United States District Court, W.D. New York
June 15, 2005.
INTERVENTIONAL THERAPIES, LLC and LSI SOLUTIONS, INC., Plaintiffs,
ABBOTT LABORATORIES and PERCLOSE, INC., Defendants.
The opinion of the court was delivered by: MICHAEL TELESCA, Senior District Judge
DECISION & ORDER
Plaintiffs Interventional Therapies ("IT") and LSI Solutions,
Inc. ("LSI") (collectively "plaintiffs") bring this patent
infringement action against defendants Abbott Laboratories
("Abbott") and Perclose, Inc. ("Perclose") (collectively
"defendants"), claiming that defendants have infringed a patent
owned by LSI, United States Patent 6,641,592 (the `592
Patent).*fn1 The patent, which is licensed exclusively
within the field of use of ateriotomy closure by IT, teaches a
percutaneous vessel closure device used to make blind sutures in
vascular wounds, such as a puncture hole, following an
intravascular catheterization procedure. On May 9, 2005, defendants filed an Answer to Plaintiffs'
Second Amended Complaint, in which they assert the affirmative
defense of inequitable conduct before the Patent and Trademark
Office ("inequitable conduct"). (Doc. No. 93). Plaintiffs now
move pursuant to Federal Rule of Civil Procedure 12(f) to strike
this defense. For the reasons set forth below, plaintiffs' motion
Plaintiff initiated this action on December 19, 2003 by filing
a Complaint, alleging that the "Perclose A-T," a device
manufactured and sold by defendants, infringed the `592 Patent.
(Doc. No. 1). Defendants filed an Answer to the Complaint on
February 24, 2004. (Doc. No. 3). By Stipulation dated July 28,
2004, plaintiffs were allowed to amend their complaint. (Doc. No.
32).*fn2 On February 10, 2005, plaintiffs moved to amend
their Complaint for a second time in order to allege that another
product manufactured and sold by defendants, the "Perclose
ProGlide," also infringed the `592 Patent. (Doc. No. 56).
Defendants then moved, on February 11, 2005, to amend their
Answer so as to allege the affirmative defense of inequitable
conduct before the Patent and Trademark Office. (Doc. No. 59).
Along with that motion, defendants submitted a proposed Amended Answer which set forth
their allegations of inequitable conduct. (Doc. No. 60). On April
25, 2005, Magistrate Judge Feldman held a hearing on these two
motions, and by Order dated April 26, 2005, he granted
plaintiffs' motion to file a second amended complaint and denied
defendants' motion to file an amended answer. (Doc. No. 90). In
so doing, Judge Feldman determined that defendants had failed to
plead their inequitable conduct defense with sufficient
particularity as required by Federal Rule of Civil Procedure
9(b). Nonetheless, he gave defendants until May 9, 2005 to file
an Amended Answer alleging the affirmative defense with greater
specificity, which they did on May 9, 2005 (Doc. No. 93).
Plaintiffs request that defendants' inequitable conduct defense
be stricken, alleging that it is insufficiently pleaded under the
special pleading requirements of Federal Rule of Civil Procedure
9(b). Specifically, plaintiffs claim that defendants fail to: (1)
explain why nondisclosure of the `686 Patent and the `010 Patent
during the prosecution of the `592 Patent constitutes inequitable
conduct; and (2) cite precisely when the alleged acts occurred.
Defendants contend that the defense is stated with sufficient
particularity, and that in fact their pleadings exceed the
requirements of Rule 9(b). A court may "order stricken from any pleading any insufficient
defense . . ." FED.R.CIV.P. 12(f). Where, as here, the defense
sounds in fraud, the heightened pleading requirements of Rule
9(b) of the Federal Rules of Civil Procedure apply, and the
circumstances surrounding the fraud must be stated with
particularity. FED.R.CIV.P. 9(b). The general purpose of this
requirement is to provide the party defending the claim with
sufficient notice to adequately respond to the allegations.
Michaels Building Company v. Ameritrust Company, N.A.,
848 F.2d 674, 680 (6th Cir. 1988).
To state a valid defense of inequitable conduct, a defendant
must: (1) specify the alleged fraudulent conduct; (2) identify to
whom the alleged fraudulent conduct may be attributed; (3) state
where and when the conduct occurred; and (4) explain why the
conduct is inequitable. See Boss Prducts Corporation v. Tapco
International Corp., 2001 WL 135819, *4 (W.D.N.Y. 2001) (quoting
Shields v. Citytrust Bancorp, Inc., 25 F.3d 1124, 1128 (2d Cir.
1994). Conduct before the Patent and Trademark Office is
inequitable only where it is both material and intended.
Halliburton Company v. Schlumberger Technology Corporation,
295 F.2d 1435, 1439 (2d Cir. 1991). In short, a defendant "must plead
the who, what, when and where of the alleged inequitable
conduct." Videojet Systems International, Inc. v. Eagle Inks,
Inc., 14 F. Supp.2d 1046, 1049 (N.D. Ill. 1998) (quoting Uni
*Quality, Inc. v. Infotronx, Inc., 974 F.2d 918, 923 (7th Cir. 1992).
Defendants' pleadings satisfy each element of this heightened
standard. First, defendants sufficiently identify the alleged
fraudulent conduct by claiming that plaintiffs failed to properly
disclose the `686 Patent and the `010 Patent in the course of
prosecuting the `592 Patent. See Abbott's Answer to Second
Amended Complaint, "Affirmative Defenses", ¶ 4(c). Second,
defendants adequately attribute the alleged omission to the
inventors of the `592 Patent, Jude S. Sauer and John F. Hammond,
as well as the attorneys who prosecuted the `592 Patent on behalf
of IT. See See Abbott's Answer to Second Amended Complaint,
"Affirmative Defenses", ¶¶ 4(c), 4(h), 4(i), 4(o), 4(p), 4(q),
4(r), 4(s), 4(t), and 4(u). Third, defendants claim that the
omission occurred before the Patent and Trademark Office between
November 15, 2000 and November 4, 2003 and particularly on
January 11, 2001. See Abbott's Answer to Second Amended
Complaint, "Affirmative Defenses", ¶¶ 4(e), 4(u). Given that
nondisclosure allegations are generally "somewhat amorphous,"
defendants' ability to cite a specific date is especially
effective. See Smith & Nephew, Inc. v. Surgical Solutions,
Inc., 353 F.Supp. 2d 135, 140 (D.Mass. 2004). Lastly, defendants
satisfactorily allege that the omission was both material and
intended. Specifically, defendants allege that there exists no
difference between Claim 1 of the `592 Patent and Claim 1 of the
`686 Patent. See Abbott's Answer to Second Amended Complaint, "Affirmative Defenses", ¶¶ 4(d)-(m). Defendants also
allege that plaintiffs were well aware of the `686 Patent because
they had been involved in previous litigation concerning that
patent. See Abbott's Answer to Second Amended Complaint,
"Affirmative Defenses", ¶¶ 4(f), 4(o). Certainly, defendants'
pleading provides plaintiff with sufficient notice to adequately
respond to the allegations.
Nonetheless, plaintiffs contend in their reply brief that
defendants must allege with specificity that the `686 Patent and
the `010 Patent were more material to the prosecution of the `592
Patent than other prior art disclosed during the prosecution and
that the `686 Patent and the `010 Patent were not cumulative of
those patents disclosed at that time. The cases to which
plaintiff refers, however, deal not with the sufficiency of an
inequitable conduct defense at the pleading stage under Rule
9(b), but rather the level of proof necessary to establish a
valid defense of inequitable conduct at the fact-finding stage.
See Regents of the University of California v. Eli Lily and
Company, 119 F.3d 1559, 1574-1575 (Fed. Cir. 1997) (at trial
stage defendant must demonstrate by clear and convincing evidence
that plaintiff not only failed to present material information to
the PTO, but also that the omitted information was not cumulative
of the information plaintiff did submit); Eli Lily and Company
v. Zenith Goldline Pharmaceuticals, Inc., 364 F. Supp.2d 820,
915 (S.D.Ind. 2005) (same). Since plaintiffs present no authority that there exists a
requirement that defendants must, at this early stage, prove by
clear and convincing evidence that the `686 Patent and the `010
Patent are more material to the prosecution of the `592 Patent
than the prior art presented during the prosecution of the `592
Patent, or that the `686 Patent and the `010 Patent are not
cumulative of prior art presented at the prosecution of the `592
Patent, their motion to strike the defense must be denied.
For the reasons set forth above, I find that defendants'
affirmative defense of inequitable conduct before the Patent and
Trademark Office satisfies the pleading requirements of Rule
9(b). Accordingly, plaintiffs' motion to strike defendants'
inequitable conduct defense is denied.
The parties are hereby directed to complete the scheduled
depositions forthwith, and then report to this Court to establish
a schedule for the balance of discovery.
ALL OF THE ABOVE IS SO ORDERED.