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Compositions Comprising 5-Methoxy-N,N-Dimethyltryptamine (5-Meo-Dmt) For Use In Treating Mental Disorders - EP3927338

The patent EP3927338 was granted to GH Research Ireland on Oct 9, 2024. The application was originally filed on Feb 24, 2020 under application number EP20710060A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3927338

GH RESEARCH IRELAND
Application Number
EP20710060A
Filing Date
Feb 24, 2020
Status
Granted And Under Opposition
Sep 6, 2024
Grant Date
Oct 9, 2024
External Links
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STRAWMANJul 9, 2025CMS CAMERON MCKENNA NABARRO OLSWANGADMISSIBLE

Patent Citations (3) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO2005055996
INTERNATIONAL-SEARCH-REPORTWO2018195455
OPPOSITIONEP1558251

Non-Patent Literature (NPL) Citations (58) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
EXAMINATION- Anonymous, "What is depression?", (20190101), pages 1 - 6, URL: https://web.archive.org/web/20190117034902/https://www.psychiatry.org/patients-families/depression/what-is-depression, (20240320), XP093143634-
EXAMINATION- Davis Alan K ET AL, "The epidemiology of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) use: Benefits, consequences, patterns of use, subjective effects, and reasons for consumption", Journal of Psychopharmacology, (20180430), pages 779 - 792, URL: https://journals.sagepub.com/doi/10.1177/0269881118769063, (20221209), XP093006797-
EXAMINATION- Ewing C Greer, "Ground to Source-experiencing the Divine within", The practical tripper, (20170415), pages 1 - 20, URL: https://thepracticaltripper.wordpress.com/2017/04/15/ground-to-source-experiencing-the-divine-within-2/, (20240320), XP093143625-
EXAMINATION- Porter R. S. ET AL, "Mood disorders", The Merck Manual of Diagnosis and Therapy - Twentieth Edition, (20180101), pages 1757 - 1766, URL: https://www.wiley.com/en-us/The+Merck+Manual+of+Diagnosis+and+Therapy%2C+20th+Edition-p-9780911910421, (20231219), XP093113475-
EXAMINATION- CARHART-HARRIS R L ET AL, "Psilocybin with psychological support for treatment-resistant depression: six-month follow-up", PSYCHOPHARMACOLOGY, SPRINGER VERLAG, BERLIN, DE, vol. 235, no. 2, doi:10.1007/S00213-017-4771-X, ISSN 0033-3158, (20171108), pages 399 - 408, (20171108), XP036477494
EXAMINATION- UTHAUG M V ET AL, "A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms", PSYCHOPHARMACOLOGY, SPRINGER VERLAG, BERLIN, DE, vol. 236, no. 9, doi:10.1007/S00213-019-05236-W, ISSN 0033-3158, (20190413), pages 2653 - 2666, (20190413), XP036863337
EXAMINATION- BARSUGLIA J P ET AL, "A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder", EVENT-RELATED DYNAMICS OF BRAIN OSCILLATIONS; [PROGRESS IN BRAIN RESEARCH. ISSN 0079-6123], ELSEVIER, AMSTERDAM, NL, (20180101), vol. 242, doi:10.1016/BS.PBR.2018.08.002, ISSN 0079-6123, ISBN 978-0-444-52183-5, pages 121 - 158, XP009520576
OPPOSITION- Anonymous, "A phase 1/2 study of GH001 in patients with treatment-resistant depression", EU Clinical Trials Register; EudraCT Number: 2018-004208-20, (20190821), EU Clinical Trials Register; EudraCT Number: 2018-004208-20, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004208-20/NL, XP093242534-
OPPOSITION- Anonymous, "Corporate Presentation GH Research PLC (NASDAQ: GHRS)", GH Research, (20220301), GH Research, URL: https://investor.ghres.com/static-files/25e586e7-aaa1-4407-b4f5-e4881a4e9ff6, XP093298656-
OPPOSITION- Anonymous, "EudraCT & EU-CTR Question and Answer table Frequently Asked Questions & Answers (FAQs) - V1.3 ", European Medicines Agency (EMA), (20190301), XP093298678-
OPPOSITION- Anonymous, "February 2025 Psychedelic Patent Update: Terran Secures New Overlapping IP; Porta Sophia Becomes USPTO Information Source", Psychedelic Alpha, (20250327), XP093298696-
OPPOSITION- Anonymous, "GH Research Announces Closing of $125 Million Oversubscribed Series B Financing", GH Research, (20210412), GH Research, URL: https://investor.ghres.com/node/6906/pdf, XP093242469-
OPPOSITION- Anonymous, "GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placeboadjusted MADRS Reduction", GH Research, (20250203), XP093298659-
OPPOSITION- Anonymous, "Janssen Announces U.S. FDA Approval of SPRAVATO (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief", Johnson&Johnson, (20190305), Johnson&Johnson, URL: https://www.jnj.com/media-center/press-releases/janssen-announces-u-s-fda-approval-of-spravatotm-esketamine-ciii-nasal-spray-for-adults-with-treatment-resistant-depression-trd-who-have-cycled-through-multiple-treatments-without-relief, XP093298689-
OPPOSITION- Anonymous, "Janssen Announces U.S. FDA Approval of SPRAVATO (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior", Johnson&Johnson, (20200803), Johnson&Johnson, URL: https://www.jnj.com/media-center/press-releases/janssen-announces-u-s-fda-approval-of-spravato-esketamine-ciii-nasal-spray-to-treat-depressive-symptoms-in-adults-with-major-depressive-disorder-with-acute-suicidal-ideation-or-behavior, XP093298690-
OPPOSITION- Anonymous, "Porta Sophia Publishes Narrative Review Manuscript Summarizing Historical Evidence of 5-MeO-DMT as a Compound Used in Therapeutic Practice ", Porta Sophia, (20241112), Porta Sophia, URL: https://www.portasophia.org/newsroom/press-releases/porta-sophia-publishes-narrative-review-manuscript-summarizing-historical-evidence-of-5-meo-dmt-as-a-compound-used-in-therapeutic-practice-2, XP093298684-
OPPOSITION- Anonymous, "The Essential Guide to 5-MeO-DMT (5-MEO, Five-methoxy, The Power, Toad venom)", thethirdwave.co (accessed via the Wayback Machine), (20181109), thethirdwave.co (accessed via the Wayback Machine), URL: https://web.archive.org/web/20181109024846/https://thethirdwave.co/psychedelics/5-meo-dmt/, XP093298665-
OPPOSITION- Anonymous, "What Is Depression?", American Psychiatric Association (accessed via the Wayback Machine), (20190117), American Psychiatric Association (accessed via the Wayback Machine), URL: https://web.archive.org/web/20190117034902/https://www.psychiatry.org/patients-families/depression/what-is-depression, XP093298655-
OPPOSITION- Cowen P. L, "Altered states: psilocybin for treatment-resistant depression", The Lancet Psychiatry, (20160101), vol. 3, no. 7, pages 592 - 593, XP093178356-
OPPOSITION- D15 - Form F-1 (Registration Statement Under Securities Act 1933) filed by GH Research PLC (of which GH Research is a subsidiary) with the Securities and Exchange Commission on 21 June 2021-
OPPOSITION- D16 - Communication under Article 94(3) on EP3927338 dated 12 December 2022.-
OPPOSITION- D30 - Michael E. Thase . Speaker at 26 Int. Symposium Controversies in Psychiatry. Barcelona: https://controversiasbarcelona.org/en/2019sp thase.php-
OPPOSITION- D34 - GH Research Ireland Limited response to Oppositions against EP3927337 on 3 June 2025.-
OPPOSITION- D3a - document summarising the use of the terms “depression” and “treatment resistant depression” by the Patentee in their public communications-
OPPOSITION- D3c - a corporate presentation from the Patentee dated May 2022-
OPPOSITION- D3d - a corporate presentation from the Patentee dated November 2022-
OPPOSITION- D3e - a corporate presentation from the Patentee dated March 2023-
OPPOSITION- D3f - a corporate presentation from the Patentee dated May 2023-
OPPOSITION- D3h - a press release from the Patentee dated 3 September 2024-
OPPOSITION- D40 - First Seelig declaration as filed on EP3927337 (also there called D40).-
OPPOSITION- D41 - Second Seelig declaration with attachments (which has been filed on EP3927337 by Porta Sophia, Opponent 1 in those ongoing opposition proceedings)-
OPPOSITION- D42 - Evidence that Dr Thase is a scientific advisor for the patentee.-
OPPOSITION- Davis, AK & Lancelotta, R., "The healing potential of 5-MeO-DMT: Results from two survey studies", Midwest Psychedelic Therapy Symposium: April 27 - 29, 2018, Madison, Wisconsin, USA, (20180428), pages 1 - 29, XP009562951-
OPPOSITION- Jeremy Bigwood, Jonathan Ott, "CHAPTER SIX DMT, DET, DPT and Other Short-Acting Tryptamines", Jeremy Bigwood, Jonathan Ott, Peter Stafford, PSYCHEDELICS ENCYCLOPEDIA, 3rd EXPANDED EDITION, USA, Ronin, (19930112), pages 309 - 332, ISBN 0-914171-51-8, XP009562658-
OPPOSITION- Meccia Juliet, Casimir David, Li Sisi, Shams Shahin, Isenbarger Thomas A, Seelig Mark, "TREATMENT OF MAJOR DEPRESSIVE DISORDER AND TREATMENT RESISTANT DEPRESSION WITH 5-MeO-DMT: IMPACT OF 25 YEARS OF NON-TRADITIONAL PUBLIC SCIENTIFIC COMMUNICATION AND EDUCATION ON CLINICAL DEVELOPMENT AND COMMERCIALIZATION", porta sophia, (20241112), XP093298683-
OPPOSITION- R. Gordon Wasson, "CHAPTER FOUR Psilocybian Mushrooms", R. Gordon Wasson, PETER STAFFORD: ", ", 1993, pages: 1-257 (whole book), Psychedelics Encyclopedia. (Third Edition), US, Ronin, (19930112), pages 225 - 280, ISBN 0-914171-51-8, XP009562659-
OPPOSITION- Howard G. Birnbaum; Ronald C. Kessler; David Kelley; Rym Ben‐Hamadi; Vijay N. Joish; Paul E. Greenberg, "Employer burden of mild, moderate, and severe major depressive disorder: mental health services utilization and costs, and work performance", DEPRESSION AND ANXIETY, NEW YORK, NY, US, US , (20090630), vol. 27, no. 1, doi:10.1002/da.20580, ISSN 1091-4269, pages 78 - 89, XP072005575
OPPOSITION- Araújo Ana Margarida; Carvalho Félix; Bastos Maria de Lourdes; Guedes de Pinho Paula; Carvalho Márcia , "The hallucinogenic world of tryptamines: an updated review", Archives of Toxicology, SPRINGER, DE, DE , (20150416), vol. 89, no. 8, doi:10.1007/s00204-015-1513-x, ISSN 0340-5761, pages 1151 - 1173, XP035516380
OPPOSITION- Carhart-Harris R. L.; Bolstridge M.; Day C. M.; Rucker J.; Watts R.; Erritzoe D. E.; Kaelen M.; Giribaldi B.; Bloomfield M.; Pilling S.; Rickard J. A.; Forbes B.; Feilding A.; Taylor D.; Curran H. V.; Nutt D. J., "Psilocybin with psychological support for treatment-resistant depression: six-month follow-up", Psychopharmacology, SPRINGER VERLAG, BERLIN., DE, DE , (20171108), vol. 235, no. 2, doi:10.1007/s00213-017-4771-x, ISSN 0033-3158, pages 399 - 408, XP036415992
OPPOSITION- Uthaug Malin V; Lancelotta Rafael; Szabo Attila; Davis Alan K; Riba Jordi; Ramaekers Johannes G, "Prospective examination of synthetic 5-methoxy-N,N-dimethyltryptamine inhalation: effects on salivary IL-6, cortisol levels, affect, and non-judgment", Psychopharmacology, SPRINGER VERLAG, BERLIN., DE, DE , (20191210), vol. 237, no. 3, doi:10.1007/s00213-019-05414-w, ISSN 0033-3158, pages 773 - 785, XP037030419
OPPOSITION- Kennett, G.A. ; Marcou, M. ; Dourish, C.T. ; Curzon, G., "Single administration of 5-HT"1"A agonists decreases 5-HT"1"A presynaptic, but not postsynaptic receptor-mediated responses: relationship to antidepressant-like action", European Journal of Pharmacology, Elsevier science, NL, NL , (19870612), vol. 138, no. 1, doi:10.1016/0014-2999(87)90336-0, ISSN 0014-2999, pages 53 - 60, XP023751821
OPPOSITION- Kaufman Joshua; DeLorenzo Christine; Choudhury Sunia; Parsey Ramin V., "The 5-HT1Areceptor in Major Depressive Disorder", European Neuropsychopharmacology, Elsevier Sience Publishers BV , Amsterdam, NL, NL , (20160111), vol. 26, no. 3, doi:10.1016/j.euroneuro.2015.12.039, ISSN 0924-977X, pages 397 - 410, XP029457824
OPPOSITION- Riga Maurizio S.; Lladó-Pelfort Laia; Artigas Francesc; Celada Pau, "The serotonin hallucinogen 5-MeO-DMT alters cortico-thalamic activity in freely moving mice: Regionally-selective involvement of 5-HT1Aand 5-HT2Areceptors", Neuropharmacology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (19000101), vol. 142, doi:10.1016/j.neuropharm.2017.11.049, ISSN 0028-3908, pages 219 - 230, XP085542725
OPPOSITION- Dakic Vanja, Minardi Nascimento Juliana, Costa Sartore Rafaela, Maciel Renata De Moraes, De Araujo Draulio B., Ribeiro Sidarta, Martins-De-Souza Daniel, Rehen Stevens K., "Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT", Scientific reports, Nature Publishing Group, US, US , vol. 7, no. 1, doi:10.1038/s41598-017-12779-5, ISSN 2045-2322, XP093242538
OPPOSITION- Carhart-Harris Robin L, Roseman Leor, Bolstridge Mark, Demetriou Lysia, Pannekoek J Nienke, Wall Matthew B, Tanner Mark, Kaelen Mendel, Mcgonigle John, Murphy Kevin, Leech Robert, Curran H Valerie, Nutt David J, "Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms", Scientific reports, Nature Publishing Group, US, US , (20171013), vol. 7, no. 1, doi:10.1038/s41598-017-13282-7, ISSN 2045-2322, XP093189956
OPPOSITION- Alan K. Davis, So Sara, Lancelotta Rafael, Barsuglia Joseph P., Griffiths Roland R., "5-methoxy- N,N -dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety", AMERICAN JOURNAL OF DRUG AND ALCOHOL ABUSE, MARCEL DEKKER, NEW YORK,NY,, US, US , (20190304), vol. 45, no. 2, doi:10.1080/00952990.2018.1545024, ISSN 0095-2990, pages 161 - 169, XP055695498
OPPOSITION- Shen Hong-Wu; Jiang Xi-Ling; Yu Ai-Ming SUNY Buffalo, Sch Pharm and Pharmaceut Sci, Dept Pharmaceut Sci, 541 Cooke Hall, Buffalo, NY 14260 USA; [email protected], "Nonlinear Pharmacokinetics of 5-Methoxy-N,N-dimethyltryptamine in Mice", Drug metabolism and disposition : the biological fate of chemicals, Elsevier Inc, United States, United States, (20110630), vol. 39, no. 7, doi:10.1124/dmd.111.039107, ISSN 0090-9556, pages 1227 - 1234, XP009520579
OPPOSITION- Belser, A. B., Agin-Liebes, G., Swift, T. C., Terrana, S., Devenot, N., Friedman, H. L., Guss, J., Bossis, A., & Ross, S., "Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis", Journal of Humanistic Psychology, Sage publications, (20170428), vol. 57, no. 4, doi:10.1177/0022167817706884, ISSN 1552-650X, pages 354 - 388, XP009562216
OPPOSITION- Carhart-Harris RL, Roseman L, Haijen E, Erritzoe D, Watts R, Branchi I, Kaelen M., "Psychedelics and the essential importance of context", Journal of psychopharmacology, Oxford Univ. Press, USA, USA , (20180215), vol. 32, no. 7, doi:10.1177/0269881118754710, ISSN 1461-7285, pages 725 - 731, XP009562217
OPPOSITION- Alan K Davis, Joseph P Barsuglia, Rafael Lancelotta, Robert M Grant, Elise Renn, "The epidemiology of 5-methoxy- N, N -dimethyltryptamine (5-MeO-DMT) use: Benefits, consequences, patterns of use, subjective effects, and reasons for consumption", JOURNAL OF PSYCHOPHARMACOLOGY., OXFORD UNIVERSITY PRESS., GB, GB , (20180701), vol. 32, no. 7, doi:10.1177/0269881118769063, ISSN 0269-8811, pages 779 - 792, XP055695664
OPPOSITION- Thase Michael E., "Using biomarkers to predict treatment response in major depressive disorder: evidence from past and present studies", Dialogues in Clinical Neuroscience, Taylor & Francis, (20141201), vol. 16, no. 4, doi:10.31887/DCNS.2014.16.4/mthase, ISSN 1958-5969, pages 539 - 544, XP093298686
OPPOSITION- Lima da Cruz Rafael Vitor; Moulin Thiago C; Petiz Lyvia Lintzmaier; Leao Richardson N, "A Single Dose of 5-MeO-DMT Stimulates Cell Proliferation, Neuronal Survivability, Morphological and Functional Changes in Adult Mice Ventral Dentate Gyrus", Frontiers in molecular neuroscience, Frontiers Research Foundation, CH, CH , (20180904), vol. 11, doi:10.3389/fnmol.2018.00312, ISSN 1662-5099, pages Art. 312, 1 - 11, XP009520556
OPPOSITION- Leor Roseman, David J. Nutt, Robin L. Carhart-Harris, "Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression", Frontiers in Pharmacology, vol. 8, doi:10.3389/fphar.2017.00974, XP055707475
OPPOSITION- Reckweg Johannes, Mason Natasha L., Van Leeuwen Cees, Toennes Stefan W., Terwey Theis H., Ramaekers Johannes G., "A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers", Frontiers in pharmacology, Frontiers Research Foundation, CH, CH , (20211125), vol. 12, doi:10.3389/fphar.2021.760671, ISSN 1663-9812, XP055932663
OPPOSITION- Joseph Barsuglia, Alan K. Davis, Robert Palmer, Rafael Lancelotta, Austin-Marley Windham-Herman, Kristel Peterson, Martin Polanco, Robert Grant, Roland R. Griffiths, "Intensity of Mystical Experiences Occasioned by 5-MeO-DMT and Comparison With a Prior Psilocybin Study", Frontiers in Psychology, Frontiers Research Foundation, vol. 9, doi:10.3389/fpsyg.2018.02459, ISSN 1664-1078, pages 1 - 6, XP055695516
OPPOSITION- Reckweg Johannes T., Van Leeuwen Cees J., Henquet Cécile, Van Amelsvoort Therese, Theunissen Eef L., Mason Natasha L., Paci Riccardo, Terwey Theis H., Ramaekers Johannes G., "A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression", Frontiers in Psychiatry, Frontiers Media SA, Frontiers in psychiatry Switzerland 2020, Frontiers in psychiatry Switzerland 2020, (20230620), vol. 14, doi:10.3389/fpsyt.2023.1133414, ISSN 1664-0640, XP093182606
OPPOSITION- Thase ME, "The multifactorial presentation of depression in acute care", Journal of Clinical Psychiatry, Physicians Postgraduate Press, Inc, US, US , (20131015), vol. 74, no. 2, doi:10.4088/JCP.12084su1c.01, ISSN 0160-6689, pages 3 - 8, XP009562219
OPPOSITION- Rakofsky Jeffrey, Schettler Pamela, Kinkead Becky, Frank Ellen, Judd Lewis, Kupfer David, Rush, Thase Michael, Yonkers Kimberly, Rapaport Mark, "The prevalence and severity of depressive symptoms along the spectrum of unipolar depressive disorders: a post hoc analysis", Journal of Clinical Psychiatry, Physicians Postgraduate Press, Inc, US, US , (20131115), vol. 74, no. 11, doi:10.4088/JCP.12m08194, ISSN 0160-6689, pages 1084 - 1091, XP009562218

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