`Case 1:20-cv-00393-LMB-WEF Document 1425-15 Filed 09/09/22 Page 1 of 4 PagelD# 37039
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`
`
`
`EXHIBIT 71
`EXHIBIT 71
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1425-15 Filed 09/09/22 Page 2 of 4 PageID# 37040
`Case: 22-1227 Document: 50 Page: 1 Filed: 06/29/2022
`
`
`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, AND R.J. REYNOLDS TOBACCO COMPANY,
`
`
`
`Intervenors
`
`
`
`
`
`
`
`
`
`
`
`
`Appeal from the United States International Trade Commission
`in Investigation No. 337-TA-1199
`
`
`
`
`
`
`
`CORRECTED NON-CONFIDENTIAL
`RESPONSE BRIEF FOR INTERVENORS
`
`
`
`
`
`
`
`
`
`
`
`
`Gregory A. Castanias
`Amelia A. DeGory
`JONES DAY
`51 Louisiana Avenue, NW
`Washington, D.C. 20001-2113
`Telephone: (202) 879-3939
`Facsimile: (202) 626-1700
`
`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121-3134
`Telephone: (858) 314-1200
`Facsimile: (844) 345-3178
`
`
`
`David M. Maiorana
`Ryan B. McCrum
`Susan M. Gerber
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114-1190
`Telephone: (216) 586-3939
`Facsimile: (216) 579-0212
`
`
`
`Counsel for Intervenors
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1425-15 Filed 09/09/22 Page 3 of 4 PageID# 37041
`Case: 22-1227 Document: 50 Page: 77 Filed: 06/29/2022
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`
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`essentially a private FDCA enforcement action, which is prohibited. 923 F.3d at
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`962, 968. Here, Reynolds did not sue for violations of the FDCA; it sued to
`
`enforce its patent rights. The Commission properly investigated that complaint
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`and remedied the wrong.
`
`Second, PM says the Commission made de facto determinations that all e-
`
`cigarettes are purportedly substitutable for IQOS. Br.66. It did no such thing.
`
`There are many e-cigarettes available to consumers under FDA’s current
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`enforcement policy. All of those products are substitutes for IQOS under
`
`Commission precedent; that is enough to address the statutory public-interest
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`factors. Appx68-69. And FDA’s premarket authorizations for Reynolds’s
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`tobacco-flavored Solo and Vibe products (in addition to other products, such as
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`Logic and NJOY) further show the numerous available substitutes for IQOS.
`
`https://www.fda.gov/tobacco-products/premarket-tobacco-product-
`
`applications/premarket-tobacco-product-marketing-granted-orders.
`
`IV. THE COMMISSION APPROPRIATELY CONSULTED WITH
`OTHER AGENCIES
`PM leads its brief with a never-before-made argument—that the
`
`Commission violated Section 337(b)(2) by failing to consult with HHS. In
`
`addition to being forfeited and waived, this new argument fails on its merits.
`
`61
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`
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`Case 1:20-cv-00393-LMB-WEF Document 1425-15 Filed 09/09/22 Page 4 of 4 PageID# 37042
`Case: 22-1227 Document: 50 Page: 90 Filed: 06/29/2022
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`
`
`CONCLUSION
`The Commission’s final determination and orders should be affirmed.
`
`Dated: June 17, 2022
`
`
`
`
`
`David M. Maiorana
`Ryan B. McCrum
`Susan M. Gerber
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114-1190
`Telephone: (216) 586-3939
`Facsimile: (216) 579-0212
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`/s/ Gregory A. Castanias
`Gregory A. Castanias
`Amelia A. DeGory
`JONES DAY
`51 Louisiana Avenue, NW
`Washington, D.C. 20001-2113
`Telephone: (202) 879-3939
`Facsimile: (202) 626-1700
`
`Anthony M. Insogna
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121-3134
`Telephone: (858) 314-1200
`Facsimile: (858) 345-3178
`
`Attorneys for Intervenors
`
`74
`
`
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