Case 1:20-cv-00393-LMB-WEF Document 1462-7 Filed 04/05/23 Page 1 of 13 PageID# 39607
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`Exhibit 7
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`Case 1:20-cv-00393-LMB-WEF Document 1462-7 Filed 04/05/23 Page 2 of 13 PageID# 39608
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`Investigation No. 337-TA-1199
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`In the Matter of
`CERTAIN TOBACCO HEATING
`ARTICLES AND COMPONENTS
`THEREOF
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`COMMISSION OPINION DENYING RESPONDENTS’ MOTION TO STAY LIMITED
`EXCLUSION ORDER AND CEASE AND DESIST ORDERS PENDING APPEAL
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`I.
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`BACKGROUND
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`On May 15, 2020, the Commission instituted this investigation based on a complaint filed
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`by RAI Strategic Holdings, Inc., R.J. Reynolds Vapor Company, and R.J. Reynolds Tobacco
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`Company, all of Winston-Salem, North Carolina (collectively, “Reynolds”). 85 Fed. Reg.
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`29482-83 (May 15, 2020). The complaint, as supplemented, alleges a violation of section 337
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`based upon the importation and sale of certain tobacco heating articles and components thereof
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`by reason of infringement of certain claims of U.S. Patent Nos. 9,901,123 (“the ’123 patent”),
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`9,930,915 (“the ’915 patent”), and 9,839,238 (“the ’238 patent”) (collectively, “the Asserted
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`Patents”). Id. The complaint also alleges the existence of a domestic industry. The notice of
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`investigation names the following respondents: Altria Client Services LLC (“ACS”), Altria
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`Group, Inc. (“AGI”), and Philip Morris USA, Inc. (“Philip Morris USA”), all of Richmond,
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`Virginia; Philip Morris International Inc. (“PMI”) of New York, New York; and Philip Morris
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`Products S.A. (“PMP”) of Neuchatel, Switzerland (collectively, “Philip Morris” or
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`“Respondents”). See id. The Office of Unfair Import Investigations (“OUII”) was also a party to
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`the investigation. See id.
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`III. ANALYSIS
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`A.
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`Philip Morris’s Motion Does Not Raise Any Admittedly Difficult Legal
`Questions
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`Philip Morris argues that it is entitled to a stay because: 1) the Commission failed to
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`“consult with” the Department of Health and Human Services (“HHS”) as required under section
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`337; 2) the Commission erred in finding a domestic industry based on allegedly unlawful
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`products; and 3) the Commission further erred in finding infringement and validity of the ’123
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`patent and the ’915 patent. PM Mot. at 4-11. Inasmuch as Philip Morris’s stay motion did not
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`argue error as to the Commission’s validity determination as to the asserted claims of the
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`’915 patent, Philip Morris’s subsequent notice to the Commission concerning the PTAB’s Final
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`Written Decision as to these claims is irrelevant to the issues actually presented in the motion to
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`stay. Moreover, the notice fails to identify any admittedly difficult legal issue arising from the
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`Commission’s invalidity determinations as to the ’915 patent on the Commission’s
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`administrative record. Philip Morris’s arguments are not persuasive.
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`Philip Morris’s New “Consult With” Argument is Abandoned
`Because It Was Neither Raised nor Preserved Before the ALJ and
`Before the Commission
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`Philip Morris argues that the Commission legally erred in failing to “consult with” HHS
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`under section 337, which mandates that “[d]uring the course of each investigation under this
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`at *80 (July 9, 1998); Certain Baseband Processor Chips & Chipsets, Transmitter & Receiver
`(Radio) Chips, Power Control Chips &Products Containing Same, Including Cellular Telephone
`Handsets, Inv. No. 337-TA-543 (“Baseband Processors”), Comm’n Op. Denying Mots. for Stay
`at 5-6 (June 21, 2007); Certain High-Brightness Light Emitting Diodes, and Products Containing
`Same, Inv. No., 337-TA-556, Comm’n Op., 2008 WL 2556199, at *4-*5 (Sept. 11, 2007);
`Certain Semiconductor Chips with Minimized Chip Packages, Inv. No. 337-TA-605
`(“Semiconductor Chips”), Comm’n Op., 2009 WL 2350644, at *2-*4 (July 29, 2009); Certain
`Digital Television Products and Certain Products Containing Same and Methods of Using Same,
`Inv. No. 337-TA-617, Comm’n Op., 2009 WL 2598777, at *2-*3 (Aug. 21, 2009).
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`5
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`section, the Commission shall consult with, and seek advice and information from, the
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`Department of Health and Human Services, . . . and such other departments and agencies as it
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`considers appropriate.” PM Mot. at 4-8 (citing 19 U.S.C. § 1337(b)(2)). However, Philip
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`Morris’s motion to stay is the first time that Philip Morris made such an argument before the
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`Commission.
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`The Commission finds that there is no admittedly difficult legal question, much less a
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`likelihood of success as to the “consult with” argument. The Commission has rules governing
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`when issues must be raised in Commission investigations and how they must be preserved. As
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`set forth below, Philip Morris did not adequately raise or preserve the argument that it now seeks
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`to raise.
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`Philip Morris’s argument is forfeited because it was not raised and preserved before the
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`ALJ in conformance with the ALJ’s Ground Rules for the investigation. See, e.g., Order No. 2
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`(May 15, 2020) at Ground Rule 14.1 (“Any contentions for which a party has the burden of proof
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`that are not set forth in detail in the post-hearing initial brief shall be deemed abandoned or
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`withdrawn.”); see also id. Rule 11.2 (pre-hearing brief).
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`When the Commission instituted the investigation, it ordered the ALJ to take evidence on
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`the public interest and to make findings of fact on the public interest. Notice, 85 Fed. Reg.
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`29482, 29482 (May 15, 2020); see 19 C.F.R. § 210.50(b)(1) (allowing the Commission to
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`authorize the ALJ to take evidence and engage in factfinding concerning the public interest).
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`Thus, the appropriate time for the parties to present and preserve public-interest arguments in
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`this investigation began at the time the proceeding commenced before the ALJ. During the
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`evidentiary hearing before the ALJ on February 21, 2021, the ALJ inquired whether section 337
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`allowed the Commission to consult with HHS. See Hrg. Tr. at 1524:17-21 (Feb. 21, 2021).
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`Specifically, the ALJ stated, “I am interested in your views about my authority under 19 U.S.C.
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`1337(b)(2), which instructs that the Commission may consult with the Department of Health and
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`Human Services, and, by implication, the Food and Drug Administration.” Id. at 1524:17-21.
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`Counsel for Philip Morris responded that “[w]e have absolutely no objection whatsoever to any
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`of that,” meaning apparently, that Philip Morris had no objection to the Commission’s authority
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`to consult with the Department of Health and Human Services. Id. at 1571:7-8. But Philip
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`Morris never identified a specific consultation with the Department of Health and Human
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`Services that was required (as opposed to being merely unobjectionable) or what form that
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`coordination must take. Nor did Philip Morris ever tell the ALJ that failure to engage in Philip
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`Morris’s unspecified consultation would be an error of law.
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`That Philip Morris lay in the weeds is not a procedural wrinkle that can be brushed aside;
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`it strikes at the bedrock of the requirement of administrative exhaustion. The Administrative
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`Procedure Act, for example, generally limits the ALJ’s and the Commission’s authority to
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`engage in ex parte communications relevant to the merits of the investigation. 5 U.S.C.
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`§ 557(d)(1). Philip Morris did not subpoena the Secretary of Health and Human Services or urge
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`the ALJ to do so. Such questions concerning the relationship between coordinate government
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`entities must be raised and preserved in the investigation so that the agency can address these
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`concerns adequately and in a timely manner. Consequently, and pursuant to the ALJ’s Ground
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`Rules for the investigation, the issue is abandoned.
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`In the underlying investigation, the Commission had the authority, as tribunals do, to
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`excuse waiver in exceptional circumstances, including, for example, in instances of self-initiated
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`Commission review of an ALJ’s determinations. E.g., 19 C.F.R. § 210.44. But Philip Morris
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`never raised the “consult with” argument in its petition for Commission review of the ALJ’s
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`determinations despite Philip Morris’s actual knowledge of all proceedings before the ALJ.2 See
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`Respondents’ Petition and Contingent Review of the Final Initial Determination (May 28, 2021).
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`In view of the fact, as discussed above, that the Commission authorized the ALJ in this
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`investigation to take evidence on the public interest, Philip Morris’s contention that a public-
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`interest determination mandated further consultation with the Department of Health and Human
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`Services should have been raised as a ground of error in Philip Morris’s petition for Commission
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`review of the ALJ’s determinations. Because it was not raised, it has been deemed abandoned by
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`Commission rule. 19 C.F.R. § 210.43(b)(2) (“Any issue not raised in a petition for review will
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`be deemed to have been abandoned by the petitioning party and may be disregarded by the
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`Commission in reviewing the initial determination . . . , and any argument not relied on in a
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`petition for review will be deemed to have been abandoned and may be disregarded by the
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`Commission.”)
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`Moreover, none of Philip Morris’s other Commission-directed submissions sought
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`excusal of any abandonment, or otherwise raised or preserved the issue of the Department of
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`Health and Human Service’s participation in this investigation. On June 15, 2021, Philip Morris
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`filed a statement on public interest pursuant to 19 C.F.R. § 210.50(a)(4)(i). See Respondents’
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`Submission on the Public Interest (June 15, 2021). Philip Morris argued the FID fails to consider
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`key FDA findings that were already of record in the investigation, but did not argue that the
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`Commission must “consult with” HHS or the FDA. Id. On August 10, 2021, Philip Morris filed
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`its response to the Commission’s July 27, 2021 notice of review and schedule for submissions on
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`2 Commission proceedings are conducted on a public record that appears on the
`Commission’s EDIS electronic filing and recordkeeping system. Accordingly, whether HHS or
`FDA or any other government party participated—or did not participate—was known to Philip
`Morris in real-time in the Commission investigation.
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`8
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`certain issues under review and remedy, public interest, and bonding. See Respondents’ Opening
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`Brief in Response to Commission’s Notice of Review (Aug. 10, 2021). Philip Morris did not
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`argue in its response that the Commission was required and failed to “consult with” HHS or the
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`FDA. Id.3 Philip Morris requested that the Commission hold a second hearing on the public
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`interest issues, even though the ALJ previously held a hearing on public interest issues. Id. at 85;
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`Comm’n Op. at 75-76. However, even if a second hearing was held on public interest, Philip
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`Morris never requested, much less requested the Commission to order, that HHS or the FDA be
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`compelled to participate in such a hearing. Id. On August 17, 2021, Philip Morris filed a reply
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`submission in response to the other parties’ initial responses. Respondents’ Reply Submission to
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`Commission’s Notice (Aug. 17, 2021). There, Philip Morris noted that “[t]he Commission may
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`find it enlightening to discuss these matters directly with various party and third-party experts in
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`this field and perhaps even representatives of FDA itself.” Id. at 62. Philip Morris’s position in
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`its reply that the Commission “may find it enlightening” is at odds with its present contention
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`that a specific, in-depth consultation with HHS is required as a matter of law.
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`The Commission is aware that Philip Morris has urged the Federal Circuit to decide the
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`consultation issue as being ostensibly a legal question. Philip Morris, Case No. 22-1227, ECF
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`No. 18 (Dec. 21, 2021). But there is no basis in law or reason for any tribunal—the Federal
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`Circuit in its proceedings, or the Commission in connection with this motion to stay—to excuse
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`3 Philip Morris states: “Several of the third parties that filed public interest comments in
`support of IQOS prior to institution of this Investigation took time again to file additional views
`on their own at the Commission phase, including PPI, AVA, and former Congressman George
`Holding,” and cites a letter from former Congressman George Holding. Id. at 79. The letter
`stated, “I urge a careful review of the FDA’s authorizations of the IQOS and encourage direct
`consultations with the agency . . . .” Id. Neither the letter, however, nor any submission by
`Philip Morris argued that the absence of “direct consultations” (whatever that may be) would
`constitute legal error.
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`Philip Morris’s abandonment. Unlike the one case that Philip Morris has cited to the Federal
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`Circuit, Ericsson Inc. v. TCL Commc’n Tech. Holdings Ltd., 955 F.3d 1317, 1322-23 (Fed. Cir.
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`2020), the issues here were never raised, much less briefed and preserved in Commission
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`proceedings. Issues about the ALJ’s obligations or the Commission’s obligations in connection
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`with the merits or the public interest inquiry must be raised at such a time as it matters. The
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`“consult with” argument raised now by Philip Morris comes far too late, and the Commission
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`deems it abandoned.
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`Philip Morris’s Motion Ignores the Commission’s Consistent and
`Longstanding Practices
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`As discussed above, Philip Morris’s argument has been abandoned, and an opinion on a
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`motion to stay presents an inappropriate opportunity for the Commission to opine at length on
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`the issue as though Philip Morris preserved it. For the benefit of the parties, the public, and the
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`Commission’s reviewing court, however, the Commission notes that the Commission’s practices
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`and procedures in this case reflect the Commission’s longstanding and consistent interpretation
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`of section 337 and Commission rules.
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`Pursuant to its longstanding rules, the Commission serves copies of the notice of
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`investigation upon various government agencies, including HHS.4 See 19 C.F.R. § 210.11(a)(4).
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`4 The Commission’s practices, in relevant part, trace at least to the mid-1990s. In 1994,
`the Commission’s Inspector General (“IG”) investigated the Commission’s practices with respect
`to other agencies. ITC Office of Inspector General Audit Report No. IG-03-94 (Aug. 1994) at 4;
`see also PM Mot. at 6-7, n.7; Reynolds Opp. at 9-10. The IG “contacted representatives from
`HHS, Justice, FTC and the Customs Service, who all similarly” commented that “resource
`constraints had severely limited their ability to review the 337 documents; two said that the
`documents were immediately discarded.” Id. at 5. The IG recommended revising the
`Commission’s rules to address these concerns. Id. The Commission agreed that the system
`needed “improvement.” ITC Proposed Rules, 60 Fed. Reg. 16,082, 16,083 (proposed Mar. 29,
`1995) (to be codified at 19 C.F.R. § 210). After the IG’s 1994 report, the Commission engaged
`in notice-and-comment rulemaking that resulted in the amended regulations at issue here.
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`The Commission actually served the Notice of Investigation on the HHS attorney who has been
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`delegated by HHS to monitor Commission investigations. See Notice of Institution at 8, 22;
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`19 U.S.C. § 1337(b)(2); 19 C.F.R. § 210.11(a)(4). Neither that attorney nor anyone else at HHS
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`thereafter requested any unusual treatment for this investigation (such as paper copies) of future
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`notices. Commission notices seeking briefing or comments from the public, including from
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`interested government agencies, are published in the Federal Register, constituting notice, as a
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`matter of law, under the Federal Register Act, 44 U.S.C. § 1501 et seq. See id. §§ 1507-1508.
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`Here, the Commission published the notice of investigation and two additional notices in the
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`Federal Register soliciting comments from the public, including government agencies. See 85
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`Fed. Reg. 29482-83 (May 15, 2020) (notice of investigation); 86 Fed. Reg. 28382 (May 26,
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`2021); 86 Fed. Reg. 41509-11 (Aug. 2, 2021).
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`The present investigation was conducted in conformity with these rules. If Philip Morris
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`was aggrieved by the application of the Commission’s duly-promulgated rules to this
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`investigation, the time for objection was before the ALJ in the Commission investigation, and
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`not in a collateral motion to stay, or in an appeal to the Commission’s reviewing court.
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`Likewise, if Philip Morris desired more engagement with other government agencies than the
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`Commission rules provide for, and which may be within the Commission’s discretion to
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`exercise, it was incumbent upon Philip Morris to seek such engagement before the Commission,
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`and to object during the proceeding itself if Philip Morris did not receive what it sought, rather
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`than after the investigation has concluded and on appeal before the Federal Circuit.
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`Philip Morris offers dictionary definitions for “consult” that it never presented to the
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`Commission in the underlying investigation. To Philip Morris, “to consult” means “to seek
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`information or advice from,” or to “to have regard to.” PM Mot., Ex. A (New Oxford American
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`Dictionary (3d ed. 2010); id., Ex. B (Merriam-Webster’s Collegiate Dictionary (10th ed. 1999).
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`It is difficult to decipher Philip Morris’s arguments because the Commission appears to have
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`satisfied each definition. The first definition is met because the Commission sought information
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`from the listed agencies in the Federal Register notices and by actual service of the notice of
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`investigation. The second definition is met because the FDA’s views were part of the record
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`here and were considered by both the ALJ and the Commission. Both the ALJ and the
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`Commission extensively considered the FDA’s statements regarding IQOS when considering the
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`public interest factors. Comm’n Op. at 56-72; FID at 103-118. Such arguments could have been
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`explored in more detail in the underlying investigation if Philip Morris had timely raised the
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`issue.
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`Reynolds argues that the Commission’s statutory obligation to consult with government
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`agencies is discretionary under section 337, but in all events, was satisfied here. Reynolds Opp.
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`at 4-10. The Commission finds it unnecessary to reach those arguments here, where Philip
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`Morris fails to show an admittedly difficult legal question, even under its preferred definitions,
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`and ignores its dispositive abandonment.
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`Philip Morris Fails to Raise an Admittedly Difficult Legal Issue
`Regarding Reynolds’s Domestic Industry
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`Philip Morris also argues that the Commission erred in finding that Reynolds satisfies the
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`domestic industry requirement. PM Mot. at 8-10. In particular, Philip Morris takes issue with
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`the Commission’s crediting of Reynolds’ investments in its VUSE Solo and Vibe e-cigarette
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`products. Id. at 9-10. The Federal Circuit has recognized that “the domestic industry
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`requirement generally involves questions of both law and fact.” Motorola Mobility, LLC v. ITC,
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`737 F.3d 1345, 1348 (Fed. Cir. 2013). In the present case, the issue is the substantiality or
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`significance of Reynolds’ investments, a question of fact. Accordingly, the Commission finds
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`that Philip Morris raises no legal question, much less an admittedly difficult one, for purposes of
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`a stay. Even if the question were viewed as legal, the Commission has addressed the issues
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`raised by Philip Morris below, and, upon further consideration has determined that none of the
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`issues are admittedly difficult. FID at 97-99. In addition to the reasons set forth in the FID,
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`Philip Morris itself notes that the FDA recently issued marketing orders for the VUSE Solo. PM
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`Mot. at 8, n.8. Philip Morris can hardly argue that a product with the same PMTA marketing
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`authorization as its own IQOS is illegal. Moreover, Philip Morris points to no authority that
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`FDA approval is a condition precedent to the establishment of a domestic industry, nor is the
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`Commission aware of any such authority.
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`Philip Morris has not shown an admittedly difficult legal issue regarding Reynolds’s
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`domestic industry products.
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`Philip Morris’s Conclusory Arguments Regarding Infringement and
`Invalidity Do Not Support a Stay
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`Philip Morris argues without support or explanation that it will “likely succeed in
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`challenging the Commission’s findings that the asserted claims of [the ’123 patent] and [the
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`’915 patent] are valid and infringed. PM Mot. at 11. Philip Morris cites the Commission’s
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`Opinion but none of its own experts’ testimony or evidence. Id. Accordingly, Philip Morris’s
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`subsequent notice to the Commission concerning the PTAB Final Written Decision is irrelevant
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`to the issues actually presented in the motion to stay.5 Philip Morris’s conclusory statement in
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`5 Moreover, the notice fails to identify any admittedly difficult legal issue arising from
`the Commission’s invalidity determinations on the Commission’s administrative record. Cf.
`Certain Network Devices, Related Software and Components Thereof (II) (“Network Devices”),
`Inv. No. 337-TA-945, Comm’n Op., 2017 WL 10954555, at *8 (Aug. 16, 2017) (finding that
`PTAB decisions that occurred after the issuance of the Commission’s remedial orders failed to
`demonstrate a changed circumstance warranting suspension of the Commission’s orders); Cisco
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`its motion, even as supplemented by its notice of supplemental authority, fails to demonstrate
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`any admittedly difficult legal questions with respect to infringement or validity.
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`B.
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`Irreparable Harm
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`Philip Morris argues that, unless the LEO and CDOs are stayed, it will be irreparably
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`harmed due to lost IQOS revenues, loss of talent, business opportunities, and goodwill in the
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`industry. PM Mot. at 11-13. Philip Morris mainly relies on loss of revenue to Philip Morris
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`USA and to PMI, but the Commission finds such economic harm insufficient to warrant a stay.
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`Id. at 11-12; Celsis, 664 F.3d at 930. The Commission has repeatedly considered and rejected
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`the argument that lost sales and lost market position constitute “irreparable injury.” See Certain
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`High-Brightness Light Emitting Diodes, and Products Containing Same, Inv. No. 337-TA-556,
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`Comm’n Op. at 10-12 (Aug. 20, 2007) (“High-Brightness LEDs”); Certain Lens-Fitted Film
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`Packages, Inv. No. 337-TA-406, Comm’n Op. at 15 (June 28, 1999)) (“LFFPs”); see also
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`Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985) (internal citations omitted).
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`The Commission has considered Philip Morris’s remaining arguments and has
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`determined that Philip Morris has not demonstrated irreparable harm. As Philip Morris notes,
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`IQOS’ release was limited and it was available in only four states with only 20,000 users in the
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`United States prior to the Commission’s final determination. PM Mot. at 12, 16. Moreover, in
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`its motion, Philip Morris offers vague and unsupported declarations with generalizations, such as
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`alleged loss of goodwill for IQOS and HeatSticks that are sold in only four states and “projected”
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`revenue losses without supporting calculations or substantiation of underlying assumptions. Id.
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`at 11-13. Philip Morris’s motion is therefore speculative and unsupported.
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`Sys., Inc. v. Int’l Trade Comm’n, No. 17-2289, Order at 3 (Fed. Cir. Sep. 22, 2017) (ECF 57)
`(denying a stay of the Commission’s remedial orders where the movant sought a stay on the
`basis of subsequent PTAB determinations).
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`intellectual property rights by excluding infringing products.” Certain X-Ray Breast Imaging
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`Devices & Components Thereof, Inv. No. 337-TA-1063, Initial Determination at 281 (July 26,
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`2018); Merial Ltd. v. Cipla Ltd., 681 F.3d 1283, 1306 (Fed. Cir. 2012) (noting “[p]ublic policy
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`favors the innovator, not the copier”); Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d
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`1336, 1345 (Fed. Cir. 2013).
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`The Commission finds that the public interest does not warrant a stay.
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`IV. CONCLUSION
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`Philip Morris’s motion to stay enforcement of the LEO and CDOs is denied.
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`By order of the Commission.
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`Issued: January 20, 2022
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`Lisa R. Barton
`Secretary to the Commission
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`17
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