Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 1 of 23 PageID #:
`11378
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
`GENENTECH, INC and CITY OF HOPE,
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`
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`v.
`
`AMGEN INC.,
`
`
`
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`
`
`
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`
`
`
`
`Plaintiffs,
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`Defendant.
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`
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`
`
`C.A. No. 18-924-GMS
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`
`PLAINTIFFS’ OPENING BRIEF IN SUPPORT OF THEIR MOTION
`TO DISMISS DEFENDANT’S UNENFORCEABILITY COUNTERCLAIMS
`AND TO STRIKE DEFENDANT’S ELEVENTH AFFIRMATIVE DEFENSE
`
`MCCARTER & ENGLISH, LLP
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4785)
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`
`Attorneys for Plaintiffs Genentech, Inc. and
`City of Hope
`
`
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY
`(212) 230-8800
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`(415) 362-6666
`
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 2 of 23 PageID #:
`11379
`
`I.
`II.
`III.
`IV.
`
`V.
`
`VI.
`
`
`
`
`
`TABLE OF CONTENTS
`
`Amgen Is Alleging That The Patents-In-Suit Are
`Unenforceable To Clear The Way For Its Biosimilar
`
`The Only Factual Allegations In Amgen’s Unenforceability
`
`NATURE AND STAGE OF THE PROCEEDINGS ................................ 1
`LEGAL STANDARD .............................................................................. 2
`SUMMARY OF ARGUMENT ................................................................ 4
`BACKGROUND ..................................................................................... 6
`A.
`Version Of Genentech’s Blockbuster Drug Herceptin®. ................ 6
`B.
`Defenses And Counterclaims Relate To The ’213 Patent. ............. 8
`ARGUMENT ......................................................................................... 11
`A.
`Counterclaim For The ’213 Patent Should Be Dismissed. ........... 11
`B.
`Should Be Dismissed. ................................................................. 15
`CONCLUSION ...................................................................................... 18
`
`Because Amgen’s Unenforceability Theory For The ’213
`Patent Is Legally Deficient, Its Eleventh Affirmative
`Defense Should Be Stricken And Its Unenforceability
`
`Amgen’s Remaining Counterclaims For Unenforceability
`
`
`
`– ii –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 3 of 23 PageID #:
`11380
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Akzo N.V. v. U.S. Int’l Trade Comm’n,
`808 F.2d 1471 (Fed. Cir. 1986) ............................................................................................ 12
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .................................................................................................... 2, 3, 18
`
`Aventis Pharma S.A. v. Hospira, Inc.,
`675 F.3d 1324 (Fed. Cir. 2012) ............................................................................................ 11
`
`Bayer Schering Pharma AG v. Barr Labs., Inc.,
`No. 05-cv-2308 (PGS), 2008 WL 628592 (D.N.J. Mar. 3, 2008) ........................................... 4
`
`Cellectis S.A. v. Precision Biosciences,
`883 F. Supp. 2d 526 (D. Del. 2012) ....................................................................................... 4
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009) .......................................................................................... 3, 4
`
`Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Systems, LLC,
`350 F.3d 1327 (Fed. Cir. 2003) .............................................................................................. 3
`
`Genentech, Inc. v. Amgen Inc.,
`No. 17-1407-GMS, 2018 WL 503253 (D. Del. Jan. 22, 2018) ............................................... 7
`
`Genetic Techs. Ltd. v. Interleukin Genetics Inc.,
`No. 10-CV-69-BBC, 2010 WL 3362344 (W.D. Wis. Aug. 24, 2010) ................................... 18
`
`LEO Pharma A/S v. Actavis Labs. UT, Inc.,
`No. CV 16-333-JFB-SRF, 2018 WL 1045816 (D. Del. Feb. 26, 2018) .................................. 3
`
`Medicines Co. v. Teva Parenteral Meds., Inc.,
`No. 09-750-ER, 2011 WL 13135647 (D. Del. Aug. 26, 2011) ............................................. 15
`
`O’Gara v. Countrywide Home Loans, Inc.,
`No. 08-113-JJF, 2010 WL 3070211 (D. Del. July 30, 2010) ................................................ 15
`
`Ring Plus, Inc. v. Cingular Wireless Corp.,
`614 F.3d 1354 (Fed. Cir. 2010) ...................................................................................... 13, 14
`
`Rothman v. Target Corp.,
`556 F.3d 1310 (Fed. Cir. 2009) ........................................................................................ 3, 12
`
`
`
`– iii –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 4 of 23 PageID #:
`11381
`
`Sandoz Inc. v. Amgen Inc.,
`137 S. Ct. 1664 (2017) ...................................................................................................... 6, 7
`
`Senju Pharm. Co. v. Apotex, Inc.,
`921 F. Supp. 2d 297 (D. Del. 2013) ........................................................................... 4, 14, 15
`
`Sepracor Inc. v. Teva Pharm. USA, Inc.,
`No. 09-cv-01302 (DMC)(MF), 2010 WL 2326262 (D.N.J. June 7, 2010) .............................. 4
`
`Sonos, Inc. v. D&M Holdings Inc.,
`No. 14-1330-RGA-MPT, 2016 WL 4249493 (D. Del. Aug. 10, 2016) ................................. 14
`
`Southco, Inc. v. Penn Engineering & Manufacturing Corp.,
`768 F. Supp. 2d 715 (D. Del. 2011) ..................................................................................... 13
`
`Sun Microsystems, Inc. v. Versata Enters., Inc.,
`630 F. Supp. 2d 395 (D. Del. 2009) ................................................................................. 2, 14
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) (en banc) ........................................................................ 3, 14
`
`WesternGeco L.L.C. v. ION Geophysical Corp.,
`No. 09-cv-1827, 2012 WL 567430 (S.D. Tex. Feb. 21, 2012) .............................................. 13
`
`Wyeth Holdings Corp. v. Sandoz, Inc.,
`No. 09-955-LPS-CJB, 2012 WL 600715 (D. Del. Feb. 3, 2012) .......................................... 13
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007) ........................................................................................ 3, 12
`
`Statutes
`
`35 U.S.C. § 271(e)(2) .................................................................................................................. 7
`
`42 U.S.C. §§ 262(k)-(l) ............................................................................................................... 7
`
`42 U.S.C. § 262(l)(3)(B) ....................................................................................................... 7, 17
`
`Rules
`
`Federal Rule of Civil Procedure 8 ....................................................................................... 14, 18
`
`Federal Rule of Civil Procedure 9(b) ....................................................................................... 3, 4
`
`Federal Rule of Civil Procedure 10(c) ....................................................................................... 17
`
`Federal Rule of Civil Procedure 12(b)(6)............................................................................... 2, 11
`
`Federal Rule of Civil Procedure 12(f) ........................................................................................ 11
`
`
`
`– iv –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 5 of 23 PageID #:
`11382
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`I.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`Plaintiff Genentech, Inc. (“Genentech”) invented and developed the drug Herceptin®,
`
`which is a first-of-its-kind biologic therapy that specifically targets a protein associated with an
`
`aggressive form of breast cancer. Seeking to profit from this groundbreaking work, Defendant
`
`Amgen, Inc. (“Amgen”) is seeking FDA approval to sell a biosimilar version of Herceptin®.
`
`Because Amgen’s proposed product infringes patents held by Genentech and Plaintiff City of
`
`Hope (collectively, “Plaintiffs”)—including patents covering Herceptin®, methods of using it,
`
`and methods of manufacturing it—Plaintiffs sued Amgen for patent infringement on June 21,
`
`2018. D.I. 1. Plaintiffs amended their complaint shortly thereafter to reduce the number of
`
`patents-in-suit to eighteen. D.I. 15. Pursuant to the Court’s scheduling order (D.I. 44), Plaintiffs
`
`identified ten patents and twenty claims to be litigated on November 7, 2018. One of the ten
`
`patents that Plaintiffs identified was a newly-allowed patent application that was expected to
`
`issue within a matter of weeks. That application issued as U.S. Patent No. 10,160,811 (“the ’811
`
`patent”) on December 25, 2018. Pursuant to a joint stipulation (D.I. 68), Plaintiffs filed a second
`
`amended complaint to add the ’811 patent to this case on January 17, 2019 (D.I. 75).1
`
`Amgen filed its answer to the second amended complaint on January 31, 2019. D.I. 80.
`
`As an Eleventh Affirmative Defense, it asserts that “Plaintiffs’ Complaint, and each of its
`
`purported causes of action is barred by Plaintiffs’ unclean hands, in view of at least the reasons
`
`relating to Genentech’s inequitable conduct.” D.I. 80, Aff. Defs. ¶ 11. In support of that
`
`1 Plaintiffs also amended their complaint to remove U.S. Patent No. 8,425,908 (“the ’908
`patent”), which expired on December 10, 2018. With the addition of the ’811 patent and the
`removal of the ’908 patent, the total number of patents included in Plaintiffs’ second amended
`complaint remains eighteen.
`
` On February 1, 2019, Amgen produced its BLA resubmission to Plaintiffs. Plaintiff believes
`that Amgen’s BLA submission requires adjusting the asserted patents and claims in this case,
`and the parties are currently discussing how to address those issues.
`
`– 1 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 6 of 23 PageID #:
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`defense, however, Amgen only identifies alleged conduct with respect to one of the eighteen
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`patents that Genentech has asserted, U.S. Patent No. 6,407,213 (“the ’213 patent”). D.I. 80, Aff.
`
`Defs. ¶¶ 11-23.
`
` Amgen also asserts counterclaims seeking declaratory
`
`judgment of
`
`unenforceability for each of the eighteen asserted patents. D.I. 80, Countercls., Counts 1-18.
`
`But Amgen’s counterclaims include no factual allegations of their own—they simply incorporate
`
`the rest of Amgen’s pleading by reference. See, e.g., id. ¶¶ 51-57. The only factual allegations
`
`about unenforceability in Amgen’s eighteen counterclaims therefore relate to the ’213 patent.
`
`Plaintiffs now move to strike Amgen’s “unclean hands/inequitable conduct” affirmative
`
`defense under Federal Rule of Civil Procedure 12(f) and move to dismiss Amgen’s
`
`unenforceability counterclaims under Federal Rule of Civil Procedure 12(b)(6). This is
`
`Plaintiffs’ opening brief in support of that motion. Plaintiffs previously moved to dismiss the
`
`identical allegations in Amgen’s answer filed on August 9, 2018. See D.I. 23. That motion was
`
`fully-briefed (see D.I. 24, 30, 32), but was not decided before Plaintiffs filed a second amended
`
`complaint.
`
`II.
`
`LEGAL STANDARD
`
`Federal Rule of Civil Procedure 12(f) authorizes the Court to “strike from a pleading an
`
`insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” Facts
`
`underlying a defense must be construed in favor of the nonmoving party, but the Court “is not
`
`required to accept affirmative defenses that are mere bare bones conclusory allegations, and may
`
`strike such inadequately pleaded defenses.” Sun Microsystems, Inc. v. Versata Enters., Inc., 630
`
`F. Supp. 2d 395, 408 (D. Del. 2009) (internal quotations omitted).
`
`“To survive a motion to dismiss” under Federal Rule of Civil Procedure 12(b)(6), “a
`
`complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is
`
`plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v.
`
`– 2 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 7 of 23 PageID #:
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`Twombly, 550 U.S. 544, 570 (2007)). The Court should assume the veracity of the factual
`
`allegations, but it must reject conclusory allegations. LEO Pharma A/S v. Actavis Labs. UT, Inc.,
`
`No. CV 16-333-JFB-SRF, 2018 WL 1045816, at *2 (D. Del. Feb. 26, 2018) (citing Iqbal, 556
`
`U.S. at 675, 678). In addition, the Court need not accept “‘a legal conclusion couched as a
`
`factual allegation.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555).
`
`The inequitable conduct and unclean hands doctrines are remedies for fraud on the Patent
`
`Office. See, e.g., Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326-29 (Fed. Cir.
`
`2009); Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1287 (Fed. Cir. 2011) (en
`
`banc). The patent-specific inequitable conduct doctrine, like the more general unclean hands
`
`doctrine, prevents a patent holder from enforcing its patent if the patent holder engaged in
`
`“egregious misconduct” in procuring the patent. Therasense, 649 F.3d at 1287. It requires a
`
`showing of both intent to deceive and materiality. Id. at 1290. “[T]he remedy for inequitable
`
`conduct is the ‘atomic bomb’ of patent law”—unenforceability. Id. at 1288-89.
`
`Because a claim of unenforceability is “a common litigation tactic” with “far-reaching
`
`consequences,” the Federal Circuit has held that the standard for pleading intent and materiality
`
`is high. Id. at 1289-90; see also Exergen, 575 F.3d at 1326-29. Moreover, under well-
`
`established Federal Circuit precedent, an applicant’s arguments to the patent examiner
`
`concerning the teachings of the prior art do not give rise to inequitable conduct where the patent
`
`examiner has the reference before her and has all of the information necessary to evaluate the
`
`teachings of the prior art. See Rothman v. Target Corp., 556 F.3d 1310, 1328-29 (Fed. Cir.
`
`2009); Young v. Lumenis, Inc., 492 F.3d 1336, 1349 (Fed. Cir. 2007).
`
`Whether in an affirmative defense or a counterclaim, “inequitable conduct . . . must be
`
`pled with particularity” according to Federal Rule of Civil Procedure 9(b). Ferguson
`
`– 3 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 8 of 23 PageID #:
`11385
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`Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Systems, LLC, 350 F.3d 1327, 1344
`
`(Fed. Cir. 2003);2 see also Senju Pharm. Co. v. Apotex, Inc., 921 F. Supp. 2d 297, 306 (D. Del.
`
`2013). “[I]n pleading inequitable conduct in patent cases, Rule 9(b) requires identification of the
`
`specific who, what, when, where, and how of the material misrepresentation or omission
`
`committed before the PTO.” Exergen, 575 F.3d at 1327. It also “requires that the pleadings
`
`allege sufficient underlying facts from which a court may reasonably infer that a party acted”
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`with “(1) knowledge of the withheld material information or of the falsity of the material
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`misrepresentation, and (2) specific intent to deceive the PTO.” Id.
`
`III.
`
`SUMMARY OF ARGUMENT
`
`Trial courts, including in this District, routinely dismiss at the pleadings stage or reject as
`
`a matter of law allegations that an applicant committed inequitable conduct by misrepresenting a
`
`reference before the examiner:
`
`The court appreciates [Defendant’s] position that Shier and Paques
`expressly contradicted the teachings of Arnould. [Defendant] does
`not cite authority demonstrating that this fact may substitute for
`independent evidence of intent to deceive, however, where the
`prior art at issue was a focus of the examination. Here, both
`examiners were free to credit or discount Shier and Paques’
`characterizations of Arnould in view of their own readings.
`
`Cellectis S.A. v. Precision Biosciences, 883 F. Supp. 2d 526, 535 (D. Del. 2012); see also Bayer
`
`Schering Pharma AG v. Barr Labs., Inc., No. 05-cv-2308 (PGS), 2008 WL 628592, at *49-50
`
`(D.N.J. Mar. 3, 2008); Sepracor Inc. v. Teva Pharm. USA, Inc., No. 09-cv-01302 (DMC)(MF),
`
`2010 WL 2326262, at *6 (D.N.J. June 7, 2010). The Court should reach the same result here
`
`because Amgen’s unclean hands/inequitable conduct defense and unenforceability counterclaims
`
`
`2 Federal Circuit law controls the pleading standard for inequitable conduct. Exergen, 575
`F.3d at 1318.
`
`– 4 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 9 of 23 PageID #:
`11386
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`rest on the same legally deficient theory that was fatal to the defendants’ inequitable conduct
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`defense in those prior cases.
`
`As to the ’213 patent—the only patent for which Amgen has even attempted to plead
`
`facts in support of its inequitable conduct defense—Amgen’s unenforceability theory is
`
`insufficient as a matter of law because it does not refer to any alleged misrepresentation or
`
`omission that the patent examiner was incapable of evaluating on her own. Rather, Amgen’s
`
`defense depends solely on characterizations of the prior art by prosecution counsel that the patent
`
`examiner had before her. Even assuming that Amgen had pleaded facts sufficient to show that
`
`Genentech mischaracterized the references to the patent examiner (which Amgen has not),
`
`Amgen’s unenforceability defense is insufficient as a matter of law to raise an inference of
`
`materiality or deceptive intent—two essential elements of any claim for inequitable conduct. As
`
`Amgen acknowledges in its pleading, the Patent Office explicitly considered the references that
`
`Amgen now says were “mischaracterized.” The patent examiner reviewed the references and
`
`independently evaluated their content, and Amgen concedes that Genentech provided the patent
`
`examiner with exactly the information that it now alleges was misrepresented. The Federal
`
`Circuit has long held that an applicant’s arguments about the teachings of the prior art cannot, as
`
`a matter of law, support a finding of inequitable conduct—particularly where, as here, the
`
`examiner had all of the information necessary to evaluate the disclosure of the prior art herself.
`
`Amgen’s unenforceability counterclaim for the ’213 patent should therefore be dismissed, and its
`
`related “unclean hands/inequitable conduct” affirmative defense should be stricken.
`
`As to the remaining seventeen patents in Plaintiffs’ second amended complaint, Amgen
`
`fails to include any factual allegations whatsoever in support of its unenforceability
`
`counterclaims—it simply recites boilerplate language referencing a statement about the asserted
`
`– 5 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 10 of 23 PageID #:
`11387
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`patents’ validity that Amgen provided to Genentech before this suit was filed (i.e., as part of the
`
`statutory information-exchange procedures that govern biosimilar applications). But that
`
`statement—like Amgen’s responsive pleading—is devoid of any factual allegations supporting
`
`Amgen’s unenforceability theories for these patents. Accordingly, any defense or counterclaim
`
`as to “unclean hands” or “inequitable conduct” as to these patents must be dismissed.
`
`IV.
`
`BACKGROUND
`
`A.
`
`Amgen Is Alleging That The Patents-In-Suit Are Unenforceable To Clear
`The Way For Its Biosimilar Version Of Genentech’s Blockbuster Drug
`Herceptin®.
`
`This patent dispute arises from Amgen’s efforts to market a biosimilar version of
`
`Herceptin®, a drug Genentech developed for the treatment of breast cancer. Herceptin® is a
`
`genetically engineered antibody that represents a profound breakthrough in the treatment of
`
`cancer. After the FDA approved Herceptin®, the scientific community hailed it as “the
`
`beginning of a whole new wave of biological drugs that modulate the causes of cancer” and as a
`
`sign that “the whole field of cancer research has turned a corner.” D.I. 75 ¶ 4. Herceptin® has
`
`transformed the treatment of breast cancer and has become the standard of care for its patient
`
`population.
`
`Amgen has submitted an Abbreviated Biologics License Application (“aBLA”) seeking
`
`FDA approval to market a “biosimilar” of Herceptin® called ABP 980. See D.I. 75 ¶ 19; D.I. 80,
`
`Countercl. ¶¶ 8-9. A biosimilar is a drug that is similar enough to the innovator product (here,
`
`Herceptin®) that the FDA will allow the biosimilar applicant to rely upon the innovator’s clinical
`
`trials during the approval process—thereby saving the developer of a biosimilar drug the time
`
`and expense of extensive clinical development. See Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664,
`
`1670 (2017).
`
`– 6 –
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 11 of 23 PageID #:
`11388
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`Congress created an abbreviated pathway for approval of biosimilar drugs under the
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`Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The filing of an aBLA is a
`
`technical act of patent infringement, but the BPCIA provides for a series of exchanges and
`
`negotiation before any litigation commences. See 35 U.S.C. § 271(e)(2); 42 U.S.C. §§ 262(k)-
`
`(l); see also Sandoz, 137 S. Ct. at 1670-72; Genentech, Inc. v. Amgen Inc., No. 17-1407-GMS,
`
`2018 WL 503253, at *1-2 (D. Del. Jan. 22, 2018). These exchanges, known informally as the
`
`“patent dance,” are designed to narrow disputes over infringement, in part by ensuring the
`
`“reference product sponsor” (here, Genentech) has received enough information to be able to
`
`narrow the patents to be asserted before filing suit. See Sandoz, 137 S. Ct. at 1670-71.
`
`As part of the patent dance, the biosimilar applicant is required to provide the reference
`
`product sponsor “a detailed statement that describes” why the applicant believes any relevant
`
`patent held by the sponsor is unenforceable. See 42 U.S.C. § 262(l)(3)(B). This is commonly
`
`known as a 3B Statement, based on the statutory provision that requires it. Amgen’s 3B
`
`Statement did not include unenforceability allegations for seventeen of the eighteen patents
`
`included in the second amended complaint. For the remaining patent, the ’213 patent, Amgen’s
`
`3B Statement alleged that it is unenforceable because during prosecution Genentech supposedly
`
`misrepresented the teachings of two prior art references, U.S. Patent No. 5,530,101 (“the ’101
`
`patent”) and a related scientific publication called “Queen 1989.” Amgen acknowledged,
`
`however, that both the ’101 patent and the Queen 1989 reference were provided to and
`
`considered by the patent examiner before the ’213 patent issued.
`
`When Amgen filed its answer, it repeated its unenforceability allegations for the ’213
`
`patent in its inequitable conduct/unclean hands affirmative defense (i.e., it’s Eleventh
`
`Affirmative Defense). See D.I. 80, Aff. Defs. ¶¶ 11-23. Amgen’s counterclaims identify no
`
`– 7 –
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 86 Filed 02/21/19 Page 12 of 23 PageID #:
`11389
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`further allegations to support an unenforceability theory, but they each incorporate Amgen’s
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`affirmative defenses and its 3B Statement by reference. Because Amgen’s affirmative defenses
`
`and 3B Statement only include unenforceability allegations for the ’213 patent, Amgen’s
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`counterclaims include no factual allegations supporting its unenforceability claims for the other
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`seventeen patents-in-suit.
`
`B.
`
`The Only Factual Allegations In Amgen’s Unenforceability Defenses And
`Counterclaims Relate To The ’213 Patent.
`
`Amgen’s unenforceability allegations for the ’213 patent, the only patent for which it
`
`provides unenforceability allegations, arise from communications between Genentech and the
`
`Patent Office while Genentech was applying for the patent. The ’213 patent claims humanized
`
`antibodies with amino acid substitutions at certain specified positions.3 During prosecution,
`
`Genentech disclosed—and the examiner considered—prior art references describing humanized
`
`antibodies made by others in the field. Those references included the ’101 patent and the related
`
`Queen 1989 publication. D.I. 80, Aff. Defs. ¶¶ 15, 17 (describing patent examiner’s
`
`consideration of the ’101 patent and Queen 1989).
`
`The patent examiner rejected Genentech’s proposed patent claims in view of the ’101
`
`patent and Queen 1989 because she believed that a humanized antibody disclosed in both of
`
`those references, called “anti-Tac,” contained amino acid substitutions at the positions that
`
`Genentech had claimed. See id. In response, Genentech pointed out that the numbering
`
`convention that the examiner had used to identify the location within the antibody for those
`
`substitutions (i.e., sequential numbering) in the humanized anti-Tac antibody was different from
`
`
`3 Antibodies are molecules produced by the immune system. As the ’213 patent explains, a
`“humanized” antibody is a molecule that can be created through molecular engineering
`techniques that incorporates certain amino acids from a non-human antibody (e.g., a mouse) into
`a human antibody framework. D.I. 75, Ex. C, ’213 patent, col. 8, ll. 11-51.
`
`– 8 –
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`how Genentech had identified the substitutions in its proposed claims (i.e., Kabat numbering).4
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`Id. ¶ 19. Genentech further explained that, as a result of those different numbering conventions,
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`the specific amino acid position that the examiner believed that the anti-Tac antibody disclosed
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`(“93H”) did not actually correspond with what was covered by Genentech’s proposed claims. Id.
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`Genentech also identified all of the amino acid substitutions in the antibodies disclosed in the
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`’101 patent and Queen 1989 in charts and in sequence alignments that Genentech provided to the
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`patent examiner. Id. ¶ 23 & n.1. The patent examiner subsequently allowed Genentech’s
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`proposed claims to issue over the ’101 patent and Queen 1989. Id. ¶ 20.
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`Amgen asserts that Genentech’s arguments to the patent examiner concerning the
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`teachings of the ’101 patent and Queen 1989 were misleading in two respects. D.I. 80, Aff.
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`Defs. ¶¶ 13-14. First, Amgen asserts that Genentech supposedly misrepresented the teachings of
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`the ’101 patent and Queen 1989 by arguing those references used sequential numbering to
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`identify amino acid substitutions as opposed to Kabat numbering. Id. Second, Amgen asserts
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`that Genentech omitted an amino acid substitution (“62L”) when describing the substitutions
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`disclosed in Queen 1989. Id. ¶ 14.
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`Even accepting Amgen’s well-pleaded facts as true for purposes of this motion, Amgen
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`has not pleaded facts showing any misrepresentation or omission by Genentech. Amgen never
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`
`4 An antibody is a protein consisting of amino acids arranged in a particular order. There are
`different ways to identify the amino acid positions in an antibody sequence. “Sequential
`numbering” involves consecutively numbering the amino acids in the sequence; due to sequence
`variations across antibodies, the amino acid positions identified by sequential numbering may be
`different from one antibody to another. As the ’213 patent explains, “Kabat numbering” (named
`for the scientist who devised this numbering convention) is a standardized approach to antibody
`sequence numbering that assigns fixed numbers to certain positions in the antibody amino acid
`sequence as determined by amino acid sequence alignments. D.I. 75, Ex. C, ’213 patent, col. 10,
`l. 46 - col. 11, l. 16. A sequence alignment compares the amino acid sequences of multiple
`antibodies by matching the overlapping portions of the sequences. See, e.g., D.I. 75, Ex. C, ’213
`patent, col. 10, l. 58 - col. 11, l. 16.
`
`– 9 –
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`alleges that Genentech misrepresented that the ’101 patent and Queen 1989 used a sequential
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`numbering convention when referring to a substitution at position 93 in the humanized anti-Tac
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`antibody (they do). And in any event, even if one were to apply Kabat numbering, Amgen never
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`alleges that the humanized anti-Tac antibody that was addressed in Genentech’s statements to the
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`examiner actually has a framework substitution at 93H under Kabat numbering (it does not).
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`Instead, Amgen points to a different portion of the ’101 patent that utilized Kabat numbering
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`when describing different humanized antibodies that are not the humanized anti-Tac antibody
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`that Genentech was addressing in its comments to the examiner. Id. ¶ 21 (referring to Table 5 in
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`the ’101 patent that describes the humanized antibodies called “Fd79” and “Fd138-80,” not
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`humanized anti-Tac). Those factual allegations thus do not add up to a misrepresentation by
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`Genentech; the statements that are the basis for Amgen’s inequitable conduct defense were
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`simply addressing a different issue for a different humanized antibody.5
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`Amgen also has not pleaded facts to support that Genentech “conspicuously omitted a
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`key residue (‘62L’) disclosed in the prior art” when describing Queen 1989. Id. ¶¶ 14, 23. There
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`is no substitution at position 62L under Kabat numbering in the humanized anti-Tac antibody
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`described in Queen 1989, and Amgen has not pleaded any facts to suggest otherwise. The
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`reference to position “62 of the light chain” that Amgen cites (id. ¶ 23) refers to the amino acid
`
`
`5 Amgen concedes that Genentech disclosed to the patent examiner the sequences using Kabat
`numbering for the humanized antibodies described in the ’101 patent and Queen 1989. Id. ¶ 23
`(“At the Examiner’s request, Genentech submitted a comparison of the different numbering
`systems purportedly utilized in Queen 1989 and the pending claims.”); id. ¶ 23 n.1 (“As
`requested by the Examiner in the interview, alignments of heavy chain variable domain (Exhibit
`A) and light chain variable domain (Exhibit B) sequences of the 101 patent (including the
`sequences for the murine and humanized anti-Tac antibody of Queen et al.) with sequential and
`Kabat residue numbering is attached.”). Amgen cannot contend that Genentech intended to
`mislead the patent examiner regarding how the Kabat numbering convention applies to the
`antibodies disclosed in the ’101 patent and Queen 1989 when Amgen acknowledges that
`Genentech provided that exact information to the patent examiner.
`
`– 10 –
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`position in the mouse anti-Tac antibody under sequential numbering, not the amino acid position
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`in the humanized anti-Tac antibody under Kabat numbering (which is actually 63L and is what
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`Genentech disclosed to the patent examiner).
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`But for purposes of this Rule 12 motion, the Court need not address the sufficiency of
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`Amgen’s allegations as a factual matter because the entire premise of Amgen’s inequitable
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`conduct defense rests on a legally deficient theory. Amgen’s inequitable conduct defense for the
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`’213 patent rests solely on Genentech’s arguments concerning the teachings of prior art
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`references, which as described below is insufficient as a matter of law to find inequitable conduct
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`in these circumstances—particularly where, as here, the examiner had all of the information
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`before her necessary to evaluate those arguments.
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`V.
`
`ARGUMENT
`
`A.
`
`Because Amgen’s Unenforceability Theory For The ’213 Patent Is Legally
`Deficient, Its Eleventh Affirmative Defense Should Be Stricken And Its
`Unenforceability Counterclaim For The ’213 Patent Should Be Dismissed.
`
`Amgen has not pleaded sufficient facts to support its unclean hands/inequitable conduct
`
`defense. It should therefore be stricken under Rule 12(f), and Amgen’s counterclaim that
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`incorporates the affirmative defense by reference should be dismissed under Rule 12(b)(6).
`
`Amgen’s Eleventh Affirmative Defense rests on Genentech’s statemen