The patent has been granted The patent has been granted, Grant of patent is intended, Examination is in progress, Request for examination was made, The application has been published EP Register Verified

NUCLEIC ACID VACCINES

Publication No. EP3981437

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App No. EP21191353

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Filed by ModernaTX, Inc.

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Filed on 2015-04-23

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Issued/Published on 2024-10-09

Official EPO Register

Publication No. EP3981437 A1

Application No. EP21191353 Filed: 2015-04-23

Grant Date 2024-10-09 Mention of grant

Active Oppositions 4 Active EPO Oppositions

Patent Abstract / Summary

The invention relates to compositions and methods for the preparation, manufacture and therapeutic use ribonucleic acid vaccines (NAVs) comprising polynucleotide molecules encoding one or more antigens.

IPC Classifications

A61K48/00, A61K39/00, A61K31/7105, A61K9/16

Priority Claims

US 201461983250P Date: 2014-04-23

US 201462088994P Date: 2014-12-08

Designated Contracting States (38 EPC States)

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

Parties & Representation

Applicants

ModernaTX, Inc.

325 Binney Street, Cambridge, MA 02142

Inventors (3)

CIARAMELLA, Giuseppe

Sudbury, MA 01776

BOUCHON, Axel

14532 Kleinmachnow

HUANG, Eric, Yi-Chun

Boston, MA 02118

Representatives / Agents

Hoffmann Eitle

Patent- und Rechtsanwälte PartmbB, Arabellastraße 30

Miller, David James, et al

Mathys & Squire The Shard, 32 London Bridge Street

Carpmaels & Ransford LLP

One Southampton Row, London WC1B 5HA

Pfizer

European Patent Department, 23-25 avenue du Docteur Lannelongue

Wilk, Thomas

ZSP Patentanwälte PartG mbB, Hansastraße 32

Tombling, Adrian George

Withers & Rogers LLP, 2 London Bridge

Key Procedural Dates

Request-For-Examination 2022-10-13

First-Examination-Report-Despatched 2023-03-03

Patent Oppositions

Official opposition proceedings filed against European Patent EP3981437 under EPC Article 99.

4 ACTIVE OPPONENTS

Opponent Company

SANOFI

46 avenue de la Grande Armeé, FR

Representative

Carpmaels & Ransford LLP

Filing Date

2025-03-03

Opposition in Progress

Opponent Company

Pfizer Inc.

66 Hudson Boulevard East, US

Representative

Pfizer

Filing Date

2025-07-04

Opposition in Progress

Opponent Company

BioNTech SE

An der Goldgrube 12, DE

Representative

Wilk, Thomas

Filing Date

2025-07-09

Opposition in Progress

Opponent Company

Withers & Rogers LLP

2 London Bridge, GB

Representative

Tombling, Adrian George

Filing Date

2025-07-09

Opposition in Progress

Legal Status & Event History

Official European Patent Office legal and procedural status changes recorded for this file.

79 Events Recorded

Date	Code	Event Description	Auth
2022-04-13	AC	DIVISIONAL APPLICATION: REFERENCE TO EARLIER APPLICATION	EP
2022-04-13	AK	DESIGNATED CONTRACTING STATES	EP
2022-03-11	PUAI	PUBLIC REFERENCE MADE UNDER ARTICLE 153(3) EPC TO A PUBLISHED INTERNATIONAL APPLICATION THAT HAS ENTERED THE EUROPEAN PHASE	EP
2022-03-11	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
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2022-11-16	17P	REQUEST FOR EXAMINATION FILED	EP
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2023-03-03	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2023-04-05	17Q	FIRST EXAMINATION REPORT DESPATCHED	EP
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2024-07-17	RAP3	PARTY DATA CHANGED (APPLICANT DATA CHANGED OR RIGHTS OF AN APPLICATION TRANSFERRED)	EP
2024-08-21	GRAP	DESPATCH OF COMMUNICATION OF INTENTION TO GRANT A PATENT	EP
2024-08-21	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2024-08-31	GRAS	GRANT FEE PAID	EP
2024-09-06	GRAA	(EXPECTED) GRANT	EP
2024-09-06	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2024-09-25	INTG	INTENTION TO GRANT ANNOUNCED	EP
2024-10-09	AC	DIVISIONAL APPLICATION: REFERENCE TO EARLIER APPLICATION	EP
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2024-10-15	REG	REFERENCE TO A NATIONAL CODE	EP
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2026-05-01	REG	REFERENCE TO A NATIONAL CODE	EP
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- D36 - ODs decision of 03.02.2025 on parent case (15783606.5)

- D37 - MR from parent case

- GEALL ANDREW J.; MANDL CHRISTIAN W.; ULMER JEFFREY B.: "RNA: The new revolution in nucleic acid vaccines", SEMINARS IN IMMUNOLOGY, W.B. SAUNDERS COMPANY, PA., US, vol. 25, no. 2, 1 January 1900 (1900-01-01), US , pages 152 - 159, XP028694558, ISSN: 1044-5323, DOI: 10.1016/j.smim.2013.05.001

- ALICIA RODRIGUEZ-GASCON, ANA DEL POZO-RODRÍGUEZ, MARÍA ANGELES SOLINÍS: "Development of nucleic acid vaccines: use of self-amplifying RNA in lipid nanoparticles", INTERNATIONAL JOURNAL OF NANOMEDICINE, DOVE MEDICAL PRESS, 1 April 2014 (2014-04-01), pages 1833, XP055200967, ISSN: 11769114, DOI: 10.2147/IJN.S39810

- D47 - Recoding of a change for WO 2013/151663

- D48 - Form 1200 filed for the parent patent

- BATTAGLIA LUIGI, GALLARATE MARINA: "Lipid nanoparticles: state of the art, new preparation methods and challenges in drug delivery", EXPERT OPINION ON DRUG DELIVERY, INFORMA HEALTHCARE, GB, vol. 9, no. 5, 1 May 2012 (2012-05-01), GB , pages 497 - 508, XP093296575, ISSN: 1742-5247, DOI: 10.1517/17425247.2012.673278

- GREGORY ANTHONY E., TITBALL RICHARD, WILLIAMSON DIANE: "Vaccine delivery using nanoparticles", FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY, vol. 3, XP093042960, DOI: 10.3389/fcimb.2013.00013

- LONEZ, BESSODES, SCHERMAN, VANDENBRANDEN, ESCRIOU, RUYSSCHAERT: "Cationic lipid nanocarriers activate Toll-like receptor 2 and NLRP3 inflammasome pathways", NANOMEDICINE: NANOTECHNOLOGY, BIOLOGY, AND MEDICINE, ELSEVIER, AMSTERDAM, NL, vol. 10, no. 4, 1 May 2014 (2014-05-01), AMSTERDAM, NL, pages 775 - 782, XP093296573, ISSN: 1549-9634, DOI: 10.1016/j.nano.2013.12.003

- ANDRIES OLIWIA; FILETTE MARINA DE; DE SMEDT STEFAAN C.; DEMEESTER JO; POUCKE MARIO VAN; PEELMAN LUC; SANDERS NIEK N.: "Innate immune response and programmed cell death following carrier-mediated delivery of unmodified mRNA to respiratory cells", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, NL, vol. 167, no. 2, 8 February 2013 (2013-02-08), NL , pages 157 - 166, XP028525413, ISSN: 0168-3659, DOI: 10.1016/j.jconrel.2013.01.033

- SHIZUO AKIRA (EDITOR), KEN J. ISHII (EDITOR): "Nucleic Acids in Innate Immunity", 1 January 2008, CRC PRESS-TAYLOR & FRANCIS GROUP , 6000 BROKEN SOUND PARKWAY NW, STE 300, BOCA RATON, FL 33487-2742 USA , ISBN: 978-1-4200-6825-2, article KATALIN KARIKO, DREW WEISSMAN: "Chapter 13: Impacts of Nucleoside Modification on RNA-Mediated Activation of Toll Like Receptor", pages: 179 - 188, XP009562574

- PASCOLO STEVE: "The messenger's great message for vaccination", EXPERT REVIEW OF VACCINES, FUTURE DRUGS, LONDON, GB, vol. 14, no. 2, 1 February 2015 (2015-02-01), GB , pages 153 - 156, XP093296528, ISSN: 1476-0584, DOI: 10.1586/14760584.2015.1000871

- KATHERINE HOUSER, KANTA SUBBARAO: "Influenza Vaccines: Challenges and Solutions", CELL HOST & MICROBE, ELSEVIER, NL, vol. 17, no. 3, 1 March 2015 (2015-03-01), NL , pages 295 - 300, XP055572607, ISSN: 1931-3128, DOI: 10.1016/j.chom.2015.02.012

- GROHSKOPF LISA A, SHAY DAVID K, SHIMABUKURO TOM T, SOKOLOW LESLIE Z, KEITEL WENDY A, BRESEE JOSEPH S, COX NANCY J: " Prevention and Control of Seasonal Influenza with Vaccines Recommendations of the Advisory Committee on Immunization Practices — United States, 2013-2014", CENTERS FOR DISEASE CONTROL AND PREVENTION, MORBIDITY AND MORTALITY WEEKLY REPORT, RECOMMENDATIONS AND REPORTS, vol. 62, no. 7, 20 September 2013 (2013-09-20), XP093296611

- WANG, K. HOLTZ, K.M. ANDERSON, K. CHUBET, R. MAHMOUD, W. COX, M.M.J.: "Expression and purification of an influenza hemagglutinin-one step closer to a recombinant protein-based influenza vaccine", VACCINE, ELSEVIER, AMSTERDAM, NL, vol. 24, no. 12, 15 March 2006 (2006-03-15), AMSTERDAM, NL , pages 2176 - 2185, XP005298860, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2005.11.005

- JUINE-RUEY CHEN; CHE MA; CHI-HUEY WONG;: "Vaccine design of hemagglutinin glycoprotein against influenza", TRENDS IN BIOTECHNOLOGY., ELSEVIER PUBLICATIONS, CAMBRIDGE., GB, vol. 29, no. 9, GB , pages 426 - 434, XP028383329, ISSN: 0167-7799, DOI: 10.1016/j.tibtech.2011.04.007

- ELLEBEDY, A.H. ; WEBBY, R.J.: "Influenza vaccines", VACCINE, ELSEVIER, AMSTERDAM, NL, vol. 27, 5 November 2009 (2009-11-05), AMSTERDAM, NL , pages D65 - D68, XP026694007, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2009.08.038

- ANONYMOUS: "U.S. FDA Approves Flublok®, the World's First Recombinant, Highly Purified, Egg-Free Influenza Vaccine", PRNEWSWIRE ARTICLE, 16 January 2013 (2013-01-16), XP093296613, Retrieved from the Internet <URL:https://www.prnewswire.com/news-releases/us-fda-approves-flublok-the-worlds-first-recombinant-highly-purified-egg-free-influenza-vaccine-187206411.html>

- D67 - Patentee’s reply to the oppositions of EP313413131

- D68 - PCT request Form 101 for WO 2013/151663

- D70 - OD decision following opposition proceedings on EP 3 134 131

- PARDI NORBERT, KARIKO KATALIN, HOGAN MICHAEL, MUR- AMATSU HIROMI, HOXIE JAMES A, WEISSMAN DREW, PATIL SHILPA, GADHE SHARDA, SONAWA: "P41.25 Generating an Anti-HIV Vaccine Using Nucleosidemodified mRNA Encoding Envelope", AIDS RESEARCH AND HUMAN RETROVIRUS, pages A249, XP093296615, Retrieved from the Internet <URL:https://www.liebertpub.com/doi/epub/10.1089/aid.2014.5554.abstract> DOI: 10.1089/aid.2014 5554 abstrac

- ANONYMOUS: "Moderna Launches New Venture Valera LLC for Infectious Diseases", MODERNA, 8 January 2015 (2015-01-08), XP093296618, Retrieved from the Internet <URL:https://s29.q4cdn.com/435878511/files/doc_news/2015/01/08/moderna-launches-new-venture-valera-llc-infectious-diseases.pdf>

- DE KOKER STEFAAN: "Type IIFN and mRNA vaccines: an unusual suspect", UNIVERSITEIT GENT, 1 January 2013 (2013-01-01), XP093296619

- D81 - Excerpt from 1st International mRNA Health Conference flyer

- ANONYMOUS: "Flublok (Influenza Vaccine) Sterile Solution for Intramuscular Injection - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, 1 December 2012 (2012-12-01), XP093296621

- BONILLA, F.A. ; OETTGEN, H.C.: "Adaptive immunity", JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 125, no. 2, 1 February 2010 (2010-02-01), AMSTERDAM, NL , pages S33 - S40, XP026914333, ISSN: 0091-6749, DOI: 10.1016/j.jaci.2009.09.017

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CA	CA2946751A1	A1	2015-10-29	Espacenet
CA	CA3177878A1	A1	2015-10-29	Espacenet
CN	CN106659803A	A	2017-05-10	Espacenet
CY	CY1125084T1	T1	2024-02-16	Espacenet
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DK	DK3981437T3	T3	2025-01-13	Espacenet
DK	DK4023249T3	T3	2025-01-13	Espacenet
EP	EP3134131A1	A1	2017-03-01	Espacenet
EP	EP3134131A4	A4	2018-06-13	Espacenet
EP	EP3134131B1	B1	2021-12-22	Espacenet
EP	EP4023249A1	A1	2022-07-06	Espacenet
EP	EP4023249B1	B1	2024-10-09	Espacenet
EP	EP4501318A2	A2	2025-02-05	Espacenet
EP	EP4501318A3	A3	2025-05-14	Espacenet
EP	EP4785930A2	A2	2026-08-05	Espacenet
ES	ES2909180T3	T3	2022-05-05	Espacenet
ES	ES3003986T3	T3	2025-03-11	Espacenet
ES	ES3009962T3	T3	2025-03-31	Espacenet
FI	FI3981437T3	T3	2025-01-10	Espacenet
FI	FI4023249T3	T3	2025-01-09	Espacenet
HR	HRP20220070T1	T1	2022-04-01	Espacenet
HR	HRP20241732T1	T1	2025-02-28	Espacenet
HR	HRP20241733T1	T1	2025-02-28	Espacenet
HU	HUE057800T2	T2	2022-06-28	Espacenet
HU	HUE069770T2	T2	2025-04-28	Espacenet
HU	HUE069802T2	T2	2025-04-28	Espacenet
JP	JP2017513956A	A	2017-06-01	Espacenet
JP	JP6881813B2	B2	2021-06-02	Espacenet
JP	JP2021091689A	A	2021-06-17	Espacenet
JP	JP7504464B2	B2	2024-06-24	Espacenet
JP	JP2024071384A	A	2024-05-24	Espacenet
LT	LT3134131T	T	2022-02-10	Espacenet
LT	LT3981437T	T	2025-01-10	Espacenet
LT	LT4023249T	T	2025-01-10	Espacenet
MA	MA39900A	A	2017-03-01	Espacenet
MA	MA39900B1	B1	2022-01-31	Espacenet
MA	MA58292B1	B1	2025-01-31	Espacenet
MA	MA59052B1	B1	2025-01-31	Espacenet
PL	PL3134131T3	T3	2022-04-11	Espacenet
PL	PL3981437T3	T3	2025-02-24	Espacenet
PL	PL4023249T3	T3	2025-03-10	Espacenet
PT	PT3134131T	T	2022-03-24	Espacenet
PT	PT3981437T	T	2025-01-15	Espacenet
PT	PT4023249T	T	2025-01-14	Espacenet
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Complete European Patent Register Dossier (148 Total Documents)

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European Patent Specification - Granted Patent (B1)

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Pfizer Inc.

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