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September 1, 2000


The opinion of the court was delivered by: Kane, District Judge.


In this action, Plaintiff, Dentsply International, Inc. ("Dentsply"), asserts that Defendant, Great White, Inc. ("Great White"), infringed its patent for disposable dental syringe tips, U.S.Patent No. 5,342,195 (hereinafter "'195 patent"), induced infringement of its patent for adaptors used to mount disposable syringe tips, U.S.Patent No. 5,236,356 (hereinafter "'356 patent"), and infringed its registered trademark, "SANI-TIP®," U.S.Reg. No. 2,246,056. Plaintiff also alleges false advertising, unfair competition, and, in an amended complaint, trade dress infringement by Defendant. Defendant has countersued for, inter alia, declaratory judgment of patent non-infringement, patent misuse and unenforceability, patent invalidity, and trademark non-infringement.

Now before the Court is Plaintiffs Motion for Preliminary Injunction. A hearing on the motion was held October 29, November 5, and November 12, 1999. The matter has been fully briefed and is ripe for disposition. Pursuant to Rules 52(a) and 65 of the Federal Rules of Civil Procedure, this memorandum constitutes the Court's findings of fact and conclusions of law with respect to Plaintiff's motion.

I. Background

Dentsply, a company with its principal place of business in York, Pennsylvania, is, and has been for over 100 years, in the business of manufacturing, marketing, and selling a host of dental products on a worldwide basis. Among Dentsply's products are the SANI-TIP® system, which consists of disposable air/water syringe tips and adaptors for use by dentists.

In 1997 Dentsply acquired exclusive rights to the SANI-TIP® system, pursuant to an Asset Purchase and Sales Agreement between Dentsply and DW Industries, Inc. By that agreement and related licenses, Dentsply is the exclusive licensee under various patents covering the SANI-TIP® adaptors and syringe tips, including the '195 and '356 patents.

Dentsply is also the owner, user, and registrant of a federal trademark registration for SANI-TIP®, U.S. Registration No. 2,246,056 for "disposable tri-syringe tips," and, through a wholly owned subsidiary, the owner and user of U.S. Registration No. 1,919,512 for SANI-TIP® and the corresponding design for "disposable air/water syringe tips for dental syringes and adaptors for disposable air/water syringe tips."

Great White is a New Jersey corporation with its principal place of business in Wayne, New Jersey. Its two officers and controlling shareholders are Joseph Bukowski, a mechanical engineer, and Dr. Bruce Fine, a dentist. Great White manufactures, sells, and markets a disposable air/water syringe tip called "STERI-TIP."

In 1999, Dentsply learned that, since mid-1999, Great White has been advertising and selling disposable air/water syringe tips for dental use under the name "STERI-TIP." Great White's syringe tips are highly similar in appearance to SANI-TIP® tips, and Great White markets its product as interchangeable with SANI-TIP®.

Most dentists employ a hand-held instrument known as a "tri-syringe" to rinse and clear a patient's mouth in preparation for dental procedures. Through separate air and water tubes that terminate at the "handpiece body" of the tri-syringe, the device delivers streams of air, water, and combined air and water. The handpiece body of the tri-syringe has two operating buttons used to regulate the emission of air and water. When the dentist depresses the air button, air flows out of the tip of the tri-syringe and dries the targeted area of the patient's mouth. When the dentist depresses the water button, water is emitted from the tri-syringe tip to wash away debris. Depressing both buttons at once produces an air/water aerosol spray that is used to remove debris.

Since at least the 1970s, tri-syringes were commonly equipped with a metal syringe tip and a factory-installed adaptor, which connected the tip to the handpiece body. Metal tips were not disposable and required sterilization between uses on different patients.

In 1988, with the goal of providing a safe and sanitary alternative to metal syringe tips, Dr. David Wasserman and Warren Davis designed a disposable syringe tip system using a tip made of clear plastic through which fluids could be detected visually. Their system included the tips themselves, as well as special adaptors to enable use of these disposable tips with existing tri-syringes commonly used by dentists. This system became known as the SANI-TIP® system.

In August 1988, Davis and Wasserman founded DW to manufacture and market SANI-TIP® syringe tips and adaptors. They applied for patents in September 1988. Thereafter, from 1989 to 1996, Davis and Wasserman spent over $6.3 million advertising and promoting their invention. Dentsply acquired the rights to SANI-TIP® in 1997.

Since 1995, SANI-TIP® has been the leading disposable syringe tip in the United States. Over 150,000 SANI-TIP® adaptors have been distributed in the United States alone, while more than 300 million syringe tips have been sold.

II. Jurisdiction and Venue

The Court has jurisdiction over these proceedings pursuant to 28 U.S.C. § 1331, 1338(a)-(b), 2201, 2202 and 15 U.S.C. § 1121.

Venue is proper in this judicial district pursuant to 28 U.S.C. § 1400.

III. Preliminary Injunction Standard

"A preliminary injunction requires the assessment of four factors: [(1)] the likelihood of movant's success on the merits, [(2)] the irreparability of harm to the movant without an injunction, [(3)] the balance of hardships between the parties, and [(4)] the demands of the public interest." Mentor Graphics Corp. v. Quickturn Design Sys., 150 F.3d 1374, 1377 (Fed.Cir. 1998). Of course, a preliminary injunction is "extraordinary relief," see, e.g., New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882 (Fed.Cir. 1992), and even if there is a likelihood of success on the merits, a motion for preliminary injunction should be denied if equity so requires. See, e.g., Eli Lilly & Co. v. American Cyanamid Co., 82 F.3d 1568, 1578 (Fed.Cir. 1996); Illinois Tool Works, Inc. v. Grip-Pak, Inc., 906 F.2d 679, 683 (Fed. Cir. 1990). Indeed, a preliminary injunction cannot be granted without a showing of both a likelihood of success on the merits and irreparable harm. See Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1555-56 (Fed.Cir. 1994). Conversely, though, the Court need not necessarily find that the "balance of hardships" favors the plaintiff in order to grant the preliminary injunction. See Hybritech Inc. v. Abbott Lab., 849 F.2d 1446, 1457 (Fed.Cir. 1988).

Moreover, in the patent infringement context, a "likelihood of success on the merits" means a likelihood of success both with respect to patent validity and with respect to infringement. See Reebok, 32 F.3d at 1555-56. Further, "[a] strong showing of likelihood of success on the merits coupled with continuing infringement raises a presumption of irreparable harm to the patentee." Id. at 1556.

IV. The '195 Patent

A. Likelihood of Success on the Merits

As already stated, to obtain a preliminary injunction in a patent infringement action, the plaintiff must establish the reasonable likelihood of proving patent validity and infringement by the defendant. See Reebok, 32 F.3d at 1555-56. Grant of a preliminary injunction does not require proof "beyond all question." H.H. Robertson, Co. v. United Steel Deck, Inc., 820 F.2d 384, 390 (Fed.Cir. 1987).

1. Validity

The patents are presumed to be valid under 35 U.S.C. § 282. Great White, which may overcome the presumption by a showing of clear and convincing evidence that the patents are invalid, has failed to meet that burden. First, Great White did not dispute the validity of the patents in its brief in opposition to Plaintiff's motion for preliminary injunction. Furthermore, at the hearing, though Great White sought to raise the issue, it adduced no convincing evidence of invalidity.

Moreover, in this case, where the products covered by the patents have enjoyed considerable, and undisputed, commercial success, and where competitors have avoided the patents, the presumption of patent validity is especially strong. See Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1571 (Fed.Cir. 1992) (where patented inventions enjoyed commercial success due to the technical merits of the product and patentee's competitor took license from patentee, such real world considerations provide "a solid evidentiary foundation on which to rest a non-obviousness determination"); Akzo N.V. v. United States Int'l Trade Comm'n, 808 F.2d 1471, 1481 (Fed. Cir. 1986) (commercial success of patentee's product is a strong factor favoring non-obviousness), cert. denied, 482 U.S. 909, 107 S.Ct. 2490, 96 L.Ed.2d 382 (1987). In addition, the mere fact that the parties disagree on the meaning of the patent claims does not render those claims invalid under 35 U.S.C. § 112. See, e.g., North American Vaccine, Inc. v. Am. Cyanamid Co., 7 F.3d 1571, 1579 (Fed.Cir. 1993), cert. denied, 511 U.S. 1069, 114 S.Ct. 1645, 128 L.Ed.2d 365 (1994). Because of Defendant's failure to counter the presumption of validity with clear and convincing evidence of invalidity, the '195 patent is presumed valid for the purposes of this motion.

2. Infringement

An infringement analysis requires two steps. The first step is to construe the meaning and scope of the patent claims. The second step is to determine whether the accused invention infringes the patent claims as construed. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir. 1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The court construes disputed claim language as a matter of law. See Markman, 52 F.3d at 978. The court then determines whether the accused device is likely to fall within the scope of the claims. See Sofamor, 74 F.3d at 1220. To infringe, an accused device must embody each claim limitation or its equivalent. See id.

Under a literal infringement analysis, the accused device is held up against the construed claims to determine whether each limitation on the claims can be found in the accused device. See Fonar Corp. v. Johnson & Johnson, 821 F.2d 627, 631 (Fed.Cir. 1987). Under the doctrine of equivalents, a patent is infringed if the accused device performs substantially the same work in substantially the same manner and accomplishes substantially the same result. See Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608, 70 S.Ct. 854, 94 L.Ed. 1097 (1950).

While the Court must construe the meaning and scope of the patent claims in order to determine infringement, Markman does not obligate a court to interpret claims conclusively and finally during a preliminary injunction proceeding at an early stage in a case. See id. at 1221. "A trial court may exercise its discretion to interpret the claims at a time when the parties have presented a full picture of the claimed invention and prior art." Id. Furthermore, findings and conclusions as to claim construction at the preliminary injunction stage are not binding at trial. See Illinois Tool Works, Inc. v. Grip-Pak, Inc., 906 F.2d 679, 681 (Fed.Cir. 1990). In International Communication Materials, Inc. v. Ricoh Co., 108 F.3d 316 (Fed.Cir. 1997), the Federal Circuit held that a district court did not abuse its discretion in denying a preliminary injunction based on a "tentative claim construction," given that there were "substantial open issues and questions that must be litigated before a finding of infringement can be made, including claim construction. . . ." Id. at 318.

The parties in this case have not presented comprehensive arguments on the proper interpretation of either patent at issue in this case. Though a complete and final claim construction cannot be determined on an incomplete factual record, the probability of infringement must be examined. See Atari Games Corp. v. Nintendo of Am., Inc., 897 F.2d 1572, 1575 (Fed.Cir. 1990) ("The district court need not make binding findings of fact, but at the very least, must find probabilities that the necessary facts can be proved."). Thus, the claim construction now set forth is tentative and substantial issues must be litigated before a conclusive finding of infringement or non-infringement may be made.

For purposes of this motion, Plaintiff relies solely on claim 1 of the '195 Patent, which discloses dental syringe tip assemblies having a disposable tip, an innovative adaptor, and a captivated thumb nut. The claims of the '195 Patent describe various characteristics of the disposable syringe tip.

The disputed portions of claim 1 are highlighted below.

1. A syringe tip comprising an elongated cylindrical rigid plastic member having a first central water passageway throughout the entire length of the cylindrical member, said first central water passageway being generally circular in cross-section, and a plurality of second air passageways disposed in a regular pattern circumferentially about the first central water passageway, said second air passageways extending substantially the entire length of the tip and the combined cross-sectional areas of the second air passageways being at least 30% of the total cross-sectional area that would result if the second air passageways were a single continuous annulus completely surrounding the central water passageway.
  In essence, the parties disagree on how the area of the annulus should be calculated, i.e., how "at least 30% of the total cross-sectional area" is to be measured. Obviously, this dispute is material because if, by the applicable standard of measure, the cross-sectional areas of the second air passageways of Defendant's product are greater than 30% of the total cross-sectional annulus area, then the product falls within that portion of claim 1 of the '195 patent.

Plaintiff argues that the area of the annulus should be measured by the "best fit" method, which it contends is the industry standard. This method conforms the annulus closely to each of the second air passageways, resulting in a smaller annulus than the methodology embraced by Defendant. For its part, Defendant urges a method that defines the annulus by the outermost point of the outermost air passageway and the innermost point of the innermost air passageway. Defendant's ...

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