バイオ医薬品における特許の現状

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1 DNA 4 5 A REMICADE TM New York University, Centocor, Inc. 1 1 TNF a A2 TNF b TNF

2 HERCEPTIN TM HUMIRA TM Genentech G HERCEPTIN trastuzumab 1998 FDA HER2 HER2 7 HERCEPTIN HERCEPTIN A 2 8 HERCEPTIN Chiron C HER2 US6, 054, C G C CAFC C 561 I-2 U 80/02 HERCEPTIN Abbott Laboratories HUMIRA TM Adalimumab Abbott Laboratories HUMIRA 12 HUMIRA F ab2 1 2 SEQ ID No: 1

3 LCVR SEQ ID No:2 HCVR 1 Fab Fd 1 HERCEPTIN HUMIRA 1ISIS Pharmaceuticals, Inc. 13 Vitravene DNA mrna mrna 2 Vitravene CMV d P- thio GCGTTTGCTCTTCTTCTTGCGdeoxyribonucleic acid eicosasodium salt CMV IE2 3 Vitravene Vitravene 1 Vitravene FDA, Orange book 4 US5, 264, 423, US5, 276, 019, US5, 442, 049, US5, 595, Vitravene PCT/US91/ IE1 IE2 DNA RNA DNA 9GGA CCG GGA CCA CCG TCG TC CGC AAG AAG AAG AGC AAA CGC 15 DNA RNA RNA 13CTG TCA AGT GGC ACC ATA CG GCG TTT GCT CTT CTT CTT GCG ACT CGG GCT GCC ACT TGA CAG DNA mrna RNA 3 CMVs IE1 IE2 DNA

4 CMVs CMVs CMV 1 DNA mrna AUG CMV 13GGA CCG GGA CCA CCG TCG TC CGC AAG AAG AAG AGC AAA CGC DNA RNA mrna 17CTG TCA AGT GGC ACC ATA CG GCG TTT GCT CTT CTT CTT GCG ACT CGG GCT GCC ACT TGA CAG DNA mrna RNA DNA CMV GGA CCG GGA CCA CCG TCG TC CGC AAG AAG AAG AGC AAA CGC CTG TCA AGT GGC ACC ATA CG GCG TTT GCT CTT CTT CTT GCG ACT CGG GCT GCC ACT TGA CAG ID 22 GCG TTT GCT CTT CTT CTT GCG

5 EP B RNA RNA interferencernai Andrew Z. Fire Craig C. Mello RNAi 8 DNA PCR RNAi mrna DNA RNAi RNAi RNAi RNAi RNAi RNAi mrna RNA dsrna mrna 1:1 dsrna RNase Dicer sirna small interfering RNA 21 23mer dsrna sirna RISC RNA-induced silencing complex mrna Fire 1998 C. elegans RNAi RNA Fire RNAi RNAi Fire

6 dsrna 2001 Max Plank Tuschl 21mer dsrna RNAi sirna RNAi 21 23mer dsrna sirna Tuschl sirna Fire RNAi sirna RNAi Fire RNAi RNAi PCT , RNAi Fire RNA US60/068, 562 US09/215, PCT/US98/27233 US B Fire Fire 1 RNA RNA a b RNA RNA c RNA US B1 1 in vitro 10 RNA 50 1 RNA RNA

7 Tuschl PCT PCT/US01/ Tuschl PCT PCT 3 US06/193, 594, US06/265, 232, EP US09/821, PCT PCT/EP2001/ Tuschl Tuschl 1 RNA RNA RNA RNA RNA a RNA RNA RNA b RNA RNA RNA RNA RNA RNA RNA RNA RNA RNA Tuschl PCT RNA Tuschl Fire RNA Tuschl Fire Tuschl Fire RNA Tuschl Fire 29 1 in vitro RNAi RNAi

8 RNAi RNAi RNA RNAi in vitro 20 RNA NCBI 21 MeSH RNA sirna pegaptanib 22 SELEX 23 SELEX WO91/ USP EP B1 SELEX L.GOLD 25 SELEX USP , SELEX SELEX SELEX 2011 SELEX 28 PEG PEG ENZON 29 PEG USP PEG Macugen Eyetech OSI AMD Eyetech Macugen 2008 VEGF RNA 32 USP

9 PEG 33 6 Eyetech 34 Eyetech 35 SELEX 36 SELEX Archemics 2001 exclusive lisence 37 Archemics 38 SELEX EMEA Omnitrope FDA FDA FDA FDA Federal Food, Drug and Cosmetic Act, FDCAPublic Health Service Act, PHSA 48 FDCA 49 PHSA FDCA FDA PHSA 50

10 FDA DNA EPOGEN Amgen Amgen granulocyte-colony stimulating factor; G-CSF G-CSF kDa kDa 2 G-CSF Amgen Filgrastim Neupogen E.coli 175 r-methug-csf 18.8 kd E.coli N E.coli G-CSF FDA FDA BLA Production of pluripotent G-CSF Stabilized hydrophobic protein formulations of G-CSF DNA Amgen 1 11 peg-filgrastim Neulasta FDA BLA Chemically-modified G-CSF

11 Amgen Amgen G- CSF Kirin-Amgen Amgen EU Roche Roche Genentech Amgen CAFC Amgen Genentech Amgen 2005 Annual Report Amgen Lenograstim Neutrogin - Aventis Granocyte CHO 174 r-hug-csf 20 kd N G-CSF Annual Report 2005 G- CSF EPO CHO E.coli kd Nartograstim NoiupE.coli N N G-CSF Annual Report G-CSF

12 G-CSF RNAi Vol.53 No _b3b_reach.pdf Centocor REMICADE infliximab TNF Web , 50 Web 2 Vol.54 No Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253, Fed. Cir. 2004, Docket No HER2 454C REMICADE R Web RNA 1,500 Vitravene

13 US5, 442, 049 US5, 595, 978 US5, 442, GCG TTT GCT CTT CTT CTT GCG US5, 595, CMV 1 GCG TTT GCT CTT CTT CTT GCG CMV US5, 595, GCG TTT GCT CTT CTT CTT GCG Vetravene EP B1 1 DNA RNA RNA IE1 IE2 DNA RNA DNA GGA CCG GGA CCA CCG TCG TC CGC AAG AAG AAG AGC AAA CGC 2 1 GCG TTT GCT CTT CTT CTT GCG 22 I L.Gold SELEX DNA RNA RNA RNA VEGF PEG Systematic Evolution of Ligands by Exponential enrichment Gold Larry, Tuerk Craig USP SELEXUSP SELEXUSP SELEX SELEX WO91/19813 WO91/19813 SELEX 69 35USC271 e age-related macular degeneration: AMD VEGF WO98/ Orange Book FDA 6 USP Enzon USP ShearwaterPolymerUSP USP USP USP assignee SELEX GOLD

14 HIV-1 HIV-2 Tat C NS Raf-1 SELEX BioCentury, THE BERNSTEIN REPORT ON BioBusiness January 22, 2007 Ribomic Archemic generic name biosimilar similar biologics follow-on biologics humanguidelines/multidiscipline.htm EPAR/omnitrope/omnitrope.htm Nutropin Genotropin default.htm. PHSA PHSA FDCA NDA505 b1 ANDA505 j NDA505 b2 ANDA NDA 1 NDA Henry Waxman PHSA H.R.1038 EMEA G-CSF biosimilar generic kagaku11/2/ htm drug_data/neu/if/neu_if.pdf Bioforum-3/3-Kuwabara.pdf

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2 3 4 TTT TCT TAT TGT TTC TCC TAC TGC TTA TCA TAA TGA TTG TCG TAG TGG CTT CCT CAT CGT CTC CCC CAC CGC CTA CCA CAA CGA CTG CCG CAG CGG ATT ACT AAT AGT ATC ACC AAC AGC ATA ACA AAA AGA ATG ACG AAG AGG GTT