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 B2
`__________
`
`
`
`BIOGEN’S OPPOSITION TO REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`___________
`
`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 B2
`__________
`
`
`
`BIOGEN’S OPPOSITION TO REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`The Board Did Not Abuse Its Discretion in Declining to Institute
`Based on Kappos 2005 .................................................................................... 2
`
`III. The Board Did Not Abuse Its Discretion in Declining to Institute
`Based on ClinicalTrials ................................................................................... 9
`
`IV. The Board Did Not Abuse Its Discretion in Declining to Institute
`Based on the Alleged ’514 Patent Admission ............................................... 11
`
`V.
`
`Conclusion ..................................................................................................... 15
`
`
`
`
`
`i
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`
`
`TABLE OF AUTHORITIES
`
`Federal Cases
`
`Page(s)
`
`ActiveVideo Networks, Inc. v. Verizon Communications, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .............................................................. 10, 11, 12
`
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ............................................................................ 8
`
`Daicel Corp. v. Celanese Int’l Corp.,
`IPR2014-01514, Paper No. 15 (June 26, 2015) ...........................................passim
`
`Eli Lily v. Teva Pharms. USA, Inc.
`619 F.3d 1329 (Fed Cir. 2010) ............................................................................. 8
`
`Inwood Labs., Inc. v. Ives Labs., Inc.,
`456 U.S. 844 (1982) ........................................................................................ 9, 15
`
`Ex parte McGaughey,
`6 U.S.P.Q.2d 1334 (BPAI Mar. 4, 1988) ...................................................... 12, 13
`
`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) ...................................................................passim
`
`Wowza Media Sys., LLC v. Adobe Sys. Inc.,
`IPR2013-00054, Paper 16 (PTAB July 13, 2013) ........................................ 10, 11
`
`Federal Statutes
`
`35 U.S.C. § 102(b) ................................................................................................. 2, 9
`
`Regulations
`37 C.F.R. § 42.71(d) .........................................................................................passim
`
`Other Authorities
`
`http://www.merriam-webster.com/dictionary/appear ................................................ 3
`
`MPEP § 2107.03 ........................................................................................................ 8
`
`
`
`
`
`ii
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`
`
`TABLE OF ABBREVIATIONS
`
`Definition
`
`dimethyl fumarate
`
`monomethyl fumarate
`
`multiple sclerosis
`
`relapsing remitting multiple sclerosis
`
`
`
`
`
`iii
`
`Abbreviation
`
`DMF
`
`MMF
`
`MS
`
`RRMS
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`
`I.
`
`Introduction
`
`The Board denied institution because Petitioner’s cited prior art failed to
`
`disclose that DMF was useful for treating MS. As the Board correctly recognized,
`
`the cited prior art suggested only that researchers intended to evaluate the safety
`
`and efficacy of BG00012 in MS patients in a planned Phase II study.
`
`Nothing in the Request for Rehearing shows any error in the Board’s
`
`interpretation of the prior art or its legal analysis. Petitioner identifies no matters
`
`that the Board overlooked or misapprehended; thus, the Board did not abuse its
`
`discretion in denying institution. Contrary to Petitioner’s suggestion that the Board
`
`should have accepted Dr. Linberg’s testimony, the Board properly gave more
`
`weight to the actual teachings of the prior art than to Dr. Linberg’s conclusory
`
`assertions. Petitioner’s arguments concerning the meaning of the phrase “appears
`
`to be” and other assertions show no error in the Board’s analysis. Petitioner also
`
`raises new arguments, including that the prior art allegedly provided a reasonable
`
`expectation of success, which it failed to raise in the petition.
`
`Even if the Board were to agree with any aspect of the Request for
`
`Rehearing, institution would be inappropriate. The Board provided multiple well-
`
`supported reasons for denying institution. Further, Patent Owner’s preliminary
`
`response described other compelling reasons for denying institution; for example,
`
`the petition failed to address reasonable expectation of success; did not establish
`
`1
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`that the claimed dosage of 480 mg/day would have been obvious; did not rebut the
`
`established unexpected results at the claimed dosage level; and did not prove that
`
`the ClinicalTrials document was a prior-art printed publication. Therefore, the
`
`Board should deny the Request for Rehearing.
`
`II. The Board Did Not Abuse Its Discretion in Declining to Institute Based
`on Kappos 2005
`1.
`
`On page 2, line 19 - page 3, line 15 of the Request, Petitioner states
`
`that the decision overlooked or misapprehended that Kappos 2005 is a § 102(b)
`
`printed publication. Patent Owner disagrees because the decision does not question
`
`that Kappos 2005 is a prior-art printed publication.
`
`2.
`
`On page 3, lines 3-6, Petitioner states that Kappos’s mention of a pilot
`
`study did not negate the content of Kappos or render it less than a printed
`
`publication. Patent Owner disagrees that this identifies any abuse of discretion
`
`because the Board did not question the prior-art status of Kappos 2005 or suggest
`
`that the pilot study negated the content of Kappos 2005; rather, it correctly found
`
`(and Petitioner does not dispute) that the pilot study was not of record. (Dec. at 9.)
`
`3.
`
`On page 3, line 16 - page 4, line 14, Petitioner states that the decision
`
`overlooked or misapprehended Dr. Linberg’s phrase “appears to be” in paragraph
`
`27 of his declaration. Patent Owner disagrees because the Board discussed this
`
`phrase on page 9 of its decision. Patent Owner also disagrees because these
`
`arguments about Dr. Linberg’s purported intended meaning are new; Dr. Linberg
`
`2
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`did not explain what he meant by the term “appears” and thus the Board did not
`
`abuse its discretion in giving more weight to Kappos’s disclosure than to
`
`conclusory expert testimony. See Velander v. Garner, 348 F.3d 1359, 1371 (Fed.
`
`Cir. 2003) (holding that Board did not abuse its discretion in giving little weight to
`
`broad conclusory expert statements); Daicel Corp. v. Celanese Int’l Corp.,
`
`IPR2014-01514, Paper No. 15 at 8 (PTAB June 26, 2015) (Board assesses
`
`persuasiveness of expert testimony in light of other factual evidence of record).
`
`Further, the word “appear” is also synonymous with “seem” (http://www.merriam-
`
`webster.com/dictionary/appear), consistent with the Board’s statement that what
`
`counts is what is described, not what appears to have been tested. (Dec. at 9.)
`
`4.
`
`On page 4, line 15 - page 5, line 2, Petitioner states that the decision
`
`misapprehended or overlooked Dr. Linberg’s statement that the Kappos 2005 dose-
`
`ranging study would not have been undertaken unless BG00012 had been
`
`determined to be therapeutically active in treating patients with MS; and that the
`
`decision cites no substantial evidence for interpreting Kappos in a fundamentally
`
`different way. Patent Owner disagrees because this attempt to reargue the petition
`
`fails to point out how the Board allegedly misunderstood Dr. Linberg’s testimony.
`
`See 37 C.F.R. § 42.71(d). Patent Owner also disagrees because the Board fully
`
`considered all of Petitioner’s arguments (Dec. at 16), considered Kappos 2005 (id.
`
`at 7-11), and based thereon reasonably concluded that, before completion of the
`
`3
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`planned Phase II study, one of ordinary skill would not have understood that DMF
`
`was useful for treating MS (id. at 10-11). The Board did not abuse its discretion in
`
`giving more weight to Kappos 2005’s disclosure than to Dr. Linberg’s conclusory
`
`statements. Velander, 348 F.3d at 1371; Daicel Corp., IPR2014-01514, Paper No.
`
`15 at 8. Moreover, Petitioner failed to argue, much less prove, that one would have
`
`had a reasonable expectation of success that a dose of 480 mg/day of DMF would
`
`be therapeutically effective or useful as claimed. (Prelim. Resp. at 8-11, 16-20.)
`
`5.
`
`On page 5,
`
`lines 3-14, Petitioner states
`
`that
`
`the decision
`
`misapprehended or overlooked that Kappos 2005 was not guessing, but stating a
`
`fact, i.e., that DMF had been determined to be effective, which is why there would
`
`have been a reasonable expectation of success. Patent Owner disagrees because
`
`Petitioner’s argument concerning reasonable expectation of success is new and
`
`therefore could not have been overlooked. See 37 C.F.R. § 42.71(d). (Prelim. Resp.
`
`at 8-11.) Patent Owner also disagrees because Kappos 2005 did not state that DMF
`
`had been determined to be effective, but referred to an earlier pilot study using a
`
`mixture of fumaric acid esters. (Ex. 1003A at 2 (P574); Prelim. Resp. at 17.)
`
`6.
`
`On page 5, line 15 - page 6, line 6, Petitioner states that the Board’s
`
`finding that Kappos’s description of “fumaric acid esters” was insufficient to
`
`describe DMF misapprehended or overlooked Dr. Linberg’s testimony that it was
`
`known that DMF is therapeutically active for treating RRMS based on Kappos’s
`
`4
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`disclosure of a Phase II study with BG00012. Patent Owner disagrees because the
`
`Board’s conclusion regarding fumaric acid esters concerned Kappos’s mention of
`
`the earlier pilot study, not the planned Phase II study. Petitioner does not show that
`
`the Board misapprehended any evidence regarding the pilot study’s use of fumaric
`
`acid esters. Paragraph 23 of Dr. Linberg’s declaration (cited by Petitioner) does not
`
`explain the basis for his conclusion; therefore, Petitioner’s contention that he based
`
`this paragraph on a portion of Kappos is a new argument that could not have been
`
`overlooked. See 37 C.F.R. § 42.71(d).
`
`7.
`
`On page 6, lines 7-23, Petitioner states that the Board misapprehended
`
`or overlooked Dr. Linberg’s testimony that one of ordinary skill knew that DMF
`
`was therapeutically active for treating RRMS. Patent Owner disagrees because the
`
`Board did not misapprehend or overlook Dr. Linberg’s statement. Rather, the
`
`Board considered all of Petitioner’s arguments (Dec. at 16), considered Kappos
`
`2005 (id. at 7-11), and determined that it did not indicate that DMF would be
`
`useful in treating MS (id. at 11). The Board did not abuse its discretion in giving
`
`more weight to the disclosure of Kappos 2005 than to Dr. Linberg’s conclusory
`
`testimony. Velander, 348 F.3d at 1371; Daicel Corp., IPR2014-01514, Paper No.
`
`15 at 8.
`
`8.
`
`On page 7, lines 1-4, Petitioner states that for obviousness, all that is
`
`required is a reasonable expectation of success. Patent Owner disagrees because
`
`5
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`the Board applied the correct law of obviousness. Moreover, Petitioner never
`
`argued (or proved) a reasonable expectation of success. (Prelim. Resp. at 8-11, 16-
`
`20.) As this argument is new, it could not have been overlooked, see 37 C.F.R.
`
`§ 42.71(d), and raising it for the first time in the Request does not remedy
`
`Petitioner’s earlier failures.
`
`9.
`
`On page 7, lines 4-9, Petitioner states that the Board misapprehended
`
`or overlooked Dr. Linberg’s testimony that Kappos 2005 describes a routine step in
`
`drug development taken after therapeutic activity has been detected. Patent Owner
`
`disagrees because paragraph 23 of Dr. Linberg’s declaration (cited by Petitioner)
`
`does not state that Kappos 2005 describes a routine step in drug development.
`
`Patent Owner also disagrees because, as the Board explained, Petitioner failed to
`
`establish that Kappos 2005 teaches that DMF was known to be useful in treating
`
`MS; therefore, it was unnecessary to determine whether the claimed dosage would
`
`have been obvious. (Dec. at 11.)
`
`10. On page 7,
`
`lines 10-14, Petitioner states
`
`that
`
`the Board
`
`misapprehended or overlooked Dr. Linberg’s testimony that Kappos 2005’s dose-
`
`ranging study would not have been undertaken unless BG00012 had been
`
`determined to be therapeutically active in treating patients with MS. Patent Owner
`
`disagrees because this is an inappropriate attempt to reargue the petition and
`
`present a new argument about the prior art. Patent Owner also disagrees because
`
`6
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`the Board considered all of Petitioner’s arguments (Dec. at 16), considered Kappos
`
`2005 (id. at 7-11), and determined that it did not teach that DMF was known to be
`
`useful in treating MS (id. at 11). The Board did not abuse its discretion in giving
`
`more weight to the disclosure of Kappos 2005 than to Dr. Linberg’s conclusory
`
`testimony. Velander, 348 F.3d at 1371; Daicel Corp., IPR2014-01514, Paper No.
`
`15 at 8. Moreover, the petition failed to argue or prove any reasonable expectation
`
`of success. (Prelim. Resp. at 8-11, 16-20.)
`
`11. On page 7, lines 14-18, Petitioner states that the Board abused its
`
`discretion in holding that the petition did not establish that Kappos 2005 teaches
`
`that DMF would be useful in treating patients with MS. The open question,
`
`according to Petitioner, was whether the drug could be licensed by FDA to treat
`
`MS patients, not whether DMF works. Patent Owner disagrees because this
`
`argument is new and thus could not have been overlooked. See 37 C.F.R.
`
`§ 42.71(d). In addition, the Board did not overlook Dr. Linberg’s testimony, but
`
`rather considered all of Petitioner’s arguments (Dec. at 16), considered Kappos
`
`2005 (id. at 7-11), and found that it did not teach that DMF was known to be useful
`
`in treating MS (id. at 11). The Board did not abuse its discretion in relying on
`
`Kappos’s disclosure over Dr. Linberg’s conclusory statements. Velander, 348 F.3d
`
`at 1371; Daicel Corp., IPR2014-01514, Paper No. 15 at 8.
`
`12. On page 7, line 19 - page 8, line 7, Petitioner states that a patent may
`
`7
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`be secured before conclusion of clinical trials, citing Eli Lily v. Teva Pharms. USA,
`
`Inc. 619 F.3d 1329 (Fed Cir. 2010) and MPEP § 2107.03. Patent Owner disagrees
`
`because this is a new argument and thus could not have been overlooked. See 37
`
`C.F.R. § 42.71(d). Patent Owner also disagrees because the cited case and MPEP
`
`section relate to enablement and utility, respectively, not obviousness. See
`
`Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310 (Fed. Cir. 2015) (holding that
`
`obviousness and enablement inquiries turn on different issues).
`
`13. On page 8,
`
`lines 8-17, Petitioner states
`
`that
`
`the decision
`
`misapprehended or overlooked that Kappos 2005 describes ongoing clinical trials,
`
`and therefore it was an abuse of discretion to find no reasonable expectation of
`
`success when DMF was being used. Patent Owner disagrees because the petition
`
`did not address reasonable expectation of success and therefore the Board could
`
`not have overlooked this new argument. See 37 C.F.R. § 42.71(d). (Prelim. Resp.
`
`at 8-11.) Patent Owner also disagrees because this represents an inappropriate
`
`attempt to reargue the petition. In addition, the Board did not overlook that a Phase
`
`II trial was being conducted, but held that before its completion and evaluation,
`
`one skilled in the art would not necessarily understand based on Kappos 2005 that
`
`DMF is useful for treating MS. (Dec. at 11.)
`
`14. On page 8, line 18 - page 9, line 1, Petitioner states that the Board
`
`substituted its own understanding of Kappos 2005 for that of Dr. Linberg in
`
`8
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`concluding that Kappos did not meet the description requirement of § 102(b).
`
`Patent Owner disagrees because the Board fully considered Kappos 2005 (Dec. at
`
`7-11) and did not abuse its discretion in giving more weight to the reference’s
`
`disclosure than to conclusory expert statements. Velander, 348 F.3d at 1371;
`
`Daicel Corp., IPR2014-01514, Paper No. 15 at 8.
`
`15. On page 9, lines 1-11, Petitioner states that the Board’s decision is not
`
`supported by substantial evidence because success in a pilot study, apparent in the
`
`background section of Kappos, is a well-known reason for designing dose-ranging
`
`studies. Patent Owner disagrees because the Board’s decision is fully supported by
`
`the disclosure of Kappos 2005. (Dec. at 7-11.) Patent Owner also disagrees
`
`because the pilot study is not of record (Dec. at 9); and Dr. Linberg never testified
`
`that success in a pilot study is a well-known reason for designing dose-ranging
`
`studies, making this a new argument. The Board also did not abuse its discretion
`
`because determining the weight and credibility of the evidence is the special
`
`province of the trier of fact. See Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S.
`
`844, 856 (1982).
`
`III. The Board Did Not Abuse Its Discretion in Declining to Institute Based
`on ClinicalTrials
`16. On page 10, lines 3-4 of the Request, Petitioner states that the Board
`
`overlooked or misapprehended the meaning of the term “pilot study.” Patent
`
`Owner disagrees because Petitioner fails to identify how this term was overlooked
`
`9
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`or misapprehended. See 37 C.F.R. § 42.71(d). Petitioner does not dispute that the
`
`pilot study is not of record. The Board’s conclusion that ClinicalTrials describes a
`
`pilot study (not of record) was not an abuse of discretion. (Dec. at 13.)
`
`17. On page 10, lines 3-4, Petitioner states that the Board overlooked or
`
`misapprehended the ClinicalTrials document. Patent Owner disagrees because
`
`Petitioner identifies no portion of ClinicalTrials that the Board misapprehended or
`
`overlooked. See 37 C.F.R. § 42.71(d).
`
`18. On page 10, lines 4-9, Petitioner states that the Board overlooked Dr.
`
`Linberg’s testimony that DMF has therapeutic activity for MS. Patent Owner
`
`disagrees because paragraph 23 of Dr. Linberg’s declaration (cited by Petitioner)
`
`contains only a general statement with no citation to any portion of ClinicalTrials.
`
`See ActiveVideo Networks, Inc. v. Verizon Communications, Inc., 694 F.3d 1312,
`
`1327 (Fed. Cir. 2012) (conclusory, factually unsupported expert testimony is
`
`insufficient to establish obviousness); Wowza Media Sys., LLC v. Adobe Sys. Inc.,
`
`IPR2013-00054, Paper 16 at 4-5 (PTAB July 13, 2013) (expert testimony that does
`
`not disclose the underlying facts is entitled to little or no weight). Patent Owner
`
`also disagrees because the Board considered all of the arguments presented (Dec.
`
`at 16) and found insufficient evidence that one of ordinary skill would have had a
`
`reasonable likelihood of success at the end of DMF testing for MS (id. at 14).
`
`19. On page 10, lines 9-15, Petitioner states that the Board overlooked Dr.
`
`10
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`Linberg’s testimony or “impermissibly substituted its own expertise for that of Dr.
`
`Linberg,” who testified that ClinicalTrials taught that DMF is therapeutically
`
`active. Patent Owner disagrees because this is an inappropriate attempt to reargue
`
`the case. In addition, Dr. Linberg’s opinion in the cited portion of his declaration
`
`(Ex. 1005A at ¶ 23) is conclusory and unsupported; therefore, the Board was
`
`entitled to give it little weight. ActiveVideo Networks, Inc., 694 F.3d at 1327;
`
`Wowza Media Sys., LLC, IPR2013-00054, Paper 16 at 4-5. Patent Owner also
`
`disagrees because the Board considered all of the arguments presented (Dec. at 16)
`
`and found that ClinicalTrials does not state that DMF is useful for treating MS (id.
`
`at 13). The Board did not abuse its discretion in giving more weight to the
`
`disclosure of ClinicalTrials than to Dr. Linberg’s conclusory testimony. Velander,
`
`348 F.3d at 1371; Daicel Corp., IPR2014-01514, Paper No. 15 at 8.
`
`IV. The Board Did Not Abuse Its Discretion in Declining to Institute Based
`on the Alleged ’514 Patent Admission
`20. On page 11, lines 9-16 of the Request, Petitioner states that the Board
`
`substituted its own incorrect interpretation of Drugs R&D for the alleged ’514
`
`patent admission without substantial evidence that the two are equivalent. Patent
`
`Owner disagrees because the Board did not state that these two disclosures were
`
`equivalent, but analyzed the alleged admission in the context of Drugs R&D. (Dec.
`
`at 15.) Petitioner does not dispute that the other cited reference (Schimrigk) is not
`
`of record.
`
`11
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`21. On page 11, lines 16-19, Petitioner states that the Board overlooked or
`
`misapprehended Dr. Linberg’s testimony that the ’514 patent admits that one of
`
`ordinary skill believed that DMF and MMF were therapeutically active for MS.
`
`Patent Owner disagrees because the Board correctly examined the statement in the
`
`specification in light of the Drugs R&D publication and concluded that it did not
`
`support a finding that DMF was useful for treating MS. (Dec. at 15.) Further, the
`
`petition failed to establish a prima facie case of obviousness based on the alleged
`
`’514 patent admission. (Prelim. Resp. at 28-31.)
`
`22. On page 12, lines 1-2, Petitioner states that the Board cited no
`
`substantial evidence contradicting Dr. Linberg’s opinion about the meaning of the
`
`alleged admission. Patent Owner disagrees because the Board concluded that
`
`nothing in the alleged admission or Drugs R&D supported a finding that DMF was
`
`useful for treating MS. (Dec. at 15.) The Board did not abuse its discretion in
`
`giving little weight to Dr. Linberg’s unsupported opinion. ActiveVideo Networks,
`
`Inc., 694 F.3d at 1327.
`
`23. On page 12, lines 3-19 and page 13, lines 16-19, Petitioner states that
`
`the Board’s holding that it was still an open question whether patent admissions
`
`per se can be relevant prior art in an IPR was erroneous, citing Intri-Plex. Patent
`
`Owner disagrees because the Intri-Plex panel decision has not been designated as
`
`binding authority and did not address Ex parte McGaughey, 6 U.S.P.Q.2d 1334
`
`12
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`(BPAI Mar. 4, 1988) (Ex. 2019). Consistent with McGaughey, the alleged ’514
`
`patent admission is not a patent or printed publication that can be used to institute
`
`an IPR. (Prelim. Resp. at 25-28.) Moreover, Petitioner failed to establish a prima
`
`facie case of obviousness based on the alleged admission. (Prelim. Resp. at 28-31.)
`
`24. On page 13, line 4 - page 14, line 3, Petitioner states that the Board
`
`misquoted Drugs R&D by leaving out the word “derivative” and that the drug must
`
`be an ester of fumaric acid. Patent Owner disagrees because the “derivative”
`
`argument is new and thus could not have been overlooked. See 37 C.F.R.
`
`§ 42.71(d). Patent Owner also disagrees because the Board considered all of
`
`Petitioner’s arguments (Dec. at 16), considered Drugs R&D (id. at 15), found that
`
`Phase II study results were not in the record, and found nothing establishing that
`
`DMF was useful for treating MS (id.).
`
`25. On page 14, lines 3-6, Petitioner states that the Board’s reason for not
`
`considering whether the ’514 patent admission was applicable prior art is wrong.
`
`Patent Owner disagrees because even if the Board found the alleged ’514
`
`admission to be applicable prior art, the petition still failed to establish a prima
`
`facie case of obviousness based on this ground. (Prelim. Resp. at 28-31.)
`
`26. On page 14, lines 7-12, Petitioner states that the Board overlooked or
`
`misapprehended the disclosure in Drugs R&D that Biogen Idec was evaluating
`
`“the product” in clinical trials. Patent Owner disagrees that the Board overlooked
`
`13
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`this statement because the decision analyzed this disclosure of Drugs R&D,
`
`including its mention of a Phase II study in MS. (Dec. at 15.) Patent Owner also
`
`disagrees because the Board correctly found that no Phase II study results were in
`
`the record. (Id.)
`
`27. On page 14, lines 13-20, Petitioner states that the Board overlooked or
`
`misapprehended Dr. Linberg’s testimony that the fact that this was a Phase II trial
`
`indicated that DMF was believed to have therapeutic activity against MS. Patent
`
`Owner disagrees because Petitioner fails to explain how this statement was
`
`misunderstood. See 37 C.F.R. § 42.71(d). Patent Owner also disagrees because the
`
`Board considered all of Petitioner’s arguments (Dec. at 16), considered Drugs
`
`R&D (id. at 15), found that Phase II study results were not in the record, and found
`
`nothing in the record establishing that DMF was useful for treating MS (id.). The
`
`Board did not abuse its discretion in giving more weight to the disclosure of Drugs
`
`R&D than to conclusory expert statements. Velander, 348 F.3d at 1371; Daicel
`
`Corp., IPR2014-01514, Paper No. 15 at 8. Further, the petition failed to establish a
`
`prima facie case of obviousness. (Prelim. Resp. at 28-31.)
`
`28. On page 15, lines 1-6, Petitioner states that the Board abused its
`
`discretion in finding no reasonable expectation of success in using DMF to treat
`
`RRMS after learning that BG00012 (DMF) was being used in a clinical trial.
`
`Patent Owner disagrees because Petitioner’s argument concerning reasonable
`
`14
`
`
`
`Case No. IPR2015-01136
`Patent 8,399,514
`expectation of success is new and therefore could not have been overlooked. See
`
`37 C.F.R. § 42.71(d). (Prelim. Resp. at 8-11, 30-31.)
`
`29. On page 15, lines 7-11, Petitioner states that the Board cited no
`
`substantial evidence for its conclusion that Drugs R&D indicates only a hope that
`
`DMF will be useful. Patent Owner disagrees because the Board’s decision is fully
`
`supported by the disclosure of Drugs R&D. (Dec. at 15.) Patent Owner also
`
`disagrees because the results of the Phase II trial are not in the record. (Id.) The
`
`Board did not abuse its discretion because determining the weight and credibility
`
`of the evidence is within its province as the trier of fact. See Inwood Labs., Inc.,
`
`456 U.S. at 856.
`
`V. Conclusion
`Petitioner has not established that the Board abused its discretion when
`
`declining to institute an inter partes review. Accordingly, the Board should deny
`
`Petitioner’s Request for Rehearing.
`
`Dated: October 16, 2015
`
`
`
`Respectfully submitted,
`
`By: / Michael J. Flibbert /
`Michael J. Flibbert, Reg. No. 33,234
`Maureen D. Queler, Reg. No. 61,879
`Finnegan, Henderson,
`Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`Counsel for Patent Owner in IPR2015-01136
`
`15
`
`
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing BIOGEN’S
`
`OPPOSITION TO REQUEST FOR REHEARING was served electronically
`
`via e-mail on October 16, 2015, in its entirety on the following:
`
`Robert W. Hahl
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue,
`Alexandria, VA 22304
`rhahl@neifeld.com
`
`Robert Mihail
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue,
`Alexandria, VA 22304
`rmihail@neifeld.com
`
`John K. Pike,
`Neifeld IP Law, PC, 4813-B Eisenhower Avenue,
`Alexandria, VA 22304
`Email: jkpike@neifeld.com
`
`general@neifeld.com
`
`Petitioner has agreed to electronic service.
`
`By: / Maureen D. Queler /
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: October 16, 2015
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
