Case 1:18-cv-00924-CFC-SRF Document 32 Filed 09/13/18 Page 1 of 15 PageID #:
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC and CITY OF HOPE,
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`v.
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`AMGEN INC.,
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`Plaintiffs,
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`Defendant.
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`C.A. No. 18-00924-GMS
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`PLAINTIFFS’ REPLY BRIEF IN SUPPORT OF THEIR MOTION
`TO DISMISS DEFENDANT’S UNENFORCEABILITY COUNTERCLAIMS
`AND TO STRIKE DEFENDANT’S ELEVENTH AFFIRMATIVE DEFENSE
`
`MCCARTER & ENGLISH, LLP
`
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4785)
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`
`Counsel for Plaintiffs Genentech, Inc. and City
`of Hope
`
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY
`(212) 230-8800
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`(415) 362-6666
`
`
`
`ME1 28108783v.1
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`Case 1:18-cv-00924-CFC-SRF Document 32 Filed 09/13/18 Page 2 of 15 PageID #:
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`
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`I.
`II.
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`III.
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`TABLE OF CONTENTS
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`
`
`Page
`
`INTRODUCTION ................................................................................... 1
`ARGUMENT ........................................................................................... 2
`A.
`Amgen’s Eleventh Affirmative Defense. ...................................... 2
`B.
`Suit (Counts 1-2 and 4-18). ........................................................... 7
`CONCLUSION ...................................................................................... 10
`
`The Court Should Dismiss Amgen’s Unenforceability
`Counterclaim For The ’213 Patent (Count 3) And Strike
`
`The Court Should Dismiss Amgen’s Unenforceability
`Counterclaims For The Remaining Seventeen Patents-In-
`
`
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`– ii –
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`
`
`TABLE OF AUTHORITIES
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`Cases
`
`
`
`Page(s)
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ........................................................................................................ 8, 10
`
`Bayer Schering Pharma AG v. Barr Labs., Inc.,
`No. 05-cv-2308 (PGS), 2008 WL 628592 (D.N.J. Mar. 3, 2008) ........................................... 5
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`No. 11-54-SLR, 2012 U.S. Dist. LEXIS 86215 (D. Del. June 21, 2012) ............................ 6, 7
`
`Cellectis S.A. v. Precision Biosciences,
`883 F. Supp. 2d 526 (D. Del. 2012) ................................................................................... 4, 5
`
`Fowler v. UPMC Shadyside,
`578 F.3d 203 (3d Cir. 2009) ............................................................................................ 8, 10
`
`Genetic Techs. Ltd. v. Interleukin Genetics Inc.,
`No. 10-CV-69-BBC, 2010 WL 3362344 (W.D. Wis. Aug. 24, 2010) ................................. 8, 9
`
`Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc.,
`655 F.3d 1291 (Fed. Cir. 2011) .............................................................................................. 9
`
`Genzyme Corp. v. Transkaryotic Therapies, Inc.,
`No. 00-677, 2004 U.S. Dist. LEXIS 19250 (D. Del. Sept. 27, 2004) ...................................... 4
`
`IBM v. Priceline Group, Inc.,
`2017 U.S. Dist. LEXIS 54285 (D. Del. Apr. 10, 2017) ...................................................... 6, 7
`
`Innogenetics, N.V. v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) .......................................................................................... 2, 3
`
`Quest Integrity USA, LLC v. Clean Harbor Industrial Services, Inc.,
`No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148 (D. Del. July 22, 2015) ......................... 6, 7
`
`Refac International, Ltd. v. Lotus Development Corp.,
`81 F.3d 1576 (Fed. Cir. 1996)............................................................................................ 6, 7
`
`Ring Plus, Inc. v. Cingular Wireless Corp.,
`614 F.3d 1354 (Fed. Cir. 2010) .............................................................................................. 6
`
`Rothman v. Target Corp.,
`556 F.3d 1310 (Fed. Cir. 2009) .......................................................................................... 2, 3
`
`
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`Sepracor Inc. v. Teva Pharm. USA, Inc.,
`No. 09-cv-01302 (DMC)(MF), 2010 WL 2326262 (D.N.J. June 7, 2010) .............................. 5
`
`Southco, Inc. v. Penn Engineering & Manufacturing Corp.,
`768 F. Supp. 2d 715 (D. Del. 2011) ................................................................................... 5, 6
`
`SunPower Corp. v. PaneClaw, Inc.,
`No. 12-1633-MPT, 2016 WL 5107029 (D. Del. Sept. 16, 2016) ............................................ 3
`
`Wyeth Holdings Corp. v. Sandoz, Inc.,
`No. 09-955-LPS-CJB, 2012 WL 600715 (D. Del. Feb. 3, 2012) ............................................ 5
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007) .............................................................................................. 3
`
`35 U.S.C. § 271(e)(2)(C)(i) ......................................................................................................... 9
`
`Statutes
`
`Rules
`
`Federal Rule of Civil Procedure 8(a) ........................................................................................... 8
`
`Federal Rule of Civil Procedure 9(b) ....................................................................................... 1, 7
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`ME1 28108783v.1
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`I.
`
`INTRODUCTION
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`Amgen has not identified any factual dispute that would prevent the Court from disposing
`
`of its unenforceability defenses at the pleadings stage. For the ’213 patent, Amgen argues that
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`there is a factual dispute as to whether Genentech’s statements to the patent examiner constituted
`
`permissible attorney argument or improper material misrepresentations. But Amgen’s position
`
`cannot be reconciled with long-standing Federal Circuit precedent that an applicant’s statements
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`concerning the teachings of the prior art cannot, as a matter of law, support a claim of inequitable
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`conduct so long as the patent examiner was capable of assessing the applicant’s arguments on
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`her own. Amgen has not pleaded any facts alleging that the patent examiner here was incapable
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`of fully evaluating Genentech’s statements concerning the prior art for herself, and Amgen’s
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`unenforceability counterclaim for the ’213 patent and related Eleventh Affirmative Defense are
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`therefore legally deficient. Indeed, Amgen does not even engage with the many cases dismissing
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`a defendant’s unenforceability counterclaims in exactly these circumstances, and the cases that
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`Amgen does discuss only underscore the need to plead facts alleging that the patent examiner
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`was incapable of evaluating the applicant’s arguments (which Amgen has failed to do here).
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`For the remaining seventeen patents-in-suit, Amgen asserts that it need not meet the
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`heightened pleading requirements of Federal Rule of Civil Procedure 9(b) because there are
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`ways besides inequitable conduct that a patent may be unenforceable. But that does not relieve
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`Amgen of its obligation to plead at least some facts supporting its counterclaims, and Amgen
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`does not dispute that it has pleaded none. Instead, Amgen asserts that there are “a number of
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`ways” in which the patents-in-suit might someday become unenforceable—for example, based
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`upon the anticipated expiration of certain patents, or potential future decisions in other
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`proceedings concerning the validity of those patents. But that is pure speculation about future
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`events, and even Amgen cannot say today what its theory of unenforceability for any particular
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`patent is. Amgen may not proceed with placeholder unenforceability counterclaims on the hope
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`that it might someday be able to plead facts in support of them. The Court therefore should also
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`dismiss Amgen’s unenforceability counterclaims for the remaining patents-in-suit.
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`II.
`
`ARGUMENT
`
`A.
`
`The Court Should Dismiss Amgen’s Unenforceability Counterclaim For The
`’213 Patent (Count 3) And Strike Amgen’s Eleventh Affirmative Defense.
`
`Amgen’s unenforceability counterclaim for the ’213 patent and its related Eleventh
`
`Affirmative Defense rest entirely on statements concerning the teachings of two prior art
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`references (Queen 1989 and the ’101 patent) that Genentech’s prosecution counsel made to the
`
`patent examiner during prosecution of the ’213 patent. (D.I. 30 at 4-6.) Amgen does not allege
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`that prosecution counsel had any information uniquely in its possession concerning those
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`publicly available references or that the examiner was otherwise incapable of evaluating the
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`teachings of those references on her own. (See D.I. 19, Aff. Defs. ¶¶ 11-23.) Amgen’s
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`inequitable conduct theory instead rests solely on the notion that prosecution counsel allegedly
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`misrepresented what the prior art before the examiner disclosed. (Id.)
`
`That is legally insufficient to plead inequitable conduct. To promote an open discussion
`
`between the patent examiner and the applicant, the Federal Circuit “has made clear that an
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`applicant is free to advocate its interpretation of its claims and the teachings of prior art” without
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`fear of committing inequitable conduct. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1379
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`(Fed. Cir. 2008); see also Rothman v. Target Corp., 556 F.3d 1310, 1328-1329 (Fed. Cir. 2009)
`
`(“While the law prohibits genuine misrepresentations of material fact, a prosecuting attorney is
`
`free to present argument in favor of patentability without fear of committing inequitable
`
`conduct.”). An applicant’s statements concerning the teachings of the prior art are thus, as a
`
`matter of law, not material misrepresentations that could support inequitable conduct where, as
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`here, there is no allegation that the patent examiner lacked the ability to evaluate the applicant’s
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`characterizations on her own. That is because “the Patent Act gives the examiner the discretion
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`to reject or accept an applicant’s arguments based on the examiner’s own conclusions regarding
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`the prosecution record.” Rothman, 556 F.3d at 1330.
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`What is missing from Amgen’s unenforceability counterclaim for the ’213 patent and its
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`related Eleventh Affirmative Defense is any allegation that the examiner was incapable of
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`evaluating the applicant’s statements concerning the teachings of Queen 1989 and the ’101
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`patent on her own. Absent any such allegation, Amgen has not sufficiently pleaded an
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`inequitable conduct defense under controlling Federal Circuit precedent. Innogenetics, 512 F.3d
`
`at 1379 (“[O]ur precedent has made clear that an applicant is free to advocate its interpretation of
`
`its claims and the teachings of prior art. … Given that the [prior art reference] had been
`
`submitted for the patent examiner to examine herself, she was free to accept or reject the
`
`patentee’s arguments distinguishing its invention from the prior art.”); Young v. Lumenis, Inc.,
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`492 F.3d 1336, 1349 (Fed. Cir. 2007) (“[The applicant] argued against the rejection, and the
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`examiner was free to reach his own conclusions and accept or reject [the applicant’s] arguments.
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`We therefore fail to see how the [applicant’s statements], which consist of attorney argument and
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`an interpretation of what the prior art discloses, constitute affirmative misrepresentations of
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`material fact.”).
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`Indeed, prior decisions in this District in precisely these circumstances have applied that
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`precedent to hold that the defendant’s inequitable conduct defense was legally deficient and
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`could not proceed beyond the pleadings stage. See, e.g., SunPower Corp. v. PaneClaw, Inc., No.
`
`12-1633-MPT, 2016 WL 5107029, at *10 (D. Del. Sept. 16, 2016) (holding that defendant did
`
`“not adequately plead inequitable conduct” based upon alleged misrepresentations of the prior art
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`because “[t]he examiner had the expertise to examine the prior art reference and consider [the
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`applicant’s] argument against the rejection”); Cellectis S.A. v. Precision Biosciences, 883 F.
`
`Supp. 2d 526, 535 (D. Del. 2012) (dismissing inequitable conduct defense as inadequately
`
`pleaded where the “examiners were free to credit or discount [the applicants’] characterizations
`
`of [the prior art] in view of their own readings”); Genzyme Corp. v. Transkaryotic Therapies,
`
`Inc., No. 00-677, 2004 U.S. Dist. LEXIS 19250, at *6 (D. Del. Sept. 27, 2004) (“[A]ny
`
`mischaracterization of the [prior art] is not actionable because ‘the examiner was free to reach
`
`his own conclusion regarding … the art in front of him.’” (quoting Akzo N.V. v. Int’l Trade
`
`Comm’n, 808 F.2d 1471, 1482 (Fed. Cir 1986)) (emphasis added).
`
`Amgen does not engage with this long line of precedent. Instead, Amgen advocates a
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`bright-line rule that an inequitable conduct defense based upon an alleged misrepresentation of
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`the prior art during prosecution “raises a factual dispute that is not properly resolved on a motion
`
`to dismiss”—namely, whether the applicant’s statements were permissible “attorney argument”
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`or improper “misleading statements.” (D.I. 30 at 12.) However, as the cases cited above
`
`illustrate, the dividing line between permissible attorney argument (which cannot, as a matter of
`
`law, support inequitable conduct) and material misrepresentations (which can) is whether the
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`patent examiner was capable of evaluating the applicant’s statements concerning the prior art on
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`her own. Where, as here, there is no allegation that the examiner was incapable of assessing the
`
`applicant’s statements concerning the prior art for herself, there is no factual dispute to resolve
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`and the applicant’s statements fall on the side of permissible attorney argument. See, e.g.,
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`Genzyme, U.S. Dist. LEXIS 19250, at *6 (“[A]ny mischaracterization of the [prior art] is not
`
`actionable because ‘[t]he examiner was free to reach his own conclusion regarding … the art in
`
`front of him.’” (quoting Akzo, 808 F.2d at 1482)).
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`Amgen’s contrary rule that whether an applicant’s statements are permissible attorney
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`argument or impermissible material misrepresentations presents “a factual dispute that is not
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`properly resolved on a motion to dismiss” (D.I. 30 at 12) would foreclose dismissal of
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`inequitable conduct claims whenever the defendant alleges that the applicant mischaracterized
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`the teachings of the prior art. That is not the law, and Amgen’s position cannot be reconciled
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`with the numerous cases dismissing inequitable conduct claims in exactly these circumstances.
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`See, e.g., Cellectis, 883 F. Supp. 2d at 535; Sepracor Inc. v. Teva Pharm. USA, Inc., No. 09-cv-
`
`01302 (DMC)(MF), 2010 WL 2326262, at *6-7 (D.N.J. June 7, 2010); Bayer Schering Pharma
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`AG v. Barr Labs., Inc., No. 05-cv-2308 (PGS), 2008 WL 628592, at *49-50 (D.N.J. Mar. 3,
`
`2008).
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`Amgen’s cited cases do not hold otherwise and, if anything, only highlight the type of
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`allegations necessary to plead a material misrepresentation and survive a motion to dismiss
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`(which are entirely absent here). In Wyeth Holdings Corp. v. Sandoz, Inc., No. 09-955-LPS-CJB,
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`2012 WL 600715, at *12 (D. Del. Feb. 3, 2012), the defendant alleged that the applicant’s
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`arguments had misrepresented “Wyeth’s internal testing procedures and protocols” that it was
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`“uniquely qualified to characterize and explain,” and that certain data necessary to evaluate the
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`applicant’s arguments “was never provided by Wyeth to the Examiner in any form.” Thus,
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`according to the defendant, the examiner lacked sufficient information to evaluate the applicant’s
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`arguments and “had no way of independently learning” that information. Id. at *11.
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`Similarly, in Southco, Inc. v. Penn Engineering & Manufacturing Corp., 768 F. Supp. 2d
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`715, 722 (D. Del. 2011), the applicant submitted a drawing figure of a prior art device, but there
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`was “no way to tell” from that figure whether certain relevant features were present in the
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`device. The applicant nevertheless presented arguments about the features of the device, while at
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`the same time withholding a physical sample of the device in its possession that “would have
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`demonstrated the falsity of [the applicant’s] arguments” to the patent examiner. Id. Again, what
`
`allowed the defendant to sufficiently plead inequitable in Southco was the allegation that the
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`applicant had information not available to the examiner that was essential to evaluating the
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`applicant’s arguments. Amgen has alleged no such information disparity in this case, or any
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`other reason that the patent examiner could not evaluate Genentech’s statements concerning the
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`teachings of Queen 1989 and the ’101 patent.
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`The only other case that Amgen cites where inequitable conduct was found based upon
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`statements concerning the teachings of the prior art is Ring Plus, Inc. v. Cingular Wireless Corp.,
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`614 F.3d 1354 (Fed. Cir. 2010). But the inequitable conduct finding in that case was based upon
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`a factual misstatement in the specification of the patent itself, not any attorney argument
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`describing the disclosure of the references. Id. at 1359. In fact, the Federal Circuit rejected the
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`defendant’s argument that the applicant’s arguments to the patent examiner about the teachings
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`of the prior art constituted a material misrepresentation. Id. at 1360.
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`Amgen also cites Butamax Advanced Biofuels LLC v. Gevo, Inc., No. 11-54-SLR, 2012
`
`U.S. Dist. LEXIS 86215, at *10 (D. Del. June 21, 2012), Refac International, Ltd. v. Lotus
`
`Development Corp., 81 F.3d 1576, 1584 (Fed. Cir. 1996), Quest Integrity USA, LLC v. Clean
`
`Harbor Industrial Services, Inc., No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148, at *15-16 (D.
`
`Del. July 22, 2015), and IBM v. Priceline Group, Inc., 2017 U.S. Dist. LEXIS 54285, at *39-40
`
`(D. Del. Apr. 10, 2017). (See D.I. 30 at 12.) But the inequitable conduct claims in those cases
`
`did not rest on allegations that the applicant had mischaracterized the teachings of prior art
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`references that the examiner had before her; instead, the inequitable conduct claims in those
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`cases were based upon the applicant’s alleged withholding of information within its possession
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`
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`from the patent examiner. See Butamax, 2012 U.S. Dist. LEXIS 86215, at *7 (alleging that the
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`applicant “knew of prior art that contradicted its contention” that the claimed invention achieved
`
`unexpected results, but failed to disclose that prior art to the examiner); Refac, 81 F.3d at 1581
`
`(explaining inequitable conduct allegations based upon the applicant’s failure to disclose that an
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`individual who submitted a declaration during prosecution had a prior employment relationship
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`with applicant); Quest Integrity, 2015 U.S. Dist. LEXIS 95148, at *11-12 (alleging that the
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`applicant failed to disclose commercial sales that occurred more than one year before the filing
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`of the patent application, as well as prior art references that formed the basis for the rejection of a
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`parallel patent application in Europe); IBM, 2017 U.S. Dist. LEXIS 54285, at *3-10 (alleging
`
`that the applicant failed to disclose certain publications, commercial activity, and developments
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`in a parallel patent prosecution). Amgen thus has cited no case in which an inequitable conduct
`
`claim has been allowed to proceed in these circumstances. On the contrary, Amgen’s cited cases
`
`highlight the need to allege facts suggesting that the patent examiner lacked sufficient
`
`information to evaluate the applicant’s arguments—which Amgen has failed to allege here.
`
`Because Amgen has pleaded no factual allegation that the examiner was incapable of
`
`evaluating Genentech’s statements concerning the teachings of Queen 1989 and the ’101 patent,
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`this case falls squarely within established precedent holding that an attorney’s arguments
`
`concerning the teachings of the prior art is legally insufficient to support an inequitable conduct
`
`defense. The Court therefore should dismiss Amgen’s unenforceability defense for the ’213
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`patents (Count 3) and strike Amgen’s related Eleventh Affirmative Defense.
`
`B.
`
`The Court Should Dismiss Amgen’s Unenforceability Counterclaims For The
`Remaining Seventeen Patents-In-Suit (Counts 1-2 and 4-18).
`
`Amgen argues that its inequitable conduct allegations for the remaining seventeen
`
`patents-in-suit need not satisfy the heightened pleading standard under Federal Rule of Civil
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`Procedure 9(b) because “not all unenforceability counterclaims are based in fraud.” (D.I. 30 at
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`13.) But even under the more liberal pleading standard of Federal Rule of Civil Procedure 8(a),
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`“[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory
`
`statements, do not suffice.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In other words, “a
`
`complaint must do more than allege … entitlement to relief”; it must “‘show’ such an entitlement
`
`with its facts.” Fowler v. UPMC Shadyside, 578 F.3d 203, 211 (3d Cir. 2009) (emphasis added).
`
`What Amgen has pleaded for the remaining seventeen patents-in-suit falls well short of
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`satisfying even the most liberal pleading standard. Indeed, Amgen has pleaded no facts
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`whatsoever in support of its unenforceability counterclaims for those patents and instead simply
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`asserted the bare legal conclusion that the asserted patents are “unenforceable.” (D.I. 19,
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`Countercl. ¶¶ 48-54, 60-61, 74-75, 81-82, 88-89, 95-96, 102-103, 109-110, 116-117, 123-124,
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`130-132, 138-140, 146-147, 153-154, 160-161, 167-168, 174-175; see also D.I. 24 at 15-16
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`(showing Amgen’s boilerplate language repeated for each patent).) Such “‘naked assertion[s]’
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`devoid of ‘further factual enhancement’” are insufficient to state a claim. Iqbal, 556 U.S. at 678
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`(quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 557 (2007)); see also Genetic Techs. Ltd.
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`v. Interleukin Genetics Inc., No. 10-CV-69-BBC, 2010 WL 3362344, at *2 (W.D. Wis. Aug. 24,
`
`2010) (“Defendant relies on the bare assertion that the claims are unenforceable. Such
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`assertions, unsupported by additional factual allegations, cannot satisfy Rule 8.”).
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`Amgen does not contest that its unenforceability counterclaims for seventeen of the
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`patents-in-suit fail to plead any factual basis for the requested relief. (See generally D.I. 30 at
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`13-15; see also D.I. 24 at 15-17.) Instead, Amgen now asserts (without citing any allegations in
`
`its pleading) that its counterclaims may be referring to a “number of ways” in which Amgen
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`believes that Genentech’s patents may be “unenforceable now or in the near term”—for example,
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`due to patent expiration or possible rulings concerning the validity of those patents in other
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`proceedings. (D.I. 30 at 14.) That too is insufficient to put Plaintiffs on notice of the factual
`
`basis for Amgen’s unenforceability counterclaims. See, e.g., Genetic Techs, 2010 WL 3362344,
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`at *1-2 (granting motion to dismiss unenforceability counterclaim where defendant “did not
`
`specify in its counterclaim what it means by ‘unenforceability’”). Indeed, Amgen’s vague
`
`description of the “number of ways” that it could potentially assert that the patents-in-suit are
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`unenforceable (D.I. 30 at 14) simply confirms that even Amgen does not know the basis for its
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`counterclaims.
`
`Putting aside Amgen’s failure to plead any facts whatsoever supporting its
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`unenforceability counterclaims for seventeen of the patents-in-suit, the theories of
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`unenforceability that Amgen attempts to advance in its opposition only highlight the absence of
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`any legally cognizable basis to state an unenforceability defense for those patents. Amgen
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`contends that the patents-in-suit may be unenforceable for two reasons: (1) “many of the
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`asserted patents will expire shortly—or, in one case, has already expired”; and (2) certain
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`asserted patents could be found unpatentable during parallel inter partes review proceedings, or
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`invalidated in parallel district court proceedings. (D.I. 30 at 14.) Both arguments are pure
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`speculation and thus insufficient to state a claim.
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`First, although one of the asserted patents has expired and certain others will expire in the
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`coming months, the patents-in-suit are currently enforceable and will remain enforceable as to
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`any past infringement even after they expire. See, e.g., Genetics Inst., LLC v. Novartis Vaccines
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`& Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011) (explaining that the patentees may sue
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`for past infringement of an expired patent). Amgen’s filing for FDA approval of its biosimilar
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`product is itself an act of patent infringement under 35 U.S.C. § 271(e)(2)(C)(i) that has already
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`ME1 28108783v.1
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`– 9 –
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`Case 1:18-cv-00924-CFC-SRF Document 32 Filed 09/13/18 Page 14 of 15 PageID #:
`3397
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`occurred, and Amgen has refused to state that it will refrain from any further infringement prior
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`to the expiration of the patents-in-suit. Amgen thus has no basis at this point to assert the
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`expiration of the patents-in-suit would render them unenforceable.
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`Second, Amgen’s vague assertion that the asserted patents could be found unpatentable
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`or invalid in separate proceedings at some point in the future does not satisfy Iqbal. It is not
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`enough to allege facts to “permit the court to infer the mere possibility” of entitlement to relief.
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`Iqbal, 556 U.S. at 679 (emphasis added). The complaint must “‘show’ such entitlement with its
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`facts.” Fowler, 578 F.3d at 211 (emphasis added). Amgen’s speculation about possible future
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`outcomes in other proceedings does not provide it with a basis to state a defense.
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`In sum, Amgen’s unenforceability counterclaims for the remaining seventeen patents-in-
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`suit should be dismissed for failure to state a claim because Amgen has failed to plead any facts
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`in support of those defenses. Amgen’s attempts to justify its unenforceability counterclaims in
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`its opposition to this motion only serve to highlight the absence of any basis in law or fact to
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`support those counterclaims.
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`III. CONCLUSION
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`For the foregoing reasons, and for the reasons described in Plaintiffs’ Opening Brief (D.I.
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`24), Plaintiffs respectfully request that the Court dismiss each of Amgen’s counterclaims for
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`unenforceability and strike Amgen’s Eleventh Affirmative Defense and Prayer for Relief E,
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`which seeks a declaration that the claims of the patent-in-suit are unenforceable.
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`ME1 28108783v.1
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`– 10 –
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`Case 1:18-cv-00924-CFC-SRF Document 32 Filed 09/13/18 Page 15 of 15 PageID #:
`3398
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`Dated: September 13, 2018
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(627) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`robert.gunther@wilmerhale.com
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
`
`
`ME1 28108783v.1
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`
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`Respectfully submitted,
`
`/s/ Daniel M. Silver
`
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`
`Counsel for Plaintiffs Genentech, Inc. and
`City of Hope.
`
`
`
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`