United States Court of Appeals 

for the Federal Circuit ______________________ 

PHILIP MORRIS PRODUCTS S.A., PHILIP MORRIS USA, INC., ALTRIA CLIENT SERVICES LLC,

Appellants

v.

INTERNATIONAL TRADE COMMISSION,

Appellee

RAI STRATEGIC HOLDINGS, INC., R.J. REYNOLDS VAPOR COMPANY, R.J. REYNOLDS TOBACCO COMPANY,

Intervenors

______________________ 

2022-1227

______________________ 

Appeal from the United States International Trade 

Commission in Investigation No. 337-TA-1199.

______________________ 

Decided: March 31, 2023

______________________ 

GREGORY G. GARRE, Latham & Watkins LLP, Washington, DC, argued for appellants. Also represented by GABRIEL K. BELL, MAXIMILIAN A. GRANT, BERT C.

REISER, JAMIE UNDERWOOD. 

 LYNDE FAUN HERZBACH, Office of the General Counsel, 

United States International Trade Commission, 

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2 PHILIP MORRIS PRODUCTS S.A. v. ITC

Washington, DC, argued for appellee. Also represented by 

WAYNE W. HERRINGTON, SIDNEY A. ROSENZWEIG. 

 GREGORY A. CASTANIAS, Jones Day, Washington, DC, 

argued for intervenors. Also represented by AMELIA A.

DEGORY; SUSAN M. GERBER, DAVID MICHAEL MAIORANA,

RYAN BOYD MCCRUM, Cleveland, OH; ANTHONY INSOGNA, 

San Diego, CA. 

 ______________________ 

Before PROST, REYNA, and STOLL, Circuit Judges.

STOLL, Circuit Judge. 

RAI Strategic Holdings, Inc., R.J. Reynolds Vapor 

Company, and R.J. Reynolds Tobacco Company (collectively “Reynolds”) filed a complaint at the International 

Trade Commission alleging that respondents Philip Morris 

Products S.A., Philip Morris USA, Inc., and Altria Client 

Services LLC (collectively “Philip Morris”) violated Section 337 of the Tariff Act of 1930, 19 U.S.C. § 1337, through 

the importation and sale of tobacco products that infringed 

certain claims of U.S. Patent Nos. 9,901,123 and 9,930,915. 

After conducting a Section 337 investigation, the Commission barred Philip Morris and its affiliates from importing

products infringing the asserted patents. Philip Morris appeals, contending that the Commission failed to “consult 

with, and seek advice and information from” the Department of Health and Human Services (HHS) as required by 

Section 337. In addition, Philip Morris challenges the 

Commission’s determinations on public interest, domestic 

industry, patent validity, and infringement. For the reasons set forth below, we affirm the Commission’s decision 

in full.

BACKGROUND

Philip Morris and Reynolds are competing manufacturers of tobacco products including heat-not-burn tobacco 

products. Their dispute in this case began in April 2020, 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 3

when Reynolds filed a complaint with the Commission alleging that the IQOS line of electronic nicotine delivery system products imported and sold by Philip Morris infringed 

claims 27–30 of the ’123 patent and claims 1–3 and 5 of the 

’915 patent. J.A. 1019, 3658; see also In the Matter of Certain Tobacco Heating Articles & Components Thereof, Inv. 

No. 337-TA-1199, Final Initial Determination, 2021 WL 

2333742, at *13 (May 14, 2021) (FID) (identifying Philip 

Morris’s “IQOS 2.4, IQOS 3, and IQOS 3.1 Duo systems” 

and “HeatSticks” as the accused products). 

The patents-in-suit are directed to electrically powered 

“smoking articles” that heat tobacco instead of burning it, 

providing an inhalable substance in vapor or aerosol form. 

’123 patent col. 4 ll. 42–65; ’915 patent col. 2 ll. 12–22. 

Claim 27 is representative of the asserted claims of the 

’123 patent: 

27. An electrically-powered, aerosol-generating 

smoking article comprising:

an electrical power source in the form of a battery 

within a tubular outer housing having a mouth-end 

and an end distal to the mouth-end;

at least one electrical resistance heater powered by 

said electrical power source, wherein at least a portion of the resistance heating element is elongated 

and extending downstream toward the mouth-end 

of the outer housing, the elongated portion of the 

resistance heating element positioned proximal to 

the center of the outer housing;

a controller within the tubular outer housing and 

adapted for regulating current flow through the 

electrical resistance heater; and

a cigarette-type device removably engaged with the 

mouth-end of the tubular outer housing and comprising a tobacco segment circumscribed by a 

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4 PHILIP MORRIS PRODUCTS S.A. v. ITC

wrapping material and comprising a tobacco material and an aerosol-forming material, wherein the 

elongated portion of the resistance heating element 

extends into the tobacco segment when the cigarette-type device is engaged with the mouth-end of 

the outer housing, such that during draw, aerosolforming material can be volatilized to produce a 

visible mainstream aerosol incorporating tobacco 

components or tobacco-derived components that 

can be drawn into the mouth of the user of the 

smoking article.

’123 patent col. 34 ll. 31–58.

Claim 1 is representative of the asserted claims of the 

’915 patent: 

1. A reusable control unit for use with a disposable 

smoking article, the reusable control unit comprising a control housing including:

a receiving end for receiving an engaging end of the 

disposable smoking article and having an electrical 

energy source that includes a projection extending 

outwardly therefrom and that includes a component that forms an electrical connection with electrical contacts on a separate electrical heating 

member; and

a control unit section that houses a power source, a 

switching component that actuates flow of electrical current from the electrical energy source to the 

electrical heating member, and a flow regulating 

component that regulates a previously initiated 

current flow from the electrical energy source to 

the electrical heating member, wherein the component that forms an electrical connection with the 

electrical contacts is located on the projection.

’915 patent col. 42 ll. 22–39.

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Reynolds also asserted in the complaint that its VUSE 

line of vapor nicotine products established both the economic and technical prongs of domestic industry. 

J.A. 1047–48; see also FID, 2021 WL 2333742, at *13 (noting Reynolds’ assertion that “VUSE Solo G1 and G2 devices 

are articles protected by the ’915 patent . . . and that the 

VUSE Vibe devices are articles [] protected by [the] ’123 patent.”). 

In response to Reynolds’ complaint, the Commission instituted an investigation and ordered the presiding administrative law judge (ALJ) to “provide the Commission with 

findings of fact and a recommended determination on [the] 

issue” of public interest. J.A. 3432–33 (85 Fed. Reg. 

29,482–83 (May 15, 2020)).

The ALJ conducted the investigation over the course of 

the next year. After reviewing briefing from both parties 

and holding a claim construction hearing, the ALJ issued 

an order construing certain disputed claim terms. 

J.A. 10904–36. In view of the construed claims, the ALJ 

granted summary determination that there existed an economic domestic industry for the ’915 patent.1 

J.A. 12761–62. And, following a six-day evidentiary hearing, Philip Morris stipulated that Reynolds had also established economic domestic industry for the ’123 patent. 

FID, 2021 WL 2333742, at *53. The ALJ issued a final initial determination (FID) concluding that: (1) Reynolds 

had shown that Philip Morris infringed the asserted 

claims, and that Philip Morris had not shown the asserted 

claims to be invalid, id. at *58; (2) Reynolds had established the existence of a domestic industry with respect to 

both of the asserted patents, id.; and (3) “the public interest 

evidence of record [did] not weigh against entry of a 

1 It is undisputed that Reynolds satisfied the technical prong of the domestic industry requirement with respect to the asserted patents.

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6 PHILIP MORRIS PRODUCTS S.A. v. ITC

remedy,” id. at *73. The ALJ also recommended that the 

Commission issue a limited exclusion order, id. at *74, but 

not cease and desist orders, id. at *76. Philip Morris petitioned the full Commission for review of the FID. 

The Commission decided to review the FID in part. In 

the Matter of Certain Tobacco Heating Articles & Components Thereof, Inv. No. 337-TA-1199, Commission Opinion, 

2021 WL 4947427 (Oct. 19, 2021) (Commission Op.). 

Among other things, it affirmed the ALJ’s determination of 

nonobviousness of the asserted claims of the ’123 patent 

and the ALJ’s determination that Reynolds satisfied the 

domestic industry requirement. The Commission concluded that Philip Morris had violated Section 337 and issued cease and desist orders directed to Altria Client 

Services LLC and Philip Morris USA, Inc., and issued a 

limited exclusion order banning the importation of infringing products by Philip Morris and its affiliates. 

Philip Morris appeals. We have jurisdiction under 

28 U.S.C. § 1295(a)(6).

DISCUSSION

Philip Morris raises numerous issues on appeal. First, 

it asserts that the Commission legally erred by failing to 

comply with its statutory duty to “consult with[] and seek 

advice and information from” HHS. Appellants’ Br. 27–28. 

More specifically, Philip Morris complains that the Commission failed to consult with the Food and Drug Administration (FDA), the HHS agency that exclusively oversees 

the regulation of tobacco products in the United States. Id. 

Second, Philip Morris argues that the Commission abused 

its discretion in holding that the public interest does not 

preclude issuance of remedial orders. Id. at 64. Third, 

Philip Morris challenges the Commission’s finding that a 

domestic industry exists as being legally erroneous because 

the products on which Reynolds relies for its assertion of 

domestic industry had not received FDA approval at the 

time the complaint was filed. Id. at 35.

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PHILIP MORRIS PRODUCTS S.A. v. ITC 7

Philip Morris also raises several patent-specific issues. 

Philip Morris’s fourth argument is that the Commission’s 

conclusion that Philip Morris did not show that the asserted claims of the ’123 patent would have been obvious is 

unsupported by substantial evidence. Id. at 38–39. Fifth, 

Philip Morris asserts that the Commission’s conclusion 

that the accused products infringed the asserted claims of 

the ’915 patent rests on an erroneous claim construction. 

Id. at 48. Sixth and finally, Philip Morris challenges the 

Commission’s finding—that Philip Morris failed to show 

that the asserted claims of the ’915 patent are invalid because the allegedly invalidating product does not qualify as 

prior art—as unsupported by substantial evidence. Id.

at 55. We address each issue in turn. 

Our court reviews the Commission’s decisions under 

the standards of the Administrative Procedure Act (APA). 

19 U.S.C. § 1337(c); 5 U.S.C. § 706(2). We review the Commission’s legal determinations, including statutory interpretation, de novo and its factual findings for substantial 

evidence. Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d 

1331, 1343–44 (Fed. Cir. 2010). 

Duty to Consult Under Section 337

We begin with Philip Morris’s argument that the Commission erred by failing to meet its statutory duty as set 

forth in Section 337. That statutory duty requires that: 

During the course of each investigation under this 

section, the Commission shall consult with, and 

seek advice and information from, the Department 

of Health and Human Services, the Department of 

Justice, the Federal Trade Commission, and such 

other departments and agencies as it considers appropriate.

19 U.S.C. § 1337(b)(2). 

According to Philip Morris, the FDA determined that 

the accused products “help protect, promote, and benefit 

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8 PHILIP MORRIS PRODUCTS S.A. v. ITC

public health” when it granted the accused products’ premarket tobacco product applications (PMTAs) and, later, 

the modified risk tobacco product applications (MRTPAs). 

Appellants’ Br. 4–5. Philip Morris argues specifically that 

the FDA determined (1) in granting the PMTAs, that authorizing the accused products for the U.S. market “is appropriate for the protection of the public health,” 

J.A. 41199, and (2) in granting the MRTPAs, that the science-based evidence “demonstrates” that the accused products are “appropriate to promote the public health” and 

“expected to benefit the health of the population as a 

whole,” J.A. 41391. Therefore, in Philip Morris’s view, the 

FDA’s grant of the PMTAs and MRTPAs demonstrates that 

the accused products provide “enormous public health benefits,” Appellants’ Br. 7, and that “[t]he Commission’s decision” to stop importation of those products “deprived 

consumers of an unparalleled tool to curtail [traditional 

combustible cigarette] smoking,” id. at 12. Thus, Philip 

Morris argues, had the Commission consulted the FDA, as 

was its duty, the FDA may have provided “significant information, as well as sound advice,” id. at 32, that would 

have dissuaded the Commission from ultimately issuing 

cease and desist and limited exclusion orders. Because 

Philip Morris forfeited this argument, and because in any 

event the Commission satisfied its duty to “consult with” 

HHS, we conclude that the Commission committed no error. 

A 

The Commission found that Philip Morris had forfeited 

this argument in its opinion denying Philip Morris’s motion 

to stay the Commission’s limited enforcement and cease 

and desist orders. J.A. 15054. In particular, the Commission noted that “Philip Morris’s motion to stay” before the 

Commission “[wa]s the first time that Philip Morris made 

such an argument before the Commission” or the ALJ. Id. 

The Commission posited that, if Philip Morris had

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PHILIP MORRIS PRODUCTS S.A. v. ITC 9

sought participation from HHS at the ALJ stage, 

and objected if no such participation occurred—and 

then again sought participation at the Commission 

stage—the Commission would have been in a position to determine whether [Philip Morris] had 

demonstrated the need for further outreach beyond 

what the Commission provides for in its rules, and 

exactly what further outreach, if any, might have 

been conducted.

Appellee’s Br. 34–35; see also J.A. 15055 (“[Q]uestions concerning the relationship between coordinate government 

entities must be raised and preserved” in order for the 

agency to “address these concerns adequately and in a 

timely manner.”). The Commission cited 19 C.F.R. 

§ 210.43(b)(2), which provides: “Any issue not raised in a 

petition for review will be deemed to have been abandoned 

by the petitioning party and may be disregarded by the 

Commission in reviewing the initial determination . . ., and 

any argument not relied on in a petition for review will be

deemed to have been abandoned and may be disregarded 

by the Commission.” J.A. 15056 (quoting 19 C.F.R. 

§ 210.43(b)(2)). On appeal, the Commission argues that it 

had no opportunity to address Philip Morris’s concerns due 

to Philip Morris’s own failure to raise the issue. Appellee’s 

Br. 34–35.

We agree with the Commission. As demonstrated by 

the procedural history of this case, Philip Morris had numerous opportunities to raise and preserve this issue but 

failed to do so. 

“[F]orfeiture is the failure to make the timely assertion 

of a right.” Pavo Sols. LLC v. Kingston Tech. Co., 35 F.4th 

1367, 1380 (Fed. Cir. 2022) (quoting United States 

v. Olano, 507 U.S. 725, 733 (1993)). We have “regularly 

stated and applied the important principle that a position 

not presented in the tribunal under review will not be considered on appeal.” Id. (quoting In re Google Tech. 

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10 PHILIP MORRIS PRODUCTS S.A. v. ITC

Holdings LLC, 980 F.3d 858, 863 (Fed. Cir. 2020)); see also 

Singleton v. Wulff, 428 U.S. 106, 120 (1976) (“It is the general rule . . . that a federal appellate court does not consider 

an issue not passed upon below.”).

Philip Morris failed to raise this issue before the ALJ. 

None of Philip Morris’s briefing before the ALJ addressed, 

or even mentioned, the Commission’s statutory duty to 

“consult with” HHS or the FDA. In fact, the ALJ directly 

asked the parties for their “views about [his] authority under 19 U.S.C. [§] 1337(b)(2), which instructs that the Commission may consult with [HHS], and, by implication, the 

[FDA],” J.A. 21372 (Hearing Tr. 1524:17–1524:21). But

counsel for Philip Morris responded that he had “absolutely 

no objection whatsoever,” J.A. 21383 (Hearing 

Tr. 1571:03–1571:08), to the ALJ’s authority to “consult 

with any publicly-available information on the FDA’s web 

site regarding any of the products that have been discussed 

during [the] investigation.” J.A. 21372 (Hearing 

Tr. 1524:22–1524:25). He then stated that he had “nothing 

[further] to share on that.” J.A. 21384 (Hearing 

Tr. 1574:18–1574:20). At no point during the hearing did 

counsel for Philip Morris ask the ALJ to reach out to the 

FDA or suggest that the ALJ had not properly “consulted 

with” the FDA. 

Philip Morris does not meaningfully dispute that it 

failed to raise the issue of the Commission’s statutory duty 

before the ALJ. As evidence of its efforts to “fairly alert” 

the ALJ to the issue, Philip Morris points only to its counsel’s statement that he had “nothing to share” regarding 

the Commission’s duty at the evidentiary hearing before 

the ALJ. Appellants’ Reply Br. 4–5; see also J.A. 21384 

(Hearing Tr. 1574:18–1574:20). Instead, Philip Morris asserts that “notice to the Commission regarding the ‘consult 

with’ issue was unnecessary prior to the” Commission’s final determination. Appellants’ Reply Br. 4. We disagree.

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This court recognizes that failure to raise an issue before an ALJ during an investigation constitutes forfeiture 

of that issue. Kyocera Wireless Corp. v. Int’l Trade 

Comm’n, 545 F.3d 1340, 1352 (Fed. Cir. 2008) (determining 

that an argument not set forth “until after the [ALJ] had 

made an initial determination” was “untimely and could 

properly be rejected on that ground alone”). We have also 

recognized that a party’s failure to make a specific argument in its petition for review of the FID before the Commission constitutes forfeiture. Guangdong Alison Hi-Tech 

Co. v. Int’l Trade Comm’n, 936 F.3d 1353, 1362 (Fed. Cir. 

2019) (citing 19 C.F.R. § 210.43(b)(2) and Finnigan Corp. 

v. Int’l Trade Comm’n, 180 F.3d 1354, 1362–63 (Fed. Cir. 

1999)). Here, not only did Philip Morris fail to raise this 

issue before the ALJ, but it also failed to raise it before the 

Commission.2 Two weeks after the ALJ issued the FID, 

Philip Morris filed its petition for review. The petition 

made no mention of the Commission’s alleged failure to 

“consult with” the FDA. 

Throughout August 2021, both Philip Morris and 

Reynolds filed several rounds of briefing on the public interest issue. In its reply brief, Philip Morris stated, for the 

first time in the course of the investigation, that “[t]he 

Commission may find it enlightening to discuss these matters directly with various party and third-party experts in 

this field and perhaps even representatives of FDA itself.” 

J.A. 14780–81 (emphases added). The Commission argues 

2 Philip Morris argues that it was not required to 

raise the issue before the ALJ because the statutory duty 

to consult lies ultimately with the Commission, not the 

ALJ. See Appellants’ Reply Br. 3. Here, we need not decide 

whether Philip Morris needed to raise its duty-to-consult 

argument before the ALJ in order to avoid forfeiture because its failure to raise the argument before the Commission suffices to conclude that Philip Morris forfeited it.

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12 PHILIP MORRIS PRODUCTS S.A. v. ITC

on appeal, and we agree, that this “vague suggestion is nowhere near a specific request for additional Commission 

action, nor an assertion of legal error.” Appellee’s Br. 33. 

Phillip Morris did not assert that the FDA’s participation 

was mandatory nor that the FDA’s lack of participation 

was erroneous. 

Philip Morris finally raised the issue in its motion to 

stay the Commission’s remedial orders, which it filed on 

December 3, 2021, two days after filing its notice of appeal 

before this court. There, relying on dictionary definitions 

for the ordinary meaning of “consult,” J.A. 14939–48, 

Philip Morris argued that it was entitled to a stay because 

“the Commission failed to ‘consult with’ [HHS] as required 

under [S]ection 337,” J.A. 15053.

Until its motion to stay the Commission’s final exclusion order, Philip Morris failed to do more than suggest 

that the Commission “may find” value in discussing the 

public interest issue with the FDA. J.A. 14780. Philip 

Morris certainly did not raise, develop, or preserve the issue in any of its briefing prior to the motion to stay. We 

agree with the Commission that Philip Morris’s argument 

about the Commission’s duty to consult came far too late 

and, thus, we conclude that Philip Morris forfeited the argument. 

B 

Even in the absence of forfeiture, we conclude that, in 

this case, the Commission satisfied its duty to “consult 

with” HHS and the FDA.

When the Commission instituted the investigation in 

May 2020, it published a Notice of Investigation in the Federal Register, J.A. 3432–33, and individually served letters 

enclosing the Notice of Investigation to representatives of 

the Department of Justice, the U.S. Bureau of Customs and 

Border Protection, the Federal Trade Commission, and 

HHS. J.A. 43501. The letter served on HHS was delivered 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 13

to the employee designated by HHS to monitor Section 337 

investigations. J.A. 43515. The letter stated that non-confidential pleadings could be obtained upon request and that 

any questions should be directed to the specific Commission Investigative Attorney assigned to the case. Id. The 

appended notice of investigation in turn stated 

that: (1) the Commission had ordered an investigation 

concerning whether certain imported “electric tobacco 

heating device systems and the associated tobacco sticks 

sold for use with the device systems” infringed certain 

claims of particular patents; (2) the complainant requested 

that the Commission “issue a limited exclusion order and 

cease and desist orders”; and (3) the presiding ALJ would 

“take evidence or other information and hear arguments 

from the parties or other interested persons with respect to 

the public interest in this investigation.” J.A. 3432–33.

Although the FDA did not respond to the initial letter 

with evidence or other information, the Commission had 

input from the FDA on the public interest issue. Indeed, 

the ALJ explained that he reached his conclusion on public 

interest “based on scientifically reliable information from 

expert and independent government authorities, including 

the FDA and the U.S. Surgeon General.” FID, 2021 WL 

2333742, at *60 (emphasis added). The ALJ identified the 

exhibits of record bearing on the public interest issue, including over 30 FDA documents, such as the PMTA and 

MRPTA documents. Id. at *59. 

In August 2021, after the ALJ issued the FID, the Commission published an additional notice in the Federal Register soliciting input from interested government agencies. 

J.A. 13973–75 (86 Fed. Reg. 41,509–11 (Aug. 2, 2021)). 

The notice identified the specific parties and patent issues 

under consideration, indicated that the Commission was 

considering an exclusion order, and encouraged “interested 

government agencies . . . to file written submissions on the 

issues of remedy, the public interest, and bonding.” 

J.A. 13974. The notice emphasized that “such submissions 

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should address the recommended determination by the 

ALJ on remedy.” Id. 

Philip Morris argues that even if the notice in the Federal Register “could be deemed adequate notice, there is a 

difference between notice and actual consultation.” Appellants’ Br. 28. Philip Morris argues that the Commission 

was required to take “joint action” and participate in “an 

exchange of information” with HHS. Id. To this end, Philip 

Morris urges us to adopt the Ninth Circuit’s view that the 

statutory language “consult with” requires something more 

than providing interested government agencies with notice

and an opportunity to respond. Id. In particular, Philip 

Morris stresses that consultation, as recited in the statute, 

requires “hav[ing] discussions or confer[ring] with (someone), typically before undertaking a course of action.” Id.

at 29–30 (quoting New Oxford Am. Dictionary (3d ed. 2010) 

and citing Cal. Wilderness Coal. v. U.S. Dep’t of Energy, 

631 F.3d 1072, 1087 (9th Cir. 2011)). 

We need not resolve whether the directive to “consult 

with” HHS within this particular statutory framework requires more than notice in the Federal Register and an opportunity to comment. Even if we were to adopt Philip 

Morris’s statutory construction, we conclude that, in this 

case, the record demonstrates that the Commission satisfied its duty.

Particularly persuasive is the fact that the Commission 

asked interested government agencies, including the FDA,

to provide written submissions on the public interest factor 

and address the ALJ’s FID well before the Commission issued its exclusion order. J.A. 13974. This invitation allowed agencies to respond directly to the ALJ’s public 

interest analysis for the Commission’s consideration and 

also comment on the appropriate remedy. We do not conclude that the Commission failed to perform its duty simply 

because the FDA chose not to submit any additional information. The Commission cannot force the FDA to engage.

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We are also persuaded by the fact that Philip Morris 

never articulated what, in its view, the Commission had to 

do to comply with § 1337(b)(2). Throughout the course of 

this investigation, the Commission followed its longstanding typical process for complying with § 1337(b)(2)’s mandate to “consult with” other federal agencies.3 Only 

afterward, in its motion to stay the Commission’s remedial 

orders, did Philip Morris complain that the Commission

did not properly “consult with” the FDA. Philip Morris

never asked the ALJ or the Commission to depart from its 

usual process during the investigation. For example,

Philip Morris never asked the Commission to invite briefing from the FDA or seek other submissions from the FDA 

through a different procedure. Nor did Philip Morris specify what it expected the FDA to provide beyond the upwards of 30 FDA documents that the ALJ already 

considered in analyzing the public interest factor. See FID, 

2021 WL 2333742, at *59. Even on appeal, Philip Morris 

does not articulate exactly what the Commission should 

have done to comply with § 1337(b)(2). As the Commission 

noted, the APA “generally limits the ALJ’s and the Commission’s authority to engage in ex parte communications 

relevant to the merits of the investigation,” and Philip Morris never “identified a specific consultation with [HHS] that 

was required . . . or what form that coordination must 

take.” J.A. 15055 (citing 5 U.S.C. § 557(d)(1)). Because 

Philip Morris has neither developed nor supported its 

3 The Commission’s process for complying with 

§ 1337(b)(2) had been in place for nearly 30 years. It was 

developed in 1994, when the Commission’s Inspector General investigated the Commission’s practices as part of an 

audit to “increase the economy and efficiency of the process 

for conducting Section 337 investigations.” J.A. 43516 

(cleaned up); see also J.A. 43523–24. 

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16 PHILIP MORRIS PRODUCTS S.A. v. ITC

argument, we reject its view that the Commission did not 

comply with § 1337(b)(2) in this case. 

Public Interest 

Next, we address Philip Morris’s assertion that the 

Commission abused its discretion by granting injunctive 

relief notwithstanding the evidence Philip Morris provided

on public interest. According to Philip Morris, the FDA is 

the only agency competent to oversee tobacco product regulation, and the Commission should have deferred to its

expert findings. Specifically, Philip Morris contends that 

because the FDA granted the IQO products’ PMTAs—issuing marketing orders available for products “appropriate 

for the protection of public health”—and MRTPAs—issuing

modified risk orders allowing a product to be marketed as 

“reduced risk” or “reduced exposure”—the Commission 

should have denied injunctive relief. Appellants’ Br. 9, 65.

“Congress intended injunctive relief to be the normal 

remedy for a Section 337 violation . . . .” Spansion, 629 

F.3d at 1358. Indeed, § 1337(d)(1) provides that if the 

Commission determines “that there is violation of this section, it shall direct that the articles concerned . . . be excluded . . . unless, after considering [public interest,] it 

finds that such articles should not be excluded” (emphasis 

added). In deciding this issue, the Commission must consider the effect of the remedy on four statutory public interest factors: (1) public health and welfare, 

(2) competitive conditions in the U.S. economy, (3) the production of like articles in the United States, and (4) U.S. 

consumers. 19 U.S.C. § 1337(d)(1), (f)(1). “[T]he Commission has broad discretion in selecting the form, scope and 

extent of the remedy, and judicial review of its choice of 

remedy necessarily is limited.” Viscofan, S.A. v. Int’l Trade 

Comm’n, 787 F.2d 544, 548 (Fed. Cir. 1986). Stated another way, because the Commission is “the expert body to 

determine what remedy is necessary,” it has “wide latitude 

for judgment and the courts will not interfere except where 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 17

the remedy selected has no reasonable relation to the unlawful practices found to exist.” Id. (quoting Jacob Siegel 

Co. v. Fed. Trade Comm’n, 327 U.S. 608, 611–13 (1946)). 

This court therefore must affirm the Commission’s choice 

of remedy unless the action is “arbitrary, capricious, an 

abuse of discretion, or otherwise not in accordance with 

law.” Spansion, 629 F.3d at 1358. 

For its part, the Commission asserts that record evidence, including “numerous FDA statements and documents regarding [the] IQOS” products, support the 

conclusion that “excluding [the] IQOS [products] will not 

adversely impact the public health and welfare,” and thus 

the Commission has acted within its “wide discretion to 

evaluate the public health and welfare . . . and to grant appropriate relief.” Appellee’s Br. 51–53. Reynolds notes 

that the Commission has determined that the public interest outweighed the need for injunctive relief in protecting 

intellectual property rights in only three prior investigations. In each case, the Commission determined that an 

exclusion order would have deprived the public of “products 

necessary for some important health or welfare need: energy efficient automobiles, basic scientific research, or hospital equipment.” Spansion, 629 F.3d at 1359–60. 

Reynolds asserts that this is not such a case.

We hold that the Commission provided a sufficient basis for issuance of an exclusion order and that its actions 

were not arbitrary, capricious, an abuse of its discretion, or 

otherwise not in accordance with law. The ALJ and the 

Commission properly considered and weighed the public 

interest evidence put forth by the parties, including expert 

testimony, scientific evidence, and, importantly, over 30 

FDA documents regarding the IQOS products, including 

the PMTA and MRTPA documents on which Philip Morris 

relies. The Commission reasonably agreed with the ALJ

that, notwithstanding the granted PMTAs and MRTPAs, 

numerous FDA documents in the record demonstrate that 

exclusion of the IQOS products will not adversely impact 

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18 PHILIP MORRIS PRODUCTS S.A. v. ITC

the public health and welfare, particularly given the existence of other non-tobacco therapies that reduce tobacco use

and consideration of the population as a whole. For example, the FDA stated that “[w]hile [the grant of the PMTA] 

permits the tobacco products to be sold in the U.S., it does 

not mean these products are safe or ‘FDA approved.’” Commission Op., 2021 WL 4947427, at *40 (quoting

J.A. 41199). The FDA also stated: “All tobacco products 

are potentially harmful and addictive and those who do not 

use tobacco products should continue not to.” Id. (quoting

J.A. 41199). It further stated that “the use of the IQOS 

system clearly still exposes users to HPHCs [(harmful and 

potentially harmful constituents)] and would be expected 

to cause harm.” Id. at *41 (quoting J.A. 41422). The FDA

also stated that: 

[Philip Morris] has not demonstrated that, as actually used by consumers, the products sold or distributed with the proposed modified risk 

information will significantly reduce harm and the 

risk of tobacco-related disease to individual tobacco 

users and benefit the health of the population as 

whole. 

Id. at *40 (quoting J.A. 41386) (emphasis in original). 

Because the Commission’s decision rests on a reasonable review of the public interest evidence, we conclude that 

the Commission did not abuse its discretion in its selection 

of the form, scope, and extent of the remedy. 

Domestic Industry

We turn next to Philip Morris’s assertion that the Commission legally erred in finding a domestic industry based 

on Reynolds’ investments in activities relating to its VUSE 

Vibe and Solo products, which had not yet received FDA 

authorization at the time of the complaint. According to 

Philip Morris, because Reynolds’ products had not received 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 19

FDA authorization, they were illegal and could not form 

the basis for a domestic industry. Appellants’ Br. 5. 

The domestic industry requirement of Section 337, 

19 U.S.C. § 1337(a)(2) and (a)(3), includes an economic 

prong, which “requires that there be an industry in the 

United States,” and a technical prong, which “requires that 

the industry relate to articles protected by the patent,” both 

of which must be met. InterDigital Commc’ns, LLC v. Int’l 

Trade Comm’n, 707 F.3d 1295, 1298 (Fed. Cir. 2013). 

Philip Morris does not dispute that Reynolds satisfied the 

technical prong. We are instead presented with the singular question of whether the economic prong of the domestic 

industry analysis excludes products that have not received 

regulatory authorization as of the filing of the complaint.4

To resolve this issue, we must interpret the statute. 

Statutory interpretation presents a question of law, which 

we review de novo. 5 U.S.C. § 706. We start with the language of the statute. Section 1337(a)(2)–(3) outlines the 

domestic industry requirement: 

(2) Subparagraphs (B), (C), (D), and (E) of paragraph (1) apply only if an industry in the United 

States, relating to the articles protected by the patent, copyright, trademark, mask work, or design 

concerned, exists or is in the process of being established.

(3) For purposes of paragraph (2), an industry in 

the United States shall be considered to exist if 

there is in the United States, with respect to the 

4 We note that although the FDA granted Reynolds’ 

PMTAs after the Commission issued its opinion, the filing 

date of the complaint is the “relevant date at which to determine if the domestic industry requirement” is satisfied. 

Motiva, LLC v. Int’l Trade Comm’n, 716 F.3d 596, 601 n.6 

(Fed. Cir. 2013). 

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20 PHILIP MORRIS PRODUCTS S.A. v. ITC

articles protected by the patent, copyright, trademark, mask work, or design concerned— 

(A) significant investment in plant and equipment;

(B) significant employment of labor or capital; or

(C) substantial investment in its exploitation, including engineering, research and development, or 

licensing.

19 U.S.C. § 1337(a)(2)–(3).

Nothing in the plain language of the statute requires 

that the protected articles have regulatory approval. As 

the Commission aptly explained, “Philip Morris points to 

no authority that FDA approval is a condition precedent to 

the establishment of a domestic industry, nor is the Commission aware of any such authority.” J.A. 15061. Even if 

the articles could not be sold commercially in the United 

States, the parties do not dispute that sufficient investment in labor and capital had been expended. In addition, 

the record demonstrates that, at the time of the complaint, 

Reynolds’ VUSE products were being sold in the United 

States with knowledge of the FDA. 

Philip Morris responds that the FDA’s so-called Deeming Rule, enacted on August 8, 2016, applied the Family 

Smoking Prevention and Tobacco Control Act (TCA) to 

“new tobacco products,” including Electronic Nicotine Delivery Systems, rendering non-approved products illegal 

and unusable in a domestic industry analysis. See Appellants’ Reply Br. 7; Deeming Tobacco Products to be Subject 

to the Federal Food, Drug and Cosmetic Act, as Amended 

by the Family Smoking Prevention and Tobacco Control 

Act, 81 Fed. Reg. 28,974, 29,975–76 (May 10, 2016) (“Deeming Rule”); see also 21 U.S.C. § 387j. The Deeming Rule required electronic nicotine products to receive premarket 

tobacco authorization, and retroactively applied to products already on the market. Due to the new requirement 

that manufacturers comply with the TCA by filing for 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 21

PMTA for products already being sold in the United States, 

the Deeming Rule included staggered compliance periods, 

essentially grace periods, for existing products to comply 

with certain provisions of the TCA. 81 Fed. Reg. at 29,010

(May 10, 2016). During these periods, which were extended multiple times, the FDA announced that it did not 

“intend to take enforcement action against products remaining on the market for failure to have a premarket authorization order.” Id.

At the time it filed the complaint on April 9, 2020, 

Reynolds’ VUSE products had been on the market for some 

time, and the FDA’s “May 12, 2020 deadline for PMTA[s]” 

for electronic nicotine products had not yet passed. See

J.A. 43278. Thus, Reynolds’ VUSE products still fell 

within the grace period during which a granted PMTA was 

not required for the products to remain on the market. Additionally, Reynolds had already applied for, and was 

awaiting, approval of a PMTA for its VUSE Solo product, 

and less than a week after filing the complaint filed a 

PMTA for its VUSE Vibe product. J.A. 43278–79. That the 

regulatory process, for which there was an explicit grace 

period, was not complete at the time that Reynolds filed the 

complaint does not mean the domestic industry products 

were “illegal,” as Philip Morris insists.

On this record, we conclude that Philip Morris’s argument—that Reynolds’ products that had not received FDA 

authorization are precluded from consideration by Section 337 for purposes of its domestic industry requirement—has no merit. We therefore affirm the 

Commission’s final determination that Reynolds established the existence of a domestic industry.

Obviousness of the ’123 Patent Claims

Turning to the patent-specific issues, we begin with 

Philip Morris’s challenge to the Commission’s conclusion 

that Philip Morris failed to show that claims 27–30 of the 

’123 patent would have been obvious. 

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22 PHILIP MORRIS PRODUCTS S.A. v. ITC

The asserted claims cover an electrically powered 

smoking article having a “tubular outer housing,” an electrical power source, “at least one electrical resistance 

heater” with a portion “positioned proximal to the center of 

the outer housing” of the smoking article, a controller for 

regulating current flow through the heater, and a disposable tobacco stick that can be inserted into the outer housing. ’123 patent col. 34 ll. 31–58. An exemplary smoking 

article (10) having an electrical resistance heating element

with an elongated portion (72) positioned central to the 

housing is shown in Figure 3 of the ’123 patent and depicted below. 

Id. Fig. 3 (electrical resistance heating element indicated 

in red). 

The ultimate question of obviousness is a legal question that we review de novo with underlying factual findings that we review for substantial evidence. Fleming 

v. Cirrus Design Corp., 28 F.4th 1214, 1221 (Fed. Cir. 

2022). Under the substantial evidence standard, this court 

“must affirm a Commission determination if it is reasonable and supported by the record as a whole, even if some 

evidence detracts from the Commission’s conclusion.” 

Spansion, 629 F.3d at 1344 (quoting Nippon Steel Corp. 

v. United States, 458 F.3d 1345, 1352 (Fed. Cir. 2006)); see 

also 5 U.S.C. § 706(2). “[T]he possibility of drawing two 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 23

inconsistent conclusions from the evidence does not prevent an administrative agency’s finding from being supported by substantial evidence.” Consolo v. Fed. Mar. 

Comm’n, 383 U.S. 607, 620 (1966).

Before the ALJ, Philip Morris argued that 

claims 27–30 of the ’123 patent would have been obvious 

over U.S. Patent No. 5,249,586 (“Morgan”) in view of the 

general knowledge and creativity of a person having ordinary skill in the art. FID, 2021 WL 2333742, at *27. Morgan describes a tobacco heating system, shown below,

having multiple heating elements (23) “preferably distributed substantially uniformly around the circumference of 

[a] cavity” within the smoking article that houses a disposable tobacco stick. Morgan col. 5 ll. 18–25.

Id. Fig. 2 (heating elements indicated in red). 

Morgan discloses two embodiments in which the heating elements heat the outside of the disposable tobacco 

stick and one embodiment in which the heating elements 

“actually pierce and extend into [the] disposable” tobacco 

stick “to provide the desired intimate thermal contact.” Id.

at col. 6 ll. 46–62. In all of the embodiments, the heating 

elements are arranged circumferentially and “spaced apart 

sufficiently” to heat non-overlapping regions of the 

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24 PHILIP MORRIS PRODUCTS S.A. v. ITC

disposable tobacco stick. Id. at col. 5 ll. 18–25. Morgan explains that this arrangement advantageously allows the 

heating elements to heat discrete regions of a disposable 

tobacco stick in sequence. Id. at col. 5 ll. 61–65; see also id.

at col. 3 ll. 9–21. In particular, Morgan emphasizes that 

this sequential heating provided by the circumferentially 

located heaters avoids reheating portions of tobacco stick, 

which can lead to “the production of undesired compounds 

and off tastes.” Id. at col. 5 ll. 18–25.

Morgan also recognizes that placing the heating elements around the circumference of the cavity can result in 

an “inefficient use of tobacco” when using disposable tobacco sticks filled with tobacco product because that filling

“provides bulk and compressibility but is never heated to 

deliver flavor to the smoker.” Id. at col. 6 l. 63–col. 7 l. 10. 

To address this inefficiency, Morgan proposes using an alternative disposable tobacco stick that does not contain tobacco filling and instead is a non-tobacco “fiber bundle” 

wrapped in foil and coated in a tobacco-flavored “slurry.” 

Id.

The parties agreed that only one limitation of representative claim 27 is missing from Morgan. FID, 2021 WL 

2333742, at *27. That limitation recites:

at least one electrical resistance heater powered by 

said electrical power source, wherein at least a portion of the resistance heating element is elongated 

and extending downstream toward the mouth-end 

of the outer housing, the elongated portion of the 

resistance heating element positioned proximal to 

the center of the outer housing . . . . 

’123 patent col. 34 ll. 36–42 (emphasis added).

Philip Morris argued before the ALJ that the claimed 

central heating element would have been obvious in view 

of Morgan—which discloses only multiple circumferentially placed heaters, not central heaters—in combination 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 25

with the skilled artisan’s knowledge that central heating 

elements existed at the time of the invention. 

Specifically, Philip Morris asserted that the state of the 

prior art as of the earliest priority date of the ’123 patent 

“taught not just centered heaters, but also their advantages, including simplicity, reliability, reduced cost, 

and thermal efficiency.” FID, 2021 WL 2333742, at *27. 

Relying on the testimony of its technical expert, Stewart 

Fox, Philip Morris asserted that “it is undisputed that centered heaters were well known before the priority date of 

the ’123 patent.” Id.; see also J.A. 21199 (Hearing

Tr. 1075:03–1076:01) (testifying that centered heaters 

were “not new . . . at the time of Morgan, centered heaters 

were disclosed”). According to Mr. Fox, one of ordinary 

skill would have known that central tobacco heaters provided various advantages over “a number of smaller individual heaters positioned inside . . . the cigarette.” 

J.A. 21199 (Hearing Tr. 1074:06–1074:19). For example, 

Mr. Fox testified that a single centered heater uses fewer 

electrical connections than multiple individual heaters

and, thus, would likely be more reliable. J.A. 21199 (Hearing Tr. 1074:02–1074:21). Additionally, he opined that a 

single centered heater conducts heat “in a symmetrical 

manner,” which is the “most efficient” method for heating 

tobacco in certain applications. Id. Mr. Fox further agreed 

that a skilled artisan would readily understand how to 

modify Morgan to implement a single centered heater instead of using the multiple circumferential heaters: “[A]ll 

you do is take out this array of heaters and put in one central heater in the same place.” J.A. 21200 (Hearing 

Tr. 1078:07–1078:21).

In addition to this testimony, Philip Morris pointed to

the ’123 patent specification’s statement that “[s]election of 

the power source and resistance heating elements can be a 

matter of design choice.” ’123 patent col. 29 ll. 32–50; see 

also FID, 2021 WL 2333742, at *29. In Philip Morris’s 

view, this statement established that there was a narrow 

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26 PHILIP MORRIS PRODUCTS S.A. v. ITC

list of design choices that were known and available to the 

skilled artisan. FID, 2021 WL 2333742, at *29. Philip 

Morris thus argued that the known advantages of a single 

centered heater, combined with the general knowledge that 

centered heaters were available in the art, would have motivated one of ordinary skill “to implement Morgan using a 

centered heater as the predictable solution from the narrow list of known and available design choices.” Id.

After weighing the evidence, the ALJ found that Morgan’s emphasis on placing heating elements circumferentially around the outside of the housing—and its lack of

discussion of such elements being centrally placed—was 

evidence that “Morgan itself shows that it would not have 

been obvious to modify Morgan to include a centered 

heater.” Id. Furthermore, the ALJ noted that Philip Morris had not actually cited any evidence to show that there 

was a narrow list of known and available design choices. 

The ALJ thus concluded that “Philip Morris has failed to 

show by clear and convincing evidence that Morgan in view 

of the general knowledge of a person of ordinary skill in the 

art renders obvious claims 27–30 of the ’123 patent.” Id.

at *30. 

Philip Morris petitioned for review to the full Commission, arguing that the ALJ erred in “requiring an express 

‘motivation’ to modify Morgan with a centered heater” and 

by ignoring evidence that one of ordinary skill “would have 

been aware of numerous benefits of centered heating elements . . . and therefore would have had additional good 

reason to design the Morgan smoking article with one.” 

Commission Op., 2021 WL 4947427, at *24. The Commission affirmed the ALJ’s findings and provided supplemental reasoning. Id.

In particular, the Commission explained that Philip 

Morris’s obviousness theory before the ALJ was premised 

on the “assumption that there were only three options for 

placement of the heater in the Morgan device.” Id. But, 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 27

explained the Commission, Philip Morris failed to support 

this assumption. According to the Commission, Philip 

Morris failed to “cite any evidence demonstrating there 

were a limited number of design choices for the heating element.” Id. at *25. Additionally, due to the “multitude of 

design considerations beyond just the heater location,” the 

Commission found that “heater design in an electronic cigarette was anything but a ‘simple design choice,’” as Philip 

Morris asserted. Id. This, the Commission reasoned, was 

therefore not a case in which there were only a few known, 

predictable solutions available such that a skilled artisan 

would have “faced a simple design choice between” them. 

Id. (quoting Uber Techs., Inc. v. X One, Inc., 957 F.3d 1334, 

1341 (Fed. Cir. 2020)). 

Additionally, the Commission found that Philip Morris’s reliance on the ’123 patent specification’s statement 

that “[s]election of the power source and resistance heating 

elements can be a matter of design choice” was misplaced. 

’123 patent col. 29 ll. 32–50. In so finding, the Commission 

pointed out that “[t]he ’123 patent does not state . . . that 

the arrangement and positioning of those resistance heating elements are matters of design choice.” Commission 

Op., 2021 WL 4947427, at *24. Instead, the Commission 

agreed with the ALJ’s explanation that the design choices 

described in the ’123 patent “actually refer[] to the amount 

of resistance in the resistance hea[t]ing elements and the 

voltage and current provided by the power sources,” not the 

location or placement of the heating elements. Id. at *23–

24 (citing FID, 2021 WL 2333742, at *29). In other words, 

the Commission explained that the ’123 patent’s disclosure 

did not support Philip Morris’s assertions that choosing 

heating element placements was a simple design choice or 

that there was a finite number of known solutions for such

placements. 

The Commission also agreed with the ALJ that Morgan 

itself suggests not using a central heater. The Commission 

noted that Morgan already recognized inefficiencies with 

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28 PHILIP MORRIS PRODUCTS S.A. v. ITC

its circumferential arrangement of heaters, because the 

heating elements would only heat the tobacco on the outside of a disposable tobacco stick. Id. at *24, 26. To address 

this problem, the Commission noted, Morgan did not, for 

example, disclose modifying its device to implement the allegedly “known” solution of a single centered heater to heat 

the tobacco on the inside of the disposable tobacco stick. 

Instead, Morgan describes “removing the tobacco from the 

center of the disposable portion and putting in its place a 

non-tobacco ‘fiber bundle’ surrounded by a layer of metallic 

foil with a slurry of tobacco coated onto it.” Id. at *26 (citing Morgan col. 6 l. 63–col. 7 l. 10). Thus, the Commission 

determined that the evidence of record weighed against one 

of ordinary skill implementing a single centered heater in 

Morgan.

On appeal, Philip Morris repeats the arguments that it 

made before the ALJ and the Commission. Philip Morris 

argues there was “no need to show any additional ‘reason 

for why’ [one of ordinary skill] would be motivated to modify” Morgan to implement a centered heating element. Appellants’ Br. 42–43 (citing CRFD Rsch., Inc. v. Matal, 876 

F.3d 1330, 1347 (Fed. Cir. 2017)). This is so, Philip Morris 

argues, because our court’s precedent dictates that when a 

feature is “a simple design choice,” to be selected from 

among “a finite number of identified, predictable solutions,” it “would have been obvious” to pursue one of the 

known, predictable solutions. Id. at 42–43. Philip Morris 

also reiterates its position that the ’123 “patent itself confirms” heating element placement is a “matter of design 

choice.” Id. at 38–39 (citing ’123 patent col. 29 ll. 32–50). 

While the issue of obviousness in view of Morgan is a 

close one, we are not convinced that the Commission erred 

in its fact findings or its ultimate conclusion. The Commission did not err in finding that the ’123 patent specification’s statement that “[s]election of the power source and 

resistance heating elements can be a matter of design 

choice” merely contemplates that the amount of resistance 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 29

in the resistance heating elements—not their placement—

was a simple matter of design choice. Read in context with 

the remainder of the specification, the Commission’s understanding is not unreasonable. 

The Commission also did not err in finding that Philip

Morris’s expert testimony did not establish that only a limited number of design choices were available to the skilled 

artisan. Philip Morris argues that the Commission erred 

in ignoring the “[u]ncontested” testimony “establish[ing] 

that there were just three locations for the placement of a 

heater in an electronic heat-not-burn device:” (1) outside 

the cigarette, (2) inside the cigarette but not centered, or

(3) inside and centered. Appellants’ Br. 39 (citing 

J.A. 21198 (Hearing Tr. 1072:05–1073:14)). Philip Morris 

does not accurately represent this testimony. This testimony actually states that there are “a limited category of—

limited number of categories of heater design,” and that 

“some of them,” the “main ones,” included “an internal 

heater, internal to the tobacco rod,” or “external” heater designs in the form of “either a shell around the tobacco stick 

or a plate at the end of the tobacco stick.” J.A. 21198 (Hearing Tr. 1072:05–1073:14). As the Commission points out, 

Mr. Fox “never actually opined that there were only three

locations for placement of the heater.” Appellee’s Br. 59. 

The Commission found instead that “there are numerous 

locations that are ‘inside the cigarette but not centered,’ instead of only one, as [Philip Morris] argues.” Id. We agree 

with the Commission that Mr. Fox’s testimony does not 

support Philip Morris’s assertion.

Finally, substantial evidence also supports the Commission’s finding that Morgan itself provides strong evidence against a conclusion that it would have been obvious 

to replace the circumferential heaters with a centered 

heater. Indeed, Morgan explains that its circumferential 

placement is advantageous and goes so far as to modify the 

tobacco sticks instead of resorting to a central heater. Testimony from Reynolds’ technical expert, Charles Clemens, 

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30 PHILIP MORRIS PRODUCTS S.A. v. ITC

also supports the Commission’s finding. Mr. Clemens explained that it was Morgan’s arrangement of “separate 

heaters around the periphery of the tobacco stick” that provided the advantages of Morgan’s purported invention: allowing “fresh tobacco [to] be heated with each sequential 

puff” to avoid “the reheating of the tobacco[, which] produces undesired compounds and off-taste.” J.A. 21367 

(Hearing Tr. 1505:01–1507:17); see also J.A. 21367–68 

(Hearing Tr. 1507:23–1508:21). In other words, as 

Mr. Clemens explained, “Morgan teaches the opposite of a 

centered heater.” J.A. 21367 (Hearing Tr. 1505:01–

1507:17). 

Philip Morris argues that the Commission improperly

treated Morgan’s disclosure as teaching away from centered heaters. Appellants’ Br. 46. But the Commission 

never made a teaching away finding, instead focusing on 

Morgan’s teachings as a whole as they related to motivation to modify Morgan to include central heater. Commission Op., 2021 WL 4947427, at *26 (citing Morgan col. 5 

ll. 18–25, col. 5 ll. 61–65 and FID, 2021 WL 2333742, 

at *29–30). We decline Philip Morris’s invitation to address whether Morgan teaches away from central heaters, 

an issue that the Commission never reached. Singleton, 

428 U.S. at 120 (“It is the general rule . . . that a federal 

appellate court does not consider an issue not passed on 

below.”). 

In sum, we are not convinced by Philip Morris’s arguments on appeal. Importantly, Philip Morris still has not 

cited to any evidence supporting its argument that there 

were only three design choices, let alone that it is undisputed that there are only three such choices. The question 

before us is “not whether we agree with the Commission’s 

decision, nor whether we would have reached the same result as the Commission had the matter come before us for 

decision in the first instance,” U.S. Steel Grp. v. United 

States, 96 F.3d 1352, 1357 (Fed. Cir. 1996), but whether 

the Commission’s findings are supported by substantial 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 31

evidence, see Norgren Inc. v. Int’l Trade Comm’n, 699 F.3d 

1317, 1326 (Fed. Cir. 2012) (“The responsibility of this 

court is not to re-weigh de novo the evidence on close factual questions; it is to review the decision of the Commission for substantial evidence.”). Based on the record before 

us, we cannot say that the Commission’s fact finding—

based on the disclosure of Morgan itself, the lack of evidence showing that there were only three possible heater 

locations, and expert testimony that one of ordinary skill

would not have been motivated to modify Morgan to include a central heater—was unsupported by substantial 

evidence. 

Thus, we affirm the Commission’s final determination 

with respect to the validity of the ’123 patent.

Infringement of the ’915 Patent

We turn next to the issue of infringement. Philip Morris argues that the Commission erred in finding that the 

accused IQOS products infringe claims 1–3 and 5 of the 

’915 patent. Specifically, Philip Morris contends that

(1) the Commission’s decision is grounded in an erroneous 

claim construction; and (2) under the correct claim construction, the accused products do not infringe. Appellants’

Br. 48.

The infringement analysis “entails two steps,” the first 

of which is construing the claims, and the second of which 

“is comparing the properly construed claims to the” accused 

products. Duncan Parking Techs., Inc. v. IPS Grp., Inc., 

914 F.3d 1347, 1360 (Fed. Cir. 2019) (quoting Markman 

v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 

1995)). Whether a product infringes an asserted claim is a 

question of fact. Finjan, Inc. v. Secure Computing Corp., 

626 F.3d 1197, 1202 (Fed. Cir. 2010).

Philip Morris’s accused IQOS products include a holder 

and a disposable tobacco stick. Commission Op., 2021 WL 

4947427, at *8–9. The tobacco stick is inserted into the 

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32 PHILIP MORRIS PRODUCTS S.A. v. ITC

holder, which heats, without burning, the tobacco stick to 

generate a visible nicotine-containing aerosol for inhalation. Id. A representative example of an accused product 

with a disposable tobacco stick inserted into the holder is 

shown below:

FID, 2021 WL 2333742, at *31.

The only limitation of representative claim 1 in dispute 

for purposes of infringement recites: “a receiving end for 

receiving an engaging end of the disposable smoking article 

and having an electrical energy source.” ’915 patent col. 42 

ll. 25–27. Before the ALJ, Philip Morris asserted that this

“receiving end” limitation should be interpreted as “a portion of the control housing for receiving an engaging end of 

the disposable smoking article and containing an electrical 

energy source” such that the “electrical energy source” is 

“wholly contained” within the “receiving end.” 

J.A. 10916–17. Reynolds countered that the “receiving 

end” simply means “a portion of the control housing for receiving an engaging end of the disposable smoking article 

and having an electrical energy source” such that the electrical energy source may be “only partially located within 

the ‘receiving end.’” Id.

The ALJ agreed with the parties that the “receiving 

end” must receive an engaging end of the disposable 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 33

smoking article and have an electrical energy source. 

Based on the claim language and the intrinsic evidence, 

however, the ALJ agreed with Reynolds that the limitation 

required only that “a portion of the electrical energy source 

be present within the receiving end of the control housing, 

but another portion of the electrical energy source may be 

contained elsewhere.” J.A. 10920. Philip Morris did not 

challenge this claim construction before the Commission

and, thus, it cannot do so on appeal. 

To prove infringement, Reynolds relied on the testimony of its technical expert, Ramon Alarcon. He explained 

that the accused products each include a “cap” corresponding to the claimed “receiving end” that receives a disposable tobacco stick, as depicted below. FID, 2021 WL 

2333742, at *30–33 (citing J.A. 20897 (Hearing Tr. 195:11–

196:18)).

Id. at *30. Reynolds also cited to several of Philip Morris’s 

own internal documents that characterized the IQOS product cap as the end of the device that receives the disposable 

tobacco stick. Id. at *32. Reynolds asserted that although 

the claim language did not specify a boundary between the 

“receiving end” and any other claimed structure, this description of the IQOS product cap confirmed that the “receiving end” in the accused products extends at least to the 

boundary between the front and rear housings, as depicted 

below. 

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34 PHILIP MORRIS PRODUCTS S.A. v. ITC

Id. at *31. 

Mr. Alarcon also testified that the accused IQOS products include an electrical energy source in the form of a 

printed circuit board (PCB) that is at least partially located 

within the portion of the housing corresponding to the cap 

and thus the “receiving end.” Id. (citing J.A. 20898–99 

(Hearing Tr. 200:14–201:02)). The PCBs that Reynolds allege correspond to the electrical energy sources are shown 

below: 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 35

Id.; see also Appellants’ Br. 49 (citing J.A. 4205). Thus, 

Reynolds contended, the accused IQOS products met the 

disputed limitation and infringed the asserted claims.

Philip Morris argued, to the contrary, that the boundary between the “receiving end” and the control unit section is physically defined by an isolation barrier within the 

IQOS products, indicated in purple below: 

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36 PHILIP MORRIS PRODUCTS S.A. v. ITC

Appellants’ Br. 49 (citing J.A. 42057). 

The ALJ considered Philip Morris’s arguments and its 

expert testimony, but ultimately gave Reynolds’ arguments—supported by Mr. Alarcon’s testimony and Philip 

Morris’s own internal documents—more weight. The ALJ 

thus found that the accused IQOS products met the “receiving end” limitation regardless of the existence of the isolation barrier within the “receiving end.” FID, 2021 WL 

2333742, at *31–32. 

Before the Commission and now on appeal, Philip Morris essentially asserts that the ALJ and the Commission 

erred in their interpretation of the ALJ’s claim construction. Specifically, Philip Morris argues that the ALJ and 

the Commission misconstrued the claim construction by interpreting it to define the boundaries of the “receiving end” 

based on the external structure of the smoking article or to 

include portions that extend beyond an internal isolation 

barrier. Appellants’ Br. 48–53. 

At the outset, we note that Philip Morris’s alleged 

“claim construction” argument sounds more like a challenge to the factual question of whether the claims as construed read on the accused devices. In any event, we reject 

Philip Morris’s attempt to reconstrue the claims. We see 

no error in the ALJ and Commission’s analysis and understanding of the claim construction. The claim language expressly defines “the receiving end” as (1) “receiving . . . the 

disposable smoking article” and (2) “having an electrical 

energy source.” ’915 patent col. 42 ll. 25–27. As the ALJ 

aptly stated, “[t]he term ‘receiving end’ is a term of 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 37

orientation; it is the end of the device that receives a disposable smoking article and has an electrical energy 

source.” FID, 2021 WL 2333742, at *31. In other words, 

any portion of an accused device that receives a disposable 

smoking article and has an electrical energy source is a “receiving end”; the term “receiving end” is not a name for a 

specific component. Furthermore, we agree that “[t]he 

presence of additional structures neither required nor prohibited by the claims, such as an ‘isolation barrier,’” is allowed by the claim language. Id. Nothing in the claim 

language or specification indicates that the “receiving end” 

cannot include additional elements. See Mannesmann 

Demag Corp. v. Engineered Metal Prods., 793 F.2d 1279, 

1282–83 (Fed. Cir. 1986).

Because we reject Philip Morris’s legal argument, we 

affirm the Commission’s determination that Philip Morris’s accused IQOS products infringe the ’915 patent.

Corroboration 

Finally, we turn to the issue of corroboration. Philip 

Morris challenges the ALJ’s conclusion that Philip Morris 

“failed to demonstrate, by clear and convincing evidence,” 

that the ’915 patent was invalidated by public use of a device alleged to be prior art.5 FID, 2021 WL 2333742, at *40. 

Specifically, Philip Morris relied on testimony from a former employee to establish prior public use of the allegedly 

anticipatory device, but the ALJ found that this testimony 

was insufficiently corroborated. Id.

Courts impose a corroboration requirement when a 

witness’s “testimony alone is asserted to invalidate a patent,” Finnigan, 180 F.3d at 1369, because such testimony 

“can be ‘unsatisfactory’ due to ‘the forgetfulness of witnesses, their liability to mistakes, [and] their proneness to 

5 The Commission declined to review the ALJ’s determination.

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38 PHILIP MORRIS PRODUCTS S.A. v. ITC

recollect things as the party calling them would have them 

recollect them, aside from the temptation to actual perjury.’” Id. at 1366 (quoting Washburn & Moen Mfg. Co. 

v. Beat ’Em All Barbed-Wire Co., 143 U.S. 275, 284 (1892)). 

The Supreme Court has long cautioned that “[w]itnesses 

whose memories are prodded by the eagerness of interested 

parties to elicit testimony favorable to themselves are not 

usually to be depended upon for accurate information.” 

Washburn, 143 U.S. at 284. Requiring independent confirmation of the truth of the matter asserted through a 

threshold level of corroboration thus “provides an additional safeguard against courts being deceived.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170 (Fed. Cir. 

2006). 

The “Accord K” was an “electronic heat-not-burn tobacco device developed by Philip Morris.” FID, 2021 WL 

2333742, at *39. Before the ALJ, Philip Morris asserted 

that the “Accord K” met every limitation of the asserted 

claims of the ’915 patent and that it had been publicly used 

more than one year prior to the earliest possible priority 

date of the ’915 patent—August 9, 2011—thus anticipating 

the asserted claims. To establish the prior public use, 

Philip Morris relied heavily on the testimony of Doug Burton, a former employee. Mr. Burton was the “leader of the 

product management team,” and testified that he helped 

design, manufacture, and test the “Accord K.” J.A. 21095 

(Hearing Tr. 774:03–775:06). He recalled that Philip Morris held a “series of consumer research events in Miami,” 

Florida, to demonstrate and distribute the “Accord K” to 

attendees in the late-2005 to early-2006 timeframe. 

J.A. 21099 (Hearing Tr. 788:19–789:10).

To support Mr. Burton’s testimony, Philip Morris introduced various documents that it alleged described the 

“Accord K” and its use in Miami. For example, Mr. Burton 

referenced a “presentation from June of 2006” that provided a “rundown of the events in Miami.” J.A. 21099 

(Hearing Tr. 789:11–789:22). The 2006 presentation, 

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however, discusses a device known as the “EHCSS Series 

K.” J.A. 41477. Mr. Burton claimed “EHCSS Series K” 

was an “internal designation for Accord K.” J.A. 21099 

(Hearing Tr. 789:11–789:22); see also J.A. 40774 (other 

documentation in the record referring to a “Series K 

Lighter”). The same presentation referenced an “NXT 

Smoking SystemTM,” J.A. 41482, a brand that Mr. Burton 

asserts was also “a temporary branding . . . applied to Accord K for these events.” J.A. 21099 (Hearing Tr. 789:11–

789:22). In support of this assertion, Mr. Burton pointed 

to a “marketing analysis report,” dated March 2006, for a 

device having yet another different name—the “Parliament NXT Smoking System”—that was introduced and 

tested in Miami. J.A. 21099 (Hearing Tr. 790:02–790:25); 

see also J.A. 41125. The 2006 presentation makes no mention of any device named “Accord K.”

With respect to the features of the “Accord K” device, 

Mr. Burton referenced a separate document: a “June 2004 

technical file that [he] compiled for CE marking.”6 

J.A. 21100–01 (Hearing Tr. 795:05–797:01). Mr. Burton 

contended that this technical file “describe[s] the Accord K 

that was given out at the Miami events.” Id. The only 

product designations appearing in the document, however, 

reference either a “Version NHA-PL7” or an “EHCSS 

Lighter.” J.A. 40791–824.

At the hearing, Mr. Burton also testified regarding a 

physical device that he claimed was “the same” as the “Accord K” device “that was given out at the Miami events.” 

J.A. 21100 (Hearing Tr. 794:01–795:04). Mr. Burton described an “Accord K” he had that “was turned into a 

6 On commercial products, the CE mark, stylized as 

, means that the manufacturer or importer affirms the 

good’s conformity with European health, safety, and environmental protection standard. CE marking is required for 

goods sold in the European Economic Area.

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40 PHILIP MORRIS PRODUCTS S.A. v. ITC

demonstrator for display to upper management” and included modifications such as (1) “removing the outer shell 

from the heater cartridge and cutting away part of the 

holder body” and (2) adding two push buttons, one that allowed the device to “start without a cigarette in it,” and one 

that served as a “manual replacement for the puff activated 

switch.” J.A. 21100 (Hearing Tr. 794:01–795:04). Aside 

from these structural changes to the device, Mr. Burton 

contended that it represented the “Accord K” exactly as it 

existed when it was distributed in Miami. Id. Philip Morris asserted that this physical device definitively linked the 

“Accord K” that Mr. Burton testified was publicly used in 

Miami to the contemporaneous documentation of record. 

For example, Mr. Burton identified a photo of a “battery 

assembly” that he testified was removed from his modified 

“Accord K” as including a “commercialization production 

serial number sticker” indicating that the battery assembly

was “ONLY for NHA-PL7,” and “NHA-PL7” was one of the 

product names appearing in the June 2004 technical file

that Mr. Burton testified described the “Accord K.” 

J.A. 21100 (Hearing Tr. 794:01–794:25); see also

J.A. 40073. 

Regarding the link between the “Accord K” device that 

Mr. Burton testified was in public use in Miami and the 

documentation that allegedly describes the features of the 

“Accord K,” Mr. Burton acknowledged that “if you look at 

those documents, you will not see written anywhere this is 

the one [device] that you’re going to take to Miami.” 

J.A. 21103 (Hearing Tr. 807:03–807:24). Instead, Mr. Burton asserted that “there was only one Accord K,” and that 

Philip Morris “didn’t build a special [model] for [the] Miami” conference. Id. Therefore, Mr. Burton asserted that 

although the contemporaneous documents do not “say anything about whether that device [described in the document] with that structure was given out in Miami,” the 

documentation necessarily describes the “Accord K” that 

was displayed in Miami and corroborates his testimony 

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PHILIP MORRIS PRODUCTS S.A. v. ITC 41

because every device referred to as the “Accord K” had the 

same characteristics. J.A. 21103 (Hearing Tr. 807:07–

807:12).

On appeal, Philip Morris argues that Mr. Burton’s testimony was sufficiently corroborated and challenges the 

ALJ’s contrary finding. Appellants’ Br. 55–56. The sufficiency of corroboration is evaluated under the “rule of reason,” which involves “an assessment of the totality of the 

circumstances including an evaluation of all pertinent evidence.” Adenta GmbH v. OrthoArm, Inc., 501 F.3d 1364, 

1372 (Fed. Cir. 2007). We treat the determination of 

whether oral testimony is sufficiently corroborated as a 

question of fact, which we review for substantial evidence. 

TransWeb, LLC v. 3M Innovative Props. Co., 812 F.3d 

1295, 1302 (Fed. Cir. 2016).

Substantial evidence supports the ALJ’s determination 

that Mr. Burton’s testimony was not sufficiently corroborated. As the ALJ explained, while Mr. Burton’s testimony 

“might establish that devices known as Accord K were in 

public use in Miami by no later than 2006, Philip Morris 

has failed to show that the Accord K devices used in Miami 

are the same . . . devices described in the technical documents that Philip Morris uses to support its invalidity arguments.” FID, 2021 WL 2333742, at *39. In other words, 

the ALJ found a critical gap in corroborating evidence linking the devices that were in public use with the devices that 

Philip Morris asserts invalidate the asserted claims of the 

’915 patent.

The ALJ’s finding is supported by both the documents 

and Mr. Burton’s testimony. Indeed, the ALJ noted inconsistencies between Mr. Burton’s memory of the existence of 

a single device structure associated with the “Accord K”

and the documentary evidence. For example, although 

Mr. Burton emphasized that there was “only one Accord 

K,” his testimony muddled the distinction between different Philip Morris devices, such as the “Accord JLI” and 

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42 PHILIP MORRIS PRODUCTS S.A. v. ITC

“Accord K.” J.A. 21103 (Hearing Tr. 807:07–807:12). 

Without documentary support, Mr. Burton testified that 

the Accord JLI, and the Accord K “are very much alike because the configuration is essentially the same.” 

J.A. 21102 (Hearing Tr. 800:23–801:02). Mr. Burton further testified as to the existence of an “upgrade program” 

in “late 2002” for consumers to trade in products that they 

previously purchased, known as “old Accord K kits,” or the 

“E4 version,” for “the new one[s,] . . . the JLI version.” 

J.A. 21096 (Hearing Tr. 777:13–778:01). The ALJ reasonably explained that these statements made it unclear 

whether there were indeed various Philip Morris devices, 

any one of which could have been in public use in Miami. 

Furthermore, the allegedly contemporaneous documents 

include products with multiple different names, some of 

which include: “Series K,” “EHCSS Series K,” “NXT Smoking System,” and “Version NHA-PL7,” among other designations. Not a single document referred to the device it 

described as the “Accord K.” Additionally, the ALJ reasonably found Mr. Burton’s testimony internally inconsistent. 

For example, contrary to his testimony about the “old Accord K kits” being traded in for the new versions, Mr. Burton later agreed that the “Accord K was never launched or 

sold in the United States.” J.A. 21103 (Hearing 

Tr. 804:09–804:22).

On appeal, Philip Morris argues that the ALJ applied 

“an erroneously heightened standard” in his corroboration 

analysis, and that, even under this heightened standard, 

Mr. Burton’s testimony was sufficiently corroborated. Appellants’ Br. 55–56. Philip Morris does not explain, however, how the ALJ erroneously applied a heightened 

standard or how the ALJ’s analysis differed from a proper 

rule of reason analysis. Philip Morris’s argument essentially boils down to claiming that, in its view, the ALJ erred 

because Mr. Burton’s testimony was too well-corroborated 

to be found not sufficiently corroborated. As we explained 

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above, however, the ALJ’s finding was supported by substantial evidence. 

Our precedent also supports the ALJ’s conclusion. As 

we have previously held, uncorroborated testimony cannot 

be corroborated by uncorroborated evidence. In re NTP, 

Inc., 654 F.3d 1279, 1291–92 (Fed. Cir. 2011). In In re 

NTP, we affirmed the Board’s rejection of NTP’s attempt 

“to corroborate [the affiants’] testimony with [a] document, 

but, at the same time, attempt to corroborate the date of 

[that] document with their testimony.” Id. Similarly, here, 

Philip Morris attempts to use its 2006 presentation to corroborate Mr. Burton’s testimony that the “Accord K” was 

in public use in Miami at least as of 2006. At the same 

time, Philip Morris attempts to use Mr. Burton’s testimony 

to corroborate that the 2006 presentation (as well as other 

documents) refer to the same “Accord K” device notwithstanding references to different products. Presented with 

a similar “catch-22” situation in Apator Miitors ApS 

v. Kamstrup A/S, we dismissed Apator’s “attempts to corroborate [a witness’s] testimony with the emails and the 

drawings” that could “only provide that corroboration with 

help from [that same witness’s] testimony.” 887 F.3d 1293, 

1296–97 (Fed. Cir. 2018). Following well-established precedent preventing parties from creating an ouroboros of corroboration, the ALJ reasonably rejected Philip Morris’s 

circular path of corroboration. We cannot say that the ALJ

erred in finding Mr. Burton’s testimony not sufficiently 

corroborated by documents that are corroborated by 

Mr. Burton’s testimony.

In an attempt to fill the gap identified by the ALJ, 

Philip Morris identifies a particular technical file and the 

identification number printed on the sticker on the battery 

assembly of the physical device presented to the ALJ to link 

the “Accord K” device presented in Miami in 2006 to the 

documents identifying a product with features that were 

alleged to anticipate the patent claims. At argument, 

Philip Morris’s counsel argued “the technical file actually 

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44 PHILIP MORRIS PRODUCTS S.A. v. ITC

uses an ID number for the Accord K device, and that’s the 

same ID number that is found on the picture of the Accord 

K device in the record at page 40073, it’s NHA-PL7.” Oral 

Arg. at 24:09–24:38, https://oralarguments.cafc.uscourts.g

ov/default.aspx?fl=22-1227_10032022.mp3. Philip Morris 

asserts that the technical file is therefore “an explicit document linking . . . this Accord K device to the photograph 

of the device” that bridges the gap that the ALJ identified 

between the “Accord K” that Mr. Burton testified was publicly used in Miami and the “Accord K” described in the documentation. Id. Counsel for Philip Morris argues that 

because Mr. Burton’s testimony regarding the events in 

Miami is undisputed, and because Philip Morris presented 

“all these documents using the same shorthand, the same 

way we refer to the device, the same identification number 

of the device linking it to that time frame,” reaching any 

conclusion other than one in which Mr. Burton’s testimony 

was sufficiently corroborated would be legal error and 

would impose an “impossible to meet” standard for corroboration. Oral Arg. at 25:19–26:11 (asking “[a]t what point 

is corroboration enough?”).

As an initial point, we note that it is of no import “that 

[Appellants’] evidence is ‘unrebutted,’ as [it] repeatedly 

points out. This criticism misunderstands [Philip Morris’s]

burden of proof,” Apator, 887 F.3d at 1297, which requires 

that Philip Morris prove the “Accord K” was publicly used

prior to the ’915 patent’s effective filing date, not that 

Reynolds prove it was not. Additionally, Philip Morris has 

still failed to address the problem that the device depicted 

in the photo at J.A. 40073 was presented at trial as a physical device with no provenance other than Mr. Burton’s testimony that it was the same device as presented in Miami. 

And even this testimony from Mr. Burton reveals that the 

device has been structurally modified from the state in 

which it was allegedly publicly used in Miami. J.A. 21100 

(Hearing Tr. 794:01–795:04) (describing the various structural modifications that were made, including cutting away 

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portions of the device body and adding buttons). Philip 

Morris has failed to close the gap the ALJ identified in the 

evidence purportedly linking the device in public use with 

the device Philip Morris asserts anticipates the asserted 

claims and thus failed to meet its evidentiary burden.

Under the proper rule of reason analysis for evaluating 

the sufficiency of corroboration, we cannot say that the ALJ 

erred in his factual conclusion. We therefore affirm the 

Commission’s final decision adopting the ALJ’s findings 

and conclusions with respect to corroboration.

CONCLUSION

We have considered the parties’ remaining arguments 

and find them unpersuasive. For the foregoing reasons, we 

affirm the Commission’s decision in its entirety. 

AFFIRMED

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