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`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
`__________________
`
`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
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`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 ..................................................................... 5
`
`III.
`
`FlatWing’s Response Improperly Argues the Merits ...................................... 6
`
`CONCLUSION .......................................................................................................... 8
`
`
`
`i
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`TABLE OF AUTHORITIES
`
`
`Cases:
`
`Page(s):
`
`Belden, Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015) ........................ 3, 4, 6
`
`Dell Inc. v. Realtime Data LLC, IPR2016-00972, Paper 71, 2018 WL
`2247172 (P.T.A.B. May 15, 2018) ....................................................................... 6
`
`In re NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016) ................................................. 5
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d
`1359 (Fed. Cir. 2016) ........................................................................................ 1, 4
`
`Nintendo of America Inc. v. Motion Games, LLC, 2015 WL 2395487
`(P.T.A.B. May 15, 2018) ...................................................................................... 5
`
`Statutes:
`
`35 U.S.C. § 316(e)(8) ................................................................................................. 5
`
`Rules:
`
`37 C.F.R. § 42.23(b) .......................................................................................... 1, 3, 4
`
`37 C.F.R. § 42.64 ....................................................................................................... 5
`
`Other Authorities:
`
`Office Patent Trial Guide, 77 Fed. Reg. 48,756 (Aug. 14, 2012) ............................. 3
`
`Trial Practice Guide Update (Aug. 2018) .................................................................. 4
`
`
`
`ii
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`Anacor is not insisting, as FlatWing contends, that reply evidence “be
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`exactly the same” as the evidence cited in a petition. Nor is it Anacor’s position
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`that reply evidence “must not have been previously known” to a petitioner.
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`Anacor’s position is simply that, pursuant to 37 C.F.R. § 42.23(b), reply evidence
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`must be “responsive.” FlatWing’s opposition (Paper 30, “Opp.”) states that Dr.
`
`Murthy’s reply declaration (Ex. 1048) “elaborate[s]” or “expounds” upon the
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`arguments raised in FlatWing’s petition. Opp. at 1, 6. But regardless of how
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`FlatWing now attempts to characterize it, FlatWing was required to provide its
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`explanation of its grounds for invalidity with its petition, which makes Dr.
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`Murthy’s reply declaration an improper attempt to supplement his prior opinions.
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`Under these circumstances, the exclusion of Dr. Murthy’s reply declaration in its
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`entirety is an appropriate remedy. Anacor’s motion to exclude (Paper 23, “Mot.”)
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`should be granted.
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`I.
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`Dr. Murthy’s Reply Declaration Is Not Responsive
`
`ARGUMENT
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`FlatWing’s own characterization of Dr. Murthy’s rebuttal testimony admits
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`that it “elaborate[s]” and “expounds upon [FlatWing’s] prima facie case.” Opp. at
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`6. But, FlatWing and its declarants were required state their case fully as part of
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`FlatWing’s petition for inter partes review. Their failure to do so renders such
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`evidence untimely and improper supplementation of the record. See Intelligent
`
`1
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`
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
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`Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir.
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`2016) (“It is of the utmost importance that petitioners in the IPR proceedings
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`adhere to the requirement that the initial petition identify ‘with particularity’ the
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`‘evidence that supports the grounds for the challenge to each claim.” (quoting 35
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`U.S.C. § 312(a)(3)).
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`That Dr. Murthy cites to Dr. Lane’s testimony to frame his rebuttal
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`testimony does not establish that his opinions are responsive. See Opp. at 7–9. As
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`explained in Anacor’s motion, Dr. Murthy’s opening declaration in support of
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`FlatWing’s petition asserted that a person of ordinary skill in the art (“POSA”)
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`would have combined Austin and Brehove or Freeman with Samour because
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`“Samour teaches . . . similar concentration ranges of active antifungal ingredient as
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`taught in Austin and Brehove [and Freeman].” Murthy Decl. (Ex. 1005) ¶¶ 134,
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`191. According to FlatWing and Dr. Murthy, this would have motivated a POSA
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`to “substitute [tavaborole] . . . for the higher molecular weight compound disclosed
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`in the Samour formulation.” Id. ¶¶ 136, 193. Dr. Murthy also opined that
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`“[f]ormulating pharmaceutical compositions involves nothing more than routine
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`experimentation based on well-known protocols.” Id. ¶¶ 134, 191. In response,
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`Anacor and its experts explained that the cited art teaches away from the 5%
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`limitation and that a POSA would have understood experimentation with boron-
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`containing compounds to be anything but routine due to boron’s “unique”
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`2
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`U.S. Patent No. 9,549,938
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`chemistry and the lack of experience in the art of formulating boron-containing
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`compounds as active pharmaceutical ingredients. See Lane Decl. (Ex. 2014) ¶¶
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`67–75; Reider Decl. (Ex. 2013) ¶¶ 68–71.
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`Instead of responding to either of these points, Dr. Murthy reiterated the
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`ranges disclosed in the cited art—this time accompanied by his new opinions that
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`“it would have been obvious to a POSA . . . to try the 5% solution in routine dose
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`ranging studies” and that the ranges “provid[e] a reasonable expectation of success
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`in including the 5% solution in a routine dose ranging study”—and for the first
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`time asserted that Anacor’s own work was evidence supporting his earlier opinions
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`regarding “routine experimentation.” Murthy Reply Decl. (Ex. 1048) ¶¶ 5, 10, 12;
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`id. ¶¶ 17–19 (providing a new discussion of Exhibit 1040). In other words, Dr.
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`Murthy did not engage the opinions of Anacor’s experts, but instead introduced
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`new concepts in an effort to buttress his previous opinions. Dr. Murthy’s reply
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`declaration falls squarely within the prohibition of 37 C.F.R. § 42.23(b) against
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`rebuttal testimony that “raises a new issue or belatedly presents evidence” in reply.
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`Office Patent Trial Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012); see also
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`Opp. at 5 (underscoring the same).
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`FlatWing seeks to justify Dr. Murthy’s improper supplementation by relying
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`on the proposition in Belden, Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir.
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`2015), that “[e]vidence admitted in rebuttal to respond to the patent owner's
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`3
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`criticisms will commonly confirm the prima facie case.” Id. at 1079. But Belden
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`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
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`level of detail that can be generally expected of proper reply evidence. See Belden,
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`805 F.3d at 1078 (“After summarizing Mr. Clark’s argument about JP ’910’s
`
`teaching of a need to control twisting of the core and the elimination of back
`
`twisting, the Baxter declaration explains what JP ’910 means by ‘back stranding’
`
`and distinguishes back stranding from the problem of ‘back-twisting’ addressed by
`
`Belden’s patent and JP ’910.”).
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`Finally, FlatWing is wrong to the extent it contends that Anacor’s ability to
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`file a surreply somehow cures FlatWing’s violation of 37 C.F.R. § 42.23(b).2 As
`
`FlatWing notes, although Anacor was authorized to file a surreply, Anacor was not
`
`permitted to file additional evidence beyond the cross-examination testimony of
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`FlatWing’s reply declarants. Opp. at 11; see also Trial Practice Guide Update at
`
`14 (Aug. 2018) (stating that a surreply “may not be accompanied by new evidence
`
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`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.
`
`4
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`other than deposition transcripts of the cross-examination of any reply witness”).
`
`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 (if not
`
`required) 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
`
`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 the manner in which Anacor did
`
`so. 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 filed its objections in timely fashion and
`
`complied with the rule’s requirements.
`
`5
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
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`“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 wholesale exclusion of the evidence as a prophylactic
`
`measure—particularly when the evidence at issue is rebuttal testimony elicited by
`
`party 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)
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`(observing that “demarcating . . . proper and improper portions” of a reply entails
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`the difficult task of “deciphering whether improper segments . . . may bleed into
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`other parts”). The fact that Anacor has attempted to undertake this task in order to
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`state its objections with “particularity” does not procedurally immunize Dr.
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`Murthy’s reply declaration from being excluded in its entirety as an exercise of the
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`Board’s discretion.
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`III. FlatWing’s Response Improperly Argues the Merits
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`FlatWing devotes the last section of its opposition brief to take issue with
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`Anacor’s matter-of-fact observation that FlatWing and Dr. Murthy have pivoted
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`6
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`away from arguing that “a POSA would be motivated to substitute [tavaborole] . . .
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`for the higher molecular weight compound disclosed in the Samour formulation” in
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`favor of an argument based on overlapping ranges and “routine” dose-ranging
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`studies. Murthy Decl. (Ex. 1005) ¶¶ 136, 193. While FlatWing may disagree with
`
`Anacor’s meta-analysis of its position, FlatWing’s disagreement does not give it
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`license to present pure attorney argument concerning Samour untethered to any
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`evidence in the record. See Opp. at 12–13. FlatWing’s new argument concerning
`
`Samour—including its discussion of Examples 9 and 10, “the way such products
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`are typically administered,” and whether Samour “encourages routine
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`experimentation to determine [the] amount of active ingredient”—is improper as it
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`is irrelevant to the merits of Anacor’s motion to exclude, and in fact confirms the
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`shift in FlatWing’s obviousness theory. Id. Moreover, this argument does not
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`appear in FlatWing’s reply, which was limited to arguing that Anacor’s evidence
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`of teaching away was insufficient as a matter of law, and is not supported by the
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`any testimony from FlatWing’s declarants. See Paper 19 at 22–24. This belated
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`argument, like Dr. Murthy’s declaration, is just another attempt by FlatWing to
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`introduce untimely evidence. Both should be disregarded.
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`7
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`CONCLUSION
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`For the foregoing reasons and those stated in Anacor’s motion, Dr. Murthy’s
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`reply declaration (Exhibit 1048) should be excluded.
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`
`Date: February 15, 2019
`
`
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` 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.
`
`8
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`
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`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 15, 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
`
`
`
`
`9
`
`
`
`
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