`
`Trials@uspto.gov Paper No. 54
`571.272.7822 Filed: January 4, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01490
`Patent 7,754,702 B2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`

`

`IPR2015-01490
`Patent 7,754,702 B2
`
`
`I. INTRODUCTION
`A.
`Background
`Petitioner, Pharmacosmos A/S (“Petitioner”), filed a Petition
`requesting inter partes review of claims 1–3, 10–15, 17, 23, 25‒28, 30, 34,
`41–43, and 47 (“the challenged claims”) of U.S. Patent No. 7,754,702 B2
`(“the ’702 patent”). Paper 1 (“Pet.”). Patent Owner, Luitpold
`Pharmaceuticals, Inc. (“Patent Owner”), filed a Patent Owner Preliminary
`Response. Paper 7. We determined that the information presented in the
`Petition and the Preliminary Response demonstrated that there was a
`reasonable likelihood that Petitioner would prevail in challenging claims
`1–3, 10–15, 23, 25, 27, 28, and 41–43 as unpatentable under 35 U.S.C.
`§ 102(b), and claims 17, 30, and 47 as unpatentable under § 103(a).
`Pursuant to 35 U.S.C. § 314, the Board instituted trial on January 8, 2016, as
`to claims 1–3, 10–15, 17, 23, 25, 27, 28, 30, 41–43, and 47 of the ’702
`patent. Paper 11 (“Institution Decision”; “Dec. Inst.”) and Paper 13
`(Erratum) (clarifying that trial was not instituted on claim 24).
`Patent Owner filed a Response (Paper 23, “PO Resp.”), a Motion to
`Amend (Paper 24), and a Corrected Motion to Amend (Paper 29, “Mot.
`Amend”). Petitioner subsequently filed a Reply (Paper 33, “Reply”), and an
`Opposition to Patent Owner’s Motion to Amend (Paper 34, “Opp. Mot. to
`Amend”). Patent Owner filed a Reply to the Opposition to the Motion to
`Amend. Paper 38. Patent Owner filed also a Motion to Exclude (Paper 44),
`to which Petitioner filed an Opposition (Paper 47), and Patent Owner filed a
`Reply (Paper 48).
`An oral hearing was held on September 22, 2016. The transcript of
`the hearing has been entered into the record. Paper 53 (“Tr.”). Subsequent
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`IPR2015-01490
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`to the hearing, Patent Owner also filed a Notice of Disclaimer disclaiming
`claims 28 and 29 of the ’702 patent. Paper 52.
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Based on the record before us, we conclude that Petitioner has demonstrated
`by a preponderance of the evidence that claims 1–3, 10–15, 23, 25, 27, 30,
`and 41–43 of the ’702 patent are unpatentable. We also determine that
`Patent Owner has not met its burden on its Motion to Amend regarding entry
`of proposed substitute claims. Accordingly, Patent Owner’s Motion to
`Amend is denied. Patent Owner’s Motion to Exclude is denied-in-part and
`dismissed-in-part.
`
`B. Related Proceedings
`Neither Petitioner nor Patent Owner identify any related district court
`proceedings. See, e.g. Pet. 1 (“There are no existing judicial or
`administrative matters that would affect, or be affected by, a decision in this
`proceeding.”); Paper 6 (“Patent Owner’s U.S. Patent No. 7,754,702 . . . is
`not involved in litigation.”). However, Petitioner filed petitions for inter
`partes review of related patents U.S. Patent No. 8,431,549 B2 (IPR2015-
`01493) and U.S. Patent No. 8,895,612 B2 (IPR2015-01495). Pet. 1.
`In IPR2015-01493, we instituted inter partes review of claims 1–5, 9,
`12–14, 16, and 19 of the ’549 patent. IPR2015-01493, Paper 11. We
`declined to institute inter partes review in IPR2015-01495. IPR2015-01495,
`Paper 11.
`
`C. The ’702 Patent (Ex. 1001)
`The ’702 patent issued on July 13, 2010, with Mary Jane Helenek,
`Marc L. Tokars, and Richard P. Lawrence as the listed co-inventors.
`
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`IPR2015-01490
`Patent 7,754,702 B2
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`Ex. 1001. The ’702 patent teaches that iron dextran, used for parenteral iron
`therapy, “has been associated with an incidence of anaphylactoid-type
`reactions,” which “is believed to be caused by the formation of antibodies to
`the dextran moiety.” Id. at 1:47‒54. The ’702 patent notes that other iron
`formulations that do not contain dextran have a markedly lower incidence of
`anaphylaxis. Id. at 1:55‒57. Thus, the ’702 patent relates to “methods of
`treating a disease, disorder, or condition characterized by iron deficiency or
`dysfunctional iron metabolism through the administration of at least 0.6
`grams of elemental iron via a single unit dosage of an iron carbohydrate
`complex to a subject that is in need of such therapy.” Id. at 2:32–37.
`As taught by the ’702 patent, “the method treats anemia . . . [such as]
`iron deficiency anemia.” Id. at 2:38–39. In addition, as taught by the ʼ702
`patent, the “iron carbohydrate complexes [] can be administered parenterally
`at relatively high single unit dosages for the therapeutic treatment of a
`variety of iron-associated diseases, disorders, or conditions.” Id. at 5:24–27.
`
`According to the ’702 patent:
`Applicants have discovered that certain characteristics of iron
`carbohydrate complexes make them amenable to administration
`at dosages
`far higher
`than contemplated by current
`administration protocols.
` Preferably,
`iron carbohydrate
`complexes for use in the methods described herein are those
`which have one or more of the following characteristics: a nearly
`neutral pH (e.g., about 5 to about 7); physiological osmolarity;
`stable carbohydrate component; an iron core size no greater than
`about 9 nm; mean diameter particle size no greater than about 35
`nm, preferably about 25 nm to about 30 nm; slow and
`competitive delivery of the complexed iron to endogenous iron
`binding sites; serum half-life of over about 7 hours; low toxicity;
`non-immunogenic carbohydrate component; no cross reactivity
`low
`risk
`of
`with
`anti-dextran
`antibodies;
`and/or
`anaphylactoid/hypersensitivity reactions.
`
`4
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`IPR2015-01490
`Patent 7,754,702 B2
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`Id. at 10:58‒11:5 (emphasis added).
`In some embodiments of the ’702 patent, “the iron carbohydrate
`complex is [an] iron carboxymaltose complex, iron mannitol complex, iron
`polyisomaltose complex, iron polymaltose complex, iron gluconate
`complex, iron sorbitol complex, [] iron hydrogenated dextran complex . . .
`[or] an iron polyglucose sorbitol carboxymethyl ether complex.” Id. at
`3:33–39. “In some preferred embodiments, the iron carboxymaltose
`complex is polynuclear iron (III)-hydroxide-4(R)-(poly-(1→4)-O-α-
`glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate”, which is
`also known as “VIT-45.” Id. at 3:58–61; 5:16–18. The ’702 patent teaches
`that as the iron carboxymaltose complex does not contain dextran, it does
`not react with anti-dextran antibodies, and, therefore, the risk of
`anaphylactoid/hypersensitivity reactions is low. Id. at 12:12‒15. Moreover,
`as it has a nearly neutral pH (between 5 and 7), and physiological
`osmolarity, it is possible to administer higher single unit doses over shorter
`time periods than other iron-carbohydrate complexes. Id. at 12:15‒19.
`D. Illustrative Claim
`This proceeding involves claims 1–3, 10–15, 17, 23, 25, 27, 28, 30,
`41–43, and 47 of the ’702 patent. Claim 1 is the only independent claim, is
`illustrative, and is reproduced below:
`
`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;
`
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`IPR2015-01490
`Patent 7,754,702 B2
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`
`
`wherein
`the iron carbohydrate complex is selected from the group
`consisting of an iron carboxymaltose complex, an iron
`mannitol complex, an iron polymaltose complex, an iron
`gluconate complex, and an iron sorbitol complex; and
`
`
`
`
`
`
`
`the iron carbohydrate complex has a substantially non-
`immunogenic carbohydrate component and substantially
`no cross reactivity with anti-dextran antibodies
`
`wherein said disease, disorder or condition is not Restless
`Leg Syndrome.
`
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`IPR2015-01490
`Patent 7,754,702 B2
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`
`E.
`
`Claims
`1–3, 10–13, 23, 25, 27,
`and 41–43
`282
`
`17 and 47
`
`1, 14, 15
`
`30
`
`
`
`Instituted Challenges
`Basis
`References
`§ 102(b) Geisser1
`§ 102(b) Groman3
`§ 103(a) Geisser and Groman
`§ 102(b) van Zyl-Smit4
`§ 103(a) van Zyl-Smit and Funk5
`
`
`1 Geisser et al. (“Geisser”), WO 2004/037865 A1, published May 6, 2004
`(Ex. 1002). Note that Ex. 1003 is the English language translation of
`Ex. 1002, and that US Patent No. 7,612,109 B2 (Ex. 1014) is the resulting
`patent of the U.S. National Stage application of Ex. 1002.
`2 Petitioner’s challenge of claim 28 is now moot in view of Patent Owner’s
`disclaimer of claims 28 and 29. Paper 52.
`3 Groman et al. (“Groman”), US 2003/0232084 A1, published Dec. 18, 2003
`(Ex. 1004).
`4 R. van Zyl-Smit & J. A. Halkett (“van Zyl-Smit”), Experience with the Use
`of an Iron Polymaltose (Dexrin) Complex Given by Single Total Dose
`Infusion to Stable Chronic Haemodialysis Patients, 92 NEPHRON 316–323
`(2002) (Ex. 1006).
`5 F. Funk, G. J. Long, D. Hautot, R. Büchi, I. Christl & P. G. Weidler
`(“Funk”), Physical and Chemical Characterization of Therapeutic Iron
`Containing Materials: A Study of Several Superparamagnetic Drug
`Formulations with the ß-FeOOH or Ferrihydrite Structure, 136 HYPERFINE
`INTERACTIONS 73–95 (2001) (Ex. 1026).
`
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`In addition, Petitioner relies on the Declaration of Dr. Robert
`
`Linhardt (Ex. 1005). Patent Owner relies on the Corrected
`Declaration Dr. Adriana Manzi (Ex. 2080).6
`
`II. ANALYSIS
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. See 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016)
`(upholding the use of the broadest reasonable interpretation standard).
`Under that standard, we presume that a claim term carries its “ordinary and
`customary meaning,” which “is the meaning that the term would have to a
`person of ordinary skill in the art in question” at the time of the invention.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007); see also
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016) (“Under
`a broadest reasonable interpretation, words of the claim must be given their
`plain meaning, unless such meaning is inconsistent with the specification
`and prosecution history.”). Any special definition for a claim term must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner offers explicit constructions of several claim terms (Pet. 11‒
`14), as does Patent Owner (PO. Resp. 5‒15). We determine only the
`
`
`6 The corrected Declaration of Dr. Manzi was filed also by Petitioner as
`Exhibit 1053. Note that Exhibit 1053 differs from the corrected Declaration
`of Dr. Manzi of Exhibit 2080 at least at paragraph 43, as Exhibit 1053 has
`hand-written changes made to the text of the Declaration.
`
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`following claim term requires explicit construction for purposes of this
`Decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
`1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent
`necessary to resolve the controversy.’”) (quoting Vivid Techs, Inc. v. Am.
`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`1.
`“substantially non-immunogenic carbohydrate component”
`The challenged claims require that “the iron carbohydrate complex
`has a substantially non-immunogenic carbohydrate component.” Petitioner
`argues that the broadest reasonable interpretation of “substantially non-
`immunogenic carbohydrate component” is a carbohydrate component
`resulting in a “low risk of anaphylactoid/hypersensitivity reactions.” Pet. 13
`(citing Ex. 1001, 11:5, 15:16–44). Petitioner asserts that this “does not
`necessarily mean that the iron carbohydrate complex is also substantially
`non-immunogenic in view of the specification, which consistently considers
`separately the immunogenicity of the carbohydrate and the iron complex of
`which it is a part.” Id. (citing Ex. 1001, 3:17‒24, 10:58‒11:5).
`Patent Owner responds that in the related proceeding, IPR2015-01493
`(Paper 11, 7), we construed this term as “a carbohydrate component
`resulting in a ‘low risk of anaphylactoid/hypersensitivity reactions.’” PO
`Resp. 6‒7. Patent Owner asserts, however, that our construction does not
`indicate the meaning of “low risk.” Id. at 7.
`
`Patent Owner interprets “the term ‘substantially nonimmunogenic’ as
`requiring an incidence of adverse events lower than iron dextran.” Id.
`Relying on Fishbane,7 which was cited in the ’702 patent, Patent Owner
`
`
`7 S. Fishbane (“Fishbane”), Safety In Iron Management, 41 AM. J. KIDNEY
`DIS. S18–S26 (2003) (Ex. 2012).
`
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`argues that “the term ‘substantially non-immunogenic’ should mean an
`incidence level of adverse events lower than that exhibited by iron dextran,
`i.e., lower than 0.6%.” Id. at 7‒8 (citing Ex. 2080 ¶ 21‒22).
`Petitioner argues that Patent Owner’s construction of “low risk” is
`based on the complex as a whole, rather than just the carbohydrate
`component, as Fishbane related to iron dextran complexes. Reply 10. We
`agree with Petitioner that the language of the term “substantially non-
`immunogenic carbohydrate component” itself only requires an assessment of
`the immunogenicity of the carbohydrate component, and disagree with
`Patent Owner that the claims require an assessment of the immunogenicity
`of the iron carbohydrate complex as a whole.
`In that regard, we note that the Specification of the ’702 patent
`supports our construction that the “substantially non-immunogenic
`carbohydrate component” is limited to the carbohydrate component as
`opposed to the iron carbohydrate complex as a whole. Specifically, the
`Specification teaches in the background section that previously available
`iron dextran products suffered from a “high incidence of anaphylactoid
`reactions . . . believed to be caused by the formation of antibodies to the
`dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose
`and iron gluconate) do not contain the dextran moiety, and the incidence of
`anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see
`also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross
`reactivity with anti-dextran antibodies”). Moreover, the language of
`independent claim 1 itself does not require a non-immunogenic complex, but
`only specifies that the “iron carbohydrate complex has a substantially non-
`immunogenic carbohydrate component.”
`
`10
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`
`Moreover, we decline to limit the term “substantially non-
`
`immunogenic carbohydrate complex” to require an incidence level of lower
`than 0.6%. Rather, what is supported by the claim language and the
`Specification is a low risk such that the incidence of adverse events of the
`carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel
`for Patent Owner acknowledging that Fishbane was not incorporated by
`reference, and that it was only cited as a “see generally”).
`
`Patent Owner argues further that the term “substantially non-
`immunogenic carbohydrate component” requires administration to “a cohort
`large enough to reveal adverse events.” PO Resp. 9‒10. Patent Owner
`contends that “to learn whether . . . an iron carbohydrate complex has a
`‘substantially non-immunogenic carbohydrate component’ requires
`administration to a sample size sufficient to reveal adverse immune effects
`were they to arise.” Id. at 9. Thus, Patent Owner construes “the term
`‘substantially nonimmunogenic carbohydrate component’ as a carbohydrate
`component having an ‘incidence rate of anaphylactoid/hypersensitivity
`reactions lower than that for dextran, when administered to a cohort large
`enough to reveal adverse events.’” Id. at 10.
`
`Petitioner contends that “there are no working examples supporting
`most of the carbohydrates listed in the ‘702 patent claims, let alone a ‘large
`cohort.’” Reply 10‒11.
`We decline to construe “substantially non-immunogenic carbohydrate
`complex” as requiring administration to a large enough cohort to reveal
`adverse effects, as there is nothing in the Specification of the ʼ702 patent
`that teaches or suggests that a minimum sample size in order to determine
`whether the iron carbohydrate complex has a substantially non-
`
`11
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`IPR2015-01490
`Patent 7,754,702 B2
`
`immunogenic carbohydrate component. See also Tr. 56 (counsel for Patent
`Owner acknowledging that a required cohort size “is not discussed by the
`Specification”).
`Thus, we construe “substantially non-immunogenic carbohydrate
`component” as a “carbohydrate component resulting in a low risk of
`anaphylactoid/hypersensitivity reactions, wherein a low risk is an incidence
`of adverse events lower than dextran.”
`B.
`Level of Ordinary Skill in the Art
`Petitioner asserts that the ordinary artisan “would hold at least a
`bachelor’s level degree in chemistry or biochemistry with some related post-
`graduate experience (academic or industrial) in the area of carbohydrates
`and their metal complexes.” Pet. 14 (citing Ex. 1005 ¶ 6).
`Patent Owner disagrees with Petitioner’s characterization of the level
`of skill in the ordinary artisan, contending that “some related post-graduate
`experience” may only be “a year or two or three working in an academic or
`industrial environment.” PO Resp. 4‒5 (quoting Ex. 2056, 24:8‒10). Patent
`Owner argues that as the challenged claims are drawn to a method of
`treatment, the ordinary artisan would have some relevant academic or
`industry experience in the production or administration of biologics. Id. at 5
`(citing Ex. 2080 ¶ 17).
`
`We do not find a significant different between the requirements for
`the ordinary artisan proposed by Petitioner and Patent Owner. We agree
`with Petitioner (Pet. 14) that the best evidence of the level of skill in the art
`are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350,
`1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either
`Petitioner’s or Patent Owner’s characterization of the level of skill in the art.
`
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`Moreover, we note that the result of the analysis regarding the patentability
`of the claims would be the same under the requirements for the ordinary
`artisan proposed by either Petitioner or Patent Owner.
`C.
`Patentability
`1.
`Principles of Law
`To prevail on its challenges to the patentability of claims, Petitioner
`must prove unpatentability by a preponderance of the evidence. 35 U.S.C.
`§ 316(e); 37 C.F.R. § 42.1(d). That is, in an inter partes review, the burden
`of persuasion is on the petitioner to prove unpatentability, and that burden
`never shifts to the patent owner. See 35 U.S.C. § 316(e); Dynamic
`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir.
`2015).
`
`Anticipation
`a.
`In order for a prior art reference to serve as an anticipatory reference,
`it must disclose every limitation of the claimed invention, either explicitly or
`inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). We must
`analyze prior art references as a skilled artisan would. See Scripps Clinic &
`Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991),
`overruled on other grounds by Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282
`(Fed. Cir. 2009) (stating that to anticipate, “[t]here must be no difference
`between the claimed invention and the reference disclosure, as viewed by a
`person of ordinary skill in the field of the invention”).
`b.
`Obviousness
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
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`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`The level of ordinary skill in the art usually is evidenced by the references
`themselves. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re
`Oelrich, 579 F.2d 86, 91 (CCPA 1978).
`Prior art references must be “considered together with the knowledge
`of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475,
`1480 (Fed. Cir. 1994) (quoting In re Samour, 571 F.2d 559, 562 (CCPA
`1978)). Moreover, “it is proper to take into account not only specific
`teachings of the reference but also the inferences which one skilled in the art
`would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
`825, 826 (CCPA 1968). That is because an obviousness analysis “need not
`seek out precise teachings directed to the specific subject matter of the
`challenged claim, for a court can take account of the inferences and creative
`steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S.
`at 418; see In re Translogic Tech., Inc., 504 F.3d. at 1259.
`2. Anticipation of Claim 1 under 35 U.S.C. § 102(b) Over
`Geisser
`Petitioner contends that claims 1–3, 10‒13, 23, 25–27, and 41–43 are
`unpatentable as being anticipated by Geisser. Pet. 22–39. With the
`exception of claim 26, we instituted trial on this basis for each of these
`claims. Dec. Inst. 6–11; 19.
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`
`Petitioner sets forth claim charts demonstrating where each element of
`the claims is taught by the reference (Pet. 26–39), and relies on the
`Declaration of Dr. Robert Linhardt (Ex. 1005) to support its anticipation
`challenge.
`Patent Owner disagrees with Petitioner’s assertions (PO Resp. 15–18),
`and relies on the Corrected Declaration of Dr. Adriana Manzi (Ex. 2080) as
`evidence that each limitation of the challenged claims is not taught by
`Geisser.
`
`Geisser (Ex. 1002, Ex. 1003 (as translated))
`a.
`Geisser discloses “a water-soluble iron-carbohydrate complex
`obtained from an aqueous iron(III)-salt solution and an aqueous solution of
`the product obtained by oxidizing one or several maltodextrins with an
`aqueous hypochlorite solution at an alkaline pH value” and “a method for
`the production of said complex and medicaments for the treatment and
`prophylaxis of iron deficiencies.” Ex. 1003, Abstract.
`As taught by Geisser, medications containing iron carbohydrate
`complexes “are suitable . . . in the prophylaxis or therapy of iron-deficiency
`anemia” and are “particularly suitable for parenteral use.” Id. at 1:5‒8.8
`Geisser discloses that such iron carbohydrate complexes have the advantage
`of “low toxicity and a reduced risk of anaphylactic shock.” Id. at 8:9; see
`also id. at 1:27‒28 (noting that the preparation “is supposed . . . to prevent
`the dangerous anaphylactic shocks that can be induced by dextran.”).
`Geisser teaches also that, in view of the stability of the iron carbohydrate
`
`
`8 Unless otherwise indicated, the page numbers of the Exhibits refer to the
`page numbers of the exhibit itself, and not the page numbers added by the
`parties.
`
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`complexes, it is possible to administer medications containing the complexes
`as a single dose of 500 mg to 1000 mg, over the course of an hour. Id. at
`8:16‒17.
`
`Analysis
`b.
`Petitioner asserts that Geisser discloses all the limitations of
`independent claim 1. Pet. 22–27. Specifically, Petitioner contends that
`Geisser teaches iron carboxymaltose complexes, and their use in treating
`iron deficiency anemia. Id. at 23 (citing Ex. 1003, Abstract, 1:4‒7, 2:4‒9,
`7:30‒31). Moreover, Petitioner contends that Geisser teaches administering
`iron carbohydrate complexes as a single dose of 500‒1000 mg of iron, and
`teaches that the complexes have low toxicity and a reduced danger of
`anaphylactic shock. Id. at 23 (citing Ex. 1003, 1: 26‒2:1, 8:7‒10, 8:14‒17).
`One of the specific iron carbohydrate complexes recited in claim 1 is
`an “iron carboxymaltose complex,” which Petitioner contends is disclosed
`by Geisser, despite “the term ‘carboxymaltose’ [] not [being] used by
`Geisser.” Id. at 17. Petitioner asserts that “Geisser teaches iron
`carboxymaltose as disclosed and claimed in the ʼ702 patent” because “the
`ʼ702 patent describes, as a preferred embodiment, the preparation of iron
`carboxymaltose via oxidation of maltodextrins using language that tracks
`(almost verbatim) that of Geisser (without referencing Geisser).” Id. at 17–
`18 (citing Ex. 1005 ¶ 10).
`In his Declaration, Dr. Robert Linhardt considers “Geisser to disclose
`carboxymaltose, iron carboxymaltose complexes, and methods for making
`iron carboxymaltose complexes.” Ex. 1005 ¶ 9. In the Declaration, Dr.
`Linhardt considers “an iron carboxymaltose complex to be a complex
`between carboxymaltose and iron.” Id. ¶ 8. Dr. Linhardt further considers
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`“the carboxymaltose as defined in the ’702 patent a maltose or maltodextrin,
`comprised of maltose type units, in which the aldehyde group of the
`reducing sugar end has been oxidized to form a carboxylic acid group.” Id.
`Patent Owner’s expert, Dr. Manzi, agrees with Dr. Linhardt’s description of
`carboxymaltose. Ex. 2080 ¶ 32.
`Petitioner notes further that the U.S. equivalent of Geisser, U.S. Patent
`No. 7,612,109 B2 (Ex. 1014), is cited along with the ’702 patent “in the
`F.D.A. Orange Book as covering Injectafer® (a.k.a. VIT-45).” Id. at 17
`(citing Ex. 1012). In his Declaration, Dr. Linhardt notes that “Geisser
`describes, in [the] working examples, the way to make and use iron
`carboxymaltose having the chemical name . . . as recited in claim 27” of the
`ʼ702 patent. Ex. 1005 ¶ 13. The chemical species recited in claim 27 of the
`ʼ702 patent is also known as “VIT-45.” Ex. 1001, 5:16–18, 11:37–40.
`Regarding the properties of Geisser’s iron carbohydrate complexes,
`Petitioner asserts that “Geisser discloses that the iron carbohydrate
`complexes have low toxicity and reduced danger of anaphylactic shock.”
`Pet. 23 (citing Ex. 1003, 3:26–4:1). In the Declaration, Dr. Linhardt
`“consider[s] the iron carboxymaltose complexes described in Geisser to be
`identical or nearly identical to iron carboxymaltose complex embodiments of
`the ʼ702 patent, both in terms of synthetic methods and chemical properties.”
`Ex. 1005 ¶ 10. In the Declaration, Dr. Linhardt further considers that
`because “anti-dextran antibodies [] specifically recognize dextran (a
`primarily α-1-6 linked oligomer or polymer of glucose), [he] would not
`expect an anti-dextran antibody to cross-react with iron carboxymaltose, in
`which the carbohydrate is a primarily α-1-4 linked oligomer or polymer of
`glucose.” Id. at ¶ 8.
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`Dr. Linhardt notes further that “the iron carboxymaltose complexes
`described by Geisser fall within” the molecular weight ranges disclosed in
`the ʼ702 patent, and that “Geisser describes a general synthetic method that
`is nearly identical to the method described in the ʼ702 patent.” Id. at ¶ 10.
`Thus, for the reasons discussed in this Decision and as set forth in the
`Petition (Pet. 22–27), we find that Petitioner has demonstrated by a
`preponderance of the evidence that Geisser teaches all the limitations of
`claim 1, either inherently or explicitly. That is, we agree with Petitioner that
`Geisser teaches a method of treating a disease characterized by an iron
`deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract,
`1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of
`administering an iron carbohydrate complex, that is, iron carboxymaltose, in
`a single dosage form of at least 0.6 grams of elemental iron, as Geisser
`teaches administering iron carbohydrate complexes as a single dose of 500‒
`1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17).
`In that regard, we credit the testimony of Dr. Linhardt that Geiser
`discloses iron carboxymaltose, and that Geisser describes a general synthetic
`method that is nearly identical to the method described in the ʼ702 patent.
`Ex. 1005 ¶¶ 8‒10, 13.
`
`In addition, as Geisser teaches one of the iron carbohydrate complexes
`explicitly recited by claim 1, that is, iron carboxymaltose, it would
`inherently meet the limitation that the carbohydrate component is
`substantially non-immunogenic and would have substantially no cross-
`reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed.
`Cir. 1990) (“Products of identical chemical composition can not have
`mutually exclusive properties.”). The teachings of Geisser support that
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`finding, as Geisser specifically teaches that the complexes have low toxicity
`and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒
`2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron
`carboxymaltose complex (e.g., VIT-45) generally does not contain dextran
`and [it] does not react with dextran antibodies.”).
`We have considered Patent Owner’s arguments in finding that
`Petitioner has demonstrated by a preponderance of the evidence that
`challenged claim 1 is anticipated by Geisser, but do not find them persuasive
`for the reasons discussed below.
`Patent Owner contends that Petitioner has not demonstrated that
`Geisser teaches an iron carbohydrate complex having “a substantially non-
`immunogenic carbohydrate component and substantially no cross reactivity
`with anti-dextran antibodies” as recited in independent claim 1. PO Resp.
`15–17. Patent Owner argues that “Geisser does not specifically discloses
`these properties” and that “Petitioner has not sufficiently demonstrated how
`the complexes of Geisser would have a ‘substantially non-immunogenic
`carbohydrate component’.” Id. at 15, 17.
`We are not persuaded by Patent Owner’s argument. Patent Owner
`does not dispute that Geisser discloses an iron carboxymaltose complex, and
`as we noted in our Decision instituting inter partes review, a disclosure of a
`specific iron carbohydrate complex such as iron carboxymaltose is likewise
`a disclosure of its inherent properties. Dec. Inst. 8. In contrast, as discussed
`above, Petitioner has pointed to Geisser’s teachings regarding the properties
`of the iron carbohydrate complexes taught therein, which would necessarily
`include the claimed iron carboxymaltose complex. Specifically, Geisser’s
`complexes exhibit “reduced toxicity and [] prevent[] the dangerous
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`anaphylactic shocks that can be induced by dextran.” Ex. 1003, 1:26–28.
`Petitioner has also identified similarities between Geisser’s process of
`preparing iron carboxymaltose and that which is disclosed in the ʼ702 patent,
`noting that the process disclosed in the ʼ702 patent specification for “the
`preparation of iron carboxymaltose via oxidation of maltodextrins [uses]
`language that tracks (almost verbatim) that of Geisser (without referencing
`Geisser).” Pet. 17–18. Petitioner also has pointed to the working examples
`of Geisser which disclose methods for making and us