`
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`For the Petitioner
`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
`____________________
`
`BEFORE THE 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 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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`PETITIONER REPLY TO MOTION TO ANTEDATE
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`I.
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`II.
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`Case No. IPR2015-01993
`Patent 8,399,514
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`TABLE OF CONTENTS
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`Introduction……………………………………………………….…1
`
`Biogen Is Not Entitled to a February 8, 2007 Priority Date…………1
`
`
`A.
`
`The ‘921 provisional fails to describe DMF or MMF being
`therapeutically effective when administered in a dosage of
`about 480 mg/day to an MS patient…………………………...2
`
`B.
`
`
`C.
`
`The ‘921 provisional does not describe a dosage of about 480
`mg/day administered in 2, 3, 4 or 6 equal doses………………3
`
`The ‘921 provisional does not enable the full scope of the
`claims………………………………………………………….3
`
`
`III. The ‘921 Provisional is NOT a Constructive Reduction to Practice
`of the Invention Claimed in the ‘514 Patent………………………….4
`
`
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`IV. Biogen Has Not Established Diligence Throughout the Critical
`Period…………………………………………………………………4
`
`
`
`A.
`
`Four-Month Diligence Gap from May 2006 to September 6,
`2006 Before Adding About 480 mg/day Arm to Phase III
`Clinical Trials………………………………………………….6
`
`B.
`
`C.
`
`Biogen’s Evidence of Phase III Development Diligence is too
`General to Establish Diligence in the Eight Month Critical
`Time Period……………………………………………………9
`
`The Nonclinical Animal Studies Do Not Provide the Required
`Diligence From May 2006 to February 2007………………….9
`
`D. Biogen’s Case Law Is Not On Point………………………….11
`
`V. Conclusion…………………………………………………………12
`i
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`Case No. IPR2015-01993
`Patent 8,399,514
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`TABLE OF AUTHORITIES
`
`
`Federal Cases
`
`Anderson v. Scinta,
`372 F.2d 523 (C.C.P.A. 1967)………………………………………...……..5
`
`In re Brana,
`
`51 F.3d 1560, 1568 (Fed. Cir. 1995)…………………………….…………10
`
`Cottrell v. Shafer,
`97 F.2d 121, 123 (C.C.P.A. 1938)……………………………..…………….7
`
`
`In re Hartop,
`
`311 F.2d 249, 257 (C.C.P.A. 1962)………………………..……………….10
`
`In re Jolley,
`308 F.3d 1317, 1326-28 (Fed. Cir. 2002)…………………………………..11
`
`In re Krimmel,
`
`292 F.2d 948, 954 (C.C.P.A. 1961)…………………………………..…….10
`
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572, 1577 (Fed. Cir. 1996)………………………………………...5
`
`Moore v. Harris,
`92 U.S.P.Q. 187, 189 (Bd. Pat. Int. 1951)………………………...…………8
`
`Nabor v. Cricchi,
`567 F.2d 382, 385-86 (C.C.P.A. 1977)……………………….…………5, 11
`
`Vogt v. Neuschotz,
`154 U.S.P.Q. 376, 378 (B.P.A.I. 1966)………………………….11, 12
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`ii
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`Case No. IPR2015-01993
`Patent 8,399,514
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`
`Federal Statutes
`
`35 U.S.C. §101……………………………………………………………………10
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`35 U.S.C. §102………………………………………………………………....1, 10
`
`35 U.S.C. §103……………………………………………………………………10
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`35 U.S.C. §112………………………………………………………………..1, 2, 4
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`35 U.S.C. §119……………………………………………………………………..1
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`iii
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`I.
`
`Introduction
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`Case No. IPR2015-01993
`Patent 8,399,514
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`Kappos 2006 qualifies as prior art under 35 U.S.C. §102(b) and cannot be
`
`antedated because it was published more than one year prior to February 7, 2008,
`
`the earliest possible effective filing date for U.S. Patent 8,399,514 (“the ‘514
`
`patent”).
`
`Nonetheless, Biogen attempts to remove Kappos 2006 as a prior art
`
`reference against ‘514 patent claims 1-16 and 20 by alleging conception prior to
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`Kappos’ formal publication date of May 30, 2006 (Ex. 1020 at 3) coupled with
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`diligence during the critical period which runs from prior to that publication date
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`up to the February 8, 2007 filing date of Biogen’s provisional application
`
`60/888,921 (“the ‘921 provisional”). See Motion at 2, 6, 8 and 24.
`
`Biogen’s Motion to Antedate fails for two reasons. First, the ‘921
`
`provisional is not a constructive reduction to practice of the invention claimed in
`
`the ‘514 patent. Second, there is at least an eight-month diligence gap between the
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`May 30, 2006 publication date of Kappos 2006 and the filing of the ‘921
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`provisional.
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`II. Biogen is Not Entitled to a February 8, 2007 Priority Date
`
`To receive benefit of a provisional application’s filing date, a provisional
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`application must provide §112 support for later-claimed subject matter. 35 U.S.C.
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`§119(e)(1) (pre-AIA). As established in Petitioner’s Reply to Biogen Opposition,
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`
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`1
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`
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`the ‘514 patent claims are not entitled to the February 8, 2007 filing date of the
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`‘921 provisional because it does not provide the required §112 support.
`
`A. The ‘921 provisional fails to describe DMF or MMF being
`therapeutically effective when administered in a dosage of about 480
`mg/day to an MS patient
`The ‘921 provisional does not provide written descriptive support for the
`
`claimed invention. The ‘921 provisional provides five nested ranges of
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`hypothetical daily dosages (in mg): about 100 to 1000; 200 to about 800; about 240
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`to about 720; about 480 to about 720; and, about 720 (Ex. 1012 ¶[0116]). A
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`dosage of about 720 mg/day is reiterated four times, including once by itself, while
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`the dosage of about 480 mg/day is only mentioned once, never by itself, and
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`always in the phrase “from about 480 mg/day to about 720 mg/day.” The ‘921
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`provisional blazes a trail to a dosage of about 720 mg/day, not about 480 mg/day
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`(Ex. 1045 ¶¶49-58). Furthermore, the ‘921 provisional fails to convey that a
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`dosage of about 480 mg/day DMF was effective to treat an MS patient (id.).
`
`The invention of the ‘921 provisional is said to be based on (i) the discovery
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`that DMF and MMF are potent activators of the Nrf2 pathway and (ii) the finding
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`that DMF and MMF are neuroprotective in a mouse model of autoimmune
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`neurodegenerative disease (Ex. 1012 ¶[0029]). While the ‘921 provisional
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`describes upregulation of endogenous NOQ1 production by DMF and MMF via
`
`the Nrf2 pathway in human colon carcinoma DLD1 cells in vitro (id. ¶¶[0122]-
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`
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`2
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`
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`[0124]), there is no description of DMF or MMF being neuroprotective in a mouse
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`model of any autoimmune neurodegenerative disease, e.g., EAE (a mouse model
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`used for studying compounds to treat MS) (Ex. 1050 54:8-16; 66:9-11), let alone
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`neuroprotection effective to treat an MS patient. Again, the ‘921 provisional fails
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`to reasonably convey possession of a method of treating an MS patient by orally
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`administering DMF and/or MMF in a therapeutically effective amount of about
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`480 mg/day.
`
`B.
`The ‘921 provisional does not describe a dosage of about 480
`mg/day administered in 2, 3, 4 or 6 equal doses
`
`While the ‘921 provisional mentions administering a 720 mg/day total
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`dosage in 2, 3, 4 or 6 equal point doses (Ex. 1012 ¶[0116]), it never mentions
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`multiple equal point doses totaling an about 480 mg/day dosage. (Ex. 1045 ¶58.
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`Entitlement to a filing date extends only to what is disclosed, not to subject matter
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`which would merely be obvious from what is expressly disclosed.
`
`C. The ‘921 provisional does not enable the full scope of the claims
`The ‘514 patent claims encompass both therapeutic and
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`prophylactic/preventive methods of treating MS (Ex. 1001 5:47-51; Ex. 1050
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`46:19-22) in “an obviously complex field” where “we don’t know exactly what
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`causes” MS in humans (Ex. 1050 66:16-18; Ex. 1045 ¶¶17-18, 25, 32. The two
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`working examples in the ‘921 provisional are limited to a showing of DMF and
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`MMF activating the Nrf2 pathway in vitro in a human cancer cell line, DLD1 (Ex.
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`1045 ¶¶55-56. There is no example of any testing in any MS model system, let
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`alone in an MS patient (id.).
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`Moreover, Biogen’s own experts admitted that it is unpredictable whether a
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`therapeutically effective treatment for one type of MS, e.g., RRMS, would also be
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`efficacious for treating another type, e.g., PPMS (Ex. 1050 63:14-64:1; Ex. 1053
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`27:10-19, 38:6-11). The claims cover all types of MS. Thus, it would take undue
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`experimentation to make and use the full scope of the claimed invention (Ex. 1045
`
`¶¶60-61).
`
`III. The ‘921 Provisional is NOT a Constructive Reduction to Practice of the
`Invention Claimed in the ‘514 Patent
`
`The filing of an application for a patent disclosing the invention in
`
`compliance with §112 constitutes a constructive reduction to practice and may be
`
`relied on for purposes of determining priority and patentability. The ‘921
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`provisional is not a constructive reduction to practice of the ‘514 claimed invention
`
`because it does not comply with the requirements of §112 for written descriptive
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`support and enablement as summarized in §II above.
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`IV. Biogen Has Not Established Diligence Throughout the Critical Period
`
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`4
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`Even if the ‘921 provisional were a constructive reduction to practice, which
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`it is not, Biogen still could not antedate Kappos 2006 because Biogen has failed to
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`establish the required diligence.
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`Diligence is a stringent standard of reasonably continuous activity toward
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`reduction to practice so that the inventor’s conception and reduction to practice are
`
`substantially one continuous act. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577
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`(Fed. Cir. 1996). “[T]he work relied on must ordinarily be directly related to
`
`reduction to practice of the invention.” Nabor v. Cricchi, 567 F.2d 382, 385-86
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`(C.C.P.A. 1977) (citing Anderson v. Scinta, 372 F.2d 523 (C.C.P.A. 1967)). The
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`inventor must account for the entire critical period by showing either activity
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`aimed at reduction to practice or legally adequate excuses for inactivity.
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`Biogen relies on two types of overlapping activities to show daily diligence
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`between May 2006 and February 8, 2007, i.e., nonclinical animal studies and
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`development of Phase III clinical trials (Motion 8-9). As discussed below, addition
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`of a dosage of about 480 mg/day DMF to the Phase III clinical trials did not occur
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`until September 2006 at the earliest, and none of the nonclinical animal studies
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`shows diligence in reducing the claimed invention to practice and addition of a
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`dosage of about 480 mg/day DMF to the Phase III clinical trials did not occur until
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`September 2006 at the earliest.
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`A.
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`Four Month Diligence Gap From May 2006 to September 6, 2006
`Before Adding About 480 mg/day Arm to Phase III Clinical Trials
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`Here, the critical period is from just prior to May 30, 2006 to the February 8,
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`2007 filing date of its provisional application. Conception is asserted to have
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`occurred when Dr. O’Neill presented four dosing options at a Biogen Clinical Trial
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`Review Board (CTRB) meeting on February 19, 2004 for studying DMF as a
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`possible treatment for MS (Ex. 2309 at 6, 14-16, 20-24; Ex. 2076 ¶19; Ex. 2078
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`¶¶14-15; Ex. 2079 ¶¶24-25). Options 1 and 2 both included a 240 mg DMF BID
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`dosing arm (Ex. 2309 at 14), although Dr. O’Neill did not remember having stated
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`a preferred option (Ex. 1052 102:19-22). From an operational point of view, all
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`four dosing options were viable (Ex. 1056 39:15-22; 63:24-64:4). Dosing emerged
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`as the most critical issue discussed and a BID dosing regimen was thought
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`beneficial on many different levels (Ex. 2310 at 2). After further discussions,
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`Option 3 dosing with placebo and DMF at 120 mg QD, 120 mg TID and 240 mg
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`TID was selected and approved by Dr. Bozic for Phase IIb clinical trial (Ex. 2310
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`at 2; Ex. 2076 ¶20; Ex. 2078 ¶16). According to Dr. O’Neill, “the intent was to
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`develop 480 mg at a later point” (Ex. 1052 112:21-25; Ex. 2076 ¶24) (see also Ex.
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`1054 112:24-25, 126:21-22; Ex. 1056 95:3-14).
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`Dr. O’Neill testified “Biogen worked diligently every day to plan, prepare
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`for, operate, and evaluate the Phase IIb clinical trial (Study No. C-1900) from at
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`least September 2004 to March 2006,” a study which did not include a 480 mg/day
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`dosing arm” (Ex. 2076 ¶¶21 and 27); a study which he primarily designed (Ex.
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`1052 55:23-56:2). Nonetheless, Dr. O’Neill is said to have continued to believe in
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`and remained a strong proponent of administering 480 mg/day DMF to treat MS
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`(Ex. 2017 ¶35), e.g., as shown when Biogen was calculating the number of patients
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`required in each dosing arm of its Phase III study somewhere in the middle of 2006
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`(Ex. 1052 109:4-22)
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`The evidence of record shows Biogen considered potentially adding a 480
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`mg/day dosing arm to a Phase III clinical trial sometime in June 2006 (Ex. 2316 at
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`1-2; Ex. 2078 ¶¶23-24), after the critical period began. However, the decision
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`actually adding a 480 mg/day dosing arm to a DMF MS protocol was not made
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`until September 6, 2006 (Ex. 2234 at 1; Ex. 2228 at 1) and was authorized by Dr.
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`Bozic October 16, 2006 when she signed off on two Phase III protocols (Ex. 2231
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`at 1; Ex. 2232 at 1). Thus, there was a more than four-month lack of diligence
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`during which Biogen did not administer or plan to administer a 480 mg/day dosage
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`of DMF to a single MS patient as recited in the claimed invention. “It takes
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`something more than merely keeping a complete patentable idea under
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`consideration to constitute proof of diligence in reduction to practice.” Cottrell v.
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`Shafe97 F.2d 121, 123 (C.C.P.A. 1938). “[B]efore work can begin towards
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`constructing an invention in a corporation someone in authority must reach the
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`conclusion that it is desirable to produce the invention; and, after reaching this
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`conclusion, approve the project. All work done before the conclusion is reached is
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`aimless with respect to the construction of the invention ….” Moore v. Harris, 92
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`U.S.P.Q. 187, 189 (Bd. Pat. Int. 1951).
`
`At the very least, diligence was lacking for the four-month period between
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`June 2006 and September 2006. This is too long.
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`Biogen did not take a long way around to test 480 mg/day DMF dosage to
`
`treat MS patients – it intentionally chose not to in its Phase IIb study. Biogen
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`deliberately chose to treat MS patients with dosing arms outside of the claimed 480
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`mg/day dosage. Dr. O’Neill did not state a preferred dosing option (Ex. 1052
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`102:19-22). Dr. O’Neill selected the dosing regimens used in the Phase IIb study
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`(id. 28:24-29:1). Options with 240 mg DMF BID were operationally feasible (Ex.
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`1056 39:15-22; 63:24-64:4). Instead, Biogen chose to focus on pivotal Phase III
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`studies – studies “that will be used as an important study for a regulatory authority
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`to consider when deciding whether or not to approve a drug” (Ex. 1052 26:13-17).
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`Then, Biogen did not decide to add a 240 mg DMF BID to its Phase III studies
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`until September 6, 2006 (Ex. 2234 at 1; Ex. 2228 at 1). There was no legal excuse
`
`for its delayed choice to pursue treating a MS patient with a 480 mg/day dosage of
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`DMF.
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`B.
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`Biogen’s Evidence of Phase III Development Diligence is too
`General to Establish Diligence in the Eight Month Critical Time
`Period.
`Evidence of a general nature to the effect that work was continuous and
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`which has little specificity as to the dates and facts does not constitute the kind of
`
`evidence required to establish diligence in the critical period. Hunter v.
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`Beissbarth, 230 USQ 365, 368 (BPAI 1986). Biogen provides little specificity as
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`to the dates and facts of activities directed to development of its Phase III clinical
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`trials. For example, Biogen relies on activities related to (a) FDA submissions,
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`including “planning continued throughout June and into July” of 2006 (Motion 15-
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`16); (b) European Regulatory Activities, including “prepared throughout June 2006
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`for the meetings,” (id. 17), (c) drafting protocols, including preparing an EOP2
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`meeting package which “included only the 240 mg three times a day” dosage (id.
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`19). Such evidence lacks the specificity as to dates and facts necessary to establish
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`diligence in the critical period.
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`C. The Nonclinical Animal Studies Do Not Provide the Required
`Diligence From May 2006 to February 2007
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`For the entire critical period, Biogen relies on nonclinical animal studies for
`
`evidence of daily diligence, including the at least four-month gap of June 2006 to
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`September 2006. (Motion 8; Ex. 2051). Biogen is attempting to prove it was
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`diligent in an FDA regulatory sense – an attempt that does not demonstrate
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`9
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`reasonable diligence in reducing the invention of the ‘514 patent to practice. None
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`of the animal studies addressed any limitations of the ‘514 patent claims. For
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`example, no testing was performed on any animal model of MS.
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`Preclinical studies are the rate-limiting step in the FDA approval process
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`because clinical trials cannot begin until there is sufficient data to justify human
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`testing. “FDA approval, however, is not a prerequisite for finding a compound
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`useful within the meaning of the patent laws.” In re Brana, 51 F.3d 1560, 1568
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`(Fed. Cir. 1995); see also In re Krimmel, 292 F.2d 948, 954 (C.C.P.A. 1961).
`
`Although a patent application must demonstrate that a drug has a “sufficient
`
`probability” of safety in humans, an applicant is not required to provide any
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`clinical evidence of its safety. In re Hartop, 311 F.2d 249, 257 (C.C.P.A. 1962).
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`Indeed, “the standards established by statute for the advertisement, use, sale or
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`distribution of drugs are quite different than the requirements under the Patent Act
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`for the issuance of a patent.” Id. at 258. Safety in man is not a statutory
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`requirement of 35 U.S.C. §§ 101, 102 or 103. Id. at 260. Therefore, such animal
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`studies do not support diligence toward the alleged reduction to practice.
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`The nonclinical animal studies were carried out to assess the potential
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`toxicity and carcinogenicity of the compound DMF (Ex. 1052 84:24-85:15;
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`142:17-21; 143:2-13). The nonclinical animal studies were required by the FDA
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`(Ex. 1052 142:7-10; Ex. 2077 ¶15). None of them involved testing animal models
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`10
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`of MS for potential efficacy to treat MS (Ex. 1052 143:14-24). Activities in line
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`with satisfying FDA requirements are more in the nature of commercial
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`development, which is not accepted as an excuse for delay. The legal test is
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`reasonable diligence toward reduction to practice of the claimed invention – a test
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`Biogen has not met. Accord, Nabor v. Cricchi, 567 F.2d 382, 385 (C.C.P.A.
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`1977).
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`D. Biogen’s Case Law Is Not On Point
`
`Biogen argues that activities outside the scope of the claimed invention may
`
`be relied on to prove diligence if they “are part of an overall scheme of inventive
`
`activity directed to reducing the invention to practice,” citing In re Jolley, 308 F.3d
`
`1317, 1326-28 (Fed. Cir. 2002) (Motion at 7). However, the Court held in Jolley
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`that there was substantial evidence to support the Board’s finding that the activity
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`at issue was “within the scope” of the invention defined by the count. Id. at 1327.
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`The Court expressly stated that activity outside the scope of the invention cannot
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`be relied upon to show diligence: “efforts toward a solution of the problem at hand
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`by different means than those represented by the count will not be credited as
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`diligence.” Id. at 1328 (citation omitted). Thus, Jolley is inapposite.
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`Biogen argues that activities geared to a government sponsor’s needs may be
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`credited as diligence, citing Vogt v. Neuschotz, 154 U.S.P.Q. 376, 378 (B.P.A.I.
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`1966) (Motion at 7). Vogt did not hold that mere activity for a government sponsor
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`shows diligence. The Board found that meeting the government sponsor’s needs
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`and desires was necessary because the invention “could not have been tested to
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`point of reduction to practice by [the inventor’s employer and assignee] except
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`through the facilities of the Civil Aeronautics Administration [the government
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`sponsor].” 154 U.S.P.Q. at 378. That is not the case here. None of the animal
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`testing or other activities Biogen relies upon was a necessary prerequisite to filing
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`a patent application or even treating an MS patient with a 480 mg/day dosage of
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`DMF. No government facilities were need for performing those actions. Thus,
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`Vogt is not on point.
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`V. Conclusion
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`Petitioner respectfully requests the PTAB to dismiss Biogen’s Motion to
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`Antedate as moot, or alternatively, to deny it as insufficient to establish diligence
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`from just prior to Kappos 2006’s formal publication date of May 30, 2006, through
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`February 8, 2007, coupled to a constructive reduction to practice.
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`Dated: September 28, 2016
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`Respectfully submitted,
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`By: /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
`Counsel for Petitioner
`IPR2015-01993
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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 PETITIONER
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`REPLY TO MOTION TO ANTEDATE was served on 28 September 2016, via
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`electronic mail 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
`
`Patent Owner has agreed to electronic service.
`
`
`
`Dated: 28 September 2016
`
`
`
`By: /Carol A. Spiegel /
`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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