Case 1:20-cv-00393-LMB-TCB Document 1406-1 Filed 08/12/22 Page 1 of 5 PageID# 35083
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`Exhibit 1
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`Case 1:20-cv-00393-LMB-TCB Document 1406-1 Filed 08/12/22 Page 2 of 5 PageID# 35084
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`(PUBLIC VERSION)
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
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`Before The Honorable Clark S. Cheney
`Administrative Law Judge
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`In the Matter of
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`Investigation No. 337-TA-1199
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`CERTAIN TOBACCO HEATING
`ARTICLES AND COMPONENTS
`THEREOF
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`COMPLAINANTS’ OPENING POST-HEARING BRIEF
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`Case 1:20-cv-00393-LMB-TCB Document 1406-1 Filed 08/12/22 Page 3 of 5 PageID# 35085
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` Even assuming IQOS might be meaningfully adopted in the U.S., an exclusion
`order is nonetheless warranted because there are thousands of substitute PRRPs—
`removal of one will not harm the public interest. Respondents’ own experts
`concede that those other PRRPs have not only been successful at moving smokers
`away from cigarettes, but they are the most successful products at doing so. And
`Respondents’ suggestion that some of these alternatives will not be authorized by
`FDA is belied by their own experts’ admissions that such products will, in fact,
`obtain FDA market authorization.
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` Respondents argue that IQOS is more successful at transitioning smokers from CC
`than other alternatives, but Respondents’ so-called conversion “evidence” is
`grossly misleading and unreliable, based on nothing more than self-serving, results-
`oriented studies that are wholly inconsistent with independent studies showing that
`smokers are not interested in IQOS, abandon IQOS, or at best become dual users.
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`In short, the public interest is best served by protecting Reynolds’s patent rights and
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`excluding IQOS from the U.S. market.
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`A.
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`Factors 1 And 4: Public Health/Welfare And U.S. Consumers
`1.
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`According To FDA, Respondents Have NOT Demonstrated That
`IQOS “Will Benefit The Population As A Whole”
`(a)
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`FDA Denied Respondents’ Reduced-Risk MRTPA Claims
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`Respondents submitted an MRTPA to FDA seeking three separate marketing claims for its
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`products: two reduced-risk claims and one reduced-exposure claim. (JX-0034.7-8.) FDA denied
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`the two reduced-risk claims, and authorized the reduced-exposure claim. (JX-0034.8,11.)
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`Respondents rely here on the same information they submitted to FDA. FDA reviewed this
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`information and concluded it was insufficient to establish any significant public-health benefit:
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`After conducting a thorough scientific review of the information
`contained in the MRTPAs; the recommendations from the Tobacco
`Products Scientific Advisory Committee; comments, data, and
`information submitted to FDA by interested persons; and other
`scientific information identified by the agency from other sources, I
`conclude that: With respect the risk modification order requests, the
`applicant 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 a whole, taking into account both
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`106
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`impact public health and welfare or U.S. consumers, because there are many existing PRRPs in
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`the market that are more than adequate to satisfy consumer demand.
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`(a)
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`Thousands Of PRRPs Are Currently Available On The U.S.
`Market
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`Both parties’ experts agree that thousands of PRRPs are currently available in the U.S.
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`Dr. Murrelle testified that “there are literally thousands of existing PRRPs on the U.S. market that
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`have at least the same harm reduction and transition rate, where transition rate is moving people
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`away from combusted cigarettes, … as IQOS.” (Hrg.Tr.454:8-12.) Dr. Rodu agrees: Just
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`considering e-cigarettes, “[t]here are thousands of choices, reflecting the fact that they are the most
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`popular—and most successful—quit-smoking aids.” (Hrg.Tr.1296:1-12; see also Hrg.Tr.1291:15-
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`22 (identifying “a whole host of options that are now available to smokers” including “vaping
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`products, smokeless tobaccos like dip and chew and Snus.”).) And Respondents’ Mr. Magnani
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`testified that
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`196:12.)
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`These PRRPs generally fall into 6 categories:
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` (JX-0093C.195:23-
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`126
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`(CDX-0005C.3; Hrg.Tr.455:2-459:3.) Reynolds is a leading supplier of products in all but the
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`NRT category. (Hrg.Tr.66:1-71:20.) As Dr. Murrelle testified, removal of a single PRRP (IQOS)
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`from the thousands available to U.S. consumers will not have a meaningful impact on the public
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`health and welfare of U.S. consumers. (Hrg.Tr.459:4-16.)
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`Despite these thousands of options, Respondents overemphasize that IQOS is one of few
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`HNB products on the market. The relevant market is not just HNB, see Section VII.B, infra, but
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`even if it were, Reynolds’s Eclipse HNB product will adequately serve the limited demand for
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`HNB products in the United States. Indeed, Dr. Benson agreed that she doesn’t “consider IQOS
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`to be novel in view of Eclipse.” (Hrg.Tr.1365:19-1366:3.)
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`(b)
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`Existing PRRPs Have At Least The Same Potential To Offer
`Reduced Risk And Exposure Compared To IQOS
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`Respondents try to distinguish IQOS from other PRRPs by touting it as a product that offers
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`reduced exposure and potentially reduced harm as compared to CCs. But there is no credible
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`127
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