IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
AMGEN INC.,
Plaintiff,
v.
AJANTA PHARMA LIMITED and AJANTA
PHARMA USA INC.,
Defendants.
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C.A. No. 16-899 (GMS)
PLAINTIFF’S REPLY BRIEF IN SUPPORT OF ITS MOTION TO DISMISS
DEFENDANTS’ COUNTERCLAIM FOR INVALIDITY UNDER 35 U.S.C. §§ 101, 112,
THE DEFENSES RECOGNIZED IN 35 U.S.C. § 282(b), DOUBLE PATENTING,
AND/OR OTHER JUDICIALLY-CREATED BASES FOR INVALIDATION
OF COUNSEL:
John D. Murnane
Joshua I. Rothman
Alicia A. Russo
FITZPATRICK, CELLA, HARPER & SCINTO
1290 Avenue of the Americas
New York, NY 10104-3800
(212) 218-2100
Wendy A. Whiteford
Lois M. Kwasigroch
AMGEN INC.
One Amgen Center Drive
Thousand Oaks, CA 91320-1789
(805) 447-1000
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
Attorneys for Amgen Inc.
January 10, 2017
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 1 of 11 PageID #: 178
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TABLE OF CONTENTS
TABLE OF AUTHORITIES ...................................................................................................... ii
I. INTRODUCTION ........................................................................................................... 1
II. ARGUMENT .................................................................................................................. 1
A. Defendants Do Not Provide Any Factual Support for Allegations of Invalidity
Under §§ 101, 112, and 282(b), Double Patenting, Or Other Judicially-Created
Bases for Invalidity .............................................................................................. 1
B. Defendants’ Reliance on CryoLife Is Unavailing Because Defendants Fail to
Identify Specific Bases for Their Invalidity Contentions....................................... 3
C. The Twombly/Iqbal Standard Applies to Patent Cases Even When Claim
Construction Might Be Required .......................................................................... 5
D. Defendants’ Reliance on Helferich Is Misplaced .................................................. 6
III. CONCLUSION ............................................................................................................... 6
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TABLE OF AUTHORITIES
Page(s)
CASES
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ..................................................................................................... passim
Bell Atl. Corp v. Twombly,
550 U.S. 544 (2007) ..................................................................................................... passim
CryoLife, Inc. v. C.R. Bard, Inc.,
C.A. No. 14-559-SLR, 2015 WL 1069397 (D. Del. Mar. 10, 2015) ............................... 1, 3, 4
Eli Lilly and Co. v. Barr Labs., Inc.,
251 F.3d 955 (Fed. Cir. 2011)................................................................................................ 5
EMC Corp. v. Zerto, Inc.,
C.A. No. 12-956-GMS, 2014 WL 3809365 (D. Del. July 31, 2014) ................................... 2, 6
Execware, LLC v. BJ’s Wholesale Club, Inc.,
C.A. No. 14-233-LPS, 2015 WL 5734434 (D. Del. Sept. 30, 2015) ...................................... 5
Helferich Patent Licensing, LLC v. J.C. Penney Corp.,
C.A. No. 11-cv-9143, 2012 WL 3776892 (N.D. Ill. Aug. 28, 2012) ...................................... 6
Idenix Pharm., Inc. v. Gilead Sciences, Inc.,
C.A. No. 13-1987-LPS-CJB, 2014 WL 4222902 (D. Del. Aug. 25, 2014).......................... 2, 6
Internet Media Corp v. Hearst Newspapers, LLC,
C.A. No. 10-690-SLR, 2011 WL 2559556 (D. Del. June 28, 2011) ....................................... 5
Internet Media Corp v. Hearst Newspapers, LLC,
C.A. No. 10-690-SLR, 2012 WL 3867165 (D. Del. Sept. 6, 2012) ..................................... 2, 6
Senju Pharm. Co. v. Apotex, Inc.,
921 F. Supp. 2d 297 (D. Del. 2013) ................................................................................... 2, 6
RULES AND STATUTES
Fed. R. Civ. P. 12 ........................................................................................................................ 7
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I. INTRODUCTION
Defendants’ counterclaim for invalidity under 35 U.S.C. §§ 101, 112, the defenses
recognized in 35 U.S.C. § 282(b), double patenting, and/or other judicially-created bases for
invalidation should be dismissed for failure to state a claim. Nothing in Defendants’ Opposition
(D.I. 21) justifies their failure to meet the basic pleading requirements under Supreme Court
precedent. Rather, Defendants’ Counterclaim simply lists every possible basis for invalidity,
whether statutory or judicially-created, but fails to provide any factual basis for invalidity under
§§ 101, 112, the defenses recognized in § 282(b), double patenting, and/or other judicially-
created bases for invalidation. As such, it fails to meet the required legal standard and should be
dismissed.
II. ARGUMENT
Defendants do not dispute that the standard for pleading is provided in Twombly/Iqbal: a
pleading must set forth sufficient factual allegations to give rise to “a plausible claim for relief”
(Iqbal, 556 U.S. at 679) and provide “fair notice of what the … claim is and the grounds upon
which it rests” (Twombly, 550 U.S. at 545 (internal citations omitted)).
A. Defendants Do Not Provide Any Factual Support for Allegations of
Invalidity Under §§ 101, 112, and 282(b), Double Patenting, Or Other
Judicially-Created Bases for Invalidity
Amgen seeks to dismiss only the allegations in Defendants’ counterclaim for invalidity
under §§ 101, 112, the defenses recognized in § 282(b), double patenting, and/or other judicially-
created bases for invalidation because Defendants fail to assert any factual allegations as support.
(D.I. 17 at 7-8.)
It is only for invalidity allegations under §§ 102 and 103 that Defendants cite any facts,
i.e., three prior art references:
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By way of example and not limitation, the claims of the ’405
patent are invalid under §§ 102 and/or 103, at least in view of
any combination of [three references], alone or in combination
with other prior art.
(D.I. 12 at 8.) In contrast, Defendants have not cited in their counterclaim any factual support
for their allegations of invalidity under §§ 101, 112, the defenses recognized in § 282(b), double
patenting, and/or other judicially-created bases for invalidation. (See id.) Defendants now
suggest that those prior art references are the factual support for their invalidity allegations under
§§ 101, 112, the defenses recognized in § 282(b), double patenting, and/or other judicially-
created bases for invalidation. (D.I. 21 at 2.) But this argument has no basis in their answer,
which only applies those three references to their invalidity allegations under §§ 102 and/or 103.1
And, as discussed below, these references cannot properly form the basis for all Defendants’
invalidity allegations.
In these circumstances, when invalidity allegations in counterclaims are wholly devoid of
supporting factual allegations, this Court has found the pleadings insufficient under the
Twombly/Iqbal standard. See EMC Corp. v. Zerto, Inc., C.A. No. 12-956-GMS, 2014 WL
3809365 at *2 (D. Del. July 31, 2014). So have other judges in this district. Senju Pharm. Co. v.
Apotex, Inc., 921 F. Supp. 2d 297, 303 (D. Del. 2013); Internet Media Corp v. Hearst
Newspapers, LLC, C.A. No. 10-690-SLR, 2012 WL 3867165 at *1-2 (D. Del. Sept. 6, 2012);
Idenix Pharm., Inc. v. Gilead Sciences, Inc., C.A. No. 13-1987-LPS-CJB, 2014 WL 4222902 at
*6-7 (D. Del. Aug. 25, 2014).
1 Defendants correctly note that Amgen did not challenge the sufficiency of the pleadings
for the allegations of invalidity under §§ 102 and 103. (D.I. 21 at 1.)
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B. Defendants’ Reliance on CryoLife Is Unavailing Because Defendants Fail to
Identify Specific Bases for Their Invalidity Contentions
Defendants’ reliance on Judge Robinson’s decision in CryoLife, Inc. v. C.R. Bard, Inc.,
C.A. No. 14-559-SLR, 2015 WL 1069397 (D. Del. Mar. 10, 2015), is unavailing. Defendants
assert that their counterclaim, like the invalidity claim in CryoLife, satisfies the Twombly/Iqbal
standard because it “identifies the specific statutory sections regarding invalidity” and “provides
examples of invalidating prior art.” (D.I. 21 at 4 (citing 2015 WL 1069397, at *4).) But here,
Defendants do not even identify the specific bases for their invalidity contentions and further fail
to include facts relevant to invalidity under § 282(b), judicially-created bases for invalidation, §§
112, 101, and double patenting.
First, Defendants list § 282(b) in their invalidity counterclaim (D.I. 12 at 8), but § 282(b)
includes any basis for invalidity in Title 35 of the United States Code. See § 282(b)(4) (“Any
other fact or act made a defense by this title.”). Simply listing § 282(b) in the counterclaim for
invalidity does not provide Amgen with fair notice of the statutory invalidity claims Defendants
are asserting. See Twombly, 550 U.S. at 545. Moreover, Defendants have not identified facts to
support allegations of invalidity under every possible basis for invalidity in 35 U.S.C.
Second, in addition to every possible statutory basis for invalidity, Defendants also allege
invalidity based on undefined “judicially-created bases for invalidation” (D.I. 12 at 8). Simply
saying “judicially-created bases for invalidation” does not provide Amgen with fair notice of the
invalidity claims Defendants are asserting. See Twombly, 550 U.S. at 545. Moreover,
Defendants have not identified any facts to support allegations of invalidity under every
judicially-created basis for invalidity.
Third, Defendants allege invalidity based on § 112 (D.I. 12 at 8), but § 112 provides at
least four different bases for invalidity: lack of written description, lack of enablement,
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 6 of 11 PageID #: 183
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indefiniteness of the claims, and improper claim form. Defendants fail to identify any basis for
their invalidity allegations under § 112. See Twombly, 550 U.S. at 545. CryoLife is
distinguishable because the pleading alleged the claims were “invalid under 35 U.S.C. § 112 for
lack of written description.” 2015 WL 1069397, at *4 (emphasis added). The plaintiff in
CryoLife at least identified the basis for invalidity under § 112. Defendants’ assertion of
invalidity under § 112 leaves Amgen without proper notice of which specific invalidity basis
under § 112 Defendants plan to pursue. Defendants do not discuss the specification or any
claims of the ’405 patent. Therefore, Defendants also fail to provide factual support for their
allegation of invalidity under § 112.
Fourth, Defendants allege invalidity based on § 101 (D.I. 12 at 8), but § 101 provides
four bases for invalidity: statutory double patenting, incorrect inventorship, ineligible subject
matter, and lack of utility. Defendants fail to identify any basis for their invalidity allegations
under § 101. See Twombly, 550 U.S. at 545. Simply listing § 101 does not provide Amgen with
fair notice of the basis for Defendants’ allegations under § 101. Id. Moreover, Defendants have
not identified any facts to support any basis for invalidity under § 101.
Finally, Defendants allege invalidity based on double patenting, but there are two bases
for double patenting: statutory double patenting and obviousness-type double patenting.
Defendants fail to identify which is their basis for alleging double patenting. See Twombly, 550
U.S. at 545. Simply saying “double patenting” does not provide Amgen with fair notice of the
basis for Defendants’ allegations. Id. Moreover, Defendants have not identified any patents that
could form the basis for this defense.
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C. The Twombly/Iqbal Standard Applies to Patent Cases Even When Claim
Construction Might Be Required
Defendants also argue that they “cannot” plead claims under §§ 101, 112, and double
patenting with any greater specificity because these “claims are dependent on Amgen’s claim
construction, which has not yet been provided.”2 (D.I. 21 at 5-6.) But Defendants do not cite any
cases that support the proposition that a pleading does not need to meet the Twombly/Iqbal
standard because claim construction might be necessary.
The three cases Defendants cite are not relevant. In Execware and Internet Media, rather
than file answers, the defendants moved dismiss for invalidity under § 101 or § 112,
respectively. See Execware, LLC v. BJ’s Wholesale Club, Inc., C.A. No. 14-233-LPS, 2015 WL
5734434, at *1 (D. Del. Sept. 30, 2015); Internet Media Corp. v. Hearst Newspapers, LLC, C.A.
No. 10-690-SLR, 2011 WL 2559556, at *2 (D. Del. June 28, 2011). The Court did not address
whether counterclaims met the Twombly/Iqbal standard because there were no answers and no
counterclaims. The third case concerns not a motion to dismiss, but a summary judgment
motion. See Eli Lilly and Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2011). Therefore,
these cases are not relevant to the current motion to dismiss.
In the end, Defendants’ are simply unable to offer any relevant cases for the proposition
that they “cannot” assert their counterclaims under §§ 101, 112, and double patenting with any
greater specificity. In contrast, several defendants in related cases have alleged invalidity under
§ 1123 in their answers and provided both the specific theory of invalidity under § 112 and facts
2 Defendants do not argue that claim construction is necessary before they can plead their
invalidity defenses recognized in § 282(b) or other judicially-created bases for
invalidation. Nor do they explain why they are able to plead claims under §§ 102 and
103, but not their other bases, without claim construction.
3 None of the defendants in related cases have asserted invalidity under § 101 or double
patenting.
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 8 of 11 PageID #: 185
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in support. See Amgen Inc. v. Micro Labs Limited et al., C.A. No. 16-854-GMS, D.I. 21 at ¶ 26
(D. Del.); Amgen Inc. v. Dr. Reddy’s Laboratories, Ltd. et al., C.A. No. 16-900-GMS, D.I. 19 at
¶ 26 (D. Del.); Amgen Inc. v. Hetero USA Inc. et al., C.A. No. 16-928-GMS, D.I. 12 at ¶ 24 (D.
Del.); Amgen Inc. v. Aurobindo Pharma Limited et al., C.A. No. 16-853-GMS, D.I. 16 at ¶ 24
(D. Del.); Amgen Inc. Breckenridge Pharmaceutical, Inc., C.A. No. 16-927-GMS, D.I. 17 at ¶ 25
(D. Del.)4.
D. Defendants’ Reliance on Helferich Is Misplaced
Finally, Defendants’ reliance on Helferich Patent Licensing, LLC v. J.C. Penney Corp.,
C.A. No. 11-cv-9143, 2012 WL 3776892 (N.D. Ill. Aug. 28, 2012), is misplaced. (See D.I. 21 at
6). Helferich is not binding and is inconsistent with the law of this Court. In particular, this
Court and other judges in this district have consistently held that simply citing statutory
provisions without providing any factual support does not satisfy the Twombly/Iqbal standard.
See EMC, 2014 WL 3809365 at *2; Senju, 921 F. Supp. 2d at 303; Internet Media, 2012 WL
3867165 at *1-2; Idenix, 2014 WL 4222902 at *6-7. According to the standards required by
Twombly/Iqbal and this Court, Defendants have not sufficiently pleaded their invalidity
counterclaims based on §§ 101, 112, the defenses recognized in § 282(b), double patenting,
and/or other judicially-created bases for invalidity.
III. CONCLUSION
For the reasons set forth in its Opening Brief and herein, Amgen respectfully requests
that this Court dismiss Defendants’ counterclaim for invalidity, under §§ 101, 112, the defenses
recognized in § 282(b), double patenting, and/or other judicially-created bases for invalidation,
pursuant to Fed. R. Civ. P. 12(b)(6) for failure to state a claim.
4 In fact, every other defendant in these related actions that was asked to amend its Answer
to bring it into compliance with the Twombly/Iqbal standard, voluntarily filed an
Amended Answer.
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 9 of 11 PageID #: 186
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OF COUNSEL:
John D. Murnane
Joshua I. Rothman
Alicia A. Russo
FITZPATRICK, CELLA, HARPER & SCINTO
1290 Avenue of the Americas
New York, NY 10104-3800
(212) 218-2100
Wendy A. Whiteford
Lois M. Kwasigroch
AMGEN INC.
One Amgen Center Drive
Thousand Oaks, CA 91320-1789
(805) 447-1000
MORRIS, NICHOLS, ARSHT & TUNNELL LLP
/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014)
Maryellen Noreika (#3208)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
jblumenfeld@mnat.com
mnoreika@mnat.com
Attorneys for Amgen Inc.
January 10, 2016
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 10 of 11 PageID #: 187
CERTIFICATE OF SERVICE
I hereby certify that on January 10, 2017, I caused the foregoing to be electronically filed
with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
registered participants.
I further certify that I caused copies of the foregoing document to be served on
January 10, 2017, upon the following in the manner indicated:
John C. Phillips, Jr., Esquire
David A. Bilson, Esquire
PHILLIPS GOLDMAN MCLAUGHLIN & HALL, P.A.
1200 North Broom Street
Wilmington, Delaware 19806
Attorneys for Defendants Ajanta Pharma Limited
and Ajanta Pharma USA Inc.
VIA ELECTRONIC MAIL
Sailesh K. Patel, Esquire
Jaimin H. Shah, Esquire
Tara L. Feld, Esquire
Schiff Hardin LLP
233 South Wacker Drive, Suite 6600
Chicago, IL 60606
Attorneys for Defendants Ajanta Pharma
Limited and Ajanta Pharma USA Inc.
VIA ELECTRONIC MAIL
/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014)
Case 1:16-cv-00899-GMS Document 26 Filed 01/10/17 Page 11 of 11 PageID #: 188
