| DESCRIPTION | - CARRUTHERS A.CARRUTHERS, J., Prospective, Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A in Men with Glabellar Rhytids, Dermatol. Surg., (20050000), vol. 31, pages 1297 - 1303 | - |
| DESCRIPTION | - CARRUTHERS et al., "Dilution Volume of Botulinum Toxin Type A for the Treatment of Glabellar Rhytides: Does It Matter?", Dermatol. Surg., (20070000), vol. 33, pages S97 - S104 | - |
| DESCRIPTION | - CARRUTHERS et al., "Dose-Ranging Study of Botulinum Toxin Type A in the Treatment of Glabellar Rhytids in Females", Dermatol. Surg, (20050000), vol. 31, pages 414 - 422 | - |
| DESCRIPTION | - HSU et al., "Effect of Volume and Concentration on the Diffusion of Botulinum Exotoxin A", Arch. Dermatol., (20040000), vol. 140, no. 11, pages 1351 - 1354 | - |
| DESCRIPTION | - JOSEPH et al., "Does Increasing the Dose of abobotulinumtoxina Impact the Duration of Effectiveness of the Treatment of Moderate to Severe Glabellar Lines?", J. Drugs Dermatol., (20160000), vol. 15, no. 12, pages 1544 - 1549, XP009523599 | - |
| DESCRIPTION | - WEISEMANN et al., Toxins, (20150000), vol. 7, no. 12, pages 5035 - 5054 | - |
| DESCRIPTION | - PEARCE, L.B.BORODIC, G.E.FIRST, E.R.MACCALLUM, R.D., "Measurement of botulinum toxin activity: Evaluation of the lethality assay", Toxicol. Appl. Pharmacol., (19940000), vol. 128, doi:10.1006/taap.1994.1181, pages 69 - 77, XP024880303 | |
| DESCRIPTION | - CARRUTHERS et al., "Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo", Dermatol. Surg., (20170000), vol. 43, no. 11, doi:10.1097/DSS.0000000000001206, pages 1321 - 1331, XP009523600 | |
| DESCRIPTION | - CARRUTHERS et al., "DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2", Plast. Reconstr. Surg., (20200000), vol. 145, no. 1, doi:10.1097/PRS.0000000000006327, pages 45 - 58, XP055742304 | |
| INTERNATIONAL-SEARCH-REPORT | - JOSEPH JOHN H ET AL, Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?, JOURNAL OF DRUGS IN DERMATOLOGY : JDD 01 12 2016, VOL. 15, NR. 12, PAGE(S) 1544 - 1549, (20161201), ISSN 1545-9616, XP009523599 [I] 1-15 * page 1546, column 1, paragraph 1 * * abstract * | - |
| INTERNATIONAL-SEARCH-REPORT | - CARRUTHERS ALASTAIR ET AL, "Prospective, double-blind, randomized, parallel-group, dose-ranging study of botulinum toxin type A in men with glabellar rhytids.", DERMATOLOGIC SURGERY : OFFICIAL PUBLICATION FOR AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY [ET AL.] OCT 2005, (200510), vol. 31, no. 10, ISSN 1076-0512, pages 1297 - 1303, XP002800781 [I] 1-15 * Masking; page 1298 * | |
| INTERNATIONAL-SEARCH-REPORT | - CARRUTHERS JEAN ET AL, "Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo", DERMATOLOGIC SURGERY : OFFICIAL PUBLICATION FOR AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY [ET AL.] MAR 2010,, (20171031), vol. 43, no. 11, doi:10.1097/DSS.0000000000001206, ISSN 1524-4725, pages 1321 - 1331, XP009523600 [I] 1-15 * page 1323 * * page 1330 * * page 1331 * | |
| INTERNATIONAL-SEARCH-REPORT | - JEAN D. CARRUTHERS ET AL, "DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines : Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2)", PLASTIC AND RECONSTRUCTIVE SURGERY, US, (20191223), vol. 145, no. 1, doi:10.1097/PRS.0000000000006327, ISSN 0032-1052, pages 45 - 58, XP055742304 [I] 1-15 * abstract * | |
| INTERNATIONAL-SEARCH-REPORT | - SOUPHIYEH SAMIZADEH ET AL, "Botulinum neurotoxin formulations: overcoming the confusion", CLINICAL, COSMETIC AND INVESTIGATIONAL DERMATOLOGY, (20180501), Volume 11, doi:10.2147/CCID.S156851, pages 273 - 287, XP055742573 [X] 1-15 * the whole document * * pages 279, 284 * | |
| OPPOSITION | - Anonymous, "BOCOUTURE 50 units powder for solution for injection", Merz Pharma UK Ltd, Summary of Product Characteristics (accessed via the Wayback Machine), (20200807), Merz Pharma UK Ltd, Summary of Product Characteristics (accessed via the Wayback Machine), URL: https://web.archive.org/web/20200807143838/https://www.medicines.org.uk/emc/product/600/smpc/print#expand, XP093308845 | - |
| OPPOSITION | - Anonymous, "BOTOX Cosmetic (onabotulinumtoxinA) for injection, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20191101), XP093308828 | - |
| OPPOSITION | - Anonymous, "BOTOX (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20110801), XP055979259 | - |
| OPPOSITION | - Anonymous, "DAXXIFY™ (daxibotulinumtoxinA-lanm) for injection, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20220901), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf, XP093308835 | - |
| OPPOSITION | - Anonymous, "DYSPORT® (abobotulinumtoxinA) for injection, for intramuscular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20190901), FDA, URL: https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/2019/09/26212602/Dysport_Full_Prescribing_Information.pdf, XP093308829 | - |
| OPPOSITION | - Anonymous, "XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20190501), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125360s074lbl.pdf, XP093308830 | - |
| OPPOSITION | - Ascher, B. Zakine, B. Kestemont, P. Baspeyras, M. Bougara, A. Niforos, F. Malet, T. Santini, J., "Botulinum toxin A in the treatment of glabellar lines: Scheduling the next injection", AESTHETIC SURGERY JOURNAL, MOSBY-YEAR BOOK, ST. LOUIS, MO, US, US , (20050701), vol. 25, no. 4, ISSN 1090-820X, pages 365 - 375, XP005004797 | - |
| OPPOSITION | - D14a - Maas & Singleton (2019), a copy of a poster presented at the conference Toxins 2019, between the dates of 16-19 January 2019 | - |
| OPPOSITION | - D14b - Webpage providing a list of posters presented at Toxins 2019 Conference | - |
| OPPOSITION | - D14c - Maas (Toxicon 156 (2018)) - ‘conference abstract’ - published online on 16 January 2019 | - |
| OPPOSITION | - D14D - Screenshot of webpage from which a copy of D14C was obtained, said webpage confirming this abstract was “Available online 16 January 2019” | - |
| OPPOSITION | - D18 - Relevant Prosecution History | - |
| OPPOSITION | - D26 - Joseph et al., a poster presentation that took place between 25-29 January 2021 | - |
| OPPOSITION | - D29B - Webpage obtained directly from the EMC website that outlines the “Changes History” of the smPC for BOCOUTURE® between 15 December 2018 and 25 August 2021 | - |
| OPPOSITION | - D30 - BOCOUTURE® Czechia label having a revised publication date of 13 February 2020 | - |
| OPPOSITION | - for the Reloxin Investigational Group ; Cohen, J.L. ; Schlessinger, J. ; Cox, S.E. ; Lin, X., "An Analysis of the Long-Term Safety Data of Repeat Administrations of Botulinum Neurotoxin Type A-ABO for the Treatment of Glabellar Lines", AESTHETIC SURGERY JOURNAL, MOSBY-YEAR BOOK, ST. LOUIS, MO, US, US , (20091101), vol. 29, no. 6, ISSN 1090-820X, pages S43 - S49, XP026776425 | - |
| OPPOSITION | - Joseph John H; Eaton Laura L; Robinson James; Pontius Allison; Williams Edwin F III, "Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?", JOURNAL OF DRUGS IN DERMATOLOGY, STRATEGIC COMMUNICATION IN DERMATOLOGY, NEW YORK, NY, US, US , (20161201), vol. 15, no. 12, ISSN 1545-9616, pages 1544 - 1549, XP009523599 | - |
| OPPOSITION | - The Maas Clinic, "Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids - NCT01583478", Clinical Trials, clinicaltrials.gov, (20140927), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01583478?term=NCT01583478&rank=1&a=2, XP093308843 | - |
| OPPOSITION | - Walker T J, Dayan S H, "Comparison and overview of currently available neurotoxins.", The Journal of Clinical and Aesthetic Dermatology, Matrix Medical Communications, LLC, USA, USA , (20140201), vol. 7, no. 2, ISSN 1941-2789, pages 31 - 39, XP055243263 | - |
| OPPOSITION | - Moy Ronald, Maas Corey, Monheit Gary, Huber M. Barbara, "Long-term Safety and Efficacy of a New Botulinum Toxin Type A in Treating Glabellar Lines", ARCHIVES OF FACIAL PLASTIC SURGERY, American Medical Association, US, US , (20090301), vol. 11, no. 2, doi:10.1001/archfacial.2009.5, ISSN 1521-2491, pages 77 - 83, XP009562732 | |
| OPPOSITION | - Frevert Jürgen, "Pharmaceutical, Biological, and Clinical Properties of Botulinum Neurotoxin Type A Products", Drugs in R&D, Adis International Ltd , nzl, (20150301), vol. 15, no. 1, doi:10.1007/s40268-014-0077-1, ISSN 1174-5886, pages 1 - 9, XP093308809 | |
| OPPOSITION | - Cox Sue Ellen; Joseph John H.; Fagien Steven; Glaser Dee Anna; Bruce Suzanne; Lain Edward; Yoelin Steven; Palm Melanie; Maas Corey S.; Lei Xiaofang; Maltman John; Sangha Sara; Brin Mitchell F., "Safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA 40 U, 60 U, and 80 U in subjects with moderate-to-severe dynamic glabellar lines", TOXICON, ELMSFORD, NY, US, US , (20210101), vol. 190, doi:10.1016/j.toxicon.2020.11.368, ISSN 0041-0101, XP086453023 | |
| OPPOSITION | - Kerscher Martina; Fabi Sabrina; Fischer Tanja; Gold Michael; Joseph John; Prager Welf; Rzany Berthold; Yoelin Steve; Roll Susanna; Klein Gudrun; Maas Corey, "IncobotulinumtoxinA demonstrates safety and prolonged duration of effect in a dose-ranging study for glabellar lines", TOXICON, ELMSFORD, NY, US, US , (20210101), vol. 190, doi:10.1016/j.toxicon.2020.11.421, ISSN 0041-0101, XP086453079 | |
| OPPOSITION | - Polacco Marc A, Singleton Adam E, Barnes Christian H, Maas Conner, Maas Corey S, "A Double-Blind, Randomized Clinical Trial to Determine Effects of Increasing Doses and Dose-Response Relationship of IncobotulinumtoxinA in the Treatment of Glabellar Rhytids", AESTHETIC SURGERY JOURNAL, MOSBY-YEAR BOOK, ST. LOUIS, MO, US, US , (20210518), vol. 41, no. 6, doi:10.1093/asj/sjaa220, ISSN 1090-820X, pages NP500 - NP511, XP093308820 | |
| OPPOSITION | - Benjamin Ascher, Philippe Kestemont, Dominique Boineau, Isaac Bodokh, Annette Stein, Marc Heckmann, Markus Dendorfer, Tatjana Pavicic, Magali Volteau, Anissa Tse, Philippe Picaut, Berthold Rzany, "Liquid Formulation of AbobotulinumtoxinA Exhibits a Favorable Efficacy and Safety Profile in Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trial", AESTHETIC SURGERY JOURNAL, MOSBY-YEAR BOOK, ST. LOUIS, MO, US, US , (20180117), vol. 38, no. 2, doi:10.1093/asj/sjw272, ISSN 1090-820X, pages 183 - 191, XP055714338 | |
| OPPOSITION | - Carruthers and Carruthers, "Prospective, Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A in Men with Glabellar Rhytids", Dermatol Surg., (200510), vol. 31, doi:10.1097/00042728-200510000-00006, XP002800781 | |
| OPPOSITION | - Garcia-Murray et al., "Safety and Efficacy of RT002, an Injectable Botulinum Toxin Type A, for Treating Glabellar Lines: Results of a Phase 1/2, Open-Label, Sequential Dose-Escalation Study", Dermatologic Surgery, (201501), vol. 41, doi:10.1097/DSS.0000000000000276, XP055979250 | |
| OPPOSITION | - Carruthers Jean; Solish Nowell; Humphrey Shannon; Rosen Nathan; Muhn Channy; Bertucci Vince; Swift Arthur; Metelitsa Andrei; Rubio Roman G; Waugh Jacob; Quiring John; Shears Gill; Carruthers Alastair, "Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo.", DERMATOLOGIC SURGERY : OFFICIAL PUBLICATION FOR AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY [ET AL.] MAR 2010, (20171031), vol. 43, no. 11, doi:10.1097/DSS.0000000000001206, ISSN 1524-4725, pages 1321 - 1331, XP009523600 | |
| OPPOSITION | - Carruthers et al., "DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2)", Plastic and Reconstructive Surgery, (202001), vol. 145, doi:10.1097/PRS.0000000000006327, XP055742304 | |
| OPPOSITION | - Souphiyeh Samizadeh, Koenraad De Boulle, "Botulinum neurotoxin formulations: overcoming the confusion", Clinical, Cosmetic and Investigational Dermatology, Volume 11, doi:10.2147/CCID.S156851, pages 273 - 287, XP055742573 | |
| OPPOSITION | - Joely Kaufman-Janette, "Botulinum Toxin Type A for Glabellar Frown Lines: What Impact of Higher Doses on Outcomes?", TOXINS, Molecular Diversity Preservation International (MDPI) AG., CH, CH , vol. 13, no. 7, doi:10.3390/toxins13070494, ISSN 2072-6651, page 494, XP093159249 | |
| OPPOSITION | - Joseph et al., "AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study", Journal of Drugs in Dermatology , (202109), vol. 20, doi:10.36849/JDD.6263, page 9, XP093159250 | |
| OPPOSITION | - Car Halina, Bogucki Andrzej, Bonikowski Marcin, Dec-Ćwiek Małgorzata, Drużdż Artur, Koziorowski Dariusz, Rudzińska-Bar Monika, Sarzyńska-Długosz Iwona, Sławek Jarosław, "Botulinum toxin type-A preparations are not the same medications — basic science (Part 1)", NEUROLOGIA I NEUROCHIRURGIA POLSKA, POLSKIE TOWARZYSTWO NEUROLOGICZNE, WARSAW,, PL, PL , vol. 55, no. 2, doi:10.5603/PJNNS.a2021.0027, ISSN 0028-3843, pages 133 - 140, XP055979238 | |
