`FOR THE EASTERN DISTRICT OF TENNESSEE
`
`DENTSPLY INTERNATIONAL INC.
`
`Plaintiff,
`
`v.
`
`US ENDODONTICS, LLC
`
`Defendant.
`
`Civil Action No. 2:14-CV-00196
`Judge Greer
`Magistrate Judge Inman
`
`PLAINTIFF'S MOTION FOR A PRELIMINARY INJUNCTION
`
`Pursuant to Rule 65 of the Federal Rules of Civil Procedure, Plaintiff Dentsply
`
`International Inc. ("Dentsply"), hereby moves this Court to enter an Order preliminarily
`
`enjoining Defendant US Endodontics, LLC ("Defendant" or "US Endo") from manufacturing all
`
`post-heat-treated, nickel-titanium endodontic files ("post-heat-treated files") using a method that
`
`is believed to infringe United States Patent Nos. 8,727,773 (''the '773 patent") and 8,562,341
`
`("the '341 patent") (collectively the "Asserted Patents" or the "Patents-in-suit").
`
`In support of its motion, Dentsply alleges as follows:
`
`1.
`
`On May 20, 2014, the United States Patent and Trademark Office duly and legally
`
`issued United States Patent No. 8,727,773 entitled "Dental and Medical Instruments Comprising
`
`Titanium" to Gold Standard Products, Inc. as assignee of the inventor Dr. Neill H. Luebke.
`
`2.
`
`On October 22, 2013, the United States Patent and Trademark Office duly and
`
`legally issued United States Patent No. 8,562,341 entitled "Dental and Medical Instruments
`
`Comprising Titanium" to Gold Standard Products, Inc. as assignee of the inventor Dr. Neill H.
`
`Luebke.
`
`GOLD STANDARD EXHIBIT 2019
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-01476
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 1 of 6 PageiD #: 142
`
`
`
`3.
`
`The ‘773 and ‘341 patent are generally directed to a method of manufacturing or
`
`modifying a superelastic nickel-titanium dental instrument or device where the dental instrument
`
`or device having an elongated shank of super-elastic nickel titanium alloy is provided and the
`
`entire instrument is then heat-treated at a temperature of 400ºC or above but not to the melting
`
`temperature, resulting in a device with shape memory characteristics including an angle of
`
`greater than 10 degrees of permanent deformation after torque at 45 degrees of flexion.
`
`4.
`
`Dentsply is the exclusive licensee of the ‘773 and ‘341 patents and has the right to
`
`bring suit for infringement and to recover for any current and past damages.
`
`5.
`
`Dentsply has for years sold several nickel-titanium endodontic dental files (for
`
`use in rotating drills) including the ProFile®, ProTaper®, GT-Series® and WaveOne®. In
`
`February 2012, Dentsply introduced its innovative post-heat-treated, nickel-titanium endodontic
`
`file, the Vortex Blue®. Dentsply also sells other post-heat-treated, nickel-titanium endodontic
`
`files, such as the ProTaper Gold®. Because it is post-heat-treated, the Vortex Blue® file, when
`
`bent by an endodontist, retains a bent shape. This allows the endodontist to pre-shape the file to
`
`follow the natural curved passage of the tooth when performing a root canal, thus yielding better
`
`canal shaping and a safer experience for the patient.
`
`6.
`
`Subsequent to the introduction of Dentsply’s Vortex Blue® product, US Endo
`
`began manufacturing and selling heat-treated nickel-titanium endodontic files. US Endo sold
`
`these files to Edge Endo, LLC (“Edge Endo”), a direct competitor of Dentsply, which sells the
`
`files under the name EdgeFile™. Not only was Dentsply’s innovative Vortex Blue® product on
`
`the market when US Endo began manufacturing its products, but US Endo was aware at that
`
`time of the pendency of certain patent applications that had been filed by Dr. Neill Luebke. Dr.
`
`2
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 2 of 6 PageID #: 143
`
`
`
`Luebke is the inventor of the two Patents-in-Suit. The Patents-in-Suit claim priority to earlier
`
`Luebke applications of which US Endo was aware by May 2012.
`
`7.
`
`Dentsply’s endodontic dental files directly compete with products manufactured
`
`by Defendant, US Endo, which are then provided to US Endo customers, including at least, Edge
`
`Endo, LLC (“Edge Endo”). In fact, according to information submitted by US Endo to the
`
`United States Food and Drug Administration (“FDA”), US Endo is the “contract manufacturer”
`
`of the EdgeFile™ line of products that are sold and marketed by Edge Endo. Edge Endo sells,
`
`markets and distributes the EdgeFiles directly to its customers, in particular, dentists and
`
`endodontists.
`
`8.
`
`In product literature and in promotional videos on its website, Edge Endo markets
`
`the EdgeFiles manufactured by Defendant as “effortlessly compatible” with Dentsply’s rotary
`
`files. Indeed, Edge Endo provides a “compatibility” chart instructing dentists and endodontists
`
`who use Dentsply’s WaveOne® to use EdgeFile X1; those who use Dentsply’s GT® and GT®X
`
`to use EdgeFileX5; and those who use Dentsply’s Vortex® or Profile® to use EdgeFile X7.
`
`9.
`
`Dentsply believes that US Endo is using a process that is protected by the ‘773
`
`and ‘341 patents to manufacture at least the EdgeFile X1, EdgeFile X5 and EdgeFile X7
`
`products. As explained in detail in the accompanying Memorandum in Support of Dentsply’s
`
`Motion for Preliminary Injunction, the results of testing conducted by independent, third-party
`
`laboratories on the EdgeFile X1, X5 and X7 manufactured by US Endo, including thermal
`
`analysis by differential scanning calorimetry and mechanical testing (a stiffness test in
`
`accordance with ISO 3630-1), are consistent with products that are manufactured by a process
`
`that infringes the ‘773 and ‘341 patents asserted in the Complaint.
`
`3
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 3 of 6 PageID #: 144
`
`
`
`10.
`
`Additionally, the founder of US Endo, Bobby Bennett, is the named inventor on a
`
`patent application filed in February 2012, which claims and describes a process for
`
`manufacturing post-heat-treated endodontic files that falls within the scope of the claims of the
`
`Patents-in-Suit. This patent application was filed at least 6 years after the Luebke patent
`
`applications to which the Patents-in-Suit claim priority, and stands rejected by the Patent Office.
`
`Provided that US Endo is practicing the method claimed in Mr. Bennett’s own patent application,
`
`then that method infringes claims of the ‘773 and ‘341 patents.
`
`11.
`
` To further confirm infringement and prepare for the hearing on Plaintiff’s Motion
`
`for a Preliminary Injunction, Plaintiff is seeking expedited discovery narrowly limited to the
`
`specific process used by US Endo to manufacture the EdgeFile products, including in particular,
`
`the point in in the manufacturing process when heat-treatment occurs (i.e. whether the files are
`
`post-heat treated as believed) and the specific temperature at which the files are heat-treated.
`
`12.
`
`Dentsply has suffered irreparable harm, including market price erosion and loss of
`
`market share, as well as damage to its reputation and goodwill with customers as a result of
`
`Defendant’s actions.
`
`13.
`
`Defendant US Endo has caused and will continue to cause irreparable harm to
`
`Dentsply, its business and its reputation through their making, using, offering for sale, sale,
`
`importation, marketing and/or distribution of at least the EdgeFile X1, X5 X7. Additionally,
`
`Defendant is unlikely to be able to pay an award of damages if an injunction is not issued during
`
`the time that it takes for the parties to try the case. Plaintiff is seeking limited expedited
`
`discovery specifically directed to facts concerning Defendant’s inability to pay a damages award.
`
`4
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 4 of 6 PageID #: 145
`
`
`
`14.
`
`As demonstrated more fully in the accompanying Memorandum of Law in
`
`Support of Plaintiff’s Motion for a Preliminary Injunction, Dentsply is likely to succeed on the
`
`merits of its claims of infringement and on a showing of patent validity.
`
`15.
`
`The balance of equities favors Dentsply. The continued harm to Dentsply in the
`
`absence of a preliminary injunction greatly outweighs any alleged harm that Defendant might
`
`suffer as a result of a preliminary injunction, and the issuance of an injunction is in the interest of
`
`the public.
`
`In further support of its motion, Dentsply relies upon and incorporates by reference the
`
`accompanying Memorandum of Law in Support of Plaintiff’s Motion for a Preliminary
`
`Injunction and the declarations of Dr. Robert Sinclair, Dr. Richard Gering, Dr. Neil Luebke,
`
`DDS, John Voskuil, and C. Nichole Gifford, Esq. and the supporting exhibits submitted
`
`concurrently herewith. Given the urgency of this matter, Dentsply respectfully requests authority
`
`to conducted expedited discovery and that the Court hold an expedited hearing on Plaintiff’s
`
`Motion for a Preliminary Injunction.
`
`
`
`Dated: July 9, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`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
`
`Steven Lieberman
`C. Nichole Gifford
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th St., N.W., Suite 800
`
`5
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 5 of 6 PageID #: 146
`
`
`
`Washington, DC 20005
`Phone: (202) 783-6040
`Facsimile: (202) 783-6031
`E-Mail: sliberman@rfem.com
`ngifford@rfem.com
`
`Counsel for Plaintiff
`Dentsply International, Inc.
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on the 9th day of July, 2014, a copy of the foregoing PLAINTIFF’S
`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.
`
`HUNTER, SMITH & DAVIS, LLP
`
` s/Jimmie C. Miller
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`Case 2:14-cv-00196-JRG-DHI Document 26 Filed 07/09/14 Page 6 of 6 PageID #: 147