Trials@uspto.gov
`571-272-7822
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` Paper 65
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` Entered: May 12, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioners,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`__________
`
`Case IPR2015-01993
`Patent 8,399,514 B2
`__________
`Before RICHARD E. SCHAFER, SALLY GARDNER-LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
`SCHAFER, Administrative Patent Judge.
`
`
`DECISION
`Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`

`

`IPR2015-01993
`Patent 8,399,514 B2
`
`The Coalition for Affordable Drugs, et al. (Petitioner) seeks reconsideration
`
`and reversal of our decision holding that it did not establish the unpatentability of
`claims 1-20 of Biogen Ma (Biogen) Patent 8,399,514. We have considered
`Petitioner’s request, but decline to make any change to our opinion or decision.
`
`Relying on the testimony of Biogen witnesses Drs. Thisted, Brundage and
`Rudick (Exs. 2038, 2042 and 2044), and the reports on the results of the phase III
`trials for Tecfidera® (Exs. 2025 and 2026), our opinion held that Biogen had
`established that the efficacy of treatment of MS with 480 mg/day of dimethyl
`fumarate (DMF) would have been unexpected by those of ordinary skill in the art.
`Our opinion noted that “Petitioner’s reply does not effectively address Biogen’s
`unexpected results argument and evidence.” Final Decision. Paper 63, p. 25.
`
`Petitioner argues that it provided evidence to rebut and doubt the testimony
`of Biogen’s witnesses. Pet. Req., Paper 64, pp. 2-3. Specifically, Petitioner directs
`us to the declaration testimony of Dr. Samuel Pleasure (Ex. 1045). Petitioner also
`directs us to its Reply (Paper 46) at pp. 20-21 where it referenced ¶ 69 of Dr.
`Pleasure’s testimony.
`
`Petitioner’s Reply argued that a person having ordinary skill in the art
`would recognize Kappos 2006 is a phase II study designed to
`identify potential pharmacodynamically effective point doses
`for further study and be aware of examples in the MS field, e.g.,
`Copaxane®, wherein less frequent dosing of the drug provided
`essentially equally effective therapeutic results, while lowering
`the frequency of side effects (see e.g., Ex. 1045 ¶69).
`Reply, Paper 46, pp. 20-21.
`
`We considered Dr. Pleasure’s testimony in reaching our decision, but did not
`find it enlightening with respect to the unexpected results issue raised by Biogen.
`For the most part, Dr. Pleasure’s testimony is directed to the motivation and the
`reasonable expectation of success of the person having ordinary skill in the art to
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`2
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`

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`IPR2015-01993
`Patent 8,399,514 B2
`
`modify the 720 mg/day dosage taught in Kappos 2006. Pleasure Dec., Ex. 1045,
`¶¶ 67-72. For example, Dr. Pleasure opined:
`A [person having ordinary skill in the art], knowing that GI side
`effects are a limiting problem with DMF and that an effective
`point dose of 240 mg had been established by Kappos, would
`have been motivated to test 240 mg daily and 240 mg twice
`daily in therapy trials as an obvious next step in establishing the
`safety and effectiveness of the drug as disclosed by ICH
`Guideline.
`Pleasure Dec., Paper 1045, ¶ 69. Our opinion did not disagree with his testimony
`as to motivation and reasonable expectation of success. In the Final Decision, we
`stated:
`
`[W]e determine that one having ordinary skill in the art would
`have had ample reason to use routine experimentation,
`including appropriate clinical trials, to determine the optimum
`doses for MS treatment. Kappos 2006 teaches both the
`effectiveness of the 720 mg/day dose and that DMF is a result-
`effective variable:
`[DMF] significantly reduces brain lesion activity, in a
`dose-dependent manner, as measured by MRI in patients
`with RRMS over 24 weeks of treatment.
`Ex. 1003A, p. 2 (emphasis added). Because of the reported
`side-effects from the treatment of with fumarates, (Joshi ‘999,
`Ex. 1030, 5:29-42; Press Release, Ex. 2057, p. 1), those
`working in the art would have had sufficient reason to
`investigate doses between 720 mg/day and 360 mg/day in hopes
`of identifying effective dose with fewer side-effects. Those
`working in the art would also have had a reasonable expectation
`of success in determining additional therapeutically effective
`doses. As noted by Dr. Brundage: “I would expect that 480
`mg/day of DMF to show some increase in response compared
`to 360 mg/day based on the statement in Kappos 2006 that
`BG00012 (DMF) significantly reduced brain lesion activity in a
`dose dependent manner.” Brundage Test., Ex. 2042, ¶ 39.
`Final Decision, Paper 63, pp. 25-26.
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`IPR2015-01993
`Patent 8,399,514 B2
`
`
`
`With respect to the unexpected results issue, Dr. Pleasure testified only that:
`As explained above, one of ordinary skill in the art would not
`have found it unexpected that dosages of 240 mg DMF given
`BID and TID were similarly efficacious in treating MS.
`Pleasure Dec., Ex. 1045, ¶ 75. Petitioner’s sole argument on the issue was: “[a]s
`demonstrated above, success was expected, not unexpected.” Pet. Reply, Paper 46,
`p. 24. Neither Petitioner’s Reply, nor Dr. Pleasure’s testimony addressed Biogen’s
`specific arguments and evidence of unexpected results. Thus, Petitioner’s
`argument and evidence failed to provide a basis for us to question the sufficiency
`of Biogen’s evidence to show that the degree of efficacy of the 480 mg/day dose
`would have been unexpected to one having ordinary skill in the art. As we noted
`in our Final Decision, “[o]bjective indicia of non-obviousness ‘may often establish
`that an invention appearing to have been obvious in light of the prior art was not.’”
`Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337,
`1346 (Fed. Cir. 2013).
`
`Petitioner’s request for rehearing is denied.
`ORDER
`Upon consideration of the Petition for Rehearing (Paper 64),
`
`and for the reasons given, it is
`ORDERED that the Request for Rehearing is denied.
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`IPR2015-01993
`Patent 8,399,514 B2
`
`For Petitioner
`
`James T. Carmichael
`Carol A. Spiegel
`CARMICHAEL IP, PLLC
`jim@carmichaelip.com
`carol@carmichaelip.com
`
`
`For Patent Owner
`
`Michael Flibbert
`Maureen D. Queler
`Erin M. Sommers
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`michael.flibbert@finnegan.com
`maureen.queler@finnegan.com
`erin.sommers@finnegan.com
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`5
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