Case 1:20-cv-00393-LO-TCB Document 1103 Filed 02/25/22 Page 1 of 15 PageID# 30288
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`
`RAI STRATEGIC HOLDINGS, INC. and
`R.J. REYNOLDS VAPOR COMPANY
`
`
`Plaintiffs and
`Counterclaim Defendants,
`
`
`v.
`
`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTS S.A.
`
`
`Defendants and
`Counterclaim Plaintiffs.
`
`Case No. 1:20-cv-00393-LO-TCB
`
`
`
`
`
`
`
`PMI/ALTRIA’S REPLY IN SUPPORT OF DAUBERT MOTION TO EXCLUDE
`DESIGN-AROUND TESTIMONY OF RJR’S EXPERT, DAVID CLISSOLD
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`
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`

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`Case 1:20-cv-00393-LO-TCB Document 1103 Filed 02/25/22 Page 2 of 15 PageID# 30289
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`
`
`I.
`
`II.
`
` TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1
`
`ARGUMENT .......................................................................................................................2
`
`A.
`
`
`B.
`
`
`
`C.
`
`PMI/Altria Appropriately Challenges Mr. Clissold’s Unreliable Design-
`Around Opinions At The Daubert Stage .................................................................2
`
`RJR Fails To Show That Mr. Clissold’s Opinions On The Availability Of
`The Purported Design-Arounds Are Reliable ..........................................................4
`
`RJR Fails To Show That The Designs-Arounds Would Have Been
`“Available” From A Regulatory Perspective Without PMT
`Authorization ...............................................................................................4
`
`1.
`
`
`2.
`
`Including The Design-Arounds In “Existing” PMTAs Would Not
`Have Rendered Them Available From A Regulatory Perspective ..............6
`
`
`RJR’s Transparent Attempt To Recast Mr. Clissold’s Unreliable Opinions
`Underscores The Fundamental Flaws That Pervade His Analysis ..........................9
`
`III.
`
`CONCLUSION ..................................................................................................................10
`
`
`
`
`i
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`

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`
`
`TABLE OF AUTHORITIES
`CASES
`
`Carnegie Mellon Univ. v. Marvell Technology Group, Ltd.,
`No. 09-cv-290, 2012 WL 3686736 (W.D. Pa. Aug. 24, 2012) ............................................... 4, 5
`
`Datascope Corp.,
`879 F.2d 820 (Fed. Cir. 1989) ..................................................................................................... 5
`
`Daubert v. Merrell Dow Pharms.,
`509 U.S. 579 (1993) .................................................................................................................... 3
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ................................................................................................... 5
`
`DUSA Pharms., Inc. v. Biofrontera Inc.,
`495 F. Supp. 3d 21 (D. Mass. 2020) ............................................................................................ 5
`
`Fresenius Med. Care Holdings, Inc. v. Baxter Int'l, Inc.,
`No. 03-cv-1431, 2006 WL 1390416 (N.D. Cal. May 18, 2006) ............................................. 3, 4
`
`In re Katz Interactive Call Processing Patent Litig.,
`No. 07-ML-01816, 2009 WL 3698470 (C.D. Cal. Mar. 11, 2009) ............................................. 3
`
`LaserDynamics, Inc. v. Quanta Computer, Inc.,
`No. 06-cv-348, 2011 WL 197869 (E.D. Tex. Jan. 20, 2011) .................................................. 3, 6
`
`Sherwin-Williams Co. v. PPG Indus., Inc.,
`No. 17-cv-1023, 2020 WL 1283465 (W.D. Pa. Mar. 18, 2020) .................................................. 5
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) ................................................................................................... 3
`
`STATUTES
`
`21 U.S.C. § 387a(b) ........................................................................................................................ 8
`
`RULES
`
`FED. R. EVID. 702 ............................................................................................................................ 3
`
`FED. R. EVID. 702 ......................................................................................................................... 8
`
`OTHER AUTHORITIES
`
`FDA, Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as
`Amended by the Family Smoking Prevention and Tobacco Control Act, 81 Fed. Reg. 28974
`(May 10, 2016) .............................................................................................................................8
`
`ii
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`I.
`
`INTRODUCTION
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`RJR cannot repair the unreliable premise on which Mr. Clissold’s design-around opinions
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`are based. The purported design-arounds for the ’265 and ’911 Patents simply would not have
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`been “available” from a regulatory perspective for them to be reliably considered at the time of the
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`hypothetical negotiations for those patents. None of RJR’s factually incorrect and legally
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`erroneous arguments obviate the indisputable reality—RJR’s design-arounds were unavailable
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`from a regulatory perspective and cannot be reliably considered for damages.
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`First, the Court should reject RJR’s argument that PMI/Altria’s challenge to Mr. Clissold’s
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`opinions is better suited to a summary judgment motion. PMI/Altria seeks to exclude these
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`opinions because each is grounded in a misapplication of law, rendering all of them unreliable and
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`unsuitable for a jury’s consideration. A Daubert motion is precisely the procedural vehicle to
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`review (and exclude) unreliable expert testimony based on a misunderstanding of the law,
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`particularly when the proffered opinions are as speculative as Mr. Clissold’s. Neither of the two
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`non-binding district court cases RJR relies on suggest otherwise.
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`Second, the Court should reject RJR’s legally erroneous argument that the redesigned
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`products are “available” in the reasonable royalty context based on the sheer possibility that they
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`could receive PMT authorization sometime “during the life of the patent.” Dkt. 955 at 9. RJR
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`cites no authority supporting this proposition and, instead, conflates cases addressing technical
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`feasibility of non-infringing alternatives with the regulatory availability of illegal products like
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`the redesigns at issue here. The premise of Mr. Clissold’s opinions is rank speculation, making
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`those opinions unreliable and ripe for exclusion.
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`Third, the Court should reject RJR’s eleventh-hour re-characterization of Mr. Clissold’s
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`1
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`

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`
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`opinions regarding the erroneous “options”1 that purportedly would have allowed RJR to sell the
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`redesigns on the U.S. market before earning PMT authorization. Even if the Court considers this
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`dubious re-interpretation, it still would not render Mr. Clissold’s design-around opinions reliable.
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`In sum, nothing in RJR’s opposition rehabilitates Mr. Clissold’s fundamentally unreliable
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`and speculative opinions regarding RJR’s alleged design-arounds for the ’265 and ’911 Patents.
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`Accordingly, the Court should exclude any testimony from Mr. Clissold regarding those opinions.
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`II.
`
`ARGUMENT
`
`RJR contends that the Court should deny PMI/Altria’s request to exclude because it is an
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`untimely summary judgment motion that mischaracterizes the law and Mr. Clissold’s opinions.
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`Each argument fails. In his report, Mr. Clissold describes “options” that purportedly would have
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`allowed the redesigns to be sold in the United States before earning PMT authorization. Dkt. 922-
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`1 (Clissold Rbt.) ¶¶ 35-38. The problem is that these so-called “options” are premised on a
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`misapplication of law, rendering each of them unreliable and an appropriate subject for a Daubert
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`motion.2 Dkt. 922 at 6-12. RJR’s attempt to backtrack from Mr. Clissold’s “options” tacitly
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`acknowledges as much.
`
`A.
`
`PMI/Altria Appropriately Challenges Mr. Clissold’s Unreliable Design-
`Around Opinions At The Daubert Stage
`
`RJR argues that PMI/Altria’s challenge to Mr. Clissold’s opinions is an untimely summary
`
`judgment motion that is inappropriate for Daubert review. Not so. Courts have excluded expert
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`opinions at the Daubert stage where, as here, the expert offered “speculative” opinions based only
`
`
`1 RJR only defends Mr. Clissold’s PMTA amendment “option,” calling the safety modification
`and supplemental PMTA “options” “beside the point” and “immaterial.” Dkt. 955 at 12; Dkt. 922-
`1 (Clissold Rbt.) ¶¶ 35-38; Dkt. 922 at 8-12. Thus, the Court should consider waived any argument
`opposing the exclusion of Mr. Clissold’s design-around opinions based on these other “options.”
`2 Mr. Clissold admits that his so-called “options” are merely “a possibility.” Dkt. 922 at 8. Thus,
`these opinions are speculative as well as unreliable, providing yet another basis for exclusion. Id.
`2
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`
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`on “theoretical possibilities” that alleged alternatives were “available.” LaserDynamics, Inc. v.
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`Quanta Computer, Inc., No. 06-cv-348, 2011 WL 197869, at *2-3 (E.D. Tex. Jan. 20, 2011). The
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`Court’s “gatekeeping role” at the Daubert stage is “to ensure that expert testimony admitted into
`
`evidence is both reliable and relevant.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d
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`1356, 1360 (Fed. Cir. 2008). Here, Mr. Clissold’s testimony is speculative and unreliable;
`
`excluding it would be consistent with the express purpose of Daubert. See Daubert v. Merrell
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`Dow Pharms., 509 U.S. 579, 588 (1993); FED. R. EVID. 702 (requiring expert testimony to be “the
`
`product of reliable principles” and to reliably apply those principles to the facts of the case).
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`Indeed, it would be particularly appropriate because Mr. Clissold’s testimony “is based on an
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`erroneous understanding or application of the law” and thus “cannot meet the requirements of Rule
`
`702.” In re Katz Interactive Call Processing Patent Litig., No. 07-ML-01816, 2009 WL 3698470,
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`at *2 (C.D. Cal. Mar. 11, 2009).
`
`The two non-binding cases RJR cites do not support its argument that a Daubert motion is
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`an improper procedural vehicle to challenge Mr. Clissold’s unreliable opinions. Dkt. 955 at 6-7.
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`In each, the court addressed the admissibility of the expert’s opinion and declined to decide
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`whether a design-around is a viable non-infringing alternative from a factual, technical
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`perspective. In Fresenius Medical Care Holdings, Inc. v. Baxter International, Inc., the court held
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`that the technical feasibility question of “whether the 2008H model is, in fact, a viable alternative
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`to the 2008K” is not a Daubert issue. No. 03-cv-1431, 2006 WL 1390416, *7 (N.D. Cal. May 18,
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`2006). Not only was this case not about regulatory availability of illegal products, availability was
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`not even at issue because the alternative product was already on the market. Id. Moreover, the
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`court allowed the expert’s opinions because he “clearly set[] forth the facts” that “support his
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`conclusion,” but noted that exclusion is appropriate where, as in the present matter, opinions are
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`3
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`“divorced from the facts of th[e] case.” Id. In Carnegie Mellon University v. Marvell Technology
`
`Group, Ltd., the court held that the technical feasibility question of whether alternative
`
`technologies “could achieve similar results as those derived from CMU’s patented technologies”
`
`is not a Daubert issue. No. 09-cv-290, 2012 WL 3686736, at *5 (W.D. Pa. Aug. 24, 2012).
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`Unsurprisingly, neither case pertains to the exclusion of expert opinions that, as here, are premised
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`on a misapplication of governing law, and thus unreliable.
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`B.
`
`RJR Fails To Show That Mr. Clissold’s Opinions On The Availability Of The
`Purported Design-Arounds Are Reliable
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`
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`It is undisputed that any redesigned product would not have had PMT authorization at the
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`time of the hypothetical negotiations, and that they would need to earn such authorization before
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`they could be sold in the United States legally. Dkt. 922 at 6-8; see Dkt. 955 at 7-11. Because
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`RJR cannot escape this regulatory reality, it attempts to recast Mr. Clissold’s opinions. RJR now
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`claims that what Mr. Clissold actually opines is that, because it would have been possible for RJR
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`to have added the design-arounds to the original PMTAs for its VUSE e-cigarettes at some point
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`“during the life of the patents,” and because it is possible that redesigned products could obtain
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`PMT authorization, those products are “available” for consideration in a reasonable royalty
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`assessment. Opp. at 9. This is incorrect.
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`1.
`
`RJR Fails To Show That The Designs-Arounds Would Have Been
`“Available” From A Regulatory Perspective Without PMT
`Authorization
`
`RJR contends that PMI/Altria “incorrectly argues that, as a matter of law, a product without
`
`FDA approval on the hypothetical negotiation date cannot be an available non-infringing
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`alternative.” Opp. at 9. RJR is wrong, and it fails to identify any case deeming a regulated product
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`“available” either at the hypothetical negotiation or within a reasonable time thereafter where that
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`product lacks FDA authorization. This utter lack of legal support should be dispositive.
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`4
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`Instead, in its fruitless attempt to show that the redesigned products do not need PMT
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`authorization to be relevant to a reasonable royalty analysis, RJR relies on inapposite cases that,
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`at best, stand for the proposition that, in certain limited circumstances, products that are
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`technologically feasible can be considered as part of a reasonable royalty analysis, even if they
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`have not yet been released on the U.S. market.3 See Dkt. 955 at 7-9 (citing Mars, Carnegie Mellon,
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`Prism, Baxter, and Covidien Sales).
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`Such holdings, however, have no bearing on the regulatory availability of redesigned
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`products that are undisputedly illegal and cannot be marketed or sold in the United States. unless
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`and until FDA authorizes those products. In turn, the holdings have no bearing on the reliability
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`of Mr. Clissold’s design-around opinions. See Dkt. 922 at 6-12 & Dkt. 922-1 (Clissold Rbt.) ¶¶
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`35-38; see also DUSA Pharms., Inc. v. Biofrontera Inc., 495 F. Supp. 3d 21, 30 (D. Mass. 2020)
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`(explaining that FDA approval of a product was important in determining “availability” for
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`assessing damages) (citing Datascope Corp., 879 F.2d 820, 825 (Fed. Cir. 1989)); Sherwin-
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`Williams Co. v. PPG Indus., Inc., No. 17-cv-1023, 2020 WL 1283465, at *8-9 (W.D. Pa. Mar. 18,
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`2020) (holding that, because the products in question were not “an acceptable, available, non-
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`infringing, alternative product in the market,” they could not be used to calculate lost profits or a
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`reasonable royalty); DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1332
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`(Fed. Cir. 2009) (identifying the lack of FDA authorization as a factor in determining there was no
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`acceptable non-infringing alternatives).
`
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`3 In its reply in support of its motion to exclude Dr. Sullivan’s opinions, PMI/Altria also
`distinguishes these cases and explains in detail why they are irrelevant to the impact of regulatory
`availability on the hypothetical negotiation.
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`5
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`
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`2.
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`Including The Design-Arounds In “Existing” PMTAs Would Not
`Have Rendered Them Available From A Regulatory Perspective
`
`RJR contends that because “the design-arounds could have been implemented into
`
`Reynolds’s original PMTAs, and that Reynolds would be able to sell the design-arounds on
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`FDA approval, there is no basis to exclude Mr. Clissold’s design-around opinions.” Dkt. 955 at
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`11. Once again, RJR is wrong.
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`
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`First, RJR invites reversible legal error with its contention that, even though its redesigned
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`products undisputedly lacked PMT authorization at the time of the hypothetical negotiations, they
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`are nevertheless “available” if they could obtain PMT authorization at some unidentified point
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`“during the life of the patents.” Dkt. 955 at 9. RJR cites no case extending the “availability”
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`requirement beyond the hypothetical negotiations. None. RJR’s argument fails for this reason
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`alone.
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`Indeed, RJR’s erroneous interpretation of “availability” eviscerates the requirement
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`altogether. See Dkt. 955 at 7-11. It would allow any speculative (and unsupported) assertion to
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`be sufficient to show “availability” and thus be considered in the damages assessment. But that is
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`not the law See LaserDynamics, 2011 WL 197869, at *3 (striking expert’s opinions on reasonable
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`royalty analysis that “reveal only speculation that it might have been theoretically possible for
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`[defendant] to produce his non-infringing alternatives” because that did not establish they were
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`“available” during the relevant period and thus “do not ‘assist the trier of fact to understand the
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`evidence or to determine a fact at issue’”). If RJR believed “availability” could be so remote, then
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`it would not have needed an expert to opine on whether the design-arounds could be included in
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`one of the original VUSE e-cigarette PMTAs because they would not need to be the subject of a
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`PMTA at all in order for RJR to show a possible path to PMT authorization, and thus inclusion in
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`the reasonable royalty rate analysis. Tellingly, RJR has been adamant that such information is
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`6
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`relevant. See Dkt. 955 at 7-12.
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`The “availability” approach RJR suggests is far too attenuated from any reasonable
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`evaluation of the economic and regulatory landscape the parties would have found themselves in
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`during the hypothetical negotiation periods, and thus doeslittle to assist in assessing the true value
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`of the patented technology. Accordingly, the Court should reject this factually unsupported and
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`legally erroneous position.
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`Second, RJR’s “availability” contention is factually icorrect because, as PMI/Altria’s
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`motion to exclude discussed (but RJR’s brief ignored),ee
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`Pd FDAundisputedly would still have had to grant
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`PMTauthorization for those modified products before RJR could sell them in the United States.
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`See id. Thus, the redesigned products still would have been unavailable at the time of the
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`hypothetical negotiations, and for any reasonable time period thereafter, as RJR filed its VUSEe-
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`cigarette PMTAsbetween October 2019 and September 2020. See id.*
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`Third, even if RJR were correct that some future authorization at an undetermined time
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`“during the life of the patents” sufficed to show availability (it cannot), Mr. Clissold’s purely
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`speculative opinions still do not show that the redesigned products would ever be authorized(i.e.,
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`would ever be available from a regulatory perspective). Mr. Clissold merely assumesthat: (1)
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`4 For example, RJR did not file a PMTAforits VUSE Alto
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`And the mere
`until September 2020,
`filing of the PMTA is immaterial because RJR could not sell any redesigned product not on the
`market as of August 8, 2016, unless and until FDA granted PMTauthorization. Dkt. 922 at 9-11.
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`7
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`the redesigned products would eventually be authorized; (2) adding the design-arounds to an
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`original VUSEe-cigarette PMTA would notaffect the timing of the review; (3) adding the design-
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`arounds to an original VUSEe-cigarette PMTA would notaffect the “probability” ofauthorization;
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`and (4) all product models incorporating the design-arounds would be authorized. Dkt. 922-1
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`(Clissold Rbt.) §§ 9, 57; Dkt. 955 at 11.°
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`Mr. Clissold offers no credible support for these opinions whatsoever. Cf, FDA, Deeming
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`Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended bythe
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`Family Smoking Prevention and Tobacco Control Act, 81 Fed. Reg. 28974, 28975-76 (May 10,
`
`2016) (final rule); 21 U.S.C. § 387a(b). If anything, actual FDA policies and actionsreflect their
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`unreliability and speculation. The multiple VUSE Solo PMTdenials that already have occurred
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`demonstrate that Mr. Clissold was wrong in speculating that all models incorporating the design-
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`arounds would receive authorization. See Dkt. 922-6- (FDA Slides) at 14. And, because nearly
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`all other VUSEe-cigarettes arestill the subject of a pending PMTA,his opinionsregarding design-
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`arounds for those models remain sheer speculation. Mr. Clissold’s assumption that all these
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`applications will be granted is based on unreliable principles and unsupported assumptions. See
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`FepD. R. Evip. 702. With nearly all PMTAs processed, FDA has denied PMTauthorization on
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`substantive grounds to more than a million e-cigarettes, and has granted authorization to only one,
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`RJR’s VUSESolo, and even this authorization is only partial (authorizing tobacco flavors only).
`
`Dk 922-6 (FDA Slides)a 9,11,14,
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`> Dr. Sullivan, RJR’s damages expert, opines that Dkt. 922-3 (Sullivan Rbt.) § 287. PMT denial of the VUSE e-cigarettes, however,
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`is not just about delay. There is no guarantee of authorization, and, without it, RJR would be
`forced to remove its VUSEe-cigarettes from the U.S. market entirely. Thus, anything that would
`mitigate the risk of PMT denial would be of significant value to RJR. See, e.g., Dkt. 1016.
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`8
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`predict FDA’s PMT determinations is “speculation.” See, e.g., Dkt. 1016-4 (Figlar ITC Dep.) at
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`46:10-47:7, Dkt. 1017-9 (Figlar ITC Tr.) at 99:11-25. Mr. Clissold should not be permitted to
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`present the same speculative opinions to the jury, especially since his opinions would remain
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`unreliable, and still warrant exclusion.6
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`C.
`
`RJR’s Transparent Attempt To Recast Mr. Clissold’s Unreliable Opinions
`Underscores The Fundamental Flaws That Pervade His Analysis
`
`Unable to escape the fundamental flaws in Mr. Clissold’s unreliable opinions, RJR
`
`attempts to pivot and recast those opinions. RJR now claims that Mr. Clissold is not opining that
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`RJR could sell the redesigned products prior to PMT authorization, but merely that the “design-
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`arounds could have been included in Reynolds’s original PMTAs, such that they could be sold
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`upon FDA approval.” Id. This recasting strains credulity and, in any event, confirms the
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`unreliability of Mr. Clissold’s opinions.
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`First, RJR’s argument that Mr. Clissold never opined “that the design arounds could be
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`sold prior to FDA approval” is false. Dkt. 955 at 2. In his report,
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`6 Further arguments as to why RJR’s “availability” analysis is flawed can be found in PMI/Altria’s
`reply in support of its motion to exclude certain opinions from RJR’s damages expert, Dr. Sullivan.
`9
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` Dkt. 922-1 (Clissold Rbt.) ¶¶ 35, 38.
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` Second, that RJR now attempts to distance itself from Mr. Clissold’s supposed “options”
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`for selling redesigned products in the United States before earning PMT authorization confirms
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`their inadmissibility. Even if this recasting of Mr. Clissold’s design-around opinions was credible
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`(and it is not), RJR fails to address Mr. Clissold’s misapplication of the law.
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`
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` the redesigned products could not be sold in the United States
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`until they earned PMT authorization. Dkt. 922 at 6-12.
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`III. CONCLUSION
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`PMI/Altria respectfully requests that the Court exclude Mr. Clissold’s opinions regarding
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`the regulatory availability of design-arounds for the ’265 and ’911 Patents.
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`
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`Dated: February 25, 2022
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`Respectfully submitted,
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`
`
`By: /s/ Maximilian A. Grant
`
`Maximilian A. Grant (VSB No. 91792)
`(max.grant@lw.com)
`Matthew J. Moore (pro hac vice)
`matthew.moore@lw.com
`Jamie D. Underwood (pro hac vice)
`jamie.underwood@lw.com
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, DC 20004
`Telephone: (202) 637-2200
`Facsimile: (202) 637-2201
`
`Clement J. Naples (pro hac vice)
`clement.naples@lw.com
`LATHAM & WATKINS LLP
`885 Third Avenue
`New York, NY 10022-4834
`Tel: (212) 906-1200; Fax: (212) 751-4864
`
`Gregory J. Sobolski (pro hac vice)
`greg.sobolski@lw.com
`10
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`Case 1:20-cv-00393-LO-TCB Document 1103 Filed 02/25/22 Page 14 of 15 PageID# 30301
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`LATHAM & WATKINS LLP
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111
`Telephone: (415) 391-0600
`Facsimile: (415) 395-8095
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`Brenda L. Danek (pro hac vice)
`brenda.danek@lw.com
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`Tel: (312) 876-7700; Fax: (312) 993-9767
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`Counsel for Plaintiffs Altria Client Services LLC;
`Philip Morris USA Inc.; and Philip Morris
`Products S.A.
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`11
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`Case 1:20-cv-00393-LO-TCB Document 1103 Filed 02/25/22 Page 15 of 15 PageID# 30302
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`CERTIFICATE OF SERVICE
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`I hereby certify that on February 25, 2022, a true and correct copy of the foregoing was
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`served using the Court’s CM/ECF system, with electronic notification of such filing to all counsel
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`of record:
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`/s/ Maximilian A. Grant
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`Maximilian A. Grant (VSB No. 91792)
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, DC 20004
`Telephone: (202) 637-2200
`Facsimile: (202) 637-2201
`Email: max.grant@lw.com
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`Counsel for Plaintiffs Altria Client Services
`LLC; Philip Morris USA Inc.; and Philip
`Morris Products S.A.
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`12
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