throbber
Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 1 of 81 PageID# 3298
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`
`
`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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`

`

`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 2 of 81 PageID# 3299
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`
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`INTRODUCTION AND PRELIMINARY STATEMENT OF ACS AND PM USA
`
`RJR appears to have brought this action in the hopes of stopping the innovative IQOS
`
`heated tobacco system, which has a proven track record in switching smokers away from
`
`combustible cigarettes, from disrupting its core business in combustible cigarettes and overtake its
`
`secondary line of e-vapor products. Having failed to develop a competing offering in the heated
`
`tobacco space, RJR apparently now seeks to block that space in its entirety by bringing this
`
`meritless litigation. But in its haste to do so, RJR has overlooked the fact that its own line of e-
`
`vapor products (which are far less effective in switching smokers away from combustible
`
`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
`
`profitable premium products and iconic brands, including Marlboro, Benson & Hedges,
`
`Parliament, and Virginia Slims. While ACS and PM USA will continue to lead in traditional
`
`tobacco products, ACS and PM USA recognize that adult preferences are changing. Thus, ACS
`
`and PM USA partnered with co-defendant Philip Morris Products S.A. (“PMP”) to commercialize
`
`IQOS, a product that heats rather than burns tobacco to produce an aerosol instead of smoke
`
`(known as a “Heat-Not-Burn” or “HNB” product) in the United States. ACS and PM USA have
`
`also amassed a substantial portfolio of intellectual property, covering numerous innovations
`
`relating to smoke-free technologies, including both heated tobacco and e-vapor products.
`
`PMP first launched IQOS in select cities in Italy and Japan in 2014. It is now sold in over
`
`57 countries throughout the world. To date, over 11.2 million smokers have switched to IQOS
`
`and given up smoking for good. This number is growing daily. PMP conducted 10 clinical studies
`
`on IQOS and published over 340 peer-reviewed articles on reduced risk products. There are also
`
`2
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`

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`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 3 of 81 PageID# 3300
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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.
`
`In 2019, after a lengthy review, the United States Food and Drug Administration (“FDA”)
`
`granted PMP’s request for a pre-market authorization to commercialize IQOS through PM USA
`
`in the United States. In granting that request, the FDA determined that marketing IQOS “would
`
`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
`
`“significantly reduces the production of harmful and potentially harmful chemicals.” To date, no
`
`other HNB or e-vapor product has received these authorizations.
`
`Apparently concerned by the commercial threat posed by IQOS, RJR is now attempting to
`
`stop IQOS with this case. But in its haste to stop IQOS, RJR committed two fatal errors. First, it
`
`asserted meritless patent claims. Second, it overlooked the fact that its own e-vapor products
`
`infringe multiple patents owned by ACS, PM USA and co-defendant PMP. ACS and PM USA
`
`thus respond to RJR’s Complaint and bring counterclaims to recover the considerable damages
`
`flowing from RJR’s infringement.
`
`RESPONSES TO THE SPECIFIC ALLEGATIONS OF COMPLAINT
`
`THE PARTIES
`
`1.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 1 of the Complaint and, on that basis, deny them.
`
`2.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 2 of the Complaint and, on that basis, deny them.
`
`3.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 3 of the Complaint and, on that basis, deny them.
`
`3
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`

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`
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`4.
`
`5.
`
`6.
`
`Admitted.
`
`Admitted.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 6 of the Complaint and, on that basis, deny them.
`
`JURISDICTION AND VENUE
`
`7.
`
`Paragraph 7 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the Complaint purports to be an action
`
`arising under the patent laws of the United States, 35 U.S.C. §§ 271, et seq., and that this Court
`
`has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338, but ACS and PM USA
`
`deny that there is any legal or factual basis for such action.
`
`8.
`
`Paragraph 8 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit for purposes of this action only that this
`
`Court has personal jurisdiction over it. ACS and PM USA otherwise deny the allegations in
`
`paragraph 8 of the Complaint.
`
`9.
`
`Paragraph 9 contains legal conclusions to which no answer is required. ACS and
`
`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.
`
`10.
`
`Paragraph 10 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit for purposes of this action only that venue
`
`exists in this District for the claims against ACS and PM USA pursuant to 28 U.S.C. §§ 1391 and
`
`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
`
`to admit or deny the remaining allegations in paragraph 10 of the Complaint and, on that basis,
`
`4
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`deny them. ACS and PM USA specifically deny the allegations of paragraph 10 of the Complaint
`
`relating to ACS and PM USA’s alleged infringement of any patents.
`
`11.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 11 of the Complaint and, on that basis, deny them.
`
`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
`
`admit that the face of the ’268 patent states that it issued on November 4, 2017 and that it includes
`
`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.
`
`13.
`
`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
`
`stay is lifted.
`
`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
`
`stay is lifted.
`
`15.
`
`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
`
`stay is lifted.
`
`16.
`
`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
`
`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
`
`stay is lifted.
`
`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
`
`stay is lifted.
`
`19.
`
`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
`
`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
`
`deny the allegations in paragraph 19 of the Complaint.
`
`THE ACCUSED PRODUCTS
`
`20.
`
`ACS and PM USA admit that the IQOS system includes an electrically powered
`
`device that comprises a holder and a charger, and a disposable tobacco unit. ACS and PM USA
`
`otherwise deny the allegations in paragraph 20 of the Complaint.
`
`21.
`
`Paragraph 21 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that PM USA imports and sells after
`
`importation certain IQOS systems into the United States. ACS and PM USA admit that PM USA
`
`oversees the stores in Atlanta, Georgia and in this District at 3402 W. Cary St. in the Carytown
`
`district of Richmond, Virginia that offer to sell and sell certain IQOS systems and disposable
`
`tobacco units. ACS and PM USA further admit that some of the packaging for the IQOS device
`
`that it sells in the United States recites: “Manufactured for Philip Morris USA, Richmond VA.
`
`Made in Malaysia,” and that some of the packaging for the tobacco unit states: “Mfd. for Philip
`
`6
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`Morris USA, Richmond, VA. Made in Italy.” ACS and PM USA are without knowledge or
`
`information sufficient to admit or deny the remaining allegations in paragraph 21 of the Complaint
`
`and, on that basis, deny them.
`
`22.
`
`Paragraph 22 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the IQOS holder, into which the tobacco
`
`unit is placed, heats the tobacco via a heating blade. ACS and PM USA admit the adult consumer
`
`pushes a button to turn on the heating unit. ACS and PM USA further admit the holder includes a
`
`battery and supplies heat to the tobacco unit via the heating blade for six minutes or 14 puffs,
`
`whichever comes first. ACS and PM USA are without knowledge or information sufficient to
`
`admit or deny the remaining allegations in paragraph 22 of the Complaint and, on that basis, deny
`
`them.
`
`23.
`
`Paragraph 23 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the IQOS system’s tobacco unit is
`
`designed for heating, not for burning or smoking, and contains a processed tobacco plug. ACS
`
`and PM USA admit the tobacco plug is made from tobacco leaves, which are ground and formed
`
`into tobacco sheets, called cast-leaf. ACS and PM USA further admit the adult consumer draws
`
`on the tobacco unit to inhale a nicotine containing aerosol. ACS and PM USA admit that the
`
`tobacco unit is available in different flavors, including regular and menthol flavors. ACS and PM
`
`USA further admit that the tobacco unit is sometimes referred to as a HeatStick or Marlboro
`
`HeatStick. ACS and PM USA are without knowledge or information sufficient to admit or deny
`
`the remaining allegations in paragraph 23 of the Complaint and, on that basis, deny them.
`
`24.
`
`Paragraph 24 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the IQOS device includes a charger for
`
`7
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`charging the holder and is sold with an AC power adaptor for recharging the charger. ACS and
`
`PM USA further admit that the charger contains its own battery that charges the holder. ACS and
`
`PM USA are without knowledge or information sufficient to admit or deny the remaining
`
`allegations in paragraph 24 of the Complaint and, on that basis, deny them.
`
`25.
`
`Paragraph 25 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the holder, tobacco unit, and the charger
`
`are authorized by the FDA for use as part of the IQOS system. ACS and PM USA specifically
`
`deny the allegations of paragraph 25 of the Complaint relating to ACS and PM USA’s alleged
`
`infringement of the Asserted Patents. ACS and PM USA are without knowledge or information
`
`sufficient to admit or deny the remaining allegations in paragraph 25 of the Complaint and, on that
`
`basis, deny them.
`
`26.
`
`Paragraph 26 contains legal conclusions to which no answer is required. ACS and
`
`PM USA specifically deny the allegations of paragraph 26 of the Complaint relating to ACS and
`
`PM USA’s alleged infringement of the Asserted Patents.
`
`27.
`
`Paragraph 27 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that PM USA sells the charger, holder,
`
`tobacco unit, and a cleaner. ACS and PM USA further admit that the tobacco units are sold
`
`separately in, for example, packs of 20. ACS and PM USA are without knowledge or information
`
`sufficient to admit or deny the remaining allegations in paragraph 27 of the Complaint and, on that
`
`basis, deny them.
`
`28.
`
`Paragraph 28 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that PM USA offers for sale and sells the
`
`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
`
`knowledge or information sufficient to admit or deny the remaining allegations in paragraph 28 of
`
`the Complaint and, on that basis, deny them.
`
`29.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 29 of the Complaint and, on that basis, deny them.
`
`30.
`
`Paragraph 30 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit the adult consumer inserts the tobacco unit
`
`into the holder, which contains an electronically controlled heater. ACS and PM USA admit the
`
`adult consumer pushes a button to turn on the heater, and then draws on the tobacco unit to inhale
`
`a nicotine containing aerosol. ACS and PM USA admit the tobacco units respond to the warming
`
`of the heat blade inside the holder, which heats the tobacco, and that the tobacco reaches a
`
`temperature below 350°C, which is a high enough temperature to release a nicotine-containing
`
`aerosol without burning the tobacco.
`
`31.
`
`ACS and PM USA admit that ACS is licensed to distribute, offer to sell, and sell
`
`the IQOS system and the corresponding tobacco sticks in the U.S. and that PM USA has submitted
`
`purchase orders to Philip Morris Products S.A. for certain IQOS systems since at least October
`
`2019. ACS and PM USA deny the remaining allegations of paragraph 31.
`
`32.
`
`ACS and PM USA admit that PM USA is licensed to distribute, offer to sell, and
`
`sell the IQOS system and the corresponding tobacco sticks in the U.S. and that PM USA has
`
`submitted purchase orders to Philip Morris Products S.A. for certain IQOS systems since at least
`
`October 2019. ACS and PM USA further admit that some of the packaging for the IQOS device
`
`that it sells in the United States recites: “Manufactured for Philip Morris USA, Richmond VA.
`
`Made in Malaysia,” and that some of the packaging for the tobacco unit states: “Mfd. for Philip
`
`9
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`Morris USA, Richmond, VA. Made in Italy.” ACS and PM USA are without knowledge or
`
`information sufficient to admit or deny the remaining allegations in paragraph 32 of the Complaint
`
`and, on that basis, deny them.
`
`33.
`
`Paragraph 33 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that Philip Morris Products S.A. prosecuted
`
`PMTAs with the FDA seeking approval to offer for sale and sell the IQOS system in the United
`
`States, and that ACS and PM USA consulted with Philip Morris Products S.A. in preparation of
`
`certain aspects of a PMTA. ACS and PM USA are without knowledge or information sufficient
`
`to admit or deny the remaining allegations in paragraph 33 of the Complaint and, on that basis,
`
`deny them.
`
`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
`
`S.A. prosecuted PMTAs with the FDA seeking approval to offer for sale and sell the IQOS system
`
`in the United States, and that ACS and PM USA consulted with Philip Morris Products S.A. in
`
`preparation of certain aspects of a PMTA. ACS and PM USA are without knowledge or
`
`information sufficient to admit or deny the remaining allegations in paragraph 34 of the Complaint
`
`and, on that basis, deny them.
`
`35.
`
`36.
`
`Admitted.
`
`Paragraph 36 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that PM USA has submitted purchase orders
`
`to Philip Morris Products S.A. for certain IQOS systems since at least October 2019.
`
`37.
`
`Paragraph 37 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that the IQOS system is manufactured by
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`10
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`third parties outside the United States. ACS and PM USA admit that PM USA imports and sells
`
`certain IQOS products in the United States. ACS and PM USA are without knowledge or
`
`information sufficient to admit or deny the remaining allegations in paragraph 37 of the Complaint
`
`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
`
`extent an answer is required, ACS and PM USA admit that the face of U.S. Design Patent No.
`
`D844,221 and U.S. Patent No. 10,258,087 list U.S. Patent No. 7,726,320 (“the ’320 patent”); and
`
`the face of U.S. Patent No. 10,278,424 lists U.S. Patent No. 9,078,473. ACS and PM USA are
`
`without knowledge or information sufficient to admit or deny the remaining allegations in
`
`paragraph 38 of the Complaint and, on that basis, deny them.
`
`39.
`
`40.
`
`Denied.
`
`Denied.
`
`COUNT ONE
`
`41.
`
`ACS and PM USA re-allege, adopt, and incorporate by reference the allegations
`
`included within paragraphs 1 through 40 as if fully set forth herein.
`
`42.
`
`ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 42 of the Complaint and, on that basis, deny them.
`
`43.
`
`Paragraph 43 contains legal conclusions to which no answer is required. ACS and
`
`PM USA are without knowledge or information sufficient to admit or deny the remaining
`
`allegations in paragraph 43 of the Complaint and, on that basis, deny them.
`
`44.
`
`Denied.
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`11
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`45.
`
`ACS and PM USA admit that the quoted language in paragraph 45 appears in claim
`
`16 of the ’268 patent.
`
`46.
`
`Paragraph 46 contains legal conclusions to which no response is required. To the
`
`extent an answer is required, ACS and PM USA state that the IQOS system includes an electrically
`
`powered device that comprises a holder and a charger, and a disposable tobacco unit. ACS and
`
`PM USA otherwise deny the allegations in paragraph 46.
`
`47.
`
`Paragraph 47 contains legal conclusions to which no response is required. To the
`
`extent an answer is required, ACS and PM USA state that the IQOS system includes an electrically
`
`powered device that comprises a battery. ACS and PM USA otherwise deny the allegations of
`
`paragraph 47.
`
`48.
`
`Paragraph 48 contains legal conclusions to which no response is required. To the
`
`extent an answer is required, ACS and PM USA state that the document cited speaks for itself.
`
`ACS and PM USA otherwise deny the allegations of paragraph 48.
`
`49.
`
`ACS and PM USA admit that the quoted language in paragraph 49 appears in claim
`
`16 of the ’268 patent.
`
`50.
`
`Paragraph 50 contains legal conclusions to which no response i required. To the
`
`extent an answer is required, ACS and PM USA deny the allegations in paragraph 50.
`
`51.
`
`ACS and PM USA admit that the quoted language in paragraph 51 appears in claim
`
`16 of the ’268 patent.
`
`52.
`
`Paragraph 52 contains legal conclusions to which no response is required. To the
`
`extent an answer is required, ACS and PM USA deny the allegations in paragraph 52.
`
`53.
`
`ACS and PM USA admit that the quoted language in paragraph 53 appears in claim
`
`16 of the ’268 patent.
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`12
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`54.
`
`Paragraph 54 contains legal conclusions to which no response is required. To the
`
`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.
`
`56.
`
`Paragraph 56 contains legal conclusions to which no response is required. To the
`
`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.
`
`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.
`
`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
`
`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.
`
`13
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`67.
`
`68.
`
`69.
`
`Denied.
`
`Denied.
`
`Paragraph 69 contains a summary request for relief, and no response is required.
`
`To the extent a response is required, ACS and PM USA deny that Plaintiffs are entitled to any
`
`relief sought in their Complaint or any relief whatsoever.
`
`COUNTS TWO THROUGH FOUR
`
`
`
`70-158.
`
`The Court has stayed Counts Two, Three, and Four of the Complaint under
`
`28 U.S.C. § 1659. See Dkt. 27. The Amended Complaint improperly adds allegations to Counts
`
`that this Court expressly stayed under 19 U.S.C. § 1659(a). See Dkt. 27. This is not permitted.
`
`Plaintiffs cannot amend allegations for stayed counts without leave of the Court. See, e.g., Sandisk
`
`Corp. v. Phison Elecs. Corp., Nos. 07-cv-605, 2008 WL 4533715 (W.D. Wis. Sept. 17, 2008)
`
`(addressing motions practice where the parties sought leave of the court to lift a stay under 19
`
`U.S.C. § 1659 to proceed with ministerial discovery). Consequently, the new allegations set forth
`
`in Counts Two, Three, and Four from the Amended Complaint are not properly part of this action.
`
`(Dkt. 52, ¶¶ 70-158). Absent this Court lifting the stay imposed by its June order, which Plaintiffs
`
`failed to confer on and failed to move for, Plaintiffs have no ability to amend any portion of the
`
`stayed Counts. ACS and PM USA will respond to these counts if they are properly amended and
`
`at the appropriate time when the stay is lifted.
`
`COUNT FIVE
`
`159. ACS and PM USA re-allege, adopt, and incorporate by reference the allegations
`
`included within paragraphs 1 through 158 as if fully set forth herein.
`
`160. ACS and PM USA are without knowledge or information sufficient to admit or
`
`deny the allegations in paragraph 160 of the Complaint and, on that basis, deny them.
`
`14
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 15 of 81 PageID# 3312
`
`
`
`161. Paragraph 161 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, ACS and PM USA admit that PM USA imports and sells certain
`
`IQOS products in the United States. ACS and PM USA are without knowledge or information
`
`sufficient to admit or deny the remaining allegations in paragraph 161 of the Complaint and, on
`
`that basis, deny them.
`
`162. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`163. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`164. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`165. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`15
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 16 of 81 PageID# 3313
`
`
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`166. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`167. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`168. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`169. Denied. Plaintiffs filed for the ’542 patent in September 2019 and attempted to
`
`draft claims directed at the Accused Products, but the claims are far removed from the alleged
`
`invention possessed at the time of filing and described by the inventors when they filed the original
`
`patent application on August 9, 2011 and are therefore invalid for, among other things, lack of
`
`written description, anticipation, and obviousness.
`
`16
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 17 of 81 PageID# 3314
`
`
`
`RESPONSE TO PRAYER FOR RELIEF
`
`170. ACS and PM USA deny that Plaintiffs are entitled to any relief sought in their
`
`Complaint or any relief whatsoever.
`
`AFFIRMATIVE AND OTHER DEFENSES
`
`171. Pursuant to Federal Rule of Civil Procedure 8(c), and without altering any
`
`applicable burdens of proof or burdens of persuasion, ACS and PM USA assert the following
`
`defenses to the Complaint and reserve their right to assert additional defenses.
`
`FIRST AFFIRMATIVE DEFENSE
`
`(Non-Infringement)
`
`172. ACS and PM USA do not and have not infringed any valid, enforceable, asserted
`
`claim of the Asserted Patents, either literally or under the doctrine of equivalents, under any theory
`
`of infringement.
`
`SECOND AFFIRMATIVE DEFENSE
`
`(Invalidity)
`
`173. Each asserted claim of the Asserted Patents is invalid for failure to comply with one
`
`or more of the requirements of Title 35 of the United States Code, including without limitation, 35
`
`U.S.C. §§ 101, 102, 103, 112, and 116, and the rules, regulations, and laws pertaining thereto.
`
`THIRD AFFIRMATIVE DEFENSE
`
`(Prosecution History Estoppel and Disclaimer)
`
`174. Plaintiffs are barred, based on statements, representations, and admissions made
`
`during prosecution of the patent applications resulting in the Asserted Patents or related patent
`
`applications, from asserting any interpretation of any valid, enforceable claim of the Asserted
`
`Patents that would be broad enough to cover any Accused Product alleged to infringe the Asserted
`
`Patents, either literally or under the doctrine of equivalents.
`
`17
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 194 Filed 10/16/20 Page 18 of 81 PageID# 3315
`
`
`
`FOURTH AFFIRMATIVE DEFENSE
`
`(Equitable Defenses)
`
`175. Plaintiffs’ attempted enforcement of the Asserted Patents against ACS and PM
`
`USA is barred by one or more of the equitable doctrines, such as estoppel, acquiescence, waiver,
`
`and unclean hands.
`
`FIFTH AFFIRMATIVE DEFENSE
`
`(Limitation on Damages)
`
`176. Plaintiffs’ claims for damages are statutorily limited or barred by 35 U.S.C. §§ 286
`
`and/or 287.
`
`SIXTH

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