`571.272.7822
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` Paper No. 11
` Entered: September 5, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AUROBINDO PHARMA USA INC.,
`Petitioner,
`
`v.
`
`ANDRX CORPORATION, ANDRX LABS, LLC, ANDRX
`LABORATORIES, INC., ANDRX LABORATORIES (NJ), INC., ANDRX
`EU LTD., ANDRX PHARMACEUTICALS, LLC, and TEVA
`PHARMACEUTICAL INDUSTRIES INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00530
`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
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`IPR2018-00503
`Patent 6,790,459 B1
`
`
` INTRODUCTION
`Aurobindo Pharma USA Inc. (“Petitioner”) filed a 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 1 (“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 arguments and evidence, we determine that it is appropriate to exercise
`our discretion to deny institution under 35 U.S.C. § 314(a). Accordingly, we
`decline to institute an inter partes review of the challenged claims of the
`’459 patent.
`
`Related Proceedings
`A.
`Patent Owner has asserted the ’459 patent against Petitioner in a
`pending lawsuit, Shionogi Inc. v. Aurobindo Pharma Ltd., Case No. 1.17-cv-
`00072 (D. Del., filed Jan. 25, 2017). Pet. 11; Paper 7, 3. Patent Owner also
`identifies the pending lawsuit, Shionogi Inc. v. Qingdao Baheal
`Pharmaceutical Co., Civ. No. 1:17-cv-1347-MSG (D. Del., filed Sept. 22,
`2017). Paper 7, 4.
`The parties also note that we denied institution in IPR2017-01673,
`which challenged the same claims of the ’459 patent. Paper 7, 1.
`Additionally, Patent Owner notes Petitioner has filed a petition in IPR2017-
`01648, which challenges the claims of U.S. Patent No. 6,866,866. Id. We
`instituted inter partes review in that proceeding, which is currently pending.
`
`1
`
`
`
`IPR2018-00503
`Patent 6,790,459 B1
`
`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. 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
`
`2
`
`
`
`IPR2018-00503
`Patent 6,790,459 B1
`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 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.
`
`3
`
`
`
`IPR2018-00503
`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 ground:
`References
`Cheng,1 Timmins,2 Wagner,3
`Lewis,4 Gibaldi,5 and
`DeFronzo6
`
`Claims challenged
`1–21
`
`Basis
`§ 103
`
`Petitioner also relies on the Declaration of Dr. Fatemah Akhlaghi,
`Pharm.D., Ph.D. Ex. 1009.
`
` ANALYSIS
`IPR2017-01673
`A.
`On June 23, 2017, Petitioner filed a petition seeking inter partes
`review of claims 1–21 of the ’459 patent on the following grounds:
`
`
`1 Cheng et al., WO 99/47125, published Sept. 23, 1999 (“Cheng,” Ex. 1002).
`2 Timmins et al., WO 99/47128, published Sept. 23, 1999 (“Timmins,”
`Ex. 1013).
`3 John G. Wagner, Fundamentals of Clinical Pharmacokinetics (1st ed.
`1975) (“Wagner,” Ex. 1019).
`4 Lewis et al., WO 00/28989, published May 25, 2000 (“Lewis,” Ex. 1003).
`5 Gibaldi et al., Pharmacokinetics (2d ed. 2007) (“Gibaldi,” Ex. 1018).
`6 DeFronzo et al., Efficacy of Metformin in Patients with Non-Insulin-
`Dependent Diabetes Mellitus, 333 NEW ENGLAND J. MED. 541–49 (1995)
`(“DeFronzo,” Ex. 1020).
`
`4
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`
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`IPR2018-00503
`Patent 6,790,459 B1
`Reference(s)
`Chen7
`
`Basis
`§ 102
`
`Claims challenged
`1–21
`
`1–21
`
`§ 103
`
`Cheng, Timmins, Tucker,8 and
`Lewis
`
`Aurobindo Pharma USA Inc. v. Andrx Labs, LLC, Case IPR2017-01673
`(“the First IPR”), Paper 1 at 14 (“the First Petition”). Petitioner also relied
`on the same declarant, Dr. Akhlaghi, to support its petition. Id., Ex. 1009.
`Patent Owner filed a preliminary response on October 11, 2017. Id.,
`Paper 10. We entered our decision denying institution on both grounds on
`December 29, 2017. Id., Paper 11.
`B.
`Application of Our Discretion Under 35 U.S.C. § 314(a)
`Institution of an inter partes review is discretionary. See 35 U.S.C.
`§ 314(a) (authorizing institution of an inter partes review under particular
`circumstances, but not requiring institution under any circumstances); see
`also Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016)
`(explaining that under § 314(a) “the PTO is permitted, but never compelled,
`to institute an IPR proceeding”). When determining whether to exercise our
`discretion under § 314(a), we consider the following non-exhaustive factors:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;
`
`
`7 Chen et al., WO 00/12097, published Mar. 9, 2000 (“Chen,” Ex. 1011).
`8 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
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`IPR2018-00503
`Patent 6,790,459 B1
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision
`on whether to institute review in the first petition;
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`5. whether the petitioner provides adequate explanation for the
`time elapsed between the filings of multiple petitions directed
`to the same claims of the same patent;
`6. the finite resources of the Board; and
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357,
`slip op. at 15–16 (PTAB Sept. 6, 2017) (Paper 19) (precedential)
`(hereinafter, “General Plastic”) (citing NVIDIA Corp. v. Samsung Elecs.
`Co., Case IPR2016-00134, slip op. at 6–7 (PTAB May 4, 2016) (Paper 9)).
`We address each of these factors in turn.
`1. Whether the Same Petitioner Previously Filed a Petition Directed to
`the Same Claims of the Same Patent
`Petitioner filed the First Petition in the First IPR challenging the same
`claims of the same patent as the instant case. See First Petition, 14. We,
`therefore, find this factor weighs in favor of denying institution.
`2. Whether at the Time of Filing of the First Petition the Petitioner Knew
`of the Prior Art Asserted in the Second Petition or Should Have Known of It
`The First Petition challenged the patentability of the claims as obvious
`over Cheng, Timmins, Tucker, and Lewis. Id. Here, Petitioner challenges
`the claims over Cheng, Timmins, Wagner, Lewis, Gibaldi, and DeFronzo.
`
`6
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`IPR2018-00503
`Patent 6,790,459 B1
`Pet. 14. Thus, Petitioner clearly knew of at least Cheng, Timmins, and
`Lewis at the time of filing the First Petition.
`Whether Petitioner knew of Wagner, Gibaldi, and DeFronzo at the
`time of filing the First Petition, however, is unclear. But, as Patent Owner
`notes, Wagner was published in 1975, Gibaldi in 2007, and DeFronzo in
`1995. Prelim. Resp. 29. Thus, all three of the additional references were
`available well before the filing of the First Petition on June 23, 2017.
`Absent an explanation from Petitioner, we are persuaded that it is reasonable
`to assume that Petitioner could have found the newly asserted prior art
`through the exercise of reasonable diligence in its prior searches. See Gen.
`Plastic, slip op. at 20.
`On this record, we find that this factor weighs in favor of denying
`institution.
`3. Whether at the Time of Filing of the Second Petition the Petitioner
`Already Received the Patent Owner’s Preliminary Response to the First
`Petition or Received the Board’s Decision on Whether to Institute Review in
`the First Petition
`Patent Owner filed its Preliminary Response in the First IPR on
`October 11, 2017. First IPR, Paper 10. We entered our decision denying
`institution in the First IPR on December 28, 2017. First IPR, Paper 11.
`Thus, Petitioner had both the Preliminary Response and our decision on
`whether to institute review in the First IPR when it filed the Petition in this
`case on January 24, 2018. Pet., cover.
`Indeed, Petitioner notes that the Petition in this case “is an attempt to
`address the deficiencies noted by the panel in [the decision denying
`institution in the First IPR], and entails new references in the obviousness
`assertion to address the concerns of the panel in respect of the Tucker
`reference.” Pet. 11. Similarly, Petitioner states that Dr. Akhlaghi’s
`7
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`IPR2018-00503
`Patent 6,790,459 B1
`declaration in this proceeding is “a revised (from IPR2017-016[7]3)
`declaration . . . addressing the concerns of the panel in IPR2017-016[7]3.”
`Pet. 13.
`Thus, by admission, Petitioner used our decision in the First IPR as a
`roadmap to shift its strategy and reformulate its challenge to the claims of
`the ’459 patent. As stated in General Plastic, “this is unfair to patent owners
`and is an inefficient use of the inter partes review process.” Id., at 17–18.
`Accordingly, we find that this factor weighs heavily in favor of denying
`institution.
`4.
`The Length of Time that Elapsed Between the Time the Petitioner
`Learned of the Prior Art Asserted in the Second Petition and the Filing of
`the Second Petition
`As explained above, Petitioner was aware of Cheng, Timmins, and
`Lewis at the time of filing the First Petition, but it is unclear when Petitioner
`became aware of Wagner, Gibaldi, and DeFronzo. Nevertheless, in the
`absence of an explanation from Petitioner as to why it could not have found
`the newly asserted references earlier, we agree with Patent Owner that it is
`reasonable to assume that Petitioner was aware of—or should have been
`aware of—the new references at the time it filed the First Petition.
`We, therefore, find that this factor weighs in favor of denying
`institution.
`5. Whether the Petitioner Provides Adequate Explanation for the Time
`Elapsed Between the Filings of Multiple Petitions Directed to the Same
`Claims of the Same Patent
`
`The Finite Resources of the Board
`6.
`We address Factors 5 and 6 together. Other than to assert that the
`instant Petition “is an attempt to address the deficiencies” of the First
`Petition (Pet. 11), Petitioner does not explain why it filed the second follow-
`
`8
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`IPR2018-00503
`Patent 6,790,459 B1
`on petition approximately seven months after the First Petition. Petitioner’s
`explanation is insufficient because, as explained above, allowing a petitioner
`to use our decisions as a roadmap to cure the deficiencies in a first, failed
`petition is unfair to patent owners and an inefficient use of our resources.
`See Gen. Plastic, slip op. at 21 (“[M]ultiple, staggered petition filings, such
`as those here, are an inefficient use of the inter partes review process and the
`Board’s resources.”).
`Accordingly, we find Factors 5 and 6 weigh heavily in favor of
`denying institution.
`7.
`The Requirement Under 35 U.S.C. § 316(a)(11) to Issue a Final
`Determination Not Later than 1 Year After the Date on Which the Director
`Notices Institution of Review
`Because the First Petition was denied, whether we can issue a final
`determination no later than one year after institution does not apply to our
`analysis here. This factor is therefore neutral.
`Applying the General Plastic Factors
`8.
`As explained above, six of the seven General Plastic factors weigh in
`favor of denying institution, with several weighing heavily in favor of
`denial. Moreover, we note that Petitioner was silent in response to Patent
`Owner’s General Plastic arguments in the Preliminary Response, despite
`our invitation to request authorization to file a Reply to the Preliminary
`Response. See Paper 9. Specifically, Petitioner attempted to address the
`General Plastic factors in an updated mandatory notice, which we
`subsequently expunged as an improperly filed paper. Id. at 1–2. During the
`telephone conference to discuss that paper, Petitioner sought guidance
`regarding where it could make arguments to address the General Plastic
`factors. Id. at 1. We explained to Petitioner that it “could request
`
`9
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`IPR2018-00503
`Patent 6,790,459 B1
`authorization to file a reply after Patent Owner files its Patent Owner
`Preliminary Response (assuming the Preliminary Response addresses the
`General Plastic factors).” Id. Petitioner, however, never made such a
`request.
`Although there is no per se rule precluding follow-on petitions after a
`denial of a first petition, we are persuaded that exercising our discretion
`under § 314(a) to deny institution is appropriate under the facts and
`circumstances of this case.
`
` CONCLUSION
`For the foregoing reasons, we exercise our discretion under 35 U.S.C.
`§ 314(a) and decline to institute an inter partes review of the ’459 patent
`claims.
`
` 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.
`
`
`10
`
`
`
`IPR2018-00503
`Patent 6,790,459 B1
`
`
`PETITIONER:
`Steven J. Moore
`John Winterle
`Hans Peter Hoffmann
`Alan Gardner
`WITHERS BERGMAN LLP
`steven.moore@withersworldwide.com
`john.winterle@withersworldwide.com
`peter.hoffmann@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
`
`
`11
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`