JP4580744B2 - PEG−インターフェロンα結合体の保護のための処方物 - Google Patents
PEG−インターフェロンα結合体の保護のための処方物 Download PDFInfo
- Publication number
- JP4580744B2 JP4580744B2 JP2004353441A JP2004353441A JP4580744B2 JP 4580744 B2 JP4580744 B2 JP 4580744B2 JP 2004353441 A JP2004353441 A JP 2004353441A JP 2004353441 A JP2004353441 A JP 2004353441A JP 4580744 B2 JP4580744 B2 JP 4580744B2
- Authority
- JP
- Japan
- Prior art keywords
- peg
- interferon
- interferon alpha
- formulation
- conjugate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/212—IFN-alpha
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Description
本発明は、凍結乾燥の間およびその後のPEG−インターフェロンα結合体の安定化のための処方物、その生成および使用に関する。
種々の天然および組換えタンパク質は、薬学的有用性を有する。一旦それらが精製され、分離され、そして処方されると、種々の治療的適応のために非経口投与され得る。しかし、非経口投与されるタンパク質は免疫原性であり得、比較的水に不溶性であり得、そして短い薬理学的半減期を有し得る。結果として、患者においてそのタンパク質の治療的に有用な血液レベルを達成することは困難であり得る。
Biotech,11:141−152、1985)は、ポリエチレングリコールをフェニルクロロホルメートで活性化してリボヌクレアーゼおよびスーパーオキシドジスムターゼ(superoxide dimutase)を改変することを開示する。Karteら、米国特許第4,766,106号および同第4,917,888号もまた、タンパク質をポリマー結合体化によって可溶化することを開示する。同様に、PEGおよび他のポリマーは、組換えタンパク質に結合体化されて、免疫原性を減少しそして半減期を増加させ得る。Niteckiら、米国特許第4,902,502号、Enzon,Inc.、国際出願番号PCT/US90/02133、Nishimuraら、欧州特許出願第154,316号、およびTomasi,国際出願番号PCT/US85/02572を参照のこと。例えば、インターフェロンα−2bは、腎臓細胞癌腫、AIDS関連カポージ肉腫、慢性および急性B型肝炎、慢性および急性非A型、非B/C型肝炎およびC型肝炎のような疾患状態の処置に有効であることが知られている。インターフェロンα−2bの薬理学的半減期の改良は、これらの状態の処置を改良する。
本発明は、凍結乾燥の間および後の、PEG−インターフェロンα結合体の安定化を可能にする処方物を提供する。
Injection,Abbott Laboratories,Abott
Park,IL)。
「PEG−インターフェロンα結合体」は、PEG分子に共有結合されたインターフェロンα分子である。好ましい実施態様において、本発明のPEG−インターフェロンα結合体は、インターフェロンα−2a(Roferon,Hoffman La−Roche,Nutley,NJ)、インターフェロンα 2b(Intron,Schering−Plough,Madison,NJ)、インターフェロンα−2c(Berofor Alfa,Boehringer Ingelheim,Ingelheim,Germany)または天然に存在するインターフェロンαのコンセンサス配列の決定により規定されるようなコンセンサスインターフェロン(Infergen,Amgen,Thousand Oaks,CA)を含む。
この実施例は、本発明の処方物、ならびに凍結乾燥および貯蔵の間のあるPEG−インターフェロンα結合体の保護の記載を提供する。このPEG−インターフェロン結合体を、凍結乾燥処方物に導入し、凍結乾燥し、そして乾燥粉末として貯蔵する。この処方物の成分は、以下の通りである:
Claims (6)
- ポリエチレングリコール(PEG)−インターフェロンα結合体、緩衝液、安定化剤、凍結保護剤、および溶媒を含む、凍結乾燥の間およびその後のPEG−インターフェロン
α結合体の安定化を可能にする処方物であって、該凍結保護剤がスクロースであり、そして該溶媒が水であり、該緩衝液が該処方物のpHを6.5と7.1との間に維持し、そしてクエン酸ナトリウム/クエン酸、および酢酸ナトリウム/酢酸からなる群より選択される緩衝剤系であり、そして、該安定化剤がポリソルベート80である、処方物。 - 前記緩衝液が、前記処方物のpHを6.8に維持する、請求項1に記載の処方物。
- 請求項1〜2のいずれかに記載の処方物を凍結乾燥する工程を包含する、ポリエチレングリコール(PEG)−インターフェロンα結合体の凍結乾燥粉末を製造する方法。
- 請求項3に記載の方法によって製造される、ポリエチレングリコール(PEG)−インターフェロンα結合体の凍結乾燥粉末。
- ポリエチレングリコール(PEG)−インターフェロンα結合体の溶液を生成する方法であって:
a)請求項4に記載の凍結乾燥粉末を調製する工程;および
b)該凍結乾燥粉末を水で再構成し、該溶液を生成する工程、
を包含する、方法。 - 請求項4に記載の凍結乾燥粉末を含む容器を備える、製品。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4890798A | 1998-03-26 | 1998-03-26 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000537581A Division JP3643034B2 (ja) | 1998-03-26 | 1999-03-24 | PEG−インターフェロンα結合体の保護のための処方物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2005104985A JP2005104985A (ja) | 2005-04-21 |
JP4580744B2 true JP4580744B2 (ja) | 2010-11-17 |
Family
ID=21957085
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000537581A Expired - Lifetime JP3643034B2 (ja) | 1998-03-26 | 1999-03-24 | PEG−インターフェロンα結合体の保護のための処方物 |
JP2003031774A Pending JP2003221345A (ja) | 1998-03-26 | 2003-02-07 | PEG−インターフェロンα結合体の保護のための処方物 |
JP2004353441A Expired - Lifetime JP4580744B2 (ja) | 1998-03-26 | 2004-12-06 | PEG−インターフェロンα結合体の保護のための処方物 |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000537581A Expired - Lifetime JP3643034B2 (ja) | 1998-03-26 | 1999-03-24 | PEG−インターフェロンα結合体の保護のための処方物 |
JP2003031774A Pending JP2003221345A (ja) | 1998-03-26 | 2003-02-07 | PEG−インターフェロンα結合体の保護のための処方物 |
Country Status (26)
Country | Link |
---|---|
EP (1) | EP1066059B1 (ja) |
JP (3) | JP3643034B2 (ja) |
KR (1) | KR100420642B1 (ja) |
CN (1) | CN1191863C (ja) |
AR (1) | AR014772A1 (ja) |
AT (1) | ATE297761T1 (ja) |
AU (1) | AU754002B2 (ja) |
BR (1) | BR9909087A (ja) |
CA (1) | CA2324467C (ja) |
CO (1) | CO5080738A1 (ja) |
CZ (1) | CZ302005B6 (ja) |
DE (1) | DE69925820T2 (ja) |
ES (1) | ES2241272T3 (ja) |
HK (1) | HK1029754A1 (ja) |
HU (1) | HU228877B1 (ja) |
ID (1) | ID28470A (ja) |
IL (2) | IL138221A0 (ja) |
MY (1) | MY119227A (ja) |
NO (1) | NO329916B1 (ja) |
NZ (1) | NZ506631A (ja) |
PE (1) | PE20000338A1 (ja) |
PL (1) | PL193286B1 (ja) |
PT (1) | PT1066059E (ja) |
SK (1) | SK285284B6 (ja) |
TW (2) | TWI243057B (ja) |
WO (1) | WO1999048535A1 (ja) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1066059B1 (en) * | 1998-03-26 | 2005-06-15 | Schering Corporation | Formulations for protection of peg-interferon alpha conjugates |
US6362162B1 (en) | 1999-04-08 | 2002-03-26 | Schering Corporation | CML Therapy |
JP4721488B2 (ja) * | 1999-04-08 | 2011-07-13 | シェーリング コーポレイション | 腎細胞ガン処置 |
US6923966B2 (en) | 1999-04-08 | 2005-08-02 | Schering Corporation | Melanoma therapy |
US6605273B2 (en) | 1999-04-08 | 2003-08-12 | Schering Corporation | Renal cell carcinoma treatment |
US20020009428A1 (en) * | 2000-01-24 | 2002-01-24 | Zaknoen Sara L. | Combination therapy for cancer |
EP1908477A3 (en) * | 2000-01-24 | 2008-06-11 | Schering Corporation | Combination of temozolomide and pegylated interferon-alpha for treating cancer |
KR100353392B1 (ko) * | 2000-03-13 | 2002-09-18 | 선바이오(주) | 높은 생체 활성도를 갖는 생체 활성 단백질과 peg의결합체 제조방법 |
KR100777195B1 (ko) | 2000-04-03 | 2007-11-19 | 산텐 세이야꾸 가부시키가이샤 | 송달성 물질 및 이를 이용한 약물 송달 시스템 |
DK1478339T3 (da) | 2002-02-22 | 2008-08-25 | Schering Corp | Farmaceutiske formuleringer af antineoplastiske midler, specielt temozolomid, fremgangsmåder til fremstilling og anvendelse heraf |
AU2008201682B2 (en) * | 2004-02-02 | 2011-02-24 | Ambrx, Inc. | Modified human interferon polypeptides and their uses |
DE602005022895D1 (de) * | 2004-08-12 | 2010-09-23 | Schering Corp | Stabile pegylierte interferon-formulierung |
WO2009080699A2 (en) | 2007-12-20 | 2009-07-02 | Merck Serono S.A. | Peg-interferon-beta formulations |
KR101303388B1 (ko) * | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
JP2015535238A (ja) * | 2012-10-26 | 2015-12-10 | ルピン・リミテッドLupin Limited | ペグインターフェロンα−2bの安定な医薬組成物 |
KR101736870B1 (ko) | 2014-08-20 | 2017-05-18 | 한국코러스 주식회사 | 인터페론 접합체를 포함하는 복합체 및 이의 제조방법 |
EP3463308B1 (en) | 2016-06-01 | 2021-12-01 | Servier IP UK Limited | Formulations of polyalkylene oxide-asparaginase and methods of making and using the same |
CN112358541B (zh) * | 2020-11-25 | 2022-04-01 | 广州迪澳医疗科技有限公司 | 一种重组人γ-干扰素的冻干保护剂 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2024046A1 (en) * | 1989-09-28 | 1991-03-29 | Alberto Ferro | Stabilized leukocyte-interferons |
US5382657A (en) * | 1992-08-26 | 1995-01-17 | Hoffmann-La Roche Inc. | Peg-interferon conjugates |
DK0730470T3 (da) * | 1993-11-10 | 2002-06-03 | Enzon Inc | Forbedrede interferonpolymerkonjugater |
US5766582A (en) * | 1994-10-11 | 1998-06-16 | Schering Corporation | Stable, aqueous alfa interferon solution formulations |
US5738846A (en) * | 1994-11-10 | 1998-04-14 | Enzon, Inc. | Interferon polymer conjugates and process for preparing the same |
WO1996024369A1 (en) * | 1995-02-06 | 1996-08-15 | Genetics Institute, Inc. | Formulations for il-12 |
TW426523B (en) * | 1995-04-06 | 2001-03-21 | Hoffmann La Roche | Interferon solution |
CA2226575C (en) * | 1995-07-27 | 2011-10-18 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
US5908621A (en) * | 1995-11-02 | 1999-06-01 | Schering Corporation | Polyethylene glycol modified interferon therapy |
JP2000507917A (ja) * | 1995-11-02 | 2000-06-27 | シェーリング コーポレイション | 持続的低用量サイトカイン注入治療 |
TW517067B (en) * | 1996-05-31 | 2003-01-11 | Hoffmann La Roche | Interferon conjugates |
EP1066059B1 (en) * | 1998-03-26 | 2005-06-15 | Schering Corporation | Formulations for protection of peg-interferon alpha conjugates |
-
1999
- 1999-03-24 EP EP99913822A patent/EP1066059B1/en not_active Expired - Lifetime
- 1999-03-24 TW TW088104662A patent/TWI243057B/zh not_active IP Right Cessation
- 1999-03-24 DE DE69925820T patent/DE69925820T2/de not_active Expired - Lifetime
- 1999-03-24 SK SK1426-2000A patent/SK285284B6/sk not_active IP Right Cessation
- 1999-03-24 PT PT99913822T patent/PT1066059E/pt unknown
- 1999-03-24 NZ NZ506631A patent/NZ506631A/xx not_active IP Right Cessation
- 1999-03-24 TW TW094125705A patent/TWI250024B/zh not_active IP Right Cessation
- 1999-03-24 CN CNB998044733A patent/CN1191863C/zh not_active Expired - Lifetime
- 1999-03-24 ES ES99913822T patent/ES2241272T3/es not_active Expired - Lifetime
- 1999-03-24 BR BR9909087-2A patent/BR9909087A/pt not_active Application Discontinuation
- 1999-03-24 AU AU31812/99A patent/AU754002B2/en not_active Expired
- 1999-03-24 JP JP2000537581A patent/JP3643034B2/ja not_active Expired - Lifetime
- 1999-03-24 WO PCT/US1999/004268 patent/WO1999048535A1/en active IP Right Grant
- 1999-03-24 CZ CZ20003315A patent/CZ302005B6/cs not_active IP Right Cessation
- 1999-03-24 IL IL13822199A patent/IL138221A0/xx active IP Right Grant
- 1999-03-24 ID IDW20001920A patent/ID28470A/id unknown
- 1999-03-24 CA CA002324467A patent/CA2324467C/en not_active Expired - Lifetime
- 1999-03-24 AT AT99913822T patent/ATE297761T1/de active
- 1999-03-24 PL PL345568A patent/PL193286B1/pl unknown
- 1999-03-24 HU HU0101749A patent/HU228877B1/hu unknown
- 1999-03-24 CO CO99017875A patent/CO5080738A1/es unknown
- 1999-03-24 KR KR10-2000-7010588A patent/KR100420642B1/ko not_active IP Right Cessation
- 1999-03-25 MY MYPI99001145A patent/MY119227A/en unknown
- 1999-03-25 PE PE1999000243A patent/PE20000338A1/es not_active IP Right Cessation
- 1999-03-25 AR ARP990101323A patent/AR014772A1/es active IP Right Grant
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2000
- 2000-09-03 IL IL138221A patent/IL138221A/en not_active IP Right Cessation
- 2000-09-25 NO NO20004785A patent/NO329916B1/no not_active IP Right Cessation
-
2001
- 2001-01-13 HK HK01100376A patent/HK1029754A1/xx not_active IP Right Cessation
-
2003
- 2003-02-07 JP JP2003031774A patent/JP2003221345A/ja active Pending
-
2004
- 2004-12-06 JP JP2004353441A patent/JP4580744B2/ja not_active Expired - Lifetime
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