Paper 1
`Filed: October 25, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`Case IPR2020-00084
`Patent 9,089,519
`_________________
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,089,519
`
`
`
`
`
`
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................................... 1
`I.
`II. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ................................ 1
`A. Grounds for Standing ....................................................................................... 1
`B. Identification of Challenge and Prior Art ........................................................ 1
`1. Weinkle and U.S. 2010/0028438 ................................................................. 2
`2. P050047/S005 .............................................................................................. 2
`3. Lebreton, Sadozai, and Kinney .................................................................... 3
`4. PMA P050047 .............................................................................................. 4
`III. STATE OF THE ART BEFORE THE EARLIEST CLAIMED PRIORITY
`DATE ................................................................................................................... 6
`A. Background of HA Dermal Fillers................................................................... 6
`B. Four Primary Crosslinkers Used For Dermal Fillers ....................................... 7
`C. Lidocaine Used In Crosslinked HA Fillers To Mitigate Pain .......................... 8
`IV. THE CHALLENGED PATENT ........................................................................ 11
`A. The Challenged Claims ................................................................................. 12
`B. The Prosecution History ................................................................................ 13
`C. Person of Ordinary Skill in the Art ................................................................ 14
`V. CLAIM CONSTRUCTION .............................................................................. 15
`A. Sterile (claims 1, 3, and 5) ............................................................................. 15
`B. Freely released in vivo (claims 2, 4, 8) ......................................................... 16
`C. Stable (claims 5-7) ......................................................................................... 17
`VI. CLAIMS 1-4 ARE NOT ENTITLED TO A PRIORITY DATE BEFORE
`APRIL 1, 2014 ................................................................................................... 18
`A. Law of Priority Claims .................................................................................. 19
`B. Claims 1-4 Are Not Described by The Priority Documents .......................... 20
`1. There is no literal support for the claimed features ................................... 20
`2. The disclosed species do not support the claims........................................ 22
`
`i
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`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`VII. CLAIMS 1-8 ARE UNPATENTABLE ............................................................. 26
`A. Grounds 1-3: Claims 1-4 Are Not Entitled to Their Claimed Priority
`Date And Are Anticipated By P050047/S005, Weinkle, And The ʼ438
`Application .................................................................................................... 26
`1. Ground 1: Anticipation by P050047/S005 ................................................. 27
`2. Ground 2: Anticipation by Weinkle ........................................................... 30
`3. Ground 3: Anticipation by the ʼ438 publication ........................................ 33
`B. Grounds 4 And 5: Claims 1-8 Are Obvious Over Lebreton In View of
`Sadozai, And P050047 In View Of Kinney, Regardless Of The Effective
`Priority Date ................................................................................................... 34
`1. Ground 4: Claims 1-8 would have been obvious over Lebreton in view
`of Sadozai................................................................................................... 35
`a. Motivation to combine ............................................................................ 36
`b. Detailed claim analysis ........................................................................... 39
`(i) Claim 1 ................................................................................................ 39
`(ii) Claim 2 ................................................................................................ 42
`(iii) Claims 3-4 ........................................................................................... 44
`(iv) Claims 5-8 ........................................................................................... 45
`2. Ground 5: Claims 1-8 would have been obvious over PMA P050047 in
`view of Kinney ........................................................................................... 46
`a. Motivation to combine ............................................................................ 46
`b. Detailed claim analysis ........................................................................... 47
`(i) Claim 1 ................................................................................................ 47
`(ii) Claim 2 ................................................................................................ 49
`(iii) Claims 3-4 ........................................................................................... 50
`(iv) Claims 5-8 ........................................................................................... 51
`3. Allergan cannot rebut the prima facie case of obviousness established
`above .......................................................................................................... 52
`a. The uncorroborated Inventor’s Declaration does not accurately
`characterize the state of the art .............................................................. 53
`
`ii
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`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`b. Example 4 does not provide evidence of non-obviousness .................... 56
`c. Cui is not relevant ................................................................................... 60
`4. Summary .................................................................................................... 61
`VIII. DISCRETIONARY FACTORS FAVOR INSTITUTION .............................. 62
`A. Section 325(d) factors .................................................................................... 63
`IX. CONCLUSION ................................................................................................. 68
`X. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ...................................... 68
`A. Real Parties in Interest ................................................................................... 68
`B. Related Matters .............................................................................................. 68
`C. Lead and Back-Up Counsel and Service Information ................................... 69
`
`
`
`
`
`iii
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`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`
`
`Exhibit
`No.
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`U.S. Patent No. 9,089,519 to Lebreton
`(issued July 28, 2015) (the ’519 patent or the challenged patent)
`Declaration of Dale Devore, Ph.D.
`CV of Dale Devore, Ph.D.
`Steven Fagien & Arnold W. Klein, A Brief Overview and History of
`Temporary Fillers: Evolution, Advantages, and Limitations, Plastic
`and Reconstructive Surgery, Vol. 120 Supplement 6S, 8S–16S (Nov.
`2007)
`Mary P. Lupo, Hyaluronic Acid Fillers in Facial Rejuvenation,
`Seminars in Cutaneous Medicine and Surgery, Vol. 25, No. 6, 122–126
`(Sept. 2006)
`Seth L. Matarraso, Understanding and Using Hyaluronic Acid,
`Aesthetic Surgery Journal Vol. 24, No. 4, 361–364 (July/August 2004)
`Rhoda S. Narins & Paul H. Bowman, Injectable Skin Fillers, Clinics
`in Plastic Surgery, Vol. 32, Issue 2, 151–162 (April 2005)
`Clifford P. Clark III, Animal-Based Hyaluronic Acid Fillers: Scientific
`and Technical Considerations, Plastic and Reconstructive Surgery,
`Vol. 120 Supplement 6S, 27S-32S (Nov. 2007)
`Kevin C. Smith, Practical Use of Juvéderm: Early Experience, Plastic
`and Reconstructive Surgery, Vol. 120 Supplement 6S, 67S-73S (Nov.
`2007)
`Rod J. Rohrich, et al., The Role of Hyaluronic Acid Fillers (Restylane)
`in Facial Cosmetic Surgery: Review and Technical Considerations,
`Plastic and Reconstructive Surgery, Vol. 120 Supplement 6S, 41S-54S
`(Nov. 2007)
`Michael H. Gold, Use of Hyaluronic Acid Fillers for the Treatment of
`the Aging Face, Clinical Interventions in Aging, Vol. 2, Issue 3, 369-
`376 (Sept. 2007)
`Brian M. Kinney, Injecting Puragen Plus Into the Nasolabial Folds:
`Preliminary Observations of FDA Trial, Aesthetic Surgery Journal,
`Vol. 26, Issue 6, 741-748 (Nov. 2006), also available at
`https://academic.oup.com/asj/article/26/6/741/238376
`
`iv
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`1021
`
`Description
`
`U.S. Provisional App. Serial No. 61/085,956 (filed Aug. 4, 2008)
`(priority document for challenged patent)
`Gary D. Monheit & Chad L. Prather, Juvéderm: A Hyaluronic Acid
`Dermal Filler, Journal of Drugs in Dermatology, Vol. 6, Issue 11,
`1091-1095 (Nov. 2007)
`Leslie S. Baumann, et al., Comparison of Smooth-Gel Hyaluronic Acid
`Dermal Fillers with Cross-linked Bovine Collagen: A Multicenter,
`Double-masked, Randomized, Within-Subject Study, Dermatologic
`Surgery, Vol. 33 Supplement 2, S128-S135 (Dec. 2007)
`Deborah, S. Sarnoff, et al., Comparison of Filling Agents for Lip
`Augmentation, Aesthetic Surgery Journal, Vol. 28, Issue 5, 556-563
`(September/October 2008)
`Michael S. McCracken, et al., Hyaluronic Acid Gel (Restylane) Filler
`for Facial Rhytids: Lessons Learned From American Society of
`Ophthalmic Plastic and Reconstructive Surgery Member Treatment of
`286 Patients, Ophthalmic Plastic and Reconstructive Surgery, Vol. 22,
`Issue 3, 188-191 (May-Jun 2006)
`Barry L. Eppley & Babak Dadvand, Injectable Soft-Tissue Fillers:
`Clinical Overview, Plastic and Reconstructive Surgery, Vol. 118, Issue
`4, 98e-106e (Sept. 15, 2006)
`M.J.A. Sapijaszko, Dermal Fillers: Ever-Expanding Options for
`Esthetic Use, Skin Therapy Letter, Vol. 12, No. 8, 4–7 (Oct. 2007)
`Update on Drugs, Skin Therapy Letter, Vol. 13, No. 3, 8 (Apr. 2008)
`Carol A. Toth, et al., Preclinical evaluation of a novel hyaluronic acid
`28 mg/ml lidocaine 0.3% stable combination product, (abstract),
`Journal of the American Academy of Dermatology, Vol. 56, No. 2,
`AB94 (Feb. 2007), Abstract P1039
`
`and
`
`C. William Hanke, et al., Effectiveness and durability of a hyaluronic
`acid 28 mg/ml, lidocaine 0.3% stable combination product as
`demonstrated in a multicenter, randomized trial (abstract), Journal of
`the American Academy of Dermatology, Vol. 56, No. 2, AB94 (Feb.
`2007), Abstract P1040
`
`v
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1022
`
`1023
`
`1024
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`1035
`
`Description
`
`Gary D. Monheit, Hyaluronic Acid Fillers: Hylaform and Captique,
`Facial Plastic Surgery Clinics, Vol. 15, No. 1, 77 (Feb. 2007)
`Excerpts from file history of U.S. Application 12/393,884 (filed
`2/26/2009)
`Lebreton Declaration
`Yu jia Cui, et al., The Comparison of Physicochemical Properties of
`Four Cross-Linked Sodium Hyaluronate Gels with Different Cross-
`Linking Agents, Advanced Materials Research, Vols. 396-398, 1506-
`1512 (2012)
`Excerpts from file history of U.S. Application 13/419,079 (filed
`3/13/2012)
`Claim Construction Order, Allergan USA, Inc. v. Medicis Aethetics,
`Inc., No. 8:13-cv-01436-AG-JPR, slip op. (Aug. 12, 2014), ECF No.
`79, also available at 2014 WL 5488895
`U.S. Provisional App. Serial No. 61/087,934 (filed Aug. 11, 2008)
`(priority document for challenged patent)
`U.S. Patent Publication No. 2006/0194758 to Lebreton (Lebreton),
`published Aug. 31, 2006
`U.S. Patent Publication No. 2005/0136122 to Sadozai et al. (Sadozai),
`published June 23, 2005
`CTA Product Insert (“Label”)
`Amy E. Newburger, Cosmetic Medical Devices and Their FDA
`Regulation, Archives of Dermatology, Vol. 142, 225–228 (Feb. 2006)
`Excerpts from file history of U.S. Application 12/393,768 (filed
`2/26/2009)
`RESERVED
`Inja Bogdan Allemann & Leslie Baumann, Hyaluronic Acid Gel
`(Juvedérm) Preparations in the Treatment of Facial Wrinkles and
`Folds, Clinical Interventions in Aging, Vol. 3, Issue 4, 629–634 (Dec.
`2008)
`
`vi
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1036
`
`1037
`
`1038
`1039
`
`1040
`
`1041–
`1043
`1044
`
`1045
`
`1046
`1047
`
`1048
`
`1049
`
`1050
`1051
`1052
`
`Description
`
`Åke Öhrlund, et al., Extrusion Force and Syringe Dimensions of Two
`Hyaluronic Acid Dermal Fillers, 8th Anti-aging Medicine World
`Congress (AMWC) (April 2010)
`U.S. Patent Publication No. 2008/0188441 to Reinmuller et al.
`(Reinmuller 2008), published Aug. 7, 2008, and filed in the U.S. on
`July 14, 2006
`RESERVED
`Samuel J. Falcone & Richard A. Berg, Crosslinked Hyaluronic Acid
`Dermal Fillers: A Comparison of Rheological Properties, Journal of
`Biomedical Materials Research, Vol. 87A, Issue 1, 264–271 (Jan. 15,
`2008)
`Excerpts from file history of U.S. Application 13/746,170 (filed
`1/21/2013)
`RESERVED
`
`U.S. Provisional App. Serial No. 61/096,278 (filed Sept. 11, 2008)
`(priority document for challenged patent)
`Ahmet Tezel & Glenn H. Fredrickson, The Science of Hyaluronic Acid
`Dermal Fillers, Journal of Cosmetic and Laser Therapy, Vol. 10, Issue
`1, 35-42 (Mar. 2008)
`Update on Drugs, Skin Therapy Letter, Vol. 12, No. 7, 8 (Sept. 2007)
`U.S. Patent Publication No. 2005/0271729 to Wang, published Dec. 8,
`2005
`U.S. Patent No. 6,521,223 to Calias et al. (issued Feb. 18, 2003)
`(Calias)
`Excerpts from file history of U.S. Application 14/242,747 (filed
`4/1/2014)
`CTA Summary of Safety and Effectiveness, December 20, 2006
`RESERVED
`Prevelle Silk; PMA P030032, February 26, 2008
`
`vii
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1053
`
`1054
`1055
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`1062
`
`1063
`
`1064
`
`1065
`
`1066–
`1069
`
`Description
`
`Mentor Corp. Announces FDA Approval of Prevelle Silk,
`https://www.businesswire.com/news/home/20080321005064/en/Ment
`or-Corporation-Announces-FDA-Approval-Prevelle-Silk (Mar. 21,
`2008)
`RESERVED
`RESERVED
`Robert Stern, et al., The Many Ways to Cleave Hyaluronan,
`Biotechnology Advances, Vol. 25, Issue 6, 537–557
`(November/December 2007)
`J.W. Kuo, Practical Aspects of Hyaluronan Based Medical Products,
`CRC Press, Taylor & Francis Group, 2006, pp. 34-43, 79-93
`U.S. Patent Publication No. 2005/0250939 to Zhao (Zhao), published
`Nov. 10, 2005
`U.S. Patent No. 5,731,298 to Reinmuller (issued Mar. 24, 1998)
`(Reinmuller 298)
`Premarket Approval (PMA) Supplement Summary Review Memo for
`P050047/S005 (Jan. 6. 2010), available at
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id
`=P050047S005
`U.S. Provisional App. Serial No. 60/953,661 (filed Aug. 2, 2007)
`U.S. Patent No. 4,605,691 to Balazs et al. (issued Aug. 12, 1986)
`(Balazs 691)
`U.S. Patent No. 4,713,448 to Balazs et al. (issued Dec. 15, 1987)
`(Balazs 448)
`Excerpts from file history of U.S. Application 13/891,052 (filed
`5/9/2013)
`Transcript of Claim Construction Hearing, Allergan USA, Inc. v.
`Medicis Aethetics, Inc., No. 8:13-cv-01436-AG-JPR (Aug. 12, 2014),
`ECF No. 81
`RESERVED
`
`viii
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1070
`
`1071
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`1081
`
`1082
`
`Description
`
`Susan H. Weinkle, et al., A multi-center, double-blind, randomized
`controlled study of the safety and effectiveness of Juvéderm®
`injectable gel with and without lidocaine, Journal of Cosmetic
`Dermatology, Vol. 8, No. 3, 205-2010 (Sept. 2009), also available at
`https://onlinelibrary.wiley.com/doi/10.1111/j.1473-2165.2009.00451.x
`RESERVED
`U.S. Patent Publication No. 2010/0028438 to Lebreton (‘’438),
`published June 23, 2005
`Update on Drugs, Skin Therapy Letter, Vol. 15, No. 3, 6 (March 2010)
`
`Premarket Approval (PMA) Summary Review Memo for P050047
`(June 2, 2006), available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050047B.pdf
`Food and Drug Administration, Medical Devices; Availability of
`Safety and Effectiveness Summaries for Premarket Approval
`Applications, 71 Fed. Reg. 56,157 (September 26, 2006)
`Update on Drugs, Skin Therapy Letter, Vol. 11, No. 6, 10 (July-
`August 2006)
`January 7, 2010, FDA Letter to Allergan, available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050047S005A.pdf
`Gary D. Monheit et al., Novel Hyaluronic Acid Dermal Filler: Dermal
`Gel Extra Physical Properties and Clinical Outcomes, Dermatologic
`Surgery, Vol. 36, No. S3, 1833-1841 (Nov. 2010)
`Lynnelle Smith et al., Hyaluronic acid dermal fillers: can adjunctive
`lidocaine improve patient satisfaction without decreasing efficacy or
`duration?, Patient Preference and Adherence, Vol. 5, 133-139 (Mar.
`14, 2011)
`Hylaform – Instructions for Use - USA
`Restylane Summary of Safety and Effectiveness, March 25, 2005,
`available at
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id
`=P140029
`U.S. Patent No. 8,357,795 to Lebreton. (issued Jan. 22, 2013)
`
`ix
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Exhibit
`No.
`1083
`
`Description
`
`U.S. Patent No. 6,921,819 to Piron et al. (issued Jul. 26, 2005)
`
`x
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`I.
`
`INTRODUCTION
`
`Petitioner Prollenium US Inc. (“Prollenium”) seeks inter partes review
`
`(IPR) of claims 1-8 of U.S. Patent 9,089,519 (the ʼ519 patent, EX1001), owned by
`
`Allergan Industrie, SAS (Allergan or the Patent Owner).
`
`The challenged patent, one among several challenged by Prollenium in
`
`parallel IPRs, is directed to “injectable soft tissue fillers and more specifically …
`
`hyaluronic acid-based dermal and subdermal fillers including an anesthetic agent,”
`
`namely lidocaine. EX1001, 1:20-24. As detailed below, claims 1-4 of the patent are
`
`not entitled to the claimed priority date because they recite features not disclosed
`
`until the filing date of the application. Grounds 1-3 below rely on this later priority
`
`date challenge to claims 1-4. Grounds 4-5, on the other hand, show that all eight
`
`claims are obvious even if the claims are entitled to an earlier priority date.
`
`II. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A. Grounds for Standing
`
`Prollenium certifies that the challenged patent is available for IPR and that it
`
`is not barred or estopped from requesting IPR challenging the claims of the patent
`
`on the grounds identified in this Petition.
`
`B.
`
`Identification of Challenge and Prior Art
`
`Ground
`1
`2
`
`Basis
`§ 102(a)(1)
`§ 102(a)(1)
`
`Claims
`1-4
`1-4
`
`References
`PMA P050047/S005
`Weinkle
`
`1
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`Basis
`§ 102(a)(1)
`§ 103
`§ 103
`
`Claims
`1-4
`1-8
`1-8
`
`References
`U.S. 2010/0028438
`Lebreton in view of Sadozai
`PMA P050047 in view of Kinney
`
`Ground
`3
`4
`5
`
`
`1. Weinkle and U.S. 2010/0028438
`U.S. Patent Application Pub. No. 2010/0028438 to Lebreton (“the ʼ438
`
`publication,” EX1072) published February 4, 2010. Weinkle is a September 2009
`
`journal article published in the Journal of Cosmetic Dermatology. EX1070 includes
`
`the cover to the journal and shows a stamp from the National Library of Medicine
`
`and an indication (in the top left corner) of the cataloging and public availability
`
`within the library’s “General Collection.”
`
`Thus, Weinkle and the ’438 publication are prior art under AIA § 102(a)(1)
`
`(AIA) (or pre-AIA 102(b)) to claims 1-4, as explained in Section VI below.
`
`2. P050047/S005
`P050047/S005 is a printed publication with a publication date no later than
`
`March 2010. The Juvéderm XC family of fillers received FDA approval around
`
`January 6, 2010. EX1060, 1; EX1077, 1. Skin Therapy Letter published notice of
`
`the approval shortly after in March 2010. EX1073, 1, 6. Additionally, before 2011,
`
`the literature repeatedly disclosed that Juvéderm has been combined with
`
`lidocaine. EX1070, 206 (describing in 2009 a trial of Juvéderm with lidocaine);
`
`2
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`EX1078, 1840 (November 2010 publication describing that Juvéderm Ultra and
`
`Ultra Plus XC were “widely available,” citing Juvéderm 2010 product labels ).
`
`As explained above, the POSITA would have known that Juvéderm was initially
`
`approved under the publicly-available PMA P050047. The POSITA could have
`
`easily located the supplement to the same PMA relating to lidocaine on FDA’s
`
`webpage as well. EX1002 ¶ 155. Moreover, the POSITA would have been
`
`monitoring FDA’s webpage for announcements relating to Juvéderm. EX1002 ¶¶
`
`76-77. Because a POSITA exercising reasonable diligence would have been able
`
`to locate P050047/S005 at least as of March 2010, P050047/S005 is a printed
`
`publication available for IPR. P050047/S005 is prior art under AIA § 102(a)(1)
`
`(AIA) (or pre-AIA 102(b)) to claims 1-4, as explained in Section VI below.
`
`3. Lebreton, Sadozai, and Kinney
`U.S. Patent Application Pub. 2006/0194758 to Lebreton (“Lebreton,”
`
`EX1029) published August 31, 2006. U.S. Patent Publication 2005/0136122 to
`
`Sadozai et al. (“Sadozai,” EX1030) published June 23, 2005. These references are
`
`prior art under pre-AIA § 102(b) or AIA § 101(a)(1).
`
`“Kinney” (EX1012) was published in the “November/December 2006” issue
`
`of the Aesthetic Surgery Journal. EX1012 includes the cover of the journal,
`
`stamped with date of receipt at the British Library (the national library of the U.K.)
`
`3
`
`

`

`IPR2020-00084
`
`Petition for IPR of Patent 9,089,519
`
`on 25 January 2007, further showing it was publicly available and accessible to
`
`interested persons around that date. Kinney is prior art under § 102(b).
`
`PMA P050047
`4.
`P050047 is a printed publication with a publication date no later than June
`
`30, 2006. The Juvéderm family of dermal fillers received premarket approval
`
`(PMA) from FDA on June 2, 2006 (EX1074) based on PMA P050047 filed by
`
`Inamed Corporation1 (“Inamed”). According to the Food & Drug Administration
`
`(FDA) Notice in the Federal Register, the “Safety and Effectiveness Data” for
`
`Juvéderm was available on FDA’s website2 by June 30, 2006. EX1075, 56,158
`
`(listing the Juvéderm gel implants among the “List of Safety and Effectiveness
`
`Summaries for Approved PMAs Made Available” in the second quarter of 2006
`
`(emphasis added)). FDA publishes the list in accordance with federal law “to
`
`inform the public of the availability of safety and effectiveness summaries of
`
`approved PMAs through the Internet.” Id. at 56,158. FDA’s “procedure expedites
`
`public notification of these [approval] actions” because the “Internet is accessible
`
`to more people.” Id. at 56,158. The notice explains that FDA notifies the public of
`
`approval orders so that the public can “request review of the order under” the
`
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`1 Allergan acquired Inamed.
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`2 At http://www.fda.gov/cdrh/pmapage.html.
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`4
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`IPR2020-00084
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`Petition for IPR of Patent 9,089,519
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`Federal Food, Drug, and Cosmetic Act. Id. Further, the public has only thirty days
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`after the “notice[] announcing approval … is placed on the Internet,” so FDA
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`expects the interested public—including the POSITAs here—to be aware of and
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`locate such PMA approval orders. Id.; see also EX1002 ¶¶ 76-77.
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`POSITAs in the relevant timeframe reviewed such PMA notices and were
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`educated about how to search FDA’s online database to locate them. EX1002
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`¶¶ 75-77, 118 (testifying about experience with FDA approvals); EX1032, 227
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`(2006 journal article explaining regulation of dermal fillers and how to search
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`“Premarket Notification database” to find PMA letters).
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`For example, in a January 2008 publication comparing properties of several
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`commercial HA fillers, the authors cited Summary of Safety and Effectiveness for
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`Juvéderm, plus PMA documents for two other products. EX1039, 271. The “Skin
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`Therapy Letter” periodical also provided a recurring section titled “Update on
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`Drugs” notifying readers (POSITAs) of FDA approvals and prompting them to
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`seek out FDA PMAs. E.g., EX1076, 10 (noting approval of “Juvéderm Gel” as an
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`HA dermal filler); EX1019, 8 (October 2007); EX1020, 8 (April 2008 noting
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`approval of Prevelle Silk HA filler with lidocaine).
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`A POSITA would have recognized Inamed’s Juvéderm gel implant product
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`as a relevant dermal filler because Inamed was a known developer of HA-based
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`dermal fillers. EX1002 ¶ 107. The literature at the time and before also showed that
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`IPR2020-00084
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`Petition for IPR of Patent 9,089,519
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`POSITAs would have been aware of Inamed’s work in the field, so that a POSITA
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`would have taken (and did take) an interest in this FDA PMA. E.g., EX1006, 362;
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`EX1005, 125; EX1015, S128 and ref. 7 (disclosing weblink to P050047 with
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`indication the link was accessed August 23, 2006).
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`In view of FDA’s expressed policy to publish Summaries of Safety and
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`Effectiveness on the Internet for the purpose of the interested public reviewing
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`them, and based on the literature cited showing that POSITAs would have been
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`and actually were aware of FDA approval of Inamed Juvéderm products, a
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`POSITA exercising reasonable diligence would have been able to locate P050047
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`before August 4, 2007. P050047 is prior art under pre-AIA § 102(b) or AIA
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`§ 102(a)(1).
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`III. STATE OF THE ART BEFORE THE EARLIEST CLAIMED
`PRIORITY DATE
`A. Background of HA dermal fillers
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`As a person ages, facial tissue loss and thinning skin contribute to signs of
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`aging in the face. Soft-tissue or dermal “fillers have been developed to help fill in
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`facial lines and depressions and for restoring fat loss-related tissue volume loss.
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`The soft tissue fillers thereby temporarily restore a smoother, more youthful
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`appearance.” EX1001, 1:34-38.
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`A variety of materials have been used in facial dermal fillers, including
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`hyaluronic acid, autologous human fat, animal-derived collagen, human-derived
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`IPR2020-00084
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`collagen, and synthetic polymers. See generally EX1004. By 2008, fillers derived
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`from hyaluronic acid (HA), a polymer composed of repeating β-D-glucuronic acid
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`and N-acetyl-β-D-glucosamine disaccharide units, were among the most popular in
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`the United States and abroad. See EX1004, 13S–14S; EX1005, 125; EX1002
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`¶¶ 80-82.
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`Despite HA’s excellent biocompatibility, the natural polymer is ill-suited for
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`use as an implantable dermal filler. HA is rapidly degraded by enzymes after
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`injection, so it does not remain in the tissue long enough to function as a filler. To
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`delay the degradation, HA is chemically crosslinked into a water insoluble gel
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`network that prevents enzymes from accessing the polymer. EX1002 ¶ 82.
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`No single HA filler is appropriate for every clinical application. EX1002
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`¶ 83 (explaining different applications require different fillers with different
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`characteristics). Consequently, a variety of fillers have been developed with
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`different performance characteristics, based on various chemical and physical
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`characteristics of the gel. EX1045, 41; see also EX1002 ¶¶ 83-102.
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`B.
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`Four primary crosslinkers used for dermal fillers
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`One of the chemical characteristics of a gel is the choice of crosslinker. By
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`2008, nearly all crosslinked HA fillers used one of four crosslinkers:
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` 1,4- divinylsulfone (“DVS”);
` p-phenylene-bis(ethylcarbodiimide) (“BDCI”);
` diepoxyoctane (“DEO”); and
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`Petition for IPR of Patent 9,089,519
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` butanediol diglycidyl ether (“BDDE”)
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`
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`EX1002 ¶ 85-86; see also EX1035, 630-631 (describing three of the four
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`crosslinkers and indirectly referencing Anika’s BDCI product). Each of these
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`crosslinkers includes two electrophilic functional groups that can react with the
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`primary alcohol and/or carboxylic acid groups in HA. EX1002 ¶ 84.
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`By August 2008, several crosslinked HA dermal fillers had been approved
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`for sale in the U.S. and abroad, including Hylaform, Captique (HA crosslinked
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`with DVS), Puragen (HA crosslinked with DEO), Restylane and Perlane (HA
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`crosslinked with BDDE), and Juvéderm (another BDDE-crosslinked HA,
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`commercially available from Allergan). EX1002 ¶¶ 104-108. All of these clinically
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`used fillers were based on HA crosslinked with one of the four crosslinkers
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`described above.
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`C. Lidocaine used in crosslinked HA fillers to mitigate pain
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`Because dermal fillers are administered via injection, injection pain was a
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`common side effect associated with the products. To reduce pain, many types of
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`dermal fillers were co-formulated with an anesthetic like lidocaine. E.g., EX1017,
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`IPR2020-00084
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`Petition for IPR of Patent 9,089,519
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`188; EX1002 ¶ 113. Some crosslinked HA fillers did not contain lidocaine, but
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`physicians sometimes concurrently injected lidocaine to minimize pain. EX1017,
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`190-191; EX1002 ¶ 113.
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`Unsurprisingly, similar efforts were made to incorporate lidocaine into
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`crosslinked HA fillers to mitigate injection pain. As early as 1993, lidocaine was
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`incorporated into a commercially available crosslinked HA product called Hylagel
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`(crosslinked with DVS, commercially available from Biomatrix Co.). EX1059,
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`7:1-17; EX1002 ¶¶ 121-123. This composition was heat sterilized and stored
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`before being injected to treat keloids and scars. EX1059, 5:30-33, 7:1-33.
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`Lidocaine was later incorporated into other DVS-crosslinked HA dermal fillers.
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`For example, in Spring 2008, FDA approved Prevelle Silk, a DVS-crosslinked HA
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`dermal filler containing 0.3% lidocaine. EX1002 ¶ 118; EX1020, 8 (periodical
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`announcing FDA approval).
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`Lidocaine had also been incorporated in a BDCI-crosslinked HA dermal
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`filler. For example, Anika Therapeutics developed a product called Cosmetic
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`Tissue Augmentation Product (CTA), later renamed Elevess, which contained 28
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`mg/mL BDCI-crosslinked HA suspended in a buffer solution with 0.3% lidocaine.
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`EX1050, 1; EX1002 ¶¶ 114-116. This product was approved for sale by FDA at the
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`end of 2006, but its composition was generally disclosed earlier in a 2005 patent
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`publication. See EX1031, 8 (CTA product label identifying the application number
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`of EX1030); EX1002 ¶ 115.
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`Lidocaine was also included in a DEO-crosslinked HA dermal filler. A 2006
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`journal article described the clinical trials and characteristics of “Puragen Plus,”
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`which included HA crosslinked with DEO. EX1012 (“Kinney”), 742; EX1002
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`¶¶ 117, 130-131. Kinney discloses that Puragen Plus contained lidocaine at a
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`concentration of 0.3%. EX1012, 742.
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`In sum, by early 2007—more than a year before the earliest claimed priority
`
`date of the Allergan patents—0.3% lidocaine had successfully been incorporated
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`into compositions containing HA crosslinked with three of the four conventional
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`crosslinking agents: DVS, BDCI, and DEO.3
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`
`
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`3 Other parties were developing BDDE-crosslinked HA fillers including lidocaine
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`around the same time as Allergan. EX1002 ¶ 119.
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`10
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`IPR2020-00084
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`Petition for IPR of Patent 9,089,519
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`
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`IV. THE CHALLENGED PATENT
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`Against this backdrop, Allergan began filing applications generally directed
`
`towards crosslinked HA (including BDDE-crosslinked) fillers containing lidocaine,
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`including the one eventually leading to the challenged patent. EX1001, 1:10-23. In
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`August and September 2008, Allergan filed a trio of provisional applications to
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`which the challenged patent claims priority. Despite the prior art and commercially
`
`available products described above, the ’519 patent contends that it had merely
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`“been proposed to incorporate … lidocaine[] into injectable HA-based
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`compositions,” EX1001, 2:24-26 (emphasis added), without acknowledging this
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`“proposal” had alrea