| EP3264094 - METHODS FOR EVALUATING AN IMMUNE RESPONSE TO A THERAPEUTIC AGENT [Right-click to bookmark this link] | Status | Patent revoked Status updated on 20.12.2025 Database last updated on 31.03.2026 | |
| Former | The patent has been granted Status updated on 17.07.2020 | ||
| Former | Grant of patent is intended Status updated on 15.03.2020 | ||
| Former | Examination is in progress Status updated on 07.09.2018 | ||
| Former | Request for examination was made Status updated on 06.07.2018 | ||
| Former | The application has been published Status updated on 01.12.2017 | Most recent event Tooltip | 16.01.2026 | Lapse of the patent in a contracting state | published on 18.02.2026 [2026/08] | Applicant(s) | For all designated states Biogen MA Inc. 225 Binney Street Cambridge, MA 02142 / US | [2018/01] | Inventor(s) | 01 /
Subramanyam, Meena 3 Corey Avenue Stoneham, MA 02180 / US | 02 /
Amaravadi, Lakshmi 189 South Main Street Natick, MA 01760 / US | 03 /
Wakshull, Eric 13 Whittaker Lane Princeton, MA 01541 / US | 04 /
Lynn, Frances 44 Albert Road Windsor, SL4 5BU / GB | 05 /
Panzara, Michael 73 Bacon Street Winchester, MA 01890 / US | 06 /
Barbour, Robin McDaid 250 Normandy Lane Walnut Creek, CA 94598 / US | 07 /
Taylor, Julie Elizabeth 1506 7th Avenue San Francisco, CA 94122 / US | [2018/01] | Representative(s) | Pohlman, Sandra M. df-mp Patentanwälte Rechtsanwälte PartG mbB Theatinerstraße 16 80333 München / DE | [N/P] |
| Former [2018/01] | Pohlman, Sandra M. df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte PartG mbB Theatinerstrasse 16 80333 München / DE | Application number, filing date | 17174144.0 | 04.04.2006 | [2018/01] | Priority number, date | US20050668404P | 04.04.2005 Original published format: US 668404 P | [2018/01] | Filing language | EN | Procedural language | EN | Publication | Type: | A1 Application with search report | No.: | EP3264094 | Date: | 03.01.2018 | Language: | EN | [2018/01] | Type: | B1 Patent specification | No.: | EP3264094 | Date: | 19.08.2020 | Language: | EN | [2020/34] | Search report(s) | (Supplementary) European search report - dispatched on: | EP | 01.12.2017 | Classification | IPC: | G01N33/68 | [2018/01] | CPC: |
G01N33/686 (EP,US);
G01N33/6854 (US);
A61P1/00 (EP);
A61P13/12 (EP);
A61P17/00 (EP);
A61P19/02 (EP);
A61P25/00 (EP);
A61P29/00 (EP);
A61P35/00 (EP);
A61P35/02 (EP);
A61P37/00 (EP);
A61P37/02 (EP);
A61P37/06 (EP);
C07K16/2839 (US);
G01N2333/70546 (EP,US);
G01N2800/065 (EP,US);
G01N2800/102 (EP,US);
G01N2800/285 (EP,US);
G01N2800/52 (US)
(-)
| Designated contracting states | AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LI, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR [2018/32] |
| Former [2018/01] | AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LI, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR | Extension states | AL | 03.07.2018 | BA | 03.07.2018 | HR | 03.07.2018 | MK | 03.07.2018 | YU | 03.07.2018 | Title | German: | VERFAHREN ZUR BEWERTUNG EINER IMMUNREAKTION AUF EIN THERAPEUTISCHES MITTEL | [2018/01] | English: | METHODS FOR EVALUATING AN IMMUNE RESPONSE TO A THERAPEUTIC AGENT | [2018/01] | French: | PROCÉDÉS POUR ÉVALUER UNE RÉPONSE IMMUNITAIRE À UN AGENT THÉRAPEUTIQUE | [2018/01] | Examination procedure | 02.06.2017 | Date on which the examining division has become responsible | 03.07.2018 | Amendment by applicant (claims and/or description) | 03.07.2018 | Examination requested [2018/32] | 07.09.2018 | Despatch of a communication from the examining division (Time limit: M04) | 14.01.2019 | Reply to a communication from the examining division | 17.02.2020 | Cancellation of oral proceeding that was planned for 04.03.2020 | 04.03.2020 | Date of oral proceedings (cancelled) | 16.03.2020 | Communication of intention to grant the patent | 10.07.2020 | Fee for grant paid | 10.07.2020 | Fee for publishing/printing paid | 10.07.2020 | Receipt of the translation of the claim(s) | Parent application(s) Tooltip | EP06749243.9 / EP1872136 | EP13158951.7 / EP2645106 | Divisional application(s) | EP20191086.6 / EP3796003 | Opposition(s) | Opponent(s) | 01
18.05.2021
26.05.2021
ADMISSIBLE Polpharma Biologics S.A. Ul. Trzy Lipy 3 80-172 Gdansk / PL Opponent's representative Wichmann, Hendrik Wuesthoff & Wuesthoff Patentanwälte und Rechtsanwalt PartG mbB Schweigerstraße 2 81541 München / DE | [2024/15] |
| Former [2021/25] | |||
| Opponent(s) | 01
18.05.2021
Polpharma Biologics S.A. Ul. Trzy Lipy 3 80-172 Gdansk / PL Opponent's representative Wichmann, Hendrik Wuesthoff & Wuesthoff Patentanwälte PartG mbB Schweigerstraße 2 DE-81541 München / DE | 04.06.2021 | Invitation to proprietor to file observations on the notice of opposition | 13.10.2021 | Reply of patent proprietor to notice(s) of opposition | 25.04.2023 | Date of oral proceedings | 22.05.2023 | Despatch of interlocutory decision in opposition | 22.05.2023 | Despatch of minutes of oral proceedings | 19.12.2025 | Legal effect of revocation of patent [2026/05] | 19.12.2025 | Despatch of communication that the patent will be revoked | Appeal following opposition | 06.07.2023 | Appeal received No. T1253/23 | 06.07.2023 | Payment of appeal fee | 02.10.2023 | Statement of grounds filed | 16.12.2025 | Result of appeal procedure: revocation of the patent | 19.12.2025 | Despatch of the decision of the Board of Appeal | 26.07.2023 | Appeal received No. T1253/23 | 26.07.2023 | Payment of appeal fee | 29.09.2023 | Statement of grounds filed | 16.12.2025 | Result of appeal procedure: revocation of the patent | 19.12.2025 | Despatch of the decision of the Board of Appeal | Fees paid | Renewal fee | 02.06.2017 | Renewal fee patent year 03 | 02.06.2017 | Renewal fee patent year 04 | 02.06.2017 | Renewal fee patent year 05 | 02.06.2017 | Renewal fee patent year 06 | 02.06.2017 | Renewal fee patent year 07 | 02.06.2017 | Renewal fee patent year 08 | 02.06.2017 | Renewal fee patent year 09 | 02.06.2017 | Renewal fee patent year 10 | 02.06.2017 | Renewal fee patent year 11 | 02.06.2017 | Renewal fee patent year 12 | 25.04.2018 | Renewal fee patent year 13 | 30.04.2019 | Renewal fee patent year 14 | 31.03.2020 | Renewal fee patent year 15 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Lapses during opposition Tooltip | FR | 30.04.2025 | [2026/08] | Documents cited: | Search | [Y] WO03016909 (LUDWIG INST CANCER RES et al.) | [I] DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; April 2004 (2004-04-01), SANDS BRUCE E ET AL: "Safety and tolerability of natalizumab in patients concurrently receiving infliximab in a phase 2 study of active Crohn's disease", XP002401100, Database accession no. PREV200600085330 | [I] GASTROENTEROLOGY, vol. 126, no. 4, Suppl. 2, April 2004 (2004-04-01), DIGESTIVE DISEASE WEEK/105TH ANNUAL MEETING OF THE AMERICAN-GASTROENTEROLOGICAL-ASSOCIATION; NEW ORLEANS, LA, USA; MAY 16 20, 2004, pages A463, ISSN: 0016-5085 | [X] CALABRESI PETER A ET AL: "Safety and tolerability of natalizumab: Results from the SENTINEL trial", NEUROLOGY, vol. 64, no. 6, Suppl. 1, March 2005 (2005-03-01), & 57TH ANNUAL MEETING OF THE AMERICAN-ACADEMY-OF-NEUROLOGY; MIAMI BEACH, FL, USA; APRIL 09 -19, 2005, pages A277, XP009073089, ISSN: 0028-3878 | [I] ENNS R ET AL: "Enact-2 safety, tolerability, and immunogenicity results of natalizumab in patients with Crohn's disease", AMERICAN JOURNAL OF GASTROENTEROLOGY, vol. 99, no. 10, Suppl. S, October 2004 (2004-10-01), & 69TH ANNUAL MEETING OF THE AMERICAN-COLLEGE-OF-GASTROENTEROLOGY; ORLANDO, FL, USA; OCTOBER 29 -NOVEMBER 03, 2004, pages S269, XP009073091, ISSN: 0002-9270 | [Y] BAERT F ET AL: "INFLUENCE OF IMMUNOGENICITY ON THE LONG-TERM EFFICACY OF INFLIXIMAB IN CROHN'S DISEASE", NEW ENGLAND JOURNAL OF MEDICINE, MASSACHUSETTS MEDICAL SOCIETY, BOSTON, MA, US, vol. 348, no. 7, 13 February 2003 (2003-02-13), pages 601 - 608, XP009037271, ISSN: 1533-4406 DOI: http://dx.doi.org/10.1056/NEJMoa020888 | [Y] ROSKOS L K ET AL: "HUMAN ANTIGLOBULIN RESPONSES", MEASURING IMMUNITY, ELSEVIER,, NL, December 2004 (2004-12-01), pages 172 - 186, XP008058931 | by applicant | US5840299 | US6602503 | US5888507 | US2003070185 | US5789650 | WO9634096 | EP0239400 | US5693761 | US6407213 | WO9007861 | US5693762 | US5585089 | US5530101 | US5798230 | US2003232333 | US4399216 | US4634665 | US5179017 | US5648260 | US5849992 | US3817837 | US3850752 | US3939350 | US3996345 | US4277437 | US4275149 | US4366241 | US4472509 | US4938948 | SHEREMATA ET AL., NEUROLOGY, vol. 52, 1999, pages 1072 - 1074 | SHEREMATA ET AL., NEUROLOGY, vol. 52, 1999, pages 1072 | SANCHEZ-MADRID ET AL., EUR. J. IMMUNOL., vol. 16, 1986, pages 1343 - 1349 | HEMLER ET AL., J. BIOL. CHEM., vol. 2, 1987, pages 11478 - 11485 | ISSEKUTZ; WYKRETOWICZ, J. IMMUNOL., vol. 147, 1991, pages 109 | PULIDO ET AL., J. BIOL. CHEM., vol. 266, no. 16, 1991, pages 10241 - 10245 | "Molecular Cloning: A Laboratory Manual", 1989, COLD SPRING HARBOR LABORATORY PRESS | "Current Protocols in Molecular Biology", JOHN WILEY & SONS, INC. | "Current Protocols in Molecular Biology", 1989, JOHN WILEY & SONS, pages: 6.3.1 - 6.3.6 | GREEN ET AL., NATURE GENETICS, vol. 7, 1994, pages 13 - 21 | RIECHMANN ET AL., NATURE, vol. 332, 1988, pages 323 - 327 | VERHOEYEN ET AL., SCIENCE, vol. 239, 1988, pages 1534 - 1536 | QUEEN ET AL., PROC NATL ACAD SCI USA., vol. 86, no. 24, December 1989 (1989-12-01), pages 10029 - 10033 | TEMPEST ET AL., BIOTECHNOLOGY, vol. 9, 1991, pages 266 - 271 | BOERNER ET AL., J. IMMUNOL., vol. 147, 1991, pages 86 - 95 | PERSSON ET AL., PROC. NAT. ACAD. SCI. 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REV., vol. 163, 1998, pages 59 - 76 | Opposition | US66840405 | EP17174144 | WO2006107962 | WO2007103112 | "FDA grants accelerated approval of TYSABRI, formerly antegren, for the treatment of MS", EUREKALERT, 23 November 2004 (2004-11-23), XP055809841 | MIRE-SLUIS ET AL.: "Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products", JOURNAL OF IMMUNOLOGICAL METHODS, vol. 289, 2004, pages 1 - 16, XP004520874 DOI: http://dx.doi.org/10.1016/j.jim.2004.06.002 | KUUS-REICHEL ET AL.: "Will immunogenicity limit the Use, Efficacy and the Future Development of therapeutic monoclonal Antibodies?", CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 1994, pages 365 - 372, XP055809845 | ROSKOS ET AL.: "Measuring Immunity, Lotze & Thomson", 2004, ISBN: 0-12-455900-X, article "HUMAN ANTIGLOBULIN RESPONSES", XP008058931 | TUBRIDY ET AL.: "The effect of anti-alpha4 integrin antibody on brain lesion activity in MS", AMERICAN ACADEMY OF NEUROLOGY, 1999, XP008050557 | NOSEWORTHY ET AL.: "Natalizumab", NATURE REVIEWS DRUG DISCOVERY, vol. 4, February 2005 (2005-02-01), pages 101 - 102, XP009123651, DOI: 10.1038/nrd1637 DOI: http://dx.doi.org/10.1038/nrd1637 | "Natalizumab", NATURE REVIEW, vol. 4, 2005, pages 101 - 102, XP009123651 DOI: http://dx.doi.org/10.1038/nrd1637 | CALABRESI ET AL., NEUROLOGY, vol. 64, no. 1, March 2005 (2005-03-01) | CALABRESI ET AL.: "The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL", NEUROLOGY, vol. 69, 2007, pages 1391 - 1403, XP002694856 DOI: http://dx.doi.org/10.1212/01.wnl.0000277457.17420.b5 | SUBRAMANYAM M: "Case Study: Immunogenicity of Natalizumab", BIOTECHNOLOGY: PHARMACEUTICAL ASPECTS, 2008, pages 173 - 187, XP055476763 | SHEREMATA ET AL.: "A Safety and Pharmacokinetic Study of Intravenous Natalizumab in Patients with MS", NEUROLOGY, vol. 52, 1999, pages 1072 - 1074, XP002997442 | "Antibody product catalogue", MAINE BIOTECHNOLOGY SERVICES INC., 2015, XP055476851 | RISPENS ET AL.: "Measurement of serum levels of natalizumab, an immunoglobulin G4 therapeutic monoclonal antibody", ANAL. BIOCHEM., vol. 411, 2011, pages 271 - 276, XP028171776 DOI: http://dx.doi.org/10.1016/j.ab.2011.01.001 | ANONYMOUS: "TYSABRI (natalizumab) DESCRIPTION", FDA, 8 March 2005 (2005-03-08), pages 1 - 11, XP093039260 |