Subcutaneous Anti-Her2 Antibody Formulation - EP2687202

The patent EP2687202 was granted to F Hoffmann LA Roche on May 10, 2023. The application was originally filed on Jul 28, 2010 under application number EP13166031A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2687202

F HOFFMANN LA ROCHE
Application Number
EP13166031A
Filing Date
Jul 28, 2010
Status
Granted And Under Opposition
Apr 7, 2023
Publication Date
May 10, 2023
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions

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

Get instant alerts for new oppositions and patent status changes

ACCORD HEALTHCAREFeb 12, 2024BRAND MURRAY FULLERWITHDRAWN

Patent Citations (55) New

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

Citation PhasePublication Number
DESCRIPTIONEP0590058
DESCRIPTIONEP0659439
DESCRIPTIONUS4816567
DESCRIPTIONUS4933294
DESCRIPTIONUS4943
DESCRIPTIONUS5212290
DESCRIPTIONUS533
DESCRIPTIONUS5401638
DESCRIPTIONUS5677171
DESCRIPTIONUS5783186
DESCRIPTIONUS5804396
DESCRIPTIONUS5821337
DESCRIPTIONUS5891996
DESCRIPTIONUS6267958
DESCRIPTIONUS6685940
DESCRIPTIONUS6821151
DESCRIPTIONUS7060268
DESCRIPTIONWO0100245
DESCRIPTIONWO03037992
DESCRIPTIONWO2004078140
DESCRIPTIONWO2005117986
DESCRIPTIONWO2006044908
DESCRIPTIONWO2006091871
DESCRIPTIONWO2010029054
DESCRIPTIONWO9105264
DESCRIPTIONWO9321319
DESCRIPTIONWO9400136
DESCRIPTIONWO9603397
DESCRIPTIONWO9630347
DESCRIPTIONWO9633978
DESCRIPTIONWO9633980
DESCRIPTIONWO9640210
DESCRIPTIONWO9704801
DESCRIPTIONWO9738983
DESCRIPTIONWO9843960
DESCRIPTIONWO9845479
DESCRIPTIONWO9850433
DESCRIPTIONWO9906378
DESCRIPTIONWO9906396
DESCRIPTIONWO9909016
DESCRIPTIONWO9957134
EXAMINATIONUS2006088523
OPPOSITIONEP2459167
OPPOSITIONEP2687202
OPPOSITIONEP3785701
OPPOSITIONUS2006088523
OPPOSITIONUS2006104968
OPPOSITIONUS2007071675
OPPOSITIONUS6267958
SEARCHUS2002035736
SEARCHUS2006104968
SEARCHUS2007071675
SEARCHUS6267958
SEARCHWO2005023328
SEARCHWO2008150949

Non-Patent Literature (NPL) Citations (111) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
DESCRIPTION- ANGEW, CHEMIE INTL. ED. ENGL., (1994), vol. 33, pages 183 - 186
DESCRIPTION- ARMING ET AL., EUR. J. BIOCHEM., (1997), vol. 247, no. 3, pages 810 - 4
DESCRIPTION- ARTEAGA ET AL., CANCER RES., (1994), vol. 54, pages 3758 - 3765
DESCRIPTION- AUKLAND K.; REED R., "Interstitial-Lymphatic Mechanisms in the control of Extracellular Fluid Volume", PHYSIOLOGY REVIEWS, (1993), vol. 73, pages 1 - 78
DESCRIPTION- BACUS ET AL., CANCER RESEARCH, (1992), vol. 52, pages 2580 - 2589
DESCRIPTION- BACUS ET AL., MOLECULAR CARCINOGENESIS, (1990), vol. 3, pages 350 - 362
DESCRIPTION- BASELGA, J. ET AL., JOURNAL OF CLIN. ONCOL., (2010), vol. 28, no. 7, pages 1138 - 1144
DESCRIPTION- BERTRAND ET AL., INT. J. CANCER, (1992), vol. 52, pages 1 - 6
DESCRIPTION- BYWATERS G.L. ET AL., "Reconstitution of the dermal barrier to dye spread after Hyaluronidase injection", BR. MED. J., (1951), vol. 2, no. 4741, pages 1178 - 1183
DESCRIPTION- CANCER RES., (1991), vol. 51, pages 5361 - 5369
DESCRIPTION- "Cell cycle regulation, oncogenes, and antineoplastic drugs", MURAKAMI ET AL., The Molecular Basis of Cancer, WB SAUNDERS, (1995), page 13
DESCRIPTION- CHAIN E., "A mucolytic enzyme in testes extracts", NATURE, (1939), pages 977 - 978
DESCRIPTION- CHERR ET AL., DEV. BIOL., (19951210), vol. 175, no. 1, pages 142 - 53
DESCRIPTION- CLARKSON ET AL., NATURE, (1991), vol. 352, pages 624 - 628
DESCRIPTION- DANILKOVITCH-MIAGKOVA ET AL., PROC. NATL. ACAD. SCI. U SA, (2003), vol. 100, no. 8, pages 4580 - 4585
DESCRIPTION- DURAN-REYNOLDS F., "A spreading factor in certain snake venoms and its relation to their mode of action", CR SOC BIOL PARIS, (1938), pages 69 - 81
DESCRIPTION- FRANKLIN ET AL., CANCER CELL, (2004), vol. 5, pages 317 - 328
DESCRIPTION- FROST, I.G. ET AL., "Purification, cloning, and expression of human plasma hyaluronidase", BIOCHEM. BIOPHYS. RES. COMMUN., (1997), vol. 236, no. 1, pages 10 - 15
DESCRIPTION- HANCOCK ET AL., CANCER RES., (1991), vol. 51, pages 4575 - 4580
DESCRIPTION- HARRIS, E.N. ET AL., "Endocytic function, glycosaminoglycan specificity, and antibody sensitivity of the recombinant human 190-kDa hyaluronan receptor for endocytosis (HARE", J. BIOL. CHEM., (2004), vol. 279, pages 36201 - 36209
DESCRIPTION- HARWERTH ET AL., J. BIOL. CHEM., (1992), vol. 267, pages 15160 - 15167
DESCRIPTION- JONES, A., ADV. DRUG DELIVERY REV., (1993), vol. 10, pages 29 - 90
DESCRIPTION- JONES ET AL., NATURE, (1986), vol. 321, pages 522 - 525
DESCRIPTION- KASPRZYK ET AL., CANCER RESEARCH, (1992), vol. 52, pages 2771 - 2776
DESCRIPTION- KIESE S. ET AL., J. PHARM. SCI., (2008), vol. 97, no. 10, pages 4347 - 4366
DESCRIPTION- KIMATA ET AL., CANCER RES., (1983), vol. 43, pages 1347 - 1354
DESCRIPTION- KLAPPER ET AL., ONCOGENE, (1997), vol. 14, pages 2099 - 2109
DESCRIPTION- KNUDSON ET AL., FASEB J., (1993), vol. 7, pages 1233 - 1241
DESCRIPTION- KOHLER ET AL., NATURE, (1975), vol. 256, page 495
DESCRIPTION- LALANCETTE ET AL., BIOL. REPROD., (2001), vol. 65, no. 2, pages 628 - 36
DESCRIPTION- LAURENT L.B. ET AL., "Catabolism of hyaluronan in rabbit skin takes place locally, in lymph nodes and liver", EXP. PHYSIOL., (1991), vol. 76, pages 695 - 703
DESCRIPTION- LAURENT T.C. ET AL., FASEB J., (1992), vol. 6, pages 2397 - 2404
DESCRIPTION- LAURENT, T.C.; FRASER, J.R.E., Degradation of Bioactive Substances: Physiology and Pathophysiology, CRC PRESS, (1991), pages 249 - 265
DESCRIPTION- LAURENT, U.B.G.; DAHL, L.B.; REED, R.K., "Catabolism of hyaluronan in rabbit skin takes place locally, in lymph nodes and liver", EXP. PHYSIOL., (1991), vol. 76, pages 695 - 703
DESCRIPTION- MARKS ET AL., J. MOL. BIOL., (1991), vol. 222, pages 581 - 597
DESCRIPTION- MCKENZIE ET AL., ONCOGENE, (1989), vol. 4, pages 543 - 548
DESCRIPTION- MORRISON ET AL., PROC. NATL. ACAD. SCI. USA, (1984), vol. 81, pages 6851 - 6855
DESCRIPTION- OZELLO ET AL., CANCER RES., (1960), vol. 20, pages 600 - 604
DESCRIPTION- Peptide and Protein Drug Delivery, MARCEL DEKKER, INC., (1991), pages 247 - 301
DESCRIPTION- PHELPS ET AL., SCIENCE, (1988), vol. 240, no. 4860, pages 1780 - 1782
DESCRIPTION- PRESTA, CURR. OP. STRUCT. BIOL., (1992), vol. 2, pages 593 - 596
DESCRIPTION- RIECHMANN ET AL., NATURE, (1988), vol. 332, pages 323 - 329
DESCRIPTION- SHAWVER ET AL., CANCER RES., (1994), vol. 54, pages 1367 - 1373
DESCRIPTION- SHIRE, S.J.; SHAHROKH, Z. ET AL., "Challenges in the development of high protein concentration formulations", J. PHARM. SCI., (2004), vol. 93, no. 6, pages 1390 - 1402
DESCRIPTION- SIAS ET AL., J. IMMUNOL. METHODS, (1990), vol. 132, pages 73 - 80
DESCRIPTION- STANCOVSKI ET AL., PNAS (USA, (1991), vol. 88, pages 8691 - 8695
DESCRIPTION- SUPERSAXO, A. ET AL., EFFECT OF MOLECULAR WEIGHT ON THE LYMPHATIC ABSORPTION OF WATER-SOLUBLE COMPOUNDS FOLLOWING SUBCUTANEOUS ADMINISTRATION, (1990), vol. 2, pages 167 - 169
DESCRIPTION- SWARTZ, M. A., ADVANCED DRUG DELIVERY REVIEW, THE PHYSIOLOGY OF THE LYMPHATIC SYSTEM, (2001), vol. 50, pages 3 - 20
DESCRIPTION- TAGLIABUE ET AL., INT. J. CANCER, (1991), vol. 47, pages 933 - 937
DESCRIPTION- TAKEUCHI ET AL., CANCER RES., (1976), vol. 36, pages 2133 - 2139
DESCRIPTION- TAMMI, R.; SAAMANEN, A.M.; MAIBACH, H.I.; TAMMI M., "Degradation of newly synthesized high molecular mass hyaluronan in the epidermal and dermal compartments of human skin in organ culture", J. INVEST. DERMATOL., (1991), vol. 97, pages 126 - 130
DESCRIPTION- TOOLE, Cell Biol. Extracell., PLENUM PRESS, (1991), pages 1384 - 1386
DESCRIPTION- WEISSMANN B., "The transglycosylative action of testicular hyaluronidase", J. BIOL. CHEM., (1955), vol. 216, pages 783 - 94
DESCRIPTION- WEISSMANN, B., "The transglycosylative action of testicular hyaluronidase", J. BIOL. CHEM., (1955), vol. 216, pages 783 - 94
DESCRIPTION- XU ET AL., INT. J. CANCER, (1993), vol. 53, pages 401 - 408
DESCRIPTION- ROSKOS, L.K.; DAVIS C.G. ET AL., "The clinical pharmacology of therapeutic antibodies", DRUG DEVELOPMENT RESEARCH, (2004), vol. 61, no. 3, doi:doi:10.1002/ddr.10346, pages 108 - 120, XP055064561
DESCRIPTION- FROST I.G.; STEM, R., "A microtiter-based assay for hyaluronidase activity not requiring specialized reagents", ANAL. BIOCHEMISTRY, (1997), vol. 251, doi:doi:10.1006/abio.1997.2262, pages 263 - 269, XP002276368
DESCRIPTION- BOOKBINDER L.H. ET AL., "A recombinant human enzyme for enhanced interstitial transport of therapeutics", J. CONTROL. RELEASE, (2006), vol. 114, doi:doi:10.1016/j.jconrel.2006.05.027, pages 230 - 241, XP024957594
DESCRIPTION- NAHTA, R. ET AL., "The HER-2-targeting antibodies Trastuzumab and Pertuzumab synergistically inhibit the survival of breast cancer cells", CANCER RES., (2004), vol. 64, doi:doi:10.1158/0008-5472.CAN-03-3856, pages 2343 - 2346, XP002521223
DESCRIPTION- FROST G.I., "Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration", EXPERT OPINION ON DRUG DELIVERY, (2007), vol. 4, doi:doi:10.1517/17425247.4.4.427, pages 427 - 440, XP008177677
DESCRIPTION- FROST, G.I., "Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration", EXPERT OPINION ON DRUG DELIVERY, (2007), vol. 4, doi:doi:10.1517/17425247.4.4.427, pages 427 - 440, XP008177677
EXAMINATION- SHIRE STEVEN J ET AL, "Challenges in the development of high protein concentration formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, (20040601), vol. 93, no. 6, doi:10.1002/JPS.20079, ISSN 0022-3549, pages 1390 - 1402, XP009108986
EXAMINATION- CHI EVA Y ET AL, "Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation", PHARMACEUTICAL RESEARCH, SPRINGER US, NEW YORK, (20030901), vol. 20, no. 9, doi:10.1023/A:1025771421906, ISSN 0724-8741, pages 1325 - 1336, XP002475010
OPPOSITION- AMBER HAYNES FRADKIN ET AL, "Immunogenicity of aggregates of recombinant human growth hormone in mouse models", JOURNAL OF PHARMACEUTICAL SCIENCES, (20090901), vol. 98, no. 9, pages 3247 - 3264, XP002643588
OPPOSITION- Anonymous, "COMMISSION IMPLEMENTING DECISION of 26.8.2013 amending the marketing authorisation granted by Decision C(2000)2539 for "Herceptin - trastuzumab", a medicinal product for human use ", EUROPEAN COMMISSION, (20130826), XP093234694
OPPOSITION- Anonymous, "Entscheidung der Kommission über die Zulassung des Humanarzneimittels "Herceptin - Trastuzumab"", Kommission der Europäischen Gemeinschaften, (20000828), XP093234559
OPPOSITION- Anonymous, "Halozyme Therapeutics, Inc.'s Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society", BioSpace, (20070709), BioSpace, URL: https://www.biospace.com/halozyme-therapeutics-inc-s-enhanze-technology-large-protein-molecule-therapeutic-clinical-trial-results-presented-at-the-34th-annual-meeting-of-the, XP093234728
OPPOSITION- Anonymous, "Herceptin® 600 mg/5ml lnjektionslösung", (20140201), XP093234684
OPPOSITION- Anonymous, "Herceptin s.c. 120 mg/ml - Safety Data Sheet", Roche, (20130829), Roche, XP093234712
OPPOSITION- Anonymous, "HERCEPTIN® Trastuzumab", FDA, (19980901), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf, XP093234733
OPPOSITION- Anonymous, "HERCEPTIN® Trastuzumab (Original US product labelling)", FDA, (19980901), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf, XP093183950
OPPOSITION- Anonymous, "Home administration of trastuzumab by subcutaneous injection - Information for patients, relatives and carers", NHS; Imperial College Healthcare, (20220601), NHS; Imperial College Healthcare, URL: https://www.imperial.nhs.uk/-/media/website/patient-information-leaflets/cancer-services/chemotherapy/home-administration-of-trastuzumab-by-subcutaneous-injection.pdf, XP093183941
OPPOSITION- D13 - Declaration by Michael Adler dated 17 August 2015, filed in connection with opposition proceedings brought against EP 2 459 167 (Annex K)
OPPOSITION- D39 - Declaration Prof. Frieß including Annexes A and B and Exhibits 1 to 5
OPPOSITION- D40 - Hylenex recombinant (hyaluronidase human injection) Prescribing Information Oct. 2008 (cannot find any date at all in the 6 pages)
OPPOSITION- D52 - Declaration Dr. Ravuri (Raw Data, Declaration of Dr. Adler)
OPPOSITION- D53 - Declaration Dr. Ravuri (Statistical Analysis of the Data contained in the opposed patent)
OPPOSITION- D55 - Declaration Prof. Frijlink
OPPOSITION- D56 - CV Henderik W. Frijlink
OPPOSITION- D61 - Second Declaration of Prof. Frijlink
OPPOSITION- De Catharina, Davies Lange, Erikson Arne, Tufto Ingunn, Berit Bjønnum Anne, Bruland Øyvind S, "The Impact of Enzymatic Degradation on the Uptake of Differently Sized Therapeutic Molecules", ANTICANCER RESEARCH, (20080101), vol. 28, pages 3557 - 3566, XP093234720
OPPOSITION- Ismael Gustavo, Et Al, "Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial ", Lancet, (20120901), vol. 13, pages 869 - 878, XP055878003
OPPOSITION- JC Hooton, N Sandler, "Methionine", JC Hooton, N Sandler, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 436 - 437, ISBN 978-0-85369-792-3, XP009556001
OPPOSITION- RATNER, "Roche plans for more convenient-to-use Herceptin and Rituxan", Nature Biotechnology, (20100400), vol. 28, no. 4, page 298, XP055922613
OPPOSITION- SHEKHAR, "The Matrix Reloaded: Halozyme's Recombinant Enzyme Helps Injected Drugs Spread Faster", Chemistry & Biology, (20070600), vol. 14, pages 603 - 604, XP022120575
OPPOSITION- Viropharma Incorporated, "ViroPharma Provides Update on Phase 2 Clinical Evaluation of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Recombinant Human Hyaluronidase (rHuPH20)", (20120801), pages 1 - 2, URL: http://www.prnewswire.com/news-releases/viropharma-provides-update-on-phase-2-clinical-evaluation-of-subcutaneous-cinryze-c1-esterase-inhibitor-human-with-recombinant-human-hyaluronidase-rhuph20-164636346.html, (20170210), XP055344487
OPPOSITION- Yocum Richard C, Vaughn Daniel E, Mongiovi Deborah J, Prupas Malin, "Clinical Trial of Recombinant Human PH20 Hyaluronidase's Effect on Subcutaneous Absorption and Pharmacokinetics of a Large Protein Molecule Therapeutic", 34th Annual Meeting and Exposition of the Controlled Release Society (Volume 1 of 3), (20070707), vol. 1, ISBN 978-1-60560-035-2, pages 10 - 11, XP093234744
OPPOSITION- Porter Seth, "Human Immune Response to Recombinant Human Proteins", Journal of Pharmaceutical Sciences, Wiley, (20010101), vol. 90, no. 1, doi:10.1002/1520-6017(200101)90:1<1::AID-JPS1>3.0.CO;2-K, ISSN 0022-3549, pages 1 - 11, XP093234654
OPPOSITION- Shire Steven J; Shahrokh Zahra; Liu Jun, "Challenges in the development of high protein concentration formulations", Journal of Pharmaceutical Sciences, Wiley, (20040601), vol. 93, no. 6, doi:10.1002/jps.20079, ISSN 0022-3549, pages 1390 - 1402, XP009108986
OPPOSITION- Carpenter John F., Randolph Theodore W., Jiskoot Wim, Crommelin Daan J.A., Russell Middaugh C., Winter Gerhard, Fan Ying-Xin, Kirshner Susan, Verthelyi Daniela, Kozlowski Steven, Clouse Kathleen A., Swann Patrick G., Rosenberg Amy, Cherney Barry, "Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality", Journal of Pharmaceutical Sciences, Wiley, (20090401), vol. 98, no. 4, doi:10.1002/jps.21530, ISSN 0022-3549, pages 1201 - 1205, XP093234582
OPPOSITION- Peng Aaron, Gaitonde Puneet, Kosloski Matthew P., Miclea Razvan D., Varma Prashant, Balu-Iyer Sathy V., "Effect of Route of Administration of Human Recombinant Factor VIII on Its Immunogenicity in Hemophilia A Mice", Journal of Pharmaceutical Sciences, Wiley, (20091201), vol. 98, no. 12, doi:10.1002/jps.21765, ISSN 0022-3549, pages 4480 - 4484, XP093234717
OPPOSITION- Gligorov J.; Ataseven B.; Verrill M.; De Laurentiis M.; Jung K.H.; Azim H.A.; Al-Sakaff N.; Lauer S.; Shing M.; Pivot X., "Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients", European Journal of Cancer, Elsevier, 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Barcelona, Spain, 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Barcelona, Spain, (20170616), vol. 82, doi:10.1016/j.ejca.2017.05.010, ISSN 0959-8049, pages 237 - 246, XP085149230
OPPOSITION- Mahler, H.-C. Muller, R. Frie@b, W. Delille, A. Matheus, S., "Induction and analysis of aggregates in a liquid IgG1-antibody formulation", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20050401), vol. 59, no. 3, doi:10.1016/j.ejpb.2004.12.004, ISSN 0939-6411, pages 407 - 417, XP004780138
OPPOSITION- Bookbinder, L.H. ; Hofer, A. ; Haller, M.F. ; Zepeda, M.L. ; Keller, G.A. ; Lim, J.E. ; Edgington, T.S. ; Shepard, H.M. ; Patton, J.S. ; Frost, G.I., "A recombinant human enzyme for enhanced interstitial transport of therapeutics", Journal of Controlled Release, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL , (20060828), vol. 114, no. 2, doi:10.1016/j.jconrel.2006.05.027, ISSN 0168-3659, pages 230 - 241, XP024957594
OPPOSITION- Kretsinger Juliana, Frantz Neha, Hart Scott A., Kelley Wayne P., Kitchen Bob, Novick Shawn, Rellahan Barbara, Stranges Daniela, Stroop Corné J.M., Yin Ping, Gastens Martin H., "Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics", Journal of Pharmaceutical Sciences, Wiley, (20190401), vol. 108, no. 4, doi:10.1016/j.xphs.2018.11.042, ISSN 0022-3549, pages 1442 - 1452, XP093234663
OPPOSITION- Strickley Robert G., Lambert William J., "A review of formulations of commercially available antibodies", Journal of Pharmaceutical Sciences, Wiley, (20210701), vol. 110, no. 7, doi:10.1016/j.xphs.2021.03.017, ISSN 0022-3549, pages 2590 - 2608.e56, XP055799313
OPPOSITION- Mieczkowski Carl A., "The Evolution of Commercial Antibody Formulations", Journal of Pharmaceutical Sciences, Wiley, (20230701), vol. 112, no. 7, doi:10.1016/j.xphs.2023.03.026, ISSN 0022-3549, pages 1801 - 1810, XP093225366
OPPOSITION- John F. Carpenter, Brent S. Kendrick, Byeong S. Chang, Mark C. Manning, Theodore W. Randolph, "[16] Inhibition of stress-induced aggregation of protein therapeutics", Amyloid, Prions, and Other Protein Aggregates, US, Academic Press, (19990101), vol. 309, pages 236 - 255, doi:10.1016/S0076-6879(99)09018-7, ISBN 0-12-182210-9, XP009558797
OPPOSITION- Reed J. Harris, Bruce Kabakoff, Frank D. Macchi, Felicity J. Shen, May Kwong, James D. Andya, Steven J. Shire, Nancy Bjork, Klara Totpal, Anthony B. Chen, "Identification of multiple sources of charge heterogeneity in a recombinant antibody.", Journal of Chromatography B, ELSEVIER SCIENCE PUBLISHERS, NL, NL , (20010310), vol. 752, no. 2, doi:10.1016/S0378-4347(00)00548-X, ISSN 0378-4347, pages 233 - 245, XP002682609
OPPOSITION- Shen Felicity, May Y. Kwong, Rodney G. Keck, Reed J. Harris, "The application of tert-butylhydroperoxide oxidation to study sites of potential methionine oxidation in a recombinant antibody", Techniques in Protein Chemistry, (19960101), vol. 7, doi:10.1016/S1080-8914(96)80031-7, pages 275 - 284, XP093234707
OPPOSITION- Pivot Xavier, Gligorov Joseph, Müller Volkmar, Barrett-Lee Peter, Verma Sunil, Knoop Ann, Curigliano Giuseppe, Semiglazov Vladimir, López-Vivanco Guillermo, Jenkins Valerie, Scotto Nana, Osborne Stuart, Hoff Mann- F, Roche La, Chu Jean, Minjoz, Besançon, Petrov N N, Hoff Mann-La F, Ltd Roche, Msc Osborne, "Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study", Lancet Oncol, (20130914), vol. 14, doi:10.1016/S1470-2045, pages 962 - 970, XP093234574
OPPOSITION- CHI EVA Y ET AL, "Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation.", Environmental Science and Pollution Research, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20030901), vol. 20, no. 9, doi:10.1023/A:1025771421906, ISSN 0724-8741, pages 1325 - 1336, XP002475010
OPPOSITION- SHPILBERG O.; JACKISH C., "Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase", British Journal of Cancer, Nature Publishing Group UK, London, London, (20130917), vol. 109, no. 6, doi:10.1038/bjc.2013.371, ISSN 0007-0920, pages 1556 - 1561, XP002782443
OPPOSITION- Kuzman Drago, Bunc Marko, Ravnik Miha, Reiter Fritz, Žagar Lan, Bončina Matjaž, "Long-term stability predictions of therapeutic monoclonal antibodies in solution using Arrhenius-based kinetics", Scientific Reports, (20211201), vol. 11, no. 1, doi:10.1038/s41598-021-99875-9, XP055911550
OPPOSITION- Huelsmeyer M., Kuzman D., Bončina M., Martinez J., Steinbrugger C., Weusten J., Calero-Rubio C., Roche W., Niederhaus B., Vanhaelst Y., Hrynyk M., Ballesta P., Achard H., Augusto S., Guillois M., Pszczolinski C., Gerasimov M., Neyra C., Ponduri D., Ramesh S., Clénet D., "A universal tool for stability predictions of biotherapeutics, vaccines and in vitro diagnostic products", Scientific Reports, Nature Publishing Group, US, US , vol. 13, no. 1, doi:10.1038/s41598-023-35870-6, ISSN 2045-2322, XP093234657
OPPOSITION- Schellekens Huub, "Factors influencing the immunogenicity of therapeutic proteins", Nephrology Dialysis Transplantation, Oxford university Press, GB, GB , (20050601), vol. 20, no. suppl_6, doi:10.1093/ndt/gfh1092, ISSN 0931-0509, pages vi3 - vi9, XP093234580
OPPOSITION- Schwartzman Sergio, Morgan G James, "Does route of administration affect the outcome of TNF antagonist therapy?", ARTHRITIS RESEARCH AND THERAPY, BIOMED CENTRAL, LONDON, GB, GB , (20040601), vol. 6, no. S2, doi:10.1186/ar996, ISSN 1478-6354, XP093234648
OPPOSITION- Shire Steven J., "2005 AAPS Biotechnology Conference Open Forum on Aggregation of Protein Therapeutics — Panel Discussion June 5-8, 2005 San Francisco, CA", The AAPS Journal, Springer-Verlag, New York, New York , (19010101), vol. 8, no. 4, doi:10.1208/aapsj080473, pages E644 - E654, XP035718859
OPPOSITION- FROST et al., "Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration", Expert Opin. Drug Deliv., (20070000), vol. 4, no. 4, doi:10.1517/17425247.4.4.427, pages 427 - 440, XP008177677
OPPOSITION- Riedl Marc A., Lumry William R., Li H. Henry, Banerji Aleena, Bernstein Jonathan A., Baş Murat, Björkander Janne, Magerl Markus, Maurer Marcus, Rockich Kevin, Chen Hongzi, Schranz Jennifer, "Subcutaneous administration of human C1 inhibitor with recombinant human hyaluronidase in patients with hereditary angioedema", ALLERGY AND ASTHMA PROCEEDINGS., PROVIDENCE, RI, US, US , (20161101), vol. 37, no. 6, doi:10.2500/aap.2016.37.4006, ISSN 1088-5412, pages 489 - 500, XP009558801
SEARCH- BOOKBINDER ET AL, "A recombinant human enzyme for enhanced interstitial transport of therapeutics", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, (20060828), vol. 114, no. 2, doi:10.1016/J.JCONREL.2006.05.027, ISSN 0168-3659, pages 230 - 241, XP005625403 [Y] 1-26 * the whole document *

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents