throbber
For the Petitioner
`Backup counsel: Robert W. Hahl, Reg. No. 33,893
`Backup counsel: Robert Mihail, Reg. No. 66,021
`Backup counsel: John K. Pike, Reg. No. 41,253
`Neifeld IP Law, PC
`
`Paper No. __
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`Coalition For Affordable Drugs V LLC
`Petitioner
`v.
`
`Biogen MA Inc.
`Patent Owner
`____________
`
`Case: IPR2015-01136
`Patent 8,399,514
`Title: TREATMENT FOR MULTIPLE SCLEROSIS
`____________
`
`
`Petitioner’s Request for Rehearing under 37 C.F.R. § 42.71(c)
`
`
`
`Mail Stop PATENT BOARD
`U.S. Patent Trial & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-14
`
`

`
`Table of Contents
`
`I. INTRODUCTION ............................................................................................. 1
`
`II. APPLICABLE LEGAL STANDARDS ........................................................ 1
`
`A.
`
`Standards Applicable to a Request for Rehearing ......................................... 1
`
`B.
`
`Standard Applicable to Instituting an Inter Partes Review ........................... 2
`
`III. BASIS FOR RELIEF REQUESTED ........................................................... 2
`
`A. The Kappos 2005 Publication ....................................................................... 2
`
`B.
`
`C.
`
`The ClinicalTrials publication. ...................................................................... 9
`
`The ‘514 patent admission that DMF was known to be therapeutically
`
`active on MS ......................................................................................................... 10
`
`D. The Drugs R&D publication ....................................................................... 13
`
`IV. CONCLUSION ............................................................................................. 15
`
`
`
`i
`
`
`
`
`
`

`
`Table of Authorities
`
`
`Cases
`
`In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)……………………………….7
`
`In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)………………………………...7
`
`In re Montgomery, 677 F.3d 1375, 1382-1383 (Fed. Cir. 2012)………...………6, 7
`
`Intri-Plex Technologies, Inc. and MMI Holdings, Ltd. v. Saint-Gobain
`
`Performance Plastics Rencol Limited, IPR2014-00309, Paper 83, (PTAB
`
`2014)………………………………………………………………………………12
`
`Mems Tech. Berhad v. ITC, 447 Fed. Appx. 142, 162 (Fed. Cir. 2011)…….…..2, 9
`
`Statutes
`
`35 U.S.C. § 102……………………………………………….…………..2, 3, 9, 13
`
`35 U.S.C. § 103………………………………………………..….……..…………1
`
`35 U.S.C. § 314……………………………………………………...……………..2
`
`Regulations
`
`37 C.F.R. § 42.71…………………………………………………..…..…...………1
`37 C.F.R. § 42.108…………………………………………………………..…..1, 2
`
`
`
`
`
`ii
`
`

`
`I.
`
`
`
`
`INTRODUCTION
`On September 2, 2015, the Board issued a Decision under 37 C.F.R. §
`
`42.108 (“Decision”) denying institution of Inter Partes Review of U.S. Patent
`
`8,399,514 (‘514 patent) on three (3) challenges raised by Petitioner in an amended
`
`Petition (“Petition”). The challenges as stated on page 5 of the Decision are:
`
`Challenge
`No.
`1
`
`2
`
`3
`
`
`
`Claims
`
`35 U.S.C.
`
`1–20
`
`1-20
`
`1-20
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`Prior art forming
`basis of challenge
`Kappos and ICH
`Guideline
`ClinicalTrials and
`ICH Guideline
`Prior art
`admissions and
`ICH Guideline
`
`This Request for Rehearing (“Request”) seeks reconsideration of challenges
`
`1, 2 and 3.
`
`
`
`This Request is authorized under 37 C.F.R. § 42.71(c). Prior authorization of
`
`the Board is not required. 37 C.F.R. §42.71(d). As this Request is being filed
`
`within 30 days of the entry of a decision not to institute a trial, 37 C.F.R. § 42.71
`
`(d)(2), this Request is being timely filed.
`
`II. APPLICABLE LEGAL STANDARDS
`
`
`
`Petitioner urges that the Decision misapprehended or overlooked the
`
`following:
`
`A. Standards Applicable to a Request for Rehearing
`1
`
`
`
`

`
`
`
`Under the APA, the Federal Circuit stated that "[a]n abuse of discretion
`
`occurs where the decision is based on an erroneous interpretation of the law, on
`
`factual findings that are not supported by substantial evidence, or represents an
`
`unreasonable judgment in weighing relevant factors." Mems Tech. Berhad v. ITC,
`
`447 Fed. App’x. 142, 162 (Fed. Cir. 2011) citing Star Fruits S.N.C. v. United
`
`States, 393 F.3d 1277, 1281 (Fed. Cir. 2005).
`
`B. Standard Applicable to Instituting an Inter Partes Review
`
`
`
`Under 35 U.S.C. § 314(a), as implemented by 37 C.F.R. § 42.108, an inter
`
`partes review will only be instituted for a ground of unpatentability where the
`
`Board decides that “the petition supporting the ground would demonstrate that
`
`there is a reasonable likelihood that at least one of the claims challenged in the
`
`petition is unpatentable.”
`
`III. BASIS FOR RELIEF REQUESTED
`
`Petitioner urges that the Decision misapprehended or overlooked the following:
`
`A. The Kappos 2005 Publication
`
`
`
`On pages 9 and 10 of the Decision, the Board declined “to find that Kappos
`
`describes the use of DMF as a compound useful for treating multiple sclerosis” and
`
`gives four separate reasons for its decision.
`
`In relying on its first reason, the Decision, on page 9, overlooks or
`
`misapprehends that Kappos 2005 is itself a 102(b) printed publication which
`
`
`
`2
`
`

`
`suggests orally administering DMF to treat patients with RRMS. Ex. 1005A, page
`
`11, ¶23. Whatever additional information a POSITA would have understood from
`
`its disclosure of a previous pilot study (not of record), the mention of that pilot
`
`study in Kappos 2005 does not negate the content of Kappos 2005, or render it
`
`something less than a printed publication available under 35 USC 102(b) for what
`
`it teaches. Kappos 2005 is prior art at least under 35 U.S.C. § 102(b) (pre-AIA)
`
`because it is an abstract of a conference poster presented on June 22, 2005, in
`
`Vienna, Austria to the European Neurological Society. Ex. 1020A, pages 1-2. That
`
`abstract was formally published in the Journal of Neurology, 22, Supplement 2
`
`(June 2005), page II/148 and distributed as a printed publication, a copy of which
`
`was received at the University of Maryland Health Sciences and Human Services
`
`Library, Baltimore, MD., date-stamped July 6, 2005. Id. The Journal of Neurology
`
`is held by almost 600 libraries world‐wide. Id. The June 2005 Supplement to the
`
`Journal of Neurology, where Kappos 2005 was published, was available to readers
`
`at the University of Maryland by August 2005. Id.
`
`
`
`In relying on its second reason, the Decision, on page 9, misapprehends or
`
`overlooks Dr. Linberg’s phrase in paragraph 27 of his declaration, Ex. 1005A. The
`
`Decision interpreted Dr. Linberg’s phrase “appears to be” as if he were guessing
`
`about something. That is not correct. According to the Merriam-Webster
`
`Dictionary, the meaning of the verb “appear” does not include the sense of
`
`
`
`3
`
`

`
`uncertainty or guess. The verb “to appear” when used in conjunction with the verb
`
`“to be” means “to become evident or manifest” as in “there appears to be evidence
`
`to the contrary.” See http://www.merriam-webster.com/dictionary/appear. On the
`
`same Merriam-Webster Dictionary webpage, the list of synonyms for “appear” is
`
`“come out, materialize, show, show up, turn up, unfold.” In the context of Dr.
`
`Linberg’s declaration, the phrase “appears to be” means the Kappos 2005
`
`disclosure became evident or manifest to a POSITA, i.e., “Kappos 2005 discloses a
`
`pilot study that orally administered to patients what appears to be [what apparently
`
`was or what was evidently or what was clearly] a therapeutically effective amount
`
`of fumaric acid esters, indicated by a ‘significantly reduced the number of
`
`gadolinium-enhancing (Gd+) lesions in patients with RRMS.’ Ex. 1003A, page 2,
`
`1:13-16.” Therefore the Board either misapprehended what Dr. Linberg said, or
`
`else the Board impermissibly substituted its own understanding of Kappos 2005 for
`
`that of the expert.
`
`Furthermore, in relying on its second reason, the Decision, on page 9 also
`
`misapprehends or overlooks Dr. Linberg’s declaration in paragraph 28, where he
`
`explains that Kappos 2005 discloses a “dose-ranging” study using BG00012,
`
`which contains DMF, and that “the Kappos 2005 dose-ranging study would not
`
`have been undertaken unless BG00012 had previously been determined to be
`
`therapeutically active in treating patients with MS.” Ex. 1005A, pages 14-15, ¶28.
`
`
`
`4
`
`

`
`Emphasis added. The Decision cites to no substantial evidence for interpreting
`
`Kappos 2005 in a fundamentally different way than Dr. Linberg does.
`
`
`
`Furthermore, in relying on its second reason, the Decision, on page 9, also
`
`misapprehends or overlooks the actual basis for Petitioner’s reliance on Kappos
`
`2005, where it notes that, “[w]hat counts is what is described, not what appears to
`
`have been tested (a prior use, public or otherwise, is not prior art available in an
`
`IPR).” Kappos 2005 was not cited as evidence of prior use, it was cited as a printed
`
`publication which explicitly teaches that DMF has therapeutic activity on RRMS.
`
`Ex. 1005A, page 11, ¶23. Kappos 2005 was not guessing, but stating a fact, i.e.,
`
`that DMF had previously been determined to have been effective in a pilot study
`
`for therapeutic utility in MS. That is why there would have been a reasonable
`
`expectation of success to determine the appropriate dosing range of DMF or MMF,
`
`including its minimum effective dose (standard procedure) in accordance with
`
`government guidance: ICH Guideline E4.” Id.
`
`
`
`In relying on its third reason, the Decision, on page 10 misapprehends or
`
`overlooks the testimony of Dr. Linberg. On page 10, the Board states, “we are
`
`unable to find that ‘fumaric acid ester’ as described by Kappos is DMF or MMF.”
`
`Dr. Linberg testified that “…it was known that DMF is therapeutically active for
`
`treating RRMS, as taught by Kappos 2005...” Emphasis added. Ex. 1005A, page
`
`11, ¶23. Dr. Linberg’s conclusion was based on the Kappos 2005 disclosure of
`
`
`
`5
`
`

`
`“this phase II study was designed to evaluate the efficacy of three doses of
`
`BG00012 on brain lesion activity” in MS patients. Ex.1003A, page 2, 1:17-20. The
`
`Board itself concluded that “[t]he active ingredient of BG12 or BG00012 is
`
`dimethyl fumarate;” Decision page 7; footnote 5. The evidence of record shows
`
`that Kappos 2005 taught a POSITA that oral administration of DMF (and
`
`specifically not MMF) has therapeutic activity on RRMS.
`
`In relying on its fourth reason, the Decision, on pages 10-11, states
`
`The nature of the pilot study is not apparent. Petitioner has not
`established the precise nature of the study and whether researchers were
`determining a therapeutically effective amount. The Pilot Study is not a
`description that DMF is useful for treating MS; rather, at best it is a “hope”
`that DMF will turn out to be useful for treating MS. A hope may or may not
`come true and does not establish that DMF is useful for treating MS.
`Assuming Phase I does not reveal unacceptable toxicity, FDA Phase
`II may determine whether a “drug works in people who have a certain
`disease or condition.” Id. Phase II may or may not establish that DMF is
`useful for treating MS. However, prior to completion and evaluation of
`Phase II, one skilled in the art would not necessarily understand from
`Kappos that DMF is useful for treating MS.
`
`The Board misapprehends or overlooks Dr. Linberg’s testimony that a
`
`
`
`
`
`POSITA knew DMF was therapeutically active for treating RRMS. Dr. Linberg
`
`testified that “…once it was known that DMF is therapeutically active for treating
`
`RRMS, as taught by Kappos 2005…” Emphasis added. Ex. 1005A, page 11, ¶23.
`
`
`
`6
`
`

`
`The CAFC held that “obviousness does not require absolute predictability of
`
`success” and that “[f]or obviousness under § 103, all that is required is a
`
`reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir.
`
`1988). The Board also misapprehends or overlooks the remainder of Dr. Linberg’s
`
`paragraph 23, which states that Kappos 2005 describes a routine step in drug
`
`development taken after therapeutic activity has been detected. The CAFC held
`
`that routine testing is “the product not of innovation but of ordinary skill and
`
`common sense.” KSR, 550 U.S. at 421…. See O’Farrell, 853 F.2d at 904.” In re
`
`Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009).
`
`
`
`The Board also misapprehends or overlooks Dr. Linberg’s testimony in
`
`paragraph 28 which explains that “the Kappos 2005 dose-ranging study would not
`
`have been undertaken unless BG00012 had previously been determined to be
`
`therapeutically active in treating patients with MS.” Emphasis added. Ex. 1005A,
`
`page 15, ¶28. The open questions presented by Kappos 2005 were not whether
`
`DMF “works” in people who have MS, but whether the drug could be licensed for
`
`such use (e.g., by the FDA), and if so, at what dose(s). Therefore the Board abused
`
`its discretion by holding in its Decision, on page 11, that “[p]etitioner has failed to
`
`establish that Kappos teaches that DMF would be useful for treating MS.”
`
`The CAFC stated that “[i]t is well established that a patent may be secured,
`
`and typically is secured, before the conclusion of clinical trials. See Eli Lilly & Co.
`
`
`
`7
`
`

`
`v. Teva Pharms. USA, Inc., 619 F.3d 1329, 1335, 1343 (Fed. Cir. 2010) (rejecting
`
`an enablement challenge to patents that were filed while clinical trial results were
`
`pending); MPEP § 2107.03 (8th ed., rev. 6, Sept. 2007) ("[I]f an applicant has
`
`initiated human clinical trials for a therapeutic product or process, Office personnel
`
`should presume that the applicant has established that the subject matter of that
`
`trial is reasonably predictive of having the asserted therapeutic utility.").” In re
`
`Montgomery, 677 F.3d 1375, 1382-1383 (Fed. Cir. 2012).
`
`The Decision on page 11 states that “prior to completion and evaluation of
`
`Phase II, one skilled in the art would not necessarily understand from Kappos 2005
`
`that DMF is useful for treating MS.” This misapprehends or overlooks that Kappos
`
`2005 describes ongoing human clinical trials, i.e., “[t]his is a randomized, double-
`
`blind, placebo-controlled, phase II study being conducted at 45 clinical centers in
`
`Europe.” Ex. 1003A, page 2, 1:21-22; Ex. 1005A, page 26, ¶51. Emphasis added.
`
`It was an abuse of discretion for the Board to find as matter of fact, or hold as
`
`matter of law, that there was no reasonable expectation of success in using DMF to
`
`treat RRMS even after learning that BG00012 (DMF) was being used for that
`
`purpose in 45 clinical centers in Europe. Id.
`
`
`
`In summary, the Board overlooks or misapprehends the evidence on the
`
`record or substituted its own understanding of Kappos 2005 for that of Dr. Linberg
`
`when saying that Kappos 2005 does not meet the “description” requirement of
`
`
`
`8
`
`

`
`102(b). Decision, page 11. The Board held, in essence, that a well-known reason
`
`for designing dose-ranging studies, i.e., success in a pilot study, which success is
`
`apparent in the Background section of Kappos 2005 according to Dr. Linberg (Ex.
`
`1005A, page 14, ¶27) still does not establish “a reasonable likelihood that Kappos
`
`teaches that DMF was known to be useful in treating MS.” Decision, page 11. But
`
`no expert has said that, and the Board is not qualified to reach that conclusion on
`
`its own, since that conclusion is not supported by substantial evidence. See Mems
`
`Tech. Berhad v. ITC, 447 Fed. Appx. 142, 162 (Fed. Cir. 2011) citing Star Fruits
`
`S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005).
`
`The Board is simply contradicting, without any support, Dr. Lindberg’s
`
`opinion about what Kappos 2005 describes.
`
`B. The ClinicalTrials publication.
`
`
`
`On page 13 of the Decision, the Board found that “ClinicalTrials is deficient
`
`as a prior art teaching of DMF being useful to treat MS for many of the same
`
`reasons that Kappos is deficient.” On page 13 the Decision states “[n]owhere does
`
`ClinicalTrials state that DMF is useful for treating MS. Rather, what is described is
`
`a ‘pilot MS study of BG00012’ (not of record) and based on that study going
`
`forward with ‘a proof of concept study in MS.’ Ex. 1022A 1–2. ClinicalTrials, at
`
`best, describes a ‘possible therapeutic efficacy in MS,’ citing a 2001 article by
`
`Schimrigk et al. (not of record).” On page 14 the Board concluded that
`
`
`
`9
`
`

`
`“ClinicalTrials might support a finding that one skilled in the art ‘hopes’ DMF will
`
`be useful in treating MS.” Emphasis added.
`
`The Decision overlooked or misapprehended the content of ClinicalTrials
`
`and the meaning of the term “pilot study.” The Board overlooked or Dr. Linberg’s
`
`testimony or impermissibly substituted its own expertise for that of Dr. Linberg,
`
`where he testified ClinicalTrials teaches that DMF has therapeutic activity for MS:
`
`“[i]n my opinion, once it was known that DMF is therapeutically active for
`
`treating RRMS, as taught by… ClinicalTrials NCT00168701.…” Ex. 1005A, page
`
`11, ¶23. Emphasis added. Furthermore, the Decision also overlooked Dr. Linberg’s
`
`testimony, or impermissibly substituted its own expertise for that of Dr. Linberg,
`
`where he testified that “[i]n my opinion,…ClinicalTrials NCT00168701...teach a
`
`POSITA that DMF and MMF are therapeutically active on RRMS.” Ex. 1005A,
`
`page 15, ¶30. Emphasis added. It is immaterial if MMF was also thought to be
`
`therapeutically effective. Dr. Linberg specifically stated that “DMF…[is]
`
`therapeutically active on RMMS” Id.
`
`C. The ‘514 patent admission that DMF was known to be
`therapeutically active on MS
`
`
`
`On page 14, the Decision quotes an admission (or statement) contained in
`
`the ‘514 patent: “Fumaric acid esters, such as DMF, have been proposed for
`
`treatment of MS (see, e.g., [1] Schimrigk et al., Eur. J. Neurol., 2006, 13(6):604-
`
`
`
`10
`
`

`
`10; [2] Drugs R&D, 2005, 6(4):229-30). Ex. 1001A, col 5:6–8.” The Board notes,
`
`“Patent Owner attacks use of the admission on the ground that an alleged
`
`admission is not a patent or printed publication, and, therefore, cannot be a basis to
`
`institute an inter partes review. 35 U.S.C. § 311(b).” Prelim. Resp. 25.” But then
`
`on page 15, the Board avoids the issue by holding that “[w]e do not reach, leaving
`
`for another day, any issue of whether an “admission” per se can be relevant prior
`
`art in an IPR.” This gives no reason why the Board is leaving the question for
`
`another day, other than “[t]he ‘admission’ (or statement in the ʼ514 Patent) is
`
`supported by a citation to Drugs R&D.” Decision, page 15. The Board then
`
`substituted its own factually incorrect interpretation of the Drugs R&D disclosure
`
`(see the next section of this Request) for the ’514 patent admission itself, without
`
`citing any substantial evidence showing that the two are equivalent. (Note that the
`
`admission cites two references as examples, “Fumaric acid esters, such as DMF,
`
`have been proposed for treatment of MS (see, e.g., Schimrigk et al., Eur. J.
`
`Neurol., 2006, 13(6):604-10; Drugs R&D, 2005, 6(4):229-30). Ex. 1001A, col
`
`5:6–8”). In doing so the Board overlooks or misapprehends the testimony of Dr.
`
`Linberg, or impermissibly substitutes its own expertise for that of Dr. Linberg
`
`where he testified, “the ‘514 Patent admits a POSITA believed that DMF and
`
`MMF were therapeutically active for MS.” Ex. 1005A, pages 28–29, ¶57. The
`
`
`
`11
`
`

`
`Decision cites no substantial evidence contradicting Dr. Linberg’s expert opinion
`
`about the meaning of the ‘514 patent admission (or statement) in question.
`
`
`
`The Board’s holding that it is still an open question whether patent
`
`admissions per se can be relevant prior art in an IPR is erroneous. See Intri-Plex
`
`Technologies, Inc. and MMI Holdings, Ltd. v. Saint-Gobain Performance Plastics
`
`Rencol Limited, IPR2014-00309, Paper 83, pages 19-29 (PTAB 2014)1.
`
`
`1 In reference to statements in the challenged patent’s specification, the Board said:
`
`“Saint-Gobain’s challenge to Admitted Prior Art as beyond the scope of Section
`
`311(b) appears to be a case of first impression since enactment of AIA. Our
`
`rationale for considering Admitted Prior Art in an IPR falls under at least one of
`
`three alternative lines of reasoning: (1) statements within the four corners of the
`
`challenged patent that constitute admissions may be considered “prior art
`
`consisting of patents” for purposes of Section 311(b); or, (2) Section 311(b) was
`
`intended to narrow the scope of statutory prior art listed under 35 U.S.C. § 102, but
`
`was not intended to restrict our ability to consider Admitted Prior Art, which is not
`
`listed expressly under Section 102, but has nevertheless traditionally been
`
`considered by the Office as prior art; or alternatively (3) even if Admitted Prior Art
`
`is not treated as a prior art reference per se for purposes of Section 311(b), Saint-
`
`Gobain’s admission nevertheless constitutes background knowledge that may be
`
`
`
`12
`
`

`
`D. The Drugs R&D publication
`
`
`
`On page 15, the Decision finds that “nothing in the admission or Drugs
`
`R&D supports a finding that DMF is useful for treating MS.”
`
`
`
`
`
`In reaching this finding, on page 15 the Decision states, “Drugs R&D says
`
`that Fumapharm AG developed a second-generation fumarate (‘fumaric acid’—
`
`which is not DMF) for oral treatment of psoriasis.” This interpretation of Drugs
`
`R&D is wrong. The reference is not talking about fumaric acid itself. The Board
`
`has misquoted Drugs R&D by leaving out the word “derivative” in the first
`
`sentence of the Drugs R&D Abstract: “Fumapharm AG has developed a second-
`
`generation fumarate (fumaric acid) derivative, BG12” (emphasis added) which
`
`refers to esters of fumaric acid, as in dimethylfumarate and monomethylfumarate.
`
`Now, adding the next word left off of the Board’s quote gives: “fumarate (fumaric
`
`acid) derivative, BG 12,” which narrows it down to DMF, not MMF. The Board
`
`recognized that BG12 is DMF (Decision, page 7, footnote 5) but even without
`
`knowing what BG12 means, one can see that Drugs R&D does not say that fumaric
`
`
`imputed to a hypothetical person of ordinary skill for purposes of an obviousness
`
`analysis. See Randall Mfg. v. Rea, 733 F.3d at 1363 (non-applied art may be
`
`considered as background information known to a person of ordinary skill in the
`
`art).” IPR2014-00309, Paper 83, page 21, footnote 8.
`
`
`
`13
`
`

`
`acid was being developed as a second generation drug. Because it refers to a
`
`“fumarate…derivative” so the drug must be an ester of fumaric acid, not fumaric
`
`acid itself. Moreover, because the Decision overlooks or misapprehends the
`
`teachings of Drug R&D, the Decision’s reason for not considering whether the
`
`‘514 patent admission (or statement) per se is applicable prior art in an IPR is
`
`factually wrong. This issue should not be left for another day.
`
`
`
`In reaching its finding that on page 15 that “nothing in…Drugs R&D
`
`supports a finding that DMF is useful for treating MS,” the Decision
`
`misapprehends or overlooks the Drugs R&D disclosure: “Biogen Idec is currently
`
`evaluating the product in clinical trials as an oral treatment for multiple sclerosis
`
`(phase II) and psoriasis (phase III) trials.” Emphasis added. Ex. 1021A, Abstract.
`
`As shown above, “the product” in this sentence is not fumaric acid, it is DMF.
`
`
`
`
`
`Furthermore, the Decision overlooks, misapprehends or substitutes the
`
`Board’s own expertise for the testimony of Dr. Linberg who said:
`
`Drugs R&D reports the following entry in Table II: “Nov 2004 Phase II in
`Multiple sclerosis in Europe (PO)” Ex. 1021A, p2. In my opinion, this table
`entry indicates to a POSITA that a phase 2 clinical trial using the oral
`BG00012 composition was conducted on MS patients beginning in 2004.
`The fact that this was a phase 2 trial indicates that DMF was believed to
`have therapeutic activity against MS at that time. Ex. 1005A, ¶24.
`
`
`
`14
`
`

`
`
`
`Thus, Drugs R&D describes ongoing clinical studies of DMF for the
`
`treatment of MS. Ex. 1021A, Abstract and page 2, Table II. It was an abuse of
`
`discretion for the Board to find as matter of fact, or hold as matter of law, that there
`
`was no reasonable expectation of success in using DMF to treat RRMS even after
`
`learning that BG00012 (DMF) was being used for that purpose in a European
`
`Phase II clinical trial.
`
`
`
`On page 15 the Decision cites no substantial evidence supporting the
`
`conclusion that, “[i]n other words, as of the date of the admission or Drugs R&D,
`
`we are back to a ‘hope’ that DMF will be useful in treating MS.” Evidence of
`
`record shows that the therapeutic activity of DMF in multiple sclerosis was not just
`
`a “hope” at that point, it was known to be present.
`
`IV.
`
`CONCLUSION
`
`
`
`In view of the foregoing, Petitioner respectfully requests that the Board
`
`institute Inter Partes Review on Ground 1, challenges 1, 2 and 3.
`
`
`
`15
`
`
`
`/RobertHahl#33,893/
`Robert W. Hahl, Reg. No. 33,893
`Lead Counsel for the Petitioner
`Tel: 1-703-415-0012 Ext. 103
`Email: rhahl@neifeld.com
`Backup Counsel for Petitioner
`Robert Mihail, Reg. No. 66,021
`Tel: 1-703-415-0012 Ext. 107
`Email: rmihail@neifeld.com
`
`
`
`

`
`42.6(e) CERTIFICATE OF SERVICE
`
`Agreements on Service: “Under 37 C.F.R. § 42.6(e), Patent Owner consents to
`electronic service by email at michael.flibbert@finnegan.com and
`maureen.queler@finnegan.com.” Patent Owner’s Mandatory Notice of 5/22/2015.
`
`
`I certify that this document was served or simultaneously is being served on each
`opposing party with the filing of this document.
`
`42.6(e)(4) (iii)(A) The date and manner of service:
`
`Date of Service: 10/01/2015
`
`Manner of service: Email to: michael.flibbert@finnegan.com;
`maureen.queler@finnegan.com
`
`42.6(e)(4)(iii)(B) The name and address of every person served are:
`Lead Counsel for patent owner, telephone and email: Michael J. Flibbert (Reg.
`No. 33,234); Tel: 202.408.4493
`Backup Counsel for patent owner, telephone and email: Maureen D. Queler
`(Reg. No. 61,879); Tel: 202.408.4294
`Postal Address for lead and backup counsel for patent owner: Finnegan,
`Henderson, Farabow, Garrett & Dunner, LLP, 901 New York Avenue, NW,
`Washington, DC 20001.
`Fax Address for lead and backup counsel for patent owner: 202-408-4000
`
`
`/RobertMihail/
`Robert Mihail, Reg. No. 66,021
`Back-up Counsel for the Petitioner
`Neifeld IP Law, PC
`4813-B Eisenhower Avenue
`Alexandria, VA 22304
`Tel: 1-703-415-0012 Ext. 107
`Fax: 1-703-415-0013
`Email: rmihail@neifeld.com
`
`
`
`16

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