United States District Court, D. New Jersey
November 1, 2005.
DAIICHI PHARMACEUTICAL CO., LTD. and DAIICHI PHARMACEUTICAL CORPORATION, Plaintiffs,
APOTEX, INC. and APOTEX CORP., Defendants.
The opinion of the court was delivered by: WILLIAM BASSLER, District Judge
Plaintiffs Daiichi Pharmaceutical Co. Ltd., and Daiichi
Pharmaceutical Corporation (collectively as "Daiichi" or
"Plaintiffs") filed a motion in limine to preclude defendants
Apotex, Inc. and Apotex Corp. (collectively as "Apotex" or
"Defendants") from asserting an affirmative defense of failing to
name the proper inventors of Daiichi's patent pursuant to
35 U.S.C. § 102(f).
For the reasons set forth below, Daiichi's motion is granted.
Daiichi brought suit against Apotex alleging patent
infringement of all seven claims of Daiichi's U.S. Patent No.
5,401,741 ("the '741 patent"), entitled a "Topical Preparation
for Treating Otopathy." Daiichi now argues that Apotex did not
sufficiently put Daiichi on notice of the defense that it is not
entitled to the '741 patent for failure to name the proper
inventors pursuant to 35 U.S.C. § 102(f). Section 102 states: "A
person shall be entitled to a patent unless . . . (f) he did not
himself invent the subject matter sought to be patented. . . ."
Daiichi argues that section 102 provides an affirmative defense
that must be pled in a way that sufficiently gives a plaintiff
notice of the defense, and by failing to do so Apotex waived such
defense. Furthermore, Daiichi contends that allowing Apotex to present evidence to that end not only unduly prejudices
Daiichi but also thwarts the purpose of contention
Apotex asserts that it raised the section 102(f) issue in its
Amended Answer. Apotex also argues that Fed.R.Civ.P. 8(c) does
not list 102(f) as an affirmative defense and, therefore, it need
not be specifically pleaded. In addition, Apotex makes argues
that Daiichi will not be prejudiced and was aware of the
likelihood of the defense because of questioning during
depositions. Moreover, Appotex argues Daiichi was in possession
of documents that suggested the defense would be raised.*fn1
A. Affirmative Defenses Under Rule 8(c)
Rule 8(c) of the Federal Rules of Civil Procedure requires that
"In a pleading to a preceding pleading, a party shall set forth
affirmatively . . . any  matter constituting an avoidance or
affirmative defense. . . ." (Emphasis added.) The Rule itself
does not list every affirmative defense. The fact that the
defense under 35 U.S.C. § 102(f) is not provided for under Rule
8(c) does not mean that it falls outside the category of affirmative
defenses; this is evident from the plain language of Rule 8(c).
See e.g. Williams v. Ashland Engineering Co., Inc.,
45 F.3d 588, 593 (1st Cir. 1995) (discussing preemption as an
affirmative defense); Cornwall v. U.S. Const. Mfg. Inc.,
800 F.2d 250, 252 (Fed. Cir. 1986) (discussing invalidity as an
affirmative defense); Freedman Seating Co. v. American Seating
Co., 420 F.3d 1350, 1363 n. 6 (Fed. Cir. 2005) (discussing
enforceability as an affirmative defense); Ray v. Kertes,
285 F.3d 287, 291-92 (3d Cir. 2002) (discussing exhaustion as an
affirmative defense); Shechter v. Comptroller of City of New
York, 79 F.3d 265, 270 (2d Cir. 1996) (discussing immunity as an
affirmative defense); Kennan v. Dow Chemical Co.,
717 F.Supp. 799, 808-09 (M.D.Fla. 1989) (discussing preemption as an
The issue for the Court is whether section 102(f) falls within
the category of a matter constituting avoidance or an affirmative
defense. "Generally speaking, the rule's reference to `an
avoidance or affirmative defense' encompasses two types of
defensive allegations: those that admit the allegations of the
complaint but suggest some other reason why there is no right to
recovery, and those that concern allegations outside of the
plaintiff's prima facie case that the defendant therefore cannot
raise by a simple denial in the answer." 5 CHARLES A. WRIGHT &
ARTHUR R. MILLER, FEDERAL PRACTICE AND PROCEDURE § 1271 (3d ed.
2004). The argument underlying section 102(f), that a plaintiff is not
entitled to recover because he is not the true inventor, falls
well within the category of affirmative defenses considered by
other courts as well as the first type of defensive allegations
listed by Wright and Miller.
B. Pleading Affirmative Defenses
"Parties are generally required to assert affirmative defenses
early in litigation, so they may be ruled upon, prejudice may be
avoided, and judicial resources may be conserved." Robinson v.
Johnson, 313 F.3d 128, 134 (3d. Cir. 2002). The Rule technically
requires that such a defense be pleaded in the answer. Id. at
135. The purpose behind Rule 8(c) is to put "plaintiff on notice
well in advance of trial that defendant intends to present a
defense in the nature of an avoidance." Marino v. Otis
Engineering Corp., 839 F.2d 1404, 1408 (10th Cir. 1988)
(internal citations omitted). "A defendant should not be
permitted to `lie behind a log' and ambush a plaintiff with an
unexpected defense." Perez v. United States, 830 F.2d 54, 57
(5th Cir. 1987) (internal citations omitted).
In order to assert an affirmative defense under Rule 8(c) the
pleading party must at least put plaintiff on reasonable notice
of that defense. While some courts have considered harmless a
technical failure to comply with Rule 8(c), others have taken
into account the stage of the proceeding in deciding whether fair notice was satisfied. See Venters v. City of
Delphi, 123 F.3d 956, 968-69 (7th Cir. 1997) (holding that
defendants' statute of limitations defense, submitted after an
exhaustive discovery process and a trial scheduled a month away,
deprived the plaintiff of fair notice and a reasonable
opportunity to respond) (cited in Robinson, 313 F.3d at 136).
The Court must therefore determine whether Apotex put Daiichi
on reasonable notice of its intent to argue section 102(f).
Apotex argues that Daiichi was fully aware that the issue of the
proper inventor was on the table: (1) section 102(f) was raised
in its Answer, (2) the issue was explored throughout discovery
and depositions, and (3) Daiichi's internal documents flagged the
C. Whether Sufficient Notice Was Provided
While Apotex's Answer and Additional Defenses, at paragraph 20,
broadly lists 35 U.S.C. § 102 among other statutes as an
Additional Defense, this is insufficient to apprise Daiichi that
it is raising the inventorship defense. As the Court in Advanced
Cardiovascular Systems, Inc. v. Medtronic, Inc. 41 U.S.P.Q.2d
1770, 1773 (N.D.Cal. 1996), noted, "[s]ince [35 U.S.C.] sections
101, 102, 103, and 112 provide numerous grounds for finding a
patent invalid, defendant must provide a more specific statement
of the basis for this defense in order to give [plaintiff] fair
notice of the claims being asserted." The purpose of raising an affirmative defense early on in
litigation is to put the plaintiff on reasonably fair notice of
that defense. In light of the contention interrogatories and
extensive discovery between the parties, broadly citing the
statute does not provide sufficient notice. While the general
pleading standards of Rules 8(b) and (e) should be "consulted"
when considering an affirmative defense, it cannot be said that
Apotex's perfunctory listing provides the reasonably fair notice
necessary under Rule 8(c). WRIGHT & MILLER at § 1274; see also
Cornwall v. U.S. Const. Mfg. Inc., 800 F.2d 250 (Fed. Cir.
1986); Shechter v. Comptroller of City of New York,
79 F.3d 265, 270 (2d Cir. 1996).
Apotex also claims that Daiichi was on notice of its section
102(f) claims because the issue was explored throughout discovery
and depositions. Defendants, however, cite no authority for the
contention that a plaintiff may be sufficiently put on notice of
an affirmative defense by the implications underlying discovery
requests. This diverges from the purpose of providing notice of
an affirmative defense and it makes no sense. In essence, Apotex
argues Daiichi should be considered on reasonable notice of the
section 102(f) claim based on Defendants' trial tactics. If this
were true, it would undermine the purpose of early notification
of affirmative defenses; a plaintiff would have to guess whether
the affirmative defense will be raised, along with any other defenses, at trial based on the materials sought in discovery or
the line of questions asked during depositions.
In Transclean Corp. v. Bridgewood Services, Inc., the court
dealt with a similar issue and reached a similar result.
Transclean Corp. v. Bridgewood Services, Inc.,
77 F.Supp.2d 1045, 1062 (M.D.Minn. 1999) rev'd on other grounds,
290 F.3d 1364 (Fed. Cir. 2002). The defendant argued that plaintiffs were
put on notice of its contentions by way of discovery requests.
The court held that following this line of thinking would
"condone `hide the ball' discovery practices, and subvert the
purposes of Rule 26(e), by permitting contention discovery to be
an elusive guessing exercise." Id.
Daiichi was not implicitly put on notice by its discovery
requests and its questions during depositions.
The same can be said for Apotex's argument that Daiichi's own
documents put Daiichi on notice of the issue of inventorship. The
fact that Daiichi is in possession of documents relating to
inventorship does not mean it is on notice of an affirmative
defense under section 102(f). How would the Plaintiffs know which
of its documents or evidence the Defendants plan to introduce to
prove the section 102(f) defense? Only Apotex's discovery
responses could properly provide Daiichi with notice of their
102(f) claim before the expiration of the discovery period. See
Transclean Corp., 77 F.Supp.2d at 1062. The purpose of an affirmative defense is to hedge against the complete litigation
of a full defense. The Court rejects Apotex's arguments that
Daiichi was on reasonable notice to the section 102(f) defense
based on discovery, depositions, and Daiichi's own documents.
This conclusion is further supported by Apotex's failure to
raise the defense of 102(f) in its answers to Daiichi's
contention interrogatories. In their third set of interrogatories
to Defendants, interrogatory number 32, Plaintiffs make the
Explain the factual and legal bases for any and all
allegations by Apotext that any of claims 1-7 of
Daiichi's patent-in-suit is invalid or otherwise
unenforceable due to alleged patent misuse and
identify all knowledgeable individuals and the
documents and deposition testimony reviewed,
considered and/or relied on in support thereof.
In its response, Apotex provides no specific justifications for
its belief that Daiichi is not entitled to the '741 patent based
on section 102(f). Rather, Apotex blandly states that it "adopts
and incorporates by reference all prior art reference and factual
and legal bases . . . pursuant to 35 U.S.C. § 102. . . ." The
Court emphasizes the fact that a section 102(f) claim is not a
run-of-the-mill defense. "[M]isjoinder or nonjoinder of inventors
must be proven by facts supported by clear and convincing
evidence." Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292
1301 (Fed. Cir. 2002). Multiple inventors may be involved without
equal rights to the patent. Id. at 1302. Inventorship is determined on a claim-by-claim basis, and
involves a complex analysis of the contributions of each
individual to the subject matter at issue. Id. This is the type
of complicated information that is best considered as early in
the litigation as possible so as to clearly define the issues for
The purpose of contention interrogatories is to narrow and
define issues for trial beyond what may be ascertained from the
parties' pleadings. Transclean Corp., 77 F.Supp.2d at 1062;
Thorn EMI N. Am. v. Intel Corp., 936 F.Supp. 1186, 1191 (D.Del.
1996) ("The court will prevent a party from raising a claim or
defense at trial that was not adequately described in a response
to a contention interrogatory."); Sperling v. Hoffman-La Roche,
Inc., 924 F.Supp. 1396, 1411-12 (D.N.J. 1996). "It is
well-recognized that complete and accurate responses to discovery
are imperative to the functioning of the modern trial process . . .
The `modern instruments of discovery' are thus a principal
means by which trials are rendered `less a game of blindman's
bluff and more a fair contest with the basic issues and facts
disclosed to the fullest practicable extent.'" Averbach v. Rival
Mfg. Co., 879 F.2d 1196, 1201 (3d. Cir. 1989) citing United
States v. Procter & Gamble Co., 356 U.S. 677, 682 (1958). A
failure to disclose may be grounds for automatic exclusion of the
evidence under Fed.R.Civ.P. 37(c)(1). See Transclean
Corp., 77 F.Supp.2d at 1063 (considering four factors in "assessing the
substantiality of any proffered justification for the failure to
disclose, as well as the harmlessness of that failure.")
Apotex does not dispute the fact that an affirmative defense as
to the proper inventor was not fully laid out in its responses to
Daiichi's interrogatories, rather it argues that it "assumed
that the inventorship issue had been raised by Bausch &
Lomb. . . ." Apotex's Opp. Br. at 16 (emphasis added). Such an
assumption does not excuse Apotex's failure to sufficiently
address the affirmative defense in its answer or responses to
"A party who fails to raise an affirmative defense in a timely
fashion is deemed to have waived the defense." McCoy v. Bd. of
Trs. of the Laborers' Int'l Union Local #222 Pension Plan,
188 F.Supp.2d 461, 468 (D.N.J. 2002) aff'd, 2003 U.S. App. LEXIS
5756 (3d Cir. 2003); see also WRIGHT & MILLER at § 1278 ("It is
a frequently stated proposition of virtually universal acceptance
by the federal courts that a failure to plead an affirmative
defense as required by Federal Rule 8(c) results in the waiver of
that defense and its exclusion from the case . . ."). The Third
Circuit has held that a defendant does not waive an affirmative
defense if he raised the issue at a pragmatically sufficient
time, and the plaintiff was not prejudiced in its ability to
respond. Eddy v. V.I. Water & Power Auth., 256 F.3d 204, 209 (3d. Cir. 2001). The Court, however, finds that the issue of
proper inventorship was not raised at "a pragmatically sufficient
time" and Daiichi will be prejudiced by Apotex's eleventh-hour
Daiichi served three separate interrogatories on Apotex. Apotex
did not respond with a clear statement on the grounds for its
section 102(f) defense. Only after the close of extensive
discovery and at the hearing to set the trial date did Apotex
place Plaintiffs on notice. See 07-21-2005 Transcript of
Hearing Before Magistrate Judge Arlea at 50-51. The Court,
therefore, finds this affirmative defense has been untimely
raised and is deemed waived.
Daiichi is now without opportunity to take discovery on the
section 102(f) defense or retain an expert on the issue. The
issue of true inventorship is complex and is determined on a
case-by-case basis. Travan, 299 F.3d at 1302. It involves
comparing the contributions of each asserted co-inventor to each
claim of the patent. Id. The contributors must prove their
contribution with corroborating evidence; that is, more than
their own testimony. Id. Because of the intricacy of a 102(f)
claim it demands adequate notice so that a plaintiff might
properly counter the argument.
The Court agrees with Daiichi's argument that Apotex has
frustrated the purpose of contention interrogatories. Affirmative defenses need to be asserted early in litigation to
avoid this type of surprise and undue prejudice. See Long v.
Wilson, 393 F.3d 390, 397 (3d Cir. 2004). If there is good cause
for not raising an affirmative defense in the answer, "it must be
raised as early as practicable thereafter." Id. at 398
(internal citations omitted). The Court finds that Apotex missed
several opportunities throughout discovery to raise the section
102(f) defense, to fully flesh out the basis behind the claim,
and to give Daiichi ample notice and time to demonstrate why the
affirmative defense should not succeed. The Court, therefore,
holds Apotex has waived its section 102(f) affirmative defense.
For the foregoing reasons, Daiichi's motion in limine is
granted. Apotex is precluded from asserting an affirmative
defense of alleged improper inventorship pursuant to
35 U.S.C. § 102(f).
An appropriate Order follows.
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