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Methods Of Treatment For Cystic Fibrosis - EP3880197

The patent EP3880197 was granted to Vertex Pharmaceuticals Incorporated on Jul 2, 2025. The application was originally filed on Nov 13, 2019 under application number EP19817037A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3880197

VERTEX PHARMACEUTICALS INCORPORATED
Application Number
EP19817037A
Filing Date
Nov 13, 2019
Status
Granted And Under Opposition
Jan 20, 2023
Grant Date
Jul 2, 2025
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (2)

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TEVA PHARMACEUTICALSNov 22, 2023D YOUNGADMISSIBLE
GENERICS UKNov 21, 2023TER MEER STEINMEISTER & PARTNERADMISSIBLE

Patent Citations (28) New

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

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DESCRIPTIONWO2007134279
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INTERNATIONAL-SEARCH-REPORTUS2019248809
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OPPOSITIONUS62767202
OPPOSITIONWO2016057572
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Non-Patent Literature (NPL) Citations (33) 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
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INTERNATIONAL-SEARCH-REPORT- Anonymous, "Symdeko in Cystic Fibrosis Patients", ClinicalTrials.gov, Internet, (20180423), pages 1 - 9, URL: https://clinicaltrials.gov/ct2/show/record/NCT03506061, (20200124), XP055661778 [A] 1-49 * Detailed Description *-
INTERNATIONAL-SEARCH-REPORT- SCOTT H. DONALDSON ET AL, "Tezacaftor/Ivacaftor in Subjects with Cystic Fibrosis and F508del / F508del-CFTR or F508del / G551D-CFTR", AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE., US, (20170920), vol. 197, no. 2, doi:10.1164/rccm.201704-0717OC, ISSN 1073-449X, pages 214 - 224, XP055498649 [A] 1-49 * abstract * * figures 1-6; tables 1-3 *
OPPOSITION- Anonymous, "A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis", ClinicalTrials.gov; NCT03912233, (20191010), ClinicalTrials.gov; NCT03912233, URL: https://classic.clinicaltrials.gov/ct2/history/NCT03912233?V_6=View#StudyPageTop, (20240321), XP093144130-
OPPOSITION- Anonymous, "EudraCT 2018-000126-55", EU Clinical Trials Register, (20180515), EU Clinical Trials Register, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000126-55/NL, (20240321), XP093144120-
OPPOSITION- Anonymous, "EudraCT 2018-002496-18", EU Clinical Trials Register, (20190128), EU Clinical Trials Register, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002496-18/DE, (20240321), XP093144125-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO Drug Information, (20170119), vol. 31, no. 4, pages 635 - 754, XP055612042-
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OPPOSITION- Anonymous, "Pre-stems*: Suffixes used in the selection of INN November 2014 ", World Health Organization (WHO); INN Working Document 14.349 rev. 2, (20150108), World Health Organization (WHO); INN Working Document 14.349 rev. 2, URL: https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/prestem-suffixes-201411.pdf?sfvrsn=7a8d1e4c_4, (20240321), XP093144115-
OPPOSITION- Anonymous, "TRIKAFTATM", Highlights of Prescribing Information, (20191001), pages 1 - 16, XP093191899-
OPPOSITION- Anonymous, "Vertex Announces Positive Results From Pivotal Trials of Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis", Vertex, (20240205), pages 1 - 7, Vertex, URL: https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-pivotal-trials, (20240801), XP093191892-
OPPOSITION- Armstrong Madeleine, "Galapagos goes for broke in cystic fibrosis", (20171121), URL: https://www.evaluate.com/vantage/articles/news/galapagos-goes-broke-cystic-fibrosis, (20240212), XP093130423-
OPPOSITION- Pollack Andrew, "F.D.A. Approves New Cystic Fibrosis Drug", The New York Times, (20120131), The New York Times , URL: https://www.nytimes.com/2012/02/01/business/fda-approves-cystic-fibrosis-drug.html, (20240321), XP093144107-
OPPOSITION- Heijerman Harry G, Mckone Edward F, Downey Damian G, Van Braeckel Eva, Rowe Steven M, Tullis Elizabeth, Mall Marcus A, Welter John J, Ramsey Bonnie W, Mckee Charlotte M, Marigowda Gautham, Moskowitz Samuel M, Waltz David, Sosnay Patrick R, Simard Christopher, Ahluwalia Neil, Xuan Fengjuan, Zhang Yaohua, Taylor-Cousar Jennifer L, Mccoy Karen S, "Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial", The Lancet, AMSTERDAM, NL , (20191101), vol. 394, no. 10212, doi:10.1016/S0140-6736(19)32597-8, ISSN 0140-6736, pages 1 - 21, XP093191895
OPPOSITION- Uttamsineh V.; Pilja L.; Grotbeck B.; Brummei C.L.; Uddin N.; Harbeson S.L.; Braman V.; Cassella J., "WS13.6 CTP-656 tablet confirmed superiority of pharmacokinetic profile relative to Kalydeco®in Phase I clinical studies", Journal of Cystic Fibrosis, Elsevier, NL, NL , (20160601), vol. 15, no. Suppl. 1, doi:10.1016/S1569-1993(16)30138-2, ISSN 1569-1993, pages S22 - S22, XP029572015
OPPOSITION- Ahmet Z Uluer, "Safety and efficacy of vanzacaftor-tezacaftor-deutivacaftor in adults with cystic fibrosis: randomised, double-blind, controlled, phase 2 trials", The Lancet, Oxford , (20230223), vol. 11, no. 6, doi:10.1016/S2213-2600(22)00504-5, ISSN 2213-2600, pages 550 - 562, XP093161417
OPPOSITION- Wang Xueqing, Liu Bo, Searle Xenia, Yeung Clinton, Bogdan Andrew, Greszler Stephen, Singh Ashvani, Fan Yihong, Swensen Andrew M, Vortherms Timothy, Balut Corina, Jia Ying, Desino Kelly, Gao Wenqing, Yong Hong, Tse Chris, Kym Philip, "Discovery of 4-[(2 R ,4 R )-4-({[1-(2,2-Difluoro-1,3-benzodioxol-5-yl)cyclopropyl]carbonyl}amino)-7-(difluoromethoxy)-3,4-dihydro-2 H -chromen-2-yl]benzoic Acid (ABBV/GLPG-2222), a Potent Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector for the Treatment of Cystic Fibrosis", Journal of Medicinal Chemistry, American Chemical Society, US, US , (20180222), vol. 61, no. 4, doi:10.1021/acs.jmedchem.7b01339, ISSN 0022-2623, pages 1436 - 1449, XP093130421
OPPOSITION- Jennifer L. Taylor-Cousar, Munck Anne, Mckone Edward F., Van Der Ent Cornelis K., Moeller Alexander, Simard Christopher, Wang Linda T., Ingenito Edward P., Mckee Charlotte, Lu Yimeng, Lekstrom-Himes Julie, Elborn J. Stuart, "Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del", The New England journal of medicine, Massachusetts Medical Society, US, US , (20171103), vol. 377, no. 21, doi:10.1056/NEJMoa1709846, ISSN 0028-4793, pages 2013 - 2023, XP055498655
OPPOSITION- Steven M. Rowe, Cori Daines, Felix C. Ringshausen, Eitan Kerem, John Wilson, Elizabeth Tullis, Nitin Nair, Christopher Simard, Linda Han, Edward P. Ingenito, Charlotte Mckee, Julie Lekstrom-Himes, Jane C. Davies, "Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis", The New England journal of medicine, Massachusetts Medical Society, US, US , (20171123), vol. 377, no. 21, doi:10.1056/NEJMoa1709847, ISSN 0028-4793, pages 2024 - 2035, XP055498652
OPPOSITION- Davies Jane C., Moskowitz Samuel M., Brown Cynthia, Horsley Alexander, Mall Marcus A., Mckone Edward F., Plant Barry J., Prais Dario, Ramsey Bonnie W., Taylor-Cousar Jennifer L., Tullis Elizabeth, Uluer Ahmet, Mckee Charlotte M., Robertson Sarah, Shilling Rebecca A., Simard Christopher, Van Goor Fredrick, Waltz David, Xuan Fengjuan, Young Tim, Rowe Steven M., "VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles", The New England journal of medicine, Massachusetts Medical Society, US, US , (20181025), vol. 379, no. 17, doi:10.1056/NEJMoa1807119, ISSN 0028-4793, pages 1599 - 1611, XP093144919
OPPOSITION- Keating Dominic, Marigowda Gautham, Burr Lucy, Daines Cori, Mall Marcus A., Mckone Edward F., Ramsey Bonnie W., Rowe Steven M., Sass Laura A., Tullis Elizabeth, Mckee Charlotte M., Moskowitz Samuel M., Robertson Sarah, Savage Jessica, Simard Christopher, Van Goor Fredrick, Waltz David, Xuan Fengjuan, Young Tim, Taylor-Cousar Jennifer L., "VX-445-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles", The New England journal of medicine, Massachusetts Medical Society, US, US , (20181025), vol. 379, no. 17, doi:10.1056/NEJMoa1807120, ISSN 0028-4793, pages 1612 - 1620, XP093144920
OPPOSITION- Mcelvaney Oliver J, Gunaratnam Cedric, Mcelvaney Oisin Fiachra, Bagwe Isha, Reeves Emer P, Mcelvaney Noel G, "Emerging pharmacotherapies in cystic fibrosis", Expert Review of Respiratory Medicine, Expert Reviews, GB, GB , (20181003), vol. 12, no. 10, doi:10.1080/17476348.2018.1512409, ISSN 1747-6348, pages 843 - 855, XP009553012
OPPOSITION- Harbeson Scott L., Morgan Adam J., Liu Julie F., Aslanian Ara M., Nguyen Sophia, Bridson Gary W., Brummel Christopher L., Wu Lijun, Tung Roger D., Pilja Lana, Braman Virginia, Uttamsingh Vinita, "Altering Metabolic Profiles of Drugs by Precision Deuteration 2: Discovery of a Deuterated Analog of Ivacaftor with Differentiated Pharmacokinetics for Clinical Development", Journal of pharmacology and experimental therapeutics, American Society for Pharmacology and Experimental Therapeutics, US, US , (20170801), vol. 362, no. 2, doi:10.1124/jpet.117.241497, ISSN 0022-3565, pages 359 - 367, XP055981784

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