Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 12
`
` Entered: December 29, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AUROBINDO PHARMA USA, INC.
`Petitioner,
`
`v.
`
`ANDRX CORPORATION,
`ANDRX LABORATORIES, INC.
`ANDRX LABORATORIES (NJ), INC.
`ANDRX EU LTD.
`ANDRX PHARMACEUTICALS, LLC,
`TEVA PHARMACEUTICAL INDUSTRIES LTD.
`Patent Owner(s).
`____________
`
`
`
`Case IPR2017-01648
`Patent 6,866,866 B1
`____________
`
`
`
`
`
`
`Before SUSAN L.C. MITCHELL, TINA E. HULSE, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`
`NEWMAN, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 12
`
` Entered: December 29, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AUROBINDO PHARMA USA, INC.
`Petitioner,
`
`v.
`
`ANDRX CORPORATION,
`ANDRX LABORATORIES, INC.
`ANDRX LABORATORIES (NJ), INC.
`ANDRX EU LTD.
`ANDRX PHARMACEUTICALS, LLC,
`TEVA PHARMACEUTICAL INDUSTRIES LTD.
`Patent Owner(s).
`____________
`
`
`
`Case IPR2017-01648
`Patent 6,866,866 B1
`____________
`
`
`
`
`
`
`Before SUSAN L.C. MITCHELL, TINA E. HULSE, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`
`NEWMAN, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2017-01648
`Patent 6,866,866 B1
`
`
` INTRODUCTION
`Aurobindo Pharma USA, Inc. (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1–25 of U.S. Patent No. 6,866,866 B1
`(Ex. 1001, “the ’866 patent”). Paper 1. Petitioner subsequently filed a
`Corrected Petition seeking the same relief. Paper 8 (“Pet.”). Andrx, LLC
`(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 11
`(“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
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–25 of the ’866 patent. Accordingly, we institute
`an inter partes review of those claims.
`Related Proceedings
`A.
`Petitioner identifies a currently pending district court action filed by
`Patent Owner against the Petitioner, asserting infringement of the ’866
`patent, Shionogi Inc. and Andrx Labs. L.L.C. v. Aurobindo Pharma Ltd. et
`al., Civ. Act. No. 1:17-cv-00072-UNA (D. Del. 1-25-17). Pet. 7. Petitioner
`also states that the “’866 patent has been the subject of extensive previous
`litigation, both in the District of Delaware, the Federal Circuit (EX1006),
`and in the District of New Jersey, all of which has settled.” Pet. 7–8. Patent
`Owner identifies several additional individual or consolidated actions
`involving the ’866 patent that were filed and dismissed, including by
`settlement. Prelim. Resp. 11–12.
`
`2
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`IPR2017-01648
`Patent 6,866,866 B1
`
`
`The ’866 Patent
`B.
`The ’866 patent relates to “controlled release unit dose formulations
`containing an antihyperglycemic drug. . . [specifically] an oral dosage form
`comprising a biguanide such as metformin.” Ex. 1001, 1:6–11. Metformin
`is used to manage non-insulin dependent diabetes mellitus (NIDDM). Id. at
`1:56–58.
`According to the Specification, various techniques have been used to
`provide pharmaceutical dosage forms that are controlled or as extended-
`release forms to permit stable therapeutic serum levels of the drug, thereby
`minimizing missed doses. Id. at 1:14–18. Because metformin is a short-
`acting drug, it required twice- or thrice-daily doses. Id. at 2:4–6. The ’866
`patent states that, due to adverse events associated with use of metformin,
`reducing the dosage or using an extended-release form would provide a
`benefit, in addition to reducing the frequency of administration and
`improving the drug’s safety profile. Id. at 2: 6–16.
`The disclosed metformin dosage is a controlled release dosage form
`suitable for once-a-day dosing in the “fed” state, preferably at dinner. Id. at
`8:54–56. The ’866 patent states that, when administered in this manner, the
`bioavailability of the drug is improved relative to the fasted state, which is
`the opposite result of the commercially available form of metformin,
`Glucophage. Id. at 8:56–59. In addition, when dosed at dinnertime, the
`controlled release formulations provide a Tmax from 5.5 to 7.5 hours after
`oral administration, which is delayed relative to the Tmax provided by
`Glucophage. With the delayed Tmax of the disclosed controlled release
`formulation, the level of the drug peaks coincident with when the subject
`
`3
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`IPR2017-01648
`Patent 6,866,866 B1
`manufactures the highest levels of glucose, i.e. at night, while also lowering
`insulin levels. Id. at 8:66–9:14.
`
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–25 of the ’866 patent, of which
`claim 1 is the only independent claim. Claim 1 is representative and
`is reproduced below:
`1. A controlled release oral dosage form for the reduction of
`serum glucose levels in human patients with NIDDM, comprising
`an effective dose of metformin or a pharmaceutically acceptable
`salt thereof and a controlled-release carrier to control the release of
`said metformin or pharmaceutically acceptable salt thereof from
`said dosage form, said dosage form being suitable for providing
`once-a-day oral administration of the metformin or
`pharmaceutically acceptable salt thereof, wherein following oral
`administration of a single dose, the dosage form provides a mean
`time to maximum plasma concentration (Tmax) of the metformin
`from 5.5 to 7.5 hours after administration following dinner.
`Real Parties in Interest
`D.
`Petitioner identifies the real parties in interest for itself as Aurobindo
`Pharma USA, Inc., and Aurobindo Pharma Ltd. Pet. 7. Patent Owner does
`not identify a real party in interest but responds on behalf of Andrx Labs,
`LLC, as Patent Owner. Prelim. Resp., cover page.
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1–25 of the
`’866 patent on the following grounds:
`
`4
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`IPR2017-01648
`Patent 6,866,866 B1
`Reference(s)
` Chen1
`
`Timmins2
`
`Cheng3 and Timmins
`
`Basis
`§ 102(a)
`
`§ 102(a)
`
`§ 103
`
`Claims challenged
`1–25
`
`1–3
`
`1–25
`
`Petitioner also relies on the Declaration of Dr. Fatemeh Akhlaghi, Pharm.D.,
`Ph.D. (Ex. 1019) (hereinafter, “Akhlaghi Dec.”)
` ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art would have
`had “a Pharm.D. and/or Ph.D. with experience in pharmaceutical sciences,
`dosage forms, clinical pharmacology or related fields, such as
`pharmacology.” Pet. 11; Ex. 1019 ¶¶ 91–96. Petitioner further asserts that a
`person of ordinary skill in the art would have had “experience in the research
`or development of pharmaceuticals and have the ability to gather and
`interpret pharmacokinetic data and the relationship between drug release
`from a dosage form and its effect on pharmacokinetic parameters.” Id.
`Moreover, Petitioner contends that “pharmaceutical development is an
`inherently collaborative process” and that the skilled artisan would have had
`“access to, or be part of a team including, other skilled individuals, such as
`an M.D. with experience in the field of diabetes treatment.” Id.
`
`
`1 Chen, Chi-Ming, et al., WO 00/12097, published March 9, 2000 (“Chen”
`Ex. 1007).
`2 Timmins, Peter et al., WO 99/47128, published September 23, 1999
`(“Timmins” Ex. 1003).
`3 Cheng, Xiu, Xiu et al., WO 99/47125, published September 23, 1999
`(“Cheng” Ex. 1002).
`
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`Patent 6,866,866 B1
`Patent Owner asserts that a person of ordinary skill in the art at the
`time of the invention would have “held 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 [and would have been
`familiar] with the methods used in formulating oral dosage forms, modified
`release dosage forms, and osmotic delivery, and [understand] fundamental
`principles as to how osmotic dosage forms behave and function.” Prelim.
`Resp. 15–16.
`We do not discern an appreciable 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 the development of pharmaceuticals and the ability to analyze
`pharmacokinetic data including the relationship between oral dosage forms
`and osmotic delivery. 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, in this case, 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
`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
`
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`IPR2017-01648
`Patent 6,866,866 B1
`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).
`“Tmax”
`1.
`The term “Tmax” appears in each of the challenged claims. Both parties
`agree that Tmax should be construed as “the time period which elapses after
`administration of the dosage form at which the plasma concentration of the
`drug attains the highest plasma concentration of drug attained within the
`dosing interval (i.e., about 24 hours).” This definition is provided in the
`’866 patent at col. 7, ll. 49–53. Pet. 24; Prelim Resp. 18.
`We agree that the Specification defines the claim term with reasonable
`clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d at 1480.
`Accordingly, we construe “Tmax” as “the time period which elapses after
`administration of the dosage form at which the plasma concentration of the
`drug attains the highest plasma concentration of drug attained within the
`dosing interval (i.e., about 24 hours).”
`At this stage of the proceedings, we do not find it necessary to
`construe any other claim terms.
`
`7
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`IPR2017-01648
`Patent 6,866,866 B1
`
`Anticipation by Chen
`C.
`Petitioner asserts that claims 1–25 of the ’866 patent are anticipated
`by Chen under 35 U.S.C. § 102(a). Pet. 14–17, 25–38. Patent Owner
`opposes Petitioner’s assertion. Prelim. Resp. 19–21. On this record, we
`determine that Petitioner has not established a reasonable likelihood that it
`would prevail in showing that claims 1–25 are anticipated by Chen, as
`Petitioner has not established that Chen qualifies as prior art to the ’866
`patent.
`
` Chen (Ex. 1007)
`1.
`Chen is an international application published under the Patent
`Cooperation Treaty on March 9, 2000. Ex. 1007. Chen relates to a
`controlled release pharmaceutical tablet containing an antihyperglycemic
`drug and a hypoglycemic drug. Id. at 1:5–6. Chen discloses a preferred
`embodiment that contains a combination of a biguanide and a sulfonylurea
`in which the biguanide is “preferably metformin.” Id. at 15–17.
`Analysis
`2.
`Pre-AIA 35 U.S.C. § 102(a) provides that “A person shall be entitled
`to a patent unless - (a) the invention was known or used by others in this
`country, or patented or described in a printed publication in this or a foreign
`country, before the invention thereof by the applicant for a patent.”
`Patent Owner raises a threshold issue that Petitioner has not
`established that Chen qualifies as prior art to the ’866 patent under pre-AIA
`35 U.S.C. § 102. Prelim. Resp. 19. Patent Owner argues Chen is not prior
`art to the ’866 patent because:
`First, Chen lists the same inventive entity as the ’866
`patent (i.e., Chih-Ming Chen, Xiu-Xiu Cheng, Joseph Chou,
`and Steve Jan), and is accordingly disqualified as prior art
`under pre-AIA 35 U.S.C. § 102(a) because it is not “by others.”
`
`8
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`IPR2017-01648
`Patent 6,866,866 B1
`See In re Katz, 687 F.2d 450 (C.C.P.A. 1982); see also MPEP §
`2132(III); MPEP § 2136.04.
`Second, because Chen was published less than one year
`prior to the November 3, 2000 filing date of the ’866 patent,
`Chen does not qualify as prior art under pre-AIA 35 U.S.C. §
`102(b).
`Third, because Chen is an international publication of an
`application filed prior to November 29, 2000, it has no prior art
`effect under pre-AIA 35 U.S.C. § 102(e). See MPEP §
`706.02(F)(1)(I)(C)(3) (“For U.S. application publications and
`WIPO publications directly resulting from international
`applications under PCT Article 21(2), never apply these
`references under pre-AIA 35 U.S.C. 102(e)”).4
`Id. at 20.
`The parties do not dispute that the critical date is November 3, 2000.
`Pet. 7; Prelim. Resp. 20. Petitioner states that Chen was “art published prior
`to November 3, 2000 . . . published on March 9, 2000,” less than one year
`prior to the undisputed critical date. Pet. 13. Petitioner has provided no
`other information or argument to support an alternative publication date.
`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
`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
`
`
`4 Patent Owner also cites “the December 11, 2002 Examination Guidelines
`for 35 U.S.C. § 102(e), as amended by the American Inventors Protection
`Act of 1999, and further amended by the Intellectual Property and High
`Technology Technical Amendments Act of 2002, and 35 U.S.C. § 102(g)
`(Revised 1) at 1 (“A U.S. or WIPO publication of an international
`application filed prior to November 29, 2000 will have no prior art effect
`under § 102(e)”).
`
`9
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`Patent 6,866,866 B1
`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. 1007, [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(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.
` On this record, we are persuaded by Patent Owner that Chen does not
`qualify as prior art to the ’866 patent. Accordingly, on this record, we
`determine Petitioner has not established a reasonable likelihood that it would
`prevail in its assertion that claims 1–25 are anticipated by Chen.
`Anticipation by Timmins
`D.
`Petitioner asserts that claims 1–3 of the ’866 patent are anticipated by
`Timmins under 35 U.S.C. § 102(a). Pet. 17–19, 38–40. Patent Owner
`opposes Petitioner’s assertion. Prelim. Resp. 21–26. On this record, we
`
`10
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`IPR2017-01648
`Patent 6,866,866 B1
`determine that Petitioner has not established a reasonable likelihood that it
`would prevail in showing that claims 1–3 are anticipated by Timmins.5
`Timmins (Ex. 1003)
`1.
`Timmins relates to a “biphasic controlled release delivery system for
`pharmaceuticals. . . such as the antidiabetic metformin HCl salt.” Ex. 1003,
`Abstract. Timmins discloses “a new dosage form for medicaments [such as]
`metformin, which provides for extended release of the drug and also for
`prolonged gastric residence which enables efficient delivery of drugs
`normally absorbed in the gastrointestinal tract” and methods of its
`preparation. Id. at 1:5–11.
`Petitioner alleges “Timmins[’] disclosure covers Bristol-Myers
`Squibb’s product, Glucophage XR, which was approved for marketing
`(October 13, 2000) before the priority date of the ’866 patent.” Pet. 18.
`Example 3 of Timmins discloses a 0.5 mg metformin hydrocholoride
`tablet that revealed the following profile of in vitro release of metformin:
`
`
`
`5 Patent Owner argues that because the Examiner expressly considered
`Timmins during prosecution of the ’866 patent, we should exercise our
`discretion under 35 U.S.C. § 325(d) and deny institution based on this
`ground. Prelim. Resp. 25–26. We have considered Patent Owner’s
`argument, and decline to exercise our discretion to deny under § 325, in light
`of the evidence in this record.
`
`
`
`11
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`IPR2017-01648
`Patent 6,866,866 B1
`The Table above shows the in vivo release profile of metformin by hour
`intervals. Ex. 1003, 32:20–33:9.
`Timmins discloses a Tmax range of 4–8 hours, with a median6 (not
`mean) Tmax of 5 hours for a single dose after dinner administration. Id. at
`34:24–30.
`
`Analysis
`2.
`Anticipation requires that “each and every element as set forth in the
`claim is found, either expressly or inherently described, in a single prior art
`reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation
`omitted). “To establish inherency, the extrinsic evidence ‘must make clear
`that the missing descriptive matter is necessarily present in the thing
`described in the reference.’” Id.
`Petitioner provides a claim chart identifying where it contends each
`limitation of the challenged claims is taught in Timmins. Pet. 39–40.
`Petitioner relies in part on the following statement made by the Court of
`Appeals for the Federal Circuit:
`Although Timmins expressly discloses a median Tmax [of 5
`hours], it also provides the raw data from which one skilled in
`the art could compute the range of possible mean Tmax
`values…Based on this data, one skilled in the art would
`understand that the mean Tmax in Timmins must fall between
`4.67 and 6.33 hours.
`Pet. 39 (quoting Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1262 (Fed.
`Cir. 2012)). Petitioner’s expert, Dr. Akhlaghi, likewise relies on the Federal
`
`
`6 The median of a set of values is “a value in an ordered set of values
`below and above which there is an equal number of values or which is
`the arithmetic mean of the two middle values if there is no one middle
`number.” See https://www.merriam-webster.com/dictionary/median, last
`visited December 22, 2019.
`
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`Patent 6,866,866 B1
`Circuit’s holding for the finding that “the [person of skill in the art] would
`understand a mean Tmax of between 4.67 and 6.33 hours.” Akhlaghi Decl.
`¶ 182. Dr. Akhlaghi also states that “[t]he Tmax of Timmins overlaps and
`intrudes into each of the ranges claimed by claims 1–3 of the ’866 patent.”
`Id. ¶ 183.
`
`Patent Owner argues that Petitioner’s assertions regarding Timmins
`do not establish that Timmins “discloses a single value for mean Tmax that
`actually falls within the claimed range.” Prelim. Resp. 23. Rather, Patent
`Owner argues that Petitioner “cannot explain where the actual mean Tmax
`from Timmins falls, and its calculations offer no insight into what the mean
`Tmax for the population in Timmins was.” Id. Patent Owner argues that
`Timmins’ purported disclosure of a calculated mean Tmax value within the
`claimed range does not constitute a disclosure of a mean Tmax value of either
`purported endpoint. Id. at 23–24 (citing Atofina7 and INEOS8 in support).
`Patent Owner further argues the Examiner “expressly considered the
`substance of Timmins (in the form of the ’521 patent) during the prosecution
`of the ’866 patent.” Id. at 25.
`
`Having considered the arguments and evidence, we are persuaded, at
`this stage of the proceeding, that Petitioner has not shown sufficiently that
`each limitation of claims 1–3 is taught by Timmins.
`Claim 1 recites that, following administration after dinner of a single
`dose, the “mean time to maximum plasma concentration (Tmax) of the
`metformin [is] from 5.5 to 7.5 hours.” Claim 2 and 3 depend from claim 1
`and claim a mean time to maximum plasma concentration (Tmax) of the
`
`
`7 Atofina v. Great Lakes Chemical Corp., 441 F.3d 991 (Fed. Cir. 2006).
`8 Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865 (Fed. Cir. 2015).
`13
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`Patent 6,866,866 B1
`metformin of from “6.0 to 7.0 hours” and “5.5 to 7.0 hours,” respectively.
`Thus, each challenged claim requires a particular mean time range of the
`maximum plasma concentration.
`On the record before us, we agree with Patent Owner that Petitioner
`has not shown that “each and every element as set forth in the claim is
`found, either expressly or inherently described, in a single prior art
`reference.” Robertson, 169 F.3d at 745. While we recognize the Federal
`Circuit’s finding that the skilled artisan may have been able to calculate a
`mean Tmax from the data provided, Timmins discloses a median Tmax of 5
`hours, not a mean Tmax, as claimed. Timmins does not disclose expressly the
`concept of a range of mean Tmax values as in claims 1–3.
`We further agree that Atofina, along with other precedent, establishes
`that to anticipate a claimed range, the prior art must describe the claimed
`range with sufficient specificity. Atofina, 441 F.3d at 999. Although
`Petitioner alleges that “[c]laims 1–3 of the ’866 patent are taught in every
`detail by Timmins,” Petitioner does not identify in Timmins any teaching of
`the mean Tmax within the claimed range, or explain how Timmins inherently
`describes the claimed range of mean Tmax values of claims 1–3 with the
`single identified formulation of Example 3, aside from relying on the
`Federal Circuit’s finding that the skilled artisan could potentially calculate
`these values. However, the Federal Circuit’s cited analysis pertained to
`whether Cheng in view of Timmins raised a substantial question of validity,
`i.e., whether these two references together rendered certain claims of the
`’866 patent obvious under 35 U.S.C. § 103. We do not read the Federal
`Circuit’s analysis as a factual finding that Timmins alone expressly or
`inherently discloses any mean Tmax value, much less describes the claimed
`range with sufficient specificity, as required for anticipation.
`
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`In this regard, we distinguish the facts of this case from those in
`ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340 (Fed. Cir.
`2012), in which the Federal Circuit found that the disclosure in the prior art
`of a broad range anticipated a claimed point within the range, absent
`evidence of criticality of the point or a difference in the function achieved by
`the claimed point. Id. at 1345. Timmins’ disclosed median of 5 hours does
`not fall within the claimed ranges (5.5 to 7.5 hours), and without additional
`information expressly disclosed in Timmins to indicate that the mean value
`of the data in Timmins would fall within the claimed range, Timmins does
`not describe the claimed range with the specificity required to anticipate.
`Accordingly, on this record, we determine Petitioner has not
`established a reasonable likelihood that it would prevail in its assertion that
`claims 1–3 are anticipated by Timmins.
`E. Obviousness over Timmins and Cheng
`Petitioner asserts that claims 1–25 of the ’866 patent are unpatentable
`as obvious over Timmins and Cheng. Pet. 19–23, 40–53. Patent Owner
`opposes Petitioner’s assertion. Prelim. Resp. 26–30. On this record, we
`determine that Petitioner has established a reasonable likelihood that it
`would prevail in showing claims 1–25 are unpatentable based on the
`combined teachings of Timmins and Cheng.
`We incorporate here our findings and discussion above regarding the
`disclosures of Timmins.
`
`Cheng (Ex. 1004)
`1.
`Cheng relates to “an oral dosage form comprising a biguanide such as
`metformin . . . or a pharmaceutically acceptable salt thereof.” Ex. 1004,
`1:7–9. Cheng has the same inventive entity as the ’866 patent. Id. at [75].
`Cheng discloses a controlled release pharmaceutical tablet comprising 1) a
`
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`IPR2017-01648
`Patent 6,866,866 B1
`core, including an antihyperglycemic drug, a binding agent, an absorption
`enhancer; 2) a semipermeable membrane coating covering the core that is
`permeable to water and biological fluids but impermeable to the
`antihyperglycemic drug; and 3) at least one passageway in the membrane for
`the release of the antihyperglycemic drug. Id. at 9:61–10:6. Cheng
`discloses that “the term passageway includes an aperture, orifice, bore, hole,
`weaken area or an erodible element such as a gelatin plug that erodes to
`form an osmotic passageway for the release of the antihyperglycemic drug
`from the dosage form.” Id. at 5:8–11.
`Example 3 of Cheng is reproduced below:
`
`
`Example 3 discloses the formula of “a controlled release tablet containing
`850 mg of metformin HCl.” Id. at 7:35–44. Cheng discloses that “an
`additional hole was drilled on the plain side of the coated tablet.” Id. at
`9:1–2. A depiction of the “in vivo plasma profile” of the product is shown
`in Figure 8, reproduced below:
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`16
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`IPR2017-01648
`Patent 6,866,866 B1
`
`
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`
`
`Figure 8 depicts the in vivo plasma profiles of the sustained release
`metformin product and the Glucophage product when administered “shortly
`after dinner.” Id. at 9:28–32, Figure 8.
`Analysis
`2.
`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;
`(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
`
`17
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`IPR2017-01648
`Patent 6,866,866 B1
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine 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).
`Petitioner provides a detailed claim chart identifying where it
`contends each limitation of the challenged claims is taught in Cheng or
`Timmins. Pet. 43–53. Having considered the arguments and evidence, we
`are persuaded, at this stage of the proceeding, that Petitioner has shown
`sufficiently that each limitation of claims 1–25 is taught by the combination
`of Cheng and Timmins.
`Claim 1 recites an oral dosage form comprising an effective dose of
`metformin or its salt and a controlled release carrier facilitating once-a-day
`administration after dinner such that the “mean time to maximum plasma
`concentration (Tmax) of the metformin [is] from 5.5 to 7.5 hours” following
`administration. Petitioner argues that Cheng discloses the tablet structure
`taught in the ’866 patent, a tablet “with a unitary core surrounded by a
`semipermeable membrane with at least one passageway in the membrane.”
`Pet. 19.
`Relying on the testimony of its declarant, Dr. Akhlaghi, Petitioner
`argues that the “composition and structure of the 850 mg tablet of Example 3
`of [Cheng is] essentially identical to that described in the ’866 patent [,
`including] the type, qualities and amounts of excipients used . . . and releases
`metformin approximately the same as the tablets disclosed in the ’866
`patent.” Id. at 19–20. Petitioner argues the Cheng disclosure may contain a
`second laser drilled hole, which “would be expected by a POSA to lead to a
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`IPR2017-01648
`Patent 6,866,866 B1
`faster rate of release of metformin from the tablets of the ’866 patent.” Id. at
`20.
`
`Petitioner argues that Cheng discloses continuous antihyperglycemic
`drug delivery to a subject over a 12–24 hour period, with a stated “Tmax of
`8–12 hours.” Id. However, Petitioner contends, Figures 4–8 indicate that a
`“Tmax range of 4–10 hours is actually demonstrated” with Figure 8 showing a
`Tmax of 10 hours. Id.
`Petitioner argues that “‘being otherwise identical, it would be trivial
`for the [skilled artisan] to increase the rate of release of metformin from the
`tablet of Example 3 of WO 99/47125 to match that shown in the ’866
`patent,’” and that Patent Owner stated that matching the Tmax values in vivo
`was easy “‘irrespective of the technology employed.’” Id. at 21 (citing
`Ex. 1019 ¶ 155; Ex. 1010, 9–8).
`Petitioner argues that to achieve the Tmax of the invention of the ’866
`patent, the skilled artisan would only need to “drill an additional hole in the
`tablet” or follow the guidance suggested by Cheng, and by doing so, would
`“expect the Tmax of the altered product to be concisely within the Tmax range
`recited in claim 1” along with other pharmacokinetic parameters. Id.
`Finally, Petitioner argues that the Federal Circuit “previously ruled on
`the significance of Timmins and Cheng combination . . . and concluded there
`was more than sufficient motivation to combine the Cheng and Timmins
`references to arrive at the invention of the ’866 patent.” Pet. 21–22 (citing
`Sciele Pharma, Inc. v. Lupin Ltd., 684 F.3d 1253, 1261 (Fed. Cir. 2012)).
`Petitioner argues the Federal Circuit stated “‘lowering the Tmax allows one
`skilled in the art to approach the drug profile of Glucophage, the industry
`standard drug’ so as to reach the mean Tmax” of the ’866 patent. Id. at 22.
`Petitioner cites the following passage from the Federal Circuit opinion:
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`IPR2017-01648
`Patent 6,866,866 B1
`The ’866 patent admits that Cheng ‘discloses controlled release
`metformin formulations providing a Tmax from 8 to 12 hours.’
`’866 patent col.2 ll.46–47. Although Timmins expressly
`discloses a median Tmax, it also provides the raw data from
`which one skilled in the art could compute the range of possible
`mean Tmax values. . . . Based on this data, one skilled in the art
`would understand that the mean Tmax in Timmins must fall
`between 4.67 and 6.33 hours. Counsel for [Patent Owner]
`agreed that the only element missing from Cheng is the Tmax
`range, and that Timmins discloses a range of possible mean
`Tmax between 4.67 and 6.33 hours.
`Id. (quoting Sciele Pharma, 684 F.3d at 1262). Petitioner also cites the
`Federal Circuit’s findings that:
`Timmins also identifies a number of benefits stemming from
`an earlier extended release, including ‘reduction in dosing
`frequency, providing patient convenience that would probably
`improve compliance’ as well as ‘an extended time period over
`which therapeutically beneficial plasma levels of drug were
`maintained’. These benefits would motivate one skilled in the
`art to modify Cheng to achieve a lower Tmax range.
`Id. Petitioner argues that the Federal Circuit’s statement me
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