【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(gè)重要因素。本文將介紹美國(guó)藥物相關(guān)專利保護(hù)政策,企業(yè)通過(guò)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(rùn),延長(zhǎng)銷售平穩(wěn)階段的時(shí)間,從而將該藥物的收益最大化。本文淺析我國(guó)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(qǐng)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(zhǎng)專利保護(hù)期,鞏固市場(chǎng)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(jiǎn)約新藥申請(qǐng)ANDA;此時(shí)防守型策略需要原研企業(yè)采取行動(dòng)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(guò)專利保護(hù)期,通過(guò)再次開發(fā),結(jié)合專利申請(qǐng)策略,有效延長(zhǎng)產(chǎn)品生命周期,與仿制藥直接競(jìng)爭(zhēng)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(lái)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(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R95

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