The opinion of the court was delivered by: HENRY PITMAN, Magistrate Judge
Defendants in this patent infringement action move for a
separate trial on the issue of willfulness and to defer discovery
concerning willfulness until the conclusion of the trial of
liability issues. For the reasons set forth below, defendants'
motion is denied in all respects.
Plaintiff Novartis AG is the owner of United States Patent No.
5,733,569 ("the '569 Patent") which describes and claims, among
other things, liquid pharmaceutical compositions for the nasal
administration of calcitonin, a hormone known to participate in
calcium and phosphorus metabolism. The '569 Patent claims
compositions that contain benzalkonium chloride to enhance bioavailability as well as an application device and
method for administering the compositions.
Novartis AG is also the owner of United States Patent No.
5,759,565 ("the '565 Patent") which claims liquid pharmaceutical
compositions for the nasal administration of calcitonin which
contain benzalkonium chloride.
In or about September 2002, defendants filed an abbreviated new
drug application with the United States Food and Drug
Administration for approval of the commercial manufacture, use
and sale of a salmon calcitonin nasal spray. As required by
21 U.S.C. § 355 (j)(2) (vii), defendants submitted with their
application an opinion letter from the firm of Caesar, Rivise,
Berstein, Cohen & Pokotilow, Ltd., ("Caesar, Rivise") opining
that the '569 and '565 Patents were invalid on the grounds of
obviousness and prosecution laches. If plaintiffs' patents are
valid and defendants' products are within the scope of the
patents' claims, defendants' abbreviated new drug application
constitutes an act of infringement. 35 U.S.C. § 271 (e)(2).
Plaintiffs commenced the pending infringement action in
November 2002. Plaintiffs allege that defendants have willfully
infringed the '569 and '565 Patents and seek an injunction,
damages and other relief. In the course of discovery, defendants
have admitted that the subject of their abbreviated new drug
application is within the scope of the claims of the '569 and
'565 Patents (Defendants Supplemental Responses to Plaintiffs'
First Set of Requests for Admission, dated November 7, 2003, Nos. 20-22; Defendants' Responses to Plaintiffs' Second Set of
Requests for Admissions, dated December 1, 2003, Nos. 60-67).
Thus, the principal issues at trial will be the validity of the
'569 and '565 Patents and, if the patents are valid, whether
defendants' infringement was willful.
In October 2003, defendants advised plaintiffs that they would
rely on an advice-of-counsel defense to plaintiffs' claim of
willful infringement and produced 75 pages of documents that had
previously been withheld on the ground of privilege. Because
plaintiffs believe that the documents produced by defendants are
incomplete, and in order to explore further the advice-of-counsel
defense, plaintiffs seek additional documents and deposition
testimony from Caesar, Rivise and to depose defendants'
principals concerning the advice of counsel. Defendants oppose
this discovery, claiming that trying validity and willfulness
together will lead to confusion, delay and unfairly prejudice
defendants by forcing a premature waiver of the attorney-client
The factors to be considered in resolving a motion for separate
trials were succinctly and cogently summarized by the Honorable
Laura Taylor Swain, United States District Judge, in Dallas v.
Goldberg, 143 F. Supp.2d 312, 315 (S.D.N.Y. 2001):
Under Rule 42(b) of the Federal Rules of Civil
Procedure the Court, in its discretion, can bifurcate
the trial of an action for "convenience or to avoid
prejudice, or when separate trials will be conducive to expedition and
economy." Fed.R.Civ.P. 42(b). The decision to
bifurcate a trial rests within the sound discretion
of the trial court. See Simpson v. Pittsburgh
Corning Corp., 901 F.2d 277, 283 (2d Cir. 1990);
Agron v. Trustees of Columbia Univ., No. 88 Civ.
6294, 1997 WL 399667 at *1 (S.D.N.Y. July 15, 1997).
Although bifurcation of trials is not unusual and may
under appropriate circumstances be the preferred
method, bifurcation remains the exception rather than
the rule. See Lewis v. Triborough Bridge, No. 97
CIV. 0607, 2000 WL 423517 at *2 (S.D.N.Y. Apr. 19,
2000); Agron, 1997 WL 399667 at *1; Kerman v. City
of New York, No. 96 Civ. 7865, 1997 WL 666261 at *5
(S.D.N.Y. Oct. 24, 1997).
The application of Rule 42(b) does not lend itself to
a bright-line test but, rather, requires case-by-case
analysis. See Monaghan v. SZS 33 Associates,
827 F. Supp. 233, 245 (S.D.N.Y. 1993). Factors that courts
consider in determining whether bifurcation is
appropriate include: (1) whether the issues are
significantly different from one another; (2) whether
the issues are to be tried before a jury or to the
court; (3) whether the posture of discovery on the
issues favors a single trial or bifurcation; (4)
whether the documentary and testimonial evidence on
the issues overlap; and (5) whether the party
opposing bifurcation will be prejudiced if it is
granted. See Lewis, 2000 WL 423517 at *2;
Reading Indus., Inc. v. Kennecott Copper Corp.,
61 F.R.D. 662, 664 (S.D.N.Y. 1974). The party seeking
bifurcation bears the burden of establishing that
bifurcation is warranted. See Lewis, 2000 WL
423517 at *2.
See also Kos Pharm., Inc. v. Barr Labs., Inc.,
218 F.R.D. 387, 390-91 (S.D.N.Y. 2003).
Application of relevant factors to this case leads to the
conclusion that separate trials are not appropriate here. A. Overlap of Issues
Although defendants state that there is no overlap between the
issues of willfulness and validity, their argument does not
"In order to find willful infringement, [a] district court
`[is] required to find by clear and convincing evidence in view
of the totality of the circumstances that [the infringer] acted
in disregard of the [patentee's] patent and lacked a reasonable
basis for believing it had a right to do what it did.'" WMS
Gaming, Inc. v. International Game Tech., 184 F.3d 1339, 1354
(Fed. Cir. 1999), quoting Amsted Indus., Inc. v. Buckeye Steel
Castings Co., 24 F.3d 178, 181 (Fed. Cir. 1994). Accord
Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1339
(Fed. Cir. 2004); Crystal Semiconcductor Corp. v. TriTech
Microelectronics Int'l, Inc., 246 F.3d 1336, 1346 (Fed. Cir.
2001). Although "[i]t is well settled that an important factor in
determining whether willful infringement has been shown is
whether or not the infringer obtained the opinion of counsel,"
Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182,
1191 (Fed. Cir. 1998), the mere fact that an infringer has
received the advice of counsel is not the end of the analysis.
Amsted Indus. Inc. v. Buckeye Steel Castings Co., supra, 24
F.3d at 182; Kori Corp. v. Wilco Marsh Buggies & ...