Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 14
`
` Entered: August 25, 2015
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`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-00644
`Patent 8,399,413 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 14
`
` Entered: August 25, 2015
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-00644
`Patent 8,399,413 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`IPR2015-00644
`Patent 8,399,413 B2
`
`
`INTRODUCTION
`
`
`I.
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a corrected Petition
`
`requesting an inter partes review of claims 1–20 of U.S. Patent No.
`
`8,399,413 B2 (Ex. 1001, “the ’413 patent”). Paper 8 (“Pet.”). Yeda
`
`Research & Development Co. Ltd. (“Patent Owner”) filed a Preliminary
`
`Response to the Petition. Paper 12 (“Prelim. Resp.”).
`
`We have jurisdiction 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
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`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 1–20. Accordingly, we institute an inter partes
`
`review of those claims.
`
`A.
`
`Related Proceedings
`
`Petitioner states that it is a defendant in several litigations involving
`
`the ’413 patent. Pet. 2. Petitioner also identifies numerous other cases
`
`against other defendants involving the ’413 patent. Id.
`
`Petitioner has also filed petitions for inter partes review of related
`
`patents in IPR2015-00643 (US 8,232,250 B2) and IPR2015-00830
`
`(US 8,969,302 B2).
`
`B.
`
`The ’413 Patent
`
`Multiple sclerosis (“MS”) is a chronic, autoimmune disease of the
`
`central nervous system. Ex. 1001, 1:16–18. There are five main forms of
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`MS, including Relapsing-Remitting Multiple Sclerosis (“RRMS”). Id.
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`2
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`IPR2015-00644
`Patent 8,399,413 B2
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`at 1:29. Patients suffering from RRMS experience sporadic exacerbations or
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`relapses, as well as periods of remission. Id. at 1:30–31.
`
`Glatiramer acetate (“GA” or “copolymer-1”) is a mixture of
`
`polypeptides that do not all have the same amino acid sequence, and is
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`marketed as Copaxone ®. Id. at 1:53–54. Administering 20 mg per day of
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`Copaxone is an FDA-approved therapy for patients with RRMS. Id.
`
`at 2:13–16. The ’413 patent discloses “an effective low frequency dosage
`
`regimen of GA administration to patients suffering from a relapsing form of
`
`[MS], including patients who have experienced a first clinical episode and
`
`have MRI features consistent with [MS].” Id. at 2:43–47. The disclosed
`
`method comprises administering to a patient suffering from RRMS three
`
`subcutaneous injections of a therapeutically effective dose of GA over a
`
`period of seven days with at least one day between every subcutaneous
`
`injection so as to thereby alleviate a symptom of the patient. Id. at 2:51–60.
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–20 of the ’413 patent. Claim 1 is
`
`illustrative and is reproduced below:
`
`1. A method of reducing the frequency of relapses in a
`human patient suffering from relapsing-remitting multiple
`sclerosis or a patient who has experienced a first clinical
`episode and has MRI features consistent with multiple sclerosis
`comprising administering to the human patient a therapeutically
`effective dosage regimen of three subcutaneous injections of 1
`ml of a pharmaceutical composition comprising 40 mg of
`glatiramer acetate over a period of seven days with at least one
`day between every subcutaneous injection, the regimen being
`sufficient to reduce the frequency of relapses in the patient.
`
`3
`
`
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`IPR2015-00644
`Patent 8,399,413 B2
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`D.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–20 of the
`
`’413 patent on the following grounds:
`
`References
`
`Pinchasi1
`
`Pinchasi
`
`Basis
`
`§ 102
`
`§ 103
`
`Pinchasi and the 1996 SBOA2
`
`§ 103
`
`Pinchasi and Flechter3
`
`§ 103
`
`
`
`Claims challenged
`
`1–6 and 8–20
`
`1–20
`
`1–20
`
`1–20
`
`
`II.
`
`ANALYSIS
`
`A.
`
`Person of Ordinary Skill in the Art
`
`The parties dispute the proper definition of a person of ordinary skill
`
`in the art. Petitioner contends that a person of ordinary skill in the art would
`
`have had (1) several years of experience in the pharmaceutical industry or in
`
`practicing medicine; (2) experience with the administration or formulation of
`
`therapeutic agents, dosing schedules and frequencies, and drug
`
`developmental study and design; and (3) a Ph.D. in pharmacology or be a
`
`physician with experience in clinical pharmacology. Pet. 12. Patent Owner
`
`disagrees with Petitioner’s definition because it does not include experience
`
`
`1 Irit Pinchasi, WO 2007/081975 A2, published July 19, 2007 (Ex. 1005).
`
`2 Summary Basis of Approval (“SBOA”) for the New Drug Application for
`20 mg daily Copaxone ® (NDA #20-622) (Ex. 1007).
`
`3 S. Flechter et al., Copolymer 1 (Glatiramer Acetate) in Relapsing Forms of
`Multiple Sclerosis: Open Multicenter Study of Alternate-Day
`Administration, 25 CLINICAL NEUROPHARM. 11–15 (2002) (Ex. 1008).
`
`4
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`IPR2015-00644
`Patent 8,399,413 B2
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`with MS or GA, which, according to Patent Owner, are both requirements
`
`for a person of ordinary skill in the art. Prelim. Resp. 34–35.
`
`We agree with Patent Owner that a person of ordinary skill in the art
`
`should have experience with MS and GA. We note that one of Petitioner’s
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`declarants, Dr. Ari Green, states that a person of ordinary skill in the art
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`would have “direct experience administering therapeutic agents for the
`
`treatment of MS, as well as familiarity with the dosing schedules and
`
`frequencies of the different therapeutic agents available for MS treatment.”
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`Ex. 1004 ¶ 27. Patent Owner does not otherwise dispute Petitioner’s
`
`definition. Prelim. Resp. 34–35.
`
`Accordingly, we adopt Petitioner’s definition of a person of ordinary
`
`skill in the art, with the addition that that person would also have experience
`
`with MS and GA.
`
`B.
`
`Claim Construction
`
`In an inter partes review, the Board interprets claim terms in an
`
`unexpired patent according to the broadest reasonable construction in light
`
`of the specification of the patent in which they appear. See In re Cuozzo
`
`Speed Techs., LLC, No. 2014-1301, 2015 WL 4097949, at *5–*8 (Fed. Cir.
`
`July 8, 2015); 37 C.F.R. § 42.100(b). Under that standard, and absent any
`
`special definitions, we 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).
`
`Each of the claims of the ’413 patent recites administering a
`
`“therapeutically effective dosage regimen of three subcutaneous injections
`
`5
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`IPR2015-00644
`Patent 8,399,413 B2
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`of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer
`
`acetate over a period of seven days with at least one day between every
`
`subcutaneous injection.” The parties dispute whether the claims encompass
`
`a dosage regimen that can include more than three subcutaneous injections
`
`within seven days, or if they are limited to a dosage regimen with only three
`
`subcutaneous injections over seven days. Petitioner argues the former
`
`construction, whereas Patent Owner argues the latter.
`
`More specifically, Petitioner argues that the use of the open-ended
`
`“comprising” transition supports its proposed construction. Pet. 14.
`
`Petitioner also argues that the term “a regimen,” which is not defined by the
`
`Specification, does not limit the open-ended nature of “comprising.” Id. at
`
`14–15. Thus, Petitioner concludes that “the use of the open-ended transition
`
`‘comprising’ coupled with the use of the indefinite article ‘a’ before
`
`‘regimen’ reinforces that the independent claims are each open-ended and
`
`allow for additional, unrecited elements to fall within the scope of the
`
`claim.” Id. at 15.
`
`Patent Owner disagrees. Patent Owner argues that Petitioner
`
`improperly uses the “comprising” transition to “reach into subsequent
`
`individual method step limitations and render each of them open-ended.”
`
`Prelim. Resp. 28–29 (citing Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337,
`
`1343 (Fed. Cir. 2007)). Patent Owner also argues that the applicant
`
`expressly disclaimed dosage regimens with alternate-day administration
`
`during prosecution. As noted by Patent Owner, the examiner rejected the
`
`claims as anticipated by Flechter, which discloses administration of
`
`copolymer-1 “in an alternate-day administration schedule for up to two
`
`years.” Id. at 24–25 (quoting Ex. 1002, 92). In response, the applicant
`
`amended the claims to require a therapeutically effective “regimen,” and
`
`6
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`IPR2015-00644
`Patent 8,399,413 B2
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`argued that Flechter did not disclose “a ‘regimen’ requiring administration
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`3 times during a seven day period because the treatment protocol of Flechter
`
`et al. results in four administrations every other successive seven day
`
`period.” Id. (quoting Ex. 1002, 186) (emphasis omitted). In other words,
`
`the applicant expressly disclaimed Flechter’s alternate-day administration of
`
`copolymer-1.
`
`At this stage of the proceeding, we are persuaded that Patent Owner’s
`
`construction constitutes the broadest reasonable interpretation of the claims.
`
`We agree with Patent Owner that, while the term “comprising” allows for
`
`additional steps in the claimed method, the term does not “reach into each
`
`[limitation] to render every word and phrase therein open-ended.” Dippin’
`
`Dots, 476 F.3d at 1343. Thus, we do not find that the term “comprising”
`
`requires us to construe the claims to encompass more than three
`
`subcutaneous injections of 40 mg of GA over a period of seven days, as
`
`Petitioner contends.
`
`Moreover, in determining the broadest reasonable interpretation of a
`
`claim, the Federal Circuit stated that we cannot construe claims “so broadly
`
`that [our] constructions are unreasonable under general claim construction
`
`principles.” See Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298
`
`(Fed. Cir. 2015). Thus, the court instructed that we should “also consult the
`
`patent’s prosecution history in proceedings in which the patent has been
`
`brought back to the agency for a second review.” Id.; see also Tempo
`
`Lighting, Inc. v. Tivoli, LLC, 742 F.3d 978 (Fed. Cir. 2014) (affirming the
`
`Board’s application of prosecution history disclaimer). Here, we agree with
`
`Patent Owner that, during prosecution, the applicant clearly disavowed
`
`administering the drug on alternate days by amending and distinguishing its
`
`claims over the prior art.
`
`7
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`IPR2015-00644
`Patent 8,399,413 B2
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`Accordingly, we determine that the broadest reasonable interpretation
`
`of the claims does not encompass a dosage regimen that alternates days over
`
`a period of seven days (i.e., one that administers the drug three times in one
`
`week and four times the next).
`
`C.
`
`Anticipation by Pinchasi
`
`Petitioner asserts that claims 1–6 and 8–20 are anticipated by
`
`Pinchasi. Pet. 20–45. Petitioner relies on the testimony of two declarants,
`
`Dr. Stephen J. Peroutka (Ex. 1003) and Dr. Ari Green (Ex. 1004). Patent
`
`Owner opposes Petitioner’s assertion. Prelim. Resp. 32–33. Based on the
`
`current record, we determine that Petitioner has not established a reasonable
`
`likelihood that it would prevail in showing the claims are anticipated by
`
`Pinchasi.
`
`1.
`
`Pinchasi (Ex. 1005)
`
`Pinchasi is a published PCT application that relates to a method of
`
`alleviating a symptom of a patient suffering from a relapsing form of MS.
`
`Ex. 1005, 9.4 The method comprises periodically administering by
`
`subcutaneous injection a 40 mg dose of GA. Id. Pinchasi discloses that the
`
`GA can be administered daily or every other day. Id. Pinchasi also
`
`discloses that the alleviated symptom can be the frequency of relapses. Id.
`
`2.
`
`Analysis
`
`Petitioner argues that Pinchasi discloses each limitation of claims 1–6
`
`and 8–20. For example, for independent claims 1, 19, and 20, Petitioner
`
`argues that Pinchasi’s disclosure of 40 mg injections of GA every other day
`
`
`4 Unless stated otherwise, we cite to the unique page numbers provided by
`the parties in the lower right hand corner of the exhibits, pursuant to
`37 C.F.R. 42.63(d)(2). For purposes of clarity, we suggest the parties do the
`same in future filings.
`
`8
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`IPR2015-00644
`Patent 8,399,413 B2
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`discloses the limitation requiring three injections over seven days with at
`
`least one day in between every injection. Pet. 22–26. As explained above,
`
`however, we do not construe the claims so broadly. That is, at this stage of
`
`the proceeding, we determine that the broadest reasonable interpretation of
`
`each of the claims does not encompass Pinchasi’s disclosure of GA
`
`injections every other day. Accordingly, we conclude that Petitioner has
`
`failed to establish a reasonable likelihood that it would prevail in showing
`
`that Pinchasi anticipates claims 1–6 and 8–20.
`
`D. Obviousness over Pinchasi and the 1996 SBOA
`
`Petitioner argues that claims 1–20 are unpatentable as obvious over
`
`Pinchasi and the 1996 SBOA. Pet. 51–55. Patent Owner opposes. Prelim.
`
`Resp. 34–53. Based on the current record, we determine that Petitioner has
`
`established a reasonable likelihood that it would prevail in showing claims
`
`1–20 are unpatentable over Pinchasi and the 1996 SBOA.
`
`1.
`
`The 1996 SBOA (Ex. 1007)
`
`The 1996 SBOA is a compilation of documents relating to the
`
`Summary Basis of Approval for the New Drug Application (“NDA”) for 20
`
`mg Copaxone®. The compilation includes a review and evaluation of
`
`clinical data submitted by the sponsor of the NDA, Teva Pharmaceuticals,
`
`USA (“Teva”). Ex. 1007, 24–124. It also includes a review of the
`
`pharmacology and toxicology studies submitted by Teva. Id. at 125–292.
`
`The NDA was approved on December 20, 1996. Id. at 4.
`
`2.
`
`Analysis
`
`a. Whether the 1996 SBOA Is Prior Art
`
`As support for its contention that the 1996 SBOA is prior art,
`
`Petitioner included a declaration from Marlene S. Bobka, the president of
`
`FOI Services, Inc., which provided the 1996 SBOA to Petitioner.
`
`9
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`IPR2015-00644
`Patent 8,399,413 B2
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`Ex. 1007, 1. Ms. Bobka states that FOI Services specializes in U.S. Food &
`
`Drug Administration (“FDA”) information and “maintains a private library
`
`of over 150,000 FDA documents obtained under the Freedom of Information
`
`Act.” Id. Ms. Bobka further states that FOI Services sells the documents
`
`and provided the 1996 SBOA to Petitioner on July 17, 2007. Id.
`
`Patent Owner argues that this evidence is not sufficient for Petitioner
`
`to establish that the 1996 SBOA is a “printed publication” under 35 U.S.C.
`
`§ 102(b). Prelim. Resp. 48–49. Specifically, Patent Owner argues that the
`
`1996 SBOA was not published by the FDA, and that Ms. Bobka’s
`
`declaration is insufficient to show that the 1996 SBOA was publicly
`
`available before the earliest possible priority date of the ’413 patent. Prelim.
`
`Resp. 49–50.
`
`At this stage of the proceedings, we are persuaded that Petitioner has
`
`set forth sufficient evidence that the 1996 SBOA constitutes prior art to the
`
`’413 patent. That is, we are persuaded—for purposes of this Decision—that
`
`the 1996 SBOA was sufficiently accessible to the public at least by July 17,
`
`2007, when Ms. Bobka states FOI Services provided the 1996 SBOA to
`
`Petitioner, and which is before the earliest possible critical date of the ’413
`
`patent (i.e., August 20, 2008). See Voter Verified, Inc. v. Premier Election
`
`Solutions, 698 F.3d 1374, 1380 (Fed. Cir. 2012) (“[T]he key inquiry is
`
`whether the reference was made ‘sufficiently accessible to the public
`
`interested in the art’ before the critical date.’”) (quoting In re Cronyn, 890
`
`F.2d 1158, 1160 (Fed. Cir. 1989)).
`
`b.
`
`Obviousness Analysis
`
`Petitioner asserts that claims 1–20 are unpatentable as obvious over
`
`Pinchasi and the 1996 SBOA. For example, regarding claim 1, Petitioner
`
`asserts that Pinchasi discloses each limitation of the claim, except for the
`
`10
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`IPR2015-00644
`Patent 8,399,413 B2
`
`dosing regimen of three doses per seven day period. Specifically, Petitioner
`
`argues that Pinchasi teaches the preamble of claim 1 by disclosing that the
`
`invention provides a method of alleviating a symptom of a patient suffering
`
`from a relapsing form of MS, where the symptom is the “frequency of
`
`relapses.” Pet. 21 (citing Ex. 1005, 8:2–4, 14–15). Regarding the dosage
`
`amount, Petitioner asserts that Pinchasi teaches administering a
`
`subcutaneous injection of a pharmaceutical composition comprising 40 mg
`
`of GA and 40 mg of Mannitol USP in 1 mL sterilized water. Id. at 22–23
`
`(citing Ex. 1005, 5:2–8, 13:21–24, Example 1). Based on the current record,
`
`we are persuaded that Petitioner has shown sufficiently that Pinchasi teaches
`
`each limitation of claim 1, except the dosing frequency.
`
`Petitioner argues that the dosing frequency would have been obvious
`
`over Pinchasi and the 1996 SBOA because the 1996 SBOA teaches that the
`
`half-life for Copaxone® is approximately 80 hours in a monkey, which,
`
`according to Petitioner and its declarant, is a reliable model for predicting
`
`human pharmacokinetic parameters and creating dosing schedules. Pet. 52
`
`(citing Ex. 1007, 197; Ex. 1003, ¶¶ 127, 133, 136–38). Petitioner also notes
`
`that the 1996 SBOA questions whether daily injections are necessary and
`
`that a reviewer “recommend[ed] that [Teva] evaluate the necessity of daily
`
`[subcutaneous] injections as opposed to more infrequent intermittent
`
`administration of the drug.” Pet. 52 (citing Ex. 1007, 252). Given these
`
`teachings of the 1996 SBOA, Petitioner argues that a person of ordinary skill
`
`in the art would have understood that the “injection frequencies [of
`
`Copaxone®] could be reduced as far as approximately once every 80 hours
`
`while maintaining the same safety and tolerability profiles.” Id. (citing
`
`Ex. 1003 ¶¶ 139–41). Accordingly, Petitioner and its declarants assert that a
`
`person of ordinary skill in the art would have expected both 40 mg of GA
`
`11
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`IPR2015-00644
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`three times over a seven-day period and 20 mg daily to provide the same
`
`therapeutic profile to a patient. Id. (citing Ex. 1003 ¶¶ 145–47; Ex. 1004
`
`¶¶ 103–04).
`
`Petitioner also argues that it would have been obvious to a person of
`
`ordinary skill in the art to modify Pinchasi’s alternate-day injection schedule
`
`to three times in seven days to reduce the number of injections and thereby
`
`reduce the frequency of side effects. Id. at 46–47 (citing Ex. 1004 ¶¶ 103–
`
`04, 109). According to Petitioner, administering the drug three times in
`
`seven days would also allow for a more convenient dosing schedule, which
`
`would improve patient compliance. See id. at 46–47 (citing Ex. 1004
`
`¶¶ 103–05; Ex. 1003 ¶¶ 107–10).
`
`Patent Owner makes several arguments in response, which we address
`
`below. But based on the current record, we conclude that Petitioner has
`
`established a reasonable likelihood of prevailing on its assertion that claim 1
`
`is unpatentable as obvious over Pinchasi and 1996 SBOA. We have
`
`considered the parties’ arguments and evidence with respect to the
`
`remaining claims, and we determine that Petitioner has made a sufficient
`
`showing as to those claims, as well.5
`
`E. Obviousness over Pinchasi and Flechter
`
`Petitioner argues that claims 1–20 of the ’413 patent are obvious over
`
`Pinchasi and Flechter. Pet. 55–56. Patent Owner opposes. Prelim.
`
`
`5 We recognize that Patent Owner argues that Petitioner “did not set forth
`any specific argument that the limitations of dependent claims 6 and 14–18
`are rendered obvious over the prior art.” Prelim. Resp. 51. We disagree.
`Petitioner argues that the additional limitations of those dependent claims
`are taught by Pinchasi, and that the claims are obvious over the cited
`references. Pet. 28–32. Thus, on this record, we find that Petitioner has
`shown sufficiently that the claims are obvious over the cited references.
`
`12
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`Resp. 34–53. Based on the current record, we determine that Petitioner has
`
`established a reasonable likelihood that it would prevail in showing claims
`
`1–20 are unpatentable over Pinchasi and Flechter.
`
`1.
`
`Flechter (Ex. 1008)
`
`Flechter discloses the results of a multicenter study treating patients
`
`with relapsing MS with 20 mg doses of copolymer-1 on alternate days.
`
`Ex. 1008, 1.6 Flechter states that the results of the trial “suggest that
`
`alternate-day treatment with Copolymer 1 is safe, well tolerated, and
`
`probably as effective as daily Copolymer 1 in reducing relapse rate and
`
`slowing neurologic deterioration.” Id. at 5. Flechter concedes, however,
`
`that its study “was uncontrolled,” that its conclusions “cannot be used to
`
`prove efficacy,” and that “these preliminary observations will have to be
`
`examined in larger studies.” Id.
`
`2.
`
`Analysis
`
`Petitioner argues that claims 1–20 are unpatentable as obvious over
`
`the combination of Pinchasi and Flechter. As above with respect to the 1996
`
`SBOA, Petitioner asserts that Pinchasi teaches each of the limitations of the
`
`claims, except the dosing frequency of three injections per week. And, as
`
`above, we are persuaded by Petitioner’s argument at this stage of the
`
`proceeding.
`
`Petitioner then argues that the dosing frequency would have been
`
`obvious because a person of ordinary skill in the art would have recognized
`
`that the GA dosage from the claimed dosing frequency of three times per
`
`
`6 Because the original pagination of Flechter (Ex. 1008) has unique page
`numbers, it was unnecessary to repaginate the exhibit under 37 C.F.R.
`§ 42.63(d)(2). For purposes of consistency, however, we will continue to
`cite to the pagination provided by the parties.
`
`13
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`IPR2015-00644
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`week falls within the alternate-day 40 mg dosage regimen of Pinchasi and
`
`the alternate-day 20 mg dosage regimen of Flechter. Pet. 55 (citing
`
`Ex. 1003 ¶ 154). Petitioner further argues that a person of ordinary skill in
`
`the art would have been motivated to set a course of treatment for the same
`
`day each week, for example on Monday, Wednesday, and Friday, to increase
`
`compliance with the dosage regimen. Id. (citing Ex. 1005 ¶¶ 115–16, 18).
`
`Patent Owner makes several arguments in response, which we address
`
`below. Based on the current record, however, we conclude that Petitioner
`
`has established a reasonable likelihood that it would prevail on its assertion
`
`that claim 1is unpatentable as obvious over Pinchasi and Flechter. We have
`
`considered the parties’ arguments and evidence with respect to the
`
`remaining claims, and we determine that Petitioner has made a sufficient
`
`showing as to those claims, as well.7
`
`F.
`
`Patent Owner’s Arguments Regarding Obviousness
`
`Patent Owner challenges several aspects of Petitioner’s obviousness
`
`arguments. For example, Patent Owner argues that a person of ordinary skill
`
`in the art would not have had a reasonable expectation of success in using a
`
`40 mg three times per week regimen given GA’s complex mechanism of
`
`action and the lack of PK/PD correlation. Prelim. Resp. 35–38. Patent
`
`Owner also argues that a person of ordinary skill in the art would not have
`
`been motivated to dose GA three times per week, particularly when the
`
`regimen claimed in the ’413 patent “provides 14% less GA to the patient
`
`than the approved 20 mg daily dose or Pinchasi’s 40 mg, alternate day
`
`regimen.” Id. at 38–44. Moreover, Patent Owner argues that a person of
`
`
`7 We address Patent Owner’s argument regarding the dependent claims
`above. See supra n.5.
`
`14
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`
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`IPR2015-00644
`Patent 8,399,413 B2
`
`ordinary skill in the art would not have been motivated to use a 40 mg dose
`
`of GA in light of other clinical trials that allegedly show a 40 mg daily dose
`
`was not superior to a 20 mg daily dose. Id. at 45–46. Finally, Patent Owner
`
`argues that there was no reason to combine Pinchasi with the 1996 SBOA or
`
`Flechter, and that secondary considerations support a finding of
`
`nonobviousness of the claims. Id. at 46–48, 54–58.
`
`Although Patent Owner’s arguments are compelling, they generally
`
`amount to a difference in opinion as to the evidence set forth by Petitioner.
`
`At this stage of the proceeding, we find that Petitioner has offered sufficient
`
`evidence to institute trial. That being said, we will be able to evaluate both
`
`parties’ arguments more thoroughly once the record is developed further
`
`during trial.
`
`G.
`
`Remaining Challenge
`
`Petitioner also asserts that claims 1–20 are unpatentable as obvious
`
`over Pinchasi alone. Pet. 20–45. In light of our findings above with respect
`
`to Pinchasi, the 1996 SBOA, and Flechter, we exercise our discretion not to
`
`institute an inter partes review on this ground. See 37 C.F.R. § 42.108(a).
`
`
`III.
`
`CONCLUSION
`
`We conclude that Petitioner has established a reasonable likelihood of
`
`prevailing on its assertions that claims 1–20 of the ’413 patent are
`
`unpatentable as obvious.
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the patentability of any challenged claim or the
`
`construction of any claim term.
`
`IV.
`
`
`
`ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`
`15
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`
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`IPR2015-00644
`Patent 8,399,413 B2
`
`review is hereby instituted on the following grounds:
`
`A. Claims 1–20 as obvious over Pinchasi and 1996 SBOA; and
`
`B. Claims 1–20 as obvious over Pinchasi and Flechter.
`
`FURTHER ORDERED that no other proposed grounds of
`
`unpatentability are authorized.
`
`FURTHER ORDERED that 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
`
`commencing on the entry date of this decision.
`
`
`
`
`
`
`
`
`
`16
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`IPR2015-00644
`Patent 8,399,413 B2
`
`
`PETITIONER:
`
`Jeffrey Guise
`Wilson Sonsini Goodrich & Rosati
`jguise@wsgr.com
`
`Brandon White
`Perkins Coie LLP
`BMWhite@perkinscoie.com
`
`PATENT OWNER:
`
`Elizabeth Holland
`William James
`Eleanor Yost
`Goodwin Proctor LLP
`eholland@goodwinprocter.com
`wjames@goodwinprocter.com
`eyost@goodwinprocter.com
`
`
`17
`
`
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