantial

    revenue from articles used, offered for sale, and sold in this District.

    VENUE

    8. Venue is proper in this District pursuant to 28 U.S.C. 1391 and 1400(b) at leastbecause Lepu and/or Vascular have transacted business within this District and have used, sold,

    offered for sale, or imported products in this District that infringe Terumos patent and trademark

    rights. Further, venue is proper because Terumo Medical has its principal place of business in

    this District, and Terumo has suffered and will continue to suffer harm in this District as a result

    of Lepus and/orVasculars infringement.

    BACKGROUND

    9. Terumo Corporation is a global supplier of superior health care products andequipment, including a broad array of products for vascular interventional treatment and

    cardiovascular surgery. Terumo Interventional Systems (Terumo Interventional), a strategic

    business unit of Terumo Medical, markets a full line of medical devices in the vascular medicine

    field, including introducer sheaths, guiding sheaths, guidewires, angiographic catheters, coronary

    catheters, microcatheters, embolics, and an innovative radial compression device marketed under

    the TR Band trademark.

    10. The TR Band device is a medical device designed to safely and comfortablystop bleeding following transradial catheterization, an endovascular procedure that uses the

    radial artery at the wrist to access a patients endovascular system. The TR Band device set a

    new standard of excellence in patient care when it was launched in the United States in 2007.

    Before the introduction of the TR Band device, the leading radial compression devices were

    tourniquet-style devices frequently associated with poor circulation, patient discomfort, and

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    radial artery occlusion. The TR Band device is substantially different from those prior art

    devices. The TR Band device uses two inflatable balloons positioned on a curved plate to

    provide adjustable point compression on the radial artery, while avoiding unnecessary collateral

    compression of the ulnar artery and surrounding nerve tissue. The result is a safer and more

    comfortable device that provides excellent hemostatic effect at the radial puncture site. The TR

    Band device has achieved significant commercial success in the marketplace, quickly

    becoming the de facto standard in the U.S. transradial industry and the leading radial hemostatic

    compression device in the U.S. transradial market. For example, an estimate provided by

    Morgan Stanley MUFG Research indicates that, as of March 2011, Terumos TR Band device

    had captured 72% of the relevant market in the United States.

    11. The TR Band device has also played a pivotal role in the recent growth oftransradial procedures in the United States. Prior to the TR Band devices launch, use of

    transradial procedures was relatively rare in the United States. For example, a research study

    published in 2008 by Dr. Sunil Rao of Duke University found that only about 1.3% of the

    interventional catheterization procedures in the United States were performed transradially. The

    overwhelming majority of interventional procedures in the United States were performed

    transfemorallythat is, by using the femoral artery in the groin as the point of access to the

    endovascular system. Transfemoral procedures, however, may result in a higher incidence of

    major vascular complications, such as life-threatening bleeding. These complications increase

    the cost of patient care. By contrast, transradial procedures tend to have a much lower incidence

    of major vascular complications, resulting in more cost-effective patient care. Today, due in

    considerable part to Terumo Interventionals efforts to market the TR Band device and

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    promote transradial medicine in the United States, the number of transradial procedures relative

    to transfemoral procedures has increased significantly.

    TERUMOS PATENT AND

    TRADEMARK RIGHTS

    12. Terumo has the exclusive right to market and sell the TR Band device in theUnited States by virtue of its patent and trademark rights.

    13. The TR Band device is protected by United States Patent No. 7,498,477 (the477 patent), entitled Hemostatic Device, which has been owned by Terumo Corporation

    since it issued on March 3, 2009. A true and correct copy of the 477 patent is attached hereto as

    Exhibit A. Terumo Medical owns the 510(k) Premarketing Approval covering the TR Band

    device, which gives Terumo Medical the right to market and sell the TR Band device in the

    United States. Further, Terumo Medical is an exclusive licensee underthe 477 patent in the

    United States because it has the right to market and sell the patented TR Band device in the

    United States to the exclusion of others.

    14. Terumo also has protectable common law trademark rights in the TR Bandmark. Terumo Corporation has filed a use-based application for registration of the TR Band

    mark with the United States Patent and Trademark Office. Terumo Corporation has given

    Terumo Medicalpermission to use the TR Band mark in the United States, which Terumo

    Medical has been using in the United States continuously since it launched the TR Band

    device in the United States in July 2007.

    15. Terumo has not licensed any third party to practice the 477 patent in the UnitedStates, or to use the TR Band mark in connection with radial compression devices in the

    United States, but has enjoyed the exclusive competitive benefits of those rights for itself.

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    LEPUS AND VASCULARS INFRINGING CONDUCT

    16. Lepu and Vascular compete with Terumo in the U.S. endovascular catheterizationmedical device market. In October 2012, over five years after Terumo Interventional began

    selling the TR Band device in the United States, Vascular announced that it was launching the

    R-Band device in the United States under an exclusive distribution agreement with Lepu, the

    developer and manufacturer of the R-Band device. In its announcement, Vascular further stated:

    The R-Band, which has received 510(k) clearance, is a radial

    compression device that is used by interventional cardiologists to

    achieve hemostasis following transradial diagnostic andinterventional catheterization procedures. The device consists of a

    soft plastic wrist strap with adjustable hook and loop fasteners, twoinflatable compression balloons, and an inflation syringe with aproprietary connector tip. After applying the strap around the

    patients wrist, the physician inflates the compression balloons to

    apply gentle pressure to the puncture site of the radial artery, whilemaintaining flow through the ulnar artery. The clear plastic strap

    and clear compression balloons allow the clinician to visualize the

    access site during the entire process.

    17. The R-Band device is a cheap knockoffof Terumos TR Band device thatinfringes Terumos 477 patent. The R-Band device also uses a trademarkthe R-Band mark

    that is confusingly similar to the TR Band mark. The R-Band device has substantially the

    same design and appearance as Terumos TR Band device, as shown by the pictures below.

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    Terumos TR Band Device Lepus R-Band Device

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    Terumos TR Band Device Lepus R-Band Device

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    Terumos TR Band Device Lepus R-Band Device

    Terumos TR Band Mark Lepus R-Band Mark

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    18. The striking similarity between Terumosprotected TR Band device and markand Lepu/Vasculars infringing R-Band device and mark strongly suggests that Lepu and/or

    Vascular designed the R-Band device and mark by obtaining a TR Band device and blatantly

    copying its essential features, including those protected by Terumos 477patent and its

    trademark rights. Indeed, when Lepu sought FDA clearance for the R-Band device, Lepu

    submitted to the FDA a premarket notification 510(k) summary (the Lepu 510(k) Summary),

    dated June 27, 2011, that listed the TR Band, Terumo Corporation, K070423as a predicate

    device forLepus own R-Band productmeaning that Lepu sought FDA clearance on the basis

    that its R-Band device was substantially equivalent to Terumos TR Band device. Lepu also

    stated in its 510(k) Summary that it had performed a side-by-side comparison of the two

    devices, and that the balloon profile performance characteristics of both devices are very

    similar.

    19. Terumo is informed and believes, and on that basis alleges, that Lepu has hadactual knowledge ofTerumos 477 patent and Terumos rights in the TR Band marksince at

    least before the launch of the R-Band device in the United States in October 2012.

    20. On or about October 31, 2006, Lepu filed an application for a utility patententitled Radial artery puncture point hemostat pressure device (Appl. No. CN-200620148224,

    Pub. No. CN-200970252) in the State Intellectual Property Office of the Peoples Republic of

    China (SIPO), also known as the Chinese Patent Office. On May 24, 2011, Terumo Corporation

    filed a request for an invalidation trial in connection with Lepus utility patent. In that

    proceeding, Terumo Corporation referenced one of its European patentsEP-1382306as a

    basis for invalidating Lepus utility patent. Terumo Corporations EP-1382306 patent is a

    European counterpart to the 477 patent, exists in the same family as the 477 patent, and covers

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    the TR Band device sold in Europe. The Chinese Patent Office held a hearing on or about

    September 13, 2011, and issued a decision on or about November 28, 2011, invalidating all

    claims ofLepus utility patent in light of Terumo Corporations EP-1382306 patent.

    21. Further, on July 4, 2011, and again on March 7, 2012, Terumo Corporation sentcease-and-desist letters to Lepu, warning Lepu that it was infringing three European patents

    owned by Terumo CorporationEP-1382306, EP-2070483, and EP-2245998by selling a

    radial compression device known as the Radial Artery Compression Tourniquet in various

    European countries. Those three European patents are the European counterparts to the 477

    patent, exist in the same patent family as the 477 patent, and cover the TR Band device in

    Europe. In response to Terumo Corporations cease-and-desist letters, Lepu modified the design

    of its European radial compression device, presumably in an attempt to avoid Terumo

    Corporations European patents.

    22. Based on these facts, Terumo is informed and believes, and on that basis alleges,that Lepu conducted an investigation into Terumos European patents mentioned above, which

    cover the TR Band device in Europe, and in the course of that investigation discovered the

    existence of the 477 patent, which issued on March 3, 2009, and which is in the same family as

    those same European patents, before Lepu decided to launch a knockoff of the TR Band

    device in the United States in October 2012.

    23. Further, since Terumo first introduced the TR Band device in the United Statesin 2007, Terumo hasput the public on notice of its claim of rights in the TR Band mark by

    using the symbol in connection withits TR Band device at least on its product packaging

    and product literature, or in connection with its product press releases. Nor were Terumos

    efforts atputting the public on notice of its claim of rights in the TR Band mark lost on Lepu.

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    In its 510(k) Summary covering the R-Band device, Lepu listed the TR Band, Terumo

    Corporation, K070423 as a predicate device ofLepus R-Band product.

    24. Alternatively, Terumo is informed and believes, and on that basis alleges, thatLepu was willfully blind to the existence of the 477 patent, and took active steps to avoid

    gaining actual knowledge of the 477 patent, at least because Lepu had actual knowledge of

    Terumo Corporations above-mentioned European patent rights covering the TR Band device

    in Europe, and yet deliberately refused to investigate Terumo Corporations corresponding

    United States patent rights before launching a knockoff of the TR Band device in the United

    States.

    25. Terumo is also informed and believes, and on that basis alleges, that Vascular hadknowledge ofTerumos477 patentand Terumos rights in the TR Band mark, or alternatively

    was willfully blind to the existence of the 477 patent and took active steps to avoid gaining

    actual knowledge of the 477 patent, since at least before the launch of the R-Band device in the

    United States in October 2012.

    26. Terumo is informed and believes, and on that basis alleges, that Vascularcompetes in the same market as Terumo, is aware of the relevant patent and trademark rights of

    its competitors, including those of Terumo, as a result of publicity within the industry and

    Vasculars own competitive analysis, and knows that the R-Band device is a knockoff of the TR

    Band device. Indeed, Terumo is informed and believes, and on that basis alleges, that

    Vascular has developed and is currently implementing a carefully orchestrated marketing

    campaign designed to target Terumos U.S. customer base, including Terumos largest U.S.

    customers, by stating that the R-Band device works just like the TR Band device, but is sold

    for about half the price. Further, Terumo is informed and believes, and on that basis alleges, that

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    Vascular has met with the same customers and potential customers as Terumo regarding

    interventional medical devices, and has seen the TR Band device in connection with those

    meetings.

    27. At the very least, both Lepu and Vascular received actual notice of the 477patentwhen Terumo served them with a copy of this Complaint.

    28. Since October 2012, Lepu and Vascular have engaged in numerous acts of patentand trademark infringement in the United States by using, selling, and/or offering to sell, in the

    United States, and/or by importing into the United States, the R-Band device. These infringing

    activities have damaged Terumo at least by confusing customers into believing that there is an

    association between Vascular and/or its R-Band device and Terumo; depriving Terumo of sales

    of the TR Band device (including the return for credit of TR Band devices previously

    shipped); depressing prices for the TRBand device at existing and potential customers;

    diverting opportunities for future sales of the TR Band device away from Terumo; and

    damaging Terumos business reputation and goodwill. For example, a Terumo customer

    reported that it had been requested to evaluate a competitive pressure band, stating that they

    [Vascular] are blowing your price out of the water, and asking Terumo if it would cut your

    price in 1/2? Another customer sent Terumo an email stating that Vascular Solutions is able to

    provide us with an R-Band for less than half the price of Terumos TR Band device, asking

    Is there any possibility that Terumo can match this price? At least one customer has recently

    informed Terumo that it would stop purchasing Terumos TR Band device, and would instead

    be switching to Vasculars infringing R-Band device.

    29. Terumo is informed and believes, and on that basis alleges, that Lepu has alsoknowingly induced Vascular to engage in patent and trademark infringement, with actual

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    knowledge or willful blindness to the existence ofTerumos477 patentand Terumos rights in

    the TR Band mark, with the specific intent for Vascular to infringe the 477 patent and the TR

    Band mark, and with actual knowledge or willful blindness that the acts Lepu was causing

    would infringe the 477 patentand Terumos trademark rights.

    30. For example, Terumo is informed and believes, and on that basis alleges, thatLepu obtained FDA clearance to market the R-Band device in the United States, and specifically

    designed and manufactured the R-Band device for the United States market, with actual

    knowledge or willful blindness to the existence ofTerumos477 patentand Terumos rights in

    the TR Band mark, with the specific intent for a United States distributor (Vascular) to

    infringe the 477 patent and the TR Band mark by using, selling, or offering for sale the R-

    Band device in the United States, or by importing the R-Band device into the United States,

    while having actual knowledge or being willfully blind to the fact that the acts Lepu was causing

    would infringe the 477 patentand Terumos trademark rights. Indeed, product labeling for the

    R-Band device states that the device is manufactured for Vascular, while Lepu is listed in

    certain FDA medical device databases as the applicant of the 510(k) Premarketing Approval for

    the R-Band device and as the manufacturer of the R-Band device. Terumo is further informed

    and believes, and on that basis alleges, that Lepu entered into an exclusive distributorship

    agreement with Vascular for the sale of the R-Band device in the United States, and thereby

    aided and abetted the importation of the R-Band device into the United States, and encouraged

    Vascular to use, sell, and offer for sale the R-Band device in the United States, with actual

    knowledge or willful blindness to the existence ofTerumos477 patentand Terumos rights in

    the TR Band mark, with the specific intent for Vascular to infringe the 477 patent and the TR

    Band mark by using, selling, or offering for sale the R-Band device in the United States, or by

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    importing the R-Band device into the United States, while having actual knowledge or being

    willfully blind to the fact that the acts Lepu was causing would infringe the 477 patent and

    Terumos trademark rights.

    31. Terumo is further informed and believes, and on that basis alleges, that Vascularhas knowingly induced health care professionals and health care consumers to engage in patent

    infringement, with actual knowledge or willful blindness to the existence of the 477 patent, with

    the specific intent for such persons to infringe the 477 patent, and with actual knowledge or

    willful blindness that the acts Vascular was causing would infringe the 477 patent.

    32.

    For example, Terumo is informed and believes, and on that basis alleges, that

    Vascular has offered to sell and/or has sold the R-Band device to hospitals, physicians, and other

    health care professionals together with promotional and instructional materials encouraging them

    to use the R-Band device on patients undergoing transradial catheterization, with actual

    knowledge or willful blindness to the existence of the 477 patent, with the specific intent for

    such hospitals, physicians, and otherhealth care professionals to infringe the 477 patent, while

    having actual knowledge or being willfully blind to the fact that the acts Vascular was causing

    would infringe the 477 patent.

    COUNT ONE

    (Direct Infringement ofthe 477 Patent)

    (Against Lepu and Vascular)

    33. Terumo incorporates and realleges paragraphs 1 to 32 of this Complaint.34. Lepu and/or Vascular have infringed and continue to infringe one or more claims

    of the 477 patent in violation of 35 U.S.C. 271(a), either literally or under the doctrine of

    equivalents, by using, selling, and/or offering to sell, in the United States, and/or by importing

    into the United States, the R-Band device.

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    35. Terumo is informed and believes, and on that basis alleges, that Lepus and/orVascularsinfringement of the 477 patent has been and continues to be intentional, willful, and

    without regard to Terumos rights, and that Lepu and/or Vascular should be held liable to

    Terumo for treble damages and attorneys fees pursuant to 35 U.S.C. 285.

    36. Terumo has sustained and will continue to sustain damages, including lost profits,as a direct and proximate result ofLepus and/or Vascularsinfringement of the 477 patent.

    37. Terumo is suffering and will continue to suffer irreparable harm from Lepusand/or Vascularsinfringement of the 477 patent. Terumo has no adequate remedy at law and is

    entitled to an injunction against Lepus and Vasculars continuing infringement of the 477

    patent. Unless enjoined, Lepu and/or Vascular will continue such infringing conduct.

    COUNT TWO

    (Indirect Infringement of the 477 Patent)

    (Against Lepu and Vascular)

    38. Terumo incorporates and realleges Paragraphs 1 to 37 of the Complaint.39. Terumo is informed and believes, and on that basis alleges, that Lepu and/or

    Vascular have actively induced infringement ofone or more claims of the 477 patent, and

    continue to induce infringement of the 477 patent in violation of 35 U.S.C. 271(b), with

    knowledge or willful blindness to the existence of the 477 patent, with specific intent to induce

    infringement, and with knowledge or willful blindness that the induced acts would constitute

    patent infringement, by engaging in at least the following activities: designing and

    manufacturing the R-Band device specifically for sale and use in the United States; aiding and

    abetting the importation, sale, and offer for sale of the R-Band device in the United States;

    entering into an exclusive distribution agreement for the distribution of the R-Band device in the

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    United States; and soliciting, encouraging, and enabling infringing activity in the United States

    through promotional and instructional materials relating to the R-Band device.

    40. Terumo is informed and believes, and on that basis alleges, that Lepus and/orVasculars induced infringement of the 477 patent has been and continues to be intentional,

    willful, and without regard to Terumos rights, and that Lepu and/or Vascular should be held

    liable to Terumo for treble damages and attorneys fees pursuant to 35 U.S.C. 285.

    41. Terumo has sustained and will continue to sustain damages, including lost profits,as a direct and proximate result of Lepus and/or Vasculars induced infringement of the 477

    patent.

    42. Terumo is suffering and will continue to suffer irreparable harm from Lepusand/or Vasculars induced infringement of the 477 patent. Terumo has no adequate remedy at

    law and is entitled to an injunction against Lepus and Vasculars continuing induced

    infringement of the 477 patent. Unless enjoined, Lepu and/or Vascular will continue such

    induced infringing conduct.

    COUNT THREE

    (False Designation of Origin Under 15 U.S.C. 1125(a))

    (Against Lepu and Vascular)

    43. Terumo incorporates and realleges paragraphs 1 to 42 of this Complaint.44. Terumo has had valid and protectable rights in the TR Band mark since prior to

    Lepus and/or Vasculars first use of the R-Band designation on their competing products in the

    United States.

    45. The TR Band mark is inherently distinctive, or alternatively, has acquiredsecondary meaning at least by virtue of Terumos extensive sales of the TR Band device over

    the past five years, Terumos use of the TR Band mark in the United States in association with

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    its advertising and training efforts to promote transradial medicine, and the TR Banddevices

    position as the market-leading radial compression device in the transradial industry.

    46. Terumo is informed and believes, and on that basis alleges, that Lepu and/orVascular had actual knowledge of Terumos ownership and use of the TR Band mark prior to

    their adoption and use of the R-Band designation on their competing products.

    47. Terumo has not authorized Lepu or Vascular to use the R-Band designation inconnection with their competing products.

    48. Lepus and/or Vasculars use of the infringing R-Band designation in the UnitedStates is likely to cause confusion or mistake, or deceive the consumer as to the affiliation,

    connection, or association of Terumo with Lepu and/or Vascular, or as to the origin, sponsorship,

    or approval by Terumo of the R-Band device, and such use constitutes false designation of origin

    in violation of 15 U.S.C. 1125(a).

    49. Terumo is informed and believes, and on that basis alleges, that as a result ofLepus and/or Vasculars unauthorized use of the R-Band designation, Lepu and/or Vascular

    have received and will continue to receive substantial profits to which they are not entitled, and

    Terumo has or will suffer actual monetary damages, including lost profits and impairment of the

    value of the TR Band markand its associated goodwill.

    50. As a direct and proximate result ofLepus and/or Vasculars wrongful conduct,Terumo has been, is now, and will be irreparably injured and damaged by Lepus and/or

    Vasculars aforementioned acts, and unless enjoined by the Court, Terumo will suffer further

    harm to its name, reputation, and goodwill. This harm constitutes an injury for which Terumo

    has no adequate remedy at law.

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    51. On information and belief, Lepu and/or Vascular have acted willfully to usurpTerumos rights, and Lepu and/or Vascular should be held liable to Terumo for treble damages

    and attorneys fees pursuant to 15 U.S.C. 1117(a).

    COUNT FOUR

    (Federal Common Law Trademark Infringement)

    (Against Lepu and Vascular)

    52. Terumo incorporates and realleges paragraphs 1 to 51 of this Complaint.53. Terumo has had valid and protectable rights in the TR Band mark since prior to

    Lepusand/or Vasculars first use of the R-Band designation on their competing products in the

    United States.

    54. The TR Band mark is inherently distinctive, or alternatively, has acquiredsecondary meaning at least by virtue of Terumos extensive sales of the TR Band device over

    the past five years, Terumos use of the TR Band mark in the United States in association with

    its advertising and training efforts to promote transradial medicine, and the TR Band devices

    position as the market-leading radial compression device in the transradial industry.

    55. Terumo is informed and believes, and on that basis alleges, that Lepu and/orVascular had actual knowledge of Terumos ownership and use of the TR Band mark prior to

    their adoption and use of the R-Band designation on their competing products.

    56. Terumo has not authorized Lepu and/or Vascular to use the R-Band designation inconnection with their competing products.

    57. Lepus and/or Vasculars use of the infringing R-Band designation in the UnitedStates is likely to cause confusion or mistake, or deceive the consumer as to the affiliation,

    connection, or association of Terumo with Lepu and/or Vascular, or as to the origin, sponsorship,

    or approval by Terumo of the R-Band device.

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    58. Lepus and/or Vasculars trademark infringement allows them to benefit unfairlyfrom Terumos reputation and success, thereby conferring on sales and other commercial

    activities relating to Lepus and/or Vasculars infringing R-Band device value that such activities

    otherwise would not have.

    59. Terumo is informed and believes, and on that basis alleges, that Lepus and/orVasculars infringement of the TR Band mark has been and continues to be intentional,

    willful, and without regard to Terumos rights.

    60. Terumo is informed and believes, and on that basis alleges, that Lepu and/orVascular have gained profits by virtue of their infringement of the TR Band mark.

    61. Terumo has sustained and will continue to sustain damages as a direct and/orproximate result of Lepus and/orVasculars infringement of the TR Band mark.

    62. Terumo is suffering and will continue to suffer irreparable harm from Lepusand/or Vasculars infringement of the TR Band mark. Terumo has no adequate remedy at law

    and is entitled to an injunction against Lepus and/orVasculars continuing infringement of the

    TR Band mark. Unless enjoined, Lepu and/or Vascular will continue their infringing conduct.

    COUNT FIVE

    (Contributory Trademark Infringement Under 15 U.S.C. 1125(a))

    (Against Lepu)

    63. Terumo incorporates and realleges paragraphs 1 to 62 of this Complaint.64. Terumo has had valid and protectable rights in the TR Band mark since prior to

    Lepusand/or Vasculars first use of the R-Band designation on their competing products in the

    United States.

    65. The TR Band mark is inherently distinctive, or alternatively, has acquiredsecondary meaning at least by virtue ofTerumos extensive sales of the TR Band device over

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    the past five years, Terumos use of the TR Band mark in the United States in association with

    its advertising and training efforts to promote transradial medicine, and the TR Band

    devices position as the market-leading radial compression device in the transradial industry.

    66. Terumo is informed and believes, and on that basis alleges, that Lepu hasintentionally induced Vascular to infringe Terumos TR Band mark, or continued to supply

    Vascular with the R-Band device knowing or having reason to know that Vascular is engaging in

    trademark infringement, and is therefore contributorily responsible for any harm done as a result

    of that infringement, including by engaging in at least the following activities: designing and

    manufacturing the R-Band device specifically for sale and use in the United States; aiding and

    abetting the sale and offer for sale of the infringing R-Band device in the United States; entering

    into an exclusive distribution agreement for the distribution of the R-Band device in the United

    States; all the while specifically knowing that Vascular would sell, and is selling, the R-Band

    device in the United States with a markthe R-Band markthat is confusingly similar to

    Terumos TR Band mark.

    67. Terumo is informed and believes, and on that basis alleges, that as a result ofLepus wrongful conduct, Lepu has received and will continue to receive substantial profits to

    which it is not entitled, and Terumo has or will suffer actual monetary damages, including lost

    profits and impairment of the value of the TR Band mark and its associated goodwill.

    68. As a direct and proximate result ofLepus wrongful conduct, Terumo has been, isnow, and will be irreparably injured and damaged by Lepus aforementioned induced

    infringement, and unless enjoined by the Court, Terumo will suffer further harm to its name,

    reputation, and goodwill. This harm constitutes an injury for which Terumo has no adequate

    remedy at law.

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    69. On information and belief, Lepu has acted willfully to usurp Terumos rights, andLepu should be held liable to Terumo for treble damages and attorneys fees pursuant to 15

    U.S.C. 1117(a).

    PRAYER FOR RELIEF

    1. WHEREFORE, Terumo requests the following relief:a. A judgment that Lepu and Vascular have infringed and/or induced

    infringement of one or more claims of the 477 patent.

    b. An order and judgment awarding temporary, preliminary, permanent, andother injunctive relief against Lepu and Vascular and their respective officers, directors, agents,

    servants, employees, affiliates, attorneys, and all others acting in privity or in concert with each

    of them, and their parents, subsidiaries, divisions, successors and assigns, enjoining all of them

    from further acts of infringement and/or induced infringement of the 477 patent.

    c. A judgment awarding Terumo all damages adequate to compensate forLepus and Vasculars infringement of the 477 patent, including lost profit damages, but in no

    event less than a reasonable royalty for Lepus and Vasculars infringement of the 477 patent, as

    well as all pre-judgment and post-judgment interest at the maximum rate permitted by law.

    d. A judgment awarding Terumo all damages, including treble damages,based on any infringement found to be willful, pursuant to 35 U.S.C. 284, together with

    prejudgment interest.

    e. A judgment declaring that, pursuant to 35 U.S.C. 285, this is anexceptional case.

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    f. A judgment that Terumo has protectable rights in the TR Band mark,that Lepu and Vascular have infringed Terumos TR Band mark, and that Lepu has induced

    Vascular to infringe Terumos TR Band mark.

    g. An order and judgment awarding temporary, preliminary, permanent andother injunctive relief against Lepu and Vascular and its respective officers, directors, agents,

    servants, employees, affiliates, attorneys, and all others acting in privity or in concert with each

    of them, and their parents, subsidiaries, divisions, successors and assigns, enjoining all of them

    from further acts of infringement of the TR Band mark.

    h.

    A judgment awarding Terumo all damages adequate to compensate for

    Lepus and Vasculars infringement of the TR Band mark, as well as prejudgment interest as

    authorized by law.

    i. An accounting of Lepus and Vasculars profitspursuant to 15 U.S.C. 1117.

    j. A judgment trebling any damages award pursuant to 15 U.S.C. 1117.k. Costs and expenses of suit and reasonable attorneys fees under 35 U.S.C.

    285 and/or 15 U.S.C. 1117(a)(3).

    l. Any other remedy to which Terumo may be entitled, including allremedies provided for in 15 U.S.C. 1116, 1117, and 35 U.S.C. 283, 284, 285, and any such

    further relief as the Court may deem just and proper.

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    Dated: _February 14, 2013_________ /s/Eric I. Abraham

    Eric I. Abraham

    Christina SaverianoHILL WALLACK LLP

    202 Carnegie Center

    Princeton, New Jersey 08540Telephone: 609.924.0808Facsimile: 609.452.1888

    [email protected]

    Of Counsel:

    David C. Doyle

    MORRISON & FOERSTER LLP12531 High Bluff Drive

    San Diego, California 92130

    Telephone: 858.720.5100Facsimile: 858.720.5125

    [email protected]

    Peter J. SternWynne Cathcart Erickson

    Christopher L. Robinson

    MORRISON & FOERSTER LLP425 Market Street

    San Francisco, California 94105-2482

    Telephone: 415.268.7000

    Facsimile: [email protected]

    [email protected]

    [email protected]

    A. Max Olson

    Tak MiuraMORRISON & FOERSTER LLP

    Shin-Marunouchi Building, 29th Floor

    5-1, Marunouchi 1-Chome

    Chiyoda-ku, Tokyo 100-6529Telephone: 011.81.3.3214.6522

    Facsimile: 011.81.3.3214.6512

    [email protected]

    [email protected]

    Attorneys for Plaintiffs

    TERUMO CORPORATIONTERUMO MEDICAL CORPORATION

    mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]
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    JURY DEMAND

    Terumo requests trial by jury for any issues so triable.

    Respectfully submitted,

    /s/Eric I. Abraham

    Eric I. AbrahamChristina Saveriano

    HILL WALLACK LLP

    202 Carnegie Center

    Princeton, New Jersey 08540Telephone: 609.924.0808

    Facsimile: 609.452.1888

    [email protected]

    Of Counsel:

    David C. DoyleMORRISON & FOERSTER LLP

    12531 High Bluff Drive

    San Diego, California 92130Telephone: 858.720.5100

    Facsimile: 858.720.5125

    [email protected]

    Peter J. Stern

    Wynne Cathcart Erickson

    Christopher L. RobinsonMORRISON & FOERSTER LLP

    425 Market Street

    San Francisco, California 94105-2482Telephone: 415.268.7000

    Facsimile: 415.268.7522

    [email protected]

    [email protected]@mofo.com

    mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]
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    A. Max Olson

    Tak MiuraMORRISON & FOERSTER LLP

    Shin-Marunouchi Building, 29th Floor

    5-1, Marunouchi 1-ChomeChiyoda-ku, Tokyo 100-6529Telephone: 011.81.3.3214.6522

    Facsimile: 011.81.3.3214.6512

    [email protected]@mofo.com

    Attorneys for Plaintiffs

    TERUMO CORPORATIONTERUMO MEDICAL CORPORATION

    mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]
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    LOCAL CIVIL RULE 11.2 CERTIFICATION

    I hereby certify pursuant to Local Civil Rule 11.2, that to the best of my knowledge,

    information and belief the patent and trademark rights in controversy in this action are not the

    subject of any other action pending in any court, or of any pending arbitration or administrative

    proceeding.

    ___/s/Eric I. Abraham_______________Eric. I. Abraham

    Dated: _February 14, 2013______________________