Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 1 of 20 PageID #: 11420
`
`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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`
`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 2 of 20 PageID #: 11421
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`Table of Contents
`
`
`Page
`
`
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`VI.
`
`
`
`
`
`
`
`NATURE AND STAGE OF THE PROCEEDINGS ........................................................ 1
`
`SUMMARY OF ARGUMENT ......................................................................................... 2
`
`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
`LEGAL STANDARDS ..................................................................................................... 8
`A.
`Motion to Strike under F.R.C.P. 12(f) ................................................................... 8
`
`Motion to Dismiss under F.R.C.P. 12(b)(6)........................................................... 9
`B.
`ARGUMENT ................................................................................................................... 10
`A.
`Amgen’s Eleventh Affirmative Defense of Inequitable Conduct and Its
`Inequitable Conduct Counterclaim Count 3 Are Legally Sufficient ................... 10
`
`Amgen’s Unenforceability Counterclaims Are Legally Sufficient ..................... 13
`B.
`CONCLUSION ................................................................................................................ 15
`
`-i-
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 3 of 20 PageID #: 11422
`
`Table of Authorities
`
`
`Page(s)
`
`
`
`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
`
`
`
`
`
`-ii-
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 4 of 20 PageID #: 11423
`
`Table of Authorities
`(continued)
`
`Page(s)
`
`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
`
`
`
`
`
`-iii-
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 5 of 20 PageID #: 11424
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`Table of Authorities
`(continued)
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`Page(s)
`12(b)(6) ............................................................................................................................................9
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`8(a) .............................................................................................................................................3, 13
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`8(a)(2) ............................................................................................................................................14
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`9(b) .......................................................................................................................................2, 12, 13
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`12(f)..............................................................................................................................................2, 8
`
`12(b)(6) ............................................................................................................................................2
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`
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`-iv-
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 6 of 20 PageID #: 11425
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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
`
`1
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 7 of 20 PageID #: 11426
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`Amgen filed its Answer and Counterclaims to the second amended complaint on January
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`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.
`
`2
`
`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 8 of 20 PageID #: 11427
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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).
`
`3
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 9 of 20 PageID #: 11428
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`III.
`
`STATEMENT OF FACTS
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`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
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`to be “highly similar” to the reference product, with no clinically meaningful differences in safety,
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`purity, and potency. 42 U.S.C. § 262(k)(2). One of Amgen’s biosimilar products is ABP 980, a
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`biosimilar of Genentech’s biologic drug, Herceptin. Amgen has invested significant resources in
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`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
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`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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`4
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 10 of 20 PageID #: 11429
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`statement, which purported to set forth its validity and infringement positions for a subset of the
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`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
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`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
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`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:
`
`5
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 11 of 20 PageID #: 11430
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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.”).
`
`6
`
`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 12 of 20 PageID #: 11431
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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:
`
`
`
`
`
`7
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`

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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 13 of 20 PageID #: 11432
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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
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`generally disfavored. Fesnak & Assoc., LLP v. U.S. Bank. Nat’l Ass’n, 722 F. Supp. 2d 496, 502
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`8
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 14 of 20 PageID #: 11433
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`(D. Del. 2010). This Court has held that such a motion should not be granted “unless the
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`insufficiency of the defense is clearly apparent.” Senju Pharm. Co., Ltd. v Apotex, Inc., 921 F.
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`Supp. 2d 297, 301 (D. Del. 2013) (citing Symbol Techs., Inc., 609 F. Supp. 2d 353 at 356).
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`The purpose of pleading an affirmative defense “is to give the opposing party notice of the
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`plea.” Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 350 (1971). Generally,
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`an affirmative defense “need not be articulated with any rigorous degree of specificity.” Moody
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`v. Atl. City Bd. of Educ., 870 F.3d 206, 218 (3d Cir. 2017) (internal citations omitted). The
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`pleading standard set forth in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 583 (2007) and
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`Ashcroft v. Iqbal, 556 U.S. 662 (2009) does not extend to affirmative defenses. Senju Pharm., 921
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`F. Supp. 2d at 301 (citing Internet Media Corp. v. Hearst Newspapers, LLC, Case No. 10-cv-690,
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`2012 U.S. Dist. LEXIS 126788, at *2 (D. Del. Sept. 6, 2012)).
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`Further, when ruling on a motion to strike an affirmative defense, this Court must construe
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`all facts in favor of Amgen, the nonmoving party, and deny the motion “if the defense is sufficient
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`under the law.” Symbol Techs., 609 F. Supp. 2d at 356.
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`B. Motion to Dismiss under F.R.C.P. 12(b)(6)
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`This court, in weighing a motion to dismiss a counterclaim under Federal Rule of Civil
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`Procedure 12(b)(6), must ask “not whether a [counterclaim] plaintiff will ultimately prevail but
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`whether the claimant is entitled to offer evidence to support the claim.” Twombly, 550 U.S. at 583
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`(internal citation omitted); see also Ashcroft v. Iqbal, 556 U.S. 662 (2009). When considering a
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`Rule 12(b)(6) motion to dismiss, the court must accept as true all factual allegations in the
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`counterclaims and view them in the light most favorable to the counterclaim-plaintiff. Umland v.
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`PLANCO Fin. Servs., Inc., 542 F.3d 59, 64 (3d Cir. 2008).
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`A well-pleaded counterclaim may not be dismissed simply because “it strikes a savvy judge
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`that actual proof of [the alleged] facts is improbable, and that a recovery is very remote and
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 15 of 20 PageID #: 11434
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`unlikely.” Twombly, 550 U.S. at 556 (internal citation omitted). Determining whether a claim is
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`plausible is “a context-specific task that requires the reviewing court to draw on its judicial
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`experience and common sense.” Fowler v. UPMC Shadyside, 578 F.3d 203, 211 (3d Cir. 2009)
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`(quoting Iqbal, 556 U.S. at 679).
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`V.
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`ARGUMENT
`A.
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`Amgen’s Eleventh Affirmative Defense of Inequitable Conduct and Its
`Inequitable Conduct Counterclaim Count 3 Are Legally Sufficient
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`It is black letter law that Genentech may not seek to enforce rights that were obtained by
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`fraud against the public. Precision Instrument Mfg. Co. v. Auto Maint. Mach. Co., 324 U.S. 806,
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`816 (1945) (“The far-reaching social and economic consequences of a patent, therefore, give the
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`public a paramount interest in seeing that patent monopolies spring from backgrounds free from
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`fraud or other inequitable conduct.”); see also Therasense Inc. v. Becton Dickenson & Co., 649
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`F.3d 1276, 1285 (Fed. Cir. 2011) (“Inequitable conduct is an equitable defense to patent
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`infringement, that, if proved, bars enforcement of a patent.”).
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`Amgen properly pled its affirmative defense of inequitable conduct, calling out
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`Genentech’s fraudulent behavior and including the “who, what, when, where, and how” of
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`Genentech’s inequitable conduct. See Section III.B; Exergen Corp. v. Wal-Mart Stores, Inc., 575
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`F.3d 1312, 1327 (Fed. Cir. 2009). For example, Amgen alleged that during prosecution of the ’213
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`patent, Genentech deliberately misrepresented the teachings of the ’101 patent and the Queen 1989
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`references to overcome a rejection of pending claims, and further provided empirical information
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`at the Examiner’s request that conspicuously omitted a claim element disclosed in the prior art.
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`D.I. 19 at 30-33. Amgen further pled that “deceptive intent by Genentech is the single most
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`reasonable inference to be drawn” from Genentech’s conduct in prosecuting the ’213 patent. Id. at
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`30.
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`10
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 16 of 20 PageID #: 11435
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`Other courts in this District have denied a patent owner’s motion to dismiss inequitable
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`conduct counterclaims based on allegations nearly identical to Amgen’s: that a patentee committed
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`inequitable conduct when it affirmatively “misrepresented the teachings of the prior art in a manner
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`that would be recognized as false by a person of ordinary skill in the art, and also submitted
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`incomplete, misleading, and internally inconsistent empirical data.” Wyeth Holdings Corp. v.
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`Sandoz, Inc., No. 09-cv-00955, 2012 U.S. Dist. LEXIS 26912, at *28 (D. Del. Feb. 3, 2012); see
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`also Southco, Inc. v. Penn Eng’g & Mfg. Corp., 768 F. Supp. 2d 715 (D. Del. 2011). In Wyeth,
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`the court rejected the patent owner’s argument that simply presenting arguments and
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`interpretations concerning a reference that was in front of the examiner did not constitute
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`inequitable conduct. Wyeth, 2012 U.S. Dist. LEXIS 26912 at *33-34, 36 (“As an initial matter,
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`the Court agrees with Sandoz that Wyeth is not relieved of responsibility for any alleged
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`misstatements simply because the ’277 reference and the stabilization data were before the PTO.”).
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`Instead, the court found that at the motion to dismiss stage, it “could reasonably infer that Wyeth’s
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`statements crossed the line from permissible advocacy to impermissible representation.” Id.
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`Further, while Plaintiffs dispute Amgen’s allegations and attempt to characterize
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`Genentech’s misleading statements as merely attorney argument, this is irrelevant. Butamax Adv.
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`Biofuels v. Gevo, No. 11-54, 2012 U.S. Dist. LEXIS 86215, at *10 (D. Del. June 21, 2012) (noting
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`that whether plaintiffs agree or disagree with defendants’ inequitable conduct allegations “is
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`irrelevant, as the court is not required to judge the merits of the parties’ respective positions at this
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`stage in the proceedings”); Refac Int’l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1584 (Fed. Cir.
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`1996) (“While an affiant may insist that his sworn statements were truthful or that any omissions
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`were not material or not made with intent to deceive, these are matters of proof and credibility.”).
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`Whether Genentech’s statements are misleading statements or attorney argument raises a
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`11
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`Case 1:18-cv-00924-CFC Document 94 Filed 03/07/19 Page 17 of 20 PageID #: 11436
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`factual dispute that is not properly resolved on a motion to dismiss. Quest Integrity USA, LLC v.
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`Clean Harbors Indus. Servs., No. 14-cv-01482, 2015 U.S. Dist. LEXIS 95148, at *15-16 (D. Del.
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`July 22, 2015) (declining to dismiss inequitable conduct claim where the patentee merely
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`“disagree[d] with the factual representations made by [defendant]”); IBM v. Priceline Grp., Inc.,
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`No. 15-cv-00137, 2017 U.S. Dist. LEXIS 54285, at *39-4