`
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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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`
`
`COALITION RESPONSE TO BIOGEN’S MOTION FOR OBSERVATIONS
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`Case No. IPR2015-01993
`Patent 8,399,514
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`As authorized by the 22 March 2016 Scheduling Order (Paper 21), Petitioner
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`respectfully submits the following Response to Biogen’s Motion for Observations
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`on Cross-Examination of Petitioner’s reply expert, Dr. Samuel J. Pleasure filed 2
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`November 2016 (Paper 59).
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`Biogen’s Motion should be disregarded in its entirety. A motion for
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`observations “is not an opportunity to raise new issues, reargue issues, or pursue
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`objections.” PTAB Trial Practice Guide 77 Fed. Reg. 48756, 48768. However,
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`that is exactly what Biogen’s Motion does.
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`For example, at least Observations 1 through 6 in Biogen’s Motion
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`improperly argue the procedural issue of whether Petitioner’s Reply had a proper
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`scope under 37 C.F.R. §42.23(b). But the Board already explicitly ordered Biogen
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`not to file a motion addressing that issue:
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`There is no apparent reason why the matter cannot be
`adequately addressed as part of the oral argument. The
`Board can also determine sua sponte whether an
`inappropriate new issue has been raised. A motion and
`conference call are therefore unnecessary.
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`Paper No. 52 at 2. Biogen’s defiance of that Order justifies disregarding the
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`Motion for Observations in its entirety.
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`
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`Likewise, at least Observations 14-15 and 18 misuse the Motion as a sur-
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`reply to reargue obviousness. Observation 19 improperly raises a new issue about
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`what scientists have not determined as of today.
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`Case No. IPR2015-01993
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`If even a single observation is improper, the entire Motion for Observations
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`may be disregarded. See Medtronic v. Nuvasive, IPR2013-00506, Paper 37 at 2-4
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`(entire Motion for Observations dismissed due to a single improper observation).
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`In the present case, as discussed above, there are at least ten improper
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`Observations: Observations 1-6, 14-15, and 18-19. This more than justifies
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`disregarding the entire Motion for Observations under Medtronic.
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`
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`For the sake of completeness, if the Board were not to disregard Biogen’s
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`Motion for Observations, Petitioner provides the following responses to individual
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`Observations.
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`Response to Observation # 1. In Observation 1, Patent Owner argues that
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`Dr. Pleasure’s inability at his deposition to recall specific arguments from Biogen’s
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`“Patent Owner Response” was somehow relevant to whether Dr. Pleasure’s
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`declaration was outside the scope of a proper reply. Petitioner Responds that the
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`deposition questions about a “Patent Owner Response” were misleading and
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`confusing; there was no paper filed in this IPR titled “Patent Owner Response.”
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`Biogen did not even favor Dr. Pleasure with a copy of its Opposition after Dr.
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`Pleasure said he did not know what document he was being asked about. Exhibit
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`2384, page 27, lines 16-22. Dr. Pleasure said he did consider the issues discussed
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`in such papers generally. Exhibit 2384, page 27, line 25, through page 28, line 10.
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`As demonstrated in Petitioner’s Reply, Dr. Pleasure’s testimony is evidence
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`Patent 8,399,514
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`responsive to the Opposition. This is true regardless of whether Dr. Pleasure
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`identified particular statements in the Opposition.
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`
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`Response to Observation # 2. Petitioner responds that Biogen’s summary
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`of the cited testimony is misleading and inaccurate. Dr. Pleasure testified that he
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`“was provided with a couple of those [Patent Owner’s expert] declarations, that I
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`did read at some point” (Exhibit 2384, page 17, lines 20-24) and that he “read
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`Daniel Wynn’s expert declaration” but did not “recall whether – the names of any
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`other ones of any people that I’ve read” (Exhibit 2384, page 18, lines 11-14). Dr.
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`Pleasure was not favored with a copy of any of these declarations or depositions at
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`his deposition. As demonstrated in Petitioner’s Reply, Dr. Pleasure’s testimony
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`rebuts the Opposition evidence. This is true regardless of whether Dr. Pleasure
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`could remember off the top of his head all of Biogen’s numerous declarations.
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`
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`Response to Observation # 3. Petitioner responds that Biogen’s summary
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`of the cited testimony is misleading and inaccurate. When asked about a petition,
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`Dr. Pleasure testified he was unsure what document he was being asked about, and
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`Biogen did not provide a copy. Exhibit 2384, page 26, lines 7-19. Dr. Pleasure
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`further testified he viewed such pleadings as legalese, and that he applied his
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`education, training, and experience to come up with his own thinking about the
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`underlying evidence he reviewed, rather than relying on the pleadings. (Id. Page
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`3
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`26, line 7, through page 27, line 24, and page 23, line 18 through page 24, line 15.).
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`This does not detract from the Reply’s use of his testimony to rebut the Opposition.
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`Response to Observation # 4. Petitioner responds that Biogen’s summary
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`of the cited testimony is misleading and inaccurate. First, the testimony in Ex.
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`2384, at page 23, line 14 through page 24, line 15 relates to Dr. Pleasure’s
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`testimony concerning the declaration of Dr. Wynn, not Dr. Linberg. Second, Dr.
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`Pleasure testified he agreed with Dr. Linberg “in some substance, in most
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`substance I do, I believe, but I’m not a hundred percent sure because I didn’t
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`review his opinions in great detail” (Ex. 2384, p. 24, ll. 16-22). In any event, if
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`Biogen is correct that Dr. Pleasure did not rely on Dr. Linberg’s opinions, that does
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`not make his testimony improper.
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`
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`Response to Observation # 5. Petitioner responds that the cited testimony
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`does not detract from Dr. Pleasure’s reasoned testimony on the issues of
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`unexpected results and long-felt need. (Ex. 1045, ¶¶69-72 and 74-76). Observation
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`# 5 is another improper attempt to pursue the procedural issue of proper scope of
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`reply under §42.23(b).
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`
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`Response to Observation # 6. Petitioner responds that the cited testimony
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`does not detract from Dr. Pleasure’s reasoned testimony on unexpected results.
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`(Ex. 1045, ¶¶69-72 and 75). Observation # 6 is another improper attempt to pursue
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`the procedural issue of proper scope of reply under §42.23(b).
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`4
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`Response to Observation # 7. Petitioner responds that Dr. Pleasure’s cited
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`testimony does not detract from Dr. Pleasure’s credentials as a person of ordinary
`
`skill or an expert qualified to testify as to the conclusions of one of ordinary skill
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`(see Dr. Pleasure’s CV Ex. 1046, e.g., p. 1 (post-graduate education in Neurology;
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`Board Certification in Neurology), 3 (clinical activities), and 7 (Member of
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`National MS Society Scientific Review Panel A)). Dr. Pleasure testified that he
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`provided his opinions from two different viewpoints, using two possible definitions
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`of POSA (Ex. 2384, p. 67, l. 15 – p. 68, l. 7). He further testified that at least three
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`years of clinical experience treating MS, under one definition, could be met by
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`treating MS patients part-time (id. p. 75, l. 12 – p. 76, l. 2).
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`
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`Response to Observation # 8. Petitioner responds that Dr. Pleasure’s cited
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`testimony does not detract from Dr. Pleasure’s credentials as a person of ordinary
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`skill or an expert qualified to testify as to the conclusions of one of ordinary skill in
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`2007 (see Dr. Pleasure’s CV, Ex. 1046, e.g., p. 1 (post-graduate education in
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`Neurology; Board Certification in Neurology), 3 (clinical activities), and 7
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`(Member of National MS Society Scientific Review Panel A)).
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`
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`Response to Observation # 9. Petitioner responds that Biogen’s summary
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`of the cited testimony is inaccurate and misleading, omitting important credentials
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`and experience of Dr. Pleasure. For example, Dr. Pleasure testified he had
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`“reviewed clinical trials as research programs” and decided “whether they should
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`be funded or not, both within the University of California, San Francisco, as well
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`as for the National MS Society” (Ex. 2384. p. 38, ll. 20-25), “wanted to make clear
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`that I am not unfamiliar with clinical trials” (id. p. 39, ll. 12-20), and was “an
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`expert witness having to do with whether a clinical trial might have some flaws or
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`other problems with it or some features of it … I do that all the time” (id. p. 52, ll.
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`16-19). See also Dr. Pleasure’s CV, Ex. 1046.
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`
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`Response to Observation # 10. Petitioner responds that the cited testimony
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`is mischaracterized. Dr. Pleasure also testified “I have familiarity of clinical
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`pharmacology such that is needed to be a physician who is an academician, who is
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`teaching young physicians and residents and fellows” (Ex. 2384 p. 45, ll. 4-7). See
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`also Dr. Pleasure’s CV, Ex. 1046¸e.g., academic, professional, and editorial board
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`positions, professional service activities, and mentoring (pp. 1-3 and 9-12).
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`
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`Response to Observation # 11. Petitioner responds that even if Dr.
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`Pleasure could not recall where he first heard the term “point dose” and so on, he
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`further testified it’s a term “useful to help to sort of keep track of what people
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`mean in different situations” (id. p. 59, ll. 21-24). Thus, Dr. Pleasure’s use of the
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`term helps clarify issues raised in the Opposition concerning the Petition’s
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`argument that it would have been obvious to go from 240 mg three times a day to
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`240 mg twice a day of DMF (Paper 1 at 27). Dr. Pleasure further explained: “I
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`don’t care whether the patient takes `two 300 milligram capsules or one 600
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`milligram capsule. I do care that the patient is taking X dosage per administration.
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`That’s what the point dose is, is my understanding” (id., p. 131, ll. 10-15). Further,
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`Biogen’s own expert Dr. Rudick used the same terminology when discussing the
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`DEFINE clinical study in his deposition (Ex. 1053, p. 71, ll. 12-19). Even if “point
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`dose” was not a well known term, that would not show unobviousness in lowering
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`the number of times 240mg DMF was administered to MS patients, from three
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`times a day in Kappos 2006 to two times a day as claimed. Dr. Pleasure explained
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`his opinion that such lowering was still obvious no matter whether you call it a
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`“point dose” or something else. Ex. 2384 at page 153, lines 13-24.
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`
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` Response to Observation # 12. This Observation mischaracterizes the
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`cited testimony. In the cited testimony, when asked whether the efficacy of DMF
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`in treating MS is driven by its Cmax, Dr. Pleasure testified that DMF’s efficacy in
`
`treating MS is due to its immunomodulatory effects that change the responsiveness
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`of the immune system to the nervous system. Ex. 2384, on p. 45, l. 25 – p. 46, l.
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`14. The cited testimony is consistent with Dr. Pleasure’s opinion that “a drug’s in
`
`vivo effect links point dose concentration to the effect site (here, the immune
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`system) concentration” (Paper 46 at 22-23; Ex. 1045 ¶ 70) because the time course
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`of drug concentration cannot in itself predict the time course or magnitude of the
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`drug’s pharmacodynamics effect (id.).
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`Response to Observation # 13. First, Observation #13 argues Dr.
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`Pleasure’s testimony, that Kappos 2006 was not designed to determine whether
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`efficacy resulted from the point dose or the daily dosage, somehow contradicts Dr.
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`Pleasure’s declaration. However, Dr. Pleasure’s declaration did not say Kappos
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`2006 was designed to determine whether efficacy resulted from the point dose or
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`the daily dosage. (Ex. 1045 at ¶¶ 69.). Second, Observation #13 asserts Dr.
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`Pleasure testified “that the only conclusion one could draw from Kappos 2006 is
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`that 720 mg/day is effective.” To the contrary, Dr. Pleasure testified Kappos 2006
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`supported additional conclusions about what persons of skill in the art were
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`motivated to do, with a reasonable likelihood of success. Ex. 2384, page 140, line
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`21, through 141, line 9. These additional conclusions included POSA focusing on
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`the fact that the patient is getting 240 milligrams as a single dose each time (Ex.
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`2384, page 142, lines 15-21), viewing that fact as the key factor (Ex. 2384, page
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`143, lines 15-24), recognizing that the short half-life of MMF points towards the
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`importance of 240mg as a point dose rather than 720mg as a total daily dosage
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`(Ex. 2384, page 148, line 20, through page 149, line 6), taking as the next step
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`administering the same 240 mg point dose at a different frequency (Ex. 2384, page
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`144, lines 4-9), and decreasing the frequency of taking the DMF dose to reduce
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`side effects including upset stomach (Ex. 2384, page 145, lines 16-22).
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`Response to Observation # 14. This Observation takes testimony out of
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`context. The full context includes testimony by Dr. Pleasure that given what is
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`known about the way immunomodulatory drugs work in MS, that “if given in
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`lower intervals, intervals at which they are no longer pharmacokinetically really
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`present in large amounts in the circulation,” it is reasonable to believe that the
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`effectiveness of the drug is “actually not dependent on the pharmacokinetic
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`concentration” (id. p. 156, l. 13 – p. 158, l. 8).
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`
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`Response to Observation # 15. Petitioner responds that the observation
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`makes improper inferences and fails to cite other testimony from Dr. Pleasure. In
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`Ex. 2384, on p. 151, l. 10 – p. 152, l. 7 (cited in the observation), Dr. Pleasure
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`testified that he was “not aware of anybody who stated it [i.e., the effect in Kappos
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`was due to a 240 mg point dose] in the way that I’ve stated it. … [T]hey may
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`choose to describe it in some other way.”
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`Response to Observation # 16. Petitioner responds that Biogen’s summary
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`mischaracterizes the cited testimony of Dr. Pleasure. According to Biogen, in Ex.
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`2384, p. 151, l. 10 – p. 152, l. 7 (cited in the observation), Dr. Pleasure testified he
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`thought identifying the effective dosage in the Results section of Kappos 2006 as
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`240 mg of DMF administered three times a day was “dispensable.” Dr. Pleasure
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`testified that meeting abstracts have a defined word counts and since Kappos 2006
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`had previously described 240 mg three times daily (720 mg per day), he would
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`have thought describing the results as (720 mg per day) versus 240 mg three times
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`(720 mg per day) would save some “dispensable” words but leave their meaning
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`“incredibly clear” (id. p. 138, l. 9 – p. 139, l. 5).
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`Response to Observation # 17. This Observation fails to mention that, in
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`his declaration, Dr. Pleasure was asked specifically to respond to Patent Owner’s
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`argument that the side-effect profile for DMF treatment groups was very similar to
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`that of placebo based on Table 3 of the 2008 Lancet publication (Ex. 2058) (see
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`Biogen’s Opposition to the Petition, Paper 38 at pp. 38-39). Thus, the
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`Observation is misleading when it says Dr. Pleasure relied on Exhibit 2058 “to
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`support his obviousness opinion.”
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`
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`Response to Observation # 18. This Observation mischaracterizes the cited
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`testimony and omits important context. For example, Dr. Pleasure testified “240
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`milligrams given as a single dose achieves a peak level that has a biological effect
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`that is not present … when 120 milligrams is given” (Ex. 2384 on p. 158, l. 9 – p.
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`159, l. 18). While Dr. Pleasure did not form off-the-cuff opinions on various
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`hypotheticals, Dr. Pleasure repeatedly turned to what was known, e.g., “we know
`
`what the maximum effect of 240 three times a day is” (id. p. 163, l. 4 – p. 165, l.
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`2), and testified that administering 240 mg two times a day was an identifiable and
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`predictable solution at the time of the invention at least because POSA would have:
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`focused on the fact that patients in Kappos 2006 received 240 mg as a single dose
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`each time (Ex. 2384, page 142, lines 15-21); viewed that fact as the key factor (Ex.
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`2384, page 143, lines 15-24); recognized that the short half-life of MMF points
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`towards the importance of 240 mg as a point dose rather than 720 mg as a total
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`daily dosage (Ex. 2384, page 148, line 20, through page 149, line 6); taken as the
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`next step administering the same 240 mg point dose at a different frequency (Ex.
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`2384, page 144, lines 4-9); and decreased the frequency of taking the DMF dose to
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`reduce side effects including upset stomach (Ex. 2384, page 145, lines 16-22).
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`
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`Response to Observation # 19. Petitioner responds that Biogen’s summary
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`of the cited testimony is inaccurate and misleading. Dr. Pleasure testified in Ex.
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`2384, on p. 167, l. 21 – p. 168, l. 4 (cited in the observation) that he could not give
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`an informed opinion on an article without adequate time to read it and further
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`testified “Another – another just a thing to point out for the record is I could not
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`actually read this paper even if I wanted to right now because the figures are
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`reproduced in a manner that I can’t even see them” (id. p. 169, ll. 6-10) (not cited
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`in the observation). The cited testimony is consistent with his earlier testimony
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`that DMF is efficacious in treating MS because of its immunomodulatory effects
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`(id. p. 46, ll. 4-9).
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`Response to Observation # 20. The cited testimony concerning Avonex®,
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`Rebif®, Betaseron®, Copaxone®, and Tysabri® is consistent with Dr. Pleasure’s
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`testimony that those drugs would inform POSA’s views on Kappos 2006 at least
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`because they are thought to act by modifying immune processes that are believed
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`to be responsible for the pathogenesis of MS (see e.g., Ex. 2384,. p. 87, l. 15 – p.
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`89, l. 5).
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`Response to Observation # 21. Biogen’s summary of the cited testimony
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`mischaracterizes Dr. Pleasure’s testimony. According to Biogen, Ex. 2384, on (a)
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`page 77, line 4 through page 91, line 2 and (b) page 67, lines 2 to 11 and page 98,
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`line 23 through page 99, line 23 (cited in the observation), Dr. Pleasure testified
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`that (a) Avonex®, Rebif®, Betaseron®, Copaxone®, and Tysabri® have different
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`mechanisms of action than Tecfidera® which (b) are not fully understood. This
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`cited testimony is not relevant because Dr. Pleasure testified that what these drugs
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`have in common is that they are thought to act by modifying immune processes
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`that are believed to be responsible for the pathogenesis of MS (see e.g., id. p. 87, l.
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`15 – p. 89, l. 5).
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`Response to Observation # 22. The cited testimony does not detract from
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`Dr. Pleasure’s reasoned testimony on the issue of no long-felt need for an oral MS
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`treatment (Ex. 1045, ¶76) or his testimony that oral disease-modifying agents for
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`treating MS were in development in 2007 (Ex. 2384, p. 97, ll. 15-18).
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`Response to Observation # 23. Petitioner responds that the cited testimony
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`is taken out of context. Dr. Pleasure and Petitioner clearly applied the correct
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`standard for written description. See e.g., Paper 45 at pp. 2-4 (“the ‘921
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`provisional is NOT a constructive reduction to practice of the invention claimed in
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`the ‘514 patent.”). For inventions in unpredictable technologies more evidence is
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`needed to show possession. The use of the word “made” can refer to a
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`constructive reduction to practice, which Dr. Pleasure and Petitioner addressed.
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`Compare 60 Fed. Reg. 20195, 20206, Comment 15 (a constructive reduction to
`
`practice can satisfy 35 U.S.C. 102(g) which uses the word “made”).
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`Response to Observation # 24. This Observation makes improper
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`inferences and takes cited testimony out of context. The cited testimony is part of
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`a much larger response to the question of what is unknown about MS in Ex. 2384,
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`on page 62, line 17 through page 66, line 5, wherein Dr. Pleasure also testifies that
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`for the most part, disease-modifying therapies which tend to work in relapsing
`
`forms of MS do not work in relapsing forms of MS for some unknown reason (id.
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`p. 65, ll. 20-25). Taken in context, contrary to the Observation, the testimony
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`supports a conclusion that the provisional application does not enable the full
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`scope of the ‘514 claims.
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`Response to Observation # 25. Petitioner responds that the cited testimony
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`mischaracterizes the testimony of Dr. Pleasure. In Ex. 2384, on page 119, lines
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`15-23 (cited in the observation), Dr. Pleasure testified paragraph 116 of the
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`provisional “describes a range of doses, a large range of doses, 480 is in that
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`range.” When asked in a non-leading question what he meant “by described,
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`literally or in the legal sense,” Dr. Pleasure further testified “I quite clearly meant
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`described in the sense that it was written in English and printed in this paragraph”
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`(Ex. 2384, p. 174, ll. 4-24). This is consistent with Dr. Pleasure’s testimony that
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`the provisional does not disclose to POSA that Biogen was in possession of the
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`claimed invention. [Ex. 1045, ¶¶ 49-58.]
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`Dated: 09 November 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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`14
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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 COALITION RESPONSE
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`TO BIOGEN’S MOTION FOR OBSERVATIONS was served on 09 November
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`2016, via electronic mail directed to counsel of record for the Patent Owner at the
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`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
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`Dated: 09 November 2016
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