throbber
Case 1:20-cv-00393-LMB-WEF Document 1462-17 Filed 04/05/23 Page 1 of 4 PageID# 39714
`
`Exhibit 17
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1462-17 Filed 04/05/23 Page 2 of 4 PageID# 39715
`Case: 22-1227 Document: 39 Page: 1 Filed: 03/21/2022
`
`
`No. 22-1227
`
`
`
`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.
`
`
`
`
`
`______________________________________________
`On Appeal from the United States International Trade Commission
`in Investigation No. 337-TA-1199
`______________________________________________
`NONCONFIDENTIAL BRIEF OF APPELLANTS
`______________________________________________
`Gregory G. Garre
`Maximilian A. Grant
`Bert C. Reiser
`Jamie D. Underwood
`Gabriel K. Bell
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW, Suite 1000
`Washington, DC 20004
`(202) 637-2200
`Counsel for Appellants
`
`
`
`
`
`
`
`
`
`
`
`
`March 21, 2022
`
`
`
`
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1462-17 Filed 04/05/23 Page 3 of 4 PageID# 39716
`Case: 22-1227 Document: 39 Page: 83 Filed: 03/21/2022
`
`
`And IQOS’s MRTP authorization allows Appellants to communicate with U.S.
`
`consumers about the reduced exposure benefits IQOS provides. No other inhalable
`
`smoke-free CC alternatives can do so lawfully, and none will be able to do so for
`
`years, as there are no MRTP applications even pending for such alternatives.
`
`Appx41387; Appx41104; Appx21343, Appx21358 (Tr. 1409:12-23, 1468:8-15);
`
`Appx20874, Appx20876 (Tr. 101:5-7, 109:4-9); FDA, Modified Risk Granted
`
`Orders,
`
`Decision
`
`Summary
`
`MR0000133
`
`(July
`
`7,
`
`2020),
`
`https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-
`
`orders.
`
`
`
`Second, no other CC alternative provides the same ritual, sensory experience,
`
`or satisfaction as IQOS. As organizations, physicians, and IQOS users told the
`
`Commission, IQOS is not interchangeable with other products; it plays a unique and
`
`vital role in reducing CC smoking. Supra at 11-12; Appx21295, Appx21299 (Tr.
`
`1347:1-24; 1349:13-17, 1350:1-5, 1366:4-9); Appx21360 (Tr. 1479:17-23);
`
`Appx20865 (Tr. 67:16-24); Appx21140 (Tr. 840:9-25); Appx21273-21274 (Tr.
`
`1260:14-18, 1263:9-25).18
`
`
`18 See Appx41200-41201; Appx41256; Appx41432-41433; Appx40941;
`Appx40965-40966; Appx41981; Appx14003-14004; Appx13942; Appx13916;
`Appx13998; Appx13927; Appx13987; Appx13977; Appx14007; Appx14011;
`Appx13988; Appx13990; Appx14005; Appx13995; Appx13989; Appx13914-
`13918.
`
`69
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1462-17 Filed 04/05/23 Page 4 of 4 PageID# 39717
`Case: 22-1227 Document: 39 Page: 85 Filed: 03/21/2022
`
`
`
`
`Nicotine replacement therapies are designed to stop all nicotine intake.
`
`Appx41594-41595 (Gilchrist Dep. 32:16-33:20); Appx21140 (Tr. 839:4-16);
`
`Appx21295 (Tr. 1349:6-10). Those are, therefore, fundamentally different from
`
`IQOS and regulated in a different manner. Appx21295 (Tr. 1349:10-12);
`
`Appx40959; 21 U.S.C. §§ 321(rr), 387k.
`
`In sum, the lack of lawful, effective alternatives should have weighed heavily
`
`in the Commission’s public interest analysis. But it did not.
`
`CONCLUSION
`
`The Commission’s determination and orders should be reversed or vacated.
`
`Dated: March 21, 2022
`
`Respectfully submitted,
`
`
`
`
`
`
`/s/ Gregory G. Garre
`Gregory G. Garre
`Maximilian A. Grant
`Bert C. Reiser
`Jamie D. Underwood
`Gabriel K. Bell
`LATHAM & WATKINS LLP
`555 Eleventh Street, NW, Suite 1000
`Washington, DC 20004
`(202) 637-2200
`gregory.garre@lw.com
`
`Counsel for Appellants Philip Morris
`Products S.A., Philip Morris USA,
`Inc., and Altria Client Services LLC
`
`71
`
`

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