Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 1 of 22 PageID #:
`3357
`
`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-GMS
`
`
`
`
`AMGEN INC.’S OPPOSITION TO PLAINTIFFS’ MOTION TO DISMISS
`AMGEN’S UNENFORCEABILITY COUNTERCLAIMS AND TO STRIKE
`AMGEN’S ELEVENTH AFFIRMATIVE DEFENSE
`
`
`
`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.
`
`Dated: September 6, 2018
`
`
`
`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
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 2 of 22 PageID #:
`3358
`
`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
`
`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
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 3 of 22 PageID #:
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`Table of Contents
`
`
`Page
`NATURE AND STAGE OF THE PROCEEDINGS ........................................................ 1
`
`SUMMARY OF ARGUMENT ......................................................................................... 2
`
`STATEMENT OF FACTS ................................................................................................ 3
`A.
`Amgen’s Compliance With The BPCIA................................................................ 3
`
`B.
`
`Amgen’s Eleventh Affirmative Defense Is That Genentech Committed
`Inequitable Conduct Before the U.S.P.T.O............................................................ 4
`
`C.
`
`Many Patents-In-Suit Will Expire Soon or Are Being Challenged In Other
`Proceedings ............................................................................................................ 6
`LEGAL STANDARDS ..................................................................................................... 9
`A.
`Motion to Strike under F.R.C.P. 12(f) ................................................................... 9
`
`Motion to Dismiss under F.R.C.P. 12(b)(6)......................................................... 10
`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-
`
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`VI.
`
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 4 of 22 PageID #:
`3360
`
`Table of Authorities
`
`
`Page(s)
`
`Cases
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .............................................................................................................9, 10
`
`Bayer CropScience AG v. Dow AgroSciences LLC,
`Case No. 10-1045-RMB/JS, U.S. Dist. LEXIS 149636 (D. Del. Dec. 30, 2011) ....................14
`
`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).........................................12
`
`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)................................................................................................11
`
`Fesnak & Assoc., LLP v. U.S. Bank. Nat’l Ass’n,
`722 F. Supp. 2d 496 (D. Del. 2010) ...........................................................................................9
`
`Fowler v. UPMC Shadyside,
`578 F.3d 203 (3d Cir. 2009)...............................................................................................10, 15
`
`IBM v. Priceline Grp., Inc.,
`Case No. 15-137-LPS-CJB, 2017 U.S. Dist. LEXIS 54285 (D. Del. Apr. 10,
`2017) ....................................................................................................................................2, 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
`
`Internet Media Corp. v. Hearst Newspapers, LLC,
`Case No. 10-cv-690, 2012 U.S. Dist. LEXIS 126788 (D. Del. Sept. 6, 2012) ..........................9
`
`Kimble v. Marvel Entm’t, LLC,
`135 S. Ct. 2401 (2015) .............................................................................................................14
`
`Moody v. Atl. City Bd. of Educ.,
`870 F.3d 206 (3d Cir. 2017).......................................................................................................9
`
`
`
`
`
`-ii-
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 5 of 22 PageID #:
`3361
`
`Table of Authorities
`(continued)
`
`Page(s)
`
`Phillips v. Cnty. of Allegheny,
`515 F.3d 224 (3d Cir. 2008).....................................................................................................15
`
`Precision Instrument Mfg. Co. v. Auto Maint. Mach. Co.,
`324 U.S. 806 (1945) .................................................................................................................10
`
`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)..................................................................................................12
`
`Ring Plus, Inc. v. Cingular Wireless Corp.,
`614 F.3d 1354 (Fed. Cir. 2010)..........................................................................................12, 13
`
`Rothman v. Target Corp.,
`556 F.3d 1310 (Fed. Cir. 2009)................................................................................................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, 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).......................................................................................................10
`
`Wyeth Holdings Corp. v. Sandoz, Inc.,
`No. 09-cv-00955, 2012 U.S. Dist. LEXIS 26912 (D. Del. Feb. 3, 2012) ....................11, 12, 13
`
`Statutes
`
`42 U.S.C.
`§ 262(k)(2) .................................................................................................................................3
`§ 262(l) ...................................................................................................................................1, 4
`
`
`
`
`
`
`-iii-
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 6 of 22 PageID #:
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`
`Table of Authorities
`(continued)
`
`Page(s)
`
`Other Authorities
`
`Federal Rule of Civil Procedure
`8(a) ...........................................................................................................................3, 13, 14, 15
`9(b) .......................................................................................................................................2, 13
`12(b)(6) ..........................................................................................................................2, 10, 14
`12(f)........................................................................................................................................2, 9
`
`
`
`
`
`
`
`
`
`-iv-
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 7 of 22 PageID #:
`3363
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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 it
`
`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 twenty-two patents, leaving
`
`eighteen patents. D.I. 15.
`
`Amgen filed its Answer and Counterclaims on August 2, 2018. D.I. 19. Amgen’s Answer
`
`includes an eleventh affirmative defense of unclean hands and inequitable conduct stemming from
`
`false statements that Genentech made to the 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-
`
`1
`
`

`

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`
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`suit is invalid and/or unenforceable and not infringed.
`
`On August 23, 2018, 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 Procedure 12(b)(6). D.I. 23. 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
`
`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 conflate unenforceability with
`
`inequitable conduct, arguing that all counterclaims of unenforceability are based in fraud and must
`
`meet the heightened pleading standard of Federal Rule of Civil Procedure 9(b). But Genentech’s
`
`2
`
`

`

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`
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`patents can be found unenforceable due to a number of reasons, beyond inequitable conduct. For
`
`example, eight of Genentech’s patents are set to expire within the next 12 months or have already
`
`expired. An unexpired patent is no longer enforceable. Additionally, many patents are currently
`
`being challenged in numerous inter partes review proceedings or other district court litigations.
`
`These patents will be unenforceable in this proceeding if they are found unpatentable at the Patent
`
`Office or invalid in another district court 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).
`
`III.
`
`STATEMENT OF FACTS
`
`Amgen is a biotechnology pioneer with expertise in the development and manufacture of
`
`biologic drugs, including biosimilars. D.I. 19, (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. 19, (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. 19, (Ans.) ¶¶ 10, 12. Amgen is seeking FDA
`
`approval for ABP 980 as a biosimilar to Genentech’s Herceptin. Id., ¶ 7. Under the BPCIA, the
`
`reference product sponsor (here, Genentech) and the biosimilar applicant (here, Amgen)
`
`3
`
`

`

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`
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`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)
`
`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. Amgen timely filed its Answer and Counterclaims that are the basis of the instant
`
`motion. D.I. 19.
`
`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,
`
`4
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`

`

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`
`
`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:
`“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.1 The alignments provided by Genentech to
`
`
`
` 1
`
` See [D.I. 19] 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.”).
`
`5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 12 of 22 PageID #:
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`
`
`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 twelve months or have already expired, are being challenged at the PTAB,
`
`and/or are involved in other district court proceedings.
`
`The chart below indicates the eight patents that have expired or will expire within the year.
`
`The chart also identifies the six patents that are currently being challenged at the PTAB. All six
`
`of these inter partes reviews are in advanced stages—the trials have been instituted, oral hearings
`
`have been held, and Final Written Decisions are expected in the upcoming months. The Final
`
`Written Decisions for inter partes reviews of U.S. Patent Nos. 6,627,196, 7,371,379, and
`
`7,846,441 are due in four weeks, by October 4th, 2018. The Final Written Decisions for inter
`
`partes reviews of U.S. Patent Nos. 7,892,549, and a second inter partes review of U.S. Patent No.
`
`7,846,441 are due three weeks later, by October 26th, 2018. The remaining Final Written
`
`Decisions are due in December 2018 and March 2019. As shown below, each of the patents is
`
`also being asserted in other litigations.
`
`Expiration
`date in next
`U.S. Patent
`12 months
`No.
`6,331,415 12/18/2018
`
`Expected
`date of FWD
`of instituted
`IPRs
`
`
`Asserted in other district court litigations
`• Genentech, Inc. v. Amgen Inc., Case Nos. 17-
`01407, 17-01471 (D. Del.)
`• Genentech, Inc. v. Pfizer, Inc. Case No. 17-01672
`(D. Del.)
`
`6
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 13 of 22 PageID #:
`3369
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`
`
`U.S. Patent
`No.
`
`Expiration
`date in next
`12 months
`
`Expected
`date of FWD
`of instituted
`IPRs
`
`7,923,221 12/18/2018
`
`
`
`Asserted in other district court litigations
`• Genentech, Inc. v. Celltrion, Inc., Case Nos. 18-
`00095, 18-01025 (D. Del.)
`• Genentech, Inc. v. Samsung Bioepis Co., Ltd., Case
`No. 18-01363 (D. Del.)
`• Genentech, Inc. v. Sandoz, Inc., Case No. 17-13507
`(D.N.J.)
`• Genentech, Inc. v. Celltrion, Inc., Case Nos. 18-
`11553, 18-00574 (D.N.J.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`• Case Nos. 18-11553, 18-00574 (D.N.J.)
`
`6,407,213
`
`6/18/2019
`
`7,846,441
`
`7,892,549
`
`6,627,196
`
`7,371,379
`
`
`
`
`
`
`
`
`
`6,417,335
`
`5/3/2019
`
`9,249,218
`
`5/3/2019
`
` 12/1/2018
`
`10/4/2018,
`10/26/2018
`
`10/4/2018
`
`10/4/2018
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`10/26/2018 • Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 1-18-cv-00095, 1-18-cv-01025 (D. Del.)
`• Case No. 1-18-cv-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`
`
`
`3/12/2019
`
`7
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 14 of 22 PageID #:
`3370
`
`
`
`U.S. Patent
`No.
`
`Expiration
`date in next
`12 months
`
`Expected
`date of FWD
`of instituted
`IPRs
`
`8,574,869
`
`
`
`6,620,918
`
`5/6/2019
`
`7,993,834
`
`8,076,066
`
`
`
`
`
`8,425,908 12/10/2018
`
`8,440,402
`
`
`
`6,121,428
`
`6/12/2018
`
`8,512,983
`
`9,714,293
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Asserted in other district court litigations
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case Nos. 17-01407, 17-01471 (D. Del.)
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`• Case Nos. 18-11553, 18-00574 (D.N.J.)
`
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`
`• Case No. 17-01672 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`
`• Case Nos. 17-01407, 17-01471 (D. Del.)
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`• Case No. 18-01363 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`
`• Case Nos. 18-00095, 18-01025 (D. Del.)
`
`8
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 15 of 22 PageID #:
`3371
`
`
`
`U.S. Patent
`No.
`
`Expiration
`date in next
`12 months
`
`Expected
`date of FWD
`of instituted
`IPRs
`
`Asserted in other district court litigations
`• Case No. 18-01363 (D. Del.)
`• Case No. 17-13507 (D.N.J.)
`
`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
`
`(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. v. Aruba Networks, Inc., 609 F. Supp.
`
`2d 353, 356 (D. Del. 2009)).
`
`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.
`
`9
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`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 16 of 22 PageID #:
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`
`
`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
`
`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.”).
`
`10
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`Case 1:18-cv-00924-CFC-SRF Document 30 Filed 09/06/18 Page 17 of 22 PageID #:
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`
`
`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 U.S.
`
`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.
`
`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 Wy