UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WATSON LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2017-01621
`Patent No. 9,358,240
`
`
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`
`
`PETITIONER’S COMBINED MOTION TO SUBMIT SUPPLEMENTAL
`INFORMATION UNDER 37 C.F.R. § 42.123 AND MOTION FOR
`ADDITIONAL DISCOVERY UNDER 37 C.F.R. §42.51
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via PTAB E2E
`
`
`
`
`
`

`

`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ........................................................................................... 1
`
`FACTUAL BACKGROUND .......................................................................... 1
`
`III. LEGAL STANDARDS ................................................................................... 3
`
`IV. MOTION TO SUBMIT SUPPLEMENTAL INFORMATION ..................... 3
`A.
`The Proposed Supplemental Information is Relevant. .......................... 3
`B. Allowing the Supplemental Information Now Will Allow the
`Issue to be Decided on a Fully Developed Record. .............................. 6
`
`V. MOTION FOR ADDITIONAL DISCOVERY .............................................. 7
`A.
`The Additional Discovery Will Lead to the Discovery of Useful
`Information. ........................................................................................... 7
`The Additional Discovery Does Not Implicate Patent Owner’s
`Litigation Positions. .............................................................................. 8
`The Remaining Garmin Factors Support Granting Petitioner’s
`Motion for Additional Discovery ........................................................ 10
`
`C.
`
`B.
`
`VI. CONCLUSION .............................................................................................. 10
`
`
`
`
`
`
`
`
`
`
`
`i
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Ethicon Endo-Surgery, Inc. v. Hologic, Inc.,
`689 F. Supp. 2d 929 (S.D. Ohio 2010) ................................................................. 4
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs., LLC,
`Case No. IPR2012–00001, Paper 26 (PTAB Mar. 5, 2013) ............................. 3, 8
`
`Mylan v. Allergan,
`Case No. IPR2016-01127, Paper 28 (PTAB May 31, 2017) ................................ 8
`
`Riverwood Int’l Corp. v. R.A. Jones & Co., Inc.,
`324 F.3d 1346 (Fed. Cir. 2003) ............................................................................ 4
`
`Sprint Communications Co. L.P. v. Comcast IP Holdings, LLC,
`No. 12–1013–RGA, 2015 WL 452289 (D. Del. Jan. 30, 2015) ........................... 4
`
`Varian Med. Sys. v. Wm. Beaumont Hosp.,
`IPR2016-163, Paper 79 (PTAB May 4, 2017) ..................................................... 5
`
`Statutes
`
`35 U.S.C. § 102(a) ..................................................................................................... 1
`
`Other Authorities
`
`37 C.F.R. § 42.51(b)(2) .............................................................................................. 3
`
`37 C.F.R. § 42.51(b)(2)(i) .......................................................................................... 7
`
`37 C.F.R. § 42.123(a) ................................................................................................. 3
`
`37 C.F.R. § 42.123(a)(1) ............................................................................................ 6
`
`Fed. R. Evid. 401 ....................................................................................................... 6
`
`
`
`
`
`ii
`
`

`

`PETITIONER’S EXHIBIT LIST
`
`1003
`
`1004
`
`1005
`
`1006
`1007
`1008
`1009
`
`Exhibit Description
`1001
`U.S. Patent No. 9,358,240
`1002
`Declaration of Maureen D. Donovan in Support of the Petition for
`Inter Partes Review of U.S. Patent No. 9,358,240
`Robert Voswinckel, et al. “Inhaled treprostinil sodium for the
`treatment of pulmonary hypertension” Abstract #1414, Circulation,
`110, 17, Supplement (Oct. 2004): III-295 (“Voswinckel”)
`U.S. Patent Application Publication No. 2004/0265238 A1 to Chaudry
`(“Chaudry”)
`Hossein Ardeschi Ghofrani, Robert Voswinckel, et al., “Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie,” Hertz, 30,4 (June 2005): 296-302 (“Ghofrani”)
`Opti-Neb-ir® Operating Instructions, Model ON-100/2 (2005)
`RESERVED
`Venta-Neb-ir® A-I-C-I Operating Instructions, Model VN-100/4
`Annexes to Commission Decision C(2005)3436 of 05 September
`2005, http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/anx_10259_en.pdf (Annex III –
`Ventavis® Labelling and Package Leaflet)
`U.S. Patent No. 6,606,989 (“Brand ’989”)
`Amendment and Reply Accompanying RCE filed in 12/591,200 (Jul.
`2, 2013) (with accompanying Declaration of Lewis Rubin, M.D.)
`WO 93/00951 to Patton
`Declaration of Scott Bennett, Ph.D.
`Affidavit of Christopher Butler, June 15, 2017
`Affidavit of Christopher Butler, June 16, 2017
`RESERVED
`RESERVED
`U.S. Patent No. 6,521,212 (“Cloutier ’212”)
`U.S. Patent No. 4,306,075 (“Aristoff ’075”)
`U.S. Patent No. 5,190,972 (“Dumble ’972”)
`European Patent Specification 0347243 B1, published January 13,
`1993
`U.S. Patent No. 6,261,539 (“Adjei ’539”)
`European Patent Application Publication No. EP 0372777 A2
`(“Purewal EP ’777”)
`U.S. Patent No. 4,895,719 (“Radhakrishnan ’719”)
`
`1010
`1011
`
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`1021
`
`1022
`1023
`
`1024
`
`iii
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`
`
`
`
`

`

`1025
`1026
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`
`
`U.S. Patent No. 5,153,222 (“Tadepalli ’222”)
`U.S. Patent No. 6,357,671 (“Cewers ’671”)
`Gessler, et al., Ultrasonic versus Jet Nebulization of Iloprost in Severe
`Pulmonary Hypertension, Eur. Respiratory J., 17:14-19 (2001)
`Olschewski H., et al., Aerosolized Prostacyclin and Iloprost in Severe
`Pulmonary Hypertension, 1996 Ann. Intern. Med. 124(9), 820-824
`(1996) (“Olschewski 199”)
`Olschewski, et al., Pharmacodynamics and Pharmacokinetics of
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`Pulmonary Hypertension, Chest J., 124(4), 1294-1304 (Oct. 2003)
`Byron, Drug Delivery Devices: Issues in Drug Development, Proc.
`Am. Thorac. Soc., 1:321-328 (2004)
`U.S. Patent No. 5,544,646 (“Lloyd”)
`Edwards D.A. et al., Recent Advances in Pulmonary Drug Delivery
`Using Large Porous Inhaled Particles, Journal of Applied Physiology,
`85(2): 379-385 (1998) (“Edwards 1998”)
`Badesch, et al., Prostanoid Therapy for Pulmonary Arterial
`Hypertension, J. of the Am. C. of Cardiology, 43(12):Suppl. S (2004)
`U.S. Patent No. 6,054,486 (“Crow ’486”)
`U.S. Food and Drug Administration, Drug Approval Package:
`Remodulin® (approved on May 21, 2002),
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
`272_Remodulin.cfm (“Remodulin® Approval Package”)
`Electronic Medicines Compendium, Ventavis®,
`http://www.medicines.org.uk/emc/medicine/13743
`European Agency Approves Ventavis for Primary Pulmonary
`Hypertension, P&T Community (Sep. 22, 2003),
`https://www.ptcommunity.com/news/2003-09-22-000000/european-
`agency-approves-ventavis-primary-pulmonary-hypertension
`EU Community Register of Medicinal Products, Homepage,
`http://ec.europa.eu/health/documents/community-
`register/html/index_en.htm
`EMEA Scientific Discussion, Ventavis® (2004),
`http://www.ema.europa.edu/docs/en_GB/document_library/
`EPAR_Scientific_Discussion/human/000474/WC500048688.pdf
`Muller et al., “Use of Inhaled Iloprost in a Case of Pulmonary
`Hypertension during Pediatric Congenital Heart Surgery,” 99
`Anesthesiology 743-747 (2003)
`
`iv
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`

`

`1041
`
`1042
`
`1043
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`1044
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`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`
`
`Mueller et al., “Inhaled Iloprost in the Management of Pulmonary
`Hypertension in Infants Undergoing Congenital Heart Surgery,”
`21 Eur. J. Anaesthesiology (suppl. 33) 2-36 (2004)
`Commission Decision C(2005)3436 of 05 September 2005,
`http://ec.europa.eu/health/documents/community-
`register/2005/2005090510259/dec_10259_en.pdf
`EU Community Register of Medicinal Products for Human Use,
`Ventavis, http://ec.europa.eu/health/documents/community-
`register/html/h255.htm#
`Summary of Community Decisions, Official Journal of the European
`Union (Oct. 28, 2005) http://eur-lex.europa.eu/legal-
`content/EN/TXT/?uri=uriserv:OJ.C_.2005.268.01.0002.01.ENG&toc=
`OJ:C:2005:268:TOC (noting a modification of marketing approval for
`Ventavis®)
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`http://www.medicines.org.uk/emc/history/13743#version1 (noting a
`change to section 4.2 – Posology and Method of Administration on
`September 22, 2005)
`Voswinckel, R., et al., “Inhaled treprostinil is a potent pulmonary
`vasodilator in severe pulmonary hypertension,” 25 European Heart
`Journal 22, at 218 (2004) (“Voswinckel II”)
`Sulica, R and Poon, M. “Medical Therapeutics for Pulmonary Arterial
`Hypertension From Basic Science and Clinical Trial Design to
`Evidence-Based Medicine.” 3(2) Expert Rev. Cardiovas. Ther. 347-
`360 (2005)
`American Heart Association’s Scientific Sessions 2004 – Largest
`Cardiovascular Meeting Plans to ‘Jazz It Up’ in New Orleans, PR
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`releases/american-heart-associations-scientific-sessions-2004---
`largest-cardiovascular-meeting-plans-to-jazz-it-up-in-new-orleans-
`74293197.html#
`EU Community Register of Medicinal Products, Frequently Asked
`Questions, http://ec.europa.eu/health/documents/community-
`register/register_faq_2015.pdf
`Regulation (EC) No 726/2004 of the European Parliament and of the
`Council of 31 March 2004, http://eur-lex.europa.eu/LexUriServ/
`LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF
`Register of Commission Documents, European Union,
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=home
`
`v
`
`

`

`1052
`
`1053
`
`1054
`1055
`1056
`1057
`1058
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`1059
`1060
`
`1061
`
`1062
`
`1063
`1064
`1065
`1066
`1067
`1068
`1069
`1070
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`1072
`1073
`1074
`1075
`1076
`1077
`
`
`
`Regulation (EC) No. 1049/2001 of the European Parliament and of the
`Council of 30 May 2001,
`http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf
`Register of the Commission Documents, European Commission,
`https://ec.europa.eu/transparency/regdoc/index.cfm?fuseaction=
`list&n=10&adv=0&coteId=&year=2005&number=
`3436&version=ALL&dateFrom=&dateTo=
`&serviceId=&documentType=&title=&titleLanguage=&titleSearch=
`EXACT&sortBy=NUMBER&sortOrder=DESC (search result for
`document search of Commission reference number ‘3436’ for year
`‘2005’)
`U.S. Patent No. 5,234,953 (“Crow ’953”)
`Declaration of DeForest McDuff, Ph.D.
`U.S. Patent No. 9,339,507
`U.S. Patent No. 6,756,033
`Amendment and Reply filed in 12/591,200 (May 23, 2012) (with
`accompanying Declaration of Lewis Rubin, M.D.)
`Reply in 12/,591,200 (Apr. 28, 2014)
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`1995)
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`Financial Results” (Feb. 23, 2006)
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`Actelion Pharmaceuticals, Annual Report, 2006
`Actelion Pharmaceuticals, Annual Report, 2007
`Actelion Pharmaceuticals, Annual Report, 2008
`Actelion Pharmaceuticals, Annual Report, 2010
`Actelion Pharmaceuticals, Annual Report, 2011
`Actelion Pharmaceuticals, Annual Report, 2012
`Actelion Pharmaceuticals, Annual Report, 2013
`Actelion Pharmaceuticals, Annual Report, 2014
`Actelion Pharmaceuticals, Annual Report, 2015
`Actelion Pharmaceuticals, Annual Report, 2016
`Adcirca, FDA Label, 5/2017
`Adempas, FDA Label, 10/2016
`Bayer, Annual Report, 2014
`Bayer, Annual Report, 2015
`
`vi
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`

`

`1078
`1079
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`1080
`1081
`1082
`1083
`1084
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`1085
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`1086
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`1089
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`
`Bayer, Annual Report, 2016
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`Returns to New Drug Development: A Review of the Evidence,” in
`Patricia Danzen and Sean Nicholson, ed., The Oxford Handbook of the
`Economics of the Biopharmaceuticals Industry, New York: Oxford
`University Press
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`(“Orange Book”), FDA (30th ed. 2010)
`Approved Drug Products with Therapeutic Equivalance Evaluations
`(“Orange Book”), FDA (37th ed. 2017)
`FDA Drug Details Website, Adcirca,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Adempas,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Flolan,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Letairis,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Opsumit,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Orenitram,
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`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Remodulin,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`
`vii
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`

`

`1094
`
`1095
`
`1096
`
`1097
`
`1098
`
`1099
`
`1100
`
`1101
`
`1102
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`1103
`1104
`1105
`1106
`1107
`1108
`1109
`1110
`1111
`1112
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`
`
`FDA Drug Details Website, Revatio,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Tracleer,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Tyvaso,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Uptravi,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Veletri,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Basi
`cSearch.process (accessed 5/17/2017)
`FDA Drug Details Website, Ventavis,
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`Federal Reserve Website, Data Download, USD to EUR, 1999‐2016,
`Federal Reserve Website, Data Download, USD to GBP, 1998‐2016,
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`Gilead, Form 10‐K, 2010
`Gilead, Form 10‐K, 2011
`Gilead, Form 10‐K, 2012
`Gilead, Form 10‐K, 2013
`Gilead, Form 10‐K, 2014
`Gilead, Form 10‐K, 2015
`Gilead, Form 10‐K, 2016
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`viii
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`

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`1121
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`ix
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`

`

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`UTC, Form 10‐K, 2015
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`accompanying Second Declaration of Dr. Roham T. Zamanian)
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`1145
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`1150
`1151
`1152
`1153
`1154
`1155
`1156
`1157
`1158
`1159
`1160
`1161
`1162
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`1163
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`1164
`1165
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`1166
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`1167
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`1168
`1169
`1170
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`1171
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`1172
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`
`
`

`

`I.
`
`INTRODUCTION
`
`The prior art status of Ghofrani is a central issue to the instituted ground. To
`
`determine whether Ghofrani is “by another” under 35 U.S.C. § 102(a), the Board
`
`must determine the “inventive entity” of each of the challenged claims, and compare
`
`that entity with the entity responsible for the relevant portion of Ghofrani.
`
`Petitioners’ motions relate to evidence that is squarely relevant to determining the
`
`“inventive entity” of the challenged claims. Specifically, Petitioner seeks: (1) to
`
`submit three exhibits as supplemental information; and (2) discovery in the form of
`
`an unredacted copy of one of the three exhibits referenced above. Petitioner’s
`
`motions are justified under the rules, and as we show herein, they should be granted.1
`
`II.
`
`FACTUAL BACKGROUND
`
`Ghofrani is a June 2005 journal article that discusses, among other things, a
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`clinical trial in Giesen, Germany in which inhaled treprostinil was administered to
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`patients with pulmonary hypertension, or “PAH.” Ex. 1005. Ghofrani lists five
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`authors, two of whom are identified as inventors of the challenged patent (Seeger
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`and Voswinckel) and three who are not (Ghofrani, Reichenberger and Grimminger).
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`In addition to Seeger and Voswinckel, the challenged patent lists five additional
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`1 Following a teleconference with the Board, Petitioner was authorized to file these
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`motions by an Order entered on February 28, 2018. See Paper 21.
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`named inventors (Rubin, Schmehl, Roscigno, Sterritt, and Olschewski).
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`Petitioner seeks to submit as supplemental information three documents
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`related to the contribution of the various named inventors to the challenged claims:
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` Two documents (the complaint and a declaration from named inventor Rubin)
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`from a Maryland state court litigation between Rubin and Patent Owner over
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`ownership of the challenged patent in which Dr. Rubin alleged that he
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`“conceived of a new PAH treatment program using an inhalation
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`methodology for the drug treprostinil,” Ex. 1170 at ¶ 23, and that he
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`“conceptualized the invention which is the subject of the [challenged
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`patent]—the treatment of PAH by administration of treprostinil by a metered
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`dose inhaler or a pulsed nebulizer,” Ex. 1171 at ¶ 5.
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` A November 2007 declaration submitted to the Patent Office during
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`prosecution of a parent application to the challenged patent, which attached
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`as exhibits certain correspondence between named inventor Seeger and Patent
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`Owner, including statements that Dr. Seeger and certain of the other named
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`inventors were willing to “withdraw from the patent [application]” and that
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`their names could be “removed from the patent.” Ex. 1172 at 25, 27.
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`Petitioner also seeks as additional discovery unredacted copies of exhibits
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`attached to the file history declaration discussed above, which appear from the
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`unredacted portions and related context to be discussing contribution of the named
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`2
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`inventors. For example, there is an unredacted passage in which Dr. Seeger, on
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`behalf of himself and other named co-inventors, states that they “remain of the
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`opinion that the metered dose inhaler approach was not part” but the remainder of
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`the sentence is redacted. Ex. 1172 at 24.
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`III. LEGAL STANDARDS
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`A “party may file a motion to submit supplemental information” that is
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`“relevant to a claim for which the trial has been instituted,” and the motion is
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`authorized by the Board. 37 C.F.R. § 42.123(a). A party may move for additional
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`discovery and must show that such discovery is “in the interests of justice.” 37
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`C.F.R. § 42.51(b)(2). When considering whether to grant additional discovery, the
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`Board considers whether the requested discovery: (1) is based on more than a mere
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`possibility of finding something useful; (2) seeks the other party's litigation positions
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`or the basis for those positions; (3) seeks information that reasonably can be
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`generated without the discovery requests; (4) is easily understandable; and (5) is
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`overly burdensome to answer. See Garmin Int'l, Inc. v. Cuozzo Speed Techs., LLC,
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`Case No. IPR2012–00001, Paper 26 at 6–7 (PTAB Mar. 5, 2013).
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`IV. MOTION TO SUBMIT SUPPLEMENTAL INFORMATION
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`A. The Proposed Supplemental Information is Relevant.
`Patent Owner’s primary challenge to Petitioner’s motion is that the
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`supplemental information is not relevant to the prior art status of Ghofrani. But,
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`3
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`Patent Owner ignores that a determination of the inventive entity of the challenged
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`claims is a prerequisite to determining whether prior art is “by another.” The
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`proposed supplemental information speaks directly to the inventive entity of the
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`challenged claims and thus is plainly relevant to the prior art status of Ghofrani.
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`To determine whether a prior art reference is by a different “inventive entity,”
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`courts consider “whether the portions of the reference relied on as prior art, and the
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`subject matter of the claims in question, represent the work of a common inventive
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`entity.” Riverwood Int’l Corp. v. R.A. Jones & Co., Inc., 324 F.3d 1346 (Fed. Cir.
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`2003) (emphasis added). In Riverwood, the prior art status of the alleged references
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`turned on the inventive entity of the challenged claims. 324 F.3d at 1357 (“[I]f
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`Riverwood sustains its burden of proof that Ziegler is the sole inventor of the
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`[challenged] ’361 patent [claims], then the ’806 patent would not be prior art to the
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`’361 patent [because Ziegler was the sole inventor of the prior art].”); see also Sprint
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`Communications Co. L.P. v. Comcast IP Holdings, LLC, No. 12–1013–RGA, 2015
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`WL 452289, *2-*3 (D. Del. Jan. 30, 2015) (“[T]here is no evidence from which the
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`factfinder could conclude that Mr. Bog was solely responsible for the asserted claims
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`of the ’832 patent and the anticipating disclosures of the Kaplan patent.”); Ethicon
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`Endo-Surgery, Inc. v. Hologic, Inc., 689 F. Supp. 2d 929, 942 (S.D. Ohio 2010)
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`(“[A] factual inquiry needs to be done to determine what claims or elements of the
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`[reference] patents were invented by John Hibner and/or Mark Burdorff and which
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`4
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`claims or elements of [two asserted] patents were also invented by them.”).
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`The Board’s decision in Varian confirms that the inventive entity of the
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`challenged claims is relevant to whether a prior art reference is “by another.” See
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`Varian Med. Sys. v. Wm. Beaumont Hosp., IPR2016-163, Paper 79 (PTAB May 4,
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`2017). In Varian, the Petitioner asserted that two references were prior art works of
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`another. In response, the Patent Owner came forward with evidence as to the
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`inventorship of the challenged claims, id. at 21, and argued that the alleged prior art
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`had the same inventive entity as the challenged claims, id.at 22. Petitioner
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`challenged Patent Owner’s claims regarding the inventive entity of the claims and
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`prior art. Id. at 28-29. The Board ultimately found that Petitioner had not “cast
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`sufficient doubt on Patent Owner’s representations concerning the proper co-
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`inventors of the subject matter claimed in the [challenged patent], or the proper
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`attribution of the subject matter of [the prior art].” Id. at 29 (emphasis added). Thus,
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`the fact that the other named inventors are not also authors of Ghofrani is not the
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`issue. What matters is who invented the challenged claims, and who contributed to
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`the cited portion of Ghofrani. At a minimum, the proffered evidence here—which
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`includes statements by one named inventor that the challenged claims were
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`conceived by him prior to involvement of the other co-inventors, as well as
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`statements from other named inventors that they were willing to be withdrawn from
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`the patent—is relevant to inventive entity of the challenged claims.
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`5
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`With respect to the Rubin materials, Patent Owner notes that the litigation
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`between Dr. Rubin and Patent Owner has been dismissed. But that is of no moment.
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`The case was dismissed on statute of limitations grounds, and alternatively for
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`failing to state certain contract and fraud claims, but that has no bearing on the claims
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`made by Dr. Rubin that the invention of challenged patent originated with him.
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`Patent Owner’s argument that the file history declaration is not relevant
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`because it was from a now-abandoned parent application directed to different claims
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`also misses the mark. Under the Federal Rules, evidence is relevant if “it has any
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`tendency to make a fact more or less probable than it would be without the evidence;
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`and the fact is of consequence in determining the action.” FED. R. EVID. 401. Here,
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`the evidence includes a discussion of the contribution of certain inventors, including
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`that they were willing to “withdraw from the patent [application]” and have their
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`names “removed from the patent.” Ex. 1172 at 25, 27. At a minimum, that evidence
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`has a tendency to make a fact (the contribution of the named inventors to the
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`challenged claims) less probable, which would support Petitioner’s argument that
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`Ghofrani is by another, as discussed above.
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`B. Allowing the Supplemental Information Now Will Allow the
`Issue to be Decided on a Fully Developed Record.
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`Petitioner timely requested authorization to submit the supplemental
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`information in order for the record to be fully developed on this issue. See 37 C.F.R.
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`§ 42.123(a)(1). Petitioner could have introduced this evidence with its reply brief in
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`6
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`response to arguments made and evidence submitted by Patent Owner in its Patent
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`Owner Response. Rather than waiting to do so, Petitioner has come forward with
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`the evidence now so that Patent Owner can address the evidence in response and the
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`Board can decide the issue on a fully developed record.
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`V. MOTION FOR ADDITIONAL DISCOVERY
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`Petitioner’s motion for additional discovery should be granted because the
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`additional discovery Petitioner seeks is in the interest of justice as required by 37
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`C.F.R. § 42.51(b)(2)(i) and the Garmin factors.
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`A. The Additional Discovery Will Lead to the Discovery of Useful
`Information.
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`The first Garmin factor requires that there is “more than a possibility and mere
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`allegation that something useful will be discovered.” See Garmin, Paper 26 at 6-7.
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`“The party requesting discovery should already be in possession of evidence tending
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`to show beyond speculation that in fact something useful will be uncovered.” Id.
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`The unredacted declaration sought by Petitioner meets this standard.
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`Petitioner already has the redacted version of the declaration, and submitted
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`it with this motion. Ex. 1172. As explained above, even the redacted version is
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`favorable to Petitioner’s arguments, because one of the named inventors (who is also
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`an author of Ghofrani) states that he and certain other named co-inventors were
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`willing to “withdraw from the patent [application]” and have their names “removed
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`from the patent.” Id. at 25, 27. These are not the actions of people that steadfastly
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`7
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`maintain that they are properly named as inventors. And, the complete copies of
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`these documents is fertile ground for cross-examination.
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`The context of the redacted passages suggests that they contain further
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`relevant information. For instance, Dr. Seeger sets forth “the view of the Giessen
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`team,” which “remain[ed] of the opinion that the development of the metered dose
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`inhaler approach was not part [redacted].” Ex. 1172 at 24. A prior email from
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`UTC’s Paul Mahon stated that his “review of the file indicates that [redacted]” and
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`that “[s]ince the work [redacted] was done with drug substance and financial support
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`provided by [Patent Owner’s predecessor] under the study agreement . . . we believe
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`that ownership falls within the terms of those agreements.” Id. at 16-17. If, as
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`appears to be the case, Dr. Seeger and Mr. Mahon are discussing the contributions
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`of the Giessen team to the inventions disclosed in the pending application, that
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`creates “more than a possibility and mere allegation that something useful will be
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`discovered” from the unredacted documents.
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`The Board has found the first Garmin factor met where the material sought
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`“will aid Petitioner's rebuttal to Patent Owner's arguments and evidence, and will
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`afford Petitioner a fair cross-examination of Patent Owner's witnesses.” Mylan v.
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`Allergan, IPR2016-01127, Paper 28 at 3 (PTAB May 31, 2017). Here, the
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`unredacted declaration will do just that.
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`B.
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`The Additional Discovery Does Not Implicate Patent Owner’s
`Litigation Positions.
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`8
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`The second Garmin factor asks whether the discovery sought seeks the “other
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`party’s litigation positions and the underlying basis for those positions.” During the
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`February 23 conference call, Patent Owner asserted that “those redactions . . . would
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`relate to positions of the patent owner pertaining to this contractual dispute,” under
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`which “some of the inventors refused to sign the declaration at one point in time
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`because they believed they were entitled to additional compensation.” Ex. 2032
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`13:4-9, 16-18. Patent Owner failed to elaborate on this point, and in any event, this
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`sort of information is not the concern of the second Garmin factor.
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`As the Board has made clear, this Garmin factor serves to protect parties from
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`being forced to reveal their arguments in the instant proceeding. In Garmin itself,
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`the Board recognized that it had “established rules for the presentation of arguments
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`and evidence,” and a “party may not attempt to alter the Board's trial procedures
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`under the pretext of discovery.” Garmin, Paper 26 at 6. Accordingly, one party “is
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`not obligated to keep” t