【摘要】：新藥的開發(fā)需要大量的投資,持續(xù)有效的專利保護(hù)是制藥行業(yè)保障藥品銷量的一個重要因素。本文將介紹美國藥物相關(guān)專利保護(hù)政策,企業(yè)通過制定有效的專利保護(hù)策略和產(chǎn)品發(fā)展戰(zhàn)略,充分運(yùn)用藥品專利保護(hù),保障新藥的銷售和利潤,延長銷售平穩(wěn)階段的時間,從而將該藥物的收益最大化。本文淺析我國制藥企業(yè)專利保護(hù)的反思與啟示。進(jìn)取型策略是指,制藥企業(yè)在原研產(chǎn)品專利保護(hù)期內(nèi),不斷開發(fā)研究新的化學(xué)藥物成分,不斷申請新的輔助專利,并充分利用現(xiàn)有專利保護(hù)體制,最大限度延長專利保護(hù)期,鞏固市場領(lǐng)導(dǎo)地位,抗擊并阻止仿制藥的上市。專利保護(hù)期的后期階段,仿制藥紛紛提交簡約新藥申請ANDA;此時防守型策略需要原研企業(yè)采取行動計(jì)劃,防備仿制藥上市及其收益,這些策略有助于延續(xù)原研產(chǎn)品的收入。包括專利侵權(quán)訴訟、授權(quán)仿制藥、OTC轉(zhuǎn)換、橙皮書除名。收入最大化策略,是指藥品已過專利保護(hù)期,通過再次開發(fā),結(jié)合專利申請策略,有效延長產(chǎn)品生命周期,與仿制藥直接競爭的策略。本文主要討論三種專利保護(hù)策略:進(jìn)取型策略、防守型策略、收入最大化策略,很多產(chǎn)品應(yīng)用策略獲得商業(yè)成功。然而藥物研發(fā)實(shí)踐不斷發(fā)展,企業(yè)必須不斷調(diào)整其專利保護(hù)策略,必須關(guān)注并考慮這些影響未來保護(hù)策略的因素。
[Abstract]:The development of new drugs requires a large amount of investment, and effective patent protection is an important factor to ensure drug sales in pharmaceutical industry. This article will introduce the United States drug related patent protection policy. By formulating effective patent protection strategies and product development strategies, enterprises will make full use of drug patent protection, ensure the sale and profit of new drugs, and prolong the time of smooth sales. In order to maximize the benefits of the drug. This paper analyzes the reflection and enlightenment of patent protection in Chinese pharmaceutical enterprises. Aggressive strategy means that during the patent protection period of original products, pharmaceutical enterprises continuously develop and study new chemical components, continuously apply for new auxiliary patents, make full use of the existing patent protection system, and extend the patent protection period to the maximum extent. Consolidate market leadership to combat and prevent the marketing of generic drugs. At the late stage of patent protection, generic drugs apply for ANDA.At this time, the defensive strategy requires the original research enterprise to take action plan to guard against the listing of generic drugs and their income, which helps to continue the revenue of the original product. Including patent infringement litigation, authorized generic drug OTC conversion, orange book delisting. Revenue maximization strategy refers to the strategy of extending product life cycle effectively and competing directly with generic drugs through re-development and patent application strategy. This paper mainly discusses three kinds of patent protection strategies: aggressive strategy, defensive strategy, revenue maximization strategy, and many product application strategies to obtain commercial success. However, with the continuous development of drug research and development practice, enterprises must constantly adjust their patent protection strategies, and must pay attention to and consider these factors that affect the future protection strategies.
【學(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前9條

1 許美婷;薛云麗;楊悅;;美國Rx-OTC轉(zhuǎn)換審評中消費(fèi)者行為研究對我國的啟示[J];中國藥物警戒;2015年01期

2 陳嬌;王玉麗;徐為人;湯立達(dá);;美國橙皮書制度給我國發(fā)展通用名藥的啟示[J];現(xiàn)代藥物與臨床;2012年05期

3 Garth Boehm;姚立新;韓亮;鄭強(qiáng);;美國仿制藥行業(yè)發(fā)展頭25年的經(jīng)驗(yàn)教訓(xùn)[J];中國新藥雜志;2012年16期

4 劉立春;朱雪忠;;專利懸崖期的授權(quán)仿制藥發(fā)展及其對制藥行業(yè)的影響[J];情報(bào)雜志;2012年06期

5 余煊強(qiáng);張清;阮文興;;美國FDA仿制藥的法規(guī)及審批程序[J];中國處方藥;2008年09期

6 余煊強(qiáng);張清;阮文興;;美國仿制藥的歷史演變[J];中國處方藥;2008年09期

7 劉瑩;梁毅;;論藥品可及性與藥品專利保護(hù)[J];中國藥房;2007年13期

8 周和平;藥品知識產(chǎn)權(quán)保護(hù)的策略與技巧[J];中國藥科大學(xué)學(xué)報(bào);2003年01期

9 趙煉鋼;企業(yè)生命周期及戰(zhàn)略應(yīng)用[J];企業(yè)研究;2002年07期

，

本文編號：2194683