`571.272.7822
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` Paper No. 11
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` Entered: December 29, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AUROBINDO PHARMA USA INC.,
`Petitioner,
`
`v.
`
`ANDRX LABS, LLC,
`Patent Owner.
`____________
`
`Case IPR2017-01673
`Patent 6,790,459 B1
`____________
`
`
`Before SUSAN L.C. MITCHELL, TINA E. HULSE, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`IPR2017-01673
`Patent 6,790,459 B1
`
` INTRODUCTION
`Aurobindo Pharma USA Inc. (“Petitioner”) filed a Corrected Petition
`requesting an inter partes review of claims 1–21 of U.S. Patent No.
`6,790,459 B1 (Ex. 1001, “the ’459 patent”). Paper 8 (“Pet.”). Andrx Labs,
`LLC (“Patent Owner”) filed a Preliminary Response to the Petition.
`Paper 10 (“Prelim. Resp.”).
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the Petition and Preliminary Response, we determine that Petitioner has not
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–21 of the ’459 patent. Accordingly, we decline
`to institute an inter partes review of those claims.
`Related Proceedings
`A.
`The ’459 patent has been asserted against Petitioner in pending district
`court case Shionogi Inc. v. Aurobindo Pharma Ltd., No. 1:17-cv-00072-
`UNA (D. Del.). Pet. 11–12; Paper 6, 4.
`The ’459 Patent
`B.
`The ’459 patent relates to a method for treating patients with non-
`insulin-dependent diabetes mellitus (NIDDM) by administering a controlled
`release oral dosage form containing preferably a biguanide drug such as
`metformin on a once daily basis. Ex. 1001, Abstract. Metformin is an oral
`antihyperglycemic drug that improves glucose tolerance in NIDDM patients
`by lowering both basal and postprandial plasma glucose. Id. at 1:57–62.
`Metformin hydrochloride is marketed as Glucophage, for which there is no
`fixed dosage regimen for managing hyperglycemia in diabetes mellitus. Id.
`
`2
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`IPR2017-01673
`Patent 6,790,459 B1
`at 1:62–67. Glucophage dosing is individualized based on both
`effectiveness and tolerance, while not exceeding the maximum
`recommended dose of 2550 mg per day. Id. at 1:67–2:3.
`Metformin is a short acting drug that requires dosing two or three
`times a day. Id. at 2:5–7. Metformin use, however, is often associated with
`gastrointestinal adverse side effects, which may be partially avoided by
`either reducing the initial and/or maintenance dose or using an extended
`release dosage form. Id. at 2:7–12. An advantage of using an extended
`release dosage form is reducing the frequency of administration. Id. at 2:12–
`14.
`
`The ’459 patent states that vast amounts of research have been
`performed on controlled or sustained release compositions, but very little
`research has been performed on controlled or sustained release compositions
`that employ antihyperglycemic drugs. Id. at 1:51–55. Thus, according to
`the specification, “an extended-release dosage form of metformin may
`improve the quality of therapy in patients with N[I]DDM and the safety
`profile relative to a conventional dosage form.” Id. at 2:15–17.
`Illustrative Claim
`C.
`Petitioner challenges claims 1–21 of the ’459 patent, of which
`claim 1 is the only independent claim. Claim 1 is representative and
`is reproduced below:
`1. A method for lowering blood glucose levels in human
`patients needing treatment for non-insulin-dependent diabetes
`mellitus (NIDDM), comprising orally administering to human
`patients on a once-a-day basis at least one oral controlled release
`dosage form comprising an effective dose of metformin or a
`pharmaceutically acceptable salt thereof and an effective amount
`of a controlled release carrier to control the release of said
`metformin or pharmaceutically acceptable salt thereof from said
`
`3
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`IPR2017-01673
`Patent 6,790,459 B1
`dosage form, wherein following oral administration of a single
`dose, the dosage form provides a mean time to maximum plasma
`concentration (Tmax) of metformin at from 5.5 to 7.5 hours after
`administration following dinner; and the administration of the at
`least one metformin dosage form provides a mean AUC0-24 of
`22590±3626 ng.hr/ml and a mean Cmax of 2435±630 ng/ml on the
`first day of administration and a mean AUC0-24 of 24136±7996
`ng.hr /ml and a mean Cmax of 2288±736 n[g]/ml on the 14th day of
`administration, for administration of a 2000 mg once-a-day dose of
`metformin.
`Ex. 1001, 22:13–30.
`Dependent claims 2–10, 12, and 13 further limit the
`pharmacokinetic parameters of claim 1. Dependent claims 11 and 17–
`21 further limit the dose of metformin. Dependent claims 14 and 15
`further recite administering at least one additional pharmaceutically
`active ingredient for treatment of NIDDM. And dependent claim 16
`requires that the dose of metformin comprises metformin
`hydrochloride. Id. at 22:31–24:32.
`
`4
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`IPR2017-01673
`Patent 6,790,459 B1
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–21 of the
`’459 patent on the following grounds:
`Reference(s)
`Basis
`Chen1
`§ 102
`
`Claims challenged
`1–21
`
`Cheng,2 Timmins,3 Tucker,4
`and Lewis5
`
`§ 103
`
`1–21
`
`Petitioner also relies on the Declaration of Dr. Fatemah Akhlaghi, Pharm.D.,
`Ph.D. Ex. 1009.
`
` ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art as of
`November 3, 2000, would have had “experience in the research or
`development of pharmaceuticals and have the ability to gather and interpret
`pharmacokinetic data, as well as understand the relationship between drug
`release from a dosage form and its effect on pharmacokinetic parameters.”
`Pet. 15; Ex. 1009 ¶ 70. Petitioner further asserts that a person of ordinary
`skill in the art would include “an individual with a Pharm.D. and/or Ph.D.
`with experience in pharmaceutical sciences, dosage form design, clinical
`pharmacology or related fields such as pharmacology.” Pet. 15; Ex. 1009
`
`
`1 Chen et al., WO 00/12097, published Mar. 9, 2000 (“Chen,” Ex. 1011).
`2 Cheng et al., WO 99/47125, published Sept. 23, 1999 (“Cheng,” Ex. 1002).
`3 Timmins et al., WO 99/47128, published Sept. 23, 1999 (“Timmins,”
`Ex. 1013).
`4 Tucker et al., Metformin Kinetics in Healthy Subjects and in Patients with
`Diabetes Mellitus, 12 BR. J. CLIN. PHARMAC. 235–46 (1981) (“Tucker,”
`Ex. 1005).
`5 Lewis et al., WO 00/28989, published May 25, 2000 (“Lewis,” Ex. 1003).
`5
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`IPR2017-01673
`Patent 6,790,459 B1
`¶ 70. Moreover, Petitioner contends that a skilled artisan would have had
`access to other skilled individuals with experience in the field of diabetes
`treatment. Pet. 15; Ex. 1009 ¶¶ 70–73.
`Patent Owner contends that a person of ordinary skill in the art would
`have been a person with “a degree in pharmacy, chemistry, chemical
`engineering, or a related field with at least three to five years of
`pharmacokinetics, biopharmaceutics, medicinal chemistry, pre-formulation,
`or formulation experience, research or training.” Prelim. Resp. 16. Patent
`Owner further states that such a person would have been familiar with “the
`methods used in formulating oral dosage forms, modified release dosage
`forms, and osmotic delivery, and have an understanding of the fundamental
`principles as to how osmotic dosage forms behave and function.” Id. at 16–
`17.
`
`Although Patent Owner provides its own definition of the level of
`ordinary skill in the art, it does not address how its definition differs from
`that of Petitioner. Having considered the arguments, we do not discern a
`significant difference in the parties’ respective definitions of the level of
`ordinary skill in the art. Both parties contend that a person of ordinary skill
`in the art would have had experience with and knowledge of formulating
`oral dosage forms. To the extent Patent Owner specifies knowledge
`regarding osmotic dosage forms, we understand Petitioner’s definition to
`include such knowledge. Thus, on this record, we determine it is
`unnecessary to resolve any perceived differences in the parties’ definitions
`of the level of ordinary skill in the art, as any distinction does not impact our
`Decision. We further note that the prior art itself demonstrates the level of
`skill in the art at the time of the invention. See Okajima v. Bourdeau, 261
`F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
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`IPR2017-01673
`Patent 6,790,459 B1
`ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown”) (quoting Litton
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`1985)).
`
`Claim Construction
`B.
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R. § 100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming
`applicability of broadest reasonable construction standard to inter partes
`review proceedings). Under that standard, and absent any special
`definitions, we generally give claim terms their ordinary and customary
`meaning, as would be understood by one of ordinary skill in the art at the
`time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth
`with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30
`F.3d 1475, 1480 (Fed. Cir. 1994).
`The parties disagree as to the meaning of the word “membrane.”
`Pet. 22; Prelim. Resp. 17–19. We note, however, that the word “membrane”
`does not appear in the claims of the ’459 patent and, thus, does not require
`construction for the purposes of this decision. As for the remaining terms
`proposed by Petitioner, the parties appear to agree on the constructions of
`those terms at this stage of the proceeding. Pet. 18–23; Prelim. Resp. 19–20.
`Accordingly, we determine that it is unnecessary to expressly construe any
`claim terms for purposes of this decision. See 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
`
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`Patent 6,790,459 B1
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999)).
`
`Anticipation by Chen
`C.
`Petitioner asserts that claims 1–21 of the ’459 patent are anticipated
`by Chen. Pet. 30–38. Patent Owner opposes Petitioner’s assertion. Prelim.
`Resp. 21–23. On this record, we determine that Petitioner has not
`established a reasonable likelihood that it would prevail in showing claims
`1–21 are anticipated by Chen.
` Chen (Ex. 1011)
`1.
`Chen is a published International Patent Application relating to a
`controlled release pharmaceutical tablet containing a hypoglycemic drug and
`an antihyperglycemic drug. Ex. 1011, Abstract. Biguanides are the
`preferred antihyperglycemic drugs and sulfonylureas are the preferred
`hypoglycemic drugs. Id. at 1:10–14.6
`Analysis
`2.
`Petitioner asserts that Chen is prior art to the ’459 patent under
`35 U.S.C. § 102. Pet. 14, 30. Patent Owner, however, argues that Chen
`does not qualify as prior art under pre-AIA 35 U.S.C. § 102. Prelim. Resp.
`21–23. Although Petitioner does not specify under which subsection of
`§ 102 it contends Chen is prior art, we agree with Patent Owner that Chen
`does not qualify as prior art to the ’459 patent under any part of § 102.
`Section 102(a) requires that a printed publication describes the work
`of another. § 102(a) (“the invention was known or used by others in this
`country, or . . . described in a printed publication”); see also In re Katz, 687
`
`6 Like the parties, and unless stated otherwise, we cite to the original page
`numbers of the exhibits rather than the page numbers provided pursuant to
`37 C.F.R. § 42.63(d)(2)(i).
`
`8
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`Patent 6,790,459 B1
`F.2d 450, 454 (CCPA 1982) (“[O]ne’s own work is not prior art under
`§102(a) even though it has been disclosed to the public in a manner or form
`which otherwise would fall under § 102(a).”). The inventive entity of Chen
`is the same as that of the ’459 patent: Chih-Ming Chen, Xiu Cheng, Joseph
`Chou, and Steve Jan. Compare Ex. 1011, [72] with Ex. 1001, [75]. Absent
`evidence to the contrary, which has not been submitted here, we find that
`Chen is not work “by others” and does not qualify as prior art under
`§ 102(a).
`Section 102(b) requires that the invention be described in a printed
`publication more than one year before the effective date of the patent. The
`’459 patent was filed on November 3, 2000. Ex. 1001, [22]. Chen was
`published less than one year before that on March 9, 2000.7 Ex. 1011, [43].
`Chen, therefore, does not qualify as prior art under § 102(b).
`Section 102(e) does not apply to international publications filed
`before November 29, 2000. 35 U.S.C. § 102(e) (2002). Chen was filed on
`August 31, 1999. Ex. 1011, [22]. Regardless, even if § 102(e) applied to the
`Chen application, Chen does not describe an invention “by another,” as
`explained above. Accordingly, we find that Chen does not qualify as prior
`art under § 102(e).
`Finally, we do not find any evidence on the record—nor does
`Petitioner argue—that § 102(c) (abandonment), § 102(d) (prior foreign
`patent), § 102(f) (derivation), or § 102(g) (interference) applies to Chen.
`
`
`7 We note that in IPR2017-01648, Petitioner asserts that Chen is prior art
`under § 102(a), as it admits that Chen was published on March 9, 2000.
`IPR2017-01648, slip op. at 13 (PTAB July 18, 2017) (Paper 8).
`9
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`Patent 6,790,459 B1
`Accordingly, we determine Petitioner has not established a reasonable
`likelihood that it would prevail in its assertion that claims 1–21 are
`anticipated by Chen.
`D. Obviousness over Cheng, Timmins, Tucker, and Lewis
`Petitioner asserts that claims 1–21 of the ’459 patent are unpatentable
`as obvious over Cheng, Timmins, Tucker, and Lewis. Pet. 38–58. Patent
`Owner opposes Petitioner’s assertion. Prelim. Resp. 23–32. On this record,
`we determine that Petitioner has not established a reasonable likelihood that
`it would prevail in showing any of the claims are unpatentable over the cited
`references.
`
`Cheng (Ex. 1002)
`1.
`Cheng relates to a “controlled release antihyperglycemic tablet that
`does not contain an expanding polymer and comprising a core containing the
`antihyperglycemic drug, a semipermeable membrane coating the core and at
`least one passageway in the membrane.” Ex. 1002, Abstract. The ’459
`patent refers to Cheng, stating “[o]ur own WO 99/47125 discloses controlled
`release metformin formulations providing a Tmax from 8 to 12 hours.”
`Ex. 1001, 2:48–49. For example, Figure 8 of Cheng shows a Tmax of 10
`hours for a controlled release tablet containing 850 mg metformin
`hydrochloride administered shortly after dinner. Ex. 1002, 15:37–39, Fig. 8.
`Timmins (Ex. 1013)
`2.
`Timmins relates to an extended release dosage form for highly water
`soluble drugs, such as metformin. Ex. 1013, 1:5–8. The dosage form also
`prolongs gastric residence, which enables efficient delivery of drugs
`normally absorbed in the upper gastrointestinal tract. Id. at 1:8–10.
`According to one example, Timmins teaches a Tmax range of 4–8 hours, with
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`10
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`IPR2017-01673
`Patent 6,790,459 B1
`a median Tmax of 5 hours, for a single 1000 mg dose taken immediately after
`dinner. Id. at 34:11–29.
`
`Tucker (Ex. 1005)
`3.
`Tucker describes a study of the kinetics of metformin after
`intravenous and oral administration in healthy subjects and after oral
`administration in NIDDM patients. Ex. 1005, Abstract. The patients in
`Group II consisted of four newly diagnosed NIDDM patients. Id. at 236.
`The patients received a single 1.0 g oral dose of Glucophage followed 3 days
`later by continuous oral dosing of 0.5 g twice a day. Id. Metformin
`concentrations were determined in serial plasma samples up to 24 hours and
`in plasma samples during days 7 and 14 of continuous twice daily dosing.
`Id.
`
`Lewis (Ex. 1003)
`4.
`Lewis relates to a modified release pharmaceutical composition for
`treating diabetes mellitus comprising an insulin sensitizer and another
`antidiabetic agent. Ex. 1003, Abstract. Examples of other antidiabetic
`agents include an alpha glucosidase inhibitor, a biguanide (such as
`metformin), or an insulin secretagogue. Id. at 2:12–13. Lewis states that a
`suitable dosage of metformin is between 100–3000 mg. Id. at 5:13–14.
`Analysis
`5.
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which the
`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;
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`IPR2017-01673
`Patent 6,790,459 B1
`(2) any differences between the claimed subject matter and the prior art; (3)
`the level of skill in the art; and (4) objective evidence of nonobviousness.
`Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`“[A] patent composed of several elements is not proved obvious
`merely by demonstrating that each of its elements was, independently,
`known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” Id. Moreover, a person of ordinary skill in the art must have had a
`reasonable expectation of success of doing so. PAR Pharm., Inc. v. TWi
`Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).
`Regarding claim 1, Petitioner asserts that the osmotic dosage forms of
`Cheng have an identical composition to the tablet osmotic dosage forms
`claimed in the ’459 patent. Pet. 40–41 (citing Ex. 1009 ¶¶ 154–156).
`According to Petitioner, the only difference between the tablets of Cheng
`and the ’459 patent is that Cheng teaches one laser-drilled hole, while the
`tablet of the ’459 patent comprises two laser-drilled holes. Id. (citing Ex.
`1009 ¶ 155). Petitioner then compares the release rates for the Cheng and
`’459 patent tablets, asserting that the comparisons “demonstrate the high
`degree of similarity of the dosage forms.” Id. at 41–43 (citing Ex. 1009
`¶ 159). Petitioner further alleges that because the Tmax will inherently
`depend on the release rate of metformin from the dosage form, and because
`all other elements of the tablets are identical, “given the similarities of the in
`vitro release rates of the tablet of [Cheng] and the ’459 patent, the artisan
`would recognize the routine ease of obtaining a Tmax using the dosage form
`of [Cheng] as recited in the claims of the ’459 patent.” Id. at 43 (citing Ex.
`1009 ¶ 161).
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`IPR2017-01673
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`Petitioner also asserts that Cheng describes the release characteristics
`for a controlled release tablet containing 850 mg metformin HCl, including
`the AUC0-24 and Cmax. Id. at 43. Petitioner then contends that a person of
`ordinary skill in the art would expect the AUC and Cmax to be
`“approximately doubled when two 850 mg tablets, that is a 1700 mg dose,
`was administered.” Id. at 44 (citing Ex. 1009 ¶ 166). Because claim 1 of the
`’459 patent recites administration of a 2000 mg once-a-day dose of
`metformin, Petitioner extrapolates the data in Cheng and argues that a
`person of ordinary skill in the art “would expect that administration of two
`1000 mg higher strength tablets formulated according to Cheng[] Example 3
`would produce an AUC0-24 and mean Cmax within the ranges recited in claim
`1 for [the] first day of administration.” Id. at 44–45 (citing Ex. 1009 ¶ 167).
`Moreover, Petitioner contends that any slight difference can be accounted
`for by the second hole drilled in the tablet of the ’459 patent versus the
`single hole in Cheng or a variation in length/width of the holes. Id.
`Regarding the mean AUC0-24 and mean Cmax on the 14th day of
`administration of claim 1, Petitioner relies on Tucker’s teachings of the
`mean plasma concentrations for standard therapy Glucophage after the first
`dose and during days 7 and 14 of continuous treatment. Pet. 45 (citing Ex.
`1005, 243, Fig. 7). Petitioner contends it would have been obvious for a
`person of ordinary skill in the art “to mimic such mean Cmax of
`GLUCOPHAGE on the 14th day of administration in the tablets of the ’459
`patent, such that the mean Cmax range would cover the mean Cmax disclosed
`in Tucker.” Id. Similarly, Petitioner contends that the mean AUC0-24 on day
`14 is about 22,000 ng.hr/ml, which is within the recited limitation of claim 1.
`Id. (citing Ex. 1009 ¶ 169). Thus, Petitioner asserts that “it would have been
`obvious to mimic the AUC0-24 on the 14th day of administration in the tablets
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`IPR2017-01673
`Patent 6,790,459 B1
`of the ’459 patent, such that the mean AUC0-24 matched that disclosed in
`Tucker et al. as GLUCOPHAGE was the gold standard of treatment at the
`time.” Id. at 45–46. Petitioner argues that doing so would have been “easily
`effectuated,” as noted by the Federal Circuit in Sciele Pharma Inc. v. Lupin
`Ltd., 684 F.3d 1253 (Fed. Cir. 2012) (stating “such pharmaceutical
`formulators know that controlled release technologies can be manipulated”).
`Id. at 45–46.
`Having considered Petitioner’s arguments and evidence, we are not
`persuaded that Petitioner has established a reasonable likelihood of
`prevailing on its assertion that claim 1 would have been obvious over the
`combination of Cheng, Timmins, Tucker, and Lewis. Although we agree
`with Petitioner that the formulation of Cheng is similar to dosage forms
`disclosed in the ’459 patent, Petitioner does not persuasively explain why a
`person of ordinary skill in the art would have been motivated to modify
`Cheng to obtain the Tmax, AUC, and Cmax values recited in the claims.
`Instead, Petitioner and its declarant merely state, for example, that a person
`of ordinary skill in the art “would recognize the routine ease of obtaining a
`Tmax using the dosage form of [Cheng] as recited in the claims of the ’459
`patent.” Pet. 43. But, as Patent Owner notes, “simply stating that a [person
`of ordinary skill in the art] could modify the alleged disclosure of Cheng to
`arrive at the Tmax [AUC or Cmax] recited in the present claims does not
`constitute an explanation as to why such a person would be motivated to do
`so.” Prelim. Resp. 25. That is, Petitioner must provide “some articulated
`reasoning with some rational underpinning to support the legal conclusion of
`obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
`We are not persuaded that Petitioner has met its burden, particularly in
`light of the apparent inconsistencies of its arguments. For example,
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`IPR2017-01673
`Patent 6,790,459 B1
`regarding the claimed AUC and Cmax on the first day of administration of
`2000 mg metformin, Petitioner extrapolates the data from Cheng’s single
`850 mg tablet. Petitioner states a person of ordinary skill in the art would
`expect the AUC and Cmax to be approximately doubled when two 850 tablets
`are administered, and further would expect the AUC and Cmax of two 1000
`mg metformin tablets to be higher than that achieved from dosing with two
`850 mg tablets. As such, Petitioner and its declarant, Dr. Akhlaghi,
`conclude that a person of ordinary skill in the art would recognize that the
`Cmax and AUC of two 1000 mg tablets of Cheng would be within the ranges
`recited in claim 1. Pet. 43–44 (citing Ex. 1009 ¶ 67).
`Regarding the claimed Cmax and AUC after the 14th day of
`administration, however, Petitioner asserts that it would have been obvious
`for a person of ordinary skill in the art reading Tucker “to mimic” the mean
`Cmax and AUC of Glucophage. Pet. 45–46 (citing Ex. 1009 ¶¶ 168–169).
`But neither Petitioner nor Dr. Akhlaghi explains why a person of ordinary
`skill in the art would mimic the parameters of Tucker when the dosages of
`Glucophage administered in Tucker differ from the dosage administered in
`claim 1 of the ’459 patent. Specifically, Tucker studies the release data in
`patients who received a single 1.0 g dose of Glucophage on day one,
`followed three days later by 0.5 g Glucophage continuously administered
`twice a day (i.e., 1000 mg per day). Claim 1 recites administration of a 2000
`mg once-a-day dose of metformin. Thus, Tucker describes daily dosages
`that are half that of the dosage recited in claim 1.
`Petitioner, however, does not address the difference in dosages and
`what effect it may have on the pharmacokinetic parameters of the drugs. If
`we were to extend the logic of Petitioner’s argument with respect to Cheng,
`a person of ordinary skill in the art would expect the Cmax and AUC of
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`Tucker to be approximately half that of the 2000 mg composition of claim 1.
`See Pet. 44–45. At best, Petitioner asserts that a person of ordinary skill in
`the art would “mimic” the mean Cmax and AUC of Glucophage because
`Glucophage “was the gold standard of treatment at the time.” Pet. 46. But
`Petitioner cites no objective evidence to support that assertion (including any
`testimony from its declarant). We, therefore, give no weight to Petitioner’s
`assertion, as it has long been held that attorney argument is no substitute for
`record evidence. Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed.
`Cir. 1997) (“[A]rguments of counsel cannot take the place of evidence
`lacking in the record.”) (quoting Knorr v. Pearson, 671 F.2d 1368, 1373
`(CCPA 1982)).
`Even if we were to assume that Glucophage is the gold standard of
`treatment, Dr. Akhlaghi’s testimony fares no better. Dr. Akhlaghi concludes
`that “[i]t would have been obvious to mimic” the parameters of Tucker on
`the 14th day of administration of the ’459 patent tablet. See Ex. 1009
`¶¶ 168–169. But, as explained above, Dr. Akhlaghi fails to explain why a
`person of ordinary skill in the art would want to match the Glucophage Cmax
`and AUC taught by Tucker when the dosage of Glucophage administered by
`Tucker is only half the metformin administered by the claimed method.
`Without such an explanation, we give Dr. Akhlaghi’s testimony little weight.
`See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
`(Fed. Cir. 1985) (finding lack of factual support for expert opinion “may
`render the testimony of little probative value in a validity determination”).
`Taken as a whole, we are not persuaded that Petitioner has shown
`sufficiently that a person of ordinary skill in the art would have combined
`Tucker with Cheng, Timmins, and Lewis to achieve the claimed invention.
`Accordingly, on this record, we determine that Petitioner has not established
`
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`IPR2017-01673
`Patent 6,790,459 B1
`a reasonable likelihood that it would prevail in its assertion that claims 1–21
`of the ’459 patent are unpatentable as obvious over the cited references.
` CONCLUSION
`For the foregoing reasons, we conclude that Petitioner has not
`established a reasonable likelihood of prevailing on its assertion that claims
`1–21 of the ’459 patent are unpatentable.
` ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’459 patent and no trial is instituted.
`
`
`
`
`
`
`17
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`
`
`IPR2017-01673
`Patent 6,790,459 B1
`
`PETITIONER:
`Steven J. Moore
`Hans Peter Hoffmann
`John Winterle
`Alan Gardner
`WITHERS BERGMAN
`steven.moore@withersworldwide.com
`peter.hoffmann@withersworldwide.com
`john.winterle@withersworldwide.com
`alan.gardner@withersworldwide.com
`
`
`PATENT OWNER:
`David L. Cavanaugh
`Jonathan B. Roses
`WILMER CUTLER PICKERING HALE AND DORR LLP
`David.Cavanaugh@wilmerhale.com
`Jonathan.Roses@wilmerhale.com
`
`David A. Chavous
`Chavous Intellectual Property Law LLC
`dchavous@chavousiplaw.com
`
`David A. Giordano
`Wilmer Cutler Pickering Hale and Dorr LLP
`davidg@giordanolawllc.com
`
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