Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 1 of 16 PageID #: 1583
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`C.A. No. 19-638-CFC
`
`
`
`
`
`
`GENENTECH, INC. and CITY OF HOPE,
`
`
`Plaintiffs and Counterclaim Defendants,
`
`
`v.
`
`
`PFIZER INC.,
`
`
`Defendant and Counterclaim Plaintiff.
`PFIZER INC.,
`
`
`Counterclaim Plaintiff,
`
`
`v.
`
`HOFFMANN-LA ROCHE, INC.,
`
`
`Counterclaim Defendant.
`
`
`
`PLAINTIFFS AND COUNTERCLAIM DEFENDANTS’ REPLY BRIEF IN SUPPORT
`OF THEIR MOTION TO DISMISS DEFENDANT’S COUNTERCLAIMS AND TO
`STRIKE CERTAIN AFFIRMATIVE DEFENSES
`
`OF COUNSEL:
`
`Christopher N. Sipes
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`Daralyn J. Durie
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`(415) 362-6666
`
`(additional counsel listed
`on signature page)
`
`
`MCCARTER & ENGLISH, LLP
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4785)
`Alexandra M. Joyce (# 6423)
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs/Counterclaim
`Defendants Genentech, Inc. and City of Hope
`and Counterclaim Defendant
`Hoffmann-La Roche, Inc.
`
`PUBLIC VERSION FILED - June 14, 2019
`
`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 2 of 16 PageID #: 1584
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`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .......................................................................................................... ii
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`ARGUMENT ...................................................................................................................... 1
`
`A.
`
`Pfizer’s Counterclaims Are Barred Due to Non-Compliance with the
`BPCIA. .................................................................................................................... 1
`
`B.
`
`C.
`
`1.
`
`2.
`
`3.
`
`Pfizer’s failure to comply with the requirements of 42 U.S.C.
`§ 262(l)(2)(A) are proper grounds for this motion...................................... 1
`
`Pfizer’s failure to produce its entire aBLA precludes bringing
`declaratory judgment counterclaims. .......................................................... 2
`
`Pfizer has indisputably “brought an action” against HLR. ......................... 4
`
`Pfizer May Not Exceed the Positions It Took During the Patent Dance. ............... 5
`
`Pfizer Fails to State a Claim for Inequitable Conduct Where the
`Documents on Which Pfizer Relies Prove that There Was No
`Misinformation. ...................................................................................................... 7
`
`1.
`
`2.
`
`3.
`
`No actionable false statements were made to the Patent Office. ................ 7
`
`Pfizer failed to plead deceptive intent. ........................................................ 8
`
`Pfizer failed to plead materiality. ................................................................ 9
`
`III.
`
`CONCLUSION ................................................................................................................. 10
`
`
`
`
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`i
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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 3 of 16 PageID #: 1585
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Aktiebolag v. Kremers Urban Dev. Co.,
`No. 99 Civ. 8928, 2000 WL 257125 (S.D.N.Y. Mar. 8, 2000) .................................................5
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ...................................................................................................................9
`
`Barrett Mobile Home Transp., Inc. v. McGugin,
`530 So. 2d 730 (Ala. 1988) ........................................................................................................4
`
`Cellectis S.A. v. Precision Biosciences,
`883 F. Supp. 2d 526 (D. Del. 2012) ...........................................................................................9
`
`Cornell Univ. v. Illumina, Inc.,
`C.A. No. 10-433-LPS-MPT, 2016 WL 3046258 (D. Del. May 27, 2016) ............................7, 9
`
`Courtesy Prods. LLC v. Hamilton Beach Brands Inc.,
`C.A. No. 13-2012-SLR-SRF, 2015 WL 6159113 (D. Del. Oct. 20, 2015) .............................10
`
`Jonathan H. v. Souderton Area School District,
`562 F.3d 527 (3d Cir. 2009).......................................................................................................3
`
`Krisa v. Equitable Life Assurance Soc’y,
`109 F. Supp. 2d 316 (M.D. Pa. 2000) ........................................................................................3
`
`Parilla v. IAP Worldwide Serv., VI, Inc.,
`368 F.3d 269 (3d Cir. 2004).......................................................................................................2
`
`Southco, Inc. v. Penn Eng’g & Mf’g Corp.,
`768 F. Supp. 2d 715 (D. Del. 2011) ...........................................................................................8
`
`Sovereign Bank v. BJ’s Wholesale Club, Inc.,
`533 F.3d 162 (3d Cir. 2008).......................................................................................................2
`
`Talley v. Christiana Care Health Sys.,
`C.A. No. 17-926-CJB, 2018 WL 4938566 (D. Del. Oct. 11, 2018) ..........................................2
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) (en banc) .................................................................................1
`
`Unverferth Mfg. Co. v. Par-Kan Co.,
`No. 3:13-cv-97-TLS, 2014 WL 2206922 (N.D. Ind. May 27, 2014) ......................................10
`
`
`
`ii
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`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 4 of 16 PageID #: 1586
`
`Vorchheimer v. Philadelphian Owners Ass’n,
`903 F.3d 100 (3d Cir. 2018).......................................................................................................8
`
`Wyeth Holdings Corp. v. Sandoz, Inc.,
`C.A. No. 09-955-LPS-CJB, 2012 WL 600715 (D. Del. Feb. 3, 2012) ..................................7, 9
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007)..................................................................................................8
`
`
`
`Statutes
`
`21 U.S.C. § 355(j)(5)(B)(iii) ............................................................................................................5
`
`42 U.S.C. § 262(l)(2)(A) ..........................................................................................................1, 2, 4
`
`42 U.S.C. § 262(l)(3)(B) ..................................................................................................................6
`
`42 U.S.C. § 262(l)(3)(C) ..................................................................................................................5
`
`42 U.S.C. § 262(l)(4)–(6), (8) ..........................................................................................................7
`
`42 U.S.C. § 262(l)(5)(B) ..................................................................................................................5
`
`42 U.S.C. § 262(l)(9)(C) ..............................................................................................................2, 4
`
`42 Pa.C.S.A. § 8351 .........................................................................................................................3
`
`
`
`Other Authorities
`
`5C Wright & Miller, Fed. Prac. & Proc. § 1363 (3d ed. Apr. 2019) ...............................................2
`
`52 Am. Jur. 2d Malicious Prosecution § 11 .....................................................................................4
`
`D.N.J. L. Pat. R. 3.6(c), (e) ..............................................................................................................6
`
`D.N.J. L. Pat. R. 3.7 .........................................................................................................................6
`
`Restatement (Second) of Torts § 674 cmt. a (1977) ........................................................................3
`
`
`
`
`
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`iii
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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 5 of 16 PageID #: 1587
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`I.
`
`INTRODUCTION1
`
`The BPCIA establishes a “patent dance” by which biosimilar applicants and reference
`
`product sponsors can narrow the scope of patent litigation. In the patent dance, the reference
`
`product sponsor must rely on the information the biosimilar applicant provides to decide on which
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`patents to bring suit. Pfizer, by way of its counterclaims and affirmative defenses, wants to change
`
`the positions it took, and on which Genentech relied, now that the parties are in litigation. At the
`
`same time, Pfizer seeks to avoid the penalties associated with its failure to comply with the patent
`
`dance. Instead, Pfizer wants this Court to condone its failure to produce its entire aBLA—a fact
`
`admitted by Pfizer that it now affirmatively ignores—and permit it to assert counterclaims, which
`
`themselves assert new invalidity and unenforceability theories that exceed the scope of what Pfizer
`
`disclosed in the patent dance. Pfizer also seeks to drop “the atomic bomb of patent law,”
`
`Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1288 (Fed. Cir. 2011) (en banc),
`
`rendering an issued patent unenforceable for inequitable conduct, for a non-actionable statement,
`
`and without pleading the necessary deceptive intent or but-for materiality.
`
`Pfizer’s Opposition, D.I. 22, does nothing to address the serious deficiencies raised in
`
`Plaintiffs and Counterclaim Defendants’ Opening Brief, D.I. 20. Pfizer ignores its own allegations,
`
`the case law, and inconvenient facts. Plaintiffs and Counterclaim Defendants’ requested relief
`
`should be granted, for the reasons provided in D.I. 20 and herein.
`
`II.
`
`ARGUMENT
`A.
`
`Pfizer’s Counterclaims Are Barred Due to Non-Compliance with the BPCIA.
`1.
`
`Pfizer’s failure to comply with the requirements of 42 U.S.C.
`§ 262(l)(2)(A) are proper grounds for this motion.
`
`Pfizer ignores its own admissions in its Answer by arguing that it “disputes that its
`
`
`1 All abbreviations used herein are the same as in D.I. 20.
`
`
`
`1
`
`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 6 of 16 PageID #: 1588
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`production of its application pursuant to § 262(l)(2)(A) was deficient in any way.” D.I. 22 at 7.
`
`Focusing on one legal conclusion Pfizer alleges in its Counterclaims that it acted “in full
`
`compliance with 42 U.S.C. § 262(l)(2)(A),” see D.I. 22 at 6–7 (quoting D.I. 14, Counterclaim
`
`¶ 32), Pfizer ignores that, in the same pleading, Pfizer admits that “portions of Pfizer’s aBLA were
`
`not produced.” D.I. 14, Answer ¶ 8.2 “[F]ormal concessions in the pleadings . . . are binding upon
`
`the party making them.” Sovereign Bank v. BJ’s Wholesale Club, Inc., 533 F.3d 162, 181 (3d Cir.
`
`2008) (quoting Parilla v. IAP Worldwide Serv., VI, Inc., 368 F.3d 269, 275 (3d Cir. 2004)). And
`
`“[w]hile the court must accept as true all well-pleaded facts at the Rule 12(b)(6) stage, it need not
`
`accept allegations that are contradicted by other allegations in the [complaint].” Talley v.
`
`Christiana Care Health Sys., C.A. No. 17-926-CJB, 2018 WL 4938566, at *5 n.4 (D. Del. Oct.
`
`11, 2018); see also 5C Wright & Miller, Fed. Prac. & Proc. § 1363 (3d ed. Apr. 2019) (“The district
`
`court will not accept as true pleading allegations that are contradicted … by other allegations ….”).
`
`Whether Pfizer thinks it acted in “full compliance” with the statute is irrelevant. Pfizer’s
`
`failure to produce its entire aBLA is indeed undisputed. See D.I. 14, Answer ¶ 8. This is not a
`
`factual dispute that precludes resolution on a motion to dismiss, as Pfizer suggests. See D.I. 22 at
`
`7. Rather, this is an admission that shows Pfizer failed to meet the requirements of the patent dance,
`
`and should face the consequences of that failure.
`
`2.
`
`Pfizer’s failure to produce its entire aBLA precludes bringing
`declaratory judgment counterclaims.
`
`Because Pfizer failed to produce its entire aBLA, it cannot file counterclaims for
`
`declaratory relief. The prohibition in 42 U.S.C. § 262(l)(9)(C) against the biosimilar applicant
`
`
`2 Pfizer “repeats and incorporates by reference each of the foregoing Paragraphs of Pfizer’s Answer
`and Affirmative Defenses to the Complaint.” D.I. 20 at 5 n.4 (quoting D.I. 14, Counterclaim ¶ 2).
`The admissions in the Answer are part of the Counterclaim and cannot be disregarded.
`
`
`
`2
`
`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 7 of 16 PageID #: 1589
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`being able to “bring an action” for declaratory judgment applies with equal force to counterclaims.
`
`Pfizer relies on Jonathan H. v. Souderton Area School District, 562 F.3d 527 (3d Cir. 2009)
`
`to argue that the only relevant statutory context is the phrase “bring an action” as opposed to the
`
`entire BPCIA. See D.I. 22 at 9. That is incorrect: Jonathan H. does not control the outcome here.
`
`See D.I. 20 at 8 n.6. The court’s holding shows that it considered not only the phrase “bring an
`
`action” but also its meaning in the context of the statute at issue: “only a plaintiff may ‘bring an
`
`action’ for purposes of the IDEA.” 562 F.3d at 530 (emphasis added). If the court wanted to make
`
`the broad holding that “bring an action” in all contexts excludes counterclaims, the court would
`
`have done so. In the context of the BPCIA, the phrase “bring an action” does not exclude
`
`counterclaims. See D.I. 20 at 7–8.
`
`Even if the Court accepts the definition from Jonathan H. that “bring an action” means “to
`
`sue; institute legal proceedings” as Pfizer urges, see D.I. 22 at 8, this does not help Pfizer. The
`
`Restatement (Second) of Torts makes clear in discussing the tort of wrongful use of civil
`
`proceedings that to “bring an action”—or “institute legal proceedings,” per Jonathan H.—includes
`
`bringing counterclaims: “The person who initiates civil proceedings is the person who sets the
`
`machinery of the law in motion . . . . Since the term ‘civil proceedings’ includes a counterclaim,
`
`one who files a counterclaim to a cause of action initiates a civil proceeding.” Restatement
`
`(Second) of Torts § 674 cmt. a (1977) (emphases added). Multiple courts have agreed. See Krisa
`
`v. Equitable Life Assurance Soc’y, 109 F. Supp. 2d 316, 322 (M.D. Pa. 2000)3 (finding that moving
`
`
`3 Pfizer’s attempts to distinguish Krisa in a footnote fall flat. See D.I. 22 at 9 n.6. The elements of
`the statute at issue in Krisa include “the procurement, initiation or continuation of civil proceedings
`against another.” 109 F. Supp. 2d at 321 (quoting 42 Pa.C.S.A. § 8351, et seq.). The court there
`found that the defendant “procured or initiated a civil proceeding” by filing a counterclaim. Id. at
`322. And this is exactly how Pfizer contends the phrase “bring an action” should be construed,
`consistent with Jonathan H. See D.I. 22 at 8. Krisa is squarely on point.
`
`
`
`3
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`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 8 of 16 PageID #: 1590
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`to amend a pleading in previous litigation to assert a counterclaim “procured or initiated a civil
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`proceeding against [the original plaintiff]: there was a request to a court of law that [the moving
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`party] be allowed to charge [the original plaintiff] with [a counterclaim]”); Barrett Mobile Home
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`Transp., Inc. v. McGugin, 530 So. 2d 730, 733–34 (Ala. 1988) (disagreeing with the argument that
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`“filing of counterclaims against the plaintiffs in the underlying case should not be construed as the
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`initiation or continuation of original judicial proceedings”); accord 52 Am. Jur. 2d Malicious
`
`Prosecution § 11 (“The filing of a counterclaim constitutes an initiation of a proceeding . . . .”).4
`
`Finally, Pfizer’s complaints that adopting Plaintiffs’ argument “would be disproportionate
`
`and upend the balance inherent in the BPCIA framework,” see D.I. 22 at 11–12, is not an argument
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`for this Court, but for Congress. Congress determined that failure to comply with the exchange in
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`Section 262(l)(2)(A) precludes the biosimilar applicant from “bring[ing] an action.” Section
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`262(l)(9)(C) precludes a non-compliant applicant from bringing an action to prevent that party
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`from raising issues when the party failed to provide the information as required by the patent dance.
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`Although Pfizer was not the first to file a suit in this case, by asserting counterclaims, it is bringing
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`actions and claims it lost the right to bring by failing to provide the information it was required to
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`provide under the BPCIA.
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`3.
`
`Pfizer has indisputably “brought an action” against HLR.
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`Even if the Court accepts Pfizer’s position that it did not “bring an action” against Plaintiffs
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`within the meaning of 42 U.S.C. § 262(l)(9)(C), the Court should reject that argument for HLR,
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`which was only added to this matter because Pfizer brought an action against it. See D.I. 20 at 8.
`
`
`4 This Court’s own Form Scheduling Order recognizes that bringing counterclaims constitutes
`“bring[ing] an action” in the context of deposition locations: “A defendant who becomes a
`counterclaimant . . . shall be considered as having filed an action in this Court for the purpose of
`this provision.” Form Scheduling Order, Rev. Apr. 22, 2019, ¶ 9(e)(ii) (emphasis added).
`
`
`
`4
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`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 9 of 16 PageID #: 1591
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`There can be no question that Pfizer “brought an action” against HLR by filing counterclaims
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`against it and serving it with a Summons. After spending pages arguing that the formalities of
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`process distinguish a complaint from counterclaims, see D.I. 22 at 7–12, Pfizer glosses over the
`
`fact it brought a new party into the case, merely because the “counterclaims against HLR . . . are
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`duplicative of those filed against Plaintiffs.” See id. at 12–13. This is irrelevant. Pfizer cannot
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`ignore that it has sued a new party just because it has the same claims against Plaintiffs.
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`B.
`
`Pfizer May Not Exceed the Positions It Took During the Patent Dance.
`
`Pfizer’s analysis of the BPCIA information exchange to support expansion of its invalidity
`
`and unenforceability positions is untenable in view of the purpose of the patent dance, and should
`
`be rejected. As detailed in the pleadings and the Opening Brief, see, e.g., D.I. 20 at 4–6, the BPCIA
`
`created the “patent dance”—an elaborate scheme of contention exchanges to identify and ideally
`
`limit the number of patents involved in litigation. It includes numerous obligations for both parties
`
`and includes benefits and penalties for either party’s failure to comply.
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`In contrast, the Hatch-Waxman scheme to which Pfizer attempts to analogize has different
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`purposes and mechanisms. See D.I. 22 at 20. As Pfizer’s own cited case explains, “[t]he purpose
`
`of the Paragraph IV certification is to put the patent owner on notice . . . .” Aktiebolag v. Kremers
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`Urban Dev. Co., No. 99 Civ. 8928, 2000 WL 257125, at *1 (S.D.N.Y. Mar. 8, 2000). Also, in the
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`Hatch-Waxman context, there is no pre-litigation back and forth between the parties. Sending a
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`Paragraph IV certification triggers only the filing deadline. See 21 U.S.C. § 355(j)(5)(B)(iii). The
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`BPCIA’s patent dance is entirely different. Pfizer’s interpretation would allow applicants to engage
`
`in gamesmanship to lure the reference product sponsor to not include certain patents in its
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`§ 262(l)(3)(C) statement, its § 262(l)(5)(B) list, or its complaint. This dynamic is absent from the
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`Hatch-Waxman context, and thus Paragraph IV certifications case law is not persuasive here.
`
`Pfizer complains that it would be “unfair and prejudicial” to require Pfizer to set forth non-
`5
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`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 10 of 16 PageID #: 1592
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`infringement, invalidity, and unenforceability contentions to which it must be bound in 60 days in
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`the absence of discovery and claim construction theories. See D.I. 22 at 19–22. This is baseless.
`
`Indeed, in the District of New Jersey, parties are required under the default rules to provide such
`
`contentions within 30 days of the initial scheduling conference in Hatch-Waxman cases, see D.N.J.
`
`L. Pat. R. 3.6(c), (e), and those contentions can only be amended with court approval and for good
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`cause, see D.N.J. L. Pat. R. 3.7. If discovery revealed new defenses and theories, then Pfizer could
`
`appropriately move to includes those in the case upon showing of good cause, but at the outset,
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`Pfizer must be bound to what it told Plaintiffs its theories were in its Section 262(l)(3)(B)
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`contentions. Pfizer cannot decide to disclose certain theories to induce Plaintiffs’ filing decisions,
`
`and then later reverse course without new information coming to light.
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`Additionally, Pfizer’s complaints that biosimilar applicants who provide such contentions
`
`would be in a worse position than biosimilar applicants who do not, fall flat. See D.I. 22 at 17–18.
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`Pfizer ignores that the point of the information exchange is to narrow the scope of the litigation,
`
`providing a compliant biosimilar applicant a significant benefit. In contrast, a biosimilar applicant
`
`who does not participate in the patent dance is subject not only to an immediate action for
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`declaratory judgment, but also to an action on patents the reference product sponsor thinks the
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`biosimilar product may infringe. That, alone, is a deterrent to non-participation in the patent dance.
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`Finally, because the reference product sponsor has to rely on an applicant’s 262(l)(3)(B)
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`statement to identify which patents to include in litigation, the consequences of Pfizer’s position—
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`that it is not bound to its non-infringement, invalidity, and unenforceability positions taken during
`
`the patent dance—are real and serious. For example, if the biosimilar applicant takes a position in
`
`its 262(l)(3)(B) statement such that the reference product sponsor does not include that patent in
`
`the first phase of litigation, but the biosimilar applicant then changes its position (as Pfizer argues
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`
`
`6
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`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 11 of 16 PageID #: 1593
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`it should be allowed to do), the reference product sponsor has been falsely induced to litigate only
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`certain patents in the first phase, and cannot litigate the unasserted patent until the second phase
`
`of litigation. See 42 U.S.C. § 262(l)(4)–(6), (8). The reference product sponsor is irreparably
`
`harmed by this bait-and-switch, whereas the biosimilar applicant suffers no consequences.
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`For these reasons and those expressed in the Opening Brief, the Court should not permit
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`Pfizer to exceed the bounds of its existing contentions, dismiss Pfizer’s new invalidity and
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`unenforceability allegations, and strike the corresponding Third and Fourth Affirmative Defenses.
`
`C.
`
`Pfizer Fails to State a Claim for Inequitable Conduct Where the Documents
`on Which Pfizer Relies Prove that There Was No Misinformation.
`1.
`
`No actionable false statements were made to the Patent Office.
`
`Pfizer generally asserts that Genentech’s statements during prosecution of the Carter/Presta
`
`patent were “demonstrably false.” See D.I. 22 at 21–27. Yet, the case law and Pfizer’s pleadings
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`make clear that Genentech’s statements were neither false nor anything more than attorney
`
`argument that cannot provide the basis for an inequitable conduct claim. See D.I. 20 at 13–18.
`
`Unlike here, each of the cases cited by Pfizer, see D.I. 22 at 21–27, concerns situations
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`where the applicants’ alleged misrepresentations concerned information uniquely known to the
`
`applicants that the Examiner had no means to independently verify. In Cornell, the inventors
`
`submitted a declaration that attempted to provide an earlier conception date in order to swear
`
`behind three prior art references. See Cornell Univ. v. Illumina, Inc., C.A. No. 10-433-LPS-MPT,
`
`2016 WL 3046258, at *2–3, 7 (D. Del. May 27, 2016). Only the inventors could prove or disprove
`
`the truth of their assertions. See id. at *9. Similarly, the Wyeth applicants allegedly misrepresented
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`“Wyeth’s internal testing procedures and protocols [which] is precisely the sort of information that
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`[the applicant] was uniquely qualified to characterize and explain[.]” Wyeth Holdings Corp. v.
`
`Sandoz, Inc., C.A. No. 09-955-LPS-CJB, 2012 WL 600715, at *12 (D. Del. Feb. 3, 2012). And in
`
`
`
`7
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`

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`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 12 of 16 PageID #: 1594
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`Southco, the applicants misrepresented that they had “pre-existing knowledge” of a reference.
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`Southco, Inc. v. Penn Eng’g & Mf’g Corp., 768 F. Supp. 2d 715, 722–23 (D. Del. 2011).
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`The allegations here stand in stark contrast. Pfizer does not (and cannot) allege that
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`Genentech had any uniquely known information about the ’101 Patent contents. Instead, Pfizer
`
`alleges only that Genentech’s statements about the numbering protocols used to number antibody
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`sequences were “demonstrably false” because portions of the ’101 Patent—portions of the ’101
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`Patent that were irrelevant to the Examiner’s rejection—discuss Kabat numbering. See D.I. 22 at
`
`22 (citing D.I. 14, Counterclaim ¶¶ 121, 126, 129, 131–33). The underlying facts, including the
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`numbering scheme used in the sequences, were all available to the Examiner here.
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`Instead, the facts here are in line with Young v. Lumenis, Inc., 492 F.3d 1336 (Fed. Cir.
`
`2007). In Young, the Federal Circuit looked at how the applicant characterized the reference and
`
`also the relationship between the applicant’s argument and the Examiner’s use of the reference.
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`492 F.3d at 1349. The applicant provided his “interpretation of what the [prior art reference]
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`teaches,” the applicant “argued against the rejection, and the examiner was free to reach his own
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`conclusions and accept or reject [the applicant]’s arguments.” Id. This is what Genentech did here.5
`
`2.
`
`Pfizer failed to plead deceptive intent.
`
`Pfizer all but concedes that it failed to adequately plead deceptive intent. After
`
`
`5 In arguing that Genentech was referencing the ’101 Patent as a whole, see D.I. 22 at 23, Pfizer’s
`selective quotation ignores the allegation in its pleading that Genentech is focused on anti-Tac, not
`the ’101 Patent as a whole. See D.I. 14, Counterclaim ¶ 129 (“[R]esidue no. 93 in the heavy chain
`of the anti-Tac antibody in the cited references, is actually 89H utilizing the numbering system set
`forth in Kabat.” (quoting D.I. 20-1, Ex. B at 7)). Pfizer has not, and cannot allege that the anti-Tac
`antibody used Kabat numbering. Moreover, Pfizer’s arguments ignore that Genentech’s responses
`identified that some embodiments in the ’101 Patent contain a substitution at 93H using Kabat
`numbering. See D.I. 20-1, Ex. C at 7, 9. Pfizer’s allegations that Genentech concealed this fact,
`see D.I. 14, Counterclaim ¶¶ 131–32, are contradicted by the actual facts, and thus cannot be
`considered. See Vorchheimer v. Philadelphian Owners Ass’n, 903 F.3d 100, 112 (3d Cir. 2018).
`
`
`
`8
`
`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 13 of 16 PageID #: 1595
`
`acknowledging that Cellectis S.A. v. Precision Biosciences, 883 F. Supp. 2d 526 (D. Del. 2012)
`
`“focuses on intent to deceive as opposed to attorney argument,” D.I. 22 at 22, Pfizer does not
`
`address or distinguish Cellectis, see id. at 24–25.6
`
`The court’s decision in Cellectis demonstrates the fallibility of Pfizer’s allegations: even
`
`where the applicants “expressly contradicted the teachings of [a reference]” in their
`
`characterization, if “the prior art at issue was a focus of the examination” and the Examiner was
`
`“free to credit or discount [the applicant’s] characterizations of [the reference] in view of [her]
`
`own reading[],” then the contradiction may not “substitute for independent evidence of intent to
`
`deceive.” 883 F. Supp. 2d at 535. Although Pfizer attempts to rely on Wyeth and Cornell to support
`
`its case, see D.I. 22 at 24, as discussed above, the misrepresentations at issue in those cases were
`
`completely different from what Pfizer alleges Genentech has done here. Pfizer’s entire argument
`
`rests on allegations of misrepresentation of a prior art reference that was in front of the Examiner,
`
`and does not rely on knowledge that Genentech uniquely possessed that the Examiner could not
`
`independently evaluate. As Cellectis shows, Pfizer has failed to adequately plead deceptive intent.
`
`3.
`
`Pfizer failed to plead materiality.
`
`Pfizer has also failed to plead that Genentech’s alleged misrepresentation is but-for
`
`material to patentability. The alleged misrepresentation concerned statements Pfizer attempts to
`
`paint as about the entirety of the ’101 Patent. See D.I. 22 at 22. However, as discussed above, the
`
`Examiner’s rejection was limited to one embodiment of the ’101 Patent, and it is undisputed that
`
`the particular embodiment does not use Kabat numbering, which Pfizer’s own pleading
`
`
`6 As an initial matter, conclusory allegations are entitled to no weight on a motion to dismiss. Thus,
`Pfizer’s bare pleading that “[d]eceptive intent by Genentech is the single most reasonable inference
`to be drawn,” see D.I. 22 at 22 (quoting D.I. 14, Counterclaim ¶ 133), does nothing to advance
`Pfizer’s claim. See also Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“Threadbare recitals of the
`elements of a cause of action, supported by mere conclusory statements, do not suffice.”).
`
`
`
`9
`
`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 14 of 16 PageID #: 1596
`
`demonstrates. See D.I. 14, Counterclaim ¶ 129 (identifying that anti-Tac is the focus of the
`
`rejection); see also D.I. 20 at 16–18; D.I. 20-1, Ex. A at 7.
`
`Moreover, Pfizer’s efforts to characterize two rejections by the Examiner as not having
`
`“actually rejected the misrepresentation” are nonsensical. See D.I. 22 at 26–27 & n.10. Pfizer fails
`
`to plead facts that the alleged misrepresentations traversed the earlier rejections. After an initial
`
`rejection based on a specific embodiment in the ’101 Patent, Genentech first made the alleged
`
`misstatements about residue numbering on October 6, 1997. See D.I. 14, Counterclaim ¶¶ 125–26.
`
`The Examiner rejected Genentech’s argument on December 23, 1997, and suggested that claiming
`
`the numbering system could overcome the rejection. See D.I. 22 at 27. After an amendment on
`
`August 23, 1998, allegedly to incorporate this suggestion, see id., the Examiner again rejected the
`
`claims on the basis of that specific embodiment in the ’101 Patent on October 25, 2000. See D.I.
`
`14, Counterclaim ¶ 128; see also D.I. 20-1, Ex. A. Genentech then pointed back to its previously-
`
`rejected argument, after which the claims were allowed. D.I. 14, Counterclaim ¶¶ 129–30; see also
`
`D.I. 20-1, Exs. B & C. The Examiner had “actually rejected” these arguments, making Courtesy
`
`Prods. LLC v. Hamilton Beach Brands Inc., C.A. No. 13-2012-SLR-SRF, 2015 WL 6159113, at
`
`*6 (D. Del. Oct. 20, 2015) and Unverferth Mfg. Co. v. Par-Kan Co., No. 3:13-cv-97-TLS, 2014
`
`WL 2206922, at *4–5 (N.D. Ind. May 27, 2014) particularly apt. See also D.I. 20 at 19–20.
`
`At bottom, Pfizer does not and cannot allege facts supporting a claim for inequitable
`
`conduct. Pfizer’s alleged “misrepresentations” are attorney argument, and Pfizer has not alleged
`
`that anyone had deceptive intent or that such statements were but-for material to patentability.
`
`III. CONCLUSION
`
`Plaintiffs and Counterclaim Defendants respectfully request that the Court dismiss each of
`
`Pfizer’s Counterclaims, fully strike Pfizer’s Third Affirmative Defense, partially strike Pfizer’s
`
`Fourth Affirmative Defense, and dismiss HLR as a party to this case.
`10
`
`
`
`
`
`

`

`Case 1:19-cv-00638-CFC Document 24 Filed 06/14/19 Page 15 of 16 PageID #: 1597
`
`Dated: June 10, 2019
`
`OF COUNSEL
`
`Christopher N. Sipes
`Megan P. Keane
`Philip S. May
`Allison A. Schmitt
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`Alexa R. Hansen
`COVINGTON & BURLING LLP
`Salesforce Tower
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`(415) 591-6000
`
`Andrew Regan
`COVINGTON & BURLING LLP
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`(650