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
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
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
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.
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).
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
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