Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 1 of 18 PageID# 25892
`
`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
`
`ORAL ARGUMENT REQUESTED
`
`
`
`
`
`
`
`
`
`BRIEF IN SUPPORT OF PMI/ALTRIA’S DAUBERT MOTION TO EXCLUDE
`DESIGN-AROUND TESTIMONY OF RJR’S EXPERT, DAVID CLISSOLD
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 2 of 18 PageID# 25893
`
` TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`FACTUAL BACKGROUND ..............................................................................................1
`
`A.
`
`B.
`
`RJR’s Design-Arounds ............................................................................................1
`
`The Development Of E-Cigarette Regulations ........................................................2
`
`III.
`
`LEGAL STANDARDS .......................................................................................................4
`
`A.
`
`B.
`
`Admissibility Of Expert Testimony Under Federal Rule Of Evidence 702 ............4
`
`Availability Of Redesigns For Assessing A Reasonable Royalty ...........................4
`
`IV.
`
`ARGUMENT .......................................................................................................................6
`
`A.
`
`
`B.
`
`
`
`Mr. Clissold’s Regulatory Availability Opinions Are Unreliable, Lack
`Any Factual Basis, And Are Belied By His Own Report And Deposition
`Testimony ................................................................................................................6
`
`None of Mr. Clissold’s Unreliable And Speculative “Options” Show A
`Regulatory Exception That Would Have Rendered The Redesigns
`Available ..................................................................................................................8
`
`1.
`
`2.
`
`3.
`
`
`4.
`
`Redesigns Are Not Available Via A Safety Modification “Option” ...........9
`
`Redesigns Are Not Available Via A PMTA Amendment “Option” ...........9
`
`Redesigns Are Not Available Via A Supplemental PMTA
`“Option” .....................................................................................................11
`
`Redesigns Are Not Available Via Potential Lack of Detection .................11
`
`V.
`
`CONCLUSION ..................................................................................................................12
`
`
`
`
`i
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`

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`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 3 of 18 PageID# 25894
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`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Acceleration Bay LLC v. Activision Blizzard Inc.,
`No. 16-cv-453, 2019 WL 4194060 (D. Del. Sep. 4, 2019) ......................................................... 8
`
`Am. Acad. of Pediatrics v. FDA,
`399 F. Supp. 3d 479 (D. Md. 2019) ........................................................................................... 10
`
`Aqua Shield v. Inter Pool Cover Team,
`774 F.3d 766 (Fed. Cir. 2014) ................................................................................................. 4, 5
`
`Cooper v. Smith & Nephew, Inc.,
`259 F.3d 194 (4th Cir. 2001) ................................................................................................... 4, 8
`
`Daubert v. Merrell Dow Pharms.,
`509 U.S. 579 (1993) ............................................................................................................ 4, 6, 8
`
`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, 6
`
`Ethicon Endo-Surgery Inc. v. Covidien, Inc.,
`No. 1:11-cv-871, 2019 WL 2164090 (S.D. Oh. May 17, 2019) ................................................. 5
`
`Kumho Tire Co. v. Carmichael,
`526 U.S. 137 (1999) ................................................................................................................ 4, 8
`
`Mars, Inc. v. Coin Acceptors, Inc.,
`527 F.3d 1359 (Fed. Cir. 2008) ................................................................................................... 5
`
`Sherwin-Williams Co. v. PPG Indus., Inc.,
`No. 17-1023, 2020 WL 1283465 (W.D. Pa. Mar. 18, 2020) ...................................................... 7
`
`Shire Viropharma Inc. v. CSL Behring LLC,
`No. 17-cv-414, 2021 WL 1227097 (D. Del. Mar. 31, 2021) ..................................................... 12
`
`Smart Skins LLC v. Microsoft Corp.,
`No. 15-cv-544, 2016 WL 4148091 (W.D. Wash. July 1, 2016) ................................................. 5
`
`Sound View Innovations, LLC v. Hulu, LLC,
`No. 17-cv-4146, 2019 WL 9047211 (C.D. Cal. Nov. 18, 2019) ................................................. 5
`
`SPEX Techs. v. Apricorn, Inc.,
`No. 16-cv-7349, 2020 WL 1289546 (C.D. Cal. Jan. 21, 2020) .................................................. 5
`
`ii
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`

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`
`TecSec, Inc. v. Adobe Sys., Inc.,
`No. 10-cv-115, Dkt. 1152 (E.D. Va. June 8. 2018) ..................................................................... 8
`
` STATUTES
`
`21 U.S.C. § 387a(b) ........................................................................................................................ 2
`
`RULES
`
`Fed. R. Evid. 702 .......................................................................................................... 4, 6, 8, 9, 12
`
` 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) ........................................................................................ 2, 3
`
`
`
`iii
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`

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`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 5 of 18 PageID# 25896
`
`I.
`
`INTRODUCTION
`
`The Court should exclude RJR’s expert, David Clissold, from testifying that RJR’s alleged
`
`design-arounds to the technology claimed in U.S. Patent Nos. 9,814,265 (“the ’265 Patent”) and
`
`10,104,911 (“the ’911 Patent”) would have been “available” to RJR from a regulatory perspective
`
`at the time of the hypothetical negotiations for those patents
`
`.
`
`These opinions are unreliable, untethered to basic laws governing tobacco products, and
`
`speculative. Mr. Clissold’s own report and deposition testimony contravene his design-around
`
`conclusions. In fact, Mr. Clissold admits that e-cigarette
`
`
`
` Ex. 1 (Clissold Rbt.) ¶ 18;
`
`see Ex. 2 (Clissold Dep.) 45:20-46:4, 47:5-48:18, 53:12-58:10. As such, it is undisputed that, as
`
`of the hypothetical negotiations
`
`, RJR was barred from selling modified versions of e-
`
`cigarettes that were on the market on August 8, 2016 (i.e., Accused Products incorporating the
`
`alleged design-arounds), unless and until the U.S. Food and Drug Administration (“FDA”) granted
`
`premarket tobacco (“PMT”) authorization to those products.
`
`In an attempt to circumvent applicable law and FDA’s enforcement discretion policy, Mr.
`
`Clissold speculates that RJR had multiple “options” that would have allowed the sale of RJR’s
`
`unauthorized, redesigned products prior to PMT authorization. Each of Mr. Clissold’s alleged
`
`“options,” however, lacks any factual or legal support. They are pure speculation based on an
`
`unsound and unacceptable (indeed, unidentifiable) methodology. Accordingly, the Court should
`
`exclude Mr. Clissold’s opinions.
`
`II.
`
`FACTUAL BACKGROUND
`A.
`
`RJR’s Design-Arounds
`
`PMI/Altria assert five patents against RJR’s VUSE Solo, Vibe, Ciro, and Alto e-cigarettes
`
`(“Accused Products”), including the ’265 Patent against the Alto and the ’911 Patent against all
`
`1
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`

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`Accused Products. Dkts. 65, 66; Ex. 1 (Clissold Rbt.) § 50. To inform his opinions regarding the
`
`appropriate royalty rate for the ’265 and ’911 Patents, RJR’s damagesexpert, Ryan Sullivan,relies
`
`in part on theoretical non-infringing design-arounds that RJR contends could have been available
`
`at the time of the hypothetical negotiations for those patents. Ex. 3 (Sullivan Rbt.) §§ 86, 198, 201,
`
`286, 345, 378.! According to Dr.Sullivan,
`
`Id. ¥§ 36, 39, 187.2 Because
`
`B.
`
`The Development Of E-Cigarette Regulations
`
`Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in
`
`2009, which gave FDA authority to regulate cigarettes and certain other tobacco products. 21
`
`U.S.C. § 387a(b); FDA, Deeming Tobacco Products to be Subject to the Federal Food, Drug and
`
`Cosmetic Act, as Amended bythe Family Smoking Prevention and Tobacco Control Act, 81 Fed.
`
`1 PMI/Altria have separately moved to exclude Dr. Sullivan’s design-around opinions.
`
`
`
`* Unless otherwise noted, all emphases are added.
`
`2
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 7 of 18 PageID# 25898
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`Reg. 28974, 28975 (May 10, 2016) (final rule); Ex. 6 (Oct. 2020 FDA Slides) at 8; Ex. 7 (Apr.
`
`2020 FDA ENDS Guidance) at -4121. The “Deeming Rule,” which went into effect on August 8,
`
`2016, expanded the TCA’s applicability to inter alia e-cigarettes, including the requirement that
`
`e-cigarettes must earn PMT authorization from FDA before they can be legally marketed and sold
`
`in the United States. 81 Fed. Reg. at 28975-76; Ex. 7 (Apr. 2020 FDA ENDS Guidance) at -4121,
`
`-4122; Ex. 8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450. Consequently, all e-cigarettes on sale
`
`as of August 8, 2016, were instantaneously rendered illegal. See Ex. 7 (Apr. 2020 FDA ENDS
`
`Guidance) at -4128.
`
`
`
`In order to shield this specific group of products from instantaneous removal from the U.S.
`
`market, FDA unveiled a compliance policy whereby e-cigarettes (and other new tobacco products
`
`in the newly deemed categories) already on the U.S. market as of the Deeming Rule’s effective
`
`date could remain so until a specified deadline for submitting PMT applications (“PMTAs”). See
`
`81 Fed. Reg. at 28977-80; Ex. 8 (Aug. 2020 Zeller Art.) at -6449. FDA made clear, however, that
`
`the compliance policy “did not confer lawful marketing status on new tobacco products being
`
`marketed without the necessary premarket authorization.” Ex. 7 (Apr. 2020 FDA ENDS
`
`Guidance) at -4121.
`
`
`
`Products lose the protections of this compliance policy, however, if they are modified from
`
`the design that existed as of the effective date of the Deeming Rule, August 8, 2016. See id. at
`
`4122, -4128, -4129; Ex. 8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450. For example, if an e-
`
`cigarette on the U.S. market as of August 8, 2016, is subsequently redesigned, FDA treats it as a
`
`different product that cannot be marketed in the United States before obtaining PMT authorization.
`
`See Ex. 8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450; Ex. 7 (Apr. 2020 FDA ENDS Guidance)
`
`at -4122, -4128, -4129; Ex. 9 (Ehrlich Op.) ¶¶. 22-30.
`
`
`
`3
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`III. LEGAL STANDARDS
`A.
`
`Admissibility Of Expert Testimony Under Federal Rule Of Evidence 702
`
` Expert testimony may be admitted if:
`
`(a) the expert’s scientific, technical, or other specialized knowledge will help the
`trier of fact to understand the evidence or to determine a fact in issue; (b) the
`testimony is based on sufficient facts or data; (c) the testimony is the product of
`reliable principles and methods; and (d) the expert has reliably applied the
`principles and methods to the facts of the case.
`
`FED. R. EVID. 702.
`
`Trial courts act as “gatekeepers” to “ensure the reliability and relevancy of expert
`
`testimony,” and to “make certain that an expert . . . employs in the courtroom the same level of
`
`intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co.
`
`v. Carmichael, 526 U.S. 137, 152 (1999) (citation omitted). Mr. Clissold’s opinions are
`
`inadmissible unless RJR shows that: (1) he is qualified “as an expert by knowledge, skill,
`
`experience, training, or education;” (2) the reasoning or methodology underlying his opinions are
`
`reliable; and (3) his opinions are relevant—that is, they help the jury understand the evidence or
`
`determine a factual issue. Daubert v. Merrell Dow Pharms., 509 U.S. 579, 588 (1993). “A reliable
`
`expert opinion must be based on scientific, technical, or other specialized knowledge and not on
`
`belief or speculation.” Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 200 (4th Cir. 2001)
`
`(citations omitted).
`
`B.
`
`Availability Of Redesigns For Assessing A Reasonable Royalty
`
`Patent damages experts often “attempt[] to ascertain the royalty upon which the parties
`
`would have agreed had they successfully negotiated an agreement just before infringement began.”
`
`Aqua Shield v. Inter Pool Cover Team, 774 F.3d 766, 770-72 (Fed. Cir. 2014) (citations omitted).
`
`While such “evidence … may be used in the inquiry to determine ‘the economic value of the
`
`
`
`4
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`

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`patented technology,’” it should be admitted only where the “evidence is reliable, relevant, and
`
`not unduly prejudicial.” Id.
`
`Where, as here,
`
`
`
` the accused infringer (i.e., RJR) has the burden to show availability. SPEX Techs. v.
`
`Apricorn, Inc., No. 16-cv-7349, 2020 WL 1289546, at *2 (C.D. Cal. Jan. 21, 2020); Smart Skins
`
`LLC v. Microsoft Corp., No. 15-cv-544, 2016 WL 4148091, at *2 (W.D. Wash. July 1, 2016).
`
`“Mere speculation or conclusory assertions will not suffice to overcome the inference that posited
`
`non-infringing alternatives that were not on the market nevertheless were available during the
`
`relevant period of alleged infringement.” Ethicon Endo-Surgery Inc. v. Covidien, Inc., No. 1:11-
`
`cv-871, 2019 WL 2164090, at *13-14 (S.D. Oh. May 17, 2019) (internal quotation marks and
`
`citation omitted); see Mars, Inc. v. Coin Acceptors, Inc., 527 F.3d 1359, 1372-73 (Fed. Cir. 2008)
`
`(affirming damages award in part because there was “no available and acceptable non-infringing
`
`alternative to which Coinco could have switched at the time of the hypothetical negotiation; there
`
`was merely the possibility that it could have come up with one”); Sound View Innovations, LLC v.
`
`Hulu, LLC, No. 17-cv-4146, 2019 WL 9047211, at *14 (C.D. Cal. Nov. 18, 2019) (excluding
`
`expert opinions in part because there was an insufficient basis for the assumption that unaccused
`
`products were available).
`
`These standards apply with greater force where, as here, the accused products must have
`
`FDA authorization. Under such circumstances, and as a matter of law, a redesigned product cannot
`
`be an “acceptable non-infring[ing] alternative if it does not have FDA approval.” DUSA Pharms.,
`
`Inc. v. Biofrontera Inc., 495 F. Supp. 3d 21, 30 (D. Mass. 2020); see, e.g., DePuy Spine, Inc. v.
`
`Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1332 (Fed. Cir. 2009) (affirming finding that
`
`
`
`5
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`

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`redesigned product was not “available” in part because it was not on the market and “had never
`
`been submitted to the Food & Drug Administration” for the necessary vetting).
`
`IV. ARGUMENT
`
`Mr. Clissold’s opinions about the regulatory availability of design-arounds for the ’265 and
`
`’911 Patents at the time of the hypothetical negotiations are unreliable and cannot survive scrutiny
`
`under Daubert and Federal Rule of Evidence 702. 509 U.S. at 588; FED. R. EVID. 702. Instead of
`
`being grounded in the facts of this case and the applicable law governing e-cigarettes, Mr.
`
`Clissold’s opinions hinge on speculation, are contradicted by his own report and deposition
`
`testimony, and ask the jury to circumvent mandatory FDA authorizations with which Congress
`
`sought to protect the American public. Ex. 8 (Aug. 2020 Zeller Art.) at -6448; Ex. 7 (Apr. 2020
`
`FDA ENDS Guidance) at -4121, -4122, -4142 n.81, -4146.; 81 Fed. Reg. at 28975. For these
`
`reasons, the Court should exclude Mr. Clissold’s design-around opinions.
`
`A. Mr. Clissold’s Regulatory Availability Opinions Are Unreliable, Lack Any
`Factual Basis, And Are Belied By His Own Report And Deposition
`Testimony
`
`
`
`
`
` Yet his design-around opinions ignore this
`
`undisputed legal reality and fail to recognize that the redesigned products were not FDA-
`
`authorized, did not fall within FDA’s enforcement dispensation for tobacco products on the U.S.
`
`market as of August 8, 2016, and, thus, could not have been sold (legally) as of the hypothetical
`
`negotiation dates – they were legally “unavailable” as a matter of law. See, e.g., DUSA Pharms.,
`
`495 F. Supp. 3d at 30; see also Ex. 6 (Oct. 2021 FDA Slides) at 19 (“All new tobacco products on
`
`
`
`6
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`

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`the market without the statutorily required premarket authorization are marketed unlawfully and
`
`are subject to enforcementaction at FDA’s discretion.”).
`
`Mr. Clissold admits that:
`
`These undisputed facts warrant exclusion of Mr. Clissold’s testimony because there is no
`
`basis, muchless a reliable one, supporting Mr. Clissold’s opinions that the design-arounds for the
`
`°265 and °911 Patents were available to RJR from a regulatory perspective at the time of the
`
`hypothetical negotiations.° See Sherwin-Williams Co. v. PPG Indus., Inc., No. 17-1023, 2020
`
`WL 1283465, at *8-10 (W.D. Pa. Mar. 18, 2020) (finding a product unavailable for a reasonable
`
`> Mr. Clissold’s admissions are consistent with Dr. Sullivan’s testimony and the opinions of
`
`
`PMI/Altria’s regulato
`Ehrlich. See Ex. 5
`(Sullivan Dep.)
`at 291:16-292:15
`302:16-
`Ex. 9 (Ehrlich
`
`
`
`-arounds were unavailable from an economic perspective.
`
`
`
`See Ex. 8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450; Ex. 7 (Apr. 2020 FDA ENDS Guidance
`at -4122, -4128, -4129: Ex. 2 (Clissold Dep.) 36:3-42:22. This would have cost RJR over
`
` Ex. 3
`
`(Sullivan Rbt.) Attach. B-1: Ex. 2
`Clissold Dep.) at 66:5-14, 68:14-19. Because
`
`the redesigns were unavailable as a practical matter, because no
`reasonable business person would have considered them an economically viable choice. Compare
`Ex. 3 (Sullivan Rbt.) Attach. B-1 with Ex. 4 (Meyer Op.) § 28.
`
`7
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`royalty analysis in part because it required “a complicated and time-consuming qualification
`
`process” at FDA before being sold). Mr. Clissold’s opinionsare classic ipse dixit that this Court
`
`can, and should, reject. See Kumho, 526 U.S. at 157 (“[N]othing in either Daubert or the Federal
`
`Rules of Evidence requires a district court to admit opinion evidencethat is connected to existing
`
`data only by the ipse dixit of the expert.”); TecSec, Inc. v. Adobe Sys., Inc., No. 10-cv-115, Dkt.
`
`1152 at 5 (E.D. Va. June 8. 2018) (excluding “ipse dixit testimony” lacking any “corroborating
`
`evidence”).
`
`B.
`
`Noneof Mr. Clissold’s Unreliable And Speculative “Options” Show A
`Regulatory Exception That Would Have Rendered The Redesigns Available
`
`In an attempt to sidestep the legal requirements under the TCA and Deeming Rule barring
`
`the subject redesigned products, Mr. Clissold opines that
`
`there are certain “options” that
`
`nevertheless would have allowed RJR to sell its redesigned products in the United States before
`
`they recetved PMT authorization. Ex. 1 (Clissold Rbt.) § 38. These “options” lack a legal or
`
`factual basis, are unreliable, and, by Mr. Clissold’s own admission, are highly speculative. See
`
`ae
`
`e
`ee
`Po This theoretical possibility does not pass muster under Daubert. 509 U.S.at
`
`588; see Cooper, 259 F.3d at 199; Acceleration Bay LLC v. Activision Blizzard Inc., No. 16-cv-
`
`453, 2019 WL 4194060, at *8 (D. Del. Sep. 4, 2019) (“A damages’ expert’s assumption is not
`
`sufficient to support a damages opinion based on a particular non-infringing alternative.”); FED.
`
`7 Mr. Clissold’s experience with including modified or redesigned products in e-cigarette PMTAs
`
`is, at best, sparse.
`
`

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`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 13 of 18 PageID# 25904
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`R. EVID. 702. Accordingly, the Court should exclude Mr. Clissold’s opinions regarding these
`
`purported “options.”
`
`1.
`
`Redesigns Are Not Available Via A Safety Modification “Option”
`
`One “option” on which Mr. Clissold relies involves product modifications to address
`
`particularized safety issues. Ex. 1 (Clissold Rbt.) ¶ 36.
`
`
`
`
`
`
`
`
`
`
`
`the design-arounds for the ’265 and ’911 Patents involve either of those very specific
`
` Mr. Clissold, however, does not opine that
`
`modifications. They plainly do not.
`
`Moreover, the referenced FDA guidance makes plain that the scope of these narrow
`
`allowances cannot be expanded. The FDA guidance document is entitled “Compliance Policy for
`
`Limited Modifications to Certain Marketed Tobacco Products.” Ex. 11 (Nov. 2019 FDA Limited
`
`Modifications) at 1. In that guidance, FDA warns that while it did “not intend to enforce violations
`
`of the premarket review requirements against such modified products solely on the basis of the
`
`modifications described in this guidance,” it reserves the right to “take enforcement action against
`
`these products for violating the premarket review requirements for other reasons.” Id. at 3 n.6, 5
`
`n.8. Consequently, Mr. Clissold’s lone example is inapt, and his attempt to extrapolate from this
`
`exceptional circumstance (expressly limited by FDA) to a general allowance of modifications to
`
`new tobacco products on sale as of August 8, 2016, is unreliable and speculative.
`
`2.
`
`Redesigns Are Not Available Via A PMTA Amendment “Option”
`
` second “option” on which Mr. Clissold relies involves amending an existing PMTA to
`9
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` A
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`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 14 of 18 PageID# 25905
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`add a modified design to the submission. Ex. 1 (Clissold Rbt.) ¶ 35. A general ability to amend,
`
`however, does not make the proposed design-arounds available. Mr. Clissold’s opinion assumes
`
`that one or more PMTAs for the Accused Products existed as of the hypothetical negotiation dates.
`
`None did, and there is no evidentiary basis to contend one would.8
`
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`
`
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`Even if RJR had amended one or more of its post-hypothetical negotiation PMTAs for the
`
`Accused Products in order to include the redesigns, FDA still would have had to grant PMT
`
`authorization for those modified products before they could be legally sold in the United States.
`
`See Ex. 8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450; Ex. 7 (Apr. 2020 FDA ENDS Guidance)
`
`at -4122, -4128, -4129.
`
`
`
` See Ex. 1 (Clissold Rbt.) ¶ 9. The PMTA process is complex,
`
`takes years to complete, and has a statistically low chance of success. See, e.g., Ex. 6 (FDA Slides)
`
`at 11. To date, the Accused Products still have not earned PMT authorization, save a few tobacco-
`
`flavored Solos in October 2021
`
`
`
`
`8 For example, as part of a 2019 lawsuit brought by the American Academy of Pediatrics and others
`to enforce compliance with the TCA, the district court judge found “a purposeful avoidance by the
`Industry of complying with the premarket requirements despite entreaties from the FDA that it can
`do so, and it establishes a shockingly low rate of filings.” Am. Acad. of Pediatrics v. FDA, 399 F.
`Supp. 3d 479, 485-86 (D. Md. 2019).This resistance by e-cigarette manufacturers to comply with
`the TCA was so great that the judge concluded that “the record offers little assurance that, in the
`absence of a deadline for filing, the Industry will do anything other than raise every roadblock it
`can and take every available dilatory measure to keep its products on the market without approval.”
`Id.
`
`
`
`10
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`

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`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 15 of 18 PageID# 25906
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`16; Ex. 8 (Aug. 2020 Zeller Art.) at -6450; Ex. 2 (Clissold Dep.) at 45:10-12.
`
`3.
`
`Redesigns Are Not Available Via A Supplemental PMTA “Option”
`
`A third “option” on which Mr. Clissold relies involves the submission of supplemental
`
`PMTAs for the redesigned products. Ex. 1 (Clissold Rbt.) ¶ 37. As Mr. Clissold readily admits,
`
`9 Id. at 14,
`
`however,
`
` Id.; Ex. 2 (Clissold Dep.) at 151:4-20.
`
`
`
`
`
`
`
` Compare Ex. 1 (Clissold Rbt.) ¶¶ 55 with
`
`id. Ex. 2 (Clissold Dep.) at 36:3-42:22. And, again, even if RJR could have submitted a
`
`supplemental PMTA for the redesigned products, those products could not have been sold until
`
`they earned PMT authorization—a milestone not yet achieved by nearly all Accused Products or,
`
`indeed, the overwhelming majority of e-cigarette products. See Ex. 6 (FDA Slides) at 14, 16; Ex.
`
`8 (Aug. 2020 Zeller Art.) at -6448, -6449, -6450; Ex. 7 (Apr. 2020 FDA ENDS Guidance) at
`
`-4122, -4128, -4129; Ex. 2 (Clissold Dep.) at 45:10-12.
`
`4.
`
`Redesigns Are Not Available Via Potential Lack of Detection
`
`A fourth “option” on which Mr. Clissold at least tacitly relies involves a
`
`
`
`
`
` Ex. 1 (Clissold Rbt.) ¶¶ 39-42 (internal citations omitted). To the extent Mr. Clissold is
`
`opining
`
` that ipse dixit opinion should be excluded. Mr.
`
`
`
`
`9 FDA already has rejected some of RJR’s PMTAs, issuing ten marketing denial orders that bar
`U.S. sales of flavored Vuse Solos. See, e.g., Ex. 6 (FDA Slides) at 11.
`11
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`
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`

`

`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 16 of 18 PageID# 25907
`
`Clissold cannot opine on FDA’s intent. See Shire Viropharma Inc. v. CSL Behring LLC, No. 17-
`
`cv-414, 2021 WL 1227097, at *5 (D. Del. Mar. 31, 2021) (“It is well settled that experts may not
`
`provide testimony concerning the ‘state of mind’ … of defendants, corporations, regulatory
`
`agencies, and others.”). And it would be pure speculation for him to suggest to the jury
`
`
`
`
`
` does not reflect opinions that are sound or based on
`
`accepted principles and methods in the field. FED. R. EVID. 702.
`
`V.
`
`CONCLUSION
`
`PMI/Altria respectfully request that the Court exclude Mr. Clissold’s opinions regarding
`
`the regulatory availability of design-arounds for the ’265 and ’911 Patents at the time of the
`
`hypothetical negotiations for those patents.
`
`
`
`Dated: January 21, 2022
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`12
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 17 of 18 PageID# 25908
`
`Gregory J. Sobolski (pro hac vice)
`greg.sobolski@lw.com
`LATHAM & WATKINS LLP
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111
`Telephone: (415) 391-0600
`Facsimile: (415) 395-8095
`
`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
`
`Counsel for Plaintiffs Altria Client Services LLC;
`Philip Morris USA Inc.; and Philip Morris
`Products S.A.
`
`
`
`13
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 918 Filed 01/21/22 Page 18 of 18 PageID# 25909
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on January 21, 2022, a true and correct copy of the foregoing was
`
`served using the Court’s CM/ECF system, with electronic notification of such filing to all counsel
`
`of record:
`
`
`
`
`
`/s/ Maximilian A. Grant
`
`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
`
`
`Counsel for Plaintiffs Altria Client Services
`LLC; Philip Morris USA Inc.; and Philip
`Morris Products S.A.
`
`14
`
`