`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`
`v.
`
`
`AMERICAN REGENT, INC.,
`Patent Owner.
`
`________________
`
`
`Case No. IPR2019-01142
`United States Patent No. 8,431,549
`
`________________
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,431,549
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450, Alexandria, Virginia 22313-1450
`
`AMERICAS 93505379
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`
`
`Petition for IPR of U.S. 8,431,549
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ....................................................................................... 1
`
`II. MANDATORY NOTICES ......................................................................... 4
`A.
`Petitioner and Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) ......... 4
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) .......................................... 4
`C.
`Counsel and Service Information (37 C.F.R. § 42.8(b)(3) and (4)) .. 5
`
`III. FEES (37 C.F.R. § 42.15(a)) ....................................................................... 6
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104 ........................................ 6
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) ................................. 6
`B.
`Statement of Relief Requested (37 C.F.R. § 42.104(b)) ................... 6
`
`V.
`
`THE ’549 PATENT ..................................................................................... 7
`A.
`The Claims ........................................................................................ 8
`B.
`The Level of Ordinary Skill in the Art .............................................. 9
`C.
`The First IPR ..................................................................................... 9
`1.
`Institution and Scope ............................................................... 9
`2.
`Claim Construction ...............................................................11
`3.
`The Board’s Findings on Anticipation ..................................13
`
`VI. CLAIM CONSTRUCTION ......................................................................16
`A.
`Substantially Non-Immunogenic Carbohydrate Component .......... 17
`B.
`Iron Polyisomaltose Complex ......................................................... 17
`
`VII. LEGAL STANDARDS .............................................................................18
`
`VIII. DETAILED STATEMENT OF GROUNDS FOR INVALIDITY ...........18
`A. Anticipation by van Zyl-Smit and Groman ..................................... 19
`1.
`Ground 1: van Zyl-Smit Anticipates Claims 7, 8, and 15 ....19
`2.
`Ground 2: Groman Anticipates Claim 21 .............................22
`3.
`Collateral Estoppel Precludes Re-Litigation of van Zyl-
`Smit’s and Groman’s Teachings ...........................................24
`B. No Basis to Deny Institution ........................................................... 27
`1.
`The Concerns Addressed in General Plastic and Related
`Decisions Are Not Present Here ...........................................27
`Instituting this IPR Would Promote Equity and Efficiency .29
`The General Plastic Factors Weigh Against Denying
`Institution Under 35 U.S.C. § 314(a) ....................................31
`The Board Should Not Deny Institution Under § 325(d) .....35
`
`2.
`3.
`
`4.
`
`
`
`ii
`
`
`

`

`
`
`Cases
`
`Petition for IPR of U.S. 8,431,549
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`B & B Hardware, Inc. v. Hargis Indus., Inc.,
`135 S. Ct. 1293 (2015) ........................................................................................ 34
`
`Brassica Protection Prods. LLC v. Sunrise Farms (In re Cruciferous
`Sprout Litig.),
`301 F.3d 1343 (Fed. Cir. 2002) .......................................................................... 18
`
`Brown v. 3M,
`265 F.3d 1349 (Fed. Cir. 2001) .......................................................................... 18
`
`Callaway Golf Co. v. Acushnet Co.,
`576 F.3d 1331 (Fed. Cir. 2009) .................................................................... 22, 31
`
`Conopco, Inc. v. Proctor & Gamble Co.,
`No. IPR2014-00506, Paper 25 (P.T.A.B. Dec. 10, 2014) .................................. 36
`
`Conopco, Inc. v. Proctor & Gamble Co.,
`No. IPR2014-00628, Paper 21, (P.T.A.B. October 20, 2014) ............................ 33
`
`Ericsson Inc. v. Intellectual Ventures LLC,
`No. IPR2018-01318, Paper 6, (P.T.A.B. Jan. 15, 2019) .................................... 35
`
`Fox Factory, Inc. v. SRAM, LLC,
`No. IPR2016-01876, Paper 8, (P.T.A.B. Apr. 3, 2017) ..................................... 35
`
`In re Freeman,
`30 F.3d 1459 (Fed. Cir. 1994) ............................................................................ 25
`
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`No. IPR2016–01357, Paper 19 (P.T.A.B. Sept. 6, 2017) ............................passim
`
`Luitpold Pharms., Inc. v. Pharmacosmos A/S,
`718 Fed.Appx. 989 (Fed. Cir. 2018) ............................................................passim
`
`Maxlinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1376 (Fed. Cir.
`2018) ....................................................................................................... 24, 25, 26
`
`iii
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`In re Morsa,
`713 F.3d 104 (Fed. Cir. 2013) ............................................................................ 18
`
`Nestlé USA, Inc. v. Steuben Foods, Inc.,
`884 F.3d 1350 (Fed. Cir. 2018) .................................................................... 24, 25
`
`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) .......................................................................... 24
`
`Papst Licensing GMBH & Co. v. Samsung Elecs. Am., Inc.,
`2019 U.S. App. LEXIS 15274, *13 (Fed. Cir. 2019) ................................... 25, 26
`
`Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.,
`No. IPR2015-01493, Paper No. 54 (P.T.A.B Dec. 28, 2016) .............................. 1
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .................................................... 16, 17
`
`Soverain Software LLC v. Victoria’s Secret Direct Brand Mgmt., LLC,
`778 F.3d 1311 (Fed. Cir. 2015) .......................................................................... 25
`
`Toyota Motor Corp. v. Cellport Sys., Inc.,
`No. IPR2015-01423, Paper 7, (P.T.A.B. Oct. 28, 2015) .................................... 31
`
`Statutes
`
`35 U.S.C. § 102(b) ............................................................................................passim
`
`35 U.S.C. § 103 ........................................................................................................ 10
`
`35 U.S.C. §§ 311-318................................................................................................. 6
`
`35 U.S.C. § 314(a) (2012) ...................................................................... 18, 30, 34, 35
`
`35 U.S.C. § 315(e)(1) ................................................................................................. 6
`
`35 U.S.C. § 325(d) ....................................................................................... 34, 35, 36
`
`
`
`
`
`
`
`
`iv
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`
`

`

`
`
`
`Exhibit # Title
`
`Petition for IPR of U.S. 8,431,549
`
`TABLE OF EXHIBITS
`
`Short Cite
`
`1001
`
`U.S. Patent No. 8,431,549 (filed May 25, 2010)
`
`’549 Patent
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Certified File History of U.S. Patent Application
`No. 12/787,283 (issued as U.S. Patent No.
`8,431,549) (certified on March 27, 2019)
`
`’283 Application
`
`U.S. Patent App. Pub. No. 2003/0232084
`[Pharmacosmos A/S v. Luitpold Pharmaceuticals,
`Inc., No. IPR2015-01493, Ex. 1003]
`
`Groman
`
`van Zyl-Smit and Halkett, Experience with the Use
`of an Iron Polymaltose (Dextrin) Complex Given by
`Single Total Dose Infusion to Stable Chronic
`Haemodialysis Patients, 92 Nephron, 316-323
`(2002) [Pharmacosmos A/S v. Luitpold
`Pharmaceuticals, Inc., No. IPR2015-01493, Ex.
`1004]
`
`Patent Assignment recorded at Reel: 048067
`Frame: 0271 - Assignment and Change of Name
`from Luitpold Pharmaceuticals, Inc. to American
`Regent, Inc. (Jan. 2, 2019)
`
`Declaration of Richard P. Lawrence under 37
`C.F.R. § 1.132 [Pharmacosmos A/S v. Luitpold
`Pharmaceuticals, Inc., No. IPR2015-01493, Ex.
`1011]
`
`van Zyl-Smit
`
`Patent
`Assignment
`
`Lawrence Decl.
`
`U.S. Pharmacopeia for Dextran 1 (USP 28:2005)
`[Pharmacosmos A/S v. Luitpold Pharmaceuticals,
`Inc., No. IPR2015-01493, Ex. 1037]
`
`Material Specification Sheet for Dextran T1
`[Pharmacosmos A/S v. Luitpold Pharmaceuticals,
`Inc., No. IPR2015-01493, Ex. 1038]
`
`
`
`
`
`Expert Declaration of Robert Linhardt, Ph.D.
`
`Linhardt Decl.
`
`Curriculum Vitae of Robert Linhardt, Ph.D.
`
`Linhardt C.V.
`
`Declaration of Robert Linhardt, dated June 22,
`2015 [Pharmacosmos A/S v. Luitpold
`
`
`
`v
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`Pharmaceuticals, Inc., No. IPR2015-01493, Ex.
`1014]
`
`vi
`
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Petition for IPR of U.S. 8,431,549
`
`Pharmacosmos A/S (“Petitioner”) requests inter partes review (“IPR”) and
`
`cancellation of four patent claims, based solely on the Board’s prior factual findings
`
`that were affirmed by the Federal Circuit. See Pharmacosmos A/S v. Luitpold
`
`Pharmaceuticals, Inc., No. IPR2015-01493, Paper No. 54 (P.T.A.B Dec. 28, 2016),
`
`aff’d Luitpold Pharms., Inc. v. Pharmacosmos A/S, 718 Fed.Appx. 989 (Mem) (Fed.
`
`Cir. 2018). Those established facts, without more, compel cancellation of Claims 7,
`
`8, 15, and 21 (the “Challenged Claims”) of U.S. Patent No. 8,431,549 (the “’549
`
`Patent”; Ex. 1001).
`
`The ’549 Patent claims methods of treating disorders related to iron
`
`deficiency, such as anemia, with an iron carbohydrate complex selected from a group
`
`of five different complexes. Independent Claim 1 requires the complex to be
`
`“substantially non-immunogenic,” and requires the use of a “single dosage unit”
`
`containing at least about 0.6 grams of elemental iron. Dependent Claims 7 and 8
`
`require higher doses of 1.0 grams and 1.5 grams, respectively, while dependent
`
`Claim 15 requires the dose to be administered parenterally (i.e., non-orally).
`
`The van Zyl-Smit reference (Ex. 1004) anticipates Claims 7, 8, and 15. In the
`
`prior IPR, the Board found that van Zyl-Smit describes the treatment of iron
`
`deficiency anemia with iron polymaltose—one of the claimed complexes—in a
`
`single intravenous bolus dose of up to 3.2 grams, without causing any adverse
`
`1
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`immunogenic response. The Board rejected Patent Owner’s only argument in
`
`response (that van Zyl-Smit’s complex may have been immunogenic) and concluded
`
`that van Zyl-Smit anticipated Claims 1-5, 9, 16, and 19 of the ’549 Patent. Although
`
`not specifically addressed in the Board’s prior Final Written Decision, the same is
`
`unquestionably true for Claims 7, 8, and 15. The Board’s previous findings confirm
`
`that those related limitations do not confer patentability on those three claims.
`
`Additionally, while Claim 15 was absent from the Board’s prior Final Written
`
`Decision, the record is clear that it should have been included, as the Board amended
`
`its Institution Decision to explicitly include Claim 15. Petitioner respectfully
`
`requests that the Board grant this Petition to correct this inadvertent oversight and
`
`confirm unpatentability of that claim.
`
`Claim 21 limits the claimed method to one of the five iron carbohydrate
`
`complexes listed in Claim 1: an iron polyisomaltose complex. Here, too, the Board’s
`
`prior decision is dispositive. Specifically, the Board determined that the Groman
`
`reference (Ex. 1003) discloses treatment of anemia with “iron polyisomaltose” (as
`
`Patent Owner construed that term) in doses of about 0.6 grams, and that such
`
`treatments were “immunosilent.” Again, the Board rejected Patent Owner’s sole
`
`argument in response (that Groman did not disclose any of the claimed complexes)
`
`and determined that Groman disclosed the claimed iron polyisomaltose complex and
`
`thus anticipated Claims 1 and 14. The same is true for Claim 21, which is
`
`2
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`specifically limited to the iron polyisomaltose complex the Board already
`
`determined was disclosed in Groman.
`
`Petitioner files this narrow Petition to combat Patent Owner’s transparent
`
`efforts to fashion a patent portfolio encompassing Petitioner’s iron deficiency
`
`treatment, Monofer®, which Patent Owner singled out during the ’549 Patent’s
`
`prosecution as an embodiment of its “invention.” Petitioner respectfully requests
`
`the Board’s intervention to remove all doubt that these four claims are unpatentable,
`
`by extension of the factual findings in the prior IPR.
`
`Indeed, collateral estoppel precludes Patent Owner from trying to reargue any
`
`different interpretation of the van Zyl-Smit and Groman references, having had its
`
`chance and lost in a full and fair prior IPR proceeding. No prejudice will result to
`
`Patent Owner from the Board confirming what is already abundantly clear based on
`
`the record from the prior IPR: Claims 7, 8, 15, and 21 are anticipated and should be
`
`cancelled.
`
`Because of Patent Owner’s continued prosecution strategy apparently
`
`targeting Monofer®, the anticipation and estoppel issues described in this Petition
`
`require resolution. Equity and efficiency favors adjudication by the Board, which
`
`may resolve this matter based solely on the now-uncontestable factual findings that
`
`it made and the Federal Circuit confirmed. In view of Petitioner’s reliance on its
`
`sole and successful prior challenge, the balance between “the potential for abuse of
`
`3
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`the review process by repeated attacks on patents,” on the one hand, and “provid[ing]
`
`an effective and efficient alternative to district court litigation,” on the other, weighs
`
`in favor of institution. See General Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`
`No. IPR2016–01357, Paper 19, p. 16–18n.14 (P.T.A.B. Sept. 6, 2017)
`
`(precedential).
`
`The Board should grant this Petition and institute trial on all the Challenged
`
`Claims.
`
`II. MANDATORY NOTICES
`
`A.
`
`Petitioner and Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`
`Petitioner is the Real Party-in-Interest. Petitioner is a corporation organized
`
`and existing under the laws of Denmark, having its principal place of business at
`
`Roervangsvej 30, DK-4300 Holbæk, Denmark.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`Petitioner previously filed a petition for inter partes review of the ’549 Patent
`
`(IPR2015-01493, the “First IPR”). As further described below, the First IPR
`
`resulted in the invalidation of Claims 1–5, 9, 14, 16, and 19 of the ’549 Patent. First
`
`IPR, Paper 54 (“Final Written Decision” or “FWD”), aff’d Luitpold Pharms., 718
`
`Fed.Appx.
`
`Petitioner also filed petitions for inter partes review of related patents U.S.
`
`Patent No. 7,754,702 (“the ’702 Patent”) (IPR2015-01490) and U.S. Patent No.
`
`8,895,612 (IPR2015-01495). IPR2015-01490 resulted in invalidation of Claims 1–
`
`4
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`3, 10–15, 23, 25, 27, 30, and 41–43 of the ’702 Patent. IPR2015-01490, Paper 54,
`
`aff’d Luitpold Pharms., 718 Fed.Appx. IPR2015-01495 was not instituted. See
`
`IPR2015-01495, Paper 11.
`
`Petitioner is unaware of any other existing judicial or administrative matters
`
`that may affect or be affected by a decision in this proceeding.
`
`C. Counsel and Service Information (37 C.F.R. § 42.8(b)(3) and (4))
`
`Petitioner identifies its lead and backup counsel below:
`
`Lead
`Counsel
`
`Jeffrey Oelke
`FENWICK & WEST LLP
`902 Broadway, New York, NY 10010
`(212) 921-2001
`joelke@fenwick.com
`USPTO Reg. No. 37,409
`
`Backup
`Counsel
`
`Ryan Johnson
`FENWICK & WEST LLP
`902 Broadway
`New York, NY 10010
`(212) 921-2001
`ryan.johnson@fenwick.com
`(To seek pro hac vice admission)
`
`Vanessa Park-Thompson
`FENWICK & WEST LLP
`902 Broadway
`New York, NY 10010
`(212) 921-2001
`vpark-thompson@fenwick.com
`(To seek pro hac vice admission)
`
`Please address all correspondence to lead and backup counsel. Petitioner
`
`consents to service by email. A power of attorney is being filed concurrently with
`
`the designation of counsel in accordance with 37 C.F.R. § 42.10(b).
`
`5
`
`
`

`

`
`
`III. FEES (37 C.F.R. § 42.15(A))
`
`Petition for IPR of U.S. 8,431,549
`
`Petitioner authorizes the United States Patent and Trademark Office
`
`(“USPTO”) to deduct $15,500 from Deposit Account No. 192555 for the fee set
`
`forth in 37 C.F.R. § 42.15(a), and authorizes charging any additional fees associated
`
`with this Petition to the same account.
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioner certifies that the ’549 Patent is available for IPR and that Petitioner
`
`is not barred or estopped from requesting an IPR challenging the Challenged Claims
`
`on the grounds identified in this Petition.
`
`
`
`Specifically, 35 U.S.C. § 315(e)(1) does not apply, as the Challenged Claims
`
`have not been addressed in any final written decision. See FWD.
`
`B.
`
`Statement of Relief Requested (37 C.F.R. § 42.104(b))
`
`Petitioner requests inter partes review, under 35 U.S.C. §§ 311-318 and 37
`
`C.F.R. §§ 42.100-42.123, and cancellation of the Challenged Claims as unpatentable
`
`on the following grounds:
`
`Ground Claims
`
`Prior Art
`
`Basis
`
`1
`
`2
`
`7, 8, and 15
`
`van Zyl-Smit
`
`35 U.S.C. § 102(b)1
`
`21
`
`Groman
`
`35 U.S.C. § 102(b)
`
`
`1 References in this Petition to 35 U.S.C. are to the pre-AIA version of the statute.
`
`6
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`The full statement of reasons for the relief requested is set forth in detail
`
`below. In accordance with 37 C.F.R. § 42.6(c), copies of the exhibits are filed
`
`herewith and a Table of Exhibits is provided above. The Expert Declaration of
`
`Robert Linhardt, Ph.D., on behalf of Petitioner, accompanies this Petition. See
`
`Linhardt Decl. (Ex. 1009). Dr. Linhardt has extensive experience in the relevant
`
`field and is qualified to provide opinions regarding what a person of skill in the art
`
`would have known or concluded at the relevant time. See id.; Linhardt C.V. (Ex.
`
`1010). The Board specifically relied on Dr. Linhardt’s opinions in the First IPR.
`
`See, e.g., FWD, p. 16 (“We credit [Dr. Linhardt’s] testimony, and thus disagree with
`
`Patent Owner’s contention . . .”), p. 22 (“. . . we give [Patent Owner’s expert’s]
`
`testimony less weight in comparison to Dr. Linhardt’s testimony.”).
`
`V. THE ’549 PATENT
`
`The ’549 Patent issued on April 30, 2013 from U.S. Application No.
`
`12/787,283 (the “’283 Application”; Ex. 1002), filed on May 25, 2010. It claims an
`
`earliest effective filing of January 6, 2006, based on U.S. Provisional Application
`
`No. 60/757,119.
`
`When the ’549 Patent issued, it was assigned to Luitpold Pharmaceuticals,
`
`Inc. Luitpold Pharmaceuticals, Inc. subsequently changed its name to and assigned
`
`all rights in the ’549 Patent to American Regent, Inc. (“Patent Owner”) in January
`
`2019. See Patent Assignment (Ex. 1005).
`
`7
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`The ’549 Patent is entitled “Methods and compositions for administration of
`
`iron.” The patent states that prior art “iron dextrans” had been administered to treat
`
`iron-related conditions but that they caused adverse anaphylactoid-type reactions.
`
`Ex. 1001, 1:47-52; Ex. 1009, ¶ 22. The patent alleges that the claimed iron
`
`carbohydrate complexes can be administered at relatively high single unit dosages
`
`safely and efficiently. See Ex. 1001, 2:27-31; Ex. 1009, ¶ 22.
`
`A. The Claims
`
`The ’549 Patent’s sole independent claim reads:
`
`1. A method of treating a disease, disorder, or condition characterized by iron
`deficiency or dysfunctional
`iron metabolism resulting
`in reduced
`bioavailability of dietary iron,
`
`comprising administering to a subject in need thereof an iron carbohydrate
`complex in a single dosage unit of at least about 0.6 grams of elemental iron,
`
`wherein,
`
`the iron carbohydrate complex is selected from the group
`consisting of an
`iron mannitol complex, and an
`iron
`polyisomaltose complex, an iron polymaltose complex, an iron
`gluconate complex, and an iron sorbitol complex,
`
`the iron carbohydrate complex has a substantially non-
`immunogenic carbohydrate component, and
`
`the disease, disorder or condition is not Restless Leg Syndrome.
`
`The Challenged Claims each directly depend from Claim 1. Claim 7 recites
`
`that “the single dosage unit of elemental iron is at least about 1.0 grams.” Claim 8
`
`recites that “the single dosage unit of elemental iron is at least about 1.5 grams.”
`
`8
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`Claim 15 recites that “the iron carbohydrate complex is administered parenterally.”
`
`Claim 21 recites that “the iron carbohydrate complex is an iron polyisomaltose
`
`complex.”
`
`B.
`
`The Level of Ordinary Skill in the Art
`
`A person of skill in the art of the ’549 Patent as of the priority date would have
`
`held at least a B.S. in chemistry or biochemistry, with some related post-graduate
`
`experience (academic or industrial) in the area of carbohydrates and their metal
`
`complexes. Ex. 1009, ¶ 25.
`
`C. The First IPR
`
`1.
`
`Institution and Scope
`
`On June 24, 2015, Petitioner filed a petition for inter partes review of Claims
`
`1-5, 7-10, 12-17, 19, and 21 of the ’549 Patent. First IPR, Paper 1. Petitioner
`
`asserted four grounds of unpatentability: 2
`
`Ground Claims
`
`Description
`
`1
`
`2
`
`3
`
`1, 7, 8, 15, 17, and
`21
`
`Anticipated under 35 U.S.C. § 102(b) by U.S.
`Patent No. 5,541,158
`
`2, 3, 4, 5, 9, 16, and
`19
`
`Anticipated under 35 U.S.C. § 102(b) by van
`Zyl-Smit
`
`10 and 12-14
`
`Anticipated under 35 U.S.C. § 102(b) by
`Groman
`
`
`2 The petition in the First IPR separated Ground 3 into two grounds (challenging
`Claims 12 and 13 separately from Claims 10 and 14). The Board consolidated them
`in its Institution Decision (Paper 11, p. 4).
`
`9
`
`
`

`

`
`
`Ground Claims
`
`Description
`
`Petition for IPR of U.S. 8,431,549
`
`4
`
`10
`
`Obvious under 35 U.S.C. § 103 over van Zyl-
`Smit in view of Groman
`
`Id. at 4.
`
`The Challenged Claims were the subject of Ground 1 only, which the Board
`
`declined to institute. First IPR, Paper 11 (“Institution Decision” or “ID”), p. 9-10.
`
`The Board also declined to institute inter partes review of Claim 10 under either
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`Ground 3 or 4. Id., p. 17-19, 21. However, the Board concluded that there was a
`
`reasonable likelihood that Petitioner would prevail in challenging Claims 1–5, 9, 16,
`
`and 19 as anticipated by van Zyl-Smit (Ground 2). Id., p. 10-14. The Board also
`
`concluded that there was a reasonable likelihood that Petitioner would prevail in
`
`challenging Claims 1 and 12–14 as anticipated by Groman (Ground 3). Id., p. 14-
`
`17, 19-21.
`
`The Institution Decision noted that although the Petition had not included
`
`independent Claim 1 as part of Grounds 2 or 3, the Board would necessarily have to
`
`consider whether its limitations were met before turning to the dependent claims.
`
`Id., p. 11, 15; see also FWD, p. 12n.9, 19n.10.
`
`Shortly thereafter, the Board amended the Institution Decision to include
`
`Claim 15 in the trial on the same basis. First IPR, Paper 22, p. 6. The Institution
`
`10
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`Decision had ordered a trial as to Claim 16, but not Claim 15, from which Claim 16
`
`depended. The Board corrected this discrepancy, stating:
`
`[B]ecause a dependent claim incorporates all the limitations from the
`claims upon which it depends, Petitioner’s challenge of the dependent
`claim will also encompass the parent claims . . . The fact that we failed
`to institute trial on claim 15 in IPR2015-01493 was, therefore, an
`oversight . . . Thus, we should have stated that trial is instituted on
`claims 1–5, 9, 15, 16 and 19 under 35 U.S.C. § 102(b) as anticipated by
`van Zyl-Smit.
`
`Id., p. 5 (emphasis added).
`
`The parties acknowledged the Board’s amendment and addressed Claim 15 in
`
`their subsequent submissions. See, e.g., First IPR, Paper 24, p. 13n.1 (Patent Owner
`
`acknowledging that “[i]n Paper 22, the Board clarified that the trial includes the
`
`challenge of Claim 15 as anticipated by van Zyl-Smit”); see also id., p. 1, 18; Paper
`
`29, p. 1, 4-5; Paper 33, p. 1, 6, 17; Paper 34, p. 5, 8, 13-14; Paper 42, p. 1. However,
`
`the Board’s Final Written Decision does not address Claim 15. See FWD, p. 27
`
`(ordering “that claims 1–5, 9, 14, 16, and 19 of U.S. Patent 8,431,549 B2 are held to
`
`be unpatentable”).
`
`2.
`
`Claim Construction
`
`Applying the “broadest reasonable construction” standard, the Board
`
`construed a “substantially non-immunogenic carbohydrate component” as a
`
`“carbohydrate component resulting in a low risk of anaphylactoid/hypersensitivity
`
`11
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`reactions, wherein a low risk is an incidence of adverse events lower than dextran.”
`
`FWD, p. 6-12.
`
`The Board based this construction on the intrinsic evidence, particularly the
`
`’549 Patent’s specification. See id., p. 6-7; see also ID, p. 6-7. In particular, the
`
`Board noted that the specification emphasizes that iron dextran products had a “high
`
`incidence of anaphylactoid events,” while the claimed subject matter allegedly
`
`yields a lower risk of anaphylactoid/hypersensitivity reactions. Id.; see Ex. 1001,
`
`1:53-57, 11:1-2, 15:13-42. This purported juxtaposition set out in the specification
`
`between the claimed invention’s allegedly low risk of immunogenicity, and iron
`
`dextran’s allegedly higher risk, undergirded the Board’s construction. FWD, p. 7.
`
`The Board rejected Patent Owner’s arguments “that (i) the immunogenicity of the
`
`complex as a whole should be considered; (ii) the threshold of “low risk” should be
`
`less than a 0.6–0.7% adverse event rate; and (iii) determining a “substantially non-
`
`immunogenic [carbohydrate] component [of an iron carbohydrate complex]”
`
`requires a large enough cohort,” all of which the Board rejected as inconsistent with
`
`or unsupported by the intrinsic evidence. Id., p. 7-12.
`
`The Board did not explicitly construe the term “polyisomaltose” in its claim
`
`construction section of the Final Written Decision. See id., p. 5-12. However, in
`
`analyzing Groman’s teachings, it noted:
`
`Petitioner contends that “if ‘polyisomaltose’ were construed to include
`an essentially purely linear chemical structure of repeating α-1-6 linked
`
`12
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`glucose units which is reduced (hydrogenated) and has a molecular
`weight of 1000 Da, Groman would teach all the limitations of claim
`14.” This construction of “polyisomaltose” is consistent with what
`Patent Owner itself had proposed, and thus appears undisputed for
`purposes of this patentability challenge.
`
`Id., p. 20-21 (citations omitted).
`
`The Board applied this construction, proposed by Patent Owner, in its analysis
`
`of the Groman reference. See id., p. 21-24.
`
`3.
`
`The Board’s Findings on Anticipation
`
`The Board found that van Zyl-Smit discloses parenteral iron therapy with at
`
`least about 0.6 grams of elemental iron in the form of an iron polymaltose complex.
`
`See FWD, p. 12-18; ID, p. 10. The Board explained:
`
`van Zyl-Smit describes a study in which intravenous iron was given as
`a bolus replacement to hemodialysis patients with anemia. van Zyl-
`Smit describes the treatment regimen as follows:
`
`
`Patients were treated with an iron polymaltose (dextrin)
`preparation (Ferrimed®, Vifor International Inc., Switzerland).
`The dose required was calculated according to body mass and
`haemoglobin concentration using a table supplied by the
`manufacturer and was given as a total dose infusion (TDI). The
`dosage required ranged from 18 to 64 ml (900–3,200 mg of iron)
`and was diluted in 500 ml of normal saline and infused over a 4-
`hour period during a dialysis session.
`
`
`ID, p. 10 (citing Ex. 1004, Abstract, p. 317); see also FWD, p. 13-14.
`
`The Board found that van Zyl-Smit discloses that its iron polymaltose
`
`complex has a substantially non-immunogenic iron carbohydrate component. See
`
`FWD, p. 14-18; ID, p. 10-11. The Board noted:
`
`13
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`In describing any adverse reactions from the treatment, van Zyl-Smit
`teaches:
`
`
`No anaphylactoid and no delayed reactions such as pyrexia,
`arthralgia, or myalgia were seen. Hypotensive episodes were
`more difficult to assess as these occur frequently during the
`course of normal haemodialysis. At no stage did the clinicians
`responsible for the care of these patients feel that any of these
`episodes were related to the iron infusions, none of the infusions
`had to be stopped and no thrombophlebitis occurred. One
`patient died 19 days after the infusion of complications unrelated
`to the infusion.
`
`ID, p. 10-11 (citing Ex. 1004, p. 321); see also FWD, p. 13-14.
`
`Based on these teachings, the Board found that van Zyl-Smit anticipates
`
`Claims 1–5, 9, 16, and 19. FWD, p. 14-19.
`
`Regarding Groman, the Board found that the reference teaches parenteral iron
`
`therapy with at least about 0.6 grams of elemental iron in the form of an iron
`
`polyisomaltose complex, under Patent Owner’s construction of that term. FWD, p.
`
`18-20; ID, p. 14. The Board held that Groman’s teaching of reduced Dextran T1-
`
`coated ultrasmall superparamagnetic iron oxide (USPIOs) met Patent Owner’s
`
`proposed construction of “iron polyisomaltose complex”, because they are
`
`“essentially purely linear chemical structure[s] of repeating α-1-6 linked glucose
`
`units which [are] reduced (hydrogenated) and ha[ve] a molecular weight of 1000
`
`Da.” FWD, p. 20-23.
`
`14
`
`
`

`

`
`
`The Board further stated:
`
`Petition for IPR of U.S. 8,431,549
`
`Groman teaches that ‘compositions of the invention can serve as an iron
`supplement for patients suffering from anemia . . . .’ Groman teaches
`that the iron oxide complex can be parenterally administered at a rate
`‘for a total single dose from about 50 mg to about 600 mg.’
`. . . The iron oxide complex used by Groman can be coated with a
`reduced dextran, for example, a reduced carboxymethyl dextran.
`
`ID, p. 14 (citing Ex. 1003, ¶ 16, 31, 82); see also FWD, p. 19-20.
`
`The Board found that Groman also discloses a substantially non-immunogenic
`
`iron carbohydrate component of the iron carbohydrate complex:
`
`Groman teaches that ‘[t]he formulations of the present invention are
`prepared such that upon administration to a patient the iron oxide
`complex presents as an immunosilent agent to the patient, as indicated
`by the patient’s physical response and confirmed by ELISA assay.’
`
`ID, p. 14 (citing Ex. 1003, ¶ 174) (internal citation omitted); see also FWD,
`
`p. 19-20.
`
`Finally, the Board found that, “Groman teaches an iron carbohydrate complex
`
`that satisfies the requirements of the claimed ‘iron polyisomaltose complex,’” as
`
`Patent Owner had construed it. FWD, p. 21. Based on these teachings, the Board
`
`concluded that Groman anticipated Claims 1 and 14.3 Id., p. 19-23.
`
`
`3 Patent Owner filed a Notice of Disclaimer disclaiming Claims 12 and 13 of the
`’549 Patent after trial was instituted as to these two claims. First IPR, Paper 52. As
`a result, the Board did not adjudicate Claims 12 and 13 in its Final Written Decision.
`See FWD, p. 5n.2.
`
`15
`
`
`

`

`
`
`Petition for IPR of U.S. 8,431,549
`
`Despite the Board’s decision to institute a trial of Claim 15 (First IPR, Paper
`
`22) and extensive briefing on both sides addressing Claim 15, that claim was
`
`inadvertently omitted from the Final Written Decision. See id., p. 27 (ordering “that
`
`claims 1–5, 9, 14, 16, and 19 of U.S. Patent 8,431,549 B2 are held to be
`
`unpatentable.”).
`
`VI. CLAIM CONSTRUCTION
`
`In an IPR, the Board construes claim terms according to their plain and
`
`ordinary meaning to one of ordinary skill as of the effective filing date of the patent
`
`application. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en
`
`banc); United States Patent and Trademark Office, Department of Commerce,
`
`“Changes to the Claim Construction Standard for Interpreting Claims in Trial
`
`Proceedings Before the Patent Trial and Appeal Board,” 83 Fed. Reg. 51340 (Oct.
`
`11, 2018) (codified at 37 C.