Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 1 of 34 PageID #: 1532
`
`
`
`
`
`
`
`
`
`
`
`
`C.A. No. 1:19-cv-00638-CFC
`
`
`
`
`
`Plaintiffs and Counterclaim
`Defendants,
`
` v.
`
`PFIZER INC.,
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`Counterclaim Defendant.
`DEFENDANT’S OPPOSITION TO PLAINTIFFS AND COUNTERCLAIM
`DEFENDANTS’ MOTION TO DISMISS DEFENDANT’S
`COUNTERCLAIMS AND TO STRIKE CERTAIN AFFIRMATIVE
`DEFENSES
`
`HEYMAN ENERIO
`GATTUSO & HIRZEL LLP
`Dominick T. Gattuso (No. 3630)
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`dgattuso@hegh.law
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GENENTECH, INC. and CITY OF
`HOPE,
`
`
`Defendant and
`Counterclaim Plaintiff.
`
`PFIZER INC.,
`
`
`Counterclaim Plaintiff,
`
`
`v.
`
`HOFFMANN-LA ROCHE, INC.,
`
`
`
`
`
`
`OF COUNSEL:
`
`
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 2 of 34 PageID #: 1533
`
`
`WILLKIE FARR & GALLAGHER
`LLP
`Thomas J. Meloro
`Michael W. Johnson
`Dan Constantinescu
`787 Seventh Avenue
`New York, NY 10019
`(212) 728-8000
`
`
`Dated: June 3, 2019
`
`
`
`
`
`
`
`
`
`
`Attorneys for Defendant and
`Counterclaim Plaintiff Pfizer Inc.
`
`
`- 2 -
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 3 of 34 PageID #: 1534
`
`
`TABLE OF CONTENTS
`PRELIMINARY STATEMENT ............................................................................... 1 
`I. 
`SUMMARY OF THE ARGUMENT .............................................................. 2 
`II. 
`LEGAL STANDARDS ................................................................................... 4 
`III.  PFIZER’S COUNTERCLAIMS ARE NOT BARRED UNDER THE
`BPCIA. ............................................................................................................. 5 
`A. 
`Pfizer Has Not Violated 42 U.S.C. § 262(l)(2)(A) ............................... 6 
`B. 
`The BPCIA Does Not Bar a Subsection (k) Applicant from Filing
`Counterclaims for Declaratory Relief. .................................................. 7 
`IV.  THE BPCIA DOES NOT LIMIT PFIZER’S INFRINGEMENT,
`INVALIDITY, AND UNENFORCEABILITY THEORIES IN
`LITIGATION. ............................................................................................... 13 
`PFIZER ADEQUATELY PLED ITS INEQUITABLE CONDUCT
`COUNTERCLAIM........................................................................................ 21 
`A. 
`The Pleadings Establish that Genentech Made Demonstrably False
`Statements to the PTO. ........................................................................ 21 
`B. 
`Pfizer Has Adequately Pled Specific Intent. ....................................... 23 
`C. 
`Pfizer Has Adequately Pled But-For Materiality. ............................... 25 
`VI.  CONCLUSION .............................................................................................. 27 
`
`
`
`
`V. 
`
`
`
`
`
`
`
`i
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 4 of 34 PageID #: 1535
`
`
`TABLE OF AUTHORITIES
`Abbott Labs. v. Lupin Ltd.,
`2011 WL 1897322 (D. Del. May 19, 2011) .................................................. 20
`Aktiebolag v. Kremers Urban Dev. Co.,
`No. 99 Civ. 8928, 2000 WL 257125 (S.D.N.Y. Mar. 8, 2000) ..................... 20
`Amgen Inc. v. Sandoz Inc.,
`Civ. No. 14-4741, 2015 WL 1264756 (N.D. Cal. Mar. 19, 2015)
`aff’d in part, vacated in part, remanded 794 F.3d 1347 (Fed. Cir. 2015),
`rev ’d in part, vacated in part, 137 S. Ct. 1664 (2017) ................................. 10
`Bayer Schering Pharma AG v. Barr Laboratories., Inc.,
`Civ. No. 05-2308, 2008 WL 628592 (D.N.J. Mar. 3, 2008) ......................... 23
`Blonder-Tongue Labs. Inc. v. Univ. of Ill. Found.,
`402 U.S. 313 (1971)......................................................................................... 5
`Bruni v. City of Pittsburgh,
`824 F.3d 353 (3d Cir. 2016) ................................................................ 4, 23, 26
`Carcieri v. Salazar,
`555 U.S. 379 (2009)................................................................................. 10, 14
`Cellectis S. A. v. Precision Biosciences,
`883 F. Supp. 2d 526 (D. Del. 2012) .............................................................. 22
`Celltrion Healthcare Co. v. Kennedy Trust For Rheumatology Research,
`Civ. No. 14-2256, 2014 WL 6765996 (S.D.N.Y. Dec. 1, 2014) ................... 11
`Cornell University v. Illumina, Inc.,
`C.A. No. 10-433-LPS-MPT, 2016 WL 3046258
`(D. Del. May 27, 2016) .................................................................. 4, 24, 25, 26
`Courtesy Prods. LLC v. Hamilton Beach Brands Inc.,
`C. A. No. 13-2012-SLR-SRF, 2015 WL 6159113 (D. Del. Oct. 20, 2015) .. 27
`Genentech, Inc. v. Amgen Inc.,
`No. 17-1407 (D. Del. Mar. 1, 2019) .............................................................. 19
`IBM v. Priceline Grp., Inc.,
`No. 15-cv-00137, 2017 WL 1349175 (D. Del. Apr. 10, 2017) ....................... 4
`
`ii
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 5 of 34 PageID #: 1536
`
`
`Internet Media Corp. v. Hearst Newspapers, LLC,
`No. 10-cv-00690, 2012 WL 3867165 (D. Del. Sep. 6, 2012) ......................... 5
`Jonathan H. v. Souderton Area Sch. Dist.,
`562 F.3d 527 (3d Cir. 2009) ........................................................................ 8, 9
`Krisa v. Equitable Life Assurance Society,
`109 F. Supp. 2d 316 (M.D. Pa. 2000) .............................................................. 9
`Minnesota Mining & Mfg. Co v. Barr Labs., Inc.,
`289 F.3d 775 (Fed. Cir. 2002) ....................................................................... 20
`Moody v. Atl. City Bd. of Educ.,
`870 F.3d 206 (3d Cir. 2017) ............................................................................ 5
`Nat’l Credit Union Admin. v. First Nat’l Bank & Trust Co.,
`522 U.S. 479 (1998)......................................................................................... 8
`Pac. Biosciences of Cal, Inc. v. Oxford Nanopore Techs., Inc.,
`C.A. No. 17-1353, 2018 WL 1419082 (D. Del. Mar. 22, 2018) ................. 5, 7
`Principal Life Ins. Co. v. Lawrence Rucker 2007 Ins. Trust,
`674 F. Supp. 2d 562 (D. Del. 2009) ................................................................ 4
`Sandoz Inc. v. Amgen Inc.,
`137 S. Ct. 1664 (2017) ......................................................................... 7, 11, 15
`Senju Pharm. Co. v. Apotex, Inc.,
`921 F. Supp. 2d 297 (D. Del. 2013) ................................................................ 5
`Separacor Inc. v. Teva Pharmaceuticals USA, Inc.,
`No. 09-1302, 2010 WL 2326262 (D.N.J. June 7, 2010) ............................... 23
`Southco, Inc. v. Penn Eng’g & Mfg. Corp.,
`768 F. Supp. 2d 715 (D. Del. 2011) .............................................................. 21
`Unverferth Mfg. Co. v. Par-Kan Co.,
`No. 3:13-cv-97-TLS, 2014 WL 2206922 (N.D. Ind. May 27, 2014) ............ 27
`Wyeth Holdings Corp. v. Sandoz, Inc.,
`No. 09-955-LPS, 2012 WL 600715 (D. Del. Feb. 3, 2012) ......... 21, 24, 25,26
`
`iii
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 6 of 34 PageID #: 1537
`
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007) ..................................................................... 22
`Statutes
`21 U.S.C. § 355(j)(2)(B) .......................................................................................... 20
`21 U.S.C. § 355(j)(2)(B)(iv)(II) ............................................................................... 20
`35 U.S.C. § 271(e)(6) ............................................................................................... 14
`42 U.S.C. § 262(l) ...................................................................................................... 1
`42 U.S.C. § 262(l)(1)(F) .......................................................................................... 14
`42 U.S.C. § 262(l)(1)(G) .......................................................................................... 14
`42 U.S.C. § 262(l)(2) ......................................................................................... 14, 19
`42 U.S.C. § 262(l)(2)(A) ...................................................................................passim
`42 U.S.C. § 262(l)(3) ............................................................................................... 14
`42 U.S.C. § 262(l)(3)(A) .......................................................................................... 19
`42 U.S.C. § 262(l)(3)(B) ...................................................................................... 3, 19
`42 U.S.C. § 262(l)(3)(B)(ii)(II) .......................................................................... 16, 17
`42 U.S.C. § 262(l)(3)(C) .......................................................................................... 19
`42 U.S.C. § 262(l)(6) ........................................................................................... 8, 15
`42 U.S.C. § 262(l)(7) ............................................................................................... 14
`42 U.S.C. § 262(l)(9)(C) ...................................................................................passim
`
`
`
`iv
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 7 of 34 PageID #: 1538
`
`
`PRELIMINARY STATEMENT
`After completing the information exchange and negotiation provisions
`
`(“Patent Dance”) of the Biologics Price Competition and Innovation Act
`
`(“BPCIA”) as outlined in 42 U.S.C. § 262(l),1 Genentech, Inc. (“Genentech”) and
`
`City of Hope (collectively, “Plaintiffs”) brought suit against Pfizer Inc. (“Pfizer”)
`
`alleging infringement of 22 patents. D.I. 1. In response, Pfizer served its Answer,
`
`Affirmative Defenses, and Counterclaims. D.I. 14. Because four of the asserted
`
`patents are owned by Hoffmann-La Roche, Inc. (“HLR”), Pfizer’s Counterclaims
`
`concerning those four patents were directed against Genentech and HLR.
`
`Now, Plaintiffs move to dismiss Pfizer’s counterclaims and certain
`
`affirmative defenses based largely on unsupportable interpretations of the BPCIA.2
`
`The Patent Dance as provided in 42 U.S.C. § 262(l) is designed to encourage the
`
`exchange of information between the subsection (k) applicant and the reference
`
`product sponsor. If the subsection (k) applicant chooses to participate in the Patent
`
`Dance, it gains the ability to exert substantial control over the scope and the timing
`
`of the resulting litigation. If, however, the subsection (k) applicant chooses not to
`
`participate in the Patent Dance or fails to make the required disclosures, the statute
`
`provides a clear and specific remedy―the reference product sponsor, but not the
`
`                                                            
`1 “§ 262” refers to 42 U.S.C. § 262 unless stated otherwise.
`2 Identical statutory interpretation questions are also pending in Genentech, Inc. v.
`Amgen Inc., No. 18-00924-CFC; No. 17-1407-CFC; and No. 17-1471-CFC.
`1
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 8 of 34 PageID #: 1539
`
`
`subsection (k) applicant, can bring a declaratory judgment action. This is the only
`
`prescribed penalty should the subsection (k) applicant choose to forego the Patent
`
`Dance or fail to make any of the required disclosures.
`
`Plaintiffs now seek a draconian remedy, apparently irrespective of whether
`
`the subsection (k) applicant has complied with the Patent Dance provisions or not,
`
`that would tie the hands of a subsection (k) applicant in the resulting patent
`
`litigation. However, neither the statutory text nor the congressional intent behind
`
`the carefully balanced statutory scheme support Plaintiffs’ extreme position.
`
`Plaintiffs’ other challenges to Pfizer’s affirmative defenses and
`
`counterclaims raise factual issues that cannot be properly resolved on a motion to
`
`dismiss. Plaintiffs’ motion should be denied in its entirety.
`
`I.
`
`SUMMARY OF THE ARGUMENT
`1.
`The Court should deny Plaintiffs’ request for dismissal of Pfizer’s
`
`counterclaims because Pfizer complied with § 262(l)(2)(A) and § 262(l)(9)(C) does
`
`not preclude Pfizer’s counterclaims. First, the record on this motion does not
`
`establish Plaintiffs’ allegation that Pfizer failed to comply with § 262(l)(2)(A). At
`
`most, Plaintiffs raise a factual issue that cannot be resolved on a motion to dismiss.
`
`Second, even if Pfizer had failed to comply with § 262(l)(2)(A), Plaintiffs’ only
`
`recourse under the BPCIA was to bring an action seeking declaratory judgment of
`
`infringement, validity, and enforceability, which they have done. The remedy of
`
`2
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 9 of 34 PageID #: 1540
`
`
`precluding counterclaims in defense of the action brought by Plaintiffs is
`
`inconsistent with the language and the purpose behind the BPCIA.
`
`2.
`
`The Court should deny Plaintiffs’ request for dismissal of Pfizer’s
`
`counterclaims and certain affirmative defenses because the BPCIA does not limit
`
`Pfizer to only the legal theories in its detailed statement pursuant to § 262(l)(3)(B)
`
`(“3(B) Statement”). Plaintiffs point to no statutory text or legislative history to
`
`support such an extreme measure and only proffer a policy argument. Because the
`
`statutory text is plain and unambiguous on this issue, the Court should apply the
`
`statute according to its terms. Not only did Congress not intend to regulate a
`
`subsection (k) applicant’s rights during litigation in such a manner, Plaintiffs’
`
`position defies common sense and fairness and cannot be squared with the careful
`
`balance of the parties’ interests that Congress designed.
`
`3.
`
`The Court should also deny Plaintiffs’ request for dismissal of Pfizer’s
`
`inequitable conduct argument regarding U.S. Patent No. 6,407,213 because Pfizer
`
`has adequately pled the claim based on Genentech’s demonstrably false statements
`
`to the U.S. Patent and Trademark Office (“PTO”) that the prior art ’101 patent
`
`does not use the Kabat numbering system. The pleadings show that these
`
`statements were affirmative, material misrepresentations of facts and the law does
`
`not allow Genentech to avoid the consequences of its statement merely because the
`
`prior art was before the Examiner. The pleadings support a reasonable inference
`
`3
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 10 of 34 PageID #: 1541
`
`
`that Genentech had specific intent to deceive the PTO based on use of repeated
`
`misrepresentations to mislead the Examiner into allowing a claim with a
`
`substitution at position 93H. Finally, the pleadings establish that the patent would
`
`not have issued without the misrepresentations because Genentech provided no
`
`other arguments to overcome the ’101 patent rejection.
`
`II. LEGAL STANDARDS
`“In considering a Rule 12(b)(6) motion, courts must accept all factual
`
`allegations as true, construe the complaint in the light most favorable to the [non-
`
`movant], and determine whether, under any reasonable reading of the complaint,
`
`the [non-movant] may be entitled to relief.” Bruni v. City of Pittsburgh, 824 F.3d
`
`353, 360 (3d Cir. 2016) (quotation and citation omitted). Dismissal under Rule
`
`12(b)(6) is improper where there is a factual question material to the dispute.
`
`Principal Life Ins. Co. v. Lawrence Rucker 2007 Ins. Trust, 674 F. Supp. 2d 562,
`
`565 (D. Del. 2009) (“The purpose of a [12(b)(6) motion] is to test the sufficiency
`
`of a complaint, or in this case, a counterclaim, and not to resolve disputed facts or
`
`decide the merits of the case.”); see also IBM v. Priceline Grp., Inc., No. 15-cv-
`
`00137, 2017 WL 1349175, at *14 (D. Del. Apr. 10, 2017) (“factual disagreement .
`
`. . does not support dismissal of Defendants’ counterclaim at the pleading stage” )
`
`(emphasis in original); Cornell University v. Illumina, Inc., C.A. No. 10-433-LPS-
`
`MPT, 2016 WL 3046258, at *9 (D. Del. May 27, 2016) (“At the pleadings stage,
`
`4
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 11 of 34 PageID #: 1542
`
`
`plaintiffs’ evidence is irrelevant and the court can not address the merits of that
`
`evidence”); Pac. Biosciences of Cal, Inc. v. Oxford Nanopore Techs., Inc., C.A.
`
`No. 17-1353, 2018 WL 1419082, at *8 n.3 (D. Del. Mar. 22, 2018) (denying
`
`motion to dismiss, inter alia, because of unresolved factual disputes raised by the
`
`parties’ briefing).
`
`“[A]n affirmative defense generally need not be articulated with any
`
`rigorous degree of specificity, and is sufficiently raised for purposes of Rule 8 by
`
`its bare assertion.” Moody v. Atl. City Bd. of Educ., 870 F.3d 206, 218 (3d Cir.
`
`2017) (quotation and citation omitted); see also Blonder-Tongue Labs. Inc. v. Univ.
`
`of Ill. Found., 402 U.S. 313, 350 (1971) (noting that the “purpose” of pleading an
`
`affirmative defense “is to give the opposing party notice of the plea”). Affirmative
`
`defenses are not subject to the Iqbal/Twombly pleading standard and “need not be
`
`plausible to survive.” Senju Pharm. Co. v. Apotex, Inc., 921 F. Supp. 2d 297, 303
`
`(D. Del. 2013); see, also, Internet Media Corp. v. Hearst Newspapers, LLC, No.
`
`10-cv-00690, 2012 WL 3867165, at *3 (D. Del. Sep. 6, 2012).
`
`III. PFIZER’S COUNTERCLAIMS ARE NOT BARRED UNDER THE
`BPCIA.
`Plaintiffs’ request for relief should be denied because it is based on the
`
`incorrect premise that Pfizer violated § 262(l)(2)(A) and, separately, because it is
`
`based on an incorrect interpretation of § 262(l)(9)(C) that is inconsistent with the
`
`plain language, and Plaintiffs point to no support in the legislative history to
`
`5
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 12 of 34 PageID #: 1543
`
`
`suggest a departure from the plain language.
`
`A.
`Pfizer Has Not Violated 42 U.S.C. § 262(l)(2)(A)
`Plaintiffs’ request to dismiss Pfizer’s counterclaims is based on the incorrect
`
`premise that Pfizer failed to comply with the requirements of § 262(l)(2)(A).
`
`Specifically, Plaintiffs assert that Pfizer “failed to produce its entire aBLA or all
`
`‘other information that describes the process or processes used to manufacture the
`
`biological product that is the subject of such application’ as required by 42 U.S.C.
`
`§ 262(l)(2)(A).” D.I. 20 at 5. Plaintiffs fail to cite to any pleadings that establish
`
`noncompliance with § 262(l)(2)(A) and, in fact, Plaintiffs admit that Pfizer pled
`
`that it fully complied with § 262(l)(2)(A). Id. Indeed, the facts pled in Pfizer’s
`
`Counterclaims show that Pfizer complied with § 262(l)(2)(A). For example,
`
`Pfizer’s Counterclaims plead:
`
`On September 14, 2018, within 20 days of the FDA’s
`notice and
`in full compliance with 42 U.S.C. §
`262(l)(2)(A), Pfizer provided Genentech with Pfizer’s
`BLA, which included over 565,000 pages of information
`on Pfizer’s Product and the processes used to manufacture
`it. The produced information completely ‘describe[d] the
`process or processes used to manufacture the biological
`product that is the subject of such application’ as
`contemplated by the BPCIA.
`D.I. 14 at 52 ¶ 32; see also D.I. 14 at 4 ¶ 8. The pleadings, which must be accepted
`
`as true, do not establish Plaintiffs’ allegation that Pfizer violated § 262(l)(2)(A).
`
`
`
`Plaintiffs allege that “[i]t is undisputed that Pfizer failed to provide its entire
`
`6
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 13 of 34 PageID #: 1544
`
`
`aBLA to Genentech.” D.I. 20 at 7. But, as Pfizer’s Counterclaims show, Pfizer
`
`disputes that its production of its application pursuant to § 262(l)(2)(A) was
`
`deficient in any way. D.I. 14 at 52 ¶ 32. At most, Plaintiffs’ attorney argument
`
`raises a factual issue that cannot be resolved on a motion to dismiss. Pac.
`
`Biosciences of Cal. Inc., 2018 WL 1419082, at *8 n.3. The Court should deny
`
`Plaintiffs’ request for relief on this basis alone.
`
`B.
`
`The BPCIA Does Not Bar a Subsection (k) Applicant from
`Filing Counterclaims for Declaratory Relief.
`Even if Pfizer had violated § 262(l)(2)(A), Plaintiffs are not entitled to the
`
`relief they seek because § 262(l)(9)(C) does not preclude Pfizer from filing
`
`counterclaims for declaratory judgement in response to Plaintiffs’ complaint.
`
`Plaintiffs argue that because Pfizer allegedly failed to comply with § 262(l)(2)(A),
`
`§ 262(l)(9)(C) not only bars Pfizer from “bring[ing] an action” for declaratory
`
`judgment, but also bars Pfizer from filing counterclaims for declaratory judgment
`
`in response to the action brought by Plaintiffs.3 Section 262(l)(9)(C) provides:
`
`If a subsection (k) applicant fails to provide the application and information
`required under paragraph (2)(A), the reference product sponsor, but not the
`subsection (k) applicant, may bring an action under section 2201 of title 28
`for a declaration of infringement, validity, or enforceability of any patent
`that claims the biological product or a use of the biological product.
`
`                                                            
`3 Plaintiffs do not and cannot base their request for relief on any other provision in
`the BPCIA or other federal statute. The Supreme Court has explained that “[t]he
`remedy provided by § 262(l)(9)(C) excludes all other federal remedies, including
`injunctive relief.” Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 1675 (2017).
`7
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 14 of 34 PageID #: 1545
`
`
`(emphasis added). The plain language of § 262(l)(9)(C) prohibits a subsection (k)
`
`applicant that has failed to comply with § 262(l)(2)(A) from “bring[ing] an action”
`
`under section 2201 of title 28, but says nothing about filing counterclaims for
`
`declaratory judgement after the subsection (k) applicant has been sued. Indeed, the
`
`language “bring an action” does not refer to filing counterclaims once a party has
`
`been sued. “The phrase ‘bring an action’ is defined as ‘to sue; institute legal
`
`proceedings.’”4 Jonathan H. v. Souderton Area Sch. Dist., 562 F.3d 527, 529 (3d
`
`Cir. 2009) (quoting Black’s Law Dictionary (8th ed. 2004)). In Jonathan H., the
`
`court interpreted the language “shall have the right to bring a civil action” in a
`
`different federal statute to exclude the filing of counterclaims in response to a
`
`complaint. Id. The court explained, citing FED. R. CIV. P. 3 and Advisory
`
`Committee Notes, that “an action is ‘brought’ when plaintiff files a complaint,
`
`which is the first step that invokes the judicial process” and that “[u]nlike the
`
`proactive nature of a complaint, a counterclaim is reactive because it is filed only
`
`after the plaintiff has initiated the case by bringing a civil action.” Id.
`
`Plaintiffs’ reliance on the court’s statement in Jonathan H. that “[t]he
`
`meaning of statutory language, plain or not, depends on context” in order to argue
`
`                                                            
`4 The only other time that “bring an action” appears in § 262(l) is in the context of
`the reference product sponsor bringing an infringement action pursuant to §
`262(l)(6). See Nat’l Credit Union Admin. v. First Nat’l Bank & Trust Co., 522
`U.S. 479, 501 (1998) (“similar language contained within the same section of a
`statute must be accorded a consistent meaning”).
`8
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 15 of 34 PageID #: 1546
`
`
`that Jonathan H. is not dispositive here, is misplaced. D.I. 20 at 8 n.6. The
`
`“context” that the court referred to is the impact of the term “bring” on the
`
`meaning “action,” not the general subject matter of statutes.5 Jonathan H., 562
`
`F.3d at 529. The Court acknowledged that “action” encompasses counterclaims,
`
`but concluded that the phrase “bring a civil action,” does not. Id. at 529-530
`
`(emphasis added). Plaintiffs provide no rationale for why the outcome should
`
`differ here. Indeed, the context here is the same as in Jonathan H. because §
`
`262(l)(9)(C) recites “bring an action,” not merely “action” in a vacuum.6
`
`Thus, an action is “brought” pursuant to § 262(l)(9)(C) when the reference
`
`product sponsor sues seeking declaratory judgment. See id. (“A civil action is
`
`commenced by filing a complaint with the court.” (citing Fed. R. Civ. P. 3)).
`
`Indeed, the only other court that has reached a determination on this specific issue
`
`rejected the exact argument that Plaintiffs proffer here. Amgen Inc. v. Sandoz Inc.,
`
`                                                            
`5 Genentech’s argument that the BPCIA is “concerned with creating an efficient
`pathway for approval of biosimilar products . . .,” whereas the statute in Jonathan
`H. “dealt with the time in which an aggrieved party could effectively appeal an
`administrative decision” does not support a different meaning for “bring an action”
`here.
`6 Genentech’s reliance on Krisa v. Equitable Life Assurance Society, 109 F. Supp.
`2d 316 (M.D. Pa. 2000) is, however, unpersuasive. D.I. 20 at 7. In Krisa, the
`court interpreted a state statute that does not include the language “bring an
`action.” Krisa, 109 F. Supp 2d at 321. Indeed, Genentech’s emphasis of the
`importance of “context” in statutory interpretation undercuts the relevance of
`Krisa.
`
`
`9
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 16 of 34 PageID #: 1547
`
`
`Civ. No. 14-4741, 2015 WL 1264756, at *9 (N.D. Cal. Mar. 19, 2015) aff’d in
`
`part, vacated in part, remanded 794 F.3d 1347 (Fed. Cir. 2015), rev ’d in part,
`
`vacated in part, 137 S. Ct. 1664 (2017) (“The BPCIA addresses only an
`
`applicant’s ability to ‘bring an action,’ not to assert a counterclaim if placed in a
`
`position to defend against an infringement suit.”). The Sandoz court also explained
`
`that Plaintiffs’ reading of § 262(l)(9)(C) would result in the waiver of compulsory
`
`counterclaims and that “barring such claims in particular raises ‘real due process
`
`concerns.’” Id. (citing U.S. ex rel. Miller v. Bill Harbert Intern. Const., Inc., 505
`
`F. Supp. 2d 20, 26 (D.D.C. 2007)). Plaintiffs assert that the reasoning in Sandoz is
`
`“unpersuasive,” but do not explain why that is. D.I. 20 at 8 n.6.
`
`In any case, the meaning of “bring an action” in § 262(l)(9)(C) is clear and
`
`unambiguous. See Carcieri v. Salazar, 555 U.S. 379, 387 (2009) (noting that when
`
`“the statutory text is plain and unambiguous” the court “must apply the statute
`
`according to its terms” (citations omitted)). Plaintiffs point to nothing in the
`
`legislative history of the BPCIA to support a departure from the plain and
`
`unambiguous language of § 262(l)(9)(C).
`
`Plaintiffs’ reliance on Celltrion Healthcare Co. v. Kennedy Trust For
`
`Rheumatology Research, Civ. No. 14-2256, 2014 WL 6765996 (S.D.N.Y. Dec. 1,
`
`2014) and its assertion that “every court to consider this question has answered the
`
`same way” misses the mark completely. D.I. 20 at 7. The Celltrion decision and
`
`10
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 17 of 34 PageID #: 1548
`
`
`other similar decisions dismissed an action for declaratory judgment brought by a
`
`non-compliant subsection (k) applicant who had filed a complaint. See Celltrion,
`
`2014 WL 6765996, at *5. Thus, the decisions Plaintiffs reference simply confirm
`
`that a non-compliant subsection (k) applicant may not “bring an action” for
`
`declaratory judgement, but say nothing about the issue Plaintiffs raise
`
`here―whether a non-compliant subsection (k) applicant is also precluded from
`
`filing counterclaims after the reference product sponsor has brought an action.
`
`Further, Plaintiffs’ quotation to the Supreme Court’s Sandoz decision is inapposite
`
`for the same reason―the issue Plaintiffs raise here was not before the Court, and in
`
`any case, the Court’s statement says nothing about the filing of counterclaims.
`
`Sandoz Inc., 137 S. Ct. at 1666.
`
`Indeed, the outcomes in Sandoz and Celltrion are completely consistent with
`
`the careful balancing of the parties’ interests in the BPCIA framework. The
`
`BPCIA provides subsection (k) applicants, who choose to comply with §
`
`262(l)(2)(A), with control over the timing of litigation and the number of patents
`
`that will be the subject of the litigation. Consequently, if the subsection (k)
`
`applicant fails to comply with § 262(l)(2)(A), then § 262(l)(9)(C) takes away that
`
`benefit by permitting only the reference product sponsor to immediately bring a
`
`suit seeking declaratory judgement for any patent that claims the biological product
`
`or a use of the biological product. Thus, control over the timing and scope of the
`
`11
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 18 of 34 PageID #: 1549
`
`
`litigation is shifted to the reference product sponsor, who may choose to delay
`
`bringing an action and force the subsection (k) applicant to delay launch or launch
`
`at risk in the absence of any patent certainty―the relief for non-compliance is
`
`proportional to the benefit provided to the subsection (k) applicant. Precluding the
`
`subsection (k) applicant from pleading counterclaims in response to an action
`
`brought by the reference product sponsor would be disproportionate and upend the
`
`balance inherent in the BPCIA framework.
`
`Plaintiffs’ argument that Pfizer’s counterclaims constitute “bring[ing] an
`
`action” because Pfizer brought certain counterclaims against HLR is also
`
`unconvincing. HLR owns some of the patents that Plaintiffs assert in this action.
`
`D.I. 14 at 48 ¶ 11. Pfizer’s counterclaims against HLR are duplicative of the
`
`counterclaims against Genentech and were filed defensively in response to
`
`Genentech’s allegations of infringement of the patents owned by HLR. Thus,
`
`Pfizer’s counterclaims against HLR arise from the same case or controversy in
`
`regards to which Plaintiffs brought this action. Plaintiffs provide no rationale for
`
`why Pfizer’s counterclaims against HLR merit a different outcome, other than that
`
`Pfizer was required to formally serve HLR with a Summons and its Answer,
`
`Affirmative Defenses, and Counterclaims. D.I. 20 at 8. Plaintiffs do not explain
`
`the import of that circumstance and provide no precedent supporting that the filing
`
`of counterclaims against HLR that are duplicative of those filed against Plaintiffs
`
`12
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 19 of 34 PageID #: 1550
`
`
`constitutes “bring[ing] an action” any more than the filing of Pfizer’s
`
`counterclaims against Plaintiffs does. Rather, interpreting the BPCIA to regulate
`
`the rights of a subsection (k) applicant with respect to other parties not
`
`substantively involved in the Patent Dance would also upend Congress’s careful
`
`balancing of the parties’ interests.
`
`For these reasons, Plaintiffs’ argument that the BPCIA precludes Pfizer from
`
`filing counterclaims in response to Plaintiffs’ Complaint fails.
`
`IV. THE BPCIA DOES NOT LIMIT PFIZER’S INFRINGEMENT,
`INVALIDITY, AND UNENFORCEABILITY THEORIES IN
`LITIGATION.
`Plaintiffs ask the Court to dismiss all of Pfizer’s counterclaims and strike its
`
`Third and Fourth Affirmative Defenses concerning invalidity and unenforceability
`
`because the BPCIA allegedly limits Pfizer’s legal theories to those included in
`
`Pfizer’s 3(B) Statement. D.I. 20 at 9. However, the statutory text and legislative
`
`history do not contemplate such relief. Indeed, Plaintiffs’ position would upend
`
`Congress’s careful balancing of the parties’ interests and discourage participation
`
`in the Patent Dance.
`
`As an initial matter, Plaintiffs do not identify any language in the statute that
`
`supports their positions. That is unsurprising because there is no statutory text that
`
`even remotely suggests that a subsection (k) is limited as Plaintiffs contend. Nor
`
`do Plaintiffs point to any legislative history that supports their position. Rather,
`
`13
`
`

`

`Case 1:19-cv-00638-CFC Document 22 Filed 06/03/19 Page 20 of 34 PageID #: 1551
`
`
`Congress clearly laid out the information exchange procedures under § 262(l)(2)-
`
`(3) and (7) and the negotiation procedures leading to initiation of litigation under §
`
`262(l)(4)-(6). Those provisions are unambiguous and there is no suggestion that
`
`any of the procedures affect the subsection (k) applicant’s ability to raise
`
`noninfringement, invalidity, and unenforceability theories during subsequent
`
`litigation. When “statutory text is plain and unambiguous[,]” the Court “must
`
`apply the statute according to its terms.” Carcieri, 555 U.S. at 387 (citation
`
`omitted). The absence of any support in the