Case 1:17-cv-01407-CFC-SRF Document 626 Filed 02/11/20 Page 1 of 18 PageID #: 43341
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF
`HOPE,
`
`Plaintiffs,
`
`Civ. No. 17-1407- CFC, Consol.
`
`V.
`
`AMGEN INC.,
`
`Defendant.
`
`Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington,
`Delaware; Paul B. Gaffney, David I. Berl, Thomas S. Fletcher, Teagan J. Gregory,
`Jonathan S. Sidhu, WILLIAMS & CONNOLLY LLP, Washington, D.C. Counsel
`for Plaintiffs.
`
`Melanie K. Sharp, James L. Higgins, YOUNG CONAWAY STARGATT &
`TAYLOR, LLP, Wilmington, Delaware; Siegmund Y. Gutman, PROSKAUER
`ROSE LLP, Los Angeles, California; Steven M. Bauer, PROSKAUER ROSE LLP,
`Boston, Massachusetts. Counsel for Defendant.
`
`MEMORANDUM OPINION
`
`February 11, 2020
`Wilmington, Delaware
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF
`HOPE,
`
`Plaintiffs,
`
`Civ. No. 17-1407- CFC, Consol.
`
`V.
`
`AMGEN INC.,
`
`Defendant.
`
`Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington,
`Delaware; Paul B. Gaffney, David I. Berl, Thomas S. Fletcher, Teagan J. Gregory,
`Jonathan S. Sidhu, WILLIAMS & CONNOLLY LLP, Washington, D.C. Counsel
`for Plaintiffs.
`
`Melanie K. Sharp, James L. Higgins, YOUNG CONAWAY STARGATT &
`TAYLOR, LLP, Wilmington, Delaware; Siegmund Y. Gutman, PROSKAUER
`ROSE LLP, Los Angeles, California; Steven M. Bauer, PROSKAUER ROSE LLP,
`Boston, Massachusetts. Counsel for Defendant.
`
`MEMORANDUM OPINION
`
`February 11, 2020
`Wilmington, Delaware
`
`
`
`Case 1:17-cv-01407-CFC-SRF Document 626 Filed 02/11/20 Page 2 of 18 PageID #: 43342
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`These two consolidated patent cases were filed under the Biologics Price
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`Competition and Innovation Act of 2009 (BPCIA), 42 U.S.C. § 262. Plaintiffs
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`Genentech, Inc. and City of Hope (collectively, Genentech) accuse Defendant
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`Amgen Inc. of infringing 26 patents based on Amgen' s submission of an
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`Abbreviated Biologics License Application (aBLA) to the Food and Drug
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`Administration (FDA) for approval to market a biosimilar of Genentech's biologic
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`drug product Avastin®. C.A. No. 17-1407, D.I. 41; C.A. No. 17-1471, D.I. 39. 1
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`Amgen alleges in 29 declaratory judgment counterclaims and its third, fourteenth,
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`and fifteenth affirmative defenses that the 26 asserted patents and two other patents
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`held by Genentech are invalid and/or unenforceable. Pending before me is
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`Genentech's motion to dismiss and/or strike pursuant to Federal Rules of Civil
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`Procedure l 2{b )( 6), 12(b )( 1 ), and 12( t) Amgen' s counterclaims and these three
`
`affirmative defenses. C.A. No. 17-1407, D.I. 128; C.A. No. 17-1471, D.I. 126.
`
`1 Although these two actions have been consolidated, Genentech has not filed a
`consolidated complaint. Genentech asserts 25 patents in C.A. No. 17-1407 and
`one additional patent, for a total of 26, in C.A. No. 17-14 71. Amgen filed in both
`actions affirmative defenses and counterclaims that are verbatim identical. See
`C.A. No. 17-1407, D.I. 120; C.A. No. 17-1471, D.I. 118. Accordingly, for
`convenience, I will discuss the two sets of affirmative defenses and counterclaims
`as if they were in a single pleading and cite only to the operative answer and
`counterclaims filed in C.A. No. 1 7-1407.
`1
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`
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`I. LEGAL STANDARDS
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`A. TheBPCIA
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`The BPCIA is a complex statutory scheme that governs biologics and a
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`subset of biologics called biosimilars. Biologics, also known as biological
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`products, are drugs that are not chemically synthesized but instead are derived
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`from biological sources such as animals and microorganisms. A biosimilar is a
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`biologic that is highly similar to, and not meaningfully different in terms of safety,
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`purity, or potency from, a biologic already approved by the FDA. As its title
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`suggests, the BPCIA was designed to foster both price competition and innovation
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`in the field of biologics. To that end, the BPCIA "establishes processes both for
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`obtaining expedited FDA approval ofbiosimilars and for resolving patent disputes
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`between manufacturers of licensed biologics and manufactures of biosimilars."
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`Sandoz, Inc. v. Amgen Inc., 137 S. Ct. 1664, 1669-70 (2017).
`
`The starting point of the FDA approval process begins with the filing of the
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`aBLA by the manufacturer of the biosimilar (the applicant). The aBLA and the
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`FDA approval process are said to be abbreviated because the biosimilar applicant
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`does not need to show with independent ( and costly) evidence such as clinical trial
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`results that the biosimilar is safe, pure, and potent. Instead, the applicant can
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`"piggyback on the showing made by the manufacturer (sponsor) of [the] previously
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`licensed biologic (reference product)." Id. at 1670.
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`2
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`The BPCIA' s patent dispute-resolution process---often referred to as "the
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`patent dance"-is "a carefully calibrated scheme for preparing to adjudicate, and
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`then adjudicating, claims of infringement." Id. at 1670. The dance kicks off "not
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`later than 20 days" after the FDA notifies the biosimilar applicant that the FDA
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`accepted the aBLA. 42 U.S.C. § 262(/)(2). At that point, the applicant "shall
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`provide" to the reference product's sponsor a copy of the aBLA and "such other
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`information that describes the process or processes used to manufacture the
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`[biosimilar.]" § 262(/)(2)(A). "These disclosures enable the sponsor to evaluate
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`the biosimilar for possible infringement of patents it holds on the reference product
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`(i.e., the corresponding biologic)." Sandoz, 137 S. Ct. at 1670-71.
`
`The Court in Sandoz summarized the remainder of the BPCIA's pre-
`
`litigation patent dance as follows:
`
`After the applicant makes the requisite disclosures
`[required by § 262(/)(2)(A)],
`the parties exchange
`information to identify relevant patents and to flesh out the
`legal arguments that they might raise in future litigation.
`Within 60 days of receiving
`the application and
`manufacturing information, the sponsor "shall provide" to
`the applicant "a list of patents" for which it believes it
`could assert an infringement claim if a person without a
`license made, used, offered to sell, sold, or imported "the
`biological product that is the subject of the [biosimilar]
`application." § 262(/)(3)(A)(i). The sponsor must also
`identify any patents on the list that it would be willing to
`license. § 262(/)(3)(A)(ii).
`
`Next, within 60 days of receiving the sponsor's list, the
`applicant may provide to the sponsor a list of patents that
`3
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`
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`the applicant believes are relevant but that the sponsor
`omitted from its own list, § 262(/)(3)(B)(i), and "shall
`provide" to the sponsor reasons why it could not be held
`liable for infringing the relevant patents, § 262(/)(3)(B)(ii).
`The applicant may argue that the relevant patents are
`invalid, unenforceable, or not infringed, or the applicant
`may agree not to market the biosimilar until a particular
`patent has expired. Ibid. The applicant must also respond
`to the sponsor's offers to license particular patents. §
`262(/)(3)(B)(iii). Then, within 60 days of receiving the
`applicant's responses, the sponsor "shall provide" to the
`applicant its own arguments concerning infringement,
`enforceability, and validity as to each relevant patent. §
`262(/)(3)(C).
`
`Id. at 1671 (first set of brackets added).
`
`If the parties comply with these information exchange requirements, the
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`BPCIA "channels the parties into two phases of patent litigation." Id. The
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`specifics of these phases are not relevant to the pending motion. But it is relevant
`
`that the applicant has "substantial control" over both phases of the litigation. See
`
`id. (noting that the BPCIA's "process gives the applicant substantial control over
`
`the scope of the first phase of litigation"); id. at 1672 (noting that the applicant
`
`"wields substantial control over the timing of the second phase of litigation").
`
`The Court noted in Sandoz that "[t]o encourage parties to comply with [the
`
`BPCIA's] procedural requirements," the Act "includes various consequences for
`
`failing to do so." Id. at 1672. Two of these consequences are set forth in §
`
`262(/)(9)(C) and§ 262(/)(9)(B) of the BPCIA. As the Court explained in Sandoz:
`
`4
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`Under § 262(/)(9)(C), if an applicant fails to provide its
`application and manufacturing
`information
`to
`the
`sponsor-thus effectively pretermitting the entire two(cid:173)
`phase litigation process-then the sponsor, but not the
`applicant, may immediately bring an action "for a
`declaration of infringement, validity, or enforceability of
`any patent that claims the biological product or a use of
`the biological product."
`Section 271 ( e )(2)(C)(ii)
`facilitates this action by making it an artificial act of
`infringement, with respect to any patent that could have
`been included on the § 262( /)(3) lists, to submit a
`biosimilar application. Similarly, when an applicant
`provides the application and manufacturing information
`but fails to complete a subsequent step, § 262( /)(9)(B)
`provides that the sponsor, but not the applicant, may bring
`a declaratory-judgment action with respect to any patent
`included on the sponsor's§ 262(/)(3)(A) list of patents (as
`well as those it acquired later and added to the list). As
`noted, it is an act of artificial infringement, with respect to
`any patent on the § 262( /)(3) lists, to submit an application
`to the FDA. See§ 27l(e)(2)(C)(i).
`
`137 S. Ct. at 1672 (emphasis removed) (underline added). Thus, under§§
`
`262(/)(9)(B) and 262(/)(9)(C), when an applicant fails to comply with the
`
`information exchange requirements of the patent dance, it subjects itself to the
`
`uncertain timing and scope of a declaratory judgment infringement action brought
`
`by the reference sponsor and it loses the "substantial control" it would otherwise
`
`have been able to exert in the two phases of litigation established by the BPCIA.
`
`See id. at 1675 ("Section 262(/)(9)(C) thus vests in the sponsor the control that the
`
`applicant would otherwise have exercised over the scope and timing of the patent
`
`litigation.").
`
`5
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`
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`B. Rule 12(b)(6)
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`Under Rule 12(b)(6), a party may move to dismiss a complaint for failure to
`
`state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). To
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`survive the motion to dismiss, the complaint must contain sufficient factual matter
`
`"to state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S.
`
`662, 677-78 (2009) (quoting Bell At!. Corp. v. Twombly, 550 U.S. 544, 570
`
`(2007)). The factual allegations do not have to be detailed, but they must provide
`
`more than labels, conclusions, or a "formulaic recitation" of the claim elements.
`
`Twombly, 550 U.S. at 555. In assessing the plausibility of a claim, the court must
`
`accept all well-pleaded factual allegations in the complaint as true and draw all
`
`reasonable inferences in favor of the plaintiff. In re Rockefeller Ctr. Prop., Inc.
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`Sec. Litig., 311 F.3d 198,215 (3d Cir. 2002). The court's review is limited to the
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`allegations in the complaint, exhibits attached to the complaint, documents
`
`incorporated by reference, items subject to judicial notice, and matters of the
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`public record. Mayer v. Belichick, 605 F.3d 223,230 (3d Cir. 2010).
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`C. Rule 12(b)(l)
`
`The party asserting subject matter jurisdiction has the burden of proving its
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`existence. Lincoln Ben. Life Co. v. AEI Life, LLC, 800 F.3d 99, 105 (3d Cir. 2015).
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`"Challenges to subject matter jurisdiction under Rule 12(b)(l) may be facial or
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`factual." Id. (quoting Common Cause of Pa. v. Pennsylvania, 558 F.3d 249,257
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`6
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`
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`(3d Cir. 2009)). A facial attack contests the sufficiency of the pleadings, whereas a
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`factual attack contests the sufficiency of jurisdictional facts. Id. Here, Genentech
`
`makes a factual attack. When reviewing a factual attack, the court may weigh and
`
`consider evidence outside the pleadings. Gould Elecs. Inc. v. United States, 220
`
`F.3d 169, 176 (3d Cir. 2000). Finally, in a factual challenge, "no presumptive
`
`truthfulness attaches to plaintiffs' allegations." Mortensen v. First Fed. Sav. &
`
`Loan Ass 'n, 549 F.2d 884, 891 (3d Cir. 1977).
`
`D. Rule 12(t)
`
`Pursuant to Rule 12(f), "[t]he court may strike from a pleading any
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`insufficient defense or any redundant, immaterial, impertinent, or scandalous
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`matter." Fed. R. Civ. P. 12(f). Motions to strike are generally disfavored and
`
`ordinarily denied "unless the allegations have no possible relation to the
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`controversy and may cause prejudice to one of the parties." Sun Microsystems,
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`Inc. v. Versata Enters., Inc., 630 F. Supp. 2d 395,402 (D. Del. 2009) (quoting
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`Mcinerney v. Moyer Lumber & Hardware, Inc., 244 F. Supp. 2d 393, 402 (E.D.
`
`Pa. 2002)). When ruling on a motion to strike, "the [ c ]ourt must construe all facts
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`in favor of the nonmoving party ... and deny the motion if the defense is sufficient
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`under law." Procter & Gamble Co. v. Nabisco Brands, Inc., 697 F. Supp. 1360,
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`1362 (D. Del. 1988).
`
`7
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`
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`II. DISCUSSION
`
`Genentech attacks various combinations of counterclaims and affirmative
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`defenses on four different grounds. First, Genentech argues that Amgen did not
`
`comply with its pre-litigation production obligations under the BPCIA and,
`
`therefore, all of Amgen' s declaratory judgment counterclaims are barred by §
`
`262(/)(9)(C). D.I. 129 at 2-4. Second, Genentech argues that Amgen's invalidity
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`counterclaims and corresponding third affirmative defense are barred by the
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`BPCIA to the extent they are based on invalidity, unenforceability, and non(cid:173)
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`infringement contentions that Amgen did not disclose to Genentech in the patent
`
`dance as required by§ 262(/)(3)(B). Id. at 5-9. Third, Genentech argues that
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`Amgen has failed to state a claim for inequitable conduct and therefore Count 29
`
`and the corresponding fourteenth and fifteenth affirmative defenses should be
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`dismissed. Id. at 9-11. And finally, Genentech contends that the Court lacks
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`subject matter jurisdiction over Counts 8 and 15 of Amgen's counterclaims. I
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`address each argument in tum.
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`A. Declaratory Judgment Counterclaims
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`Genentech first alleges that Amgen failed to provide "such other
`
`information" that describes its biosimilar manufacturing process as required by §
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`262(/)(2)(A) and, therefore, Amgen is barred by § 262(/)(9)(C) from asserting
`
`counterclaims that seek a declaratory judgment that Genentech' s patents are
`
`8
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`invalid, unenforceable, and not infringed. D.I. 41 ,I 5. Amgen disputes the factual
`
`premise of this argument, claiming that it sent Genentech its aBLA and "more than
`
`a million pages of technical details and batch records" describing the
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`manufacturing processes. D.I. 120, Counterclaims ,I 20.
`
`I need not resolve the parties' factual disputes or decide whether Amgen
`
`complied with its § 262(/)(2)(A) obligations, because the filing of counterclaims
`
`does not constitute "bringing an action" and, therefore, is not barred by §
`
`262(/)(9)(C). The terms of§ 262(/)(9)(C) are clear:
`
`If a [biosimilar] applicant fails to provide the [aBLA] and
`information required under paragraph [§ 262(/)](2)(A), the
`reference product sponsor, but not the [biosimilar]
`applicant, may bring an action under section 2201 of Title
`29, for a declaration of infringement, validity, or
`enforceability of any patent that claims the biological
`product or a use of the biological product.
`
`§ 262(/)(9)(C) ( emphasis added). "The phrase 'bring an action' is defined as 'to
`
`sue; institute legal proceedings."' Jonathan H v. The Souderton Area School
`
`Dist., 562 F.3d 527, 530 (3d. Cir. 2009) (quoting Black's Law Dictionary (8th ed.
`
`2004) ). It is the filing of a complaint-not a counterclaim-that institutes an
`
`action. See Fed. R. Civ. P. 3 ("A civil action is commenced by filing a complaint
`
`with the court."). Accordingly, Amgen's counterclaims are not barred by§
`
`262(/)(9)(C).
`
`9
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`B. Invalidity Counterclaims
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`Genentech next argues that Amgen' s counterclaims should be dismissed
`
`under Rule 12(b)(6) and Amgen's invalidity and enforceability defenses should be
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`struck under Rule 12( f) to the extent the counterclaims and defenses "rely on
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`positions Amgen did not disclose during the 'patent dance."' D.I. 129 at 9.
`
`Genentech faults Amgen for failing to comply with "the obligation to provide
`
`meaningful [§ 262](/){3)(B)(ii)(I) contentions," id. at 7, and it contends that "[t]he
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`statute does not permit this," id. at 5.
`
`Genentech does not make clear in its briefing how Amgen' s §
`
`262(/)(3)(B)(ii) disclosures were deficient or what are the "new" contentions
`
`Amgen now seeks to make in support of its counterclaims and affirmative
`
`defenses. Nor does Genentech point to anything in the BPCIA or to case law
`
`inteipreting the BPCIA that would support barring a biosimilar applicant from
`
`making in a BPCIA case contentions not disclosed in the patent dance. But, in any
`
`event, Genentech's argument that the BPCIA precludes an applicant from making
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`contentions beyond the scope of its § 262( /)(3 )(B )(ii) disclosures is foreclosed by §
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`262(/)(9)(8) and the Supreme Court's decision in Sandoz.
`
`As discussed above,§§ 262(/)(9)(B) and 262(/)(9)(C) are remedial
`
`provisions in the BPCIA designed to encourage parties to comply with the
`
`disclosure requirements of the patent dance. Just as§ 262(/)(9)(C) empowers "the
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`10
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`reference product sponsor, but not the [biosimilar] applicant," to "bring an action"
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`for a declaratory judgment if the applicant "fails to provide the application and
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`information required under [§ 262(/)](2)(A)," so, too, § 262(/)(9)(B) empowers
`
`"the reference product sponsor, but not the [biosimilar] applicant," to "bring an
`
`action" for a declaratory judgment if the applicant "fails to complete an action
`
`required ... under[§ 262(/)](3)(B)(ii)." The two remedial provisions use identical
`
`language to establish the same consequence for non-compliance-i.e., the loss of
`
`control over the scope and timing of the patent litigation.
`
`In Sandoz the Court held that a reference product sponsor could not obtain
`
`an injunction to compel an applicant to comply with § 262(/)(2)(A) because"§
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`262(/)(9)(C) represents the exclusive remedy for an applicant's failure to provide
`
`[the] application and manufacturing information" required by § 262(/)(2)(A). 137
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`S. Ct. at 1675 n.2. The Court explained:
`
`The remedy provided by§ 262(/)(9)(C) excludes all other
`federal remedies, including injunctive relief. Where, as
`here, "a statute expressly provides a remedy, courts must
`be especially reluctant to provide additional remedies."
`The BPCIA's "carefully crafted and detailed enforcement
`scheme provides strong evidence that Congress did not
`intend to authorize other remedies that it simply forgot to
`incorporate expressly." The presence of§ 262(/)(9)(C),
`coupled with the absenc~ of any other textually specified
`remedies, indicates that Congress did not intend sponsors
`to have access to injunctive relief, at least as a matter of
`federal law, to enforce the disclosure requirement.
`
`11
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`Statutory context further confirms that Congress did not
`authorize courts to enforce § 262(/)(2)(A) by injunction.
`Section 262(/)(l)(H) provides that "the court shall
`consider immediate injunctive relief to be an appropriate
`and necessary remedy for any violation or threatened
`violation" of the rules governing the confidentiality of
`information disclosed under § 262(/). We assume that
`Congress acted
`intentionally when
`it provided an
`injunctive remedy for breach of the confidentiality
`requirements but not for breach of § 262(/)(2)(A)'s
`disclosure requirement.
`
`13 7 S. Ct. at 13 7 5 ( citations and footnote omitted).
`
`There is no material difference between § 262(/)(9)(B) and § 262(/)(9)(C).
`
`Accordingly, it follows from Sandoz that§ 262(/)(9)(B) is the exclusive federal
`
`remedy available to the reference product sponsor to address an applicant's failure
`
`to comply with§ 262(/)(3)(B)(ii). Thus, Genentech's sole remedy for Amgen's
`
`non-compliance with§ 262(/)(3)(B)(ii) is to do what Genentech did here-bring a
`
`declaratory judgment action for artificial infringement. Nothing in§ 262(/)(9)(B)
`
`or in any other provision of the BPCIA limits the defenses an applicant can assert
`
`in such an action. And in light of the BPCIA' s "carefully crafted and detailed
`
`enforcement scheme," the fact that Congress did not expressly limit an applicant's
`
`defenses in a declaratory judgment action brought pursuant to§ 262(/)(9)(B)
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`"provides strong evidence that Congress did not intend" to limit those defenses.
`
`137 S. Ct. at 1675. Accordingly, I will not preclude Amgen from asserting in this
`
`case contentions not disclosed in the patent dance, and I will deny Genentech' s
`
`12
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`request to dismiss Amgen' s counterclaims and strike its defenses to the extent
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`those counterclaims and defenses are based on contentions not disclosed in the
`
`patent dance.
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`C. Inequitable Conduct and Unclean Hands
`
`Amgen has asserted a counterclaim and two affirmative defenses-based on
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`alleged misconduct by Genentech before the United States Patent & Trademark
`
`Office (PTO) during the prosecution of U.S. Patent No. 6,407,213 (the "#213
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`patent"). D.I. 120, Affirmative Defenses ,r,r 14, 15-26 and Counterclaims ,r,r 269-
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`282. Specifically, in Count 29 of the counterclaims, Amgen seeks a declaratory
`
`judgement that the #213 patent is unenforceable based on inequitable conduct. D.I.
`
`120, Counterclaims ,r,r 269-82. And in the fourteenth and fifteenth affirmative
`
`defenses, Amgen asserts respectively unclean hands and inequitable conduct
`
`defenses based on the same allegations made in support of Count 29. D.I. 120.
`
`Genentech asks that I dismiss Count 29 and strike the fourteenth and fifteenth
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`affirmative defenses for failure to state a claim.
`
`The alleged misrepresentations underlying the inequitable conduct
`
`unenforceability claim and the two affirmative defenses concern two prior art
`
`references: U.S. Patent No. 5,530,101 (the "#101 patent") and Queen 1989.
`
`Amgen alleges that Genentech argued to the PTO that the # 101 patent and Queen
`
`1989 used "sequential numbering" and not "the Kabat numbering" when in fact
`
`13
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`both references expressly refer to the Kabat numbering system. D.I. 120,
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`Counterclaims ,r,r 277, 279-82. Amgen further alleges that Genentech misled the
`
`examiner by providing him a comparison of the numbering systems used in Queen
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`1989 and the #213 patent that omitted the "62L" residue in both numbering
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`systems. Id. at ,r 281.
`
`Genentech argues that these allegations fail to state cognizable claims of
`
`inequitable conduct and unclean hands, because they are based on "attorney
`
`argument" and because the patentee disclosed the prior art references in question
`
`and the examiner was free to reach his own conclusions about what the references
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`taught. D .I. 129 at 9-11. "Although an attorney is free to argue vigorously in
`
`favor of patentability without being subject to allegations of inequitable conduct,
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`the law prohibits genuine misrepresentations of material fact." Rothman v. Target
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`Corp., 556 F.3d 1310, 1328 (Fed.Cir.2009) (internal quotation marks and citation
`
`omitted). Amgen has alleged with sufficient particularity that Genentech
`
`deliberately mischaracterized the prior art and made other misrepresentations
`
`during the prosecution. For purposes of Rule 12(b)(6) and Rule 12{f), I must
`
`assume that those allegations are true and interpret them in Amgen' s favor.
`
`Accordingly, I will deny Genentech's motion insofar as it seeks to dismiss Count
`
`29 and strike Amgen's inequitable conduct and unclean hands defenses.
`
`14
`
`
`
`Case 1:17-cv-01407-CFC-SRF Document 626 Filed 02/11/20 Page 16 of 18 PageID #: 43356
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`D. Subject Matter Jurisdiction
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`Finally, Genentech argues that Counts 8 and 15 of Amgen's counterclaims
`
`should be dismissed for lack of subject matter jurisdiction. D .I. 129 at 11-12.
`
`These counterclaims seek a declaratory judgment that U.S. Patent Nos. 6,610,516
`
`(the "#516 patent") and 7,323,553 (the "#553 patent") are invalid, unenforceable,
`
`and will not be infringed by Amgen's proposed biosimilar. D.I. 120,
`
`Counterclaims 11 118-24, 169-75.
`
`Genentech had included the #516 and #553 patents in the list of patents it
`
`disclosed to Amgen under§ 262(/)(3)(A) as part of the patent dance. See§
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`262(/)(3)(A) (requiring the reference product sponsor to provide the applicant with
`
`a list of the patents "for which the reference product sponsor believes a claim of
`
`patent infringement could reasonably be asserted" if the applicant were to market
`
`its proposed biosimilar). But Genentech did not include the patents in its
`
`subsequent statement of contentions made pursuant to§ 262(/)(3)(C). See§
`
`262(/)(3)(C) (requiring the reference product sponsor within 60 days of receiving
`
`the applicant's§ 262(/)(3)(B) disclosures to provide the applicant with the
`
`sponsor's infringement, validity, and enforceability contentions). As Genentech
`
`explained to Amgen in correspondence exchanged during the patent dance,
`
`"having reviewed your[§ 262](/)(3)(8) contentions, Genentech has not served
`
`infringement contentions for [the #516 and #553 patents] and does not intend to
`
`15
`
`
`
`Case 1:17-cv-01407-CFC-SRF Document 626 Filed 02/11/20 Page 17 of 18 PageID #: 43357
`
`assert them against [Amgen's proposed biosimilar]." D.I. 130-1, Ex. 2. Consistent
`
`with that correspondence, Genentech did not assert the #516 and #553 patents in
`
`these consolidated actions.
`
`For a court to exercise jurisdiction under the Declaratory Judgment Act,
`
`there must be an "actual controversy." 28 U.S.C. § 2201(a). The controversy must
`
`be "of sufficient immediacy and reality to warrant the issuance of a declaratory
`
`judgment." Juno Therapeutics, Inc. v. Kite Pharma, Inc., 2017 WL 2559735, at * 1
`
`(D. Del. June 13, 2017) (quoting Md Cas. Co. v. Pac. Coal & Oil Co., 312 U.S.
`
`270,273 (1941)). Genentech argues that there is no actual controversy regarding
`
`the #516 and #553 patents, because Genentech has already represented to Amgen
`
`that it does not plan to assert those patents against Amgen's proposed biosimilar
`
`and did not assert those patents in the complaints filed in this consolidated action.
`
`I agree.
`
`Amgen argues that an actual controversary exists, because Genentech' s
`
`representation that it does not intend to assert claims based on the #516 and #553
`
`patents is not binding. D.I. 146 at 18-19. Under Amgen's theory, an actual
`
`controversy will exist until Genentech provides a covenant not sue. Id. Although
`
`"a defendant's failure to sign a covenant not to sue is one circumstance to consider
`
`in evaluating the totality of the circumstances, it is not sufficient to create an actual
`
`controversy." Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1341 (Fed.
`
`16
`
`
`
`Case 1:17-cv-01407-CFC-SRF Document 626 Filed 02/11/20 Page 18 of 18 PageID #: 43358
`
`Cir. 2008). I will therefore dismiss Counts 8 and 15 of Amgen's counterclaims for
`
`lack of subject matter jurisdiction.
`
`III. CONCLUSION
`
`For the foregoing reasons, I will grant in part and deny in part Gen en tech' s
`
`motion to dismiss Amgen' s first amended counterclaims and strike Amgen' s third,
`
`fourteenth, and fifteenth affirmative defenses (C.A. No. 17-1407, D.I. 128; C.A.
`
`No. 17-1471, D.I. 126). I will grant Genentech's motion insofar as it seeks to
`
`dismiss Counts 8 and 15 of Amgen' s counterclaims for lack of subject matter
`
`jurisdiction. I will deny the motion in all other respects.
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`The Court will issue an Order consistent with this Memorandum Opinion.
`
`17
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`
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