Recombinant Fsh Including Alpha 2,3- And Alpha 2,6-Sialylation - EP3045471

The patent EP3045471 was granted to Ferring on Mar 29, 2017. The application was originally filed on Apr 16, 2009 under application number EP16158141A. The patent is currently recorded with a legal status of "Revoked".

EP3045471

FERRING
Application Number
EP16158141A
Filing Date
Apr 16, 2009
Status
Revoked
Jan 7, 2022
Grant Date
Mar 29, 2017
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

MERCK SERONODec 22, 2017WEISS -

Patent Citations (7) New

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

Citation PhasePublication NumberPublication Link
OPPOSITIONUS5994128
OPPOSITIONWO03035686
OPPOSITIONWO03048348
OPPOSITIONWO2005080585
OPPOSITIONWO9700326
SEARCHWO03035686
SEARCHWO2012016576

Non-Patent Literature (NPL) Citations (58) 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- ANDERSEN CY; WESTERGAARD LG; VAN WELY M., "FSH isoform composition of commercial gonadotrophin preparations: a neglected aspect?", REPROD BIOMED ONLINE, (2004), vol. 9, no. 2, pages 231 - 236-
DESCRIPTION- AREY BJ; STEVIS PE; DEECHER DC; SHEN ES; FRAIL DE; NEGRO-VILAR A; LOPEZ FJ, "Induction of promiscuous G protein coupling of the follicle-stimulating hormone (FSH) receptor: a novel mechanism for transducing pleiotropic actions of FSH isoforms", MOL ENDOCRINOL., (1997), vol. 11, no. 5, pages 517 - 526-
DESCRIPTION- BAENZIGER JU; GREEN ED, "Pituitary glycoprotein hormone oligosaccharides: structure, synthesis and function of the asparagine-linked oligosaccharides on lutropin, follitropin and thyrotropin", BIOCHIM BIOPHYS ACTA, (1988), vol. 947, no. 2, pages 287 - 306-
DESCRIPTION- BASSETT RM; DRIEBERGEN R., "Continued improvements in the quality and consistency of follitropin alfa, recombinant human FSH", REPROD BIOMED ONLINE, (2005), vol. 10, no. 2, pages 169 - 177-
DESCRIPTION- DALPATHADO DS; IRUNGU J; GO EP; BUTNEV VY; NORTON K; BOUSFIELD GR; DESAIRE H., "Comparative glycomics of the glycoprotein follicle stimulating hormone: glycopeptide analysis of isolates from two mammalian species", BIOCHEMISTRY, (2006), vol. 45, no. 28, pages 8665 - 8673-
DESCRIPTION- DAMIAN-MATSUMURA P; ZAGA V; MALDONADO A; SANCHEZ-HERNANDEZ C; TIMOSSI C; ULLOA-AGUIRRE A., "Oestrogens regulate pituitary alpha2,3-sialyltransferase messenger ribonucleic acid levels in the female rat", J MOL ENDOCRINOL., (1999), vol. 23, no. 2, pages 153 - 165-
DESCRIPTION- D'ANTONIO M.; BORRELLI F.; DATOLA A.; BUCCI R.; MASCIA M.; POLLETTA P.; PISCITELLI D.; PAPOIAN R., "Biological characterization of recombinant human follicle stimulating hormone isoforms", HUMAN REPRODUCTION, (1999), vol. 14, pages 1160 - 1167-
DESCRIPTION- DE LEEUW, R.; MULDERS, J.; VOORTMAN, G.; ROMBOUT, F.; DAMM, J.; KLOOSTERBOER, L., "Structure-function relationship of recombinant follicle stimulating hormone (Puregon", MOL. HUM. REPROD., (1996), vol. 2, pages 361 - 369-
DESCRIPTION- DIAS JA; VAN ROEY P., "Structural biology of human follitropin and its receptor", ARCH MED RES., (2001), vol. 32, no. 6, pages 510 - 519-
DESCRIPTION- FIDDES, J. C.; GOODMAN, H. M., "Isolation, cloning and sequence analysis of the cDNA for the alpha-subunit of human chorionic gonadotropin", NATURE, (1979), vol. 281, pages 351 - 356-
DESCRIPTION- FLACK, M.R.; BENNET, A.P.; FROEHLICH, J.; ANASTI, JN; NISULA, B., "Increased biological activity due to basic isoforms in recombinant human follicle-stimulating hormone produced in a human cell line", J. CLIN. ENDOCRINOL. METAB., (1994), vol. 79, pages 756 - 760-
DESCRIPTION- FOX KM; DIAS JA; VAN ROEY P, "Three-dimensional structure of human follicle-stimulating hormone", MOL ENDOCRINOL., (2001), vol. 15, no. 3, pages 378 - 89-
DESCRIPTION- GOODMAN and GILMAN's THE PHARMACOLOGICAL BASIS FOR THERAPEUTICES-
DESCRIPTION- GRABENHORST E; HOFFMANN A; NIMTZ M; ZETTLMEISSL G; CONRADT HS, "Construction of stable BHK-21 cells coexpressing human secretory glycoproteins and human Gal(beta 1-4 )GIcNAc-R alpha 2,6-sialyltransferase alpha 2,6-linked NeuAc is preferentially attached to the Gal(beta 1-4 )GIcNAc(beta 1-2 )Man(alpha 1-3 )-branch of diantennary oligosaccharides from secreted rec", EUR J BIOCHEM., (1995), vol. 232, no. 3, pages 718 - 25-
DESCRIPTION- GREEN ED; BAENZIGER JU, "Asparagine-linked oligosaccharides on lutropin, follitropin, and thyrotropin. . Distributions of sulfated and sialylated oligosaccharides on bovine, ovine, and human pituitary glycoprotein hormones", J BIOL CHEM., (1988), vol. 263, no. 1, pages 36 - 44-
DESCRIPTION- GRUNDMANN,U.; NERLICH,C.; REIN,T.; ZETTLMEISSL, G., "Complete cDNA sequence encoding human beta-galactoside alpha-2,6-sialyltransferase", G NUCLEIC ACIDS RES., (1990), vol. 18, no. 3, page 667-
DESCRIPTION- HOWLES, C.M., "Genetic engineering of human FSH (Gonal-F", HUM REPROD. UPDATE, (1996), vol. 2, pages 172 - 191-
DESCRIPTION- KAGAWA Y; TAKASAKI S; UTSUMI J; HOSOI K; SHIMIZU H; KOCHIBE N; KOBATA A, "Comparative study of the asparagine-linked sugar chains of natural human interferon-beta 1 and recombinant human interferon-beta 1 produced by three different mammalian cells", J BIOL CHEM., (1988), vol. 263, no. 33, pages 17508 - 17515-
DESCRIPTION- KEENE, J.L.; MATZUK, M.M.; OTANI, T.; FAUSER, B,C,J,M.; GALWAY, A.B.; HSUEH, A.J.W.; BOIME, ., "Expression of Biologically active Human Follitropin in Chinese Hamster Ovary Cells", THE JOURNAL OF BIOLOGICAL CHEMISTRY, (1989), vol. 264, no. 9, pages 4769 - 4775-
DESCRIPTION- KITAGAWA,H.; PAULSON,J.C, "Cloning of a novel alpha 2,3-sialyltransferase that sialylates glycoprotein and glycolipid carbohydrate groups", J. BIOL. CHEM., (1994), vol. 269, no. 2, pages 1394 - 1401-
DESCRIPTION- LEE EU; ROTH J; PAULSON JC, "Alteration of terminal glycosylation sequences on N-linked oligosaccharides of Chinese hamster ovary cells by expression of beta-galactoside alpha 2,6-sialyltransferase", J BIOL CHEM., (1989), vol. 264, no. 23, pages 13848 - 13855-
DESCRIPTION- LOWRY OH; ROSEBROUGH NJ; FARR AL; RANDALL RJ, "Protein measurement with the Folin phenol reagent", J BIOL CHEM., (1951), vol. 193, no. L, pages 265 - 75-
DESCRIPTION- LOWRY, PJ; MCLEAN, C; JONES RL; SATGUNASINGAM N, "Purification of anterior pituitary and hypothalamic hormones", CLIN PATHOL SUPPL (ASSOC CLIN PATHOL, (1976), vol. 7, pages 16 - 21-
DESCRIPTION- PIERCE JG; PARSONS TF, "Glycoprotein hormones: structure and function", ANNU REV BIOCHEM., (1981), vol. 50, pages 465 - 495-
DESCRIPTION- PRICER WE JR; ASHWELL G, "The binding of desialylated glycoproteins by plasma membranes of rat liver", J BIOL CHEM., (1971), vol. 246, no. 15, pages 4825 - 33-
DESCRIPTION- RATHNAM P; SAXENA BB, "Primary amino acid sequence of follicle-stimulating hormone from human pituitary glands. I. alpha subunit", J BIOL CHEM., (1975), vol. 250, no. 17, pages 6735 - 6746-
DESCRIPTION- REGOECZI E; DEBANNE MT; HATTON MC; KOJ A, "Elimination of asialofetuin and asialoorosomucoid by the intact rat. Quantitative aspects of the hepatic clearance mechanism", BIOCHIM BIOPHYS ACTA, (1978), vol. 541, no. 3, pages 372 - 84-
DESCRIPTION- Remington's Pharmaceutical Sciences, MATT PUBLISHING COMPANY, (1975), pages 1405 - 1412,146-
DESCRIPTION- REMINGTON; THE SCIENCE AND PRACTICE OF PHARMACY, pages 780 - 820-
DESCRIPTION- ROYLE L; RADCLIFFE CM; DWEK RA; RUDD PM, Methods in Molecular Biology, HUMANA PRESS, (2006), vol. 347, pages 125 - 144-
DESCRIPTION- RYAN RJ; KEUTMANN HT; CHARLESWORTH MC; MCCORMICK DJ; MILIUS RP; CALVO FO; VUTYAVANICH T., "Structure-function relationships of gonadotropins", RECENT PROG HORM RES., (1987), vol. 43, pages 383 - 429-
DESCRIPTION- SAXENA BB; RATHNAM P., "Amino acid sequence of the beta subunit of follicle-stimulating hormone from human pituitary glands", J BIOL CHEM., (1976), vol. 251, no. 4, pages 993 - 1005-
DESCRIPTION- STEELMAN SL; POHLEY FM, "Assay of the follicle stimulating hormone based on the augmentation with human chorionic gonadotropin", ENDOCRINOLOGY, (1953), vol. 53, no. 6, pages 604 - 616-
DESCRIPTION- STEER CJ; ASHWELL G, "Studies on a mammalian hepatic binding protein specific for asialoglycoproteins. Evidence for receptor recycling in isolated rat hepatocytes", J BIOL CHEM., (1980), vol. 255, no. 7, pages 3008 - 13-
DESCRIPTION- SVENSSON EC; SOREGHAN B; PAULSON JC, "Organization of the beta-galactoside alpha 2,6-sialyltransferase gene. Evidence for the transcriptional regulation of terminal glycosylation", J BIOL CHEM., (1990), vol. 265, no. 34, pages 20863 - 20868-
DESCRIPTION- TAKEUCHI M; TAKASAKI S; MIYAZAKI H; KATO T; HOSHI S; KOCHIBE N; KOBATA A, "Comparative study of the asparagine-linked sugar chains of human erythropoietins purified from urine and the culture medium of recombinant Chinese hamster ovary cells", J BIOL CHEM., (1988), vol. 263, no. 8, pages 3657 - 3663-
DESCRIPTION- TIMOSSI CM; BARRIOS-DE-TOMASI J; GONZASEZ-SUAREZ R; ARRANZ MC; PADMANABHAN V; CONN PM; ULLOA-AGUIRRE A, "Differential effects of the charge variants of human follicle-stimulating hormone", J ENDOCRINOL., (2000), vol. 165, no. 2, pages 193 - 205-
DESCRIPTION- TIMOSSI CM; BARRIOS DE TOMASI J; ZAMBRANO E; GONZAIEZ R; ULLOA-AGUIRRE A., "A naturally occurring basically charged human follicle-stimulating hormone (FSH) variant inhibits FSH-induced androgen aromatization and tissue-type plasminogen activator enzyme activity in vitro", NEUROENDOCRINOLOGY, (1998), vol. 67, no. 3, pages 153 - 163-
DESCRIPTION- ULLOA-AGUIRRE, A.; CRAVIOTO, A.; DAMIÀN-MATSUMURA, P.; JIMENEZ, M; ZAMBRANO, E; DIAZ-SANCHEZ, V., "Biological characterization of the naturally occurring analogues of intrapituitary human follicle stimulating hormone", HUM. REPROD., (1992), vol. 7, pages 23 - 30-
DESCRIPTION- ULLOA-AGUIRRE, A.; ESPINOZA, R.; DAMIAN-MATSUMURA, P.; CHAPPEL, S.C., "Immunological and biological potencies of the different molecular species of gonadotrophins", HUM. REPROD., (1988), vol. 3, pages 491 - 501-
DESCRIPTION- ULLOA-AGUIRRE A; MALDONADO A; DAM ÁN-MATSUMURA P; TIMOSSI C, "Endocrine regulation of gonadotropin glycosylation", ARCH MED RES., (2001), vol. 32, no. 6, pages 520 - 532-
DESCRIPTION- ULLOA-AGUIRRE A; MIDGLEY AR JR; BEITINS IZ; PADMANABHAN V, "Follicle-stimulating isohormones: characterization and physiological relevance", ENDOCR REV., (1995), vol. 16, no. 6, pages 765 - 787-
DESCRIPTION- ULLOA-AGUIRRE A; TIMOSSI C; BARRIOS-DE-TOMASI J; MALDONADO A; NAYUDU P., "Impact of carbohydrate heterogeneity in function of follicle-stimulating hormone: studies derived from in vitro and in vivo models", BIOL REPROD., (2003), vol. 69, no. 2, pages 379 - 389-
DESCRIPTION- VAN LENTEN L; ASHWELL G, "The binding of desialylated glycoproteins by plasma membranes of rat liver. Development of a quantitative inhibition assay", J BIOL CHEM., (1972), vol. 247, no. 14, pages 4633 - 40-
DESCRIPTION- WIDE, L.; ALBERTSSON-WIKLAND, K., "Change in electrophoretic mobility of human follicle-stimulating hormone in serum after administration of gonadotropin-releasing hormone", J. CLIN. ENDOCRINOL. METAB., (1990), vol. 70, pages 271 - 276-
DESCRIPTION- WIDE, L.; BAKOS, O., "More basic forms of both human follicle-stimulating hormone and luteinizing hormone in serum at midcycle compared with the follicular or luteal phase", J. CLIN. ENDOCRINOL. METAB., (1993), vol. 76, pages 885 - 889-
DESCRIPTION- WIDE L; NAESSEN T; SUNDSTR6M-POROMAA; ERIKSSON K., "Sulfonation and sialylation of gonadotropins in women during the menstrual cycle, after menopause, and with polycystic ovarian syndrome and in men", J CLIN ENDOCRINOL METAB., (2007), vol. 92, no. 11, pages 4410 - 4417-
DESCRIPTION- ZAMBRANO E; ZARINÁN T; OLIVARES A; BARRIOS-DE-TOMASI J; ULLOA-AGUIRRE A., "Receptor binding activity and in vitro biological activity of the human FSH charge isoforms as disclosed by heterologous and homologous assay systems: implications for the structure-function relationship of the FSH variants", ENDOCRINE, (1999), vol. 10, no. 2, pages 113 - 121-
DESCRIPTION- ZHANG X; LOK SH; KON OL, "Stable expression of human alpha-2,6-sialyltransferase in Chinese hamster ovary cells: functional consequences for human erythropoietin expression and bioactivity", BIOCHIM BIOPHYS ACTA, (1998), vol. 1425, no. 3, pages 441 - 452-
OPPOSITION- COMBARNOUS et al., "Structure et relations structure-activité des hormones folliculo-stimulantes recombinantes humaines", medecine/siences, (19990000), vol. 15, pages 167 - 174, XP055382547-
OPPOSITION- PAU et al., "The human cell line PER.C6 provides a new manufacturing system for the production of influenza vaccines", Vaccine, (20010000), vol. 19, pages 2716 - 2721, XP002201217
OPPOSITION- JONES et al., "High level expression of recombinant IgG in the human cell line PER.C6", Biotechnol. Prog., (20030000), vol. 19, pages 163 - 168, XP002256988
OPPOSITION- DE LEEUW et al., "Recombinat hormones: Structure-function relationship of recombinant follicle stimulating hormone (Puregon TM )", Molecular Human Reproduction, (19960000), vol. 2, no. 5, pages 361 - 369, XP055039633
SEARCH- JONES D ET AL, "High level expression of recombinant IgG in the human cell line PER.C6", BIOTECHNOLOGY PROGRESS, XX, XX, (20030101), vol. 19, ISSN 8756-7938, pages 163 - 168, XP002256988 [A] 13 * the whole document *
SEARCH- HORSMAN G ET AL, "A biological, immunological and physico-chemical comparison of the current clinical batches of the recombinant FSH preparations Gonal-F and Puregon", HUMAN REPRODUCTION 2000 GB, (2000), vol. 15, no. 9, ISSN 0268-1161, pages 1898 - 1902, XP002494716 [X] 1-10,14 * page 1898, column L, paragraph 1 * * page 1899, column L, paragraph 1 * * page 1900, column R, paragraph 4 - paragraph 5; table 1 * * page 1901; figure 2 * [A] 11-13
SEARCH- OLIJVE W ET AL, "Molecular biology and biochemistry of human recombinant follicle stimulating hormone (Puregon).", MOLECULAR HUMAN REPRODUCTION MAY 1996, (199605), vol. 2, no. 5, ISSN 1360-9947, pages 371 - 382, XP002494717 [X] 1-9,14 * page 371, paragraph 1 * * page 380, column L, paragraph L - page 381, column L, paragraph 3 * * figures 13,14 *
SEARCH- DICKEY RICHARD P ET AL, "Highly purified human-derived follicle-stimulating hormone (Bravelle(R)) has equivalent efficacy to follitropin-beta (Follistim (R)) in infertile women undergoing in vitro fertilization", REPRODUCTIVE BIOLOGY AND ENDOCRINOLOGY, BIOMED CENTRAL LTD, GB, (20031003), vol. 1, no. 1, doi:10.1186/1477-7827-1-63, ISSN 1477-7827, page 63, XP021009333 [X] 1-10,14 * page 2, column l, paragraph 2 - paragraph 4 * * page 6, column l, paragraph l - page 7, column l, paragraph 1 *
SEARCH- FLACK M R ET AL, "Increased biological activity due to basic isoforms in recombinant human follicle-stimulating hormone produced in a human cell line.", THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM SEP 1994, (199409), vol. 79, no. 3, ISSN 0021-972X, pages 756 - 760, XP002494715 [X] 1-10,12,14 * page 758, column L, paragraph 2 - page 760, column L, paragraph 1 * [A] 11,13

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