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`For the Petitioners
`Lead counsel: James T. Carmichael, Reg. No. 45,306
`Backup counsel: Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
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`Paper No. __
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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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`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 FUND, 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
`____________________
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`PETITIONERS’ REQUEST FOR REHEARING
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`I.
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`INTRODUCTION
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`Case No. IPR2015-01993
`Patent 8,399,514
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`Petitioners respectfully request rehearing under 37 C.F.R. § 42.71(d) of the
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`Patent Trial and Appeal Board’s (“Board’s”) 21 March 2017 Final Written
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`Decision (Paper 63) (“Decision”) as to claims 1-20 of U.S. Patent No. 8,399,514
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`(“the ‘514 Patent” (Ex. 1001)).
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`The Decision found Petitioners failed to challenge Biogen’s testimony that
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`the magnitude of clinical efficacy at 480 mg/day would have been unexpected.
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`Unfortunately, the Decision overlooked the fact that Petitioners did challenge that
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`testimony. Considering the Board’s other findings laying out a very strong prima
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`facie case of obviousness as presented by Petitioners, had the Decision not
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`overlooked Petitioners’ challenge to that testimony, the Board would have found
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`claims 1-20 unpatentable.
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`II.
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`STATEMENT OF PRECISE RELIEF REQUESTED
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`Petitioners respectfully request that the Board reconsider its Decision and
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`hold that Petitioners have shown claims 1-20 of the ‘514 Patent are unpatentable.
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`III. THE REQUESTED RELIEF SHOULD BE GRANTED
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`A. The Board Overlooked Petitioners’ Challenge to Biogen’s Testimony
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`on the Expected Magnitude of Results
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`1
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`According to the Decision, Petitioners did not point to evidence, or provide a
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`Case No. IPR2015-01993
`Patent 8,399,514
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`reason, to doubt Biogen’s expert testimony that the magnitude of clinical efficacy
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`at 480 mg/day would have been unexpected (Paper 63 at 25):
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`Petitioner’s Reply does not effectively address
`Biogen’s unexpected results argument and evidence.
`Petitioner responds only with a single sentence: “As
`demonstrated above, success was expected, not
`unexpected.” Pet. Reply, Paper 46, p. 24. Biogen’s
`argument, however, is not merely that it would have been
`unexpected that some lower doses would have been an
`effective therapeutic treatment. Rather, Biogen’s position
`is that the magnitude of the clinical efficacy at the
`specifically claimed dose of about 480 mg/day would
`have been unexpected. Biogen Res., Paper 38, pp. 43-49.
`Petitioner has not directed us to evidence, or provided a
`reason, for us to doubt the unrebutted testimony of
`Biogen’s highly qualified and credible experts. Biogen’s
`expert testimony on this point stands unchallenged.
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`However, Petitioners did direct the Board to evidence and did provide a
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`reason to doubt that testimony. Petitioners pointed to evidence that the magnitude
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`of clinical efficacy would have been expected to be essentially equal to or similar
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`to that of the prior art.
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`2
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`Petitioners challenged Biogen’s “unexpected results” testimony by
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`Case No. IPR2015-01993
`Patent 8,399,514
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`presenting the testimony of Dr. Samuel Pleasure. Dr. Pleasure is a renowned
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`Professor of Neurology, an attending physician at the University of California-San
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`Francisco Multiple Sclerosis Center, and a standing member of a National Multiple
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`Sclerosis Society Scientific Review Panel. Ex. 1045 ¶¶ 4-15; Ex. 1046. While
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`spending more than five pages detailing the credentials of Biogen’s experts, the
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`Decision does not once mention Dr. Pleasure, his credentials, his opinions, or even
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`his name.
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`Biogen’s experts relied on the simplistic notion that the claimed daily dosage
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`total of 480 mg/day was closer to an ineffective total (360 mg/day) than an
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`effective one (720 mg/day) in Kappos 2006. From that, they concluded it was
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`“stunning and unexpected” to find a dosage of 480 mg/day almost as effective as
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`one of 720 mg/day. Paper 63 at 25.
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`However, Dr. Pleasure explained specifically that POSA would have known
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`more about Kappos 2006 than simply the daily dosage totals. POSA also would
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`have known the amount of drug given at one time (the “point dose”), including
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`especially that the 360 mg/day regimen used three 120 mg point doses, and that the
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`successful 720 mg/day regimen used three 240 mg point doses. In other words, it
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`was the 240 mg point dose that was successful in Kappos 2006. Ex. 1045 at ¶¶ 62-
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`65 and 67-72. Dr. Pleasure testified “the finding of a point dose of 240 mg DMF
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`3
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`was the key finding of Kappos 2006 rather than the frequency of treatment.” Ex.
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`Case No. IPR2015-01993
`Patent 8,399,514
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`1045 at ¶ 70.
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`Dr. Pleasure further testified there were known examples in the MS field of
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`modifying an established dosage regimen by using successful point doses but
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`reducing the frequency with which the point dose was administered. For example,
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`he testified Copaxone had an approved dosage regimen of administering a certain
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`point dose once per day. Subsequent influential studies showed that cutting the
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`frequency in half “provided essentially equally effective therapy for MS.” Ex.
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`1045 ¶ 69 (emphasis added) (cited in Petitioners’ Reply, Paper 46, at 20-21).
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`Petitioners relied on Dr. Pleasure’s testimony to rebut Biogen’s experts and
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`support Petitioners’ position that POSA expected the successful 240 mg point dose
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`to be essentially equally effective whether given three times a day (TID) for a total
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`of 720 mg as in Kappos 2006 or twice a day (BID) for a total of 480 mg as
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`claimed. Paper 46 at 3-4, 15-17, and 20-24. In challenging Biogen’s testimony on
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`unexpected results, Petitioners stated: “[g]iven the known point dose concentration
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`of 240 mg DMF administered TID on the immune system (Kappos 2006), POSA
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`would have been motivated to administer 240 mg DMF BID with a reasonable
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`expectation of seeing similar immunomodulatory effect over time.” Paper No. 46
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`at 22-23 (emphasis added). Thus, Petitioners challenged Biogen’s expert
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`testimony and showed it was not unexpected that 480 mg per day (a 240 mg point
`4
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`dose administered BID) had an effect similar or equal to that of 720 mg per day
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`Case No. IPR2015-01993
`Patent 8,399,514
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`(the same 240 mg point dose administered TID).
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`Considering the Decision’s conclusion that “Biogen’s expert testimony on
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`this point stands unchallenged,” it is clear the Board overlooked the evidence and
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`arguments summarized above. Paper 63 at 25.
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`B. When the Overlooked Challenge to “Unexpected Results” is
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`Considered, Claims 1-20 Should Be Cancelled
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`The Decision sets forth a strong prima facia case of obviousness. For
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`example, the Decision correctly finds:
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`(1) that the difference between Kappos 2006 and the
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`subject matter of Claim 20 is the treatment of MS
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`patients with about 480 mg/day of DMF instead of 720
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`mg/day; (2) that the dosage of DMF in treating MS
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`patients is a result-effective variable with respect to
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`reducing brain lesions of MS patients and (3) the
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`administration of 720 mg/day of DMF resulted in not
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`insignificant adverse side-effects.
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`Paper 63 at 9. The Decision also correctly finds POSA would have had (1) ample
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`reason to use routine experimentation, including appropriate clinical trials, to
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`determine the optimum doses for MS treatment; (2) sufficient reason to investigate
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`5
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`doses between 720 mg/day and 360 mg/day in hopes of identifying effective doses
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`Case No. IPR2015-01993
`Patent 8,399,514
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`with fewer side-effects and (3) a reasonable expectation of success. Paper 63 at
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`26.
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`Thus, without the weight of supposedly “unchallenged” testimony on
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`unexpected results, the Board would have held the claimed invention obvious.
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`III. CONCLUSION
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`For the foregoing reasons, Petitioners respectfully request the Board
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`reconsider its Decision and find Petitioners have established by a preponderance of
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`the evidence that claims 1-20 of the ‘514 Patent are unpatentable and should be
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`cancelled.
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`Respectfully submitted,
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`By:
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`
` /James T. Carmichael/
`James T. Carmichael, Reg. No. 45,306
`Carol A. Spiegel, Reg. No. 68,033
`Carmichael IP, PLLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`(703) 646-9255
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`
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`Counsel for Petitioners
`IPR2015-01993
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`Dated: 19 April 2017
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`6
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`Case No. IPR2015-01993
`Patent 8,399,514
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`37 C.F.R. §42.6(e) CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing PETITIONERS’
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`REQUEST FOR REHEARING was served on 19 April 2017, via electronic mail
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`directed to counsel of record for the Patent Owner at the following:
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`Michael J. Flibbert
`Maureen D. Queler
`Erin M. Sommers
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`michael.flibbert@finnegan.com
`maureen.queler@finnegan.com
`erin.sommers@finnegan.com
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`Patent Owner has agreed to electronic service.
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`By: James T. Carmichael
`James T. Carmichael, Reg. No. 45,306
`CARMICHAEL IP, PLLC
`8000 Towers Crescent Drive, Ste. 1350
`Tysons Corner, VA 22182
`(703) 646-9255
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`7
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`Dated: 19 April 2017
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