Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 1 of 17 PageID #: 1251
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-1363-CFC
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`GENENTECH, INC and CITY OF HOPE,
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`v.
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`SAMSUNG BIOEPIS CO., LTD.,
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`Plaintiffs,
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`Defendant.
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`
`PLAINTIFFS’ OPENING BRIEF IN SUPPORT OF THEIR MOTION
`TO DISMISS COUNT IX OF DEFENDANT’S COUNTERCLAIMS
`REGARDING UNENFORCEABILITY OF THE ’213 PATENT
`
`Frederick L. Cottrell, III (#2555)
`Jason J. Rawnsley (#5379)
`Alexandra M. Ewing (#6407)
`RICHARDS, LAYTON & FINGER, P.A.
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`rawnsley@rlf.com
`ewing@rlf.com
`
`Counsel for Plaintiffs Genentech, Inc. and City
`of Hope
`
`
`Of Counsel:
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY
`(212) 230-8800
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`(415) 362-6666
`Dated: December 10, 2018
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`

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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 2 of 17 PageID #: 1252
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`
`TABLE OF CONTENTS
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`I. 
`
`II. 
`
` Page
`
`INTRODUCTION .......................................................................................1 
`
`LEGAL STANDARD ..................................................................................3 
`
`A. 
`
`B. 
`
`C. 
`
`Motion To Dismiss ..........................................................................3 
`
`Prosecution Estoppel ........................................................................3 
`
`Unenforceability ..............................................................................4 
`
`III. 
`
`FACTUAL BACKGROUND ......................................................................5 
`
`A. 
`
`B. 
`
`Samsung Is Seeking FDA Approval For Its Biosimilar
`Version Of Genentech’s Blockbuster Drug Herceptin. ...................5 
`
`Samsung Has Not Pleaded Any Facts Supporting Its
`Theory Of Unenforceability Based Upon Prosecution
`Estoppel............................................................................................5 
`
`IV. 
`
`ARGUMENT ...............................................................................................8 
`
`A. 
`
`B. 
`
`As A Matter Of Law, Prosecution Estoppel Is Not A Basis
`For Holding A Patent Or Claim Wholly Unenforceable. ................8 
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`Samsung Has Not Pleaded Any Facts That Would Support
`A Finding Of Prosecution Estoppel For The ’213 Patent. .............10 
`
`V. 
`
`CONCLUSION ..........................................................................................13 
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`– i –
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 3 of 17 PageID #: 1253
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`
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`AccuScan, Inc. v. Xerox Corp.,
`76 F. App’x 290 (Fed. Cir. 2003) ............................................................................................11
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ...................................................................................................................3
`
`Bayer CropScience AG v. Dow AgroSciences LLC,
`No. 10-1045-RMB/JS, 2011 WL 6934557 (D. Del. Dec. 30, 2011) .........................................9
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) ...................................................................................................................3
`
`Biodex Corp. v. Loredan Biomedical, Inc.,
`946 F.2d 850 (Fed. Cir. 1991)....................................................................................................9
`
`Conoco, Inc. v. Energy & Envtl. Int’l, L.C.,
`460 F.3d 1349 (Fed. Cir. 2006)......................................................................................4, 10, 11
`
`Deering Precision Instruments, LLC v. Vector Distrib. Sys., Inc.,
`347 F.3d 1314 (Fed. Cir. 2003)..................................................................................................4
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) .....................................................................................................3, 4, 8, 10
`
`Fromson v. Advance Offset Plate, Inc.,
`720 F.2d 1565 (Fed. Cir. 1983)..................................................................................................9
`
`Insituform Techs., Inc. v. CAT Contracting, Inc.,
`385 F.3d 1360 (Fed. Cir. 2004)..................................................................................................5
`
`Jenny Yoo Collection, Inc. v. Watters Designs, Inc.,
`No. 3:17-CV-3197-M, 2018 WL 3330025 (N.D. Tex. June 6, 2018) .......................................9
`
`LEO Pharma A/S v. Actavis Labs. UT, Inc.,
`No. 16-333-JFB-SRF, 2018 WL 1045816 (D. Del. Feb. 26, 2018) ..........................................3
`
`Opera Sols., LLC v. Schwan’s Home Serv., Inc.,
`No. 15-287-LPS, 2016 WL 3606776 (D. Del. July 1, 2016) .....................................................3
`
`Pac. Coast Marine Windshields Ltd. v. Malibu Boats, LLC,
`739 F.3d 694 (Fed. Cir. 2014)............................................................................................10, 12
`
`
`
`– ii –
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`

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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 4 of 17 PageID #: 1254
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`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`904 F.3d 965 (Fed. Cir. 2018)....................................................................................................4
`
`Sandoz Inc. v. Amgen Inc.,
`137 S. Ct. 1664 (2017) ...........................................................................................................5, 6
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`649 F.3d 1276 (Fed. Cir. 2011) (en banc) ..................................................................................4
`
`Warner Mfg. Co. v. Armstrong,
`No. 05-CV-0612 PJS/JJG, 2007 WL 3521249 (D. Minn. Nov. 15, 2007) ............................5, 8
`
`Weatherchem Corp. v. J.L. Clark, Inc.,
`163 F.3d 1326 (Fed. Cir. 1998)..................................................................................................9
`
`Statutes
`
`35 U.S.C. § 271(e)(2) .......................................................................................................................6
`
`42 U.S.C. §§ 262(k)-(l) ....................................................................................................................6
`
`42 U.S.C. § 262(l)(3)(B) ..................................................................................................................6
`
`Rules
`
`Federal Rule of Civil Procedure 10(c) .............................................................................................8
`
`Federal Rule of Civil Procedure 12(b)(6) ..................................................................................3, 13
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`– iii –
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 5 of 17 PageID #: 1255
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`
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`I.
`
`INTRODUCTION
`
`Plaintiff Genentech, Inc. (“Genentech”) invented and developed the drug Herceptin,
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`which is a first-of-its-kind biologic therapy that specifically targets a protein associated with an
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`aggressive form of breast cancer. Defendant Samsung Bioepis Co., Ltd. (“Samsung”) is seeking
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`FDA approval to sell a biosimilar version of Herceptin. Because Samsung’s proposed product
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`infringes patents held by Genentech and Plaintiff City of Hope (collectively, “Plaintiffs”)—
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`including patents covering Herceptin, methods of using it, and methods of manufacturing it—
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`Plaintiffs sued Samsung for patent infringement on September 4, 2018. D.I. 1.
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`On November 7, 2018, in accordance with the scheduling order entered in the case (D.I.
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`26), Plaintiffs narrowed the number of patents in dispute to ten. Among the patents remaining in
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`this case is U.S. Patent No. 6,407,213 (“the ’213 patent”), which claims humanized antibodies
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`with amino acid substitutions at certain specified positions. Samsung previously challenged the
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`’213 patent in inter partes review proceedings before the Patent Office, but the Patent Trial and
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`Appeal Board rejected Samsung’s arguments and confirmed the patentability of, inter alia,
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`asserted claims 65 and 79 of the ’213 patent in final written decisions issued on November 29,
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`2018. See Danford Decl., Exs. 1-2.
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`Samsung filed its answer and counterclaims on November 19, 2018. D.I. 33. As Count
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`IX of its counterclaims, Samsung asserted that “[t]he claims of U.S. Patent No. 6,407,213 are
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`unenforceable under the doctrine of prosecution estoppel[.]” D.I. 33, Countercl. ¶ 94. But there
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`is no legal or factual basis for applying prosecution estoppel here.
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`As explained below, prosecution estoppel limits a patentee’s ability to assert a particular
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`theory of infringement, called the “doctrine of equivalents,” against products that do not fall
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`within the literal scope of the claim language where the patentee narrowed the claims during
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`prosecution to satisfy the requirements of patentability. The patent’s claims remain enforceable;
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`- 1 -
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 6 of 17 PageID #: 1256
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`
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`the only consequence of prosecution estoppel is that the patentee cannot recapture the
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`surrendered claim scope by asserting infringement under the doctrine of equivalents.
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`Samsung’s unenforceability counterclaim for the ’213 patent—which seeks to hold the
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`patent’s claims wholly unenforceable for prosecution estoppel—is therefore contrary to
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`controlling Supreme Court and Federal Circuit precedent explaining the limits of prosecution
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`estoppel and should be dismissed for failure to state a claim. Indeed, no other defendant seeking
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`to market a Herceptin biosimilar has alleged that the ’213 patent is unenforceable on prosecution
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`estoppel grounds. Samsung’s reliance on prosecution estoppel is simply an attempt to avoid the
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`heightened pleading requirements of legally-recognized theories of unenforceability (e.g.,
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`inequitable conduct) and should be rejected as a matter of law.
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`Even putting aside Samsung’s flawed underlying legal theory, its unenforceability
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`counterclaim for the ’213 patent should be dismissed for the additional reason that Samsung has
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`pleaded no facts corresponding with the elements of prosecution estoppel. Prosecution history
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`estoppel requires that the patentee narrow the claim scope during prosecution by claim
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`amendment or arguments presented to the patent examiner. But Samsung has identified no
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`narrowing amendment or argument made during prosecution of the ’213 patent relevant to
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`asserted claims 65 and 79. Nor has Samsung pleaded any facts showing that its proposed
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`biosimilar product falls within the scope of any alleged narrowing amendment. Samsung cannot
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`state a claim based on prosecution estoppel without pleading any of the elements of that claim.
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`And Samsung has pleaded no other theory of unenforceability in its counterclaims.
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`Because Samsung’s unenforceability counterclaim for the ’213 patent is not supported by
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`law or any well-pleaded facts, Plaintiffs now move to dismiss Count IX of Samsung’s
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 7 of 17 PageID #: 1257
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`
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`counterclaims pursuant to Federal Rule of Civil Procedure 12(b)(6). This is Plaintiffs’ opening
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`brief in support of that motion.
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`II.
`
`LEGAL STANDARD
`A. Motion To Dismiss
`
`“To survive a motion to dismiss” under Federal Rule of Civil Procedure 12(b)(6), the
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`pleading “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is
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`plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v.
`
`Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial plausibility when the plaintiff pleads
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`factual content that allows the court to draw the reasonable inference that the defendant is liable
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`for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556). The Court should assume
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`the veracity of the factual allegations, but it must reject conclusory allegations. LEO Pharma
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`A/S v. Actavis Labs. UT, Inc., No. 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
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`conclusion couched as a factual allegation.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S.
`
`at 555). “The same standards applicable to dismissal of claims in a complaint also apply to
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`motions to dismiss counterclaims pursuant to Rule 12(b)(6).” Opera Sols., LLC v. Schwan’s
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`Home Serv., Inc., C.A. No. 15-287-LPS, 2016 WL 3606776, at *3 (D. Del. July 1, 2016).
`
`B.
`
`Prosecution Estoppel
`
`Due to the inherent imprecision of describing a technical invention in words, “[t]he scope
`
`of a patent is not limited to its literal terms but instead embraces all equivalents to the claims
`
`described.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 732 (2002).
`
`This concept, known as the doctrine of equivalents, permits a patentee to assert infringement
`
`against a product that does not fall within the literal scope of the claim language so long as any
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`differences from the claim language are “[u]nimportant and insubstantial.” Id. at 731.
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 8 of 17 PageID #: 1258
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`
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`Prosecution estoppel, also known as prosecution history estoppel, “limits the application
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`of the doctrine of equivalents” in certain circumstances. Power Integrations, Inc. v. Fairchild
`
`Semiconductor Int’l, Inc., 904 F.3d 965, 975 (Fed. Cir. 2018) (citing Festo, 535 U.S. at 733-34).
`
`The idea behind prosecution estoppel is that, if a patentee narrows the claim scope during
`
`prosecution to satisfy the requirements of patentability, the patentee may not later use the
`
`doctrine of equivalents to recapture that surrendered claim scope. Id. (“If a patentee surrenders
`
`certain subject matter during prosecution, the patentee is then barred from using the doctrine of
`
`equivalents to recover for infringement based on that same subject matter.”).
`
`“Prosecution-history estoppel can occur either when [1] the patentee makes a narrowing
`
`amendment to the claim or [2] surrenders claim scope through argument to the patent examiner.”
`
`Id. (numbering added) (citing Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1363
`
`(Fed. Cir. 2006)). Amendment-based prosecution history estoppel only applies “when an
`
`amendment is made to secure the patent and the amendment narrows the patent’s scope.” Festo,
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`535 U.S. at 736. To invoke the doctrine of argument-based prosecution estoppel, on the other
`
`hand, there must be a “‘clear and unmistakable surrender of subject matter’” by the patentee of
`
`the prosecution history. Conoco, 460 F.3d at 1364 (quoting Deering Precision Instruments, LLC
`
`v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1326 (Fed. Cir. 2003)).
`
`C.
`
`Unenforceability
`
`Unenforceability refers to a set of equitable defenses which generally render a patent
`
`unenforceable in its entirety. A commonly-asserted unenforceability defense is inequitable
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`conduct, which prevents a patentee from enforcing its patent if it engaged in “egregious
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`misconduct” while procuring the patent. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d
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`1276, 1287 (Fed. Cir. 2011) (en banc). Because prosecution history estoppel allows a patent to
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`be enforced, but only within a narrower scope, it is not an unenforceability defense that can
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 9 of 17 PageID #: 1259
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`
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`render a patent or its claims wholly unenforceable. See Warner Mfg. Co. v. Armstrong, No. 05-
`
`CV-0612 PJS/JJG, 2007 WL 3521249, at *4 (D. Minn. Nov. 15, 2007) (citing Insituform Techs.,
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`Inc. v. CAT Contracting, Inc., 385 F.3d 1360, 1367 (Fed. Cir. 2004) (“Prosecution-history
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`estoppel thus necessarily applies at the level of individual limitations within claims, and not at
`
`the level of entire claims.”)).
`
`III.
`
`FACTUAL BACKGROUND
`A.
`
`Samsung Is Seeking FDA Approval For Its Biosimilar Version Of
`Genentech’s Blockbuster Drug Herceptin.
`
`This patent dispute arises from Samsung’s efforts to market a biosimilar version of
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`Herceptin, a drug Genentech developed for the treatment of breast cancer. After the FDA
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`approved Herceptin, the scientific community hailed it as “the beginning of a whole new wave of
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`biological drugs that modulate the causes of cancer” and as a sign that “the whole field of cancer
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`research has turned a corner.” D.I. 1 ¶ 4. Herceptin has transformed the treatment of breast
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`cancer and has become the standard of care for its patient population.
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`Samsung has submitted an Abbreviated Biologics License Application (“aBLA”) seeking
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`FDA approval to market a “biosimilar” of Herceptin called SB3. See D.I. 1 ¶ 19; D.I. 33,
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`Countercl. ¶ 9. A biosimilar is a drug that is similar enough to the innovator product (here,
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`Herceptin) that the FDA will allow the biosimilar applicant to rely upon the innovator’s clinical
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`trials during the approval process—thereby saving the developer of a biosimilar drug the time
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`and expense of extensive clinical development. See Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664,
`
`1670 (2017).
`
`B.
`
`Samsung Has Not Pleaded Any Facts Supporting Its Theory Of
`Unenforceability Based Upon Prosecution Estoppel.
`
`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
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 10 of 17 PageID #: 1260
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`
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`technical act of patent infringement, but the BPCIA provides for a series of exchanges and
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`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. These exchanges, known informally as the “patent
`
`dance,” are designed to narrow disputes over infringement, in part by ensuring the “reference
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`product sponsor” (here, Genentech) has received enough information to be able to narrow the
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`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
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`product sponsor “a detailed statement that describes” why the applicant believes any relevant
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`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.
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`Samsung’s 3B Statement alleged that the ’213 patent is unenforceable because, according
`
`to Samsung, “Genentech made material misrepresentations and omissions with the specific intent
`
`to mislead or deceive the PTO” during prosecution of the patent. Danford Decl., Ex. 3 at 34.
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`However, none of what Samsung alleged in its 3B Statement relates to a claim of prosecution
`
`estoppel.
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`For example, Samsung’s 3B Statement does not describe any amendment by Genentech
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`that was made to secure the patent and which narrowed the patent’s scope. The only claim
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`amendment during prosecution of the ’213 patent that Samsung mentions is Genentech’s deletion
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`of “a substitution at amino acid position ‘93H’” from certain claims. Danford Decl., Ex. 3 at 34.
`
`However, Samsung acknowledges that Genentech later amended the patent application to add “a
`
`substitution at residue 93H in new claim 115 and claims dependent therefrom.” Id. These
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`claims later issued with a limitation providing for an amino acid substitution at position 93H, as
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`Samsung also admits. Id. at 35 (“The examiner, in the next PTO action, indicated that the
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 11 of 17 PageID #: 1261
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`
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`pending claims, including claims 115-117, 123 and 127, were allowable.”). And the only claims
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`presently at issue in this case expressly recite substitutions at position 93H. Danford Decl., Ex. 4
`
`(’213 patent), claims 65 and 79.1 Samsung’s 3B Statement does not address any amendment or
`
`argument directed to claims 114 and 128 in the patent application, which issued respectively as
`
`asserted claim 65 and 79 of the ’213 patent.
`
`Samsung cited arguments that Genentech made during prosecution about whether certain
`
`asserted prior art references disclosed a substitution at position 93H. Danford Decl., Ex. 3 at 34-
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`37. But those portions of the prosecution history relate to what the prior art before the examiner
`
`disclosed (specifically, a reference called “the Queen Patent”), not what the scope of any of
`
`Genentech’s patent claims is. In fact, Samsung’s 3B Statement acknowledges that Genentech
`
`was clear during prosecution that certain claims in the patent application included substitutions at
`
`position 93H. See, e.g., Danford Decl., Ex. 3 at 34 (“Genentech included a substitution at
`
`residue 93H in new claim 115 and claims dependent therefrom.”).
`
`Samsung’s 3B statement also did not allege several other essential elements of
`
`prosecution history estoppel. For example, Samsung did not state what claim scope was
`
`allegedly surrendered, either by amendment or argument. And Samsung did not present any
`
`allegations that its Herceptin biosimilar, SB3, would fall within the claim scope allegedly
`
`surrendered.
`
`
`1 When the Patent Office printed the ’213 patent, it incorrectly identified claim 65 as
`dependent from claim 63. Claim 65 instead depends from claim 79. That Patent Office printing
`error has been corrected by a certificate of correction. See Danford Decl., Ex. 4 (’213 patent),
`Certificate of Correction (Dec. 3, 2002).
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 12 of 17 PageID #: 1262
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`Samsung’s counterclaims merely incorporate by reference its 3B Statement and identify
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`no further allegations to support a theory of prosecution estoppel or any other unenforceability
`
`theory.2 D.I. 33, Countercl. ¶ 94.
`
`IV. ARGUMENT
`A. As A Matter Of Law, Prosecution Estoppel Is Not A Basis For Holding A Patent
`Or Claim Wholly Unenforceable.
`
`Count IX of Samsung’s counterclaims rests on the legally-incorrect theory that
`
`prosecution estoppel can render the claims of a patent wholly unenforceable. See D.I. 33,
`
`Countercls. ¶ 94 (“The claims of U.S. Patent No. 6,407,213 are unenforceable under the doctrine
`
`of prosecution estoppel[.]”). That is not how prosecution estoppel works.
`
`The application of prosecution estoppel arises solely in the context of a claim of
`
`infringement based on the doctrine of equivalents. Its purpose is to defend against such claims
`
`when the patentee narrowed a patent claim during prosecution, but later aims to capture
`
`technology that falls outside the scope of the narrowed claim. Prosecution estoppel’s function is
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`to ensure that the narrowed claim, established before the Patent Office, is read with the same
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`restriction by the court. The result is that “th[e] prosecution history estops [the patentee] from
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`later arguing that the subject matter covered by the original, broader claim was nothing more
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`than an equivalent.” Festo, 535 U.S. at 727.
`
`Importantly, prosecution estoppel only limits the patentee with respect to how it can
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`prove infringement of the particular claim limitation addressed during prosecution, not to the
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`assertion of the claim as a whole. Warner, 2007 WL 3521249, at *4 (“Prosecution-history
`
`2 Samsung failed to attach its 3B Statement to its counterclaims, despite Federal Rule of Civil
`Procedure 10(c)’s requirement that a pleading may only incorporate by reference material that is
`“elsewhere in the same pleading or in any other pleading or motion.” Samsung cannot rely on
`allegations outside of its answer and counterclaims to satisfy its pleading obligations. This
`provides a further basis to dismiss Samsung’s counterclaims.
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 13 of 17 PageID #: 1263
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`
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`estoppel thus necessarily applies at the level of individual limitations within claims, and not at
`
`the level of entire claims.”). Moreover, because prosecution estoppel relates only to the doctrine
`
`of equivalents, it does not restrict a patentee’s ability to enforce its patent under a theory of literal
`
`infringement (i.e., where the defendant’s product is covered by the literal words of the claim).
`
`While prosecution estoppel limits the ability to assert infringement under the doctrine of
`
`equivalents, a finding of “unenforceability” prevents a patent holder from enforcing all patent
`
`claims under any infringement theory. Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326,
`
`1336 (Fed. Cir. 1998) (“[A] counterclaim for a declaration of unenforceability affects the entire
`
`patent.”). Prosecution estoppel therefore is not, as a matter of law, a basis for holding a patent’s
`
`claims wholly unenforceable as Count IX of Samsung’s counterclaims suggests. At most,
`
`prosecution estoppel is a limitation on a patentee’s ability to advance a specific infringement
`
`theory, not a basis to deny a patentee any ability to assert the patent under a literal infringement
`
`theory. See Jenny Yoo Collection, Inc. v. Watters Designs, Inc., No. 3:17-CV-3197-M, 2018 WL
`
`3330025, at *5 n.7 (N.D. Tex. June 6, 2018) (“[P]rosecution history estoppel limits a patentee’s
`
`ability to recover under the doctrine of equivalents, but does not limit literal infringement.”);
`
`Biodex Corp. v. Loredan Biomedical, Inc., 946 F.2d 850, 862-63 (Fed. Cir. 1991) (quoting
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`Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1571 (Fed. Cir. 1983) (“[T]he doctrine of
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`prosecution history estoppel is ‘irrelevant’ to determination of literal claim scope[.]”)). Indeed,
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`even cases that have colloquially described prosecution history estoppel as a “counterclaim”
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`have recognized “the doctrine is a legal limitation on claim scope,” not a basis for rendering a
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`patent’s claims wholly unenforceable. Bayer CropScience AG v. Dow AgroSciences LLC, Civil
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`No. 10-1045-RMB/JS, 2011 WL 6934557, at *5 (D. Del. Dec. 30, 2011). Plaintiffs are aware of
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 14 of 17 PageID #: 1264
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`no legal authority supporting Samsung’s counterclaim seeking that the claims of the ’213 patent
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`as a whole be declared unenforceable on the basis of prosecution estoppel.
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`Because prosecution estoppel is not a legally-recognized basis for holding a patent claim
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`wholly unenforceable, the Court should dismiss Count IX of Samsung’s counterclaims for failure
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`to state a claim.
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`B.
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`Samsung Has Not Pleaded Any Facts That Would Support A Finding Of
`Prosecution Estoppel For The ’213 Patent.
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`Samsung’s unenforceability counterclaim should also be dismissed because Samsung has
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`not pleaded any facts corresponding with the elements of prosecution estoppel. To adequately
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`state a claim for prosecution estoppel, Samsung must allege facts that allow for a reasonable
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`inference that Genentech amended the asserted claims of the ’213 patent “to secure the patent,”
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`and that “the amendment narrows the patent’s scope,” Festo, 535 U.S. at 736, or that Genentech
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`made a “clear and unmistakable surrender of subject matter” with respect to the asserted claims
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`in the prosecution history, Conoco, 460 F.3d at 1364. Samsung has done neither. Moreover,
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`Samsung has not explained how its biosimilar product falls within any allegedly surrendered
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`claim scope, which is an essential element of applying prosecution estoppel to the facts of this
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`case. Pac. Coast Marine Windshields Ltd. v. Malibu Boats, LLC, 739 F.3d 694, 704 (Fed. Cir.
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`2014) (“Prosecution history estoppel only bars an infringement claim if the accused design fell
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`within the scope of the surrendered subject matter.”). Because Samsung has not recited the
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`barest facts supporting a claim of prosecution estoppel, Samsung’s prosecution estoppel
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`counterclaim should be dismissed.
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`In order for amendment-based prosecution estoppel to apply, the patentee must have
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`made an amendment during prosecution which “narrows the patent’s scope” to “secure [the
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`issuance of] the patent.” Festo, 535 U.S. at 736. Yet Samsung has pleaded no facts relating to a
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 15 of 17 PageID #: 1265
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`claim amendment made during prosecution that narrows the scope of any asserted claims. The
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`only claim amendment that Samsung mentioned at all in explaining its unenforceability theory is
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`Genentech’s amendment deleting references in certain claims to a substitution at amino acid
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`position 93H. Danford Decl., Ex. 3 at 34. However, as Samsung acknowledges, Genentech
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`included that very limitation in other claims later on during prosecution. Id. (“Genentech
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`included a substitution at residue 93H in new claim 115 and claims dependent therefrom.”). And
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`that limitation appears in several of the claims of the ’213 patent as issued. Id. (“The examiner,
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`in the next PTO action, indicated that the pending claims, including claims 115-117, 123 and
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`127, were allowable.”); see also Danford Decl., Ex. 4 (’213 patent), claims 65 and 79 (claiming
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`substitutions at site 93H). Samsung has not adequately pleaded amendment-based prosecution
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`history estoppel where it has identified no narrowing claim amendment during prosecution of the
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`’213 patent, let alone a claim amendment pertaining to asserted claims 65 and 79. See AccuScan,
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`Inc. v. Xerox Corp., 76 F. App’x 290, 291 (Fed. Cir. 2003) (noting the “settled rule” that
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`“prosecution history estoppel does not apply . . . when there is no relevant amendment during
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`prosecution of the patent application”).
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`Nor has Samsung alleged sufficient facts to state a claim for argument-based prosecution
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`estoppel, which requires a “clear and unmistakable surrender of subject matter” in the
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`prosecution history. Conoco, 460 F.3d at 1364. Here, Samsung points to certain arguments that
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`Genentech presented during prosecution regarding the disclosure of the Queen Patent. E.g.,
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`Danford Decl., Ex. 3 at 35 (“Genentech argued that the Queen Patent uses a different numbering
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`system and, in particular, does not disclose a substitution at 93H using the Kabat system.”). But
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`Samsung has not pleaded facts plausibly suggesting that those arguments amounted to a “clear
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`and unmistakable surrender of subject matter” covered by the asserted claims. On the contrary,
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`Case 1:18-cv-01363-CFC Document 46 Filed 12/10/18 Page 16 of 17 PageID #: 1266
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`Genentech was clear that its claims cover a substitution at position 93H, as Samsung
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`acknowledges. Id. at 34 (“Genentech included a substitution at residue 93H in new claim 115
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`and claims dependent therefrom.”). Genentech’s arguments to the patent examiner that certain
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`examples in the Queen Patent do not include an amino acid substitution at 93H only reinforce
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`that the claims of the ’213 patent do cover such a substitution; indeed, Genentech would have
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`had no reason to present that argument unless the ’213 patent claims covered an amino acid
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`substitution at position 93H.
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`Finally, putting aside Samsung’s failure to plead facts plausibly suggesting a narrowing
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`amendment or argument, Samsung has also failed to plead any facts indicating that its proposed
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`biosimilar product falls within the scope of any alleged claim-narrowing. Because prosecution
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`estoppel only limits a patentee’s ability to assert infringement under the doctrine of
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`equivalents—and does not entirely foreclose the patentee’s ability to assert infringement of the
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`claim—a necessary element of prosecution estoppel is that the accused product must fall within
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`the surrendered claim scope. Pac. Coast Marine Windshields, 739 F.3d at 704 (“Prosecution
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`history estoppel only bars an infringement claim if the accused design fell within the scope of the
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`surrendered subject matter.”). Here, Samsung has pleaded no facts suggesting that its biosimilar
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`product fa