IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GENENTECH, INC. and CITY OF HOPE,
Plaintiffs,
v.
AMGEN INC.,
Defendant and Counterclaim
Plaintiff.
Case No. 1:18-cv-00924-CFC
AMGEN INC.’S OPPOSITION TO PLAINTIFFS’ MOTION TO DISMISS
AMGEN’S UNENFORCEABILITY COUNTERCLAIMS AND TO STRIKE
AMGEN’S ELEVENTH AFFIRMATIVE DEFENSE
Dated: March 7, 2019
Of Counsel:
Orion Armon
Cooley, LLP
380 Interlocken Crescent
Suite 900
Broomfield, CO 80021-8023
P 720-566-4119
oarmon@cooley.com
Eamonn Gardner
Cooley, LLP
4401 Eastgate Mall
San Diego, CA 92121-1909
P 858-550-6086
egardner@cooley.com
Susan Krumplitsch
Michelle Rhyu
Daniel Knauss
Cooley, LLP
3175 Hanover Street
Palo Alto, CA 94304-1130
P 650-843-5287
skrumplitsch@cooley.com
rhyums@cooley.com
dknauss@cooley.com
SMITH, KATZENSTEIN & JENKINS, LLP
Neal C. Belgam (No. 2721)
Eve H. Ormerod (No. 5369)
1000 West Street, Suite 1501
Wilmington, DE 19801
(302) 652-8400
nbelgam@skjlaw.com
eormerod@skjlaw.com
Attorneys for Defendant Amgen Inc.
Nancy Gettel
Thomas Lavery, IV
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
P 805-447-1000
ngettel@amgen.com
tlavery@amgen.com
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Table of Contents
Page
-i-
I. NATURE AND STAGE OF THE PROCEEDINGS ........................................................ 1
II. SUMMARY OF ARGUMENT ......................................................................................... 2
III. STATEMENT OF FACTS ................................................................................................ 4
A. Amgen’s Compliance With The BPCIA................................................................ 4
B. Amgen’s Eleventh Affirmative Defense Is That Genentech Committed
Inequitable Conduct Before the U.S.P.T.O ............................................................ 5
C. Many Patents-In-Suit Will Expire Soon or Are Being Challenged In Other
Proceedings ............................................................................................................ 6
IV. LEGAL STANDARDS ..................................................................................................... 8
A. Motion to Strike under F.R.C.P. 12(f) ................................................................... 8
B. Motion to Dismiss under F.R.C.P. 12(b)(6)........................................................... 9
V. ARGUMENT ................................................................................................................... 10
A. Amgen’s Eleventh Affirmative Defense of Inequitable Conduct and Its
Inequitable Conduct Counterclaim Count 3 Are Legally Sufficient ................... 10
B. Amgen’s Unenforceability Counterclaims Are Legally Sufficient ..................... 13
VI. CONCLUSION ................................................................................................................ 15
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Table of Authorities
Page(s)
-ii-
Cases
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ...................................................................................................................9
Bell Atlantic Corp. v. Twombly,
550 U.S. 544 (2007) .............................................................................................................9, 10
Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found.,
402 U.S. 313 (1971) ...................................................................................................................9
Butamax Adv. Biofuels v. Gevo,
No. 11-54, 2012 U.S. Dist. LEXIS 86215 (D. Del. June 21, 2012).........................................11
ePlus, Inc. v. Lawson Software, Inc.,
789 F.3d 1349 (Fed. Cir. 2015)................................................................................................14
Exergen Corp. v. Wal-Mart Stores, Inc.,
575 F.3d 1312 (Fed. Cir. 2009)................................................................................................10
Fesnak & Assoc., LLP v. U.S. Bank. Nat’l Ass’n,
722 F. Supp. 2d 496 (D. Del. 2010) ...........................................................................................8
Fowler v. UPMC Shadyside,
578 F.3d 203 (3d Cir. 2009)...............................................................................................10, 14
IBM v. Priceline Grp., Inc.,
Case No. 15-137-LPS-CJB, 2017 U.S. Dist. LEXIS 54285 (D. Del. Apr. 10,
2017) ....................................................................................................................................3, 12
Idenix Pharms., Inc. v. Gilead Scis., Inc.,
Case No. 13-1987-LPS, 2014 U.S. Dist. LEXIS 118789 (D. Del. Aug. 25,
2014) ........................................................................................................................................14
Kimble v. Marvel Entm’t, LLC,
135 S. Ct. 2401 (2015) .............................................................................................................13
Moody v. Atl. City Bd. of Educ.,
870 F.3d 206 (3d Cir. 2017).......................................................................................................9
Precision Instrument Mfg. Co. v. Auto Maint. Mach. Co.,
324 U.S. 806 (1945) .................................................................................................................10
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Table of Authorities
(continued)
Page(s)
-iii-
Quest Integrity USA, LLC v. Clean Harbors Indus. Servs.,
No. 14-cv-01482, 2015 U.S. Dist. LEXIS 95148 (D. Del. July 22, 2015) ..............................12
Refac Int’l, Ltd. v. Lotus Dev. Corp.,
81 F.3d 1576 (Fed. Cir. 1996)..................................................................................................11
Ring Plus, Inc. v. Cingular Wireless Corp.,
614 F.3d 1354 (Fed. Cir. 2010)................................................................................................12
Senju Pharm. Co., Ltd. v Apotex, Inc.,
921 F. Supp. 2d 297 (D. Del. 2013) ...........................................................................................9
Southco, Inc. v. Penn Eng’g & Mfg. Corp.,
768 F. Supp. 2d 715 (D. Del. 2011) .............................................................................11, 12, 13
Symbol Techs. Inc. v. Aruba Networks, Inc.,
609 F. Supp. 2d 353 (D. Del. 2009) .......................................................................................3, 9
Therasense Inc. v. Becton Dickenson & Co.,
649 F.3d 1276 (Fed. Cir. 2011)................................................................................................10
Tyco Fire Prods. LP v. Victaulic Co.,
777 F. Supp. 2d 893 (E.D. Pa. 2011) .......................................................................................14
Umland v. PLANCO Fin. Servs., Inc.,
542 F.3d 59 (3d Cir. 2008).........................................................................................................9
Wyeth Holdings Corp. v. Sandoz, Inc.,
No. 09-cv-00955, 2012 U.S. Dist. LEXIS 26912 (D. Del. Feb. 3, 2012) ..........................11, 13
Statutes
42 U.S.C. § 262(k)(2) ......................................................................................................................4
42 U.S.C. § 262(l)(2)(B) ..................................................................................................................4
42 U.S.C. § 262(l)(3)(A) ..................................................................................................................4
42 U.S.C. § 262(l)(3)(B)(ii)(I) .....................................................................................................1, 4
42 U.S.C. § 262(l)(3)(C) ..............................................................................................................1, 5
Other Authorities
Federal Rule of Civil Procedure
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Table of Authorities
(continued)
Page(s)
-iv-
12(b)(6) ............................................................................................................................................9
8(a) .............................................................................................................................................3, 13
8(a)(2) ............................................................................................................................................14
9(b) .......................................................................................................................................2, 12, 13
12(f)..............................................................................................................................................2, 8
12(b)(6) ............................................................................................................................................2
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I. NATURE AND STAGE OF THE PROCEEDINGS
This case concerns Amgen Inc.’s (“Amgen”) ABP 980, a biosimilar trastuzumab developed
to treat various cancers, including breast cancer. Almost a year before this case began, the parties
engaged in the pre-suit exchange of information as set forth in the Biologics Price Competition
and Innovation Act (the “BPCIA”), 42 U.S.C. § 262(l) et seq.
As part of this information exchange, Genentech, Inc. (“Genentech”) and City of Hope
(collectively, “Plaintiffs”) provided a list of patents, purportedly related to trastuzumab, that they
believed could be asserted against Amgen’s ABP 980 product. In response, Amgen provided a
detailed statement under 42 U.S.C. § 262(l)(3)(B)(ii)(I) (“Amgen’s (3)(B) statement”) that
included, on a claim-by-claim basis, the factual and legal bases that the patents identified by
Plaintiffs were invalid and/or unenforceable and not infringed. Genentech then provided its
statement under 42 U.S.C. § 262(l)(3)(C) setting forth its validity and infringement positions.
After completing the information exchange, the parties negotiated the list of patents to be included
in the resulting lawsuit.
On June 21, 2018, Plaintiffs brought this action for patent infringement against Amgen.
D.I. 1. About a month later, Plaintiffs amended their complaint to drop nineteen patents, leaving
eighteen patents at issue. D.I. 15. On November 7, 2018, Plaintiffs identified ten patents and
twenty claims to assert in the litigation, including a patent application that has since issued as U.S.
Patent No. 10,160,811 (“the ’811 patent”). See D.I. 44. On January 17, 2019, Plaintiffs filed a
second amended complaint to add the ’811 patent and remove an expired patent. D.I. 75. At
present, the total number of asserted patents remains eighteen.1
1 On February 21, 2019, Plaintiffs supplemented their disclosures under the BPCIA to include
newly-issued U.S. Patent No. 10,184,106, but have not yet amended their complaint to assert this
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Amgen filed its Answer and Counterclaims to the second amended complaint on January
31, 2019. D.I. 80. Amgen’s Answer includes an eleventh affirmative defense of unclean hands
and inequitable conduct stemming from false statements that Genentech made to the U.S. Patent
Office during prosecution of U.S. Patent No. 6,407,213 (the “’213 patent”). Amgen’s
counterclaim Count 3 against the ’213 patent incorporates by reference these unclean hands and
inequitable conduct arguments. And consistent with the positions taken in its (3)(B) statement,
Amgen included counterclaims that each of the patents-in-suit is invalid and/or unenforceable and
not infringed.
On February 21, 2019, Plaintiffs filed the pending motion to strike Amgen’s eleventh
affirmative defense under Federal Rule of Civil Procedure 12(f) and to strike Amgen’s
counterclaims of unenforceability under Federal Rule of Civil Procedure 12(b)(6). D.I. 86.2
Plaintiffs do not argue that any other language should be stricken from Amgen’s counterclaims.
Because Plaintiffs’ motion is meritless and should be denied, Amgen opposes.
II. SUMMARY OF ARGUMENT
1. Plaintiffs are not entitled to the dismissal of Amgen’s inequitable conduct
affirmative defense or the striking of Amgen’s counterclaim that Genentech engaged in inequitable
conduct while prosecuting the ’213 patent. Amgen’s inequitable conduct theory meets the
pleading standard of Federal Rule of Civil Procedure 9(b). It is undisputed that Amgen’s
patent.
2 This motion is nearly identical to Plaintiffs’ motion filed on August 23, 2018 with respect to
Amgen’s Answer, Affirmative Defenses, and Counterclaims to the First Amended Complaint.
D.I. 23. Plaintiffs have not withdrawn that earlier motion, but have now abandoned their previous
argument that the counterclaims regarding seventeen of the patents-in-suit must satisfy Rule 9(b)’s
heightened pleading standard. As such, Plaintiffs concede that Rule 9(b)’s heightened pleading
standard does not apply to the counterclaims regarding these seventeen patents-in-suit. See infra
Section V.B, n.4.
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inequitable conduct allegations were pled with particularity, identifying the “who, what, when,
where, and how of the material misrepresentation or omission committed before the PTO.” IBM
v. Priceline Grp., Inc., Case No. 15-137-LPS-CJB, 2017 U.S. Dist. LEXIS 54285, at *13-14 (D.
Del. Apr. 10, 2017). Plaintiffs’ sole argument is that their false and misleading statements to the
U.S.P.T.O. should be characterized as permissible attorney argument, rather than inequitable
misrepresentations. This factual issue, however, cannot be resolved on a motion to dismiss or a
motion to strike. The Court is required to take the allegations in Amgen’s Answer as true and, as
such, Amgen has adequately pled that Plaintiffs committed inequitable conduct by deliberately
misleading the Patent Office.
2. Plaintiffs are similarly not entitled to strike Amgen’s counterclaims of
unenforceability of each of the eighteen asserted patents. Plaintiffs argue that all counterclaims of
unenforceability “fail to meet even the most liberal pleading standard.” However, seven of
Genentech’s patents are set to expire within the next three to four months or have already expired.
An expired patent cannot be enforced against activities that occurred after the expiration date.
Additionally, a subset of patents have been found invalid at the Patent Office, and if those decisions
are upheld by the Federal Circuit, those patents will also be unenforceable. Moreover, another
subset of patents are currently being challenged in other district court litigations. Those patents
will be unenforceable in this proceeding if they are found invalid in a final judgment in another
proceeding. Amgen’s counterclaims thus meet the broad notice-pleading standards of Federal
Rule of Civil Procedure 8(a). As with Genentech’s motion to dismiss, when ruling on a motion to
strike, this Court must construe all facts in favor of Amgen, “and deny the motion if the defense is
sufficient under the law.” Symbol Techs. Inc. v. Aruba Networks, Inc., 609 F. Supp. 2d 353, 356
(D. Del. 2009).
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III. STATEMENT OF FACTS
Amgen is a biotechnology pioneer with expertise in the development and manufacture of
biologic drugs, including biosimilars. D.I. 80, (Countercl.) ¶ 6. Biosimilar products are intended
to be “highly similar” to the reference product, with no clinically meaningful differences in safety,
purity, and potency. 42 U.S.C. § 262(k)(2). One of Amgen’s biosimilar products is ABP 980, a
biosimilar of Genentech’s biologic drug, Herceptin. Amgen has invested significant resources in
developing ABP 980, including developing the cell culture, harvest, and numerous purification
steps to manufacture and purify the ABP 980 antibody, and conducting numerous clinical studies
in human patients. D.I. 80, (Countercl.) ¶ 9.
A. Amgen’s Compliance With The BPCIA
The BPCIA, enacted by Congress in 2009, sets forth an abbreviated regulatory pathway
for FDA approval of biosimilar products. D.I. 80, (Countercl.) ¶¶ 10, 12. Amgen is seeking FDA
approval for ABP 980 as a biosimilar to Genentech’s Herceptin. D.I. 80 (Ans.), ¶ 7. Under the
BPCIA, the reference product sponsor (here, Genentech) and the biosimilar applicant (here,
Amgen) exchanged specific information under a statutorily proscribed timeline. Amgen complied
with these information exchange provisions. Under the first exchange, Amgen provided its BLA
to Genentech, along with additional manufacturing information requested by Genentech. 42
U.S.C. § 262(l)(2)(B). Genentech then identified patents for inclusion on its (3)(A) statement, for
which it purportedly believes that a claim of patent infringement could reasonably be brought
against Amgen. 42 U.S.C. § 262(l)(3)(A). Amgen then responded with its (3)(B) statement, a
detailed description, on a claim-by-claim basis, the factual and legal basis for its opinion that the
patents identified by Genentech are invalid, unenforceable, or will not be infringed. 42 U.S.C.
§ 262(l)(3)(B)(ii)(I). Amgen’s (3)(B) statement contains over a thousand pages setting forth its
invalidity, unenforceability, and non-infringement analysis. Genentech replied with its (3)(C)
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statement, which purported to set forth its validity and infringement positions for a subset of the
original patents on its (3)(C) list. 42 U.S.C. § 262(l)(3)(C).
After this series of information exchanges, the BPCIA provides that the parties shall engage
in good faith negotiations to identify the patents that should be asserted in the resulting district
court litigation. Genentech and Amgen negotiated a list of patents, and Genentech filed suit in this
Court. D.I. 1. Genentech later amended its complaint to exclude nineteen originally-asserted
patents. D.I. 15. Genentech amended its complaint a second time to assert one newly-issued patent
and drop one expired patent. D.I. 75. Amgen timely filed its Answer and Counterclaims that are
the basis of the instant motion. D.I. 80.
B. Amgen’s Eleventh Affirmative Defense Is That Genentech Committed
Inequitable Conduct Before the U.S.P.T.O
Amgen’s inequitable conduct theory rests on the misrepresentations and omissions made
by Genentech during the prosecution of the ’213 patent. Amgen pled with particularity the “who,
what, when, where, and how” of Genentech’s material misrepresentations and omissions. As
Amgen recited in its Answer,
Genentech deliberately misrepresented the teachings of U.S. Patent No. 5,530,101
(“the ’101 patent”) to the Patent Office in order to overcome a rejection based on
that reference. Specifically, Genentech told the Examiner that the ’101 patent does
not use the Kabat numbering system, despite its repeated references to “numbering
according to Kabat” and “the Kabat system.”
Genentech also made deliberate misrepresentations and omissions regarding Queen
1989, including (i) falsely distinguishing Queen 1989 on the ground that it used
“sequential numbering,” as opposed to the Kabat numbering system; and (ii)
providing information at the request of the Examiner that conspicuously omitted a
key residue (“62L”) disclosed in the prior art. Deceptive intent by Genentech is the
single most reasonable inference to be drawn from the prosecution history and all
other available evidence.
. . .
Contrary to Genentech’s representations to the Patent Office—namely, that the
’101 patent does not use the Kabat numbering system—the ’101 patent states:
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“Residues are numbered according to the Kabat system (E. A. Kabat et al.,
Sequences of Proteins of Immunological Interest (National Institutes of Health,
Bethesda, Md.) (1987).” (’101 patent at 9:13–18.) In addition, the ’101 patent
expressly refers to “numbering according to Kabat, op. cit.” with specific reference
to position 93 in the heavy chain. (See id. at 15:17–37.)
. . .
In order to overcome the § 102 rejection based on the ’101 patent, Genentech
falsely represented to the Patent Office that the ’101 patent used sequential
numbering, while arguing that the “claims of the instant application use Kabat
numbering for the framework region residues.” Genentech misrepresented the
teachings of the ’101 patent, despite clear and repeated references in the ’101 patent
to the Kabat numbering system. Absent Genentech’s false and misleading
distinction, the Examiner had no reason to withdraw the § 102 rejection based on
the ’101 patent.
Genentech also made deliberate and material misrepresentations and omissions
regarding Queen 1989 during the prosecution of the ’213 patent. Genentech
distinguished Queen 1989 on the ground that it used “sequential numbering,” as
opposed to the Kabat numbering system. At the Examiner’s request, Genentech
submitted a comparison of the different numbering systems purportedly utilized in
Queen 1989 and the pending claims.3 The alignments provided by Genentech to
the Examiner conspicuously omitted the “62L” residue in both numbering systems.
As noted above, residue “62L” was recited in then-pending claims of the ’213
patent, and Queen 1989 expressly discloses “residues at positions corresponding to
. . . 47 and 62 of the light chain (Fig. 2).” (See Queen 1989 at 10032.) Importantly,
Queen 1989 discloses residues in the Kabat numbering system and, in particular,
residue “62 of the light chain.”
D.I. 19 at 30-33.
C. Many Patents-In-Suit Will Expire Soon or Are Being Challenged In Other
Proceedings
Genentech currently asserts eighteen patents against Amgen. Many of these patents are set
to expire in the next three to four months or have already expired, have been found unpatentable
3 See [D.I. 19, n.1] 10/7/97 Applicant Remarks at 6–10 (“As requested by the Examiner in the
interview, alignments of heavy chain variable domain (Exhibit A) and light chain variable
domain (Exhibit B) sequences of the 101 patent (including the sequences for the murine and
humanized anti-Tac antibody of Queen et al.) with sequential and
Kabat residue numbering is attached.”).
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in inter partes review proceedings at the U.S. Patent Office, and/or are involved in other district
court or Federal Circuit proceedings.
The following patents have expired or will in the next three to four months:
EXPIRED
• 6,331,415: expired 12/18/2018
• 7,923,221: expired 12/18/2018
• 6,121,428: expired 6/12/2018
WILL EXPIRE IN NEXT 3-4 MONTHS
• 6,407,213: will expire 6/18/2019
• 6,417,335: will expire 5/3/2019
• 9,249,218: will expire 5/3/2019
• 6,620,918: will expire 5/6/2019
Amgen’s Answer plainly listed the expiration dates of each asserted patent. See D.I. 80
(Countercl.) ¶¶ 33-50.
Furthermore, the following patents have been found unpatentable at the U.S. Patent Office:
ALL CHALLENGED CLAIMS INVALIDATED
• 7,846,441 (IPR2017-01121; IPR2017-00731)
• 7,892,549 (IPR2017-00737)
SUBSET OF CHALLENGED CLAIMS INVALIDATED
• 6,407,213 (IPR2017-01488)
Finally, the following patents are at issue in other ongoing litigations:
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PATENTS ASSERTED IN CASE NO. 1-18-CV-01363 (D. DEL.)
• 6,331,415
• 7,923,221
• 6,407,213
• 7,846,441
• 7,892,549
• 6,627,196
• 7,371,379
• 6,417,335
• 9,249,218
• 8,574,869
• 7,993,834
• 8,076,066
• 8,440,402
• 8,512,983
• 9,714,293
• 10,160,811
PATENTS ASSERTED IN CASE NO. 1-17-CV-01407, -01471 (D. DEL.)
• 6,331,415
• 8,574,869
• 8,512,983
PATENTS AT ISSUE IN FEDERAL CIRCUIT APPEALS
• 7,846,441 (Case Nos. 19-1267, 19-1263)
• 7,892,549 (Case Nos. 19-1265, 19-1270)
• 6,627,196 (Case No. 19-1174)
• 7,371,379 (Case No. 19-1173)
IV. LEGAL STANDARDS
A. Motion to Strike under F.R.C.P. 12(f)
Motions to strike an affirmative defense under Federal Rule of Civil Procedure 12(f) are
generally disfavored. Fesnak & Assoc., LLP v. U.S. Bank. Nat’l Ass’n, 722 F. Supp. 2d 496, 502
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(D. Del. 2010). This Court has held that such a motion should not be granted “unless the
insufficiency of the defense is clearly apparent.” Senju Pharm. Co., Ltd. v Apotex, Inc., 921 F.
Supp. 2d 297, 301 (D. Del. 2013) (citing Symbol Techs., Inc., 609 F. Supp. 2d 353 at 356).
The purpose of pleading an affirmative defense “is to give the opposing party notice of the
plea.” Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 350 (1971). Generally,
an affirmative defense “need not be articulated with any rigorous degree of specificity.” Moody
v. Atl. City Bd. of Educ., 870 F.3d 206, 218 (3d Cir. 2017) (internal citations omitted). The
pleading standard set forth in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 583 (2007) and
Ashcroft v. Iqbal, 556 U.S. 662 (2009) does not extend to affirmative defenses. Senju Pharm., 921
F. Supp. 2d at 301 (citing Internet Media Corp. v. Hearst Newspapers, LLC, Case No. 10-cv-690,
2012 U.S. Dist. LEXIS 126788, at *2 (D. Del. Sept. 6, 2012)).
Further, when ruling on a motion to strike an affirmative defense, this Court must construe
all facts in favor of Amgen, the nonmoving party, and deny the motion “if the defense is sufficient
under the law.” Symbol Techs., 609 F. Supp. 2d at 356.
B. Motion to Dismiss under F.R.C.P. 12(b)(6)
This court, in weighing a motion to dismiss a counterclaim under Federal Rule of Civil
Procedure 12(b)(6), must ask “not whether a [counterclaim] plaintiff will ultimately prevail but
whether the claimant is entitled to offer evidence to support the claim.” Twombly, 550 U.S. at 583
(internal citation omitted); see also Ashcroft v. Iqbal, 556 U.S. 662 (2009). When considering a
Rule 12(b)(6) motion to dismiss, the court must accept as true all factual allegations in the
counterclaims and view them in the light most favorable to the counterclaim-plaintiff. Umland v.
PLANCO Fin. Servs., Inc., 542 F.3d 59, 64 (3d Cir. 2008).
A well-pleaded counterclaim may not be dismissed simply because “it strikes a savvy judge
that actual proof of [the alleged] facts is improbable, and that a recovery is very remote and
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unlikely.” Twombly, 550 U.S. at 556 (internal citation omitted). Determining whether a claim is
plausible is “a context-specific task that requires the reviewing court to draw on its judicial
experience and common sense.” Fowler v. UPMC Shadyside, 578 F.3d 203, 211 (3d Cir. 2009)
(quoting Iqbal, 556 U.S. at 679).
V. ARGUMENT
A. Amgen’s Eleventh Affirmative Defense of Inequitable Conduct and Its
Inequitable Conduct Counterclaim Count 3 Are Legally Sufficient
It is black letter law that Genentech may not seek to enforce rights that were obtained by
fraud against the public. Precision Instrument Mfg. Co. v. Auto Maint. Mach. Co., 324 U.S. 806,
816 (1945) (“The far-reaching social and economic consequences of a patent, therefore, give the
public a paramount interest in seeing that patent monopolies spring from backgrounds free from
fraud or other inequitable conduct.”); see also Therasense Inc. v. Becton Dickenson & Co., 649
F.3d 1276, 1285 (Fed. Cir. 2011) (“Inequitable conduct is an equitable defense to patent
infringement, that, if proved, bars enforcement of a patent.”).
Amgen properly pled its affirmative defense of inequitable conduct, calling out
Genentech’s fraudulent behavior and including the “who, what, when, where, and how” of
Genentech’s inequitable conduct. See Section III.B; Exergen Corp. v. Wal-Mart Stores, Inc., 575
F.3d 1312, 1327 (Fed. Cir. 2009). For example, Amgen alleged that during prosecution of the ’213
patent, Genentech deliberately misrepresented the teachings of the ’101 patent and the Queen 1989
references to overcome a rejection of pending claims, and further provided empirical information
at the Examiner’s request that conspicuously omitted a claim element disclosed in the prior art.
D.I. 19 at 30-33. Amgen further pled that “deceptive intent by Genentech is the single most
reasonable inference to be drawn” from Genentech’s conduct in prosecuting the ’213 patent. Id. at
30.
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Other courts in this District have denied a patent owner’s motion to dismiss inequitable
conduct counterclaims based on allegations nearly identical to Amgen’s: that a patentee committed
inequitable conduct when it affirmatively “misrepresented the teachings of the prior art in a manner
that would be recognized as false by a person of ordinary skill in the art, and also submitted
incomplete, misleading, and internally inconsistent empirical data.” Wyeth Holdings Corp. v.
Sandoz, Inc., No. 09-cv-00955, 2012 U.S. Dist. LEXIS 26912, at *28 (D. Del. Feb. 3, 2012); see
also Southco, Inc. v. Penn Eng’g & Mfg. Corp., 768 F. Supp. 2d 715 (D. Del. 2011). In Wyeth,
the court rejected the patent owner’s argument that simply presenting arguments and
interpretations concerning a reference that was in front of the examiner did not constitute
inequitable conduct. Wyeth, 2012 U.S. Dist. LEXIS 26912 at *33-34, 36 (“As an initial matter,
the Court agrees with Sandoz that Wyeth is not relieved of responsibility for any alleged
misstatements simply because the ’277 reference and the stabilization data were before the PTO.”).
Instead, the court found that at the motion to dismiss stage, it “could reasonably infer that Wyeth’s
statements crossed the line from permissible advocacy to impermissible representation.” Id.
Further, while Plaintiffs dispute Amgen’s allegations and attempt to characterize
Genentech’s misleading statements as merely attorney argument, this is irrelevant. Butamax Adv.
Biofuels v. Gevo, No. 11-54, 2012 U.S. Dist. LEXIS 86215, at *10 (D. Del. June 21, 2012) (noting
that whether plaintiffs agree or disagree with defendants’ inequitable conduct allegations “is
irrelevant, as the court is not required to judge the merits of the parties’ respective positions at this
stage in the proceedings”); Refac Int’l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1584 (Fed. Cir.
1996) (“While an affiant may insist that his sworn statements were truthful or that any omissions
were not material or not made with intent to deceive, these are matters of proof and credibility.”).
Whether Genentech’s statements are misleading statements or attorney argument raises a
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factual dispute that is not properly resolved on a motion to dismiss. Quest Integrity USA, LLC v.
Clean Harbors Indus. Servs., No. 14-cv-01482, 2015 U.S. Dist. LEXIS 95148, at *15-16 (D. Del.
July 22, 2015) (declining to dismiss inequitable conduct claim where the patentee merely
“disagree[d] with the factual representations made by [defendant]”); IBM v. Priceline Grp., Inc.,
No. 15-cv-00137, 2017 U.S. Dist. LEXIS 54285, at *39-40 (D. Del. Apr. 10, 2017) (“[A
patentee’s] factual disagreement . . . does not support dismissal of Defendants’ counterclaim at the
pleading stage.”).
Even though this Court need not resolve any factual disputes at this stage, Plaintiffs’
arguments that their misrepresentations were simply unobjectionable attorney argument misstates
the law. “Although an attorney is free to argue vigorously in favor of patentability without being
subject to allegations of inequitable conduct, ‘the law prohibits genuine misrepresentations of
material fact.’” Ring Plus, Inc. v. Cingular Wireless Corp., 614 F.3d 1354, 1360-61 (Fed. Cir.
2010) (citing Rothman v. Target Corp., 556 F.3d 1310, 1328 (Fed. Cir. 2009).) Accordingly, an
attorney can commit inequitable conduct by mischaracterizing references that the Examiner is free
to independently review. Ring Plus, 614 F.3d at 1360-61 (holding that a statement misrepresenting
the substance of two references before the Examiner was “outside the bounds of permissible
attorney argument”). Moreover, attorney argument made with intent to deceive can give rise to
inequitable conduct. Southco, Inc., 768 F. Supp. 2d at 723 (“[Patentee’s] arguments to the
Examiner amounted to material representations because [patentee] knew its arguments were
factually and patently false.”).
At this stage in the proceedings, to survive Plaintiffs’ motion to dismiss and strike, Amgen
must demonstrate that it pled its inequitable conduct allegations in accordance with Federal Rule
of Civil Procedure 9(b). As explained above, Amgen has provided the proper notice to Genentech;
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it need not prove that the factual allegations are true or that it will prevail on the merits. See
Southco, Inc, 768 F. Supp. 2d at 720 (“The purpose of Rule 9(b) is to provide [the opposing party]
with notice of the precise nature of the claim against them, not to test the factual allegations of the
claim.”); Wyeth, 2012 U.S. Dist. LEXIS 26912, at *20-28 (distinguishing the pleading standard
for inequitable conduct from the standard for proving it). Here, Amgen has pled with particularity
that Genentech deliberately mischaracterized the prior art and made other misrepresentations
during prosecution. This is sufficient to state an inequitable conduct affirmative defense and
counterclaim.
B. Amgen’s Unenforceability Counterclaims Are Legally Sufficient
Genentech broadly attacks all of Amgen’s unenforceability counterclaims, arguing that
they contain boilerplate allegations that fail to meet Rule 8’s pleading standard. As an initial point,
Amgen’s counterclaim of unenforceability of the ’213 patent is based on Genentech’s inequitable
conduct and adequately meets even the heightened pleading standard under Rule 9(b), as discussed
above. For the remaining counterclaims, however, Rule 8(a) simply mandates “a short and plain
statement of the claim showing that the pleader is entitled to relief.”4 Amgen’s pleadings easily
satisfy this threshold.
As described above, there are a number of ways in which Genentech’s patents are likely
unenforceable now or in the near term. For example, as explicitly set forth in Amgen’s
counterclaims, many of the asserted patents will expire shortly—or, in three cases, have already
expired. See D.I. 80 (Countercl.) ¶¶ 33-50. These patents are, or will shortly become,
unenforceable with respect to any activities that occurred after patent expiry. See, e.g., Kimble v.
4 As noted above, by removing its previous argument that the remaining seventeen counterclaims
must satisfy a heightened pleading standard, Plaintiffs concede that Rule 9(b) does not apply to
these counterclaims. See supra Section I, n.1.
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Marvel Entm’t, LLC, 135 S. Ct. 2401, 2406-09 (2015) (noting that “when the patent expires, the
patentee’s prerogatives expire too, and the right to make or use the article, free from all restriction,
passes to the public”). Similarly, in the past few months, the U.S. Patent Office has found claims
of three of Genentech’s asserted patents unpatentable. Further, many of these patents are also
being challenged in other district court and Federal Circuit proceedings. Once Genentech has
exhausted its right to appeal and the patent is held invalid, it will not be enforceable. ePlus, Inc.
v. Lawson Software, Inc., 789 F.3d 1349 (Fed. Cir. 2015).
In this district, courts use the same standard in ruling on a motion to dismiss a counter
claim under Rule 12(b)(6) as they do in assessing a claim in a complaint. See Idenix Pharms., Inc.
v. Gilead Scis., Inc., Case No. 13-1987-LPS, 2014 U.S. Dist. LEXIS 118789, at *5 (D. Del. Aug.
25, 2014); Tyco Fire Prods. LP v. Victaulic Co., 777 F. Supp. 2d 893, 898-99 (E.D. Pa. 2011)
(citing cases). This Court must accept all of the facts pled in the counterclaims as true, and
determine “whether the facts alleged in the complaint are sufficient to show that the plaintiff has
a ‘plausible claim for relief.’” Fowler, 578 F.3d at 211 (internal citations omitted). In assessing
the plausibility of a claim, the court must “construe the complaint in the light most favorable to
the plaintiff, and determine whether, under any reasonable reading of the complaint, the plaintiff
may be entitled to relief.” Id. at 210 (quoting Phillips v. Cnty. of Allegheny, 515 F.3d 224, 233 (3d
Cir. 2008)).
Amgen has met the general pleading standard set forth in Federal Rule of Civil Procedure
8(a)(2) for its counterclaims of unenforceability. Amgen has also met the heightened pleading
standard for its counterclaim of unenforceability of the ’213 patent due to inequitable conduct.
Given that Amgen’s counterclaims must be construed in the light most favorable to Amgen, these
counterclaims should not be dismissed.
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VI. CONCLUSION
For the foregoing reasons, Amgen respectfully requests that the Court deny Plaintiffs’
motion in its entirety.
Dated: March 7, 2019
Of Counsel:
Orion Armon
Cooley, LLP
380 Interlocken Crescent
Suite 900
Broomfield, CO 80021-8023
P 720-566-4119
oarmon@cooley.com
Eamonn Gardner
Cooley, LLP
4401 Eastgate Mall
San Diego, CA 92121-1909
P 858-550-6086
egardner@cooley.com
Susan Krumplitsch
Michelle Rhyu
Daniel Knauss
Cooley, LLP
3175 Hanover Street
Palo Alto, CA 94304-1130
P 650-843-5287
skrumplitsch@cooley.com
mrhyu@cooley.com
dknauss@cooley.com
SMITH, KATZENSTEIN & JENKINS, LLP
/s/ Neal C. Belgam
Neal C. Belgam (No. 2721)
Eve H. Ormerod (No. 5369)
1000 West Street, Suite 1501
Wilmington, DE 19801
(302) 652-8400
nbelgam@skjlaw.com
eormerod@skjlaw.com
Attorneys for Defendant Amgen Inc.
Nancy Gettel
Thomas Lavery, IV
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-
1799
P 805-447-1000
ngettel@amgen.com
tlavery@amgen.com
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