Trials@uspto.gov
`571-272-7822
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` Paper 29
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` Entered: 23 October 2015
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`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
`
`
`Before FRED E. McKELVEY, SALLY GARDNER LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
`
`McKELVEY, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71(d)(2)
`
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`571-272-7822
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` Paper 29
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`
` Entered: 23 October 2015
`
`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
`
`
`Before FRED E. McKELVEY, SALLY GARDNER LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
`
`McKELVEY, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71(d)(2)
`
`
`
`
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`
`
`
`
`IPR2015-01136
`Patent 8,399,514 B2
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`
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`I. Introduction
`Petitioner timely filed a Request for Rehearing under 37 C.F.R.
`§ 42.71(d)(2) (Paper 26) seeking reconsideration of our decision declining to
`institute an IPR trial (Paper 23 “Decision”).
`Patent Owner was invited to file an opposition. Paper 27.
`Biogen’s Opposition to Request for Rehearing was thereafter timely
`
`filed. Paper 28.
`For the reasons given below, the Request for Rehearing is denied.
`
`
`The analysis set out below is based in large measure on arguments as
`presented in the Opposition.
`
`II. Kappos 2005
`1. On page 2, line 19 – page 3, line 15 of the Request, Petitioner
`states that the Decision declining to institute an inter partes review and order
`a trial overlooked or misapprehended that Kappos 2005 is a § 102(b) printed
`publication. The Decision does not question the prior-art printed publication
`status of Kappos 2005.
`2. On page 3, lines 3–6, Petitioner states that mention of a pilot
`study by Kappos 2005 did not negate the content of Kappos 2005 or render
`it less than a printed publication. The Decision did not question the prior-art
`status of Kappos 2005 or suggest that the pilot study negated the content of
`Kappos 2005. Rather, we found that the pilot study was not of record.
`Decision, page 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 (Ex. 1005A). We discussed “appears
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`to be” on page 9 of the Decision. We gave more weight to pre-litigation
`statement by Kappos than to post-litigation 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 more weight to documentary
`evidence vis-à-vis witness testimony). Furthermore, as Patent Owner points
`out, the word “appear” is also synonymous with “seem”
`(http://www.merriam-webster.com/dictionary/appear),
`and is consistent with our statement that what counts is what is described,
`not what appears or seems to have been tested. Decision, page 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. The reference to
`“substantial evidence” is curious since “substantial evidence” is an appellate
`standard of review for fact finding. The argument should have been that our
`finding was not supported by a preponderance of the evidence. In any event,
`Petitioner, in effect, attempts to reargue a case it attempted to make out in
`the petition and fails to point out how we misunderstood Dr. Linberg’s
`testimony. Petitioner failed to explain adequately in the Petition why one of
`ordinary skill in the art, based on Kappos, would have understood that DMF
`was useful for treating multiple sclerosis (MS).
`
`5. On page 5, lines 3–14, Petitioner states that the Decision
`misapprehended or overlooked that Kappos 2005 was not guessing, but
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`IPR2015-01136
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`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. The
`argument concerning reasonable expectation of success, as pointed out by
`Patent Owner in the opposition, is new and therefore could not have been
`overlooked. Keebler Co. v. Murray Bakery Products, 866 F.2d 1386, 1388
`(Fed. Cir. 1989) (prescience is not a required characteristic of the board and
`the board need not divine all possible afterthoughts of counsel that might be
`asserted for the first time on appeal). Moreover, in our view Petitioner has
`not pointed out where there is a clear statement in Kappos 2005 that those
`skilled in the art knew that DMF was useful in treating MS.
`6. On page 5, line 15 – page 6, line 6, Petitioner states that our
`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 disclosure of a Phase II study with BG00012. We disagree
`because the our finding regarding fumaric acid esters concerned Kappos’s
`mention of the earlier pilot study, not the planned Phase II study. Petitioner
`has not convinced us that we 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 adequately the basis for his
`opinion.
`7. On page 6, lines 7 – 23, Petitioner states that we misapprehended
`or overlooked Dr. Linberg’s testimony that one of ordinary skill knew that
`DMF was therapeutically active for treating RRMS. We disagree because
`we did not misapprehend or overlook Dr. Linberg’s statement. Rather, after
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`considering Kappos 2005, we found, on the record before us, that Kappos
`2005 did not describe DMF as being useful in treating MS. Decision,
`page 11. The Request for Rehearing fails to convincingly establish how we
`abused our discretion in giving more weight to the disclosure of Kappos
`2005 vis-à-vis Dr. Linberg’s testimony. Velander, 348 F.3d at 1371.
`8. On page 7, lines 1 – 4, Petitioner states that for obviousness, all
`that is required is a reasonable expectation of success. Assuming Petitioner
`is correct, the reasonable expectation of success argument is new on
`rehearing. Moreover, a review of the record confirms that Petitioner never
`established any reasonable expectation of success. A new argument on
`rehearing could not have been overlooked.
`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. Paragraph 23 of Dr. Linberg’s Declaration (cited by
`Petitioner) does not state that Kappos 2005 describes a routine step in drug
`development. Moreover, we are not experts on the routine steps of drug
`development or FDA protocols and therefore if a petitioner intends to rely
`on routine steps and/or FDA protocols, the petitioner has to educate us on
`routine steps and/or FDA protocols in a petition. Upon consideration of the
`evidence presented to us, we found that Petitioner failed to establish that
`Kappos 2005 teaches that DMF was known to be useful in treating MS.
`10. On page 7, lines 10 – 14, Petitioner states that we
`misapprehended or overlooked Dr. Linberg’s testimony that Kappos 2005’s
`dose-ranging study would not have been undertaken unless BG00012 had
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`IPR2015-01136
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`been determined to be therapeutically active in treating patients with MS.
`We disagree because Petitioner inappropriately attempts to reargue its case
`and presents new argument about the prior art. We also disagree because we
`considered Petitioner’s arguments and found, on the record before us, that
`Kappos 2005 did not describe DMF as being useful in treating MS.
`11. On page 7, lines 14 – 18, Petitioner states that we abused our
`discretion in finding that the Petition did not establish that Kappos 2005
`teaches that DMF would be useful in treating patients with MS. As pointed
`out by Patent Owner, the open question—according to Petitioner—was
`whether the drug could be licensed by the FDA to treat MS patients, not
`whether DMF works. On the record before us, we found that Kappos 2005
`did not teach that DMF was known to be useful in treating MS.
`12. On page 7, line 19 – page 8, line 7, Petitioner states that a patent
`may 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.
`We can agree with Petitioner that a patent can be granted pre-clinical trials.
`However, granting a patent pre-clinical trial has not been shown to be
`relevant in this case, and in any event, is a new argument and thus could not
`have been overlooked. Moreover, we agree with Patent Owner that 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
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`IPR2015-01136
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`trials, and therefore it was an abuse of discretion to not find a reasonable
`expectation of success when DMF was being used. We agree with Patent
`Owner that the argument represents an inappropriate attempt to reargue the
`petition. In addition, we did not overlook that a Phase II trial was being
`conducted. Rather, we found that before its completion and evaluation, on
`this record one skilled in the art would not necessarily understand based on
`Kappos 2005 that DMF is useful for treating MS. Decision, page 11.
`14. On page 8, line 18 – page 9, line 1, Petitioner states that we
`substituted our own understanding of Kappos 2005 for that of Dr. Linberg in
`finding that Kappos did not meet the description requirement of § 102(b).
`We agree with Patent Owner that we considered Kappos 2005 and weighed
`it vis-à-vis Dr. Linberg’s testimony and, based on the record before us,
`accorded more weight to Kappos 2005. Velander, 348 F.3d at 1371.
`15. On page 9, lines 1 – 11, Petitioner states that the our finding is not
`supported by evidence, because success in a pilot study, said to be apparent
`in the background section of Kappos, is a well-known reason for designing
`dose-ranging studies. Kappos 2005, when weighed against Dr. Linberg’s
`testimony, led us to find, based on a preponderance of the evidence, that
`Petitioner was not likely to succeed on the merits. We also note that the
`pilot study mentioned by Kappos 2005 is not of record. Moreover, we have
`not been told where Dr. Linberg testified that success in a pilot study is a
`well-known reason for designing dose-ranging studies. As noted earlier, we
`are not experts in dose-ranging studies; even if we were experts, or even
`knowledgeable on dose-ranging studies, we would base our findings on
`evidence in the record. Fromson v. Anitec Printing Plates, Inc., 132 F.3d
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`1437, 1448 (Fed. Cir. 1997) (Mayer, C.J., concurring: I “know” what
`anodization means from my own undergraduate studies and experiments; the
`concept is not difficult and I need no further education to grasp it. I happen
`to have a dictionary in my chambers from the era pertinent here, which
`would confirm my “knowledge” about anodization. . . . But, I am neither an
`expert in the field nor one of ordinary skill in the art despite how much I
`think I “know” about a process I once studied. Nor do my colleagues on this
`court or on the district court possess such expertise, and even if they did,
`they would have to defer to the record made in the case.). Furthermore, as
`Patent Owner points out, weighing and determining 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. ClinicalTrials
`16. On page 10, lines 3 – 4 of the Request, Petitioner states that we
`overlooked or misapprehended the meaning of the term “pilot study.” But,
`Petitioner fails to identify how this term was overlooked or misapprehended.
`Petitioner does not dispute that the pilot study is not of record. Our finding
`that ClinicalTrials describes a pilot study (not of record) has not been shown
`to be wrong.
`17. On page 10, lines 3 – 4, Petitioner states that we overlooked or
`misapprehended the ClinicalTrials document. Petitioner identifies no
`portion of ClinicalTrials that we supposedly misapprehended or overlooked.
`
`18. On page 10, lines 4 – 9, Petitioner states that the Board
`overlooked Dr. Linberg’s testimony that DMF has therapeutic activity for
`MS. Paragraph 23 of Dr. Linberg’s declaration (cited by Petitioner) contains
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`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); see also Rohm and Haas
`Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (Nothing in the
`Federal Rules of Evidence or Federal Circuit jurisprudence requires the fact
`finder to credit the unsupported assertions of an expert witness); Ashland
`Oil, Inc. v. Delta Resins and Refractories, Inc., 776 F.2d 281, 294 (Fed Cir.
`1985) (lack of factual support for expert opinion “may render the testimony
`of little probative value in a validity determination”).
`19. On page 10, lines 9 – 15, Petitioner states that the Board
`overlooked Dr. Linberg’s testimony or “impermissibly substituted its own
`expertise for that of Dr. Linberg,” who testified that ClinicalTrials taught
`that DMF is therapeutically active. Petitioner is inappropriately attempting
`to reargue its case on rehearing. In addition, Dr. Linberg’s opinion in the
`cited portion of his declaration (Ex. 1005A ¶ 23) is conclusory and
`unsupported, and therefore not convincing. Moreover, we adhere to our
`finding that ClinicalTrials does not state that DMF is useful for treating MS.
`IV. The Alleged ’514 Patent Admission
`20. On page 11, lines 9 – 16 of the Request, Petitioner states that we
`substituted our own incorrect interpretation of Drugs R&D for the alleged
`’514 patent admission without evidence that the two are equivalent. We did
`not address any equivalency. Rather, we analyzed the alleged admission in
`the context of Drugs R&D. Decision, page 15. Petitioner does not dispute
`that another cited reference (Schimrigk) is not of record.
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`21. On page 11, lines 16 – 19, Petitioner states that we overlooked or
`misapprehended Dr. Linberg’s testimony that the ’514 patent admits that one
`of ordinary skill in the art would have believed that DMF and MMF were
`therapeutically active for MS. We disagree. We examined the statement in
`the specification in light of the Drugs R&D publication and determined that
`it did not support a finding that DMF was known to be useful for treating
`MS. Decision, page 15. Further, the petition failed to establish a prima
`facie case of obviousness, or a reasonable likelihood of success under AIA
`pre-trial standards, based on the alleged ’514 patent admission.
`22. On page 12, lines 1 – 2, Petitioner states that we cited no evidence
`contradicting Dr. Linberg’s opinion about the meaning of the alleged
`admission. We disagree. Rather, we determined that nothing in the alleged
`admission or Drugs R&D supported a finding that DMF was useful for
`treating MS. Decision, page 15.
`23. On page 12, lines 3 – 19 and page 13, lines 16 – 19, Petitioner
`states that our holding that it was still an open question as to whether patent
`admissions per se can be relevant prior art in an IPR was erroneous, citing
`Intri-Plex Technologies, Inc. v. Saint-Gobain Performance Plastics Rencol,
`Ltd., IPR2014-00309 (PTAB 2014) (Paper 83, 19 – 29) (admission may be
`prior art). The citation of Intri-Plex is a side show apart from the main event
`because in rendering our non-institution decision we considered the
`“admission” in context with Drugs R&D—which is a printed publication.
`Petitioner failed to establish a likelihood of success based on the alleged
`admission in combination with Drugs R&D.
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`24. On page 13, line 4 – page 14, line 3, Petitioner states we
`misquoted Drugs R&D by leaving out the word “derivative” and that the
`drug must be an ester of fumaric acid. We agree with Patent Owner because
`we considered Petitioner’s arguments in light of Drugs R&D, and found that
`(1) Phase II study results were not in the record and (2) Petitioner failed to
`establish that DMF was known to be useful for treating MS (Decision,
`page 15).
`25. On page 14, lines 3 – 6, Petitioner states that our reason for not
`considering whether the ’514 patent admission was applicable prior art is
`wrong. We disagree because even finding that the alleged ’514 admission is
`relevant prior art, the petition still failed to establish a likelihood of success.
`26. On page 14, lines 7 – 12, Petitioner states that we overlooked or
`misapprehended the disclosure in Drugs R&D that Biogen Idec was
`evaluating “the product” in clinical trials. We did not overlook this
`statement because the Decision analyzed the relevant disclosure of Drugs
`R&D, including its mention of a Phase II study in MS. (Decision, page 15);
`we also found that no Phase II study results were in the record (id.).
`27. On page 14, lines 13 – 20, Petitioner states that we overlooked or
`misapprehended Dr. Linberg’s testimony that because this was a Phase II
`trial, one skilled in the art would have believed that DMF had therapeutic
`activity against MS. Petitioner fails to explain how this statement was
`misunderstood.
`28. On page 15, lines 1 – 6, Petitioner states that we abused our
`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
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`trial. We agree with Patent Owner that Petitioner’s argument concerning
`reasonable expectation of success is new and therefore could not have been
`overlooked.
`29. On page 15, lines 7 – 11, Petitioner states that the Board cited no
`evidence for its finding that Drugs R&D indicates only a hope that DMF will
`be useful. We, like Patent Owner, disagree because our finding is supported
`by Drugs R&D. Decision, page 15.
`V. Order
`Upon consideration of Petitioner’s Request for Rehearing (Paper 26)
`
`and Patent Owner’s Opposition (Paper 28), and for the reasons given, it is
`ORDERED that the Request for Rehearing is denied.
`
`
`PETITIONER:
`
`Robert W. Hahl
`Robert Mihail
`John Pike
`NEIFELD IP LAW, PC
`rhahl@neifeld.com
`rmihail@neifeld.com
`jkpike@neifeld.com
`
`PATENT OWNER:
`
`Micheal Flibbert
`Maureen Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`michael.flibbert@finnegan.com
`maureen.queler@finnegan.com
`
`
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`12
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