`
`Case No. 1:20-cv-00393-LO-TCB
`
`ORAL ARGUMENT REQUESTED
`
`
`
`
`
`
`
`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 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 1 of 26 PageID# 29053
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`
`
`
`
`
`PMI/ALTRIA’S OPPOSITION TO RJR’S DAUBERT MOTION TO EXCLUDE
`CERTAIN EXPERT OPINIONS OF JOSEPH C. MCALEXANDER
`
`
`
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 2 of 26 PageID# 29054
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION ...............................................................................................................1
`
`FACTUAL BACKGROUND ..............................................................................................3
`
`III.
`
`ARGUMENT .......................................................................................................................6
`
`A.
`
`B.
`
`C.
`
`D.
`
`Mr. McAlexander’s Opinions On The Technical Benefits Of The ’545
`Patent And How They Relate To FDA Authorization Are Probative And
`Admissible ...............................................................................................................6
`The Court Should Not Preclude Mr. McAlexander From Offering
`Testimony On Objective Indicia Of Non-Obviousness .........................................10
`Mr. McAlexander’s Commercial Success Opinions Are Reliable And
`Based On Sound Methodology ..............................................................................15
`Mr. McAlexander Provides Detailed DOE Opinions ............................................17
`
`IV.
`
`CONCLUSION ..................................................................................................................19
`
`
`
`i
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 3 of 26 PageID# 29055
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Apple, Inc. v. Motorola, Inc.,
`757 F.3d 1286 (Fed. Cir. 2014) ............................................................................................... 7, 9
`
`CardioNet, LLC v. ScottCare Corp.,
`No. 12-cv-2516, 2017 WL 4742476 (E.D. Pa. Oct. 19, 2017) .................................................. 10
`
`Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd.,
`807 F.3d 1283 (Fed. Cir. 2015) ................................................................................................... 9
`
`Chrimar Sys., Inc. v. ADTRAN, Inc.,
`No. 15-cv-00618, 2016 WL 11746545 (E.D. Tex. Nov. 7, 2016)............................................. 16
`
`EMC Corp. v. Pure Storage, Inc.,
`154 F. Supp. 3d 81 (D. Del. Feb. 11, 2016) ................................................................................ 7
`
`Genband US LLC v. Metaswitch Networks Corp.,
`No. 14-cv-033, 2016 WL 125503 (E.D. Tex. Jan. 9, 2016) ...................................................... 11
`
`Greatbatch Ltd. v. VX Corp.,
`No. 13-cv-723, 2015 WL 9171042 (D. Del. Dec. 8, 2015) ......................................................... 1
`
`Highland Capital Management, L.P. v. Schneider,
`379 F. Supp. 2d 461 (S.D.N.Y. 2005) ....................................................................................... 11
`
`In re Namenda Direct Purchaser Antitrust Litig.,
`No. 15-cv-7488, 2019 WL 6242128 (S.D.N.Y. Aug. 2, 2019) ................................................. 13
`
`In re TMI Litig.,
`193 F.3d 613 (3d Cir. 1999) ........................................................................................................ 9
`
`InTouch Techs., Inc. v. VGO Commc'ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ................................................................................................. 15
`
`Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.,
`No. 18-cv-734, 2021 WL 5323737 (D.N.J. Nov. 16, 2021) ...................................................... 14
`
`Johns Hopkins Univ. v. Alcon Lab’ys Inc.,
`No. 15-525, 2018 WL 4178159 (D. Del. Aug. 30, 2018) ......................................................... 13
`
`Johns v. Bayer Corp.,
`No. 09-cv-1935, 2013 WL 1498965 (S.D. Cal. Apr. 10, 2013) ................................................ 11
`
`Johnson v. Air & Liquid Sys., Corp.,
`No. 4:18CV132, 2020 WL 11563846 (E.D. Va. Nov. 6, 2020) ............................................ 8, 17
`
`ii
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 4 of 26 PageID# 29056
`
`Limelight Networks, Inc. v. XO Commnc’s, LLC,
`No. 15-cv-720, 2018 WL 678245 (E.D. Va. Feb. 2, 2018) ................................................. 11, 12
`
`Lutron Elecs. Co. v. Crestron Elecs., Inc.,
`970 F. Supp. 2d 1229 (D. Utah 2013) ....................................................................................... 15
`
`Meridian Mfg. v. C&B Mfg.,
`340 F. Supp. 3d 808 (N.D. Iowa 2018) ................................................................................. 8, 15
`
`Mfg. Res. Int’l, Inc. v. Civiq Smartscapes, LLC,
`No. 17-cv-269, 2019 WL 4198194 (D. Del. Sept. 4, 2019) ...................................................... 10
`
`Miles Labs., Inc. v. Shandon Inc.,
`997 F.2d 870 (Fed. Cir. 1993) ................................................................................................... 17
`
`Mooring Capital Fund, LLC v. Knight, 388 F. App’x 814 (10th Cir. 2010) .................................. 9
`
`Numatics Inc. v. Balluf, Inc.,
`66 F. Supp. 3d 934 (E.D. Mich. 2014) ...................................................................................... 16
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`711 F.3d 1348 (Fed. Cir. 2013) ................................................................................................. 12
`
`Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc.,
`No. 2020-2070, 2022 WL 333668 (Fed. Cir. Feb. 4, 2022) ...................................................... 16
`
`Rambus Inc. v. Hynix Semiconductor Inc.,
`254 F.R.D. 597 (N.D. Cal. 2008) ........................................................................................ 15, 16
`
`S.E.C. v. Lipson,
`46 F. Supp. 2d 758 (N.D. Ill. 1998) ........................................................................................... 11
`
`Shire ViroPharma Inc. v. CSL Behring LLC,
`No. 17-cv-414, 2021 WL 1227097 (D. Del. Mar. 31, 2021) ................................................. 8, 14
`
`Talkington v. Atria Reclamelucifers Fabrieken BV (Cricket BV),
`152 F.3d 254 (4th Cir. 1998) ....................................................................................................... 7
`
`TecSec, Inc. v. Adobe Inc.,
`No. 10-cv-115, 2018 WL 11388472 (E.D. Va. Nov. 21, 2018) ................................................ 17
`
`TK-7 Corp. v. Estate of Barbouti,
`993 F.2d 722 (10th Cir. 1993) ..................................................................................................... 9
`
`Trading Techs. Int’l, Inc. v. IBG LLC,
`No. 10-cv-715, 2020 WL 12309207 (N.D. Ill. Oct. 21, 2020) .................................................. 12
`
`United Servs. Auto. Ass’n v. Wells Fargo Bank, N.A.,
`No. 18-cv-00366, 2019 WL 6896677 (E.D. Tex. Dec. 17, 2019) ............................................. 13
`
`
`
`iii
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 5 of 26 PageID# 29057
`
`United States v. Johnson,
`54 F.3d 1150 (4th Cir. 1995) ..................................................................................................... 11
`
`United States v. Lujan,
`No. 05-cv-0924, 2011 WL 13210238 (D.N.M. July 14, 2011) ................................................. 14
`
`Valley View Dev., Inc. v. United States ex rel. U.S. Army Corps of Eng’rs,
`721 F. Supp. 2d 1024 (N.D. Okla. 2010) ............................................................................ 14, 15
`
`Westfield Ins. Co. v. Harris,
`134 F.3d 608 (4th Cir. 1998) ....................................................................................................... 7
`
`Wonderland Nurserygoods Co. v. Thorley Indus. LLC,
`No. 13-cv-387, 2015 WL 5021416 (W.D. Pa. 2015) .......................................................... 15, 16
`
`RULES
`
`FED. R. EVID. 703 .......................................................................................................... 2, 10, 11, 12
`
`
`
`
`
`
`
`iv
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`

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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 6 of 26 PageID# 29058
`
`I.
`
`INTRODUCTION
`
`RJR does not dispute that PMI/Altria’s technical expert, Joseph McAlexander, is a
`
`qualified expert in electronics. RJR does not dispute that his opinions are relevant to issues in this
`
`case. RJR nevertheless seeks to exclude five of Mr. McAlexander’s technical opinions related to
`
`U.S. Patent Nos. 6,803,545 (“’545 patent”) and 10,420,374 (“’374 patent”). Specifically, RJR
`
`seeks to exclude Mr. McAlexander’s opinions related to (1) how the technical benefits of the ’545
`
`patent relate to characteristics the U.S. Food & Drug Administration (“FDA”) considers when
`
`reviewing a premarket tobacco application (“PMTA”) for e-cigarettes, (2) objective indicia of non-
`
`obviousness that rely on the testimony of prior art and named inventors, (3) skepticism by others
`
`in the industry that a lithium-ion battery could be used safely in an electrically heated smoking
`
`system, (4) commercial success of the claimed inventions, and (5) infringement under the doctrine
`
`of equivalents (“DOE”).1 Mr. McAlexander’s testimony on these technical issues readily satisfies
`
`Rules 702 and 703 and should be heard.
`
`First, RJR argues that Mr. McAlexander’s opinions that the benefits of practicing the ’545
`
`patent directly relate to the FDA’s criteria for premarket tobacco (“PMT”) authorization require
`
`him to be an FDA expert. Mot. at 10-14. But Mr. McAlexander, a technical expert, relies on
`
`PMI/Altria’s FDA expert, Stacy Ehrlich, to understand the factors FDA considers important for e-
`
`cigarette PMT authorization. Mr. McAlexander opines that the technical benefits of the ’545
`
`patent “directly relate[]” to the factors Ms. Ehrlich identifies. Ex. A (McAlexander Op.) ¶¶ 78-82,
`
`699, 788. His reliance on Ms. Ehrlich’s FDA expertise is proper and makes his opinions “more,
`
`not less, reliable.” Greatbatch Ltd. v. VX Corp., No. 13-cv-723, 2015 WL 9171042, at *5 (D. Del.
`
`Dec. 8, 2015).
`
`
`1 All emphasis added, and internal citations and quotations omitted, unless otherwise noted.
`
`1
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 7 of 26 PageID# 29059
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`Second, RJR argues that Mr. McAlexander’s opinions that rely on the deposition testimony
`
`of, or conversations with, the named inventors and a prior art inventor is improper because he is
`
`merely serving as their “mouthpiece.” Mot. at 14-18. That claim is false and unsupported. Mr.
`
`McAlexander relies on their testimony (and other evidence) to support his expert analysis of the
`
`objective indicia of non-obviousness, including that there was a long-felt unmet need. That is
`
`consistent with the express language of Rule 703, which permits an expert to base his or her
`
`opinions “on facts or data in the case that the expert has been made aware of or personally
`
`observed.” FED. R. EVID. 703.
`
`Third, RJR argues that Mr. McAlexander cannot opine about “intent, motive, or state of
`
`mind” in the context of non-obviousness. Mot. at 18-22. This is a strawman. Mr. McAlexander
`
`will not testify about a fact witness’s intent or state of mind. Instead, he properly relies on
`
`testimony from former PMI/Altria engineers who designed prior art e-cigarettes as well as
`
`PMI/Altria’s internal documents as evidence showing that the ’545 patent overcame the industry’s
`
`skepticism that a lithium-ion battery could be used safely in an e-cigarette system. Ex. B
`
`(McAlexander Rbt.) ¶¶ 470, 489-492. That “industry skepticism” is a proper subject of Mr.
`
`McAlexander’s testimony and a well-known element of the non-obviousness inquiry.
`
`Fourth, RJR argues that Mr. McAlexander’s opinions on the commercial success of third-
`
`party JUUL and the accused products require financial expertise. Mot. at 22-25. Putting aside
`
`that the commercial success of those products is readily observable to any layperson with eyes to
`
`see, Mr. McAlexander relies on PMI/Altria’s damages expert to inform him about the commercial
`
`success of these products. Ex. B (McAlexander Rbt.) ¶¶ 503-505, 997. Here, again, Mr.
`
`McAlexander only offers technical opinions on the nexus between those products and the
`
`commercial success identified by PMI/Altria’s damages expert.
`
`
`
`2
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 8 of 26 PageID# 29060
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`Finally, RJR argues that Mr. McAlexander’s (unrebutted) DOE opinions are “conclusory.”
`
`Mot. at 1. They are not. Mr. McAlexander explains in detail why any alleged difference between
`
`the accused products and the claimed invention is insubstantial, and he performs a “function, way,
`
`result” analysis to support his opinion. The simple fact is that RJR has no defense to Mr.
`
`McAlexander’s DOE opinions and RJR’s expert failed to address Mr. McAlexander’s DOE
`
`opinions in his rebuttal expert report. Worse, RJR’s lawyers elected to not examine Mr.
`
`McAlexander on his DOE opinions at his deposition. RJR’s decision not to mount any defense to
`
`PMI/Altria’s DOE case provides no basis to exclude his testimony.
`
`The Court should deny RJR’s motion to exclude Mr. McAlexander’s properly supported
`
`technical opinions.
`
`II.
`
`FACTUAL BACKGROUND
`
`Mr. McAlexander is an electrical engineer with expertise in circuit design and analysis; he
`
`has over 45 years of relevant experience. Ex. A (McAlexander Op.) ¶¶ 13-16. RJR does not (and
`
`cannot) dispute his qualifications. See Mot., passim.
`
`Technical Benefits Analysis: Mr. McAlexander opines on the benefits of the inventions
`
`claimed in the ’545 patent, which include improved battery safety and power management, and
`
`explains how those benefits “are among the characteristics [FDA] considers when reviewing” a
`
`PMTA for e-cigarettes. Ex. A (McAlexander Op.) ¶¶ 65-82. He considers whether the claimed
`
`technology and its benefits are “relevant to the factors discussed in the FDA guidance [he]
`
`reviewed and discussed with Stacy Ehrlich,” PMI/Altria’s FDA expert. Id. ¶ 699; see also ¶¶ 78-
`
`82. Ms. Ehrlich is a regulatory attorney with more than twenty-five years of experience working
`
`with FDA, who will be called to testify. Ex. C (Ehrlich Op.) ¶¶ 5-8, Ex. 1. RJR does not challenge
`
`Ms. Ehrlich’s FDA expertise.
`
`
`
`3
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`

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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 9 of 26 PageID# 29061
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`Opinions on Objective Indicia of Non-obviousness: Mr. McAlexander opines on
`
`objective indicia of non-obviousness for the ’374 and ’545 patents. Ex. B (McAlexander Rbt.) ¶¶
`
`470, 983. For example, he opines that the claimed inventions of the ’374 patent resolved a long-
`
`felt, but unmet need for a puff-activated electronic vaping device with a reliable puff sensor. Mr.
`
`McAlexander explains that prior art electronic vaping devices had known deficiencies with their
`
`puff sensors such as inadvertent triggering of the heater caused by vibration or external noise, and
`
`that the technology claimed in the ’374 patent resolved those deficiencies. See id. ¶¶ 984-990. He
`
`relies in part on the testimony of Andy Liu, the inventor of the ’374 patent, who testified that prior
`
`art puff sensors suffered from various problems, and how his invention solved those problems.
`
`Mr. McAlexander opines that there was skepticism prior to the ’545 patent. Ex. B
`
`(McAlexander Rbt.) ¶ 470. He relies on several PMI/Altria documents showing that PMI/Altria
`
`employees were skeptical that a lithium-ion battery could be used safely in an e-cigarette, even “in
`
`ten years time.” Ex. B (McAlexander Rbt.) ¶ 490; Ex. D (DEF_PUB_EDVA000055569). Mr.
`
`McAlexander cites testimony from two former PMI/Altria engineers, Bob Ripley and Grier
`
`Fleischhauer, who testified that using a lithium-ion battery in an e-cigarette system was a “
`
`” and that
`
`
`
`
`
` Ex. B (McAlexander Rbt.) ¶¶ 491-492; see also id. ¶¶ 95-110.
`
`Mr. McAlexander opines that the commercial success of the accused products and e-
`
`cigarettes sold by third-party JUUL show the ’545 patent is non-obvious.2 Ex. B (McAlexander
`
`Rbt.) ¶¶ 470, 502. In addition to his technical analysis, Mr. McAlexander relies on his
`
`understanding from PMI/Altria’s damages expert, Paul Meyer, that those products “have achieved
`
`
`2 Mr. McAlexander offers similar opinions regarding commercial success for the ’374 patent. Ex.
`B (McAlexander Rbt.) ¶¶ 983, 991-1010. His opinions as to the ’374 patent are proper for the
`same reasons as discussed herein for the ’545 patent.
`
`
`
`4
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 10 of 26 PageID# 29062
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`commercial success in the United States e-vapor market, as evidenced by significant unit sales,
`
`revenue, and market share.” Ex. B (McAlexander Rbt.) ¶¶ 503-506. Based on that input, Mr.
`
`McAlexander concludes there is a presumed nexus between the commercial success and the merits
`
`of the inventions claimed in the ’545 patent. Ex. B (McAlexander Rbt.) ¶ 506. Even if a nexus is
`
`not presumed, Mr. McAlexander finds that “a sufficient nexus exists because evidence shows that
`
`customers have purchased these products due to the novel features claimed in the ’545 Patent.”
`
`Id. ¶ 507. By showing that consumers of these products value the benefits of the ’545 patent to
`
`features—as shown by testimony of RJR’s corporate witness, marketing materials from both
`
`companies, and comments on the VUSE and JUUL websites, Mr. McAlexander concludes that
`
`such evidence shows that users purchase “these products at least in part because of the benefits
`
`provided by RJR’s [and JUUL’s] use of the ’545 patent.” Id. ¶¶ 507-528.
`
`Infringement Under DOE: Certain asserted claims of the ’374 patent recite a “controller”
`
`configured to (1) “measure a variation in an oscillation frequency” and (2) “selectively actuate a
`
`heater based on the variation in an oscillation frequency.” See, e.g., Dkt. 194-2 (’374 patent), cl.
`
`16.3 Mr. McAlexander opines that the accused products literally meet that limitation,
`
`
`
`
`
`
`
`
`
` See Ex. A (McAlexander Op.) ¶¶ 512-530, 532-536, 538-541. RJR does not
`
`dispute
`
`. Instead, RJR argues that
`
`
`3 To narrow the issues for trial, PMI/Altria will not pursue a DOE argument for the ’545 patent.
`That aspect of RJR’s motion is therefore moot.
`
`
`
`5
`
`

`

`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 11 of 26 PageID# 29063
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`its products do not literally infringe because
`
`(Blalock Rbt.) ¶¶ 143-158. Mr. McAlexander disagrees because
`
`
`
`Mr. McAlexander
`
`
`
` Ex. E
`
`
`
`
`
` To support that opinion,
`
`
`
`
`
`
`
`See Ex. A (McAlexander Op.) ¶¶ 525-542; see also id. ¶¶ 544-546 (claim 22), ¶¶ 548-550 (claim
`
`23), ¶¶ 552-554 (claim 25). He also performs a “function, way, result” analysis.
`
`
`
` he opines that the accused controller
`
`and claimed “controller” perform substantially the same function (i.e., measure a variation in an
`
`oscillation frequency and selectively actuate a heater based on the variation in an oscillation
`
`frequency), in substantially the same way (i.e., based on the variation in an oscillation frequency),
`
`to obtain the same result (i.e., selective actuation of the heater). Id.
`
`III. ARGUMENT
`A. Mr. McAlexander’s Opinions On The Technical Benefits Of The ’545 Patent
`And How They Relate To FDA Authorization Are Probative And Admissible
`
`RJR seeks to “exclude testimony from Mr. McAlexander on the federal regulation of
`
`tobacco products.” Mot. at 30. That is a strawman. Mr. McAlexander will not provide opinions
`
`on tobacco regulation; he will provide only technical opinions. He does (and will) rely on
`
`PMI/Altria’s FDA expert4 for his understanding of regulatory issues. See Ex. A (McAlexander
`
`
`4 Mr. McAlexander’s technical opinions compliment, and are not cumulative of, Ms. Ehrlich’s
`opinions. His opinions identify the features embodied in the asserted patents. Ex. A (McAlexander
`
`
`
`6
`
`

`

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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 12 of 26 PagelD# 29064
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`Op.) §§ 78, 699, 788. And it is well settled that “expert opinions may be based... on the opinions
`
`and observationsof others.” Talkington v. Atria Reclamelucifers Fabrieken BV (Cricket BV), 152
`
`F.3d 254, 265 n.8 (4th Cir. 1998) (citing Westfield Ins. Co. v. Harris, 134 F.3d 608, 612 (4th Cir.
`
`1998)); Apple, Inc. v. Motorola, Inc., 757 F.3d 1286, 1321 (Fed. Cir. 2014) (permitting reliance
`
`on another expert). “[R]eliance on the opinions of other experts is not a ground for exclusion.”
`
`EMCCorp.v. Pure Storage, Inc., 154 F. Supp. 3d 81, 115 (D. Del. Feb. 11, 2016).
`
`RJR’s motion is premised on its studied ignorance of this law and Mr. McAlexander’s
`
`statements in his expert report identifying the basis for his conclusions. Indeed, as shown below,
`
`RJR’s motion omits every reference in his report relying on Ms.Ehrlich’s regulatory input:
`
`Mot. at 12 (citing Dkt. 885-1 § 699).
`
`McAlexander’s Report>
`RJR’s Daubert Motion
`“{McAlexander] says he considered ‘whether|“I also considered whether the technology
`the technology claimed in the licensed
`claimed in the licensed patent(s) or asserted
`patent(s) or asserted patents are relevant to the|patents are relevant to the factors discussed in
`factors discussed in the FDA guidance Ihave|the FDA guidance I have reviewed and
`reviewed,’ and he opines that the technology|discussed with Stacy Ehrlich, who I
`in the patents had “significant regulatory
`understand based on my conversation is an
`importance,” whichis “valuable to a company|expert on FDA regulatory review ofe-vapor
`products, and the extent of such relevance, as
`I discuss elsewhere in this report.” Ex. A
`McAlexander Op.)
`§ 699.
`“Mr. McAlexanderalso states ‘[t]he benefits|“The benefits achieved by using the
`achieved by using the technology claimed in_|technology claimed in the ’545 Patent are
`the °545 Patent are among the characteristics|among the characteristics the Federal Drug
`the Federal Drug Administration (“FDA”)
`Administration (‘FDA’) considers when
`considers when reviewing a premarket
`reviewing a premarket tobacco application for
`tobacco application for electronic nicotine
`electronic nicotine delivery systems
`delivery systems (“PMTA’).’” Mot. at 12
`(‘PMTA’).” Ex. A (McAlexander Op.) § 699
`(citing Dkt. 885-1 § 78).
`(citing “conversation with S. Ehrlich on or
`around Feb. 18, 2021.”
`“{McAlexander] opines that the technology in|“Moreover, as I discuss elsewhere in this
`the patents had ‘significant regulatory
`report, the technology claimedin the ’545
`importance,’ whichis ‘valuable to a company|Patent has relevance and importance from a
`
`
`
`
`
`Op.) §] 65-82. Distinctly, Ms. Ehrlich identifies features that FDA considersin its review of any
`e-cigarette PMTA. Ex. C (Ehrlich Op.) §§ 85-97. Together, they show that certain features
`important to PMT authorization are covered by PMI/Altria’s patents.
`
`

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`
`
`erspective, whichis valuable to a
`
`around Feb. 18, 2021.”
`
`Mot.at 12 (citing Dkt. 885-1 4] 668, 788).
`
`” Ex. A (McAlexander Op.) § 788
`(citing “conversation with S. Ehrlich on or
`
`Mr. McAlexanderhas the “specialized knowledge”to reliably opine on “[t]he benefits
`
`achieved by using the technology claimed in the ’545 Patent,’ which include technological
`
`features FDA considers when reviewing a PMTA for e-cigarettes. Ex. A (McAlexander Op.) §
`
`78. He properly relies on Ms. Ehrlich and FDA documents he discussed with her to understand
`
`which features FDA considers relevant to PMT authorization. See, e.g., Shire ViroPharma Inc.v.
`
`CSL Behring LLC, No. 17-cv-414, 2021 WL 1227097, at *28-29 (D. Del. Mar. 31, 2021) (allowing
`
`expert to testify based on understanding of regulatory issues from FDA expert). For example, as
`
`a technical expert with expertise in “circuit design” and “electronics,” Mr. McAlexander explains
`” ¢¢,
`“power management
`
`how patent benefits like “pulse width modulation,”
`
`techniques,” and
`
`“preventing battery explosions”relate to product features that FDA considersin its assessment of
`
`e-cigarette PMTAs. Ex. A (McAlexander Op.) §§ 13-16, 78-82. To the extent RJR contends Mr.
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`McAlexander has misstated or misrepresented the product features Ms. Ehrlich identified as
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`relevant to PMTauthorization for e-cigarettes, it can cross-examine him on that. Johnsonv. Air
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`& Liquid Sys., Corp., No. 4:18CV132, 2020 WL 11563846, at *4 (E.D. Va. Nov. 6, 2020) (the
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`“resolution of [] facts and correctness of the experts’ opinions are matters for the jury”); Meridian
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`Mfg. v. C&B Mfg., 340 F. Supp. 3d 808, 845 (N.D. Iowa 2018) (holding that expert “can explain
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`her understanding of the particular feature [from another expert] that informed her analysis” and
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`the opposing party “is free to cross-examine heraboutit”).
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`RJR argues that Mr. McAlexander maynot rely on Ms. Ehrlich because he cannot confirm
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`her opinions are valid. Mot. at 13. RJR is wrong. That argument would bar any expert from
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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 14 of 26 PageID# 29066
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`relying on another expert with different expertise. That is not the law. The law allows experts
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`(and sometimes requires them) to rely on other experts. Carnegie Mellon Univ. v. Marvell Tech.
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`Grp., Ltd., 807 F.3d 1283, 1303 (Fed. Cir. 2015) (“For areas outside her expertise … the district
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`court properly concluded that [an expert] could, indeed must, rely upon [] other experts having
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`such industry-specific experience”); Apple, 757 F.3d at 1322 (“If Apple hired Napper to value the
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`asserted claims of the ’263 patent outside of litigation and there was technical issue Napper did
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`not understand, it would be reasonable for Napper to ask a technical expert hired by Apple.”).
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`Indeed, that is exactly what RJR’s own experts did in this case. See, e.g., Ex. G (Sullivan Dep.) at
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`65:18-66:3 (“
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`.”).
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`
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`RJR’s claim, that Mr. McAlexander “offer[s] unblinking reliance” on Ms. Ehrlich’s FDA
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`opinions, is incorrect. Mot. at 13. He independently reviewed FDA guidance documents,
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`discussed their import with Ms. Ehrlich, and opined on the technical aspects of those documents.
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`Ex. A (McAlexander Op.) ¶ 699 (“I also considered whether the technology claimed in the licensed
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`patent(s) or asserted patents are relevant to the factors discussed in the FDA guidance I have
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`reviewed and discussed with Stacy Ehrlich, who I understand based on my conversation is an
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`expert on FDA regulatory review of e-vapor products …”); see also id. ¶¶ 78-82, 788.
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`The case law RJR relies on is inapposite and involve instances where an expert relied on
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`another expert without any independent analysis. See In re TMI Litig., 193 F.3d 613, 715 (3d Cir.
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`1999) (excluding opinion where expert “[n]ever made any attempt to assess the validity” of other
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`expert’s opinions); TK-7 Corp. v. Estate of Barbouti, 993 F.2d 722, 732 (10th Cir. 1993) (same);
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`Mooring Capital Fund, LLC v. Knight, 388 F. App’x 814, 820-21 (10th Cir. 2010) (same). The
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`opposite is true of Mr. McAlexander—he independently reviewed and relied on FDA guidance
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`
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`9
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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 15 of 26 PageID# 29067
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`documents. See Ex. A (McAlexander Op.) ¶¶ 78-82, 699, 788 (relying on conversation with Ms.
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`Ehrlich and FDA guidance documents corroborating her opinions).
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`B.
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`The Court Should Not Preclude Mr. McAlexander From Offering Testimony
`On Objective Indicia Of Non-Obviousness
`1.
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`Mr. McAlexander properly relies on inventor testimony
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`RJR argues that all of Mr. McAlexander’s opinions that draw on the testimony of, or his
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`conversations with, the named inventors Messrs. Liu and Ripley and prior art inventor Mr.
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`Fleischhauer should be excluded because they purportedly serve no purpose other than to allow
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`him to be their “mouthpiece.” Mot. at 14-18. That is incorrect. To the extent RJR has genuine
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`“mouthpiece” concerns, they can be addressed with a hearsay objection or cross examination at
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`trial.
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`Rule 703 expressly permits an expert to base his or her opinions “on facts or data in the
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`case that the expert has been made aware of or personally observed.” FED. R. EVID. 703; see also
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`e.g., Mfg. Res. Int’l, Inc. v. Civiq Smartscapes, LLC, No. 17-cv-269, 2019 WL 4198194, at *7 (D.
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`Del. Sept. 4, 2019) (“[E]xperts are permitted to rely on facts provided by employees and other
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`experts.”); CardioNet, LLC v. ScottCare Corp., No. 12-cv-2516, 2017 WL 4742476, at *7 (E.D.
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`Pa. Oct. 19, 2017) (“[T]he Court finds that sworn testimony of the inventor of a patent is the type
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`of evidence technical experts rely upon in forming their opinions.”). Those principles apply here.
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`For the ’374 patent, Mr. McAlexander opines, for example, that the claimed invention
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`resolved a long-felt, but unmet need for a puff-activated electronic vaping device with a reliable
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`puff sensor. He explains that prior art electronic vaping devices had known deficiencies with their
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`puff sensors such as inadvertent triggering of the heater caused by vibration or external noise, and
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`that the technology described and claimed in the ’374 patent resolved those known deficiencies.
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`Ex. B (McAlexander Rbt.) ¶¶ 984-990. Mr. McAlexander relies in part on Mr. Liu, who testified
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`10
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`Case 1:20-cv-00393-LO-TCB Document 1022 Filed 02/11/22 Page 16 of 26 PageID# 29068
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`about the known problems with prior art puff sensors, and how his invention solved those
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`problems. Id. RJR does not (and cannot) dispute the reliability of Mr. Liu’s fact testimony. He
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`has a deep understanding of the e-cigarette industry, including during the relevant timeframe, and
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`his testimony is based on his personal knowledge.6 For the ’545 patent, RJR asserts in a single
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`conclusory sentence that “Mr. McAlexander quotes from and relies extensively on testimony and
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`conversations with Mr. Fleischhauer and Mr. Ripley.” Mot. at 17. But again, Mr. McAlexander
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`properly relies on such testimony and conversations to support his validity opinions. See Genband
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`US LLC v. Metaswitch Networks Corp., No. 14-cv-033, 2016 WL 125503, at *3 (E.D. Tex. Jan. 9,
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`2016) (finding expert’s reliance on discussions with employees proper).
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`By contrast, RJR’s cited cases all involve instances where an expert sought to provide a
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`factual narration of the record evidence divorced from any expert analysis. In Highland Capital
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`Management, L.P. v. Schneider, the court found that “[w]hile an expert must of course rely on
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`facts or data in formulating an expert opinion, see Fed. R. Evid. 703, an expert cannot be presented
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`to the jury solely for the purpose of constructing a factual narrative based upon record evidence.”
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`379 F. Supp. 2d 461, 468-469 (S.D.N.Y. 2005). Likewise, the court in Johns v. Bayer Corp.
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`explained the excluded expert’s report “offer[ed] nothing more than a factual narrative of these
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`documents.” No. 09-cv-1935, 2013 WL 1498965, at *28 (S.D. Cal. Apr. 10, 2013).7
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`6 RJR argues that “Mr. McAlexander seeks to recount the history of the invention claimed in the
`’374 Patent from a factual standpoint” and that “[t]his factual recitation is unaccompanied by any
`independent technical or scientific analysis.” Mot. at 3-4. RJR ignores that he relies on the same
`testimony and conversation with Mr. Liu to support his opinions regarding objective indicia of
`non-obviousness. Compare Ex. B (McAlexander Rbt.) ¶¶ 549-555 with id. ¶¶ 984-990, 993-995.
`7 See also United States v. Johnson, 54 F.3d 1150, 1157 (4th Cir. 1995) (“[Rule 703] does not
`afford the expert unlimited license to testify or present a chart in a manner that simply summarizes
`the testim