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`serious argumentthat this specific evidence is not probative of the utility and value of the patent
`
`in a hypothetical negotiation.
`
`RAIalso wants to preclude evidence of the “epidemic” of youth vaping and the argument
`
`that RAI targets their products to minors, Dkt. 829 at 15. PMA arguesthat evidence of the youth
`
`use of e-cigarettes is relevant because the technology “mitigates youth use of e-cigarettes.” Dkt.
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`1006 at 13. PMA cites a series of FDA documents, press releases, and newspaperarticles that
`
`PMAargues tie RAI to the use of e-cigarettes by young people. Dkt. 1006 at 12-13. However,
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`the FDA enforcement documents do not specifically identify any of the accused products. Dkt.
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`1007-1 at 7. Most of the FDA documents connect only the use of flavored nicotine products to
`
`youth smoking and they do not discuss any of the relevant technology. See e.g. Dkt. 1007-4 at
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`21. PMA has not pointed to any scientific data or put forth any proper expert testimony that
`
`connects the patented technology or the accused products to the epidemic of youth smoking. The
`
`use of electronic cigarettes may be of a concern to the FDA, but the causal connection of the
`
`patented technology to the prevalence of youth smoking is only established by speculation
`
`regarding unrelated statements by the regulatory agency. It would be unfairly prejudicial to allow
`evidence that implies conjectural untethered connections of a single product to a complex social
`
`problem such as the youth vaping epidemic. Testimony that RAI somehowtargets their products
`
`to young people or that RAI’s products are tied to the prevalence of electronic cigarette use by
`
`young people cannot be introduced as PMA hasnot presented a proper foundation for this
`
`evidenceor established its relevance to any material issue in this case.
`
`The Motion is GRANTEDIN PART and DENIED IN PART.Thetestimony regarding
`
`how the patented technology prevents usage by children or young adults is admissible.
`
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`Testimony regarding a “youth smoking epidemic” or the targeting of electronic cigarettes to
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`young peopleis unfairly prejudicial and therefore inadmissible.
`
`20. RAD’s Motion in limine #3.
`
`RAI argues that the Court should exclude any reference to health risks associated with
`
`electronic cigarette usage. Dkt. 829 at 17. RAI argues that this evidence has no relevance. Jd.
`
`PMAbelieves that there is evidence that the technology in specific patents prevents specific
`
`health risks and that this evidence will be relative to “validity and damages”. Dkt. 1006 at 15.
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`Certain evidence of health risks is admissible at
`
`trial, such as FDA or internal corporate
`
`documents. See /d. (referencing expert testimony, RAI internal documents discussing leakage,
`
`and FDA documents considering health considerations). If PMA introduces evidence that is
`
`irrelevant to the patented technology, a contemporaneous objection can address the issue. For
`
`this reason, the Motion in limine is DENIED.
`
`21. RAI’s Motion in limine #4.
`
`RAI has moved the Court to exclude “all evidence and argument regarding any request
`
`for, or alleged entitlement to, any injunction.” Dkt. 832 at 5, PMA characterizes this Motion as
`
`overbroad and argues that granting the Motion would improperly exclude relevant evidence.
`
`Both Parties cite to Amdocs Isr. Ltd. v. Openet Telecom, Inc. in their memoranda, and the Court
`
`finds the holding in that decision is instructive for this current Motion. 2012 U.S. Dist. LEXIS
`
`191825 at *2 (E.D. Va. March 30, 2012). In Amdocs, the district court held that:
`
`defendant may not raise any argument or introduce any evidence concerning the impact
`of injunctive relief on its business. This ruling in no respect limits defendant’s ability to
`cross-examine the defendant’s damages expert. If reference to injunctive relief is relevant
`to that cross-examination,it will be permitted.
`
`Id. The Amdocs court decided that motion on the basis that the jury would not consider whether
`
`injunctive relief would or would not be appropriate in that case as the matter of granting the
`
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`injunction was solely left to the discretion of the district court. /d. Similarly in the current case,
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`evidence solely related to a request for an injunction will not be admissible. Other evidence that
`
`is relevant may still be admissible. Therefore, the Court RESERVES RULINGon this Motion
`
`in limine.
`
`22. RAI’s Motion in limine #5.
`
`RAI has motioned the Court to exclude any evidence related to any request for enhanced
`
`damagesor attorney’s fees and costs. Dkt. 832 at 10-11. In their opposition memorandum, PMA
`
`has represented that they do not intend to make any reference to the jury about claims for
`
`attorney’s fees or enhanced damages. Dkt. 971 at 9. If any impermissible evidenceis introduced,
`
`it can be addressed by a contemporaneous objection or jury instruction. Therefore, this Motion in
`
`limine is DENIED as moot.
`
`23. RAI’s Motion in limine #6.
`
`RAI has moved to exclude “argument, evidence, or testimony regarding Reynolds not
`
`relying on an opinion of counsel or suggesting that Reynolds should have obtained one.” Dkt.
`
`839 at 2. PMA argues that RAI will open the door to this testimony by allowing a non-expert
`
`witness to give an opinion that RAI did not infringe the asserted patents. Dkt. 976 at 5. At the
`
`same time, PMArepresents that if RAI does not open the door, PMA will not argue its claims for
`
`willfulness based on a lack of advice of counsel.
`
`By statute, litigants cannot use the failure to obtain advice of counsel to prove willful
`
`infringement or the intention to induce infringement. 35 USC §298 (2021). Both Parties agree
`
`that if a defendant attempts to imply that the defendant relied on the advice of counsel, the door
`
`will open to allow testimony that would otherwise be excluded by the statute. See Ultratec, Inc.
`
`v, Sorenson Communs., Inc., 2014 U.S. Dist. LEXIS 141428 at *7 (W.D. Wis. Oct 3, 2014);
`
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`LifeNet Health v. LifeCell Corp., 2014 U.S. Dist. LEXIS 154481 at *13 (E.D. Va. 2014) (The
`
`district court reserved ruling on a Motion in limine until testimony that may possibly refer to
`
`advice of counsel was given). PMAseeksto broadenthis rule'! by arguing that if a lay witness
`
`testifies that the witness did not believe there was patent infringement, then that testimony would
`
`subsequently open the door to allow testimony that a defendant did not seek the advice of
`
`counsel. Dkt. 976at 6.
`
`The RAI witness in question, Dr. Figlar, only gave his opinion in response to PMA’s
`
`leading questions during a deposition. See Dkt. 901-12 at 4 (Dr. Figlar responded to questions
`
`regarding the ‘545 patent by saying, “In my opinion, one, I don’t think it’s appropriate for
`
`someoneto seek a patent on lithium-ion batteries...”) RAI objected to this line of questioning in
`
`the deposition. /d. In his deposition, Dr. Figlar at no time refers to either obtaining or not
`
`obtaining the advice of counsel
`
`to establish an opinion about
`
`infringement. PMA cannot
`
`circumventstatutory law byeliciting testimony through leading questions during a deposition. At
`
`trial, PMA cannot open the door to otherwise unpermitted testimony by asking leading questions
`
`on cross-examination.If at trial, RAI’s witness explicitly refers to obtaining or not obtaining the
`
`advice of counsel,
`
`the Court will
`
`then consider whether the door has been opened to the
`
`otherwise prohibited testimony and argument. See Avanos Med. Sales, LLC v. Medtronic
`
`Sofamor Danek USA, Inc., 2021 U.S. Dist. LEXIS 237262 at *16 (W.D. Tenn September 30,
`
`2021) (Iftrial testimony implies a defendant relied on advice of counsel, the protection of 35
`
`USC § 298 will “dissolve”). This testimony may be allowed if good cause is shown at the time
`
`that the testimony has become admissible (in the event the door is opened). However, at this
`
`"| It appears this rule has been adopted or addressed by several district courts but has not
`been addressed by the Federal Circuit.
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`time, the door has not been openedbythe pretrial maneuvering of PMA. The Motion in limineis
`
`DENIED.
`
`24. RAI’s Motion in limine #7.
`
`RAI has moved to exclude testimony by PMA’s witnesses that would characterize RAI’s
`
`position regarding the products made by third-party companies JUUL and NuMark. Dkt. 846 at
`
`4, RAI indicates PMA’s expert reports characterize RAI as having made an admission that the
`
`third-party products practice the ‘545 patent. Jd. RAI explains that this misconception occurred
`
`when they represented to PMA that those products practice the ‘545 patents according to how
`
`PMA construes andasserts the claims. /d. at 5. RAI asserts that its position is only that PMA has
`
`misapplied the claims to these third-party devices and therefore PMA wrongly believes that the
`
`third-party devices practice the ‘545 patent. /d. at 5. RAI now believes PMA’s experts wrongly
`
`represent RAI’s position by omitting context from the quotations used in PMA’s expert reports.
`
`Id. at 8. PMA arguesthat it is only quoting RAI’s admission, that RAI is attempting to withdraw
`
`its admission, and that PMA will be prejudiced because it withdrew its claim for presuit damages
`
`based on RAI’s admission. Dkt. 987 at 5. PMAalso asserts that whetherthe third parties practice
`
`the ‘545 patent is relevant to their damages analysis because that evidence is probative of
`
`Georgia-Pacific Factor 10, “the benefits of those who use or have used the invention.”/d. at 6.
`
`Infringement
`
`is not determined by comparing an accused product
`
`to either a
`
`commercialized embodimentor to a preferred embodiment of the patented technology. SRI Jnt’]
`
`v. Matsushita Elec. Corp., 775 F.2d 1107, 1121 (Fed. Cir. 1985); see also Zenith Labs, Inc., v.
`
`Bristol Myers Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994) (“As we have repeatedly said, it
`
`is error for a court to compare in its infringement analysis the accused product or process with
`
`the patentee’s commercial embodimentor other version of the product or process;...”) Although
`
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`PMAhas repeatedly argued that it
`
`is only quoting RAI’s experts and correspondence,it is
`
`evident that those quotations are taken out of context. Allowing PMAto assert that RAI has
`
`admitted that these third-party devices infringe the asserted patent would be confusingto the jury
`
`and would invite improper comparisonsto irrelevant devices for the analysis of infringement. In
`
`addition, PMA’s own interrogatory answers clearly demonstrate that PMA doesnotbelieve that
`
`the third-party devices practice the patented technology. See e.g. Dkt.
`
`1063-2 at 9
`
`(“Counterclaim Plaintiffs are not presently aware of any public use, sale, offer for sale, or public
`
`disclosure in the United States of any product or process within the scope of a claim of the ‘545
`
`or ‘374 patent, other than the [RAI] Accused Products...”) PMA cannot assert the third-party
`
`products are relative to damages based only on the arguably mischaracterized statements made
`
`by RAI. To apply the patent claims to devices other than the accused devices is not a proper
`
`methodto establish infringementandis not evidencethat is probative of damages.
`
`To allow this evidence in the record would lead to confusion for the jury and would be
`
`misleading. Therefore, this evidence is inadmissible under Federal Rule of Evidence 403. The
`
`Motion in limine is GRANTED.
`
`25. RAI’s Motion in limine #8.
`
`RAI has moved to preclude PMA from “offering evidence or argument at
`
`trial
`
`referencing the location in China of the manufacturers and suppliers of Reynolds’ VUSE
`
`products or components, and any negative references to Chinese or overseas manufacturing or
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`supply-chain roles.” Dkt. 849 at 5. PMA has represented that at trial “it will not make any
`
`negative references to Chinese or overseas manufacturing or supply-chain roles.” Dkt. 981 at 4.
`
`At issue in this case are components imported from several Chinese companies, Chinese
`
`inventors, and Chinese utility patents. A blanket preclusion on referencing the entire country of
`
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`China would be overbroad and potentially unnecessarily confusing by leading to the omission of
`
`a significant amount of contextual detail. On the other hand, the cases that RAI cites in its
`
`memorandum clearly reflect that there is a line that should not be crossed where references to
`
`foreign manufacturers could become unduly prejudicial. See Dkt. 849 at 8. The Court has
`
`confidencethat the litigators in this case are aware ofthat line and will proceed accordingly. Any
`
`argumentthat invokes an improperracial or nationalistic animus will not be tolerated. However,
`
`Chinese companies and Chinese persons may berelevant to the establishmentof priority dates,
`
`the inventorship of asserted patents and the theories of infringement that will be presented and
`
`argued by both Parties in this case. A blanket preclusion of any reference to the country of China
`
`is unnecessary and could potentially be infeasible. Therefore, this Motion is DENIED. Any
`
`improperforay into clearly impermissible argument will be addressed by the Court if necessary.
`
`26. RAI’s Motion in limine #9.
`
`During discovery, RAI produced a computer aided design (“CAD”) file in September of
`
`2020. Dkt. 856 at 5. In February of 2021, RAI realized that the CAD file was not an accurate
`
`representation of the VUSE Alto product. /d. RAI subsequently produced an accurate CAD file
`
`and made PMA awareofthe realization. /d. RAI now seeks to have evidence of the inaccurate
`
`CADfile excluded from trial. /d. at 4. PMA has included the inaccurate CADfile in its list of
`
`trial exhibits and has opposed this Motion. Dkt. 991 at 4. PMA arguesthat the depictions based
`
`on the inaccurate CADfiles are relevant because they were filed with the FDA and may be
`
`relevant to infringement and damages. Dkt. 991 at 5. PMA does not contend that the first
`
`produced CADfile is an accurate depiction of the accused device. Because the first produced
`
`CADfile is inaccurate, it will not be relevant to any of the patented technology at issueat trial.
`
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`Evidenceofthe first produced CADfile will be excluded unless the circumstancesoftrial create
`
`good causefor its introduction. The Motion in limine is GRANTED.
`
`27, RAD’s Motion in limine #10.
`
`RAI has moved to exclude evidence that on prior occasions RAI was accused of
`
`infringing patents which are not related to the present case. Dkt. 863 at 5. PMAhas represented
`
`that it only wants to reference one specific allegation that resulted in one of the licenses that both
`
`Parties use to estimate a reasonable royalty rate. Dkt. 997 at 4. PMAalso represents that it does
`
`not intend to argue that RAI is a serial infringer. Jd. RAI also does not dispute that the one
`
`specific allegation of infringement is relevant to the value of the settlement agreement between
`
`Fontem and Reynolds, and therefore the evidence will be relevant to the calculation of damages.
`
`Dkt. 863 at 10. Improper argument regarding other alleged prior infringement will be barred by
`
`Federal Rule of Evidence 404(b) and can be addressed with a contemporaneous objection. At
`
`this time, the Motion in limine is DENIED.
`
`28. RAI’s Motion in limine #11.
`
`RAI has movedto exclude any evidence of PMA’s IQOStobacco product. Dkt. 870 at 4.
`
`RAI argues that PMA has admitted that IQOS does not practice the technology in any of the
`
`asserted patents. /d. at 7 (ref, Dkt. 870-4 at 7; Dkt. 870-5 at 7 (PMA’s interrogatory responses)).
`
`PMAhasasserted that the evidence is relevant to the damages analysis for two reasons: 1) to
`
`show that the Parties are direct competitors in the market and 2) to aid in “showing the
`
`regulatory benefits” RAI obtains from using “patented technology.” Dkt. 1001 at 7.
`
`PMA does not dispute that the IQOS device does not practice the technology in the
`
`asserted patents. As the device does not practice the patented technology, the IQOS deviceis not
`
`relevant to any issue of infringementto be decidedattrial. In addition, there is a high likelihood
`
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`that testimony and argument regarding the IQOS device would be confusing and misleading. If
`
`evidence of the technology used in the IQOS device was allowedat trial, this admission would
`
`lead to the comparison of an irrelevant device to the accused product and invite other improper
`
`comparisonsby the jury.
`
`The Court does find that testimony regarding the IQOSdevice is relevant for the narrow
`
`purpose ofestablishing the competitive relationship of RAI and PMA. However, any evidence
`
`regarding the technology in IQOS,regulatory history of the IQOS device, or regulatory benefits
`
`of the IQOSdevice is not relevant and will not be admissible. Therefore, this Motion in limine is
`
`GRANTEDIN PARTand DENIED IN PART.
`
`29. RAI’s Motion to exclude the testimony of Stacy Ehrlich
`
`RAI has moved to exclude the expert testimony of PMA’s witness, Stacy Ehrlich. Dkt.
`
`879. Ehrlich is an attorney who specializes in tobacco regulations. Dkt. 877-1 at 4-5. PMA seeks
`
`to offer Ehrlich’s testimony to show the benefits that RAI derives from the alleged use of the
`
`patented technology. Dkt. 877-1 at 3-4. Ehrlich believes that the patented technology is valuable
`
`because the use of the technology makes the accused products more likely to receive
`
`authorization for sale from the FDA. /d. RAI has moved to exclude Ehrlich’s testimony on the
`
`grounds that her testimony is not based on either a reasonable methodology or sufficient facts
`
`and data. Dkt. 877 at 5. RAI believes that the testimony is merely speculative and conclusory,
`
`and therefore the testimony does not meet the standards established by Federal Rule of Evidence
`
`702. Id.
`
`Ehrlich will testify that on May 10, 2016 the Federal Drug Administration (“FDA”)
`
`implemented a “deeming rule” that required all new tobacco products to receive premarket
`
`tobacco authorization (“PMTA”) before those products could be sold in the United States. Dkt.
`
`39
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`877-1 at 8 J 21. A new tobacco product, such as an electronic cigarette, would require a new
`
`PMTAapplication unless there was a showing that the product was substantially equivalent to a
`
`product that was already on the market. /d. In 2019, a Maryland district court issued an Order'?
`
`that all products would be required to submit a PMTA application by September 9, 2020.
`
`Ehrlich’s report also details the subsequent enforcement of the FDA policy. Dkt. 877-1 at 17-19.
`
`Federal Rule of Evidence 702 will allow an expert to testify if their knowledge is “based
`
`on sufficient facts or data.” When deciding on the admissibility of expert testimony, the Court
`
`has discretion to “determinereliability in light of the particular facts and circumstances of the
`
`particular case.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 158 (1999).
`
`Ehrlich relies on a series of FDA documents and other witness testimony to establish her
`
`conclusion. Much of the information in Ehrlich’s expert report is not related to the patented
`
`technology that is at issue in the trial. For instance, Ehrlich describes “PMTA Authorization
`
`Generally” when she explains a series of eight factors that all describe how the FDA compares
`
`the device application to the likelihood that granting the application will increase or decrease the
`
`use of traditional tobacco products. See e.g. Dkt. 887-1 at 20-21 § 43 (the FDA will consider
`
`“Tobacco users who may opt to use the new tobacco product rather than an FDA-approved
`
`tobacco cessation medication.”) No expert testimony or other evidence has tied any of the
`
`patented technologyto a likelihood that the technology will prevent the use oftraditional tobacco
`
`products.
`
`In addition, Ehrlich’s report extensively discusses the authorization of IQOS PMTA
`
`authorization. Dkt. 877-1. The IQOS does not practice the patented technology, and there is no
`
`connection of the IQOS device to the patented technology. Ehrlich discusses the Modified Risk
`
`Tobacco Product Authorization (“MRTPA”) for certain devices that are to be sold as alternative
`
`12 Am. Academy ofPediatrics v. FDA, 399 F. Supp. 3d 479 (D. Md. 2019)
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`to traditional tobacco products. Dkt. 877-1 at 28. However, Ehrlich indicates that none of the
`
`accused products currently have MRTPAapplications. /d. at 35 4 79 (“There are no pending
`
`MRTPA’s for any aerosolized products.”) Ehrlich refers to several statements made by the FDA
`
`that indicate a concern for the prevalence of the use of electronic cigarettes in young adults. Dkt.
`
`887-1 at 53. However, all the specific documents detail concerns about the use of flavored
`
`nicotine products or the marketing of nicotine products. See e.g. Dkt. 877-1 at 55 ¥ 130.'3 The
`
`flavor of the tobacco productis not related to any of the patented technology. Ehrlich goes on to
`
`say that “No one knows how this level of youth use of e-cigarettes will affect PMTA
`
`authorizations.” /d. at 54 J 129. The level of youth smoking is not relevant to any issue to be
`
`decidedattrial.
`
`Ehrlich throughout her report also references several deficiency letters sent by the FDA
`
`to RAI regarding their PMTAapplications. /d. at 877-1 at 43 § 97, 56-57 9133-134, 59-60 1]
`
`142-143. These letters address deficiencies in the application and do not address deficiencies in
`
`the products themselves, or the letters just address the need for more adequate labeling of the
`
`device. In general, these letters only call for more data to be submitted for the application and do
`
`not express an opinion on an actual problem with the products or the technology used in the
`
`products.
`
`Mostof the information that Ehrlich discusses in her report is not tied to any relevant
`
`issues in the present case. However, Ehrlich does identify some aspects of the patented
`
`technology and ties those aspects to the requirements of the PMTA application process. Ehrlich
`
`identifies the utility of the battery technology claimed in the ‘545 patent and connects it to FDA
`
`'3 For example, Ehrlich’s report explains, “As discussed, FDA already has sent a
`deficiency letter to Reynolds regarding the VUSE Solo PMTAsinvolving flavor issues,
`among others. Included in the VUSE Solo PMTAswere seven flavors, both fruit and
`mint varieties (e..g berry, mint, and cream)” (footnotes omitted)
`
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`guidance documents based on an expert
`
`report.
`
`/d. at 39 4 89. Ehrlich discusses her
`
`understanding of leakage prevention derived from the ‘911 patent and correlates it with FDA
`
`rules based on another expert’s report. Jd. at 45 ¥ 100. Ehrlich concludes that technology used in
`
`the ‘374 patent is related to features that the FDA will consider during the PMTAprocess. /d. at
`
`46 J 105. Ehrlich discusses the benefits of the ‘256 and ‘556 patents only based on her “general
`
`understanding” and not on any expert reports. /d. at 45 ¢ 111. At no point in her expert report
`
`does Ehrlich ever conclude that the technology will lead to approval of the PMTA application.
`
`At no point in her expert report does Ehrlich identify specific requirements for the PMTA
`
`application and then tie those requirements to the technology at issue in the case. The only ties of
`
`the technology to the application process are general conclusions that the technology might be
`
`considered in the process.
`
`As RAIpoints out, Ehrlich’s deposition testimony repeatedly shows that she cannot form
`
`an opinion on how the FDA will decide a PMTAapplication.'* Ehrlich cannottie the technology
`
`to an eventual approval or prohibition of the accused devices because there is no data or other
`
`underlying facts on which to base that conclusion. Ehrlich’s report demonstratesthat it is highly
`
`likely that a device could includeall the patented technology andstill have the application denied
`
`for reasons completely unrelated to the technology itself. On the other hand, the application
`
`could also be denied because ofan insufficiency in the patented technology. There is no basis to
`
`differentiate the potential outcome beyond speculation.
`
`14 «TJhere’s no way that anyone outside of FDA could tell you when or whether FDA
`will take enforcement action in any given case.” Dkt. 1016-2 at 16. “[S]o yes, it may
`improve their chances. It’s something that’s important to FDA, but I can’t say 100
`percent for sure that it will.” Dkt. 1016-2 at 18. “Whether they get an authorization or not
`is something that is very hard to predict, impossible to predict, but it definitely will
`strengthen the application.” Dkt. 1016-2 at 19.
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`Ehrlich’s testimony as an expert is admissible, but her testimony must be limited to
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`opinions which are not based on speculation. Ehrlich may nottestify regarding the ‘256 and ‘556
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`patents for which she has no expertise or another expert’s report on which to base an opinion.
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`Ehrlich may not offer testimony regarding the IQOS device (for the reasons discussed above).
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`Ehrlich may not testify as to whether a device will or will not be granted FDA authorization.
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`Ehrlich may identify FDA documents. Ehrlich may identify the aspects of the FDA authorization
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`process so long as that testimonyis tied to actual FDA statements and documents. Therefore, the
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`Motion in limine is DENIED. However, any irrelevant testimony--as discussed above or in
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`conjunction with the Court’s holding on other Motionsin limine--will not be admissible.
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`30. RAI’s Motion to exclude the testimony of Joseph McAlexander
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`RAI has moved to exclude the testimony of PMA’s expert witness in electrical
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`engineering, Joseph McAlexander. Dkt. 885 at 11. RAI has moved to exclude McAlexander
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`from testifying on: 1) how aspects of the ‘545 and ‘374 patent apply to FDA regulations; 2) a
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`theory of infringement based on the doctrine of equivalents; 3)
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`the nexus between the
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`commercial success of a product and the asserted patents; and 4) the non-obviousness of the
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`asserted patents. /d. at 10. PMA has opposed the Motion. McAlexander has a bachelor’s degree
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`in electrical engineering and forty years of industry experience working with electrical circuits
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`and associated intellectual property. See Dkt. 885-4 at 2. Mr. McAlexander’s expertise in
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`electrical engineering is not challenged by RAI, however the basis of his opinions and the
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`reliability of his analysis are challenged under the requirements established by Federal Rule of
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`Evidence 702.
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`RAI argues that McAlexanderhas no relevant experience in FDA regulation. Dkt. 885 at
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`20. PMAassertsthat it is proper for McAlexanderto base his testimony on the opinion of PMA’s
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`other expert witness, Stacy Ehrlich. Dkt. 1021 at 12. PMA arguesthatit is proper for one expert
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`to rely on the opinion of another expert witness. Jd. (citing Apple, Inc. v. Motorola, Inc., 757
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`F.3d 1286, 1321 (Fed. Cir. 2014) (“Experts routinely rely upon other experts hired by the party
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`they represent for expertise outside of their field.”)) To the extent that McAlexander can tie
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`technical aspects of the asserted patents to any specific technical factors identified by Ehlrich,
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`McAlexander’s testimony is relevant and admissible. McAlexanderis precluded from testifying
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`on how the incorporation of any asserted patent will or might affect the regulation of the accused
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`devices or how important that technologyis to the relevant regulation.
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`RAIbelieves that McAlexander’s expert report reflects that McAlexander has performed
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`no proper analysis to present a theory of infringement under the doctrine of equivalents. Dkt. 885
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`at 36. Infringement under the doctrine of equivalents is shown whenthe differences between the
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`accused products and the patented claims are insubstantial. VirnetX, Inc. v. Cisco Sys., 767 F.3d
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`1308, 1322 (Fed. Cir. 2014) (references omitted). There are insubstantial differences when “the
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`accused device performs substantially the same function in substantially the same way to obtain
`substantially the same result as the claim limitation.” /d. (citing Graver Tank & Mfg. Co. v.
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`Linde Air Prods. Co., 339 U.S. 605, 608 (1950)). RAI argues that McAlexander's report offers
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`only conclusory allegations that the accused devices infringe under the doctrine of equivalents.
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`Dkt. 885 at 36. McAlexander does address the doctrine of equivalents within his report by
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`stating:
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`the differences, if any, between the ASIC,
`As shown by the evidence cited above,
`microcontroller, and associated circuitry in the Alto and this claim limitation is insubstantial at
`most. Further, the Alto infringes this limitation under the doctrine of equivalents at least because
`the ASIC, microcontroller, and associated circuitry in the Alto perform substantially the same
`function (e.g. measure a variation in an oscillation frequency, selectively actuate a heater based
`on the variation in an oscillation frequency,) in substantially the same way (e.g., based on the
`variation in an oscillation frequency), to obtain the sameresult (e.g. selective actuation of the
`heater).
`
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`Dkt. 1021-2 at 26. The “evidence above” that McAlexanderreferences is a series of tests on the
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`accused devices where he demonstrates that the heater respondsto oscillation in an electronic
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`frequency as described in the limitations of the claims.
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`/d. at 24-26. These tests could
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`demonstrate that the function and result are the same between the claimed invention and the
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`accused device.
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`McAlexander’s expert report does not form a basis to exclude his testimony regarding the
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`doctrine of equivalents. Expert testimony on the doctrine of equivalents requires “particularized
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`testimony and linking argument.” Paice LLC v. Toyota Motor Corp., 504 F.3d 1293, 1304-1305
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`(Fed. Cir. 2007) (quoting Texas Instruments, Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558,
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`1567 (Fed. Cir. 1996)). Testimony without the linking argument that does not
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`identify the
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`equivalents of the components and their importance to the function of the device is testimony
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`that is simply “subsumed in the plaintiff's case of literal infringement.” Lear Siegler, Inc. v.
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`Sealy Mattress Co., 873 F.2d 1422, 1425 (Fed. Cir. 1989). In McAlexander’s report he does
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`identify that differences between the accused products and the patented technology are minimal.
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`McAlexanderalso qualifies disagreements between himself and RAI’s expert on the fun