Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 1 of 96 PageID: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`BRACCO DIAGNOSTICS INC.
`
`Plaintiff,
`
`v.
`
`JUBILANT DRAXIMAGE INC., JUBILANT
`PHARMA LIMITED, and JUBILANT LIFE
`SCIENCES
`
`Defendants.
`
`)
`)
`
`) Civil Action No.: _______________
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`DEMAND FOR JURY TRIAL
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Bracco Diagnostics Inc. ( “Bracco” or “Plaintiff”), by and through its
`
`undersigned counsel, files this Complaint against Defendants Jubilant DraxImage Inc., Jubilant
`
`Pharma Limited, and Jubilant Life Sciences (collectively, “Jubilant” or “Defendants”) and
`
`alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement arising under the patent laws of the
`
`United States, Title 35, United States Code, involving United States Patent Nos. 9,814,826 (“the
`
`’826 patent”), 9,750,869 (“the ’869 patent”), 9,750,870 (“the ’870 patent”), 9,299,467 (“the ’467
`
`patent”) and 9,299,468 (“the ’468 patent”) attached hereto as Exhibits A, B, C, D, and E
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`respectively (collectively, “the patents-in-suit”).
`
`THE PARTIES
`
`2.
`
`Bracco Diagnostics Inc. is a company organized and existing under the laws of
`
`Delaware, with a principal place of business at 259 Prospect Plains Road, Monroe Township, NJ
`
`08831.
`
`1
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`JUBILANT EXHIBIT 1002
`Jubilant v. Bracco, IPR2018-01449
`
`

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`3.
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`Upon information and belief, Jubilant DraxImage Inc. is a corporation organized
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`and existing under the laws of Canada with its principal place of business at 16751 TransCanada
`
`Highway Kirkland, Québec, Canada H9H 4J4.
`
`4.
`
`Upon information and belief, Jubilant DraxImage Inc. received FDA approval for
`
`the Ruby-Fill® rubidium-82 generator and elution system on September 30, 2016.
`
`5.
`
`Upon information and belief, Jubilant Pharma Limited is a corporation organized
`
`and existing under the laws of Singapore, with its principal place of business at 6 Temasek
`
`Boulevard, #20-06 Suntec City Tower Four, Singapore 038986.
`
`6.
`
`Upon information and belief, Jubilant Life Sciences is a corporation organized
`
`and existing under the laws of India, with its principal place of business at 1A, Sector 16A,
`
`Noida – 201301, Uttar Pradesh, India.
`
`7.
`
`Upon information and belief, Jubilant DraxImage Inc. is a subsidiary of Jubilant
`
`Pharma Limited.
`
`8.
`
`Upon information and belief, Jubilant Pharma Limited is a subsidiary of Jubilant
`
`Life Sciences.
`
`9.
`
`Upon information and belief, Jubilant DraxImage Inc. is the manufacturer of the
`
`infringing strontium-rubidium radioisotope infusion system, which it sells under the tradename
`
`Ruby-Fill®. Jubilant DraxImage Inc. also filed a 505(b)(2) New Drug Application (NDA or
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`505(b)(2) NDA) No. 202153 to market and sell the infringing strontium-rubidium radioisotope
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`infusion system (Ruby-Fill®) in the United States.
`
`10.
`
`Upon information and belief, at least Jubilant Pharma Limited and Jubilant
`
`DraxImage Inc. actively participated in the development and regulatory approval process for the
`
`infringing strontium-rubidium radioisotope infusion system (Ruby-Fill®).
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`2
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`

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`11.
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`Upon information and belief, Jubilant Pharma Limited, Jubilant Life Sciences,
`
`and Jubilant DraxImage Inc. direct the manufacture and development of the Ruby-Fill® system
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`that is the subject of NDA No. 202153, and directly or indirectly, derive substantial revenue from
`
`the sale of the Ruby-Fill® system and its components thereof.
`
`12.
`
`Upon information and belief, Jubilant Pharma Limited, Jubilant Life Sciences,
`
`and Jubilant DraxImage Inc. are agents of each other and/or work in concert with each other with
`
`respect to the development, regulatory approval, marketing, sale, and distribution of the
`
`infringing strontium-rubidium radioisotope infusion system (Ruby-Fill®) throughout the United
`
`States.
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`JURISDICTION AND VENUE
`
`13.
`
`This action arises under the Patent Act, Title 35 of the United States Code, and is
`
`an action for patent infringement under § 271.
`
`14.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`15.
`
`Upon information and belief, Jubilant DraxImage Inc. is engaged in the
`
`manufacturing, marketing, and sale of pharmaceutical products for the U.S. prescription drug
`
`market with products for sale in the United States, including in the state of New Jersey.
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`According to Jubilant DraxImage Inc.’s website, it currently manufactures, markets, and/or sells
`
`pharmaceutical products in the United States, including, for example, DraxImage MAA,
`
`DraxImage DTPA, DraxImage I-131, Hicon, DraxImage MDP-25, DraxImage Sestamibi, Smart-
`
`Fill, and Ruby-Fill®.
`
`16.
`
`This Court has personal jurisdiction over Jubilant DraxImage Inc. by virtue of the
`
`fact that, inter alia, Jubilant DraxImage Inc. has committed, aided, abetted, contributed to, and/or
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`3
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`

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`participated in the commission of a tortious act of patent infringement under 35 U.S.C. § 271 that
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`has led and/or will lead to foreseeable harm and injury to Plaintiff, including in the State of New
`
`Jersey.
`
`17.
`
`Upon information and belief, Jubilant DraxImage Inc. is in the business of, inter
`
`alia, manufacturing and selling a strontium-rubidium radioisotope infusion system, which it sells
`
`under the tradename Ruby-Fill®, that are distributed throughout the United States, including in
`
`the State of New Jersey, through its own actions, and through the actions of its agents and
`
`affiliates, including.
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`18.
`
`Upon
`
`information and belief, Jubilant DraxImage Inc. participated and
`
`collaborated in the preparation, filing and seeking FDA approval of NDA No. 202153 for the
`
`Ruby-Fill® system, and participate and collaborate in the commercial manufacture, marketing
`
`offer for sale, and sale of the Ruby-Fill® system throughout the United States, including the
`
`State of New Jersey.
`
`19.
`
`This Court also has personal jurisdiction over Jubilant DraxImage Inc. by virtue
`
`of the fact that, upon information and belief, inter alia, Jubilant DraxImage Inc. has availed itself
`
`of the rights and benefits of New Jersey law, and has engaged in systematic and continuous
`
`contacts with the State of New Jersey.
`
`20.
`
`Therefore, this Court has personal jurisdiction over Jubilant DraxImage Inc. and
`
`because, inter alia: (a) Jubilant DraxImage Inc. is in the business of manufacturing drug
`
`products which it distributes, sells, and offers to sell, throughout the United States, including in
`
`New Jersey, and through the filing of 505(b)(2) NDA No. 202153, Jubilant DraxImage Inc. has
`
`sought approval to sell a product that infringes the patents-in-suit throughout the United States,
`
`including in New Jersey; (b) with knowledge of Bracco’s CardioGen-82 system, Jubilant
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`4
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`

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`DraxImage Inc. deliberately challenged intellectual property developed and held by Bracco, a
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`Delaware company, in New Jersey; (c) upon information and belief, Jubilant DraxImage Inc.
`
`utilizes Jubilant Life Sciences (USA), Inc., a New Jersey based company, to assist in the sale and
`
`distribution of pharmaceutical products; (d) Jubilant DraxImage Inc. has offered to sell and sells,
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`directly or indirectly, the Ruby-Fill® system throughout the United States and within New
`
`Jersey; (e) Jubilant DraxImage Inc.’s sales and offer for sales of the Ruby-Fill® system in the
`
`United States, has caused substantial injury to Bracco, a company headquartered within the
`
`District of New Jersey, and Jubilant DraxImage Inc. knows that Bracco has been injured by these
`
`action in New Jersey; (f) Jubilant DraxImage Inc. derives substantial revenue from products it
`
`ships to New Jersey as well as from products sold, used, or consumed within New Jersey; (g)
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`Jubilant DraxImage Inc. regularly does and solicits business in New Jersey, and is engaged in a
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`persistent, continuous, and systematic course of conduct in New Jersey.
`
`21.
`
`Upon information and belief, Jubilant Pharma Limited, Jubilant Life Sciences,
`
`and Jubilant DraxImage Inc. are agents of each other and/or work in concert with each other with
`
`respect to the development, regulatory approval, marketing, sale, and distribution of Ruby-Fill®
`
`systems throughout the United States, including into the State of New Jersey.
`
`22.
`
`This Court has personal jurisdiction over Jubilant Pharma Limited and Jubilant
`
`Life Sciences because, inter alia, upon information and belief, Jubilant Pharma Limited and
`
`Jubilant Life Sciences, itself or in concert with and/or through its various subsidiaries, regularly
`
`does or solicits business in New Jersey, engages in other persistent courses of conduct in New
`
`Jersey, and/or derives substantial revenue from services or things used or consumed in New
`
`Jersey, demonstrating that Jubilant Pharma Limited and Jubilant Life Sciences has continuous
`
`and systematic contacts with the State of New Jersey.
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`5
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`23.
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`Upon information and belief, Jubilant DraxImage Inc.’s acts of preparing and
`
`filing NDA No. 202153 were performed at the direction of, with the authorization of, and with
`
`the cooperation, participation, assistance and, at least in part, the benefit of Jubilant Pharma
`
`Limited and Jubilant Life Sciences. These are acts with real and injurious consequences giving
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`rise to this infringement action, including the present commercial manufacture, use, and/or sale
`
`of the Ruby-Fill® system before the expiration of the patents-in-suit throughout the United
`
`States, including in this judicial district. Moreover, because Bracco has its principal place of
`
`business in New Jersey, these injuries and consequences are suffered in New Jersey. Therefore,
`
`Jubilant Pharma Limited, Jubilant Life Sciences, and Jubilant DraxImage Inc. together
`
`purposefully directed their activities towards the State of New Jersey. Because defending against
`
`an infringement lawsuit such as this one is an inherent and expected part of a generic
`
`pharmaceutical companies business, Jubilant Pharma Limited, Jubilant Life Sciences, and
`
`Jubilant DraxImage Inc. reasonably anticipated being sued in New Jersey.
`
`24.
`
`Therefore, this Court has personal jurisdiction over Jubilant Pharma Limited and
`
`Jubilant Life Sciences because, inter alia: (a) Jubilant Pharma Limited and Jubilant Life
`
`Sciences has purposefully directed its activities and the activities of Jubilant DraxImage Inc., its
`
`wholly owned subsidiary, at residents and corporate entities within the State of New Jersey; (b)
`
`the claims set forth herein as to Jubilant Pharma Limited and Jubilant Life Sciences arise out of
`
`or relate to those activities; (c) Jubilant Pharma Limited and Jubilant Life Sciences’ contacts with
`
`the State of New Jersey (direct and/or indirect) are continuous and systematic; and (d) it is
`
`reasonable and fair for this Court to exercise personal jurisdiction over Jubilant Pharma Limited
`
`and Jubilant Life Sciences.
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`6
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`25.
`
`Additionally, this Court has personal jurisdiction over Jubilant DraxImage Inc.
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`under Federal Rule of Civil Procedure 4(k)(2), because Jubilant DraxImage Inc. is organized
`
`under the laws of Canada.
`
`26.
`
`Additionally, this Court has personal jurisdiction over Jubilant Life Sciences inter
`
`alia, under Federal Rule of Civil Procedure 4(k)(2), because Jubilant Life Sciences is organized
`
`under the laws of India.
`
`27.
`
`Additionally, this Court has personal jurisdiction over Jubilant Pharma Limited
`
`inter alia, under Federal Rule of Civil Procedure 4(k)(2), because Jubilant Pharma is organized
`
`under the laws of Singapore.
`
`28.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`BACKGROUND FACTS
`
`Bracco’s NDA
`
`29.
`
`Bracco is the holder of New Drug Application No. 19414 for CardioGen-82
`
`(rubidium 82 generator).
`
`30.
`
`CardioGen-82 is a closed system used to produce rubidium Rb 82 chloride
`
`injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated by the
`
`U.S. Food and Drug Administration (“FDA”) for Positron Emission Tomography (“PET”)
`
`imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional
`
`myocardial perfusion in adult patients with suspected or existing coronary artery disease. The
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`resulting images allow a physician to evaluate the blood flow (perfusion) through the coronary
`
`arteries to the heart muscle, and thus diagnose whether any heart disease exists.
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`7
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`

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`31.
`
`In 1989, the CardioGen-82 system became the first FDA approved generator-
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`based Positron Emission Tomography (“PET”) perfusion agent reimbursed for the evaluation of
`
`coronary artery disease.
`
`32.
`
`The CardioGen-82 system infuses a radioactive nuclear medicine agent,
`
`rubidium-82 which is produced from its precursor strontium-82, for the purpose of imaging the
`
`heart to determine if the heart’s blood supply is normal or not. By way of example, the existing
`
`CardioGen-82 system can be seen below (the actual generator is housed underneath in lead
`
`shielding):
`
`33.
`
`Contained inside this cart is the rubidium generator:
`
`
`
`8
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`

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`The Patents-in-Suit
`
`
`
`34.
`
`The ’826 patent is entitled “Integrated strontium-rubidium radioisotope infusion
`
`systems,” was duly and legally issued by the United States Patent and Trademark Office on
`
`November 14, 2017. A true and correct copy of the ’826 patent is attached to the Complaint as
`
`Exhibit No. A.
`
`35.
`
`36.
`
`Bracco owns by assignment the entire right, title, and interest in the ’826 patent.
`
`The ’869 patent is entitled “Integrated strontium-rubidium radioisotope infusion
`
`systems,” was duly and legally issued by the United States Patent and Trademark Office on
`
`September 5, 2017. A true and correct copy of the ’869 patent is attached to the Complaint as
`
`Exhibit No. B.
`
`37.
`
`Bracco owns by assignment the entire right, title, and interest in the ’869 patent.
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`9
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`

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`38.
`
`The ’870 patent is entitled “Integrated strontium-rubidium radioisotope infusion
`
`systems,” was duly and legally issued by the United States Patent and Trademark Office on
`
`September 5, 2017. A true and correct copy of the ’870 patent is attached to the Complaint as
`
`Exhibit No. C.
`
`39.
`
`40.
`
`Bracco owns by assignment the entire right, title, and interest in the ’870 patent.
`
`The ’467 patent is entitled “Radioisotope generator system including activity
`
`measurement and dose calibration,” was duly and legally issued by the United States Patent and
`
`Trademark Office on March 29, 2016. A true and correct copy of the ’467 patent is attached to
`
`the Complaint as Exhibit No. D.
`
`41.
`
`42.
`
`Bracco owns by assignment the entire right, title, and interest in the ’467 patent.
`
`The ’468 patent is entitled “Infusion system with radioisotope detector,” was duly
`
`and legally issued by the United States Patent and Trademark Office on March 29, 2016. A true
`
`and correct copy of the ’468 patent is attached to the Complaint as Exhibit No. E.
`
`43.
`
`Bracco owns by assignment the entire right, title, and interest in the ’468 patent.
`
`Defendants’ Infringing Activities
`
`44.
`
`Defendants submitted an abbreviated new drug application (“ANDA”) to the U.S.
`
`Food and Drug Administration on June 18, 2010 to market a system Defendants described as the
`
`equivalent of CardioGen-82.
`
`45.
`
`Due to variations in administration rates, the FDA reclassified the ANDA filing as
`
`a 505(b)(2) NDA. However, Defendants still relied on clinical studies that Bracco performed in
`
`submitting its proposed equivalent version of Bracco’s product.
`
`46.
`
`Defendants represented
`
`to
`
`the FDA
`
`that
`
`the Ruby-Fill® system
`
`is a
`
`“pharmaceutical equivalent” to Bracco’s CardioGen-82.
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`10
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`

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`47.
`
`Pharmaceutical equivalents are drug products in identical dosage forms intended
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`for the same route of administration that: (1) contain identical amounts of the identical active
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`drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, or, in the case of
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`modified release dosage forms that require a reservoir or overage or such forms as prefilled
`
`syringes where residual volume may vary, that deliver identical amounts of the active drug
`
`ingredient over the identical dosing period; (2) do not necessarily contain the same inactive
`
`ingredients; and (3) meet the identical compendial or other applicable standard of identity,
`
`strength, quality, and purity, including potency and, where applicable, content uniformity,
`
`disintegration times, and/or dissolution rates. See 21 C.F.R. § 320.1(c).
`
`48.
`
`Defendants received FDA approval for the Ruby-Fill® rubidium-82 generator and
`
`elution system on September 30, 2016 and began selling such units in the United States
`
`immediately thereafter.
`
`49.
`
`Jubilant DraxImage Inc. manufactures and/or imports infringing strontium-
`
`rubidium radioisotope infusion systems and/or components thereof, including but not limited to
`
`rubidium-82 generators, under the tradename Ruby-Fill®, which are sold in the United States.
`
`50.
`
`The Ruby-Fill® system is pictured below:
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`11
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`

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`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 12 of 96 PageID: 12
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`See http://www.draximage.com/products/us/ruby-fill/.
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`
`
`51.
`
`Upon information and belief, the Ruby-Fill® has been installed in, at least, three
`
`locations in the United States.
`
`52.
`
`The Ruby-Fill® system utilizes a rubidium (Rb 82) generator. The Ruby-Fill®
`
`system pumps saline through the generator to elute rudibium-82 for injection into the patient.
`
`The rubidium (Rb 82) generator is a critical component to the overall Ruby-Fill® system,
`
`because it is the source of the rubidium-82. There is no use for Defendants rubidium (Rb 82)
`
`generator other than with the Ruby-Fill® system.
`
`53.
`
`The Defendants unlawfully sell for importation, import, and/or sell after
`
`importation into the United States strontium-rubidium radioisotope infusion systems and
`
`components thereof that infringe the patents-in-suit.
`
`54.
`
`Defendants manufacture the rubidium-82 generator, which is an essential
`
`component of the Ruby-Fill® system as it is the source of the rubidium-82 that is used in the
`
`rubidium-82 chloride for injection into patients. The FDA approved labeling for Ruby-Fill®
`
`states that this generator may be used “only with an appropriate, properly calibrated Elution
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`12
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`System (RUBY Rubidium Elution System) labeled for use with the generator.” Defendants
`
`understand and intend that the rubidium-82 generator has no other approved use except as part of
`
`the infringing Ruby-Fill® system. Thus, Defendants encourage, recommend, and promote the
`
`use of its rubidium-82 generators as part of the infringing Ruby-Fill® system.
`
`55.
`
`Through its infringing activities, Defendants have caused direct injury to Bracco
`
`throughout the United States and in New Jersey.
`
`COUNT ONE – INFRINGEMENT OF THE ’826 PATENT
`
`56.
`
`Bracco repeats and re-alleges each of the foregoing Paragraphs as if fully set forth
`
`herein.
`
`57.
`
`Defendants make, use, offer to sell, sells, and/or imports an infusion system to
`
`deliver a rubidium radioactive eluate (i.e., Ruby-Fill®) that infringes or induces or contributes to
`
`the infringement of one or more claims of the ’826 patent.
`
`58.
`
`The elements of claim 1 of the ’826 patent are as follows:
`
`1. A method of building an infusion system to deliver a rubidium
`radioactive eluate comprising:
`
`(a) installing a first shielding compartment, a second shielding
`compartment, and a shielded well on a platform of a cart, wherein:
`
`(i) the first shielding compartment has a first opening facing
`vertically upwardly,
`
`(ii) the first opening is configured for a strontium-rubidium
`radioisotope generator to be inserted into and removed from the
`first shielding compartment,
`
`(iii) the second shielding compartment has a second opening facing
`vertically upwardly,
`
`(iv) the second opening is configured for a waste bottle to be
`inserted into and removed from the second shielding compartment,
`
`(v) the first opening is located at a lower elevation than the second
`opening, and
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`13
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`

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`(vi) the shielded well is configured to receive an eluate reservoir
`that is configured to receive a sample of the rubidium radioactive
`eluate;
`
`(b) configuring a computer with a touch screen display for the
`infusion system to:
`
`(i) fill the eluate reservoir in the shielded well on-board the cart
`with the sample of the rubidium radioactive eluate by pumping
`saline from a saline reservoir
`into
`the strontium-rubidium
`radioisotope generator via a saline tubing line thereby generating
`the rubidium radioactive eluate that is discharged through an eluate
`tubing line,
`
`(ii) determine a strontium breakthrough test result on the sample of
`the rubidium radioactive eluate filled into the eluate reservoir in
`the shielded well on-board the cart while the eluate reservoir
`remains in the shielded well on-board the cart, and
`
`(iii) not allow a patient infusion if the strontium breakthrough test
`result is greater than or equal to an allowed limit.
`
`59.
`
`As shown below, Defendants do and will install a first shielding compartment, a
`
`second shielding compartment, and a shielded well on a platform of a cart when manufacturing
`
`the Ruby-Fill® system.
`
`
`
`14
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`

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`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 15 of 96 PageID: 15
`
`
`See Exhibit No. F at 1;
`
`
`Id. at 10;
`
`
`A platform of a cart
`
`
`
`a first
`shielding
`compartment
`
`
`
`15
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 16 of 96 PageID: 16
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`a shielded well
`
`a second
`shielding
`compartment
`
`
`
`
`Id. at 9.
`
`60.
`
`As shown below, the first shielding compartment of the Ruby-Fill® system has a
`
`first opening facing vertically upwardly.
`
`the first shielding compartment has a
`first opening facing vertically
`upwardly
`
`
`
`Id. at 10.
`
`
`
`61.
`
`As shown below, the first opening of the Ruby-Fill® system is configured for a
`
`strontium-rubidium radioisotope generator to be inserted into and removed from the first
`
`shielding compartment.
`
`16
`
`

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`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 17 of 96 PageID: 17
`
`
`
`
`
`a strontium-rubidium
`radioisotope generator
`
`
`
`
`
`
`
`
`Id. at 34.
`
`the first opening is configured for
`a strontium-rubidium radioisotope
`generator to be inserted into and
`removed from the first shielding
`compartment
`
`
`62.
`
`As shown below, the second shielding compartment of the Ruby-Fill® system has
`
`a second opening facing vertically upwardly.
`
`17
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 18 of 96 PageID: 18
`
`the second shielding compartment has
`a second opening facing vertically
`upwardly
`
`
`
`Id. at 12.
`
`
`
`63.
`
`As shown below, the second opening of the Ruby-Fill® system is configured for a
`
`waste bottle to be inserted into and removed from the second shielding compartment.
`
`
`
`
`
`
`
`the second opening is configured
`for a waste bottle to be inserted
`into and removed from the
`second shielding compartment
`
`A waste bottle
`
`
`Id. at 12.
`
`
`
`64.
`
`As shown below, the first opening of the Ruby-Fill® system is located at a lower
`
`elevation than the second opening.
`
`18
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 19 of 96 PageID: 19
`
`The second opening
`
`The first opening
`
`
`
`
`Id. at 9.
`
`65.
`
`As shown below, the shielded well of the Ruby-Fill® system is configured to
`
`receive an eluate reservoir that is configured to receive a sample of the rubidium radioactive
`
`eluate.
`
`
`
`
`
`
`
`
`the shielded well is configured to receive an
`eluate reservoir that is configured to receive a
`sample of the rubidium radioactive eluate
`
`
`19
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 20 of 96 PageID: 20
`
`Id. at 9;
`
`
`
`See, e.g., id. at 42.
`
`
`
`66.
`
`As shown below, the Ruby-Fill® system has a computer with a touch screen
`
`display for the infusion system.
`
`a computer with a touch screen display
`
`
`Id. at 1.
`
`
`
`20
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 21 of 96 PageID: 21
`
`67.
`
`As shown below, the Ruby-Fill® system can be configured to fill the eluate
`
`reservoir in the shielded well on-board the cart with the sample of the rubidium radioactive
`
`eluate by pumping saline from a saline reservoir into the strontium-rubidium radioisotope
`
`generator via a saline tubing line thereby generating the rubidium radioactive eluate that is
`
`discharged through an eluate tubing line.
`
`to eluate reservoir in the shielded
`well on-board the cart
`
`from a saline reservoir
`
`an eluate tubing line
`
`strontium-rubidium radioisotope
`generator
`
`a pump for pumping saline from a
`saline reservoir into the strontium-
`rubidium radioisotope generator via
`a saline tubing line
`
`
`
`
`
`21
`
`
`Id. at 9;
`
`
`
`Id. at 28;
`
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 22 of 96 PageID: 22
`
`
`Id. at 42.
`
`
`
`68.
`
`As shown below, the Ruby-Fill® system can be configured to determine a
`
`strontium breakthrough test result on the sample of the rubidium radioactive eluate filled into the
`
`eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the
`
`shielded well on-board the cart.
`
`
`Id. at 42;
`
`
`
`
`22
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 23 of 96 PageID: 23
`
`Id. at 43.
`
`
`
`69.
`
`As shown below, the Ruby-Fill® system can be configured to not allow a patient
`
`infusion if the strontium breakthrough test result is greater than or equal to an allowed limit.
`
`
`Id. at 59;
`
`
`
`
`
`
`Id. at 44.
`
`
`
`23
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 24 of 96 PageID: 24
`
`70.
`
`Defendants infringe, contribute to the infringement of, and/or induce infringement
`
`of the ’826 patent under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b) and/or 35 U.S.C. § 271(c) by
`
`making, using, selling, offering for sale, and/or importing into the United States products
`
`covered by one or more claims of the ’826 patent including, but not limited to, at least the Ruby-
`
`Fill® system.
`
`71.
`
`Defendants directly infringe one or more claims of the ’826 patent. Defendants
`
`make, use, sell, offer for sale, and/or import, in this District and elsewhere in the United States
`
`infringing products, such as the Ruby-Fill® system and thus directly infringes the ’826 patent.
`
`72.
`
`Defendant have had knowledge and notice of the ’826 patent at least as early as
`
`the filing of this Complaint.
`
`73.
`
`Defendants’ infringement of the ’826 patent has damaged and will continue to
`
`damage Bracco.
`
`74.
`
`Defendants indirectly infringe the ’826 patent, as provided in 35 U.S.C. § 271(b),
`
`by inducing infringement by others, such as Defendants’ customers, in this District and
`
`elsewhere in the United States. For example, Defendants’ customers directly infringe through
`
`their use of the inventions claimed in the ’826 patent. Defendants induce this direct infringement
`
`through their affirmative acts of manufacturing, selling, distributing, instructing and/or otherwise
`
`making available the infringing products, such as the Ruby-Fill® system, and providing
`
`instructions, documentation, and other information to customers suggesting they use the
`
`infringing products, such as the Ruby-Fill® system in an infringing manner, including online
`
`technical support, marketing, product manuals, advertisements, and online documentation. As a
`
`result of Defendants’ inducement, Defendants’ customers use the infringing products, such as the
`
`Ruby-Fill® system in the way Defendants intend and directly infringe the ’826 patent.
`
`24
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 25 of 96 PageID: 25
`
`Defendants have performed and continue to perform these affirmative acts with knowledge of
`
`the ’826 patent and with the intent, or willful blindness, that the induced acts directly infringe the
`
`’826 patent.
`
`75.
`
`Defendants also indirectly infringes the ’826 patent, as provided by 35 U.S.C.
`
`§ 271(c), by contributing to direct infringement committed by others, such as customers, in this
`
`District and elsewhere in the United States. Defendants’ affirmative acts of selling and offering
`
`to sell, in this District and elsewhere in the United States, infringing products, such as the Ruby-
`
`Fill® system and causing these products to be manufactured, used, sold, and offered for sale
`
`contribute to Defendants’ customers’ use of the infringing products, such as the Ruby-Fill®
`
`system, such that the ’826 patent is directly infringed. Defendants have performed and continue
`
`perform these affirmative acts with knowledge of the ’826 patent and with intent, or willful
`
`blindness, that they cause the direct infringement of the ’826 patent.
`
`76.
`
`Defendants’ infringement of the ’826 patent will cause Bracco to suffer
`
`irreparable harm. Defendants’ infringement will continue unless enjoined by the Court. Bracco
`
`has no adequate remedy at law and, thus, a permanent injunction is appropriate to prohibit
`
`Defendants from infringing the ’826 patent.
`
`COUNT TWO – INFRINGEMENT OF THE ’869 PATENT
`
`77.
`
`Bracco repeats and re-alleges each of the foregoing Paragraphs as if fully set forth
`
`herein.
`
`78.
`
`Defendants make, use, offer to sell, sells, and/or imports an infusion system to
`
`deliver a rubidium radioactive eluate (i.e., Ruby-Fill®) that infringes or induces or contributes to
`
`the infringement of one or more claims of the ’869 patent.
`
`79.
`
`The elements of claim 1 of the ’869 patent are as follows:
`
`25
`
`

`

`Case 3:18-cv-04422-MAS-TJB Document 1 Filed 03/27/18 Page 26 of 96 PageID: 26
`
`1. An infusion system on-board a cart comprising:
`
`(a) a cabinet structure that comprises:
`
`(i) a platform,
`
`(ii) an exterior shell that extends upwardly above the platform and
`has a front side; a rear side; two sidewalls connecting the front side
`to the rear side; and a top surface; wherein the platform and the
`exterior shell collectively define an interior space of the cabinet
`structure and wherein the interior space of the cabinet structure is
`configured to receive a strontium-rubidium radioisotope generator
`having an inlet tubing port configured to receive saline and an
`outlet tubing port configured to discharge a rubidium radioactive
`eluate,
`
`(iii) an opening through the exterior shell configured to provide
`access to the strontium-rubidium radioisotope generator within the
`interior space of the cabinet structure, and
`
`(iv) an opening through the top surface of the exterior shell
`configured to provide access for inserting a waste bottle into or
`removing the waste bottle from the interior space of the cabinet
`structure;
`
`(b) a computer with a touch screen display configured to receive an
`input from a user for controlling operation of the infusion system,
`wherein the touch screen display is mounted on a vertical post
`having a top end extending above the cabinet structure;
`
`(c) a first shielding compartment in the interior space of the cabinet
`structure having a first opening facing vertically upwardly through
`which the strontium-rubidium radioisotope generator can be
`inserted into and removed from the first shielding compartment;
`
`(d) a first door accessible via the opening through the exterior
`shell, the first door being configured to provide access to the first
`shielding compartment and to close over the first opening;
`
`(e) a second shielding compa