Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 1 of 15 PageID #: 11444
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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-CFC
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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
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 2 of 15 PageID #: 11445
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`I.
`II.
`
`III.
`
`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-
`
`
`
`
`
`i
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 3 of 15 PageID #: 11446
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`TABLE OF AUTHORITIES
`
`Cases
`
`
`
`Page(s)
`
`Akzo N.V. v. Int’l Trade Comm’n,
`808 F.2d 1471 (Fed. Cir 1986) ............................................................................................... 4
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .................................................................................................... 7, 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
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) .............................................................................................................. 8
`
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`No. 11-54-SLR, 2012 U.S. Dist. LEXIS 86215 (D. Del. June 21, 2012) ................................ 6
`
`Cellectis S.A. v. Precision Biosciences,
`883 F. Supp. 2d 526 (D. Del. 2012) ................................................................................... 3, 5
`
`Fowler v. UPMC Shadyside,
`578 F.3d 203 (3d Cir. 2009) ............................................................................................ 7, 10
`
`Genetic Techs. Ltd. v. Interleukin Genetics Inc.,
`No. 10-CV-69-BBC, 2010 WL 3362344 (W.D. Wis. Aug. 24, 2010) ..................................... 8
`
`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) .................................. 3, 4
`
`IBM v. Priceline Grp., 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 Indus. Servs., Inc.,
`No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148 (D. Del. July 22, 2015) ............................. 6
`
`Refac Int’l, Ltd. v. Lotus Dev. Corp.,
`81 F.3d 1576 (Fed. Cir. 1996)................................................................................................ 6
`
`ii
`
`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 4 of 15 PageID #: 11447
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`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
`
`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 Eng’g & Mfg. Corp.,
`768 F. Supp. 2d 715 (D. Del. 2011) ....................................................................................... 5
`
`SunPower Corp. v. PaneClaw, Inc.,
`No. 12-1633-MPT, 2016 WL 5107029 (D. Del. Sept. 19, 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) ................................................................................... 1, 7, 8
`
`Federal Rule of Civil Procedure 9(b) ........................................................................................... 8
`
`
`
`iii
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 5 of 15 PageID #: 11448
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`I.
`
`INTRODUCTION
`
`Amgen has not identified any factual dispute that would prevent the Court from disposing
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`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
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`cannot be reconciled with long-standing Federal Circuit precedent that an applicant’s statements
`
`concerning the teachings of the prior art cannot, as a matter of law, support a claim of inequitable
`
`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, pursuant to Federal Rule of Civil Procedure
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`Rule 8(a), Amgen is obligated to plead at least some facts supporting its counterclaims—and
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`Amgen has pleaded none. Instead, Amgen asserts that there are “a number of ways” in which
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`the patents-in-suit might be unenforceable—for example, based upon the recent or anticipated
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`expiration of certain patents, or decisions in other proceedings concerning the validity of those
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`patents. But Amgen does not dispute that an expired patent remains enforceable against past
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`infringement occurring during the patent’s term. And Amgen’s speculation about future possible
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`outcomes in other proceedings is not a basis for pleading unenforceability. The Court therefore
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`should also dismiss Amgen’s unenforceability counterclaims for the remaining patents-in-suit.
`
`1
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 6 of 15 PageID #: 11449
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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
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`patent examiner during prosecution of the ’213 patent. (D.I. 94 at 5-6.) 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. 80, 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.)
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`That is legally insufficient to plead inequitable conduct. The Federal Circuit “has made
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`clear that an applicant is free to advocate its interpretation of its claims and the teachings of prior
`
`art” without fear of committing inequitable conduct. Innogenetics, N.V. v. Abbott Labs., 512
`
`F.3d 1363, 1379 (Fed. Cir. 2008); see also Rothman v. Target Corp., 556 F.3d 1310, 1328-29
`
`(Fed. Cir. 2009) (“While the law prohibits genuine misrepresentations of material fact, a
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`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
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`inequitable conduct where, as here, there is no allegation that the patent examiner lacked the
`
`ability to evaluate the applicant’s characterizations on her own. That is because “the Patent Act
`
`gives the examiner the discretion to reject or accept an applicant’s arguments based on the
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`examiner’s own conclusions regarding the prosecution record.” Rothman, 556 F.3d at 1330.
`
`2
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 7 of 15 PageID #: 11450
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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
`
`patent on her own. Absent any such allegation, Amgen has not sufficiently pleaded an
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`inequitable conduct defense. 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.
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`… Given that the [prior art reference] had been submitted for the patent examiner to examine
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`herself, she was free to accept or reject the patentee’s arguments distinguishing its invention
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`from the prior art.”); Young v. Lumenis, Inc., 492 F.3d 1336, 1349 (Fed. Cir. 2007) (“[The
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`applicant] argued against the rejection, and the examiner was free to reach his own conclusions
`
`and accept or reject [the applicant’s] arguments. We therefore fail to see how the [applicant’s
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`statements], which consist of attorney argument and an interpretation of what the prior art
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`discloses, constitute affirmative misrepresentations of 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. 19, 2016) (holding that defendant did
`
`“not adequately plead inequitable conduct” based upon alleged misrepresentations of the prior art
`
`because “[t]he examiner had the expertise to examine the prior art reference and consider [the
`
`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,
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`3
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 8 of 15 PageID #: 11451
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`Inc., No. 00-677, 2004 U.S. Dist. LEXIS 19250, at *6 (D. Del. Sept. 27, 2004) (“[A]ny
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`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
`
`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”
`
`or improper “misleading statements.” (D.I. 94 at 11-12.) 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
`
`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
`
`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)).
`
`Amgen’s contrary rule that whether an applicant’s statements are permissible attorney
`
`argument or impermissible material misrepresentations presents “a factual dispute that is not
`
`properly resolved on a motion to dismiss” (D.I. 94 at 11-12) would foreclose dismissal of
`
`inequitable conduct claims whenever the defendant alleges that the applicant mischaracterized
`
`the prior art. That is not the law, and Amgen’s position cannot be reconciled with the numerous
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`4
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 9 of 15 PageID #: 11452
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`cases dismissing inequitable conduct claims in exactly these circumstances. See, e.g., Cellectis,
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`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 AG v. Barr Labs.,
`
`Inc., No. 05-cv-2308 (PGS), 2008 WL 628592, at *49-50 (D.N.J. Mar. 3, 2008).
`
`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
`
`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 Eng’g & Mfg. Corp., 768 F. Supp. 2d 715, 722 (D.
`
`Del. 2011), the applicant submitted a drawing figure of a prior art device, but there was “no way
`
`to tell” from that figure whether certain relevant features were present. The applicant
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`nevertheless presented arguments about the features of the device, while at the same time
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`withholding a physical sample in its possession that “would have demonstrated the falsity of [the
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`applicant’s] arguments” to the patent examiner. Id. Again, what allowed the defendant to
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`sufficiently plead inequitable conduct in Southco was the allegation that the applicant had
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`information not available to the examiner that was essential to evaluating the applicant’s
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`arguments. Amgen has alleged no such information disparity in this case, or any other reason
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`that the patent examiner could not evaluate Genentech’s statements on her own.
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`5
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 10 of 15 PageID #: 11453
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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.,
`
`614 F.3d 1354 (Fed. Cir. 2010). But the inequitable conduct finding in that case was based upon
`
`a factual misstatement in the specification of the patent itself, not any attorney argument
`
`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
`
`of the prior art constituted a material misrepresentation. Id. at 1360.
`
`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 Int’l, Ltd. v. Lotus Dev. Corp., 81
`
`F.3d 1576, 1584 (Fed. Cir. 1996), Quest Integrity USA, LLC v. Clean Harbor Indus. Servs., Inc.,
`
`No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148, at *15-16 (D. Del. July 22, 2015), and IBM v.
`
`Priceline Grp., Inc., 2017 U.S. Dist. LEXIS 54285, at *39-40 (D. Del. Apr. 10, 2017). (See D.I.
`
`94 at 11-12.) But the inequitable conduct claims in those cases did not rest on allegations that
`
`the applicant had mischaracterized the teachings of prior art references that the examiner had
`
`before her; instead, the inequitable conduct claims in those cases were based upon the applicant’s
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`alleged withholding of information within its possession from the patent examiner. See
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`Butamax, 2012 U.S. Dist. LEXIS 86215, at *7 (alleging that the 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 individual who submitted a
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`declaration during prosecution had a prior employment relationship with applicant); Quest
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`Integrity, 2015 U.S. Dist. LEXIS 95148, at *11-12 (alleging that the applicant failed to disclose
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`commercial sales that occurred more than one year before the filing of the patent application, as
`
`6
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 11 of 15 PageID #: 11454
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`well as prior art references that formed the basis for the rejection of a parallel patent application
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`in Europe); IBM, 2017 U.S. Dist. LEXIS 54285, at *3-10 (alleging that the applicant failed to
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`disclose certain publications, commercial activity, and developments in a parallel patent
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`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
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`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,
`
`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
`
`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’s unenforceability allegations for the remaining seventeen patents-in-suit also fall
`
`short of the applicable pleading standard. Under Federal Rule of Civil Procedure 8(a),
`
`“[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).
`
`7
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`

`

`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 12 of 15 PageID #: 11455
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`What Amgen has pleaded for the remaining seventeen patents-in-suit falls well short of
`
`satisfying Rule 8(a).1 Indeed, Amgen has pleaded no facts whatsoever in support of its
`
`unenforceability counterclaims for those patents and instead simply asserted the bare legal
`
`conclusion that the asserted patents are “unenforceable.” (D.I. 80, Countercl. ¶¶ 63-64, 77-78,
`
`84-85, 91-92, 98-99, 105-106, 112-113, 119-120, 126-127, 133-134, 140-141, 147-148, 154-155,
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`161-162, 168-169, 175-176; see also D.I. 86 at 16-17 (showing Amgen’s boilerplate language
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`repeated for each patent).) Such “‘naked assertion[s]’ devoid of ‘further factual enhancement’”
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`are insufficient to state a claim. Iqbal, 556 U.S. at 678 (quoting Bell Atl. Corp. v. Twombly, 550
`
`U.S. 544, 557 (2007)); see also Genetic Techs. Ltd. 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 assertions, unsupported by additional factual
`
`allegations, cannot satisfy Rule 8.”).
`
`Despite failing to plead any theory of unenforceability for these patents, Amgen now
`
`asserts that its counterclaims may be referring to a “number of ways” in which Genentech’s
`
`patents may be “unenforceable now or in the near term”—for example, due to patent expiration
`
`or rulings in other proceedings. (D.I. 94 at 13.) That too is insufficient to put Plaintiffs on notice
`
`of the factual basis for Amgen’s counterclaims. See, e.g., Genetic Techs, 2010 WL 3362344, at
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`*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
`
`
`1 Amgen notes that Plaintiffs previously moved to dismiss Amgen’s unenforceability
`counterclaims for, among other things, failure to meet the heightened pleading standard under
`Federal Rule of Civil Procedure 9(b). (D.I. 94 at 2 n.2, 13 n.4.) But the fact that Genentech also
`previously moved to dismiss these counterclaims under Rule 9(b) only underscores that Amgen
`has provided no notice of what its theory of unenforceability actually is. There is no way to
`discern the basis for Amgen’s unenforceability counterclaims from what Amgen has pleaded,
`and that is exactly why Plaintiffs have moved to dismiss them.
`
`8
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`

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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 13 of 15 PageID #: 11456
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`the “number of ways” that it could potentially assert unenforceability (D.I. 94 at 13) confirms
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`that even Amgen does not know the basis for its counterclaims.
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`In any case, the theories of unenforceability that Amgen attempts to advance in its
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`opposition only highlight the absence of any legally cognizable basis to state an unenforceability
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`defense for those patents. Amgen contends that the patents-in-suit may be unenforceable for
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`three reasons: (1) “many of the asserted patents will expire shortly—or, in three cases, have
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`already expired”; (2) “many of these patents are also being challenged in other district court and
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`Federal Circuit proceedings”; and (3) “the U.S. Patent Office has found claims of three of
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`Genentech’s asserted patents unpatentable.” (D.I. 94 at 13-14.) Even if Amgen had pleaded
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`those theories (it did not), they would not be legally sufficient to state a claim.
`
`First, Amgen’s arguments with respect to patent expiration are not sufficient to state a
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`claim for unenforceability because the patents-in-suit remain enforceable as to any past
`
`infringement even after they expire. See, e.g., Genetics Inst., LLC v. Novartis Vaccines &
`
`Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011) (patentees may sue for past infringement
`
`of an expired patent). Amgen’s filing for FDA approval of its biosimilar product is itself an act
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`of patent infringement that occurred prior to the expiration of any of the patents-in-suit. See 35
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`U.S.C. § 271(e)(2)(C)(i). And although four of the patents-in-suit will expire in the next four
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`months, there is still a possibility of prospective infringement even for those patents because
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`Amgen has refused to state that it will refrain from any further infringement of those patents
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`prior to their expiration. Amgen thus has no basis to assert the expiration of the patents-in-suit is
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`a basis for stating a claim of unenforceability.
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`Second, Amgen’s vague assertion that the patents in Plaintiffs’ second amended
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`complaint could be found invalid in separate proceedings at some point in the future does not
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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 14 of 15 PageID #: 11457
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`satisfy Iqbal. It is not enough to allege facts to “permit the court to infer the mere possibility” of
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`entitlement to relief. Iqbal, 556 U.S. at 679 (emphasis added). The complaint must “‘show’
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`such an entitlement with its facts.” Fowler, 578 F.3d at 211 (emphasis added). Amgen’s
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`speculation about possible future outcomes in other proceedings does not provide it with a basis
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`to state a claim for unenforceability.
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`Third, the fact that certain claims from three patents in Plaintiffs’ second amended
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`complaint have been found unpatentable in inter partes reviews (“IPRs”) does not support an
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`unenforceability counterclaim.2 Indeed, even Amgen admits that those IPR decisions do not
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`render any of the patents-in-suit unenforceable today; Amgen merely speculates that those
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`patents may become unenforceable if those decisions are upheld on appeal. (D.I. 94 at 14
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`(“Once Genentech has exhausted its right to appeal and the patent is held invalid, it will not be
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`enforceable.”).) Amgen cannot assert a placeholder unenforceability counterclaim now on the
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`hope that it might someday have facts to support it.
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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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`86), 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 patents-in-suit are unenforceable.
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`2 The Court previously ordered Plaintiffs to narrow this case to ten patents and two claims per
`patent to litigate. (D.I. 44 ¶ 8.) None of the narrowed set of patents and claims that Plaintiffs
`have chosen to assert in this case were invalidated in IPR. Indeed, the patentability of asserted
`claims 65 and 79 of the ’213 patent was upheld in four IPRs.
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`Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 15 of 15 PageID #: 11458
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`MCCARTER & ENGLISH, LLP
`
`
`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`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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`Dated: March 14, 2019
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`
`
`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
`
`
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