Trials@uspto.gov
`571-272-7822
`
`Paper No. 10
`Entered: May 4, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`FRESENIUS KABI USA, LLC,
`
`Petitioner,
`
`V.
`
`CEPIIALON, 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.
`
`”
`
`DECISION
`
`Institution of Inter Partes Review
`
`37 CFR. § 42.108
`
`
`571-272-7822
`
`Paper No. 10
`Entered: May 4, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`FRESENIUS KABI USA, LLC,
`
`Petitioner,
`
`V.
`
`CEPIIALON, 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.
`
`”
`
`DECISION
`
`Institution of Inter Partes Review
`
`37 CFR. § 42.108
`
`
`
`IPR2016-00098
`
`Patent 8,791,270 R2
`
`INTRODUCTION
`
`Fresenius Kabi USA, LLC (“Petitioner”) filed a Petition for an inter
`
`partes review of claims 1—23 of US. 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
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`partes review of these claims. Petitioner, however, has not established a
`
`reasonable likelihood that it would prevail in showingthe unpatentability of
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`claims 1—6, 8—13, and 15—18. Therefore, we deny the Petition regarding the
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`challenges to those claims.
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`Related Proceedings
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`According to the parties, the ’270 patent is the subject of several cases
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`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
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`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 US. Patent No.
`
`8,436,190 B2, a patent in the same family as the ’270 patent. Agila
`
`2
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`
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`1PR2016-00098
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`Patent 8,791,270 B2
`
`Specialties Inc. v. Cephalon, Inc., Case IPR2015-00503, Paper 4. There, we
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`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
`
`US. Patent No. 8,895,756 B2. Fresenius Kabz' USA, LLC v. Cephalon, Ina,
`
`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 ’2 70 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
`
`211—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 2:559.
`
`According to the ’270 patent, “[b]endamustine degrades rapidly in
`
`water alone and forms predominantly the hydrolysis product, HPl
`
`(monohydroxy bendamustine)” Id. at 21 :3—5. Other degradants include the
`
`dimer of bendamustine (BMl dimer), bendamustine ethylester(BM1EE),
`
`and BMlDCE. Id. at 21:30—50.
`
`
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`IPR2016-00098
`
`Patent 8,791,270 B2
`
`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.
`
`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 HI’l:
`
`(um
`
`Hod
`
`N
`
`\ N
`
`0
`
`Cl’
`
`\/ 1‘:
`\
`
`bendamustine
`of
`composition
`A pharmaceutical
`7.
`to 4.0% (area
`hydrochloride, containing less than or equal
`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:
`
`
`
`IPR2016-00098
`
`,
`
`Patent 8,791,270 B2
`
`20. A method of treating cancer in a patient comprising I
`administering to the patient a pharmaceutical composition of
`bendamustine hydrochloride according to claim 7.
`'
`
`I Each of claims 21—23 is a method claim that depends directly from
`
`claim 20.
`
`Asserted Grounds of Unpatentability
`
`
`
`
`
`
`3 3
`
`
`
`
`Petitioner asserts the following grounds of unpatentability:
`
`___-m
`—l- Maas‘ and Tea-arden 2
`mm
`“nu“..I-..
`-.
`.1 n .43 ,,,.,,.,_
`
`,.
`1 19,
`,
`- 1V1aab,Tca uiucu, 'culu uubl.
`
`
`2
`
`
`
`
`1—23
`
`Admitted prior art in the ’270 patent and
`Tea arden
`
`
`Ribomustin® Product Mono rah4
`
`In support of its patentability challenge, Petitioner relies on the
`
`Declarations of Drs. Michael J. Akers and Bernard Olsen. Exs. .1013, 1017.
`
`1 Maas et al., Stability ofBendamustine Hydrochloride in Infusion Solutions, -
`49 PHARMAZIE 775—77 (1994) (EX. 1004, “Maas”).
`2 Teagarden and Baker, Practical Aspects ofLyophilization 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 ofBendamustin, a
`Cytostatic Agent ofthe Nitrogen Mustard Type, I. Synthesis, Isolation, and
`Characterization ofReference Substances, 128 CHEMICAL MONTHLY 291—
`99 (1997) (Ex. 1006, “Gust”).
`4 Ribomustin® Product Monograph, 2002 (Ex. 1007).
`5
`
`
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`IPR2016-00098
`
`Patent 8,791,270 B2
`
`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
`5, 6‘
`
`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
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`pharmaceutical composition “that has been dissolved in a solvent or
`
`diluent.” See Pet. 20—21.
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`
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`IPR2016-00098
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`Patent 8,791,270 B2
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`Prior Art Disclosures
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`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
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`made up solutions .
`
`.
`
`. must be injected immediately after their preparation.”
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`Id. at 5. In a stability test, Maas identified bendamustine hydrochloride by
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`reverse—phase HPLC. Id.
`
`Teagarden teaches that using non-aqueous co-solvent systems in
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`freeze-drying pharmaceutical products has numerous advantages, including
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`“increased pre-dried bulk solution or dried product stability.” Ex. 1005, 1.
`Specifically, Teagarden teaches that the tert—butanol (“TBA”)/water co-
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`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,
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`bendamustine is synthesized by cleaving dichloroester5 with HCl, whereas
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`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®
`
`5 According to Petitioner, dichloroester in Gust is the same as bendamustine
`ethylester(BM1EE) in the ’270 patent. Pet. 50.
`7
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`
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`IPR2016-00098
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`Patent 8,791,270 B2
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`is used for treating Hodgkin’s disease (stages II — IV), non-Hodgkin’s
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`lymphoma, and chronic lymphocytic leukemia. Id.
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`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
`
`'l‘eagarden for teaching using TBA to improve the stability of unstable drugs
`
`in solution. Id. at 25. According to Petitioner, Teagarden discusses the
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`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
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`contends, one of ordinary skill in the art, motivated to improve the stability
`
`of Ribomustin®, would have combined the tcachings of Maas and
`
`Teagarden. Id. at 25—27.
`
`Each of claims 1—6, 10—13, and 16—18 recites the amount of HPl 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 HPl and bendamustine degradants in
`
`bendamustine. Id. at 30—33.
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`
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`IPR2016-00098
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`Patent 8,791,270 B2
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`Specifically, Petitioner points out that the chromatogram in Maas
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`shows two degradants—a “monohydrolysis product,” which corresponds to
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`I-IPl, and an “unknown” degradant, which was a “byproduct from
`
`synthesis.” Id. at 30 (citing Ex. 1004, 5). According to Petitioner,
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`“[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
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`determine area percent bendamustine) for the two degradants in a number of
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`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
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`(2) counting the number of pixels under each peak. Id. at 30—31 (citing
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`Ex. 1017 1[ 63).
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`Petitioner presents the data Dr. Olsen obtained using these two
`
`methods:
`
`
`Peak
`
`
`
`
`
`
`
`7 Integration
`
`
`
`Pixel
`
`"
`
`
`
`
`
`Total
`4.43 — 4.81
`4.14 — 4.63-
`
`
`1d. at 32 (citing EX. 1017 1] 69). Based on these data, Petitioner concludes,
`
`the area percent of bendamustine for HP] ranges between 1.99% and 2.47%
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`(1d. at "52—33 (citing Ex. 1017 11 70)), and the total degradants in Maas ranges
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`IPR2016-00098
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`Patent 8,791,270 B2
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`from approximately 4.14% to 4.81% (area percent of bendamustine) (id. at
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`35 (citing Ex. 1017 11 95)).
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`In addition, Petitioner argues, Teagarden teaches the TBA/water co-
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`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
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`rate of degradation would correspond to a 4—5 fold reduction in the amount
`
`of degradants. Id. at 33 n.4 (citing Ex. 1017 11 71). Thus, applying the
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`teaching of Teagarden, Petitioner argues, “one of ordinary skill would have a
`
`reasonable expectation of success that the HPl 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 11 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
`
`11 96)). We are not persuaded.
`
`-
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`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.
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`We nevertheless are not persuaded that the combination of Maas and
`
`Teagarden would have rendered all of the challenged claims obvious.
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`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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`10
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`1PR2016-00098
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`Patent 8,791,270 BZ
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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.
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`33 (citing Ex. 1017 ‘H 71) (calculating the amount of HPl), 35—36 (citing
`
`Ex. 1017 1[ 96) (calculating the levels of total degradants). To be sure, we
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`agree with Petitioner that Teagarden teaches that the TBA/water co-solvent
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`system would have reduced the amounts of bendamustine degradants.
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`Indccd, Teagarden discusses the successful use of TBA/water co-solvent for
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`five different pharmaceutical compositions. Ex. 1005, 3—4. The
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`“approximately 4—5” fold reduction of degradation rate, however, was only
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`reported—in unpublished research—for trecetilide fumarate, a composition
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`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
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`that bendamustine degradants similarly would have been reduced “by a
`
`factor of approximately 4—5.” See id. at 33 (citing Ex. 1005, 4).
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`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 HPl 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
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`impurity profile of various lots of Ribomustin®. Ex. 1001, 30:33—44.
`11
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`1PR2016-00098
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`Patent 8,791,270 B2
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`According to Petitioner, “Table 13 thus provides additional detail
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`concerning the inherent properties of Ribomustin® as reported in Maas.” 1d.
`
`at 46.
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`Applying Teagarden’s teaching of a 4—5 fold reduction in degradation
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`rate, Petitioner argues, “one of skill in the art would reasonably expect that
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`substituting TBA for ethanol in Ribomustin® would yield HPl levels
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`ranging between 0.19 to 0.31.” Id. at 48. As explained above, we are not
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`persuaded that applying the teaching of Teagarden, an ordinary artisan
`
`would have a reasonable expectation of success that using TBA/water co—
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`solvent would have reduced the HPl levels “by a factor of approximately 4—
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`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,
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`10—13, and 16—18 obvious.
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`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
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`levels of total bendamustine degradants in Table 13 are already within this
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`recited range. Pet. 46, 48; Ex. 1017 1] 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
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`recite the content of a reconstituted and admixed pharmaceutical
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`composition.” Prelim. Resp. 46—47. We find Petitioner’s argument more
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`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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`12
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`IPR2016-00098
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`Patent 8,791,270 R9.
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`“pharmaceutical composition of bendamustine hydrochloride,” and thus, is
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`broad enough to encompass the lyophilized drug. Indeed, claim 14 depends
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`from claim 7 and further recites “the pharmaceutical composition is a
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`lyophilized composition.” Thus, if Ribomustin® in the lyophilized form
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`inherently contains “less than or equal to 4.0% (area percent of
`
`bendamustine) of bendamustine degradants,” it would satisfy the
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`requirements of claim 7.
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`Second, we agree with Petitioner that dissolution in methanol is
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`merely part of the testing assay and does not change the fact that lyophilized
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`Ribomustin® is a “pharmaceutical composition.” See Pet. 46—47.
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`Third, Patent Owner is correct that samples of Ribomustin® tested in
`
`Table 13 of the ’270 patent were dissolved with 200 mL of methanol.
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`Ex. 1001, 29129—3 1, 30:33—34. At this stage of the proceeding, however,
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`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
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`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
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`Ribomustin® tested are 1.86, 2.33, 3.07, and 2.39% (area percent of
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`bendamustine), respectively. See Ex. 1001, 30:36—44. Thus, evidence
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`before us sufficiently indicates that the levels of total bendamustine
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`degradants in lyophilized Ribomustin® are lower than those recited in clalm
`
`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
`
`13
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`IPR2016—00098
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`Patent 8,791,270 132
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`teaches lyophilized Ribomustin®, together with Table 13 of the ’270 patent
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`showing the inherent properties of Ribomustin®, renders claim 7 obvious.
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`Claim 8 depends from claim 7 and further requires the level of total
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`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
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`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
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`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
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`pharmaceutical composition to contain “not more than about 0.5% (area
`
`percent of bendamustine) of a compound of Formula IV.” The compound of
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`Formula IV is BMlEE, a different bendamustine degradant. Ex. 1001,
`
`14
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`IPR2016-00098
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`Patent 8,791,270 B2
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`21:48—66. Table 13 of the ’270 patent shows that the levels of BMlEE in
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`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 BMlEE in
`
`1y0philized 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.
`
`Obviousness over Maas, Teagarden, and Gust
`
`Petitioner asserts that claims 13 and 19 would have been obvious over
`
`Maas, ‘1'eagarden, and Gust. Pet. 49—5 1. 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 BMlEE). Pet. 50—51. In other
`
`words, Gust does not provide any teaching or suggestion regarding the levels
`
`of HPl, as recited in claim 10, from which claim 13 depends. ’l'hus, based
`
`on the current record, we determine that Petitioner has not shown a
`
`15
`
`
`
`1PR2016—00098
`
`Patent 8,791,270 B2
`
`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 ’2 70 Patent and Teagarderz
`
`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.’”
`
`1d. at 54. Patent Owner counters that the alleged “admitted prior art” does
`
`16
`
`
`
`IPR2016-00098
`
`Patent 8,791,270 B2
`
`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 ofthe ’270 patent.
`
`l7
`
`
`
`IPR2016-00098
`
`Patent 8,791,270 B2
`
`Accordingly, it is
`
`ORDER
`
`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 revicw; 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(0) and 37 CPR.
`
`§ 42.4, notice is hereby given of the institution of a trial.
`
`PETITIONER:
`
`Lawrence Sung
`lsung@wileyrein.com
`Neal Seth
`
`nseth@wi1eyrein.com
`
`PATENT OWNER:
`
`Soumitra Deka
`
`SOumitra.deka@kaycscholer.com
`
`18
`
`
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