︿
Top

友霖在美申請LIVALO學名藥上市,引來日本原廠Kowa控專利侵權

瀏覽次數:2733| 歡迎推文: facebook twitter wechat twitter twitter

科技產業資訊室 (iKnow) - SYL 發表於 2014年4月28日

2014年4月17日,營運總部位在日本名古屋市的興和株式會社(Kowa Company, Ltd.)及其美國分公司Kowa Pharmaceuticals America, Inc.(以下統稱Kowa),以及與Kowa合作研發生產醫藥產品、亦為本案系爭專利權利人的日產化學工業株式會社(Nissan Chemical Industries, Ltd.,下稱日產化學),向美國紐約州南區聯邦地院提起專利侵權告訴,控告我國上櫃之生技製藥公司友霖生技醫藥股份有限公司(Orient Pharma Co., Ltd.,下稱友霖),其向美國食品藥物管理局(FDA)所提出之降血脂藥LIVALOR (中文名稱為力清,有效成分為Pitavastatin Calcium)學名藥上市許可申請(Pitavastatin 1, 2, 4mg,ANDA No. 20-5932),就本案3項系爭專利構成侵權。

在美國要生產販售特定品牌藥之學名藥,須向FDA提出「簡易新藥申請」(Abbreviated New Drug Application, ANDA),而相關法規要求學名藥廠在其ANDA中保證其學名藥不會侵害品牌藥廠的專利權利(21 U.S.C.§335(j)(2)(A)(vii))。對前述法規要求,有四種:(1)學名藥廠可以說明品牌藥廠未列出任何專利、或(2)說明專利已過期、或(3)要求上市許可之起始日在專利到期後、或(4)主張專利無效或其學名藥產品未構成侵權,其中第4種方式被稱為paragraph IV certification,在美國專利法上會被視為專利侵權行為(35 U.S.C.§271(e)(2)(A)),而專利權人(品牌藥廠)可據以起訴。而Kowa與日產化學對友霖所為本案之起訴便屬此一性質。

針對本案,友霖在其興櫃公告中說明,此專利侵權訴訟係法規程序,因產品尚未上市,故無侵權賠償問題。而Kowa與日產化學在其訴狀中則是請求法院宣告侵權行為成立、核發命令要求FDA所核發之上市許可不得早於系爭專利到期日、以及對被告製造販售及輸入美國之Pitavastatin藥物產品核發禁制令等。

友霖為友華生技醫藥股份有限公司於 2008 年 2 月 1 日所成立的子公司,其藥廠位於雲林虎尾科學園區,主要進行藥品在美國的上市申請以及新藥研發,並專注開發中樞神經藥品,包括抗精神病藥物、阿茲海默症藥物、精神興奮劑及巴金森氏症藥物等。

本案三項系爭專利內容如下:

美國專利編號US 5,856,336,名稱為「硅碄型蜜巴隆內酯(Quinoline type mevalonolactones)」,於1999年1月5日核發,權利人為日產化學;

美國專利編號US 6,465,477,名稱為「穩定之醫藥組合物(Stable pharmaceutical composition)」,於2002年10月15日核發,權利人為興和株式會社與日產化學;

美國專利編號US 8,557,993,名稱為「匹伐他汀鈣之晶型體(Crystalline forms of pitavastatin calcium)」,於2013年10月15日核發,權利人為日產化學。

而Kowa與日產化學在本案起訴之同日,亦針對其他就LIVALOR提出學名藥上市申請的藥廠,例如印度藥廠Zydus Cadila(Cadila Healthcare Ltd.)及其美國分公司Zydus Pharmaceuticals (USA) Inc.(案號為1:14-cv-02760-PAC)、美國藥廠Amneal Pharamceuticals, L.L.C. (案號為1:14-cv-02758-PAC)等,基於本案系爭專利向本案相同法院提起專利侵權告訴。(1152字;表3)

表一、請求項解析

 

US 5,856,336請求項1 US 6,465,477請求項1

1. A compound of the formula,
一種化學式A之化合物

pclass_14_A142a.gif

1. A pharmaceutical composition comprising (E)-3,5-dihydroxy-7-[4'-4"-flurophenyl-2'-cyclopropyl-quinolin-3'-yl]-6-heptenoic acid, or its salt or ester, and a pharmaceutically acceptable carrier, of which an aqueous solution or dispersion of the pharmaceutical composition has pH of from 6.8 to 7.8.
一種醫藥組合物,其包含化學式(E)-3,5-dihydroxy-7-[4'-4"-flurophenyl-2'-cyclopropyl-quinolin-3'-yl]-6-heptenoic之酸、或其鹽類或內脂,以及醫藥上可接受之載體,其中醫藥組合物之溶液或分散液具備6.8至7.8的酸鹼值
請求項 2

pclass_14_A142b.gif

2. A method for reducing hyperlipidemia, hyperlipoproteinemia or atherosclerosis, which comprises administering an effective amount of the compound of formula A as defined in claim 1.
一種減緩高脂血症、高脂蛋白血症或動脈粥狀硬化之方法,其包括投藥有效劑量之如請求項1所定義的通式A化合物

(本專利並無圖式)
US 8,557,993請求項1
1. A crystalline polymorph A, B, C, D, E, F, or the amorphous form, of (3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenye)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic acid hemicalcium salt wherein
一種化學式為(3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenye)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptenoic之庚酸鈣化合物的結晶多形體A、B、C、D、E、F,或其非晶型體,其中

A) polymorph A exhibits a characteristic X-ray powder diffraction pattern (Fig.1) with characteristic peaks expressed in 2θ at 5.0 (s), 6.8 (s), 9.1 (s), 10.0 (w), 10.5 (m), 11.0 (m), 13.3 (vw), 13.7 (s), 14.0 (w), 14.7 (w), 15.9 (vw), 16.9 (w), 17.1 (vw), 18.4 (m), 19.1 (w), 20.8 (vs), 21.1 (m), 21.6 (m), 22.9 (m), 23.7 (m), 24.2 (s), 25.2 (w), 27.1 (m), 29.6 (vw), 30.2 (w), 34.0 (w);
A) 多形體A呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 5.0 (s), 6.8 (s), 9.1 (s), 10.0 (w), 10.5 (m), 11.0 (m), 13.3 (vw), 13.7 (s), 14.0 (w), 14.7 (w), 15.9 (vw), 16.9 (w), 17.1 (vw), 18.4 (m), 19.1 (w), 20.8 (vs), 21.1 (m), 21.6 (m), 22.9 (m), 23.7 (m), 24.2 (s), 25.2 (w), 27.1 (m), 29.6 (vw), 30.2 (w), 34.0 (w)

B) polymorph B exhibits a characteristic X-ray powder diffraction pattern (Fig.2) with characteristic peaks expressed in 2θ at 4.6 (w), 5.3 (vs), 6.2 (s), 7.7 (s), 9.2 (m), 9.6 (m), 10.3 (w), 11.3 (m), 11.7 (w), 12.6 (vw), 13.0 (w), 13.9 (m), 14.7 (vw), 14.9 (w), 15.6 (w), 16.3 (m), 17.0 (vw), 17.4 (vw), 18.0 (w), 18.7 (m), 19.3 (m), 20.0 (s), 20.5 (w), 20.8 (m), 21.2 (w, shoulder), 21.5 (m), 22.4 (m), 23.2 (s), 23.8 (m), 24.4 (vw), 25.2 (w, broad), 26.0 (w), 26.4 (vw), 27.0 (w), 27.9 (vw), 28.9 (w);
B)多形體B呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 4.6 (w), 5.3 (vs), 6.2 (s), 7.7 (s), 9.2 (m), 9.6 (m), 10.3 (w), 11.3 (m), 11.7 (w), 12.6 (vw), 13.0 (w), 13.9 (m), 14.7 (vw), 14.9 (w), 15.6 (w), 16.3 (m), 17.0 (vw), 17.4 (vw), 18.0 (w), 18.7 (m), 19.3 (m), 20.0 (s), 20.5 (w), 20.8 (m), 21.2 (w, shoulder), 21.5 (m), 22.4 (m), 23.2 (s), 23.8 (m), 24.4 (vw), 25.2 (w, broad), 26.0 (w), 26.4 (vw), 27.0 (w), 27.9 (vw), 28.9 (w)
C) polymorph C exhibits a characteristic X-ray powder diffraction pattern (Fig.3A) with characteristic peaks expressed in 2θ at 4.1 (m), 5.6 (s), 7.8 (m), 8.3 (m), 10.3 (m), 11.6 (w), 17.5 (w), 17.9 (w),18.7 (m), 19.5 (s), 20.6 (m), 21.5 (vw), 21.9 (m), 23.1 (m), 24.0 (w), 24.8 (w);
C)多形體C呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 4.1 (m), 5.6 (s), 7.8 (m), 8.3 (m), 10.3 (m), 11.6 (w), 17.5 (w), 17.9 (w),18.7 (m), 19.5 (s), 20.6 (m), 21.5 (vw), 21.9 (m), 23.1 (m), 24.0 (w), 24.8 (w)
D) polymorph D exhibits a characteristic X-ray powder diffraction pattern (Fig.4) with characteristic peaks expressed in 2θ at 5.0 (m), 6.5 (m), 6.8 (s), 8.7 (m), 10.0 (m), 10.2 (m), 10.8 (m), 13.1 (w), 13.5 (m), 14.3 (s), 15.3 (vw), 16.1 (m), 16.8 (w), 18.2 (w), 18.5 (m), 19.0 (w), 19.9 (m), 20.5 (m), 21.0 (vs), 21.7 (s), 22.3 (w), 23.4 (m), 24.0 (m), 25.6 (w), 26.2 (m);
D)多形體D呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 5.0 (m), 6.5 (m), 6.8 (s), 8.7 (m), 10.0 (m), 10.2 (m), 10.8 (m), 13.1 (w), 13.5 (m), 14.3 (s), 15.3 (vw), 16.1 (m), 16.8 (w), 18.2 (w), 18.5 (m), 19.0 (w), 19.9 (m), 20.5 (m), 21.0 (vs), 21.7 (s), 22.3 (w), 23.4 (m), 24.0 (m), 25.6 (w), 26.2 (m)
E) polymorph E exhibits a characteristic X-ray powder diffraction pattern (Fig.5) with characteristic peaks expressed in 2θ at 4.4 (vw), 5.0 (s), 6.6 (s), 6.8 (s), 8.9 (s), 10.0 (m), 10.3 (s), 10.8 (m), 13.3 (s), 13.6 (m), 14.0 (s), 15.2 (vw), 15.9 (w), 16.4 (w), 16.9 (vw), 17.8 (vw), 18.3 (m), 18.9 (w), 20.2 (vs), 20.4 (m), 20.7 (m), 20.9 (m), 21.1 (vs), 21.6 (m), 21.7 (m), 22.3 (m), 23.5 (m), 23.8 (m), 24.1 (w), 24.7 (vw), 25.4 (vw), 26.6 (m), 30.2 (w), 34.0 (vw); and
E)多形體E呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 4.4 (vw), 5.0 (s), 6.6 (s), 6.8 (s), 8.9 (s), 10.0 (m), 10.3 (s), 10.8 (m), 13.3 (s), 13.6 (m), 14.0 (s), 15.2 (vw), 15.9 (w), 16.4 (w), 16.9 (vw), 17.8 (vw), 18.3 (m), 18.9 (w), 20.2 (vs), 20.4 (m), 20.7 (m), 20.9 (m), 21.1 (vs), 21.6 (m), 21.7 (m), 22.3 (m), 23.5 (m), 23.8 (m), 24.1 (w), 24.7 (vw), 25.4 (vw), 26.6 (m), 30.2 (w), 34.0 (vw)
F) polymorph F exhibits a characteristic X-ray powder diffraction pattern (Fig.6) with characteristic peaks expressed in 2θ at 5.1 (m), 5.6 (w), 7.0 (s), 8.8 (m), 9.6 (s), 10.2 (w), 10.9 (m), 11.3 (w), 11.9 (m), 12.5 (m), 13.0 (s), 13.7 (m), 14.4 (s), 14.7 (m), 15.3 (vw), 15.5 (w), 16.8 (m), 17.6 (w), 18.3 (m), 19.3 (m), 19.7 (m), 20.6 (m), 21.2 (vs), 21.8 (s), 22.8 (s), 23.1 (w), 23.8 (w, shoulder), 24.1 (s), 24.8 (s), 25.7 (m), 26.2 (vw), 26.6 (m), 26.9 (w), 28.4 (w), 29.5 (w), 29.8 (vw), 30.9 (m);
F)多形體F呈現一種X光粉末繞射分析之型態,其中峰形表現為2θ at 5.1 (m), 5.6 (w), 7.0 (s), 8.8 (m), 9.6 (s), 10.2 (w), 10.9 (m), 11.3 (w), 11.9 (m), 12.5 (m), 13.0 (s), 13.7 (m), 14.4 (s), 14.7 (m), 15.3 (vw), 15.5 (w), 16.8 (m), 17.6 (w), 18.3 (m), 19.3 (m), 19.7 (m), 20.6 (m), 21.2 (vs), 21.8 (s), 22.8 (s), 23.1 (w), 23.8 (w, shoulder), 24.1 (s), 24.8 (s), 25.7 (m), 26.2 (vw), 26.6 (m), 26.9 (w), 28.4 (w), 29.5 (w), 29.8 (vw), 30.9 (m)
wherein, for each of said polymorphs, (vs) stands for very strong intensity; (s) stands for strong intensity; (m) stands for medium intensity; (w) stands for weak intensity; (vw) stands for very weak intensity.
在對前述個別多形體之描述中,(vs)代表非常強之繞射強度;(s)代表強繞射強度;(m)代表中等繞色強度;(w)代表弱繞射強度;(vw)代表非常弱之繞射強度

pclass_14_A142c.gif

Source: 科技政策研究與資訊中心—科技產業資訊室整理,2014/04

 

表二、專利訴訟案件基本資料:Kowa與日產化學控告友霖

 

訴訟名稱 Kowa Company, Ltd. et al v. Orient Pharma Co., Ltd.
提告日期 2014年4月17日
原告 Kowa Company, Ltd.Kowa Pharmaceuticals America, Inc.Nissan Chemical Industries, Ltd.
被告 Orient Pharma Co., Ltd.
案號 1:14-cv-02759-PAC
訴訟法院 the U.S. District Court for the Southern District of New York
系爭專利 US 5,856,336US 6,465,477US 8,557,993
系爭產品 友霖的學名藥尚未被核准上市,而Kowa所生產的品牌藥LIVALOR,其相關資訊可見:http://livalorx.com/(最後瀏覽日:2014/04/25)
訴狀下載 download.gif

Source: 科技政策研究與資訊中心—科技產業資訊室整理,2014/04

 

表三、Kowa與日產化學所起訴之其他LIVALO學名藥相關專利侵權訴訟

 

日期 案件名稱 被告 案號 訴訟法院 系爭專利
2014年4月9日 Kowa Company, Ltd. et al v. Aurobindo Pharma Limited et al Aurobindo Pharma LimitedAurobindo Pharma USA Inc. 1:14-cv-02497-PAC the U.S. District Court for the Southern District of New York US 5,856,336
US 8,557,993
2014年4月10日 Kowa Company, Ltd. et al v. Aurobindo Pharma Limited et al Aurobindo Pharma LimitedAurobindo Pharma USA Inc. 3:14-cv-02290-PGS-TJB the U.S. District Court for the District of New Jersey US 5,856,336
US 8,557,993
2014年4月14日 Kowa Company,Ltd. et al v. Mylan, Inc. et al Mylan, Inc.Mylan Pharmceuticals, Inc. 1:14-cv-02647-PAC the U.S. District Court for the Southern District of New York US 5,856,336
US 6,465,477
US 8,557,993
2014年4月17日 Kowa Company, Ltd. et al v. Amneal Pharamceuticals, L.L.C. Amneal Pharamceuticals, L.L.C. 1:14-cv-02758-PAC US 5,856,336
US 8,557,993
Kowa Company, Ltd. et al v. Zydus Pharmaceuticals (USA) Inc. et al Zydus Pharmaceuticals (USA) Inc.Cadila Healthcare Ltd. 1:14-cv-02760-PAC US 5,856,336
US 6,465,477
US 8,557,993
Kowa Company, Ltd. et al v. Mylan Inc. et al Mylan Inc.Mylan Pharmaceuticals Inc. 2:14-cv-00504-AJS the U.S. District Court for the Western District of Pennsylvania US 5,856,336
US 6,465,477
US 8,557,993
2014年4月18日 Kowa Company, Ltd. et al v. Amneal Pharmaceuticals, LLC Amneal Pharmaceuticals, LLC 3:14-cv-02488-PGS-TJB the U.S. District Court for the District of New Jersey US 5,856,336
US 8,557,993
2014年4月22日 Kowa Company, Ltd. et al v. Zydus Pharmaceuticals (USA) Inc. et al Zydus Pharmaceuticals (USA) Inc.Cadila Healthcare Ltd. 3:14-cv-02552-PGS-TJB US 5,856,336
US 6,465,477
US 8,557,993

Source: 科技政策研究與資訊中心—科技產業資訊室整理,2014/04

2014

09-05友霖結盟Actavis搶攻抗血脂藥學名藥Pitavastatin

原告: 友霖結盟Actavis

友華集團旗下友霖生技(Orient Pharma)於2014年9月4日宣布,與全球第3大藥品製藥商Actavis正式簽約,聯手拓展降血脂學名藥Pitavastatin的美國市場,也是友霖向美國FDA提出的第1個挑戰第4類學名藥(P4) 之專利學名藥。

友霖一旦挑戰專利成功,取得美國FDA核發之藥證,就能於美國市場擁有180天獨家專賣權。友霖與Actavis未來將共同面對挑戰專利的經費與司法程序。

友霖指出,與Actavis合約生效後,友霖將依據合約在不同里程碑向Actavis取得授權金。藥品核准上市後,友霖擁有藥證與專利技術獨佔權,並負責藥物生產製造,Actavis將負責全美的通路與銷售,銷售利潤則由雙方共享。

看好Pitavastatin在美國降血脂藥品市場的發展潛力,友霖結合Actavis在挑戰第4類學名藥的豐富經驗,以及在全美擁有完整藥品行銷通路之優勢。一旦挑戰專利成功 可藉由Actavis提早完成的通路佈建,搶攻每年約1.55億美元的商機。

Actavis為美國上市製藥公司,總部位於愛爾蘭都柏林,專門致力於研發、製造與銷售高品質且價格合理的學名藥以及創新產品給全球病患。



 
歡迎來粉絲團按讚!
--------------------------------------------------------------------------------------------------------------------------------------------
【聲明】
1.科技產業資訊室刊載此文不代表同意其說法或描述,僅為提供更多訊息,也不構成任何投資建議。
2.著作權所有,非經本網站書面授權同意不得將本文以任何形式修改、複製、儲存、傳播或轉載,本中心保留一切法律追訴權利。