Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 11
`
` Entered: December 29, 2017
`
`
`
`
`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
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 11
`
` Entered: December 29, 2017
`
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`
`
`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
`
`6
`
`
`
`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
`
`7
`
`
`
`IPR2017-01673
`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
`
`
`
`IPR2017-01673
`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
`
`
`
`IPR2017-01673
`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
`
`10
`
`
`
`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;
`
`11
`
`
`
`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).
`
`12
`
`
`
`IPR2017-01673
`Patent 6,790,459 B1
`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
`
`13
`
`
`
`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,
`
`14
`
`
`
`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
`
`15
`
`
`
`IPR2017-01673
`Patent 6,790,459 B1
`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
`
`16
`
`
`
`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
`
`
`
`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
`
`18
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
