IP Verse

Therapeutic Compositions For Treatment Of Human Immunodeficiency Virus - EP3346995

The patent EP3346995 was granted to Gilead Sciences on Aug 28, 2019. The application was originally filed on Nov 8, 2016 under application number EP16798063A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3346995

GILEAD SCIENCES
Application Number
EP16798063A
Filing Date
Nov 8, 2016
Status
Granted And Under Opposition
Jul 26, 2019
Grant Date
Aug 28, 2019
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentativeOpposition Status

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COOKEMay 28, 2020ELKINGTON AND FIFEADMISSIBLE
SANDOZMay 28, 2020TER MEER STEINMEISTER & PARTNERADMISSIBLE
TEVA PHARMACEUTICALSMay 27, 2020KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (18) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO0208241
DESCRIPTIONWO2013025788
DESCRIPTIONWO2014100323
INTERNATIONAL-SEARCH-REPORTWO2013116720
INTERNATIONAL-SEARCH-REPORTWO2014100323
INTERNATIONAL-SEARCH-REPORTWO2015022351
INTERNATIONAL-SEARCH-REPORTWO2015196116
INTERNATIONAL-SEARCH-REPORTWO2015196137
OPPOSITIONUS2014221356
OPPOSITIONWO0208421
OPPOSITIONWO2010091197
OPPOSITIONWO2013115916
OPPOSITIONWO2013116720
OPPOSITIONWO2014100323
OPPOSITIONWO2015022351
OPPOSITIONWO2015196116
OPPOSITIONWO2015196137
OPPOSITIONWO2017083304

Non-Patent Literature (NPL) Citations (26) 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
OPPOSITION- 5 November, Johnson Bylinda A, "Gilead's new four-in-one HIV pill, Genvoya, wins US approval", Medicall X press, (20151105), pages 1 - 2, Medicall X press, URL: https://medicalxpress.com/pdf365969282.pdf, (20201104), XP055747024-
OPPOSITION- Anonymous, "Approval Package for aplication number 208351Orig1s000 Odefsey", CENTER FOR DRUG EVALUATION AND RESEARCH, (20160301), pages 1 - 10, CENTER FOR DRUG EVALUATION AND RESEARCH, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208351Orig1s000Approv.pdf, (20201102), XP055745977-
OPPOSITION- Anonymous, "Choices, choices: the rapidly evolving HIV treatment landscape - PMLiVE", PMLive, (20150315), pages 1 - 2, PMLive, URL: http://www.pmlive.com/pharma_intelligence/choices,_choices_rapidly_evolving_hiv_treatment_landscape_652429, (20201102), XP055745972-
OPPOSITION- Anonymous, "Clinical Trials Register EudraCT number 2015-003988-10", Clinical Trials Register, (20151119), pages 1 - 6, Clinical Trials Register, URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003988-10/BE, (20201105), XP055747283-
OPPOSITION- Anonymous, "Drug Approval Package: VIREAD (Tenofovir Disoproxil Fumarate) NDA #21-356", FDA, (20170621), pages 1 - 2, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm, (20201103), XP055746341-
OPPOSITION- Anonymous, "European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment | Business Wire", bussinesswire, (20150528), pages 1 - 2, bussinesswire, URL: https://www.businesswire.com/news/home/20150528005752/en/European-Medicines-Agency-Validates-Gilead’s-Marketing-Application, (20201102), XP055745982-
OPPOSITION- Anonymous, "Gilead Sciences Finalizes Agreement with Tibotec Pharmaceuticals to Develop and Commercialize a Single-Tablet Regimen of Prezista(R) with Emtriva(R), GS 7340 and Cobicistat", BUSINESS WIRE) --Gilead Sciences, Inc, (20111115), pages 1 - 2, BUSINESS WIRE) --Gilead Sciences, Inc, URL: https://gilead2019tf.q4web.com/files/doc_news/archive/1a1600f5-9b89-4cf4-9b9c-bdd96e52ac1e.pdf, (20201102), XP055745967-
OPPOSITION- Anonymous, "Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF", Bussinesswire, (20150701), pages 1 - 3, XP055745978-
OPPOSITION- Anonymous, "Guidance on the establishment of new INN stems", World Health Organization, (20170611), pages 1 - 2, World Health Organization, URL: https://www.who.int/medicines/services/inn/stems_policy_explanation.pdf?ua=1, (20201102), XP055745990-
OPPOSITION- ANONYMOUS, "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO Drug Information, (20150700), vol. 29, no. 2, pages 195 - 301-
OPPOSITION- Anonymous, "Pre-stems: Suffixes used in the selection of INN", World Health Organization, (20120101), pages 1 - 5, World Health Organization, URL: http://158.232.12.119/medicines/services/inn/2-Prestem_June2012.pdf, (20201102), XP055745994-
OPPOSITION- Anonymous, "Pre-stems*: Suffixes used in the selection of INN", World Health Organization, (20150101), pages 1 - 6, World Health Organization, URL: https://www.who.int/medicines/services/inn/Prestem_Suffixes_201411.pdf, (20201102), XP055745995-
OPPOSITION- Anonymous, "statement on a nonproprietary name adopted by the usan council USAN (DE-56)", statement on a nonproprietary name adopted by the usan council, (20160224), page 1, statement on a nonproprietary name adopted by the usan council, URL: https://searchusan.ama-assn.org/usan/documentDownload?uri=/unstructured/binary/usan/bictegravir.pdf, (20201105), XP055747287-
OPPOSITION- Anonymous, "Summary of recommendations", British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2015, (20150901), pages 12 - 14, XP055745970-
OPPOSITION- Anonymous, "The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances", World Health Organization, (20130000), pages 1 - 192-
OPPOSITION- Anonymous, "U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection | Business Wire", Bussinesswire, (20150101), pages 1 - 6, Bussinesswire, URL: https://www.businesswire.com/news/home/20151105006409/en/U.S.-Food-and-Drug-Administration-Approves-Gilead’s-Single-Tablet-Regimen-Genvoya®-Elvitegravir-Cobicistat-Emtricitabine-and-Tenofovir-Alafenamide-for-Treatment-of-HIV-1-Infection, (20201102), XP055745974-
OPPOSITION- Anonymous, "Viread tenofovir disoproxil", European medicines Agency, (20020205), page 1, XP055747023-
OPPOSITION- Bhavik M Shah, "Dolutegravir: A New Integrase Strand Transfer Inhibitor for the Treatment of HIV", Pharmacotherapy, (20140101), vol. 34, no. 5, pages 506 - 520, XP055746003-
OPPOSITION- City Anonymous, "U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead's Third TAF-Based HIV Therapy 2:58 PM ET - Fixed-Dose Combination HIV Treatment Backbone Can Be Paired with Range of Third Agents", Bussinesswire, Gilead Sciences, Inc, (20160404), pages 1 - 4, Bussinesswire, URL: https://gilead2019tf.q4web.com/files/doc_news/archive/39315687-edca-49e6-807b-8426bcffab30.pdf, (20201102), XP055745979-
OPPOSITION- CLAYDEN et al., "2015 Pipeline Report", Pipeline Report, HCV, HCV, TB, (20150700), pages 1 - 183-
OPPOSITION- Margaret Patrick, "Analyzing Gilead Sciences’ Research and Development in 3Q15", Press Release, (20151023), pages 1 - 5, Press Release, URL: https://finance.yahoo.com/news/analyzing-gilead-sciences-research-development-210726557.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAAqttRcE9ZyMd7HDk9-rfC7X48bmZx-0j61qKl36sASQy8mag0n9qRF9FLXz4cLHQZRAi044iT6IurhpbhNPOeYM2zDempR7zTfkh1FVGMaQpxrb3lvDplxPir4H0BvGXEDsYeBAjf1AlatefLpzlZ-V1VcMufsRwUD8Za8fmd6f, (20201105), XP055747281-
OPPOSITION- M E Aulton, "Tablets and Compaction", Pharmaceutics: The Science of Dosage Form Design, (20020101), pages 411 - 412, XP055745985-
OPPOSITION- P. SHENDE et al., "Multi-layer Tablet: Current scenario and recent advances", International Journal of Drug Delivery, (20120000), vol. 4, pages 418 - 426, XP055702034-
OPPOSITION- Rima Kulkarni, Rebecca Hluhanich, Damian M. Mccoll, Michael D. Miller, Kirsten L. White, "ABSTRACT", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, American Society for Microbiology, US, US, (20141001), vol. 58, no. 10, doi:10.1128/AAC.03591-14, ISSN 0066-4804, pages 6145 - 6150, XP055747028
OPPOSITION- YOSHINAGA et al., "Antiviral Characteristics of GSK1265744, an HIV Integrase Inhibitor Dosed Orally or by Long-Acting Injection", Antimicrobial Agents and Chemotherapy, (20150100), vol. 51, no. 1, doi:10.1128/AAC.03909-14, pages 397 - 406, XP055437856
OPPOSITION- Tae Eun Park, Et Al, "Review of integrase strand transfer inhibitors for the treatment of human immunodeficiency virus infection", Expert Review of Anti-infective Therapy, (20150101), pages 1195 - 1212, XP055745999

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Dossier Documents

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