Case 1:20-cv-00393-LO-TCB Document 1002 Filed 02/11/22 Page 1 of 14 PageID# 27940
`
`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.
`
`
`
`
`
`
`PMI/ALTRIA’S OPPOSITION TO RJR’S MOTION IN LIMINE NO. 11
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`
`
`
`Case No. 1:20-cv-00393-LO-TCB
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`ORAL ARGUMENT REQUESTED
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`

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`Case 1:20-cv-00393-LO-TCB Document 1002 Filed 02/11/22 Page 2 of 14 PageID# 27941
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`TABLE OF CONTENTS
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`I.
`
`RJR’s MIL No. 11: REFERENCES TO IQOS SUPPORT pmi/altria’s
`DAMAGES CASE AND PRESENT NO PREJUDICE, CONFUSION, OR
`DELAY ................................................................................................................................1
`
`A.
`
`B.
`
`Evidence Of IQOS Is Relevant To Damages ...........................................................1
`
`RJR Has Not Shown That Rule 403 Bars References To IQOS ..............................5
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`II.
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`CONCLUSION ....................................................................................................................8
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`
`
`i
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`TABLE OF AUTHORITIES
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`CASES
`
`Abbott Labs. v. Sandoz, Inc.,
`743 F. Supp. 2d 762 (N.D. Ill. 2010) ........................................................................................... 6
`
`Advanced Technology Incubator, Inc. v. Sharp Corp.,
`No. 09-cv-135, 2010 WL 11451797 (E.D. Tex. Mar. 31, 2010) ................................................. 6
`
`BASF Plant Sci., LP v. Commonwealth Sci. & Indust. Rsch. Org.,
`No. 17-cv-503, 2019 U.S. Dist. LEXIS 228305 (E.D. Va. Dec. 23, 2019) ................................. 5
`
`De Reyes v. Waples Mobile Home Park Ltd. P’ship,
`No. 16-cv-563, 2017 WL 4509869 (E.D. Va. Apr. 17, 2017) ..................................................... 5
`
`Fujifilm Corp. v. Motorola Mobility LLC,
`No. 12-cv-3587, 2015 WL 12622055 (N.D. Cal. Mar. 19, 2015) ............................................... 6
`
`Georgia-Pacific Corp. v. U.S. Plywood Corp.,
`318 F. Supp. 1116 (S.D.N.Y. 1970) ............................................................................................ 1
`
`In re C.R. Bard, Inc.,
`810 F.3d 913 (4th Cir. 2016) ....................................................................................................... 8
`
`Intelligent Verification Sys., LLC v. Microsoft Corp.,
`No. 12-cv-525, 2015 WL 1518099 (E.D. Va. Mar. 31, 2015) ........................................ 2, 3, 5, 7
`
`King v. Herbert J. Thomas Mem’l Hosp.,
`159 F.3d 192 (4th Cir. 1998) ....................................................................................................... 7
`
`Lowe v. Wells Fargo Bank, N.A.,
`No. 18-cv-00126, 2018 WL 3748418 (E.D. Va. July 9, 2018) ................................................... 7
`
`Schwendimann v. Arkwright Advanced Coating, Inc.,
`No. 11-cv-820, 2018 WL 3621206 (D. Minn. July 30, 2018),
`aff’d, 959 F.3d 1065 (Fed. Cir. 2020) .......................................................................................... 2
`
`Touchcom, Inc. v. Berreskin & Parr,
`No. 7-cv-114, 2010 WL 4393282 (E.D. Va. Oct. 29, 2010) ....................................................... 5
`
`United States v. Leftenant,
`341 F.3d 338 (4th Cir. 2003) ....................................................................................................... 5
`
`United States v. Verges,
`No. 13-cv-222, 2014 WL 559573 (E.D. Va. Feb. 12, 2014) ....................................................... 3
`
`ii
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`STATUTES
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`19 U.S.C. § 1337 ............................................................................................................................. 8
`
`21 U.S.C. § 387a(b) ........................................................................................................................ 3
`
`OTHER AUTHORITIES
`
`81 Fed. Reg. 28974 (May 10, 2016) ............................................................................................... 3
`
`
`
`
`
`iii
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`I.
`
`RJR’S MIL NO. 11: REFERENCES TO IQOS SUPPORT PMI/ALTRIA’S
`DAMAGES CASE AND PRESENT NO PREJUDICE, CONFUSION, OR DELAY
`
`RJR contends that the Court should exclude anyreference to PMI/Altria’s IQOSheat not
`
`burn device becauseit is purportedly irrelevant. RJR is wrong. PMI/Altria and RJR are arch rivals
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`and hot competitors in the market for alternatives to traditional combustible cigarettes. RJR’s
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`accused VUSE e-cigarettes compete with PMI/Altria’s IQOS heat not burn products and
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`technology. Consequently, information on IQOSis directly relevant to the Georgia Pacific
`
`analysis and damages. RJR’s concerns about prejudice, confusion, or delay are conclusory,
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`overstated, and misplaced. RJR’s Motion in Limine (“MIL”) No.11 should be denied.
`
`A.
`
`Evidence Of IQOSIs Relevant To Damages
`
`PMI/Altria should be allowedto present evidence about IQOSattrial becauseit is relevant
`
`to damages for two separate reasons. First, evidence regarding IQOSis considered by both
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`parties’ damages experts when analyzing Georgia Pacific Factor No. 5. That factor looks at the
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`“{t]he commercial relationship between the licensor and licensee, such as whether they are
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`competitors in the same territory in the same line of business.” Georgia-Pacific Corp. v. U.S.
`
`Plywood Corp., 318 F. Supp. 1116, 1120 (S.D.N-Y. 1970). Here, the parties have competed
`
`throughout the entire damages period and, as Mr. Meyerexplains, that competitive relationship
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`| x. A (MeyerOp.) $9 346, 358-65.
`
`1 Each hypothetical negotiation relied on by Mr. Meyerfor his royalty assessment includes a
`licensor involved in the manufacturing, sale, and/or distribution of IQOSin the United States. Ex.
`
`34, 36, 47. For the ’545 Patent, the parties are RJR and PM USA,
`Id.§36. For the’ 265, 7911, and ’556 Patents,
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`the parties are RJR and PMP,
`Id.§47. For
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`the °374 Patent, the
`parties are RJR and ACS,
`eS |:
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`RJR undisputedly agrees that its VUSE products and PMI/Altria’s IQOS product are
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`Jxeetycompetitive,
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`P| RJR has publicly stated that it considers its VUSE e-cigarettes and IQOS to be
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`“directly competitive.” Ex. D (ITC Pub. Interest Statement) at 4. The directly competitive
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`relationship between the parties is highly relevant to Georgia Pacific Factor No. 5. See, e.g.,
`
`Schwendimannv. Arkwright Advanced Coating, Inc., No. 11-cv-820, 2018 WL 3621206, at *11
`
`(D. Minn. July 30, 2018), aff'd, 959 F.3d 1065 (Fed. Cir. 2020) (“A reasonable jury could have
`
`found that [patentee] would have demandeda higher royalty because [defendant] and [patentee]
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`directly compete for the same customers.’’).
`
`Indeed, RJR’s damages expert, Ryan Sullivan, opines thatPp
`Pe and acknowledgesthis would be considered
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`at the hypothetical negotiations:
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`
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`Ex. E (Sullivan Rbt.) § 325; see id. f§ 191, 202, 204. While Dr. Sullivan argues that certain factors
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`Pe (id. § 201), that disagreement provides no basis for
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`exclusion.”
`
`Intelligent Verification Sys., LLC v. Microsoft Corp., No. 12-cv-525, 2015 WL
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`* To the extent RJR arguesin reply that the ITC’s recent exclusion of IQOS from the United States
`mitigates the competitive relationship between RJR and PMI/Atria, that would be wrong because
`the hypothetical negotiation occurs before the date of first infrmgement. Regardless, the ITC
`determination is on appeal and notfinal. Indeed, one of the two patents that form the basis for the
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`2
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`1518099, at *9 (E.D. Va. Mar. 31, 2015) (“[A] motion in limine is not the appropriate vehicle for
`
`addressing the strength of the evidence or the substance of a complaint.”). RJR’s motion is silent
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`on Georgia Pacific Factor No. 5, which is fatal to its motion. Id. (stating that “a motion in limine
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`should be granted only when the evidence is clearly inadmissible on all potential grounds”).
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`Second, RJR’s overbroad request would exclude evidence showing the regulatory benefits
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`RJR obtains by using PMI/Altria’s patented technology, which is separately relevant to damages.
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`See, e.g., United States v. Verges, No. 13-cv-222, 2014 WL 559573, at *3 (E.D. Va. Feb. 12, 2014)
`
`(“Orders in limine which exclude broad categories of evidence should rarely be employed.”).
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`Documents from the U.S. Food and Drug Administration (“FDA”) summarizing its premarket
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`tobacco (“PMT”) authorization findings for IQOS describe the importance of specific product
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`features to PMT authorization, including features embodied in PMI/Altria’s patented technology.3
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`Relying on this IQOS-related evidence, PMI/Altria’s FDA expert, Stacy Ehrlich, opines
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`4
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`For example, FDA’s Technical Project Lead Review (“TPL”) for the IQOS 2.4 shows that
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`FDA carefully considers product features that relate directly to the ’545 Patent, such as increased
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`ITC’s determination was invalidated by the PTAB and the sole remaining patent is under PTAB
`review.
`3 The “Deeming Rule,” effective on August 8, 2016, gave FDA regulatory authority over e-
`cigarettes under the Family Smoking Prevention and Tobacco Control Act (“TCA”), and requires
`each e-cigarette to earn PMT authorization before it can be legally sold in the United States. 81
`Fed. Reg. at 28975-76 (May 10, 2016); 21 U.S.C. § 387a(b). FDA’s regulatory authority over e-
`cigarettes is described in PMI/Altria’s opposition to RJR’s motion to exclude the opinions of Stacy
`Erhlich. Dkt. 915 at 1-3.
`4 Documents identifying product features that FDA focuses on in granting PMT authorization are
`rare. In the history of the TCA, only five product sets, including IQOS, have earned PMT
`authorization, and only two of those are aerosolized noncombustible devices. Ex. F (FDA PMT
`Webpage). Consequently, documents from FDA summarizing its IQOS PMT findings on this
`subcategory of products offer highly probative insight into the authorization process.
`3
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`battery performance, improvedbattery safety, and puff consistency for uniform nicotine delivery.
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`See, e.g., Ex. G (QOS 2.4 TPL) at -0311, -0329, -0349; Ex. A (Meyer Op.) §§ 70-72.° a
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`Ex. A (Meyer Op.) § 393; Ex. I (McAlexander Op.) { 668, 671; see Ex. J (Ehrlich Op.) 495. Jj
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`Pe Ex. K (RJR’s 24th Supp. Resp.to Interrog. No.4) at 13.
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`For good reason; there is none. Based on this evidence and FDA’s IQOS-related documents
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`reinforcing the importance of these types of product features to PMT authorization, Ms. Ehrlich
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`opines that,
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`(Ehrlich Op.) 4§ 3, 95; Ex. A (Meyer Op.) 4§ 486, 512.
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`RJR presents three arguments that evidence of IQOSis irrelevant. Mot. at 4-5. Noneis
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`sound. First, RJR’s argument that PMI/Altria “cannot prove its infringement case by comparing
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`& Ex.J
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`the practices of its own FDA expert, David Clissold, whorelies on
`> RJR’s MIL is refuted by
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`.2.. Ex. H (Clissold Rbt.
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`And RJR’s argument that PMI/Altria’s opposition to this
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`MIL is inconsistent with its other MIL positions is plain wrong. PMI/Altria did not move to
`exclude evidence on IQOS PMT and MRTPauthorizations, as RJR wrongly asserts. See MIL at
`7 n.3. Instead, to avoid a mini-trial on the science supporting FDA’s findings, PMI/Altria sought
`to exclude RJR from offering evidence “challenging FDA’s IQOSauthorizations” because “RJR
`should not be allowed to second guess FDA’s regulatory conclusions.” Dkt. 901 at 20-22.
`° RJR has movedto exclude the testimony of Ms. Ehrlich in part because she purportedly lacks
`personal knowledge about FDA’s methodology. Dkt. 877 at 8. Yet, in this MIL, RJR seeks to
`preclude Ms. Ehrlich from relying on FDA documents that straightforwardly describe FDA’s
`methodology. The positions in RJR’s scattershot approach cannot be squared with each other.
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`4
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`VUSE to IQOS” is a strawman because PMI/Altria will not do so,7 and because this evidence is
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`relevant to damages, not liability.8 Id.
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`Second, RJR’s argument that IQOS is irrelevant because
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` ignores the law, which expressly states that: (i) a product need only be “competitive,”
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`
`
`
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`, to be relevant to Georgia Pacific Factor No. 5; and (ii) FDA’s
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`IQOS-related documents demonstrate the importance of battery performance, battery safety, and
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`puff consistency to PMT authorization. This second point supports the opinions of PMI/Altria’s
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`experts that RJR’s use of PMI/Atria’s patented technology is valuable to obtaining PMT
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`authorization for the Accused Products. BASF Plant Sci., LP v. Commonwealth Sci. & Indust.
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`Rsch. Org., No. 17-cv-503, 2019 U.S. Dist. LEXIS 228305 (E.D. Va. Dec. 23, 2019).
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`Third, RJR’s argument that IQOS is irrelevant to damages ignores Georgia Pacific Factor
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`No. 5, and invites legal error. At most it reflects RJR’s disagreement with the admissible opinions
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`of PMI/Altria’s FDA and damages experts.9 In sum, evidence relating to IQOS is highly relevant
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`to damages and meets the “low barrier to admissibility.” United States v. Leftenant, 341 F.3d 338,
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`346 (4th Cir. 2003).
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`B.
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`RJR Has Not Shown That Rule 403 Bars References To IQOS
`
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`7 And PMI/Altria has never done so—not in expert reports, discovery responses, depositions, or
`otherwise.
`8 RJR’s argument confirms that the Court should grant PMI/Altria’s MIL No. 4 and preclude RJR
`from presenting a legally-improper practicing the prior art defense. Dkt. 901 at 5-7.
`9 RJR’s disagreements with the opinions of Ms. Ehrlich and Mr. Meyer are incorrect for the reasons
`stated in PMI/Altria’s oppositions to RJR’s Daubert motions. In any event, a motion in limine is
`not the appropriate vehicle to address the strength of expert opinions. See Intelligent Verification
`Sys., 2015 WL 1518099, at *9; De Reyes v. Waples Mobile Home Park Ltd. P’ship, No. 16-cv-
`563, 2017 WL 4509869, at *2 (E.D. Va. Apr. 17, 2017); Touchcom, Inc. v. Berreskin & Parr, No.
`7-cv-114, 2010 WL 4393282, at *8 (E.D. Va. Oct. 29, 2010).
`5
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`

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`Unable to demonstrate that IQOS, which RJR admits “competes with e-cigarettes within
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`the U.S. non-combustible market,” is not probative of damages, RJR resorts to conclusory claims
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`of unfair prejudice. None meets RJR’s stringent burden to show that the high probative damages
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`evidence about IQOS is substantially outweighed by potential unfair prejudice, confusion, or
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`delay.
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`First, RJR’s prejudice claim rests on the false assumption that PMI/Altria’s “primary aim”
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`is to refer to IQOS “exclusively to paint PM/Altria in a good light” and “cast unfair aspersions on
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`Reynolds and its VUSE products.” Mot. at 6. RJR provides no facts to support that assertion, and
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`the cases it relies on are inapt. Advanced Technology Incubator, Inc. v. Sharp Corp. excluded
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`evidence that non-party “Japanese companies … generally engaged in illegal or inappropriate
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`business conduct” but allowed evidence relevant to “allegations particularized to the patents-in-
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`suit.” No. 09-cv-135, 2010 WL 11451797, at *10 (E.D. Tex. Mar. 31, 2010). Here, PMI/Altria
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`and RJR are relying on their own, directly competitive, products to demonstrate an appropriate
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`royalty rate. Abbott Laboratories v. Sandoz, Inc. precluded a defendant from characterizing the
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`patentee’s enforcement of its patent rights using terms such as a “milking strategy.” 743 F. Supp.
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`2d 762, 773 (N.D. Ill. 2010). The Court is able to police the use of inflammatory characterizations
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`if they occur, and unsupported speculation that they may occur is no basis to exclude otherwise
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`admissible evidence. Regardless, “[w]hatever prejudice [RJR] may suffer as a result of this
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`evidence, it is not sufficiently unfair to substantially outweigh the probative value (for the purpose
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`of assessing damages) of competition between the parties. Fujifilm Corp. v. Motorola Mobility
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`LLC, No. 12-cv-3587, 2015 WL 12622055, at *5 (N.D. Cal. Mar. 19, 2015).
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`Second, RJR argues that evidence of IQOS may “confuse” the jury. Mot. at 6. Good
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`lawyers avoid jury confusion. Here, evidence about IQOS will help the jury understand the
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`6
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`competitive commercial relationship between the parties. It also will help the jury understand the
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`key features FDA considers when analyzing a PMTA in
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` That
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`applies to both IQOS and the Accused Products. Ex. E (Sullivan Rbt.) ¶ 31. The fact that
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`
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` presents no risk of confusion, and the Court’s jury
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`instructions will state that a product can compete with an accused product
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`, thereby impacting the royalty rate a party may accept. To the extent RJR contends
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`IQOS’s distinct technology rebuts the competitive relationship
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`, that
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`is for cross-examination.10 Intelligent Verification Sys., 2015 WL 1518099, at *9.
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`Finally, RJR argues that permitting reference to IQOS would waste time and impose a
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`“mini trial” or require discussion of the ITC litigation. Mot. at 6-7. RJR is wrong. As part of their
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`damages cases, both parties already intend to call FDA experts who have thoroughly analyzed the
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`PMTA process and the product features that play an important role in PMT authorization – an
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`analysis which has included IQOS-related FDA documents. Supra at n.5. Thus, no additional
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`time is needed simply to discuss limited FDA references to IQOS. And a discussion of a non-final
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`10 Because the ITC’s determination is based at least in part on RJR’s representation that IQOS and
`its VUSE e-cigarettes are “directly competitive,” the equitable doctrine of judicial estoppel bars
`RJR “from adopting a position that is inconsistent with” RJR’s position in the ITC. The doctrine
`applies where: “(1) [t]he party to be estopped must be asserting a position that is factually
`incompatible with a position taken in a prior judicial or administrative proceeding; (2) the prior
`inconsistent position must have been accepted by the tribunal; and (3) the party to be estopped
`must have taken inconsistent positions intentionally for the purpose of gaining unfair advantage.”
`King v. Herbert J. Thomas Mem’l Hosp., 159 F.3d 192, 196 (4th Cir. 1998) (citations omitted).
`Here, these factors are readily met. Any argument from RJR that its VUSE e-cigarettes do not
`compete with IQOS would be “factually incompatible” with RJR’s positions in the ITC, which the
`Commission accepted. And there can be no credible dispute that RJR intentionally took those
`positions to advance its claims at the ITC. Having used that position to its advantage as a
`complainant in the ITC, RJR—now the defendant—should not be allowed to “play[] fast and loose
`with” this Court and undermine the “integrity of the judicial process” to gain an “unfair
`advantage.” Id.; see Lowe v. Wells Fargo Bank, N.A., No. 18-cv-00126, 2018 WL 3748418, at *7
`(E.D. Va. July 9, 2018) (applying judicial estoppel doctrine).
`7
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`

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`ITC determination (with one of two patents now invalidated), brought under a different statute,
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`with no jury to assist and no damages to assess, is unnecessary, unhelpful, and would generate the
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`very jury confusion RJR claims it seeks to avoid.11 See id.; 19 U.S.C. § 1337.
`
`II.
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`CONCLUSION
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`PMI/Altria respectfully requests that the Court deny RJR’s MIL No. 11.
`
`
`11 RJR’s sole legal citation, In re C.R. Bard, Inc. does not suggest otherwise. There, the court
`excluded information about FDA’s “substantial equivalence” process because it had “little or no
`evidentiary value” in a product liability action because the subject device could obtain substantial
`equivalence “without running the gauntlet of the [MDA premarket approval] process.” 810 F.3d
`913, 913, 917-18, 920-21 (4th Cir. 2016). In contrast, PMT authorization involves a full scientific
`review. Regardless, the IQOS-related FDA information is offered to show the regulatory
`importance of certain technical features (e.g., battery safety and performance, puff consistency).
`See Ex. F (FDA PMT Webpage); Ex. H (Clissold Rbt.) ¶ 43; Ex. J (Ehrlich Op.) ¶¶ 3, 4; Ex. A
`(Meyer Op.) ¶ 512.
`
`
`
`8
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`

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`Case 1:20-cv-00393-LO-TCB Document 1002 Filed 02/11/22 Page 13 of 14 PageID# 27952
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`Dated: February 11, 2022
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`
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`
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`Respectfully submitted,
`
`
`
`
`
`
`
`/s/ Maximilian A. Grant
`
`Maximilian A. Grant (VSB No. 91792)
`max.grant@lw.com
`Lawrence J. Gotts (VSB No. 25337)
`lawrence.gotts@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., Ste. 1000
`Washington, DC 20004
`Tel: (202) 637-2200; Fax: (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 K. Sobolski (pro hac vice)
`Greg.sobolski@lw.com
`LATHAM & WATKINS LLP
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111
`Tel: (415) 391-0600; Fax: (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 Altria Client Services LLC;
`Philip Morris USA Inc.; and Philip Morris
`Products S.A.
`
`
`
`9
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`Case 1:20-cv-00393-LO-TCB Document 1002 Filed 02/11/22 Page 14 of 14 PageID# 27953
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on this 11th day of February, 2022, a true and correct copy of the
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`foregoing was served using the Court’s CM/ECF system, with electronic notification of such
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`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 Altria Client Services LLC;
`Philip Morris USA Inc.; and Philip Morris
`Products S.A.
`
`10
`
`