IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TENNESSEE
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`DENTSPLY INTERNATIONAL INC.
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`Plaintiff,
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`v.
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`US ENDODONTICS, LLC
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`Defendant.
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`Civil Action No. 2:14-CV-00196
`Judge Greer
`Magistrate Judge Inman
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`PLAINTIFF'S MOTION FOR A PRELIMINARY INJUNCTION
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`Pursuant to Rule 65 of the Federal Rules of Civil Procedure, Plaintiff Dentsply
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`International Inc. ("Dentsply"), hereby moves this Court to enter an Order preliminarily
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`enjoining Defendant US Endodontics, LLC ("Defendant" or "US Endo") from manufacturing all
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`post-heat-treated, nickel-titanium endodontic files ("post-heat-treated files") using a method that
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`is believed to infringe United States Patent Nos. 8,727,773 ("the '773 patent") and 8,562,341
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`("the '341 patent") (collectively the "Asserted Patents" or the "Patents-in-suit").
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`In support of its motion, Dentsply alleges as follows:
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`1.
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`On May 20, 2014, the United States Patent and Trademark Office duly and legally
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`issued United States Patent No. 8,727,773 entitled "Dental and Medical Instruments Comprising
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`Titanium" to Gold Standard Products, Inc. as assignee of the inventor Dr. Neill H. Luebke.
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`2.
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`On October 22, 2013, the United States Patent and Trademark Office duly and
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`legally issued United States Patent No. 8,562,341 entitled "Dental and Medical Instruments
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`Comprising Titanium" to Gold Standard Products, Inc. as assignee of the inventor Dr. Neill H.
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`Luebke.
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`GOLD STANDARD EXHffiiT 2019
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
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`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 1 of 6 PageiD #: 142
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`3.
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`The ‘773 and ‘341 patent are generally directed to a method of manufacturing or
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`modifying a superelastic nickel-titanium dental instrument or device where the dental instrument
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`or device having an elongated shank of super-elastic nickel titanium alloy is provided and the
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`entire instrument is then heat-treated at a temperature of 400ºC or above but not to the melting
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`temperature, resulting in a device with shape memory characteristics including an angle of
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`greater than 10 degrees of permanent deformation after torque at 45 degrees of flexion.
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`4.
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`Dentsply is the exclusive licensee of the ‘773 and ‘341 patents and has the right to
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`bring suit for infringement and to recover for any current and past damages.
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`5.
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`Dentsply has for years sold several nickel-titanium endodontic dental files (for
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`use in rotating drills) including the ProFile®, ProTaper®, GT-Series® and WaveOne®. In
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`February 2012, Dentsply introduced its innovative post-heat-treated, nickel-titanium endodontic
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`file, the Vortex Blue®. Dentsply also sells other post-heat-treated, nickel-titanium endodontic
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`files, such as the ProTaper Gold®. Because it is post-heat-treated, the Vortex Blue® file, when
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`bent by an endodontist, retains a bent shape. This allows the endodontist to pre-shape the file to
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`follow the natural curved passage of the tooth when performing a root canal, thus yielding better
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`canal shaping and a safer experience for the patient.
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`6.
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`Subsequent to the introduction of Dentsply’s Vortex Blue® product, US Endo
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`began manufacturing and selling heat-treated nickel-titanium endodontic files. US Endo sold
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`these files to Edge Endo, LLC (“Edge Endo”), a direct competitor of Dentsply, which sells the
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`files under the name EdgeFile™. Not only was Dentsply’s innovative Vortex Blue® product on
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`the market when US Endo began manufacturing its products, but US Endo was aware at that
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`time of the pendency of certain patent applications that had been filed by Dr. Neill Luebke. Dr.
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`2
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`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 2 of 6 PageID #: 143
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`Luebke is the inventor of the two Patents-in-Suit. The Patents-in-Suit claim priority to earlier
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`Luebke applications of which US Endo was aware by May 2012.
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`7.
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`Dentsply’s endodontic dental files directly compete with products manufactured
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`by Defendant, US Endo, which are then provided to US Endo customers, including at least, Edge
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`Endo, LLC (“Edge Endo”). In fact, according to information submitted by US Endo to the
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`United States Food and Drug Administration (“FDA”), US Endo is the “contract manufacturer”
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`of the EdgeFile™ line of products that are sold and marketed by Edge Endo. Edge Endo sells,
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`markets and distributes the EdgeFiles directly to its customers, in particular, dentists and
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`endodontists.
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`8.
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`In product literature and in promotional videos on its website, Edge Endo markets
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`the EdgeFiles manufactured by Defendant as “effortlessly compatible” with Dentsply’s rotary
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`files. Indeed, Edge Endo provides a “compatibility” chart instructing dentists and endodontists
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`who use Dentsply’s WaveOne® to use EdgeFile X1; those who use Dentsply’s GT® and GT®X
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`to use EdgeFileX5; and those who use Dentsply’s Vortex® or Profile® to use EdgeFile X7.
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`9.
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`Dentsply believes that US Endo is using a process that is protected by the ‘773
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`and ‘341 patents to manufacture at least the EdgeFile X1, EdgeFile X5 and EdgeFile X7
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`products. As explained in detail in the accompanying Memorandum in Support of Dentsply’s
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`Motion for Preliminary Injunction, the results of testing conducted by independent, third-party
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`laboratories on the EdgeFile X1, X5 and X7 manufactured by US Endo, including thermal
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`analysis by differential scanning calorimetry and mechanical testing (a stiffness test in
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`accordance with ISO 3630-1), are consistent with products that are manufactured by a process
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`that infringes the ‘773 and ‘341 patents asserted in the Complaint.
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`3
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`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 3 of 6 PageID #: 144
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`10.
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`Additionally, the founder of US Endo, Bobby Bennett, is the named inventor on a
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`patent application filed in February 2012, which claims and describes a process for
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`manufacturing post-heat-treated endodontic files that falls within the scope of the claims of the
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`Patents-in-Suit. This patent application was filed at least 6 years after the Luebke patent
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`applications to which the Patents-in-Suit claim priority, and stands rejected by the Patent Office.
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`Provided that US Endo is practicing the method claimed in Mr. Bennett’s own patent application,
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`then that method infringes claims of the ‘773 and ‘341 patents.
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`11.
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` To further confirm infringement and prepare for the hearing on Plaintiff’s Motion
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`for a Preliminary Injunction, Plaintiff is seeking expedited discovery narrowly limited to the
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`specific process used by US Endo to manufacture the EdgeFile products, including in particular,
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`the point in in the manufacturing process when heat-treatment occurs (i.e. whether the files are
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`post-heat treated as believed) and the specific temperature at which the files are heat-treated.
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`12.
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`Dentsply has suffered irreparable harm, including market price erosion and loss of
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`market share, as well as damage to its reputation and goodwill with customers as a result of
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`Defendant’s actions.
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`13.
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`Defendant US Endo has caused and will continue to cause irreparable harm to
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`Dentsply, its business and its reputation through their making, using, offering for sale, sale,
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`importation, marketing and/or distribution of at least the EdgeFile X1, X5 X7. Additionally,
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`Defendant is unlikely to be able to pay an award of damages if an injunction is not issued during
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`the time that it takes for the parties to try the case. Plaintiff is seeking limited expedited
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`discovery specifically directed to facts concerning Defendant’s inability to pay a damages award.
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`4
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`14.
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`As demonstrated more fully in the accompanying Memorandum of Law in
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`Support of Plaintiff’s Motion for a Preliminary Injunction, Dentsply is likely to succeed on the
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`merits of its claims of infringement and on a showing of patent validity.
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`15.
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`The balance of equities favors Dentsply. The continued harm to Dentsply in the
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`absence of a preliminary injunction greatly outweighs any alleged harm that Defendant might
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`suffer as a result of a preliminary injunction, and the issuance of an injunction is in the interest of
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`the public.
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`In further support of its motion, Dentsply relies upon and incorporates by reference the
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`accompanying Memorandum of Law in Support of Plaintiff’s Motion for a Preliminary
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`Injunction and the declarations of Dr. Robert Sinclair, Dr. Richard Gering, Dr. Neil Luebke,
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`DDS, John Voskuil, and C. Nichole Gifford, Esq. and the supporting exhibits submitted
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`concurrently herewith. Given the urgency of this matter, Dentsply respectfully requests authority
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`to conducted expedited discovery and that the Court hold an expedited hearing on Plaintiff’s
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`Motion for a Preliminary Injunction.
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`Dated: July 9, 2014
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`Respectfully submitted,
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`By: s/Jimmie C. Miller
`Jimmie Carpenter Miller (BPR#009756)
`Hunter Smith & Davis LLP
`1212 North Eastman Road
`Kingsport, TN 37664
`Phone: 423-378-8852
`Fax: 423-378-8801
`E-mail: jmiller@hsdlaw.com
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`Steven Lieberman
`C. Nichole Gifford
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th St., N.W., Suite 800
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`5
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`Washington, DC 20005
`Phone: (202) 783-6040
`Facsimile: (202) 783-6031
`E-Mail: sliberman@rfem.com
`ngifford@rfem.com
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`Counsel for Plaintiff
`Dentsply International, Inc.
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`CERTIFICATE OF SERVICE
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`I hereby certify that on the 9th day of July, 2014, a copy of the foregoing PLAINTIFF’S
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`MOTION FOR A PRELIMINARY INJUNCTION was filed electronically using the Court’s
`ECF system. Notice of this filing will be sent by operation of the Court’s electronic filing
`system to all parties indicated on the electronic filing receipt. All other parties will be served by
`regular U. S. Mail. Parties may access this filing through the Court’s electronic filing system.
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`HUNTER, SMITH & DAVIS, LLP
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` s/Jimmie C. Miller
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`6
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`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 6 of 6 PageID #: 147
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