UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ANACOR PHAMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case No. IPR2018-001681
`U.S. Patent No. 9,549,938
`__________________
`
`AMENDED REPLY IN SUPPORT OF
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`1 Case No. IPR2018-01358 has been joined with this proceeding
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ANACOR PHAMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case No. IPR2018-001681
`U.S. Patent No. 9,549,938
`__________________
`
`AMENDED REPLY IN SUPPORT OF
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`1 Case No. IPR2018-01358 has been joined with this proceeding
`
`
`
`
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`TABLE OF CONTENTS
`
`ARGUMENT ............................................................................................................. 1
`
`I.
`
`Dr. Murthy’s Reply Declaration Is Not Responsive ....................................... 1
`
`II.
`
`The Board Should Exercise its Discretion to Exclude Dr. Murthy’s
`Reply Declaration in its Entirety ..................................................................... 3
`
`III.
`
`FlatWing’s Response Improperly Argues the Merits ...................................... 5
`
`CONCLUSION .......................................................................................................... 5
`
`
`
`i
`
`
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`TABLE OF AUTHORITIES
`
`Page(s):
`
`
`Cases:
`
`Belden, Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015) ............................ 2, 4
`
`Dell Inc. v. Realtime Data LLC, IPR2016-00972, Paper 71, 2018 WL
`2247172 (P.T.A.B. May 15, 2018) ....................................................................... 4
`
`In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016) ................................................. 3
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d
`1359 (Fed. Cir. 2016) ........................................................................................ 1, 2
`
`Nintendo of America Inc. v. Motion Games, LLC, 2015 WL 2395487
`(P.T.A.B. May 15, 2018) ...................................................................................... 4
`
`Statutes:
`
`35 U.S.C. § 316(e)(8) ................................................................................................. 3
`
`
`
`Rules:
`
`
`
`37 C.F.R. § 42.23(b) .............................................................................................. 1, 3
`
`37 C.F.R. § 42.64 ....................................................................................................... 4
`
`ii
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`
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`Anacor is not insisting, as FlatWing contends, that reply evidence “be
`
`exactly the same” as the evidence cited in a petition. Nor is it Anacor’s position
`
`that reply evidence “must not have been previously known” to a petitioner.
`
`Anacor’s position is simply that, pursuant to 37 C.F.R. § 42.23(b), reply evidence
`
`must be “responsive.” FlatWing’s opposition (Paper 30, “Opp.”) states that Dr.
`
`Murthy’s reply declaration (Ex. 1048) “elaborate[s]” or “expounds” upon the
`
`arguments raised in FlatWing’s petition. Opp. at 1, 6. But regardless of how
`
`FlatWing now attempts to characterize it, FlatWing was required to provide its
`
`explanation of its grounds for invalidity with its petition, which makes Dr.
`
`Murthy’s reply declaration an improper attempt to supplement his prior opinions.
`
`Anacor’s motion to exclude (Paper 23, “Mot.”) should be granted.
`
`I.
`
`Dr. Murthy’s Reply Declaration Is Not Responsive
`
`ARGUMENT
`
`FlatWing’s own characterization of Dr. Murthy’s rebuttal testimony admits
`
`that it “elaborate[s]” and “expounds upon [FlatWing’s] prima facie case.” Opp. at
`
`6. But, FlatWing and its declarants were required state their case fully as part of
`
`FlatWing’s petition for inter partes review. Their failure to do so renders such
`
`evidence untimely and improper supplementation. See Intelligent Bio-Systems,
`
`Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016).
`
`1
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`That Dr. Murthy cites to Dr. Lane’s testimony to frame his rebuttal
`
`testimony does not establish that his opinions are responsive. See Opp. at 7–9. In
`
`its Patent Owner’s Response, Anacor and its experts explained that the cited art
`
`teaches away from the 5% limitation and that a POSA would have understood
`
`experimentation with boron-containing compounds to be anything but routine due
`
`to boron’s “unique” chemistry and the lack of experience in the art. See Lane
`
`Decl. (Ex. 2014) ¶¶ 67–75; Reider Decl. (Ex. 2013) ¶¶ 68–71. Instead of
`
`responding to either of these points, Dr. Murthy reiterated the ranges in the cited
`
`art and for the first time asserted that Anacor’s own work was evidence supporting
`
`his earlier opinions regarding “routine experimentation.” Murthy Reply Decl. (Ex.
`
`1048) ¶¶ 5, 10, 12; id. ¶¶ 17–19 (providing a new discussion of Exhibit 1040). In
`
`other words, Dr. Murthy did not engage the opinions of Anacor’s experts, but
`
`instead introduced new concepts in an effort to buttress his previous opinions.
`
`FlatWing seeks to justify Dr. Murthy’s improper supplementation by relying
`
`on the proposition that “[e]vidence admitted in rebuttal to respond to the patent
`
`owner's criticisms will commonly confirm the prima facie case.” Belden, Inc. v.
`
`Berk-Tek LLC, 805 F.3d 1064, 1079 (Fed. Cir. 2015). But Belden does not give
`
`petitioners carte blanche to supplement the evidentiary record, see Intelligent Bio-
`
`Systems, 821 F.3d at 1369–70, and in fact illustrates the granular level of detail that
`
`can be generally expected of proper reply evidence. See Belden, 805 F.3d at 1078
`
`2
`
`
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`(disputing the meaning of “back stranding” in the prior art). FlatWing is also
`
`wrong that Anacor’s ability to file a surreply somehow cures FlatWing’s violation
`
`of 37 C.F.R. § 42.23(b).2 As FlatWing notes, Anacor was not permitted to file
`
`additional evidence beyond the cross-examination of FlatWing’s reply declarants.
`
`Opp. at 11. This limitation makes sense with respect to arguments and evidence
`
`that legitimately respond to points Anacor has already raised, but does not with
`
`respect to evidence that “elaborate[s] on [FlatWing’s] prima facie showing as to
`
`the 5% limitation.” Opp. at 6. For this latter category, Anacor is statutorily
`
`entitled to provide a full response, and a surreply is not “a substitute for the
`
`opportunity to present arguments and evidence.” In re NuVasive, Inc., 841 F.3d
`
`966, 973 (Fed. Cir. 2016) (emphasis added); see also 35 U.S.C. § 316(e)(8).
`
`II. The Board Should Exercise its Discretion to Exclude Dr. Murthy’s
`Reply Declaration in its Entirety
`
`FlatWing believes that because Anacor objected to Dr. Murthy’s reply
`
`declaration by identifying specific paragraphs exceeding the scope of proper reply
`
`evidence, it is now procedurally improper for Anacor to request that the Board
`
`
`2 FlatWing also incorrectly asserts that Anacor’s surreply “d[id] not address the
`
`routine experimentation of dose ranging studies and the overlapping ranges in the
`
`prior art.” Opp. at 11. To the contrary, Anacor’s surreply addressed both of these
`
`points, see Paper 24 at 12–16, 21–23.
`
`3
`
`
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`exclude Dr. Murthy’s reply declaration in its entirety. Opp. 1–2. Anacor was
`
`required to state its objections with “particularity” pursuant to 37 C.F.R. § 42.64,
`
`and there is nothing procedurally improper about this. FlatWing’s citation to
`
`Nintendo of America Inc. v. Motion Games, LLC, 2015 WL 2395487, at *15
`
`(P.T.A.B. May 15, 2018), is inapposite because unlike the patent owner in
`
`Nintendo, Anacor timely filed its objections and complied with the rule.
`
`“The Board may, in its discretion, refuse to consider a [r]eply if any part is
`
`improper.” Belden, 805 F.3d at 1079. Here, the Board should exercise its
`
`discretion to exclude Dr. Murthy’s reply declaration in toto for at least the reason
`
`that the proper and improper portions of Dr. Murthy’s reply declaration are
`
`intertwined and not cleanly separable. Where a reply declarant concededly
`
`chooses to “expound[] on the [petitioner’s] prima facie case,” Opp. at 6, instead of
`
`formulating a proper reply, the challenge of distinguishing proper from improper
`
`testimony justifies its wholesale exclusion—particularly when the evidence at issue
`
`is rebuttal testimony elicited for the purpose of the IPR. See, e.g., Dell Inc. v.
`
`Realtime Data LLC, IPR2016-00972, Paper 71, 2018 WL 2247172, at *13
`
`(P.T.A.B. May 15, 2018). The fact that Anacor has attempted to undertake this
`
`task to state its objections with “particularity” does not immunize Dr. Murthy’s
`
`reply declaration from being excluded in the Board’s discretion.
`
`4
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`III. FlatWing’s Response Improperly Argues the Merits
`
`FlatWing devotes the last section of its opposition brief to take issue with
`
`Anacor’s matter-of-fact observation that FlatWing and Dr. Murthy have pivoted
`
`away from arguing that “a POSA would be motivated to substitute [tavaborole] . . .
`
`for the . . . compound . . . in the Samour formulation” in favor of an argument
`
`based on overlapping ranges and “routine” dose-ranging studies. Murthy Decl.
`
`(Ex. 1005) ¶¶ 136, 193. FlatWing’s disagreement, however, does not give it
`
`license to present pure attorney argument concerning Samour untethered to any
`
`evidence in the record. See Opp. at 12–13. FlatWing’s new argument—including
`
`its discussion of Examples 9 and 10 of Samour, “the way such products are
`
`typically administered,” and whether Samour “encourages routine experimentation
`
`to determine [the] amount of active ingredient”—is improper as it is irrelevant to
`
`the merits of Anacor’s motion, does not appear in FlatWing’s reply, and is not
`
`supported by the testimony of FlatWing’s declarants. See Paper 19 at 22–24. This
`
`belated argument, like Dr. Murthy’s declaration, is just another attempt by
`
`FlatWing to introduce untimely evidence. Both should be disregarded.
`
`CONCLUSION
`
`For the foregoing reasons and those stated in Anacor’s motion, Dr. Murthy’s
`
`reply declaration (Exhibit 1048) should be excluded.
`
`
`
`5
`
`
`
`Date: February 21, 2019
`
`
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`
`
`
`
` Respectfully submitted,
`
`/s/ Aaron P. Maurer
`Aaron P. Maurer (Reg. No. 44,911)
`David I. Berl (Reg. No. 72,751)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`amaurer@wc.com
`dberl@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner Anacor
`Pharmaceuticals, Inc.
`
`6
`
`
`
`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
` CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that a true and correct copy of the
`
`foregoing was served on February 21, 2019, by delivering a copy via electronic
`
`mail on the following attorneys of record for Petitioners:
`
`Philip D. Segrest, Jr.
`Eric J. Rakestraw
`Edward D. Manzo
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, Illinois 60606
`Philip.Segrest@HuschBlackwell.com
`Eric.Rakestraw@HuschBlackwell.com
`PTAB-ERakestraw@HuschBlackwell.com
`Edward.Manzo@HuschBlackwell.com
`
`Counsel for Petitioner FlatWing Pharmaceuticals, LLC
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
`
`
`
`
`7
`
`
`
`
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