IP Verse

New Use Of A Combination Of Sacubitril And Valsartan - EP3411021

The patent EP3411021 was granted to Novartis on May 14, 2025. The application was originally filed on Feb 2, 2017 under application number EP17703477A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3411021

NOVARTIS
Application Number
EP17703477A
Filing Date
Feb 2, 2017
Status
Granted And Under Opposition
Apr 11, 2025
Grant Date
May 14, 2025
External Links
Slate, Register, Google Patents

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CAMULONSep 1, 2025ADMISSIBLE

Patent Citations (12) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0443983
DESCRIPTIONUS5217996
DESCRIPTIONUS5399578
DESCRIPTIONWO03059345
DESCRIPTIONWO2007056546
DESCRIPTIONWO2009061713
DESCRIPTIONWO2012027237
DESCRIPTIONWO2014029848
DESCRIPTIONWO2015028941
DESCRIPTIONWO2015030711
INTERNATIONAL-SEARCH-REPORTWO2009061713
OPPOSITIONWO2017134600

Non-Patent Literature (NPL) Citations (18) 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
DESCRIPTION- SHADDY RE; BOUCEK MM; HSU DT ET AL., "Carvedilol for children and adolescents with heart failure: A randomized controlled trial", JAMA, (2007), vol. 298, pages 1171 - 1179-
DESCRIPTION- KIRK R; DIPCHAND AL; ROSENTHAL DN ET AL., "The international society for heart and lung transplantation guidelines for the management of pediatric heart failure: Executive summary", J HEART LUNG TRANSPLANT, (2014), vol. 33, doi:doi:10.1016/j.healun.2014.06.002, pages 888 - 909, XP029042744
EXAMINATION- Anonymous, "Annex I - Summary of Product Characteristics", (20230101), pages 1 - 93, URL: https://www.ema.europa.eu/en/documents/product-information/entresto-epar-product-information_en.pdf, (20250307), XP093257022-
EXAMINATION- Anonymous, "Commission Implementing Decision", (20230526), pages 1 - 4, URL: https://ec.europa.eu/health/documents/community-register/2023/20230526159257/dec_159257_en.pdf, (20250307), XP093257023-
EXAMINATION- Anonymous, "European Medicines Agency: Assessment report Entresto International non-proprietary name: SACUBITRIL / VALSARTAN", (20150924), pages 1 - 115, URL: https://www.ema.europa.eu/en/documents/assessment-report/entresto-epar-public-assessment-report_en.pdf, (20190730), XP055609648-
EXAMINATION- Anonymous, "Novartis Entresto receives positive CHMP opinion for pediatric heart failure", (20230331), pages 1 - 6, URL: https://www.novartis.com/news/media-releases/novartis-entresto-receives-positive-chmp-opinion-pediatric-heart-failure, (20250207), XP093257021-
EXAMINATION- KIRK RICHARD ET AL, "The International Society of Heart and Lung Transplantation Guidelines for the management of pediatric heart failure: Executive summary", JOURNAL OF HEART AND LUNG TRANSPLANTATION, ELSEVIER, AMSTERDAM, NL, (20140617), vol. 33, no. 9, doi:10.1016/J.HEALUN.2014.06.002, ISSN 1053-2498, pages 888 - 909, XP029042744
INTERNATIONAL-SEARCH-REPORT- Anonymous, "European Medicines Agency decision P/0106/2014", (20140611), pages 1 - 8, URL: http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500168118.pdf, (20160708), XP055286995 [X] 1-3,9 * pages 4, 7, 8 * [I] 4-8,10-20-
OPPOSITION- Anonymous, "Guidance for Industry E11 Clinical Investigation of Medicinal Products in the Pediatric Population", U.S. Department of Health and Human Services, Food and Drug Administration, (20001201), U.S. Department of Health and Human Services, Food and Drug Administration, URL: https://www.govinfo.gov/content/pkg/GOVPUB-HE20_4000-PURL-LPS113969/pdf/GOVPUB-HE20_4000-PURL-LPS113969.pdf, XP093312846-
OPPOSITION- D11 - European Medicines Agency, “Entresto : EPAR - Product Information”, published 1 December 2015 (no date found in text)-
OPPOSITION- Evidence of how RG11 was accessed via the WayBack Machine, including evidence of publication date of RG11.-
OPPOSITION- Laird Penn Jr., "Pediatric cardiac medications: Enalapril", Pediatric Heart Specialists, (20160127), Pediatric Heart Specialists, URL: https://pediatricheartspecialists.com/heart-education/blog/56-pediatric-cardiac-medications-enalapril, XP093312849-
OPPOSITION- Novartis Pharmaceuticals, "Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure - NCT02678312", Clinical Trials, clinicaltrials.gov, (20160204), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02678312?term=NCT02678312&rank=1&tab=history&a=1#version-content-panel, XP093312843-
OPPOSITION- P Anonymous, "European Medicines Agency decision P/0106/2014 ", pages 1 - 8, URL: http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500168118.pdf, (20160708), XP055286995-
OPPOSITION- Robert Ross, "The Ross Classification for Heart Failure in Children After 25 Years: A Review and an Age-Stratified Revision", Pediatr Cardiol , (20120405), vol. 33, doi:10.1007/s00246-012-0306-8, pages 1295 - 1300, XP035145874
OPPOSITION- Kantor Paul F., Lougheed Jane, Dancea Adrian, Mcgillion Michael, Barbosa Nicole, Chan Carol, Dillenburg Rejane, Atallah Joseph, Buchholz Holger, Chant-Gambacort Catherine, Conway Jennifer, Gardin Letizia, George Kristen, Greenway Steven, Human Derek G., Jeewa Aamir, Price Jack F., Ross Robert D., Roche S. Lucy, Ryerson Lindsay, Soni Reeni, Wilson Judith, Wong Kenny, "Presentation, Diagnosis, and Medical Management of Heart Failure in Children: Canadian Cardiovascular Society Guidelines", Canadian journal of cardiology, PULSUS GROUP, INC., CANADA, CANADA , (20131201), vol. 29, no. 12, doi:10.1016/j.cjca.2013.08.008, ISSN 0828-282X, pages 1535 - 1552, XP093312853
OPPOSITION- Kirk Richard; Dipchand Anne I.; Rosenthal David N.; Addonizio Linda; Burch Michael; Chrisant Maryanne; Dubin Anne; Everitt Melanie; Gajarski Robert; Mertens Luc; Miyamoto Shelley; Morales David; Pahl Elfriede; Shaddy Robert; Towbin Jeffrey; Weintraub Robert, "The International Society of Heart and Lung Transplantation Guidelines for the management of pediatric heart failure: Executive summary", Journal of Heart and Lung Transplantation, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20140617), vol. 33, no. 9, doi:10.1016/j.healun.2014.06.002, ISSN 1053-2498, pages 888 - 909, XP029042744
OPPOSITION- John J.V. Mcmurray, Milton Packer, Akshay S. Desai, Jianjian Gong, Martin P. Lefkowitz, Adel R. Rizkala, Jean L. Rouleau, Victor C. Shi, Scott D. Solomon, Karl Swedberg, Michael R. Zile, "Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure", New England Journal of Medicine, New England Journal of Medicine, (20140911), vol. 371, no. 11, doi:10.1056/NEJMoa1409077, ISSN 00284793, pages 993 - 1004, XP055175908

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