Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 1 of 5 PageID# 35113
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`Exhibit 10
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`Exhibit 10
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`Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 2 of 5 PageID# 35114
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`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
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`PHILIP MORRIS PRODUCTS S.A.,
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`Plaintiff,
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`v.
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`R.J. REYNOLDS VAPOR COMPANY,
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`Defendant.
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`Case No. 1:20-cv-00393-LMB-TCB
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`DECLARATION OF STACY EHRLICH
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`I, Stacy Ehrlich, declare as follows:
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`I.
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`PROFESSIONAL BACKGROUND AND EXPERTISE
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`I am a partner at the law firm of Kleinfeld, Kaplan & Becker, LLP in Washington,
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`DC. I received my law degree, cum laude, from Harvard Law School, am admitted to practice in
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`the District of Columbia, and have been specializing in regulatory law for over twenty-five years.
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`A significant part of my regulatory experience involves laws and regulations related
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`to the U.S. Food and Drug Administration (“FDA”). At least half of my current practice deals
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`with FDA regulation of tobacco and nicotine products under the Federal Food, Drug, and Cosmetic
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`Act, as amended by the Family Smoking Prevention and Tobacco Control Act. This specialization
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`requires me to keep abreast of FDA’s policies, statements, decisions, and actions related to those
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`products.
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`Types of FDA tobacco and nicotine regulatory work I assist clients with include
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`consulting on and shepherding through important FDA authorization applications.
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`I also have served as an FDA expert twice—once in the above-captioned matter
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`and once in the related investigation before the U.S. International Trade Commission (“ITC”), Inv.
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`Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 3 of 5 PageID# 35115
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`No. 337-TA-1199. Both were on behalf of Philip Morris Products, S.A. (“Philip Morris”), and I
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`am generally familiar with the FDA-related aspects of both actions.
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`II.
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`FDA’S AUTHORIZATIONS FOR TOBACCO AND NICOTINE PRODUCTS
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`“New tobacco products” are tobacco or nicotine products that were either
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`introduced for the first time in the United States after February 15, 2007, or were modified after
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`that date. Companies must seek permission from FDA before they can legally offer and sell “new
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`tobacco products” on the U.S. market. The market-entry permission that e-cigarettes, like VUSE
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`products from R.J. Reynolds Vapor Company (“Reynolds”), must earn is called a premarket
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`tobacco product (“PMT”) authorization. In order to obtain PMT authorization, an applicant must
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`demonstrate to FDA that the product in question is appropriate for the protection of public health—
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`a stringent standard. I have worked on approximately forty PMT applications.
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`As of the date of this declaration, FDA has granted PMT authorization to multiple
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`e-cigarettes, including products from NJOY LLC, Logic Technology Development LLC, and
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`Reynolds. With regard to Reynolds, FDA has granted PMT authorization to its VUSE Solo (both
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`the G1 and G2 versions), VUSE Vibe, and VUSE Ciro. The PMT application for Reynolds’ VUSE
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`Alto is still pending.
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`In addition to the e-cigarette PMT authorizations listed above, FDA also has
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`granted PMT authorization to other types of tobacco and nicotine products.
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`One of the PMT-authorized non-combustibles outside of the e-cigarette category is
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`the IQOS heat-not-burn product (“HNB”) developed and commercialized by Philip Morris.
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`Besides the IQOS HNB, no other HNB has earned PMT authorization.
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`The IQOS HNB also has earned modified risk tobacco product (“MRTP”)
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`authorization. In order to obtain MRTP authorization, an applicant must demonstrate to FDA,
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`2
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`Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 4 of 5 PageID# 35116
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`among other things, that the product under review benefits or is expected to benefit the health of
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`the population as a whole. This standard is even more stringent that the standard for PMT
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`authorization.
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`No Reynolds product has earned MRTP authorization.
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`No e-cigarette has earned MRTP authorization.
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`Besides the IQOS HNB, no other inhalable smoke-free alternative (i.e., in either
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`the HNB or e-cigarette category) has earned both PMT- and MRTP authorizations. Because of
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`these distinctions, removing the IQOS HNB from the U.S. market would deprive U.S. adult
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`smokers of a product for which there is no substitute, from a regulatory perspective.
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`III. NO PUBLIC INTEREST HARM FROM LIMITED VUSE REMOVAL
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` My understanding is that, in the above-captioned matter, cartridges for Reynolds’
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`VUSE Alto and VUSE Solo G2 were found to infringe two patents owned by Philip Morris. I also
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`understand that Philip Morris now seeks to permanently enjoin Reynolds from manufacturing,
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`offering for sale, and selling those cartridges in the United States. It is my opinion that such an
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`injunction does not pose any harm to the public interest.
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`Even if the VUSE Alto and VUSE Solo G2 cartridges were removed from the U.S.
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`market, multiple PMT-authorized e-cigarettes would still be available from Reynolds and other
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`manufacturers. Consequently, American adult smokers would still have access to devices from
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`the same product category with the same FDA authorizations (or more in the case of VUSE Alto,
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`which currently has no FDA authorizations). This means there would be no meaningful negative
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`impact on the public interest from issuing the injunction that Philip Morris seeks.
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`In addition to other PMT-authorized e-cigarettes, U.S. adult smokers would
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`continue to have access to PMT-authorized non-combustibles from other product categories.
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`3
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`Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 5 of 5 PageID# 35117
`Case 1:20-cv-00393-LMB-TCB Document 1406-10 Filed 08/12/22 Page 5 of 5 PagelD# 35117
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`Although | do not consider all PMT-authorized products to be substitutes for one another, I am
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`aware that Reynolds took sucha position in the related ITC investigation. Specifically, I am aware
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`that Reynolds argued on multiple occasions that there are thousands ofpotentially reduced risk
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`products available on the U.S. market, and therefore removing any one product would not harm
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`the public interest. Reynolds’ arguments to the ITC further support that there would be no
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`meaningful negative impact onthe public interest from issuing the injunction that Philip Morris
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`seeks.
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`I declare underthe penalty ofperjury that the foregoingis true and correctto the best of by
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`knowledge.
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`Executed on August (], 2022
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`Stacy Ehrlich
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