`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
`
`RAI STRATEGIC HOLDINGS, INC. AND R.J.
`REYNOLDS VAPOR COMPANY
`
`
`Plaintiffs,
`
`
`v.
`
`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTS S.A.
`
`
`Defendants.
`
`Case No. 1:20-cv-00393-LO-TCB
`
`
`
`
`
`
`
`
`ALTRIA CLIENT SERVICES LLC; PHILIP
`MORRIS USA INC.; and PHILIP MORRIS
`PRODUCTS S.A.
`
`
`Counterclaim Plaintiffs,
`
`
`v.
`
`
`RAI STRATEGIC HOLDINGS, INC. AND R.J.
`REYNOLDS VAPOR COMPANY
`
`
`Counterclaim Defendants.
`
`
`DEFENDANTS ALTRIA CLIENT SERVICES LLC AND PHILIP MORRIS USA INC.’S
`AMENDED PARTIAL ANSWER TO THE AMENDED COMPLAINT AND AMENDED
`COUNTERCLAIMS
`
`Altria Client Services LLC (“ACS”) and Philip Morris USA Inc. (“PM USA”) respectfully
`
`submit their Partial Answer in response to Plaintiffs RAI Strategic Holding, Inc. (“RAI”) and R.J.
`
`Reynolds Vapor Company’s (“RJRV”) (collectively, “RJR”) Amended Complaint. To the extent
`
`not specifically admitted herein, the allegations of the Amended Complaint are denied, including
`
`any allegations contained in the headings of the Amended Complaint.
`
`
`
`REDACTED
`
`
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`INTRODUCTION AND PRELIMINARY STATEMENT OF ACS AND PM USA
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`RJR appears to have brought this action in the hopes of stopping the innovative IQOS
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`heated tobacco system, which has a proven track record in switching smokers away from
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`combustible cigarettes, from disrupting its core business in combustible cigarettes and overtake its
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`secondary line of e-vapor products. Having failed to develop a competing offering in the heated
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`tobacco space, RJR apparently now seeks to block that space in its entirety by bringing this
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`meritless litigation. But in its haste to do so, RJR has overlooked the fact that its own line of e-
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`vapor products (which are far less effective in switching smokers away from combustible
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`cigarettes than IQOS) infringe multiple patents owned by ACS and PM USA.
`
`ACS and PM USA have a strong legacy of leadership in traditional tobacco products, with
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`profitable premium products and iconic brands, including Marlboro, Benson & Hedges,
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`Parliament, and Virginia Slims. While ACS and PM USA will continue to lead in traditional
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`tobacco products, ACS and PM USA recognize that adult preferences are changing. Thus, ACS
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`and PM USA partnered with co-defendant Philip Morris Products S.A. (“PMP”) to commercialize
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`IQOS, a product that heats rather than burns tobacco to produce an aerosol instead of smoke
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`(known as a “Heat-Not-Burn” or “HNB” product) in the United States. ACS and PM USA have
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`also amassed a substantial portfolio of intellectual property, covering numerous innovations
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`relating to smoke-free technologies, including both heated tobacco and e-vapor products.
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`PMP first launched IQOS in select cities in Italy and Japan in 2014. It is now sold in over
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`57 countries throughout the world. To date, over 11.2 million smokers have switched to IQOS
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`and given up smoking for good. This number is growing daily. PMP conducted 10 clinical studies
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`on IQOS and published over 340 peer-reviewed articles on reduced risk products. There are also
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`2
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`over 30 independent studies corroborating PMP’s findings with respect to IQOS. Among the
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`findings: IQOS produces an aerosol with 90 to 95% less toxins than cigarette smoke.
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`In 2019, after a lengthy review, the United States Food and Drug Administration (“FDA”)
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`granted PMP’s request for a pre-market authorization to commercialize IQOS through PM USA
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`in the United States. In granting that request, the FDA determined that marketing IQOS “would
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`be appropriate for the protection of the public health.” On July 7, 2020, the FDA authorized the
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`marketing of a version of IQOS as a modified risk tobacco product, finding that IQOS
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`“significantly reduces the production of harmful and potentially harmful chemicals.” To date, no
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`other HNB or e-vapor product has received these authorizations.
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`Apparently concerned by the commercial threat posed by IQOS, RJR is now attempting to
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`stop IQOS with this case. But in its haste to stop IQOS, RJR committed two fatal errors. First, it
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`asserted meritless patent claims. Second, it overlooked the fact that its own e-vapor products
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`infringe multiple patents owned by ACS, PM USA and co-defendant PMP. ACS and PM USA
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`thus respond to RJR’s Complaint and bring counterclaims to recover the considerable damages
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`flowing from RJR’s infringement.
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`RESPONSES TO THE SPECIFIC ALLEGATIONS OF COMPLAINT
`
`THE PARTIES
`
`1.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 1 of the Complaint and, on that basis, deny them.
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`2.
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`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 2 of the Complaint and, on that basis, deny them.
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`3.
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`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 3 of the Complaint and, on that basis, deny them.
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`3
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`4.
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`5.
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`6.
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`Admitted.
`
`Admitted.
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`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 6 of the Complaint and, on that basis, deny them.
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`JURISDICTION AND VENUE
`
`7.
`
`Paragraph 7 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the Complaint purports to be an action
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`arising under the patent laws of the United States, 35 U.S.C. §§ 271, et seq., and that this Court
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`has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338, but ACS and PM USA
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`deny that there is any legal or factual basis for such action.
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`8.
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`Paragraph 8 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit for purposes of this action only that this
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`Court has personal jurisdiction over it. ACS and PM USA otherwise deny the allegations in
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`paragraph 8 of the Complaint.
`
`9.
`
`Paragraph 9 contains legal conclusions to which no answer is required. ACS and
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`PM USA are without knowledge or information sufficient to admit or deny the allegations in
`
`paragraph 9 of the Complaint and, on that basis, deny them.
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`10.
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`Paragraph 10 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit for purposes of this action only that venue
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`exists in this District for the claims against ACS and PM USA pursuant to 28 U.S.C. §§ 1391 and
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`1400(b). ACS and PM USA otherwise deny the allegations of paragraph 10 of the Complaint
`
`relating to ACS and PM USA. ACS and PM USA are without knowledge or information sufficient
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`to admit or deny the remaining allegations in paragraph 10 of the Complaint and, on that basis,
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`4
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`deny them. ACS and PM USA specifically deny the allegations of paragraph 10 of the Complaint
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`relating to ACS and PM USA’s alleged infringement of any patents.
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`11.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 11 of the Complaint and, on that basis, deny them.
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`THE ASSERTED PATENTS
`
`FACTUAL BACKGROUND
`
`12.
`
`ACS and PM USA admit that the face of U.S. Patent No. 9,814,268 (“the ’268
`
`patent”) states that it is titled “Tobacco-containing smoking article.” ACS and PM USA further
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`admit that the face of the ’268 patent states that it issued on November 4, 2017 and that it includes
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`two independent claims. ACS and PM USA admit that Plaintiffs have quoted claim 16 of the ’268
`
`patent in paragraph 12 of the Complaint. ACS and PM USA otherwise deny the allegations in
`
`paragraph 12 of the Complaint.
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`13.
`
`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
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`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`14.
`
`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
`
`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`15.
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`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
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`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`16.
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`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
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`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`5
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`17.
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`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
`
`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`18.
`
`The Court has stayed Plaintiffs’ Counts Two, Three, and Four pursuant to 28 U.S.C.
`
`§ 1659. See Dkt. 27. ACS and PM USA will provide a response at the appropriate time when the
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`stay is lifted.
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`19.
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`ACS and PM USA admit that the face of U.S. Patent No. 10,492,542 (“the ’542
`
`patent”) states that it is titled “Smoking articles and use thereof for yielding inhalation materials.”
`
`ACS and PM USA further admit that the face of the ’542 patent states that it issued on December
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`3, 2019 and that it includes two independent claims. ACS and PM USA admit that Plaintiffs have
`
`quoted claim 1 of the ’542 patent in paragraph 19 of the Complaint. ACS and PM USA otherwise
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`deny the allegations in paragraph 19 of the Complaint.
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`THE ACCUSED PRODUCTS
`
`20.
`
`ACS and PM USA admit that the IQOS system includes an electrically powered
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`device that comprises a holder and a charger, and a disposable tobacco unit. ACS and PM USA
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`otherwise deny the allegations in paragraph 20 of the Complaint.
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`21.
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`Paragraph 21 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that PM USA imports and sells after
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`importation certain IQOS systems into the United States. ACS and PM USA admit that PM USA
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`oversees the stores in Atlanta, Georgia and in this District at 3402 W. Cary St. in the Carytown
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`district of Richmond, Virginia that offer to sell and sell certain IQOS systems and disposable
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`tobacco units. ACS and PM USA further admit that some of the packaging for the IQOS device
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`that it sells in the United States recites: “Manufactured for Philip Morris USA, Richmond VA.
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`Made in Malaysia,” and that some of the packaging for the tobacco unit states: “Mfd. for Philip
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`6
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`Morris USA, Richmond, VA. Made in Italy.” ACS and PM USA are without knowledge or
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`information sufficient to admit or deny the remaining allegations in paragraph 21 of the Complaint
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`and, on that basis, deny them.
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`22.
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`Paragraph 22 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the IQOS holder, into which the tobacco
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`unit is placed, heats the tobacco via a heating blade. ACS and PM USA admit the adult consumer
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`pushes a button to turn on the heating unit. ACS and PM USA further admit the holder includes a
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`battery and supplies heat to the tobacco unit via the heating blade for six minutes or 14 puffs,
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`whichever comes first. ACS and PM USA are without knowledge or information sufficient to
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`admit or deny the remaining allegations in paragraph 22 of the Complaint and, on that basis, deny
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`them.
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`23.
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`Paragraph 23 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the IQOS system’s tobacco unit is
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`designed for heating, not for burning or smoking, and contains a processed tobacco plug. ACS
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`and PM USA admit the tobacco plug is made from tobacco leaves, which are ground and formed
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`into tobacco sheets, called cast-leaf. ACS and PM USA further admit the adult consumer draws
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`on the tobacco unit to inhale a nicotine containing aerosol. ACS and PM USA admit that the
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`tobacco unit is available in different flavors, including regular and menthol flavors. ACS and PM
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`USA further admit that the tobacco unit is sometimes referred to as a HeatStick or Marlboro
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`HeatStick. ACS and PM USA are without knowledge or information sufficient to admit or deny
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`the remaining allegations in paragraph 23 of the Complaint and, on that basis, deny them.
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`24.
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`Paragraph 24 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the IQOS device includes a charger for
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`charging the holder and is sold with an AC power adaptor for recharging the charger. ACS and
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`PM USA further admit that the charger contains its own battery that charges the holder. ACS and
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`PM USA are without knowledge or information sufficient to admit or deny the remaining
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`allegations in paragraph 24 of the Complaint and, on that basis, deny them.
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`25.
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`Paragraph 25 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the holder, tobacco unit, and the charger
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`are authorized by the FDA for use as part of the IQOS system. ACS and PM USA specifically
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`deny the allegations of paragraph 25 of the Complaint relating to ACS and PM USA’s alleged
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`infringement of the Asserted Patents. ACS and PM USA are without knowledge or information
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`sufficient to admit or deny the remaining allegations in paragraph 25 of the Complaint and, on that
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`basis, deny them.
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`26.
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`Paragraph 26 contains legal conclusions to which no answer is required. ACS and
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`PM USA specifically deny the allegations of paragraph 26 of the Complaint relating to ACS and
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`PM USA’s alleged infringement of the Asserted Patents.
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`27.
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`Paragraph 27 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that PM USA sells the charger, holder,
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`tobacco unit, and a cleaner. ACS and PM USA further admit that the tobacco units are sold
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`separately in, for example, packs of 20. ACS and PM USA are without knowledge or information
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`sufficient to admit or deny the remaining allegations in paragraph 27 of the Complaint and, on that
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`basis, deny them.
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`28.
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`Paragraph 28 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that PM USA offers for sale and sells the
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`IQOS device with a User Guide and Quick Start Guide. ACS and PM USA specifically deny any
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`8
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`allegations related to infringement of the Asserted Patents. ACS and PM USA are without
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`knowledge or information sufficient to admit or deny the remaining allegations in paragraph 28 of
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`the Complaint and, on that basis, deny them.
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`29.
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`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 29 of the Complaint and, on that basis, deny them.
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`30.
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`Paragraph 30 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit the adult consumer inserts the tobacco unit
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`into the holder, which contains an electronically controlled heater. ACS and PM USA admit the
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`adult consumer pushes a button to turn on the heater, and then draws on the tobacco unit to inhale
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`a nicotine containing aerosol. ACS and PM USA admit the tobacco units respond to the warming
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`of the heat blade inside the holder, which heats the tobacco, and that the tobacco reaches a
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`temperature below 350°C, which is a high enough temperature to release a nicotine-containing
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`aerosol without burning the tobacco.
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`31.
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`ACS and PM USA admit that ACS is licensed to distribute, offer to sell, and sell
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`the IQOS system and the corresponding tobacco sticks in the U.S. and that PM USA has submitted
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`purchase orders to Philip Morris Products S.A. for certain IQOS systems since at least October
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`2019. ACS and PM USA deny the remaining allegations of paragraph 31.
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`32.
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`ACS and PM USA admit that PM USA is licensed to distribute, offer to sell, and
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`sell the IQOS system and the corresponding tobacco sticks in the U.S. and that PM USA has
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`submitted purchase orders to Philip Morris Products S.A. for certain IQOS systems since at least
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`October 2019. ACS and PM USA further admit that some of the packaging for the IQOS device
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`that it sells in the United States recites: “Manufactured for Philip Morris USA, Richmond VA.
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`Made in Malaysia,” and that some of the packaging for the tobacco unit states: “Mfd. for Philip
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`Morris USA, Richmond, VA. Made in Italy.” ACS and PM USA are without knowledge or
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`information sufficient to admit or deny the remaining allegations in paragraph 32 of the Complaint
`
`and, on that basis, deny them.
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`33.
`
`Paragraph 33 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that Philip Morris Products S.A. prosecuted
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`PMTAs with the FDA seeking approval to offer for sale and sell the IQOS system in the United
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`States, and that ACS and PM USA consulted with Philip Morris Products S.A. in preparation of
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`certain aspects of a PMTA. ACS and PM USA are without knowledge or information sufficient
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`to admit or deny the remaining allegations in paragraph 33 of the Complaint and, on that basis,
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`deny them.
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`THE IMPORTATION, SALE, OFFER FOR SALE, AND DISTRIBUTION OF IQOS
`DEVICES
`
`34.
`
`ACS and PM USA admit that, on or around May 24, 2017, Philip Morris Products
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`S.A. prosecuted PMTAs with the FDA seeking approval to offer for sale and sell the IQOS system
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`in the United States, and that ACS and PM USA consulted with Philip Morris Products S.A. in
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`preparation of certain aspects of a PMTA. ACS and PM USA are without knowledge or
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`information sufficient to admit or deny the remaining allegations in paragraph 34 of the Complaint
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`and, on that basis, deny them.
`
`35.
`
`36.
`
`Admitted.
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`Paragraph 36 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that PM USA has submitted purchase orders
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`to Philip Morris Products S.A. for certain IQOS systems since at least October 2019.
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`37.
`
`Paragraph 37 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the IQOS system is manufactured by
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`third parties outside the United States. ACS and PM USA admit that PM USA imports and sells
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`certain IQOS products in the United States. ACS and PM USA are without knowledge or
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`information sufficient to admit or deny the remaining allegations in paragraph 37 of the Complaint
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`and, on that basis, deny them.
`
`DEFENDANTS KNOW OF THE ASSERTED PATENTS, KNOW AND SPECIFICALLY
`INTEND THAT THE IQOS PRODUCTS INFRINGE THE ASSERTED PATENTS, AND
`KNOW THAT THE IQOS PRODUCTS ARE ESPECIALLY MADE OR ESPECIALLY
`ADAPTED FOR USE IN INFRINGING THE ASSERTED PATENTS
`
`38.
`
`Paragraph 38 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that the face of U.S. Design Patent No.
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`D844,221 and U.S. Patent No. 10,258,087 list U.S. Patent No. 7,726,320 (“the ’320 patent”); and
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`the face of U.S. Patent No. 10,278,424 lists U.S. Patent No. 9,078,473. ACS and PM USA are
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`without knowledge or information sufficient to admit or deny the remaining allegations in
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`paragraph 38 of the Complaint and, on that basis, deny them.
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`39.
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`40.
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`Denied.
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`Denied.
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`COUNT ONE
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`41.
`
`ACS and PM USA re-allege, adopt, and incorporate by reference the allegations
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`included within paragraphs 1 through 40 as if fully set forth herein.
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`42.
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`ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 42 of the Complaint and, on that basis, deny them.
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`43.
`
`Paragraph 43 contains legal conclusions to which no answer is required. ACS and
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`PM USA are without knowledge or information sufficient to admit or deny the remaining
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`allegations in paragraph 43 of the Complaint and, on that basis, deny them.
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`44.
`
`Denied.
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`45.
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`ACS and PM USA admit that the quoted language in paragraph 45 appears in claim
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`16 of the ’268 patent.
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`46.
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`Paragraph 46 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA state that the IQOS system includes an electrically
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`powered device that comprises a holder and a charger, and a disposable tobacco unit. ACS and
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`PM USA otherwise deny the allegations in paragraph 46.
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`47.
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`Paragraph 47 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA state that the IQOS system includes an electrically
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`powered device that comprises a battery. ACS and PM USA otherwise deny the allegations of
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`paragraph 47.
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`48.
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`Paragraph 48 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA state that the document cited speaks for itself.
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`ACS and PM USA otherwise deny the allegations of paragraph 48.
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`49.
`
`ACS and PM USA admit that the quoted language in paragraph 49 appears in claim
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`16 of the ’268 patent.
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`50.
`
`Paragraph 50 contains legal conclusions to which no response i required. To the
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`extent an answer is required, ACS and PM USA deny the allegations in paragraph 50.
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`51.
`
`ACS and PM USA admit that the quoted language in paragraph 51 appears in claim
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`16 of the ’268 patent.
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`52.
`
`Paragraph 52 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA deny the allegations in paragraph 52.
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`53.
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`ACS and PM USA admit that the quoted language in paragraph 53 appears in claim
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`16 of the ’268 patent.
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`54.
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`Paragraph 54 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA admit that the IQOS system includes a holder that
`
`comprises a battery. ACS and PM USA otherwise deny the allegations in paragraph 54.
`
`55.
`
`ACS and PM USA admit that the quoted language in paragraph 55 appears in claim
`
`16 of the ’268 patent.
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`56.
`
`Paragraph 56 contains legal conclusions to which no response is required. To the
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`extent an answer is required, ACS and PM USA deny the allegations of paragraph 56.
`
`57.
`
`ACS and PM USA state that the document cited in paragraph 57 speaks for itself.
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`ACS and PM USA otherwise deny the remaining allegations of paragraph 57.
`
`58.
`
`ACS and PM USA admit that the quoted language in paragraph 58 appears in claim
`
`16 of the ’268 patent.
`
`59.
`
`ACS and PM USA state that the document cited in paragraph 59 speaks for itself.
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`ACS and PM otherwise deny the remaining allegations of paragraph 59.
`
`60.
`
`ACS and PM USA admit that the quoted language in paragraph 60 appears in claim
`
`16 of the ’268 patent.
`
`61.
`
`62.
`
`Denied.
`
`ACS and PM USA admit that the quoted language in paragraph 62 appears in claim
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`16 of the ’268 patent.
`
`63.
`
`ACS and PM USA state that the document cited in paragraph 63 speaks for itself.
`
`ACS and PM USA otherwise deny the allegations in paragraph 63.
`
`64.
`
`65.
`
`66.
`
`Denied.
`
`Denied.
`
`Denied.
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`13
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`67.
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`68.
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`69.
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`Denied.
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`Denied.
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`Paragraph 69 contains a summary request for relief, and no response is required.
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`To the extent a response is required, ACS and PM USA deny that Plaintiffs are entitled to any
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`relief sought in their Complaint or any relief whatsoever.
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`COUNTS TWO THROUGH FOUR
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`70-158.
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`The Court has stayed Counts Two, Three, and Four of the Complaint under
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`28 U.S.C. § 1659. See Dkt. 27. The Amended Complaint improperly adds allegations to Counts
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`that this Court expressly stayed under 19 U.S.C. § 1659(a). See Dkt. 27. This is not permitted.
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`Plaintiffs cannot amend allegations for stayed counts without leave of the Court. See, e.g., Sandisk
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`Corp. v. Phison Elecs. Corp., Nos. 07-cv-605, 2008 WL 4533715 (W.D. Wis. Sept. 17, 2008)
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`(addressing motions practice where the parties sought leave of the court to lift a stay under 19
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`U.S.C. § 1659 to proceed with ministerial discovery). Consequently, the new allegations set forth
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`in Counts Two, Three, and Four from the Amended Complaint are not properly part of this action.
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`(Dkt. 52, ¶¶ 70-158). Absent this Court lifting the stay imposed by its June order, which Plaintiffs
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`failed to confer on and failed to move for, Plaintiffs have no ability to amend any portion of the
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`stayed Counts. ACS and PM USA will respond to these counts if they are properly amended and
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`at the appropriate time when the stay is lifted.
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`COUNT FIVE
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`159. ACS and PM USA re-allege, adopt, and incorporate by reference the allegations
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`included within paragraphs 1 through 158 as if fully set forth herein.
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`160. ACS and PM USA are without knowledge or information sufficient to admit or
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`deny the allegations in paragraph 160 of the Complaint and, on that basis, deny them.
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`161. Paragraph 161 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, ACS and PM USA admit that PM USA imports and sells certain
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`IQOS products in the United States. ACS and PM USA are without knowledge or information
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`sufficient to admit or deny the remaining allegations in paragraph 161 of the Complaint and, on
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`that basis, deny them.
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`162. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`163. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`164. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`165. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`166. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`167. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`168. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`169. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
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`draft claims directed at the Accused Products, but the claims are far removed from the alleged
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`invention possessed at the time of filing and described by the inventors when they filed the original
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`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
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`written description, anticipation, and obviousness.
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`RESPONSE TO PRAYER FOR RELIEF
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`170. ACS and PM USA deny that Plaintiffs are entitled to any relief sought in their
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`Complaint or any relief whatsoever.
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`AFFIRMATIVE AND OTHER DEFENSES
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`171. Pursuant to Federal Rule of Civil Procedure 8(c), and without altering any
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`applicable burdens of proof or burdens of persuasion, ACS and PM USA assert the following
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`defenses to the Complaint and reserve their right to assert additional defenses.
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`FIRST AFFIRMATIVE DEFENSE
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`(Non-Infringement)
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`172. ACS and PM USA do not and have not infringed any valid, enforceable, asserted
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`claim of the Asserted Patents, either literally or under the doctrine of equivalents, under any theory
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`of infringement.
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`SECOND AFFIRMATIVE DEFENSE
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`(Invalidity)
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`173. Each asserted claim of the Asserted Patents is invalid for failure to comply with one
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`or more of the requirements of Title 35 of the United States Code, including without limitation, 35
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`U.S.C. §§ 101, 102, 103, 112, and 116, and the rules, regulations, and laws pertaining thereto.
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`THIRD AFFIRMATIVE DEFENSE
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`(Prosecution History Estoppel and Disclaimer)
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`174. Plaintiffs are barred, based on statements, representations, and admissions made
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`during prosecution of the patent applications resulting in the Asserted Patents or related patent
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`applications, from asserting any interpretation of any valid, enforceable claim of the Asserted
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`Patents that would be broad enough to cover any Accused Product alleged to infringe the Asserted
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`Patents, either literally or under the doctrine of equivalents.
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`FOURTH AFFIRMATIVE DEFENSE
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`(Equitable Defenses)
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`175. Plaintiffs’ attempted enforcement of the Asserted Patents against ACS and PM
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`USA is barred by one or more of the equitable doctrines, such as estoppel, acquiescence, waiver,
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`and unclean hands.
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`FIFTH AFFIRMATIVE DEFENSE
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`(Limitation on Damages)
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`176. Plaintiffs’ claims for damages are statutorily limited or barred by 35 U.S.C. §§ 286
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`and/or 287.
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`SIXTH