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`Paper No. 10
`Entered: May 4, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`CEPHALON, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00098
`Patent 8,791,270 B2
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
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`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`Patent 8,791,270 B2
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`INTRODUCTION
`Fresenius Kabi USA, LLC (“Petitioner”) filed a Petition for an inter
`partes review of claims 1–23 of U.S. Patent No. 8,791,270 B2 (“the ’270
`patent,” Ex. 1001). Paper 2 (“Pet.”). Cephalon, Inc. (“Patent Owner”)
`timely filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). We have
`jurisdiction under 35 U.S.C. § 314.
`For the reasons provided below, we determine Petitioner has satisfied
`the threshold requirement set forth in 35 U.S.C. § 314(a). Because
`Petitioner has established a reasonable likelihood that it would prevail in
`showing the unpatentability of claims 7, 14, and 19–23, we institute an inter
`partes review of these claims. Petitioner, however, has not established a
`reasonable likelihood that it would prevail in showing the unpatentability of
`claims 1–6, 8–13, and 15–18. Therefore, we deny the Petition regarding the
`challenges to those claims.
`Related Proceedings
`According to the parties, the ’270 patent is the subject of several cases
`in district courts. Pet. 7–8; Paper 5, 1–4. Even though Petitioner is not a
`party to any of those cases, its contractual partners, Hetero Labs, Ltd. and
`Hetero USA, Inc., are. Pet. 8.
`The ’270 patent is also the subject of IPR2016-00026, filed by Agila
`Specialties Inc. and Mylan Laboratories Limited. We previously denied the
`petition in that case. Agila Specialties Inc. v. Cephalon, Inc., Case IPR2016-
`00026 (PTAB April 13, 2016) (Paper 14). Agila Specialties Inc. and Mylan
`Laboratories Limited also sought inter partes review of U.S. Patent No.
`8,436,190 B2, a patent in the same family as the ’270 patent. Agila
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`Specialties Inc. v. Cephalon, Inc., Case IPR2015-00503, Paper 4. There, we
`instituted trial to review the patentability of certain claims, but denied
`review of others. IPR2015-00503, Paper 10 (PTAB July 20, 2015). The
`parties subsequently settled, and we terminated the case. IPR2015-00503,
`Paper 21 (PTAB Nov. 16, 2015).
`Petitioner also filed a petition seeking inter partes review of related
`U.S. Patent No. 8,895,756 B2. Fresenius Kabi USA, LLC v. Cephalon, Inc.,
`IPR2016-00111, Paper 2. A decision instituting inter partes review has
`issued concurrently with this decision. IPR2016-00111, Paper 9 (PTAB
`May 4, 2016).
`
`The ’270 Patent
`The ’270 patent is directed to stable pharmaceutical compositions of
`nitrogen mustards, in particular, lyophilized bendamustine, which can be
`used to treat various disease states, especially neoplastic diseases and
`autoimmune diseases. Ex. 1001, 3:20–24.
`Bendamustine was first synthesized in East Germany in 1963. Id. at
`2:1–2. At the time of the ’270 patent invention, bendamustine was marketed
`in Germany under the name Ribomustin® to treat chronic lymphocytic
`leukemia, Hodgkin’s disease, non-Hodgkin’s lymphoma, multiple myeloma,
`and breast cancer. Id. at 2:5–9.
`According to the ’270 patent, “[b]endamustine degrades rapidly in
`water alone and forms predominantly the hydrolysis product, HP1
`(monohydroxy bendamustine).” Id. at 21:3–5. Other degradants include the
`dimer of bendamustine (BM1 dimer), bendamustine ethylester (BM1EE),
`and BM1DCE. Id. at 21:30–50.
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`The ’270 patent discloses stable pharmaceutical compositions
`prepared from bendamustine, in particular, “formulations for the
`lyophilization of bendamustine HCl.” Id. at 12:27–30. According to the
`’270 patent, the lyophilized powder obtained from such formulations is more
`easily reconstituted and has a better impurity profile than Ribomustin®. Id.
`at 12:30–37.
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`Illustrative Claims
`Among the challenged claims, claims 1 and 7 are independent. They
`read as follows:
`A pharmaceutical composition that has been reconstituted
`1.
`from a lyophilized preparation of bendamustine or bendamustine
`hydrochloride, said composition containing not more than about
`0.9% (area percent of bendamustine) of HP1:
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`composition of bendamustine
`A pharmaceutical
`7.
`hydrochloride, containing less than or equal to 4.0% (area
`percent of bendamustine) of bendamustine degradants.
`Dependent claims 2–6 and 8–19 also are directed to pharmaceutical
`compositions. Claims 2–6 depend, directly or indirectly, from claim 1,
`while claims 8–19 depend, directly or indirectly, from claim 7.
`Claim 20 is a method claim that depends from claim 7. It reads:
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`20. A method of treating cancer in a patient comprising
`administering to the patient a pharmaceutical composition of
`bendamustine hydrochloride according to claim 7.
`Each of claims 21–23 is a method claim that depends directly from
`claim 20.
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`Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`Claims
`Basis
`Reference(s)
`1–20
`§ 103
`Maas1 and Teagarden 2
`13 and 19
`§ 103
`Maas, Teagarden, and Gust3
`20–23
`§ 102
`Maas, Teagarden, and
`Ribomustin® Product Monograph4
`§ 103 Admitted prior art in the ’270 patent and
`Teagarden
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Drs. Michael J. Akers and Bernard Olsen. Exs. 1013, 1017.
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`1–23
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`1 Maas et al., Stability of Bendamustine Hydrochloride in Infusion Solutions,
`49 PHARMAZIE 775–77 (1994) (Ex. 1004, “Maas”).
`2 Teagarden and Baker, Practical Aspects of Lyophilization Using Non-
`Aqueous Co-Solvent Systems, 15 EUR. J. PHARM. SCI. 115–33 (2002)
`(Ex. 1005, “Teagarden”).
`3 Gust and Krauser, Investigations on the Stability of Bendamustin, a
`Cytostatic Agent of the Nitrogen Mustard Type, I. Synthesis, Isolation, and
`Characterization of Reference Substances, 128 CHEMICAL MONTHLY 291–
`99 (1997) (Ex. 1006, “Gust”).
`4 Ribomustin® Product Monograph, 2002 (Ex. 1007).
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`ANALYSIS
`Claim Construction
`In an inter partes review, the Board interprets a claim term in an
`unexpired patent according to its broadest reasonable construction in light of
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In
`re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015),
`cert. granted sub nom. Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 890
`(mem.) (2016). Under that standard, absent any special definitions, we
`assign 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, in
`the context of the entire patent disclosure. In re Translogic Tech., Inc., 504
`F.3d 1249, 1257 (Fed. Cir. 2007).
`Petitioner proposes to construe the terms “pharmaceutical
`composition,” “pharmaceutical composition that has been reconstituted,”
`“area percent of bendamustine,” “bendamustine degradants,” and “time zero
`after reconstitution.” Pet. 19–23. For purposes of its Preliminary Response,
`Patent Owner states that it accepts Petitioner’s proposed constructions.
`Prelim. Resp. 11–12. We similarly accept Petitioner’s proposed
`constructions for purposes of this Decision. Specifically, we accept that
`(1) “pharmaceutical composition” means “a composition that is made under
`conditions such that it is suitable for administration to humans;” and
`(2) “pharmaceutical composition that has been reconstituted” means a
`pharmaceutical composition “that has been dissolved in a solvent or
`diluent.” See Pet. 20–21.
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`Prior Art Disclosures
`Maas discloses bendamustine as “very unstable in an aqueous
`solution.” Ex. 1004, 4. It explains that “[d]ue to the rapidly progressing
`hydrolysis of aqueous bendamustine hydrochloride solutions, only freshly
`made up solutions . . . must be injected immediately after their preparation.”
`Id. at 5. In a stability test, Maas identified bendamustine hydrochloride by
`reverse-phase HPLC. Id.
`Teagarden teaches that using non-aqueous co-solvent systems in
`freeze-drying pharmaceutical products has numerous advantages, including
`“increased pre-dried bulk solution or dried product stability.” Ex. 1005, 1.
`Specifically, Teagarden teaches that the tert-butanol (“TBA”)/water co-
`solvent system “significantly reduced” the degradation rate of certain water
`unstable drugs. Id. at 3–4.
`Gust teaches the synthesis, isolation, and characterization of
`bendamustine and its derivatives. Ex. 1006, 291–99. According to Gust,
`bendamustine is synthesized by cleaving dichloroester5 with HCl, whereas
`dichloroester can be formed by esterification of bendamustine in ethanolic
`HCl. Id. at 292–93. Gust also teaches that dichloroester is present in crude
`bendamustine samples. Id. at 298.
`Ribomustin® Product Monograph describes various information
`regarding Ribomustin®, including the indications. Ex. 1007, 8.
`Specifically, according to Ribomustin® Product Monograph, Ribomustin®
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`5 According to Petitioner, dichloroester in Gust is the same as bendamustine
`ethylester (BM1EE) in the ’270 patent. Pet. 50.
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`is used for treating Hodgkin’s disease (stages II – IV), non-Hodgkin’s
`lymphoma, and chronic lymphocytic leukemia. Id.
`Obviousness over Maas and Teagarden
`Petitioner argues that claims 1–20 would have been obvious over
`Maas and Teagarden. Pet. 24–45. Based on the current record, we
`determine Petitioner has established a reasonable likelihood that it would
`prevail in this assertion regarding claims 7, 14, 19, and 20, but not claims 1–
`6, 8–13, and 15–18.
`Petitioner refers to Maas for describing instability issues of
`bendamustine in aqueous solutions. Id. at 26. Petitioner next refers to
`Teagarden for teaching using TBA to improve the stability of unstable drugs
`in solution. Id. at 25. According to Petitioner, Teagarden discusses the
`successful use of TBA/water co-solvent for five different pharmaceutical
`compositions, and predicts that this stabilizing effect “would be expected to
`be observed for many other drug products which are degraded in the
`presence of water.” Id. at 27–28 (citing Ex. 1005, 4). Thus, Petitioner
`contends, one of ordinary skill in the art, motivated to improve the stability
`of Ribomustin®, would have combined the teachings of Maas and
`Teagarden. Id. at 25–27.
`Each of claims 1–6, 10–13, and 16–18 recites the amount of HP1 in a
`bendamustine composition, whereas each of claims 7–9, 14, 15, 19, and 20
`recites the amount of total bendamustine degradants in the bendamustine
`composition. Petitioner relies on the HPLC chromatogram in Maas as the
`basis to calculate the amount of HP1 and bendamustine degradants in
`bendamustine. Id. at 30–33.
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`Specifically, Petitioner points out that the chromatogram in Maas
`shows two degradants—a “monohydrolysis product,” which corresponds to
`HP1, and an “unknown” degradant, which was a “byproduct from
`synthesis.” Id. at 30 (citing Ex. 1004, 5). According to Petitioner,
`“[a]lthough Maas does not provide peak area data for these peaks, one of
`skill in the art would have been able to calculate peak area (and thus
`determine area percent bendamustine) for the two degradants in a number of
`different ways.” Id. For example, Petitioner argues, an ordinary artisan
`would know to determine the peak area by (1) digitizing the Maas
`chromatogram and integrating the peaks using commercial software, and
`(2) counting the number of pixels under each peak. Id. at 30–31 (citing
`Ex. 1017 ¶ 63).
`Petitioner presents the data Dr. Olsen obtained using these two
`methods:
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`Id. at 32 (citing Ex. 1017 ¶ 69). Based on these data, Petitioner concludes,
`the area percent of bendamustine for HP1 ranges between 1.99% and 2.47%
`(id. at 32–33 (citing Ex. 1017 ¶ 70)), and the total degradants in Maas ranges
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`from approximately 4.14% to 4.81% (area percent of bendamustine) (id. at
`35 (citing Ex. 1017 ¶ 95)).
`In addition, Petitioner argues, Teagarden teaches the TBA/water co-
`solvent system “significantly reduced” the degradation rate of certain water
`unstable drugs, sometimes “by a factor of approximately 4–5.” Id. at 25
`(citing Ex. 1005, 3, 4). Relying on the Declaration of Dr. Olsen, Petitioner
`asserts that the teaching in Teagarden regarding the 4–5 fold reduction in the
`rate of degradation would correspond to a 4–5 fold reduction in the amount
`of degradants. Id. at 33 n.4 (citing Ex. 1017 ¶ 71). Thus, applying the
`teaching of Teagarden, Petitioner argues, “one of ordinary skill would have a
`reasonable expectation of success that the HP1 levels taught in Maas would
`have been reduced to levels ranging between 0.398% and 0.494% (area
`percent of bendamustine)” (id. at 33 (citing Ex. 1017 ¶ 71)), and that the
`total degradant levels in Maas would have been reduced to levels of 2.28%
`to 2.64% (area percent of bendamustine) (id. at 35–36 (citing Ex. 1017
`¶ 96)). We are not persuaded.
`At this stage of the proceeding, we are persuaded that Petitioner has
`shown sufficiently that: (1) one of ordinary skill in the art would have had a
`reason to combine the teachings of Maas, Teagarden, and other asserted
`prior art references; and (2) digital integration and pixel counting are reliable
`methods to determine the peak areas in the HPLC chromatogram of Maas.
`We nevertheless are not persuaded that the combination of Maas and
`Teagarden would have rendered all of the challenged claims obvious.
`Central to Petitioner’s obviousness challenge is its assertion that based
`on the teachings of Teagarden, an ordinary artisan would have had a
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`reasonable expectation that using the TBA/water co-solvent system would
`have reduced the amounts of bendamustine degradants by five fold. See Pet.
`33 (citing Ex. 1017 ¶ 71) (calculating the amount of HP1), 35–36 (citing
`Ex. 1017 ¶ 96) (calculating the levels of total degradants). To be sure, we
`agree with Petitioner that Teagarden teaches that the TBA/water co-solvent
`system would have reduced the amounts of bendamustine degradants.
`Indeed, Teagarden discusses the successful use of TBA/water co-solvent for
`five different pharmaceutical compositions. Ex. 1005, 3–4. The
`“approximately 4–5” fold reduction of degradation rate, however, was only
`reported—in unpublished research—for trecetilide fumarate, a composition
`for treatment of arrhythmias. Id. at 4, 18 (“Baker, D.S., 1998. Unpublished
`results.”). Petitioner does not point to sufficient evidence or provide a
`reasonable explanation why one of ordinary skill in the art would have
`extrapolated from some unpublished data about a single drug and expected
`that bendamustine degradants similarly would have been reduced “by a
`factor of approximately 4–5.” See id. at 33 (citing Ex. 1005, 4).
`As a result, we are not persuaded that applying the teaching of
`Teagarden, an ordinary artisan would have a reasonable expectation of
`success that the HP1 levels taught in Maas would have been reduced to
`0.398–0.494% (area percent of bendamustine), and that the total degradant
`levels in Maas would have been reduced to levels of 2.28–2.64% (area
`percent of bendamustine).
`In an alternative argument, Petitioner relies on the data from Table 13
`of the ’270 patent. Pet. 45–49. Table 13 in the ’270 patent reports the
`impurity profile of various lots of Ribomustin®. Ex. 1001, 30:33–44.
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`According to Petitioner, “Table 13 thus provides additional detail
`concerning the inherent properties of Ribomustin® as reported in Maas.” Id.
`at 46.
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`Applying Teagarden’s teaching of a 4–5 fold reduction in degradation
`rate, Petitioner argues, “one of skill in the art would reasonably expect that
`substituting TBA for ethanol in Ribomustin® would yield HP1 levels
`ranging between 0.19 to 0.31.” Id. at 48. As explained above, we are not
`persuaded that applying the teaching of Teagarden, an ordinary artisan
`would have a reasonable expectation of success that using TBA/water co-
`solvent would have reduced the HP1 levels “by a factor of approximately 4–
`5.” We, thus, are not persuaded that the combined teachings of Teagarden
`and Maas, as evidenced by Table 13 of the ’270 patent, render claims 1–6,
`10–13, and 16–18 obvious.
`Claim 7 requires a pharmaceutical composition of bendamustine
`hydrochloride to contain “less than or equal to 4.0% (area percent of
`bendamustine) of bendamustine degradants.” Petitioner contends that the
`levels of total bendamustine degradants in Table 13 are already within this
`recited range. Pet. 46, 48; Ex. 1017 ¶ 129. Patent Owner asserts that “Table
`13 reports the results for bendamustine that was dissolved in pure alcohol
`before being subjected to HPLC analysis. Unlike Maas, Table 13 does not
`recite the content of a reconstituted and admixed pharmaceutical
`composition.” Prelim. Resp. 46–47. We find Petitioner’s argument more
`persuasive.
`First, claim 7, unlike claim 1, does not require a reconstituted
`bendamustine pharmaceutical composition. Instead, claim 7 merely recites a
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`“pharmaceutical composition of bendamustine hydrochloride,” and thus, is
`broad enough to encompass the lyophilized drug. Indeed, claim 14 depends
`from claim 7 and further recites “the pharmaceutical composition is a
`lyophilized composition.” Thus, if Ribomustin® in the lyophilized form
`inherently contains “less than or equal to 4.0% (area percent of
`bendamustine) of bendamustine degradants,” it would satisfy the
`requirements of claim 7.
`Second, we agree with Petitioner that dissolution in methanol is
`merely part of the testing assay and does not change the fact that lyophilized
`Ribomustin® is a “pharmaceutical composition.” See Pet. 46–47.
`Third, Patent Owner is correct that samples of Ribomustin® tested in
`Table 13 of the ’270 patent were dissolved with 200 mL of methanol.
`Ex. 1001, 29:29–31, 30:33–34. At this stage of the proceeding, however,
`Petitioner has shown sufficiently that the levels of bendamustine degradants
`in Ribomustin® dissolved in methanol and then analyzed via HPLC six
`minutes after dissolution reflect the levels of bendamustine degradants in
`lyophilized Ribomustin® itself. Pet. 47.
`According to Table 13 of the ’270 patent, when dissolved in
`methanol, the levels of total bendamustine degradants in the four lots of
`Ribomustin® tested are 1.86, 2.33, 3.07, and 2.39% (area percent of
`bendamustine), respectively. See Ex. 1001, 30:36–44. Thus, evidence
`before us sufficiently indicates that the levels of total bendamustine
`degradants in lyophilized Ribomustin® are lower than those recited in claim
`7. Because they are within the “less than or equal to 4.0% (area percent of
`bendamustine)” range recited in claim 7, we are persuaded that Maas, which
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`teaches lyophilized Ribomustin®, together with Table 13 of the ’270 patent
`showing the inherent properties of Ribomustin®, renders claim 7 obvious.
`Claim 8 depends from claim 7 and further requires the level of total
`bendamustine degradants to be “between about 2.0% and 4.0% (area percent
`of bendamustine).” Table 13 shows one of the four lots of Ribomustin®
`tested as containing less than 2% (area percent of bendamustine) of
`bendamustine degradants. See id. In other words, Table 13 does not show
`the level of bendamustine degradants is necessarily “between about 2.0%
`and 4.0% (area percent of bendamustine),” as required by claim 8. As a
`result, based on the current record, we are not persuaded that Maas, together
`with Table 13 of the ’270 patent showing the inherent properties of
`Ribomustin®, renders claim 8 and its dependent claims, claims 9 and 15,
`obvious. See In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)
`(“Inherency . . . may not be established by probabilities or possibilities. The
`mere fact that a certain thing may result from a given set of circumstances is
`not sufficient.”).
`Claim 14 depends from claim 7 and further recites “the
`pharmaceutical composition is a lyophilized composition.” For the same
`reasons explained above as related to claim 7, we are persuaded that Maas,
`together with Table 13 of the ’270 patent showing the inherent properties of
`Ribomustin®, renders claim 14 obvious.
`Claim 19 depends from claim 7 and further requires the
`pharmaceutical composition to contain “not more than about 0.5% (area
`percent of bendamustine) of a compound of Formula IV.” The compound of
`Formula IV is BM1EE, a different bendamustine degradant. Ex. 1001,
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`21:48–66. Table 13 of the ’270 patent shows that the levels of BM1EE in
`Ribomustin® dissolved in methanol are 0.21, 0.20, 0.30, and 0.19% (area
`percent of bendamustine). Id. at 30:36–44. For similar reasons explained
`above as related to claim 7, we are persuaded that the levels of BM1EE in
`lyophilized Ribomustin® similarly would be within the range recited in
`claim 19.
`Claim 20 recites a “method of treating cancer in a patient comprising
`administering to the patient a pharmaceutical composition of bendamustine
`hydrochloride according to claim 7.” Petitioner refers to Maas for teaching
`Ribomustin® as “an effective chemotherapeutic drug in the treatment of
`malignant diseases.” Pet. 38 (citing Ex. 1004, 4). Based on the current
`record, we are persuaded that Maas, together with Table 13 of the ’270
`patent showing the inherent properties of Ribomustin®, renders claim 20
`obvious.
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`Obviousness over Maas, Teagarden, and Gust
`Petitioner asserts that claims 13 and 19 would have been obvious over
`Maas, Teagarden, and Gust. Pet. 49–51. Based on the current record, we
`determine Petitioner has established a reasonable likelihood that it would
`prevail in this assertion regarding claim 19, but not claim 13.
`Petitioner relies on Gust solely for the teaching related to
`bendamustine ethylester (i.e., Formula IV, or BM1EE). Pet. 50–51. In other
`words, Gust does not provide any teaching or suggestion regarding the levels
`of HP1, as recited in claim 10, from which claim 13 depends. Thus, based
`on the current record, we determine that Petitioner has not shown a
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`reasonable likelihood that it would prevail in showing claim 13 would have
`been obvious over the asserted prior art.
`As for claim 19, for the same reasons explained above as related to the
`obviousness ground over Maas and Teagarden, we are persuaded that the
`combined teachings of Maas and Gust, together with Table 13 of the ’270
`patent showing the inherent properties of Ribomustin®, renders claim 19
`obvious.
`Obviousness over Maas, Teagarden, and Ribomustin® Product Monograph
`Petitioner asserts that claims 20–23 would have been obvious over
`Maas, Teagarden, and Ribomustin® Product Monograph. Pet. 51–53.
`Petitioner refers to Ribomustin® Product Monograph for teaching
`Ribomustin® as indicated for treating Hodgkin’s disease, non-Hodgkin’s
`lymphoma, and chronic lymphocytic leukemia, as recited in claims 20–23.
`Id. at 52 (citing Ex. 1007, 8). Based on the current record, we are persuaded
`that there is a reasonable likelihood that Petitioner will show that the
`combined teachings of Maas and Ribomustin® Product Monograph,
`together with Table 13 of the ’270 patent showing the inherent properties of
`Ribomustin®, render claims 20–23 obvious.
`Obviousness over Admitted Prior Art in the ’270 Patent and Teagarden
`Petitioner further contends that claims 1–23 would have been obvious
`over the admitted prior art in the ’270 patent and Teagarden. Pet. 53–58.
`According to Petitioner, “Table 13 of the ‘270 patent and the associated
`description of Ribomustin® are properly considered ‘admitted prior art.’”
`Id. at 54. Patent Owner counters that the alleged “admitted prior art” does
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`not constitute prior art. Prelim. Resp. 51–53. We find Patent Owner’s
`argument more persuasive.
`In this challenge, Petitioner relies on Ribomustin®, the drug itself, as
`prior art. Pet. 53–58. We agree with Patent Owner that a petition for an
`inter partes review must be “only on the basis of prior art consisting of
`patents or printed publications.” U.S.C § 311(b); Prelim. Resp. 52. Based
`on the current record, we are not persuaded that either the Ribomustin®
`product or the description of Ribomustin® in the ’270 patent qualifies as
`prior art on which we may institute an inter partes review. Also, as
`discussed above, Teagarden does not teach or suggest Ribomustin® or a
`composition comprising bendamustine. Thus, we are not persuaded that
`there is a reasonable likelihood that Petitioner would prevail with respect to
`a challenged claim on a ground based on the Ribomustin® product and the
`description thereof in the ’270 patent and Teagarden.
`CONCLUSION
`For the foregoing reasons, the information presented in the Petition
`and accompanying evidence establishes a reasonable likelihood that
`Petitioner would prevail in showing the unpatentability of claims 7, 14, and
`19–23 of the ’270 patent. The information presented in the Petition and
`accompanying evidence, however, does not establish a reasonable likelihood
`that Petitioner would prevail in showing the unpatentability of claims 1–6,
`8–13, and 15–18 of the ’270 patent.
`
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`17
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`
`IPR2016-00098
`Patent 8,791,270 B2
`
`
`ORDER
`
`Accordingly, it is
`ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is
`hereby instituted on the following grounds:
`1. claims 7, 14, 19, and 20 as obvious over Maas and Teagarden;
`2. claim 19 as obvious over Maas, Teagarden, and Gust; and
`3. claims 20–23 as obvious over Maas, Teagarden, and Ribomustin®
`Product Monograph;
`FURTHER ORDERED that no other ground of unpatentability is
`authorized in this inter partes review; and
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`partes review of the ’270 patent is hereby instituted commencing on the
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of a trial.
`
`
`
`PETITIONER:
`Lawrence Sung
`lsung@wileyrein.com
`Neal Seth
`nseth@wileyrein.com
`
`
`PATENT OWNER:
`Soumitra Deka
`Soumitra.deka@kayescholer.com
`
`18
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