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台灣學名藥廠研發管理之研究陳致福 Unknown Date (has links)
所謂的學名藥即是俗稱的專利過期藥,指與專利藥物的化學組成相同,但在專利過期後推出的藥物。開發專利過期藥與利用專利過期藥開發新劑型或新適應症藥物比開發完全的新藥開發花費少,風險低,而帶來的價值卻很大。以目前台灣製藥產業規模及投資環境而言,要開發新藥的困難度相當高,而學名藥提供了相對低的進入障礙比較適合台灣藥廠開發,所以利用學名藥開發新產品是比較適合台灣藥廠現階段發展目標應該著力的重點。
本研究主題主要在探討台灣學名藥產業之研發管理的行為,選取的研究對象為台灣具有研發學名藥能力之藥廠,以企業層次來進行分析,而其中所選取的廠商皆是在該領域表現優良的廠商,本研究選定個案公司的準則,依營業額規模區分為大中小三區塊,以期能代表產業實際狀況。
研究發現台灣學名藥廠在產品研發專案類型上,依其是否擁有製造的領導地位,大致上會分為模仿型與改良型兩類;在產品開發的選擇中,擁有製造優勢的藥廠會開發較多疾病類別的產品,以增加營業額,而較不具有製造優勢的廠商則會鎖定特定類別的產品開發,以此達到規模經濟。至於在策略定位上呈現領導與跟隨兩種類型,具有製造優勢者會選擇跟隨的類型,以此策略侵蝕原開發廠商的市場。而具有技術研發優勢的廠商會選擇領導策略,以差異化的策略避開競爭。
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WTO架構下為解決國際公共衛生危機之強制授權制度研究姜璿 Unknown Date (has links)
公共健康與藥品專利之間的衝突與調和,一直是世界貿易組織(World Trade Organization,以下簡稱WTO)各會員國所關注的焦點;儘管全球經濟發展迅速,但多數低度開發及開發中國家,卻因為無法獲得足夠且平價的醫療資源及藥品,而有大量人口死於可治療之疾病,人類最基本的健康權在該些國家境內仍無法獲得基本的保護;故WTO 在2001、2003及2005年分別通過數個宣言及決議,試圖透過該些決議,來解決該些國家境內日益嚴重的公共健康問題,並試圖調和藥品專利保護與公共衛生間的衝突。然而,該些決議仍必須透過各國修正內國法律來加以實踐,故本文以加拿大和印度之內國法修正為例,分析後發現該些國家修正專利相關法規後所建立之學名藥品出口機制對於解決上述公衛問題之效果其實相當有限,再加上始終對強制授權機制持反對意見的美國,透過其於國際社會強大之影響力,進一步的阻礙了各國的實踐,故WTO允許透過強制授權出口平價學名藥品至不具製藥能力國家之機制,對於落後國家之實際影響,仍有待未來進一步的觀察。
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Genedex co. 營運計畫書 / Genedex co. business plan王熙婷, Wang, Kate Unknown Date (has links)
Aging population is becoming the potential social and economic problem for many governments all around the world. These countries including Taiwan are seeking for solutions for the increased healthcare spending. According to the United Nations’ population estimates, we are living in a rapidly aging world. The global share of what we call “senior” or people age over 65 is expected to rise from nearly 8% in 2015 to more than 14% by 2050. The situation in Taiwan is not much different. With increasing life expectancy and a birth rate that continues to decline, the aging population in Taiwan has become more and more obvious.
Widespread adoption of Generic and Biosimilar drugs, as opposed to patented or brand name drugs, could help governments reduce healthcare costs and increase the reach of healthcare services. Patented drugs in the prescription drugs segment account for about 70% of total prescription spending in Taiwan. However, the share is set to decline gradually under pressure from government policies promoting the use of generic products and the increasing switches from prescription segment to OTC segment (RX-to-OTC). We expect the penetration of generic drugs in Taiwan OTC drugs segment to increase as the generic drug market has continued to gain prominence within the pharmaceutical sectors in recent years.
Despite the fact that OTC generic drug market is a highly competitive market in Taiwan, Genedex Co. still aims to provide good quality generic drugs at a competitive price to meet the generic drugs demands. In addition, Genedex Co. understands the ability to quickly bring new products to the market will play a large role in the future success. Thus, product innovation and differentiation will also be the center focus in the business model. Looking into the future, Genedex Co. expects to see growth at a more rapid pace starting from year 2020 as newly developed generic OTC drugs will be introduced to the market to compete with the branded counterparts and also expects to achieve a more solid presence in the market by year 2021.
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製造業服務化之研究-以藥廠為例 / A study on the servitization of manufacturing – a case of a pharmaceutical company杜明哲 Unknown Date (has links)
國際經濟環境的變遷脈動與發展趨勢,牽動我國產業未來發展方向,在全球產業環境日益變遷下,台灣未來將朝「製造業服務化、服務業科技化與國際化、傳產業特色化」之「三業四化」產業策略來發展,其中在「製造業服務化」,則以產品為中心的製造轉為以服務為中心導向的思考模式,製造業者不再只是單一產品供應者,而是提供一系列滿足客戶需求的服務,透過服務來凸顯產品差異化,進而增加客戶的黏密度,創造更高的附加價值。製造業服務化就是製造業為了獲取競爭優勢,將價值鏈由以製造為中心向以服務為中心轉變。
面對愈來愈多企業重視「服務化」的議題,台灣製造業也應改變經營策略,從產品製造導向轉變為服務導向,才能在激烈的全球化競爭中永續生存。趕上產業升級轉型的世界潮流,台灣已有不少成功執行製造業服務化的業者,在高科技產業中最為成功的案例,就是從10幾年前就力行服務化的台積電。而製藥業中,葡萄王生技從傳統製藥業,一路走向生機飲料生產到成為生物科技公司,也是非常成功的例子。再看傳統工業製造中,素有扣件王國之稱的台灣,在握有全球龐大扣件市場之後,更有多家公司積極轉型為服務業,成功跨入醫療器材產業。
本論文以T藥廠為例,分析從傳統學名藥製造廠,經歷了毛利下降導致虧損的改組轉型,初步降低成本,對藥證、客戶、業務員、工廠原物料、包材去蕪存菁留存重點,轉虧為盈,進一步朝服務化轉型,建立品牌學名藥、強化研發實力、拓展各項專注領域、人文與科技平衡、開創國際化新局,成就穩定的營收金流,現今以落實藥品劑型便民化、藥品便民包裝、製造搭配業務、行銷、跟診服務、專業代工接單製造、In-licensing & out-licensing、建立大客戶關係管理體系提供客戶全面解決方案及產業一條龍的再造:研發、製造、銷售、服務的服務化作為,未來進一步全面轉型製造業服務化的願景為佈局全球市場,包含製造國內自營或外銷產品、代理國外藥品進口或出口、接單國際藥廠委製訂單,同時朝新藥研發邁進,以T藥廠既有強項著手新劑型平台藥品開發、新覆方藥品開發及臨床試驗、新療效適應症臨床試驗查登等,最終朝新成分新藥開發邁進,成為一全球性大藥廠。
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從專利法規與國際藥廠實務變革論台灣藥廠之未來競爭策略 / Competition Strategy of Pharmaceutical Industry in Taiwan based on Changes of Patent law and Practice of International Phamaceutical Companies賴怡臻, Lai,yi chen Unknown Date (has links)
在全球一片經濟不景氣的環境下,IMS 仍預測2009年全球藥品市場將會成長4.5-5.5%達到8200億美金,這顯示醫藥產業是一個值得投入的領域,台灣政府亦透過政策大力扶植醫藥產業發展,但是醫藥產業知識密集度高,投資金額高,開發時程長,失敗風險也高,台灣醫藥企業要如何擬定經營管理策略,將是影響成敗的重要因素。本文的目的是提出適合台灣藥廠的經營管理策略。
目前國際醫藥產業概況為,受到藥品安全事件影響,FDA對新藥審查越趨嚴格,加上研發新藥的投資成本越來越高,在得到明星新藥的速度追不上失去暢銷藥速度的壓力下,國際藥廠開始削減成本,將部分研發工作分工委外,進行企業聯盟與購併,以充實專利技術與產品版圖;由於眾多專利暢銷藥喪失專利,與政府鼓勵使用低價藥,學名藥市場備受看好。台灣醫藥產業多屬中小型企業,資金與研發能量不足,因此發展學名藥是第一項建議的策略。舊藥新用可以降低研發失敗風險與成本,是第二項建議的策略。技術移轉與授權是第三項策略,由外引進技術可以解決研發能力不足的問題,對外授權技術可以解決資金不足以撐完研發全程的問題,順應國際藥廠分工委外的趨勢,在醫藥產業生態鏈中合適的點進場與出場,能避免資金不足,減輕研發失敗的負荷。
學名藥廠如果能夠提早學名藥上市的時間就能增加獲利,熟悉簡易新藥申請程序、專利延長與資料專屬權保護規定對於學名藥上市時程的規劃有很大的幫助。美國最高法院對Merck v. Integra 的判決擴張藥物研發實驗實施免責權,鼓勵使用他人具專利的化合物進行與藥物審查相關的臨床前期試驗,有利於開發既有藥品的新用途,台灣的專利法相關規定亦在研討修法,希望結果對台灣藥廠採取舊藥新用的策略有所幫助。依據公司專長,研發能力強的公司可以將臨床前期獲得的專利技術授權給國際藥廠,而擅長臨床試驗的公司可以由外授權引進專利候選藥物在台灣進行臨床試驗,之後再對外授權,政府亦頒訂生技新藥產業發展條例,幫助企業應用技術移轉與授權找到生存的利基點。熟悉並活用法律知識是發展醫藥產業必備的工具。 / Even though people are worried about global economy recession, IMS still optimistically predicts that global pharmaceutical market will have 4.5 – 5.5 Percent growth in 2009, exceeding $820 billion. It means that pharmaceutical industry is a field worth investigating. The Taiwan government also provides fully support for pharmaceutical industry development through laws and regulations. However pharmaceutical industry is characterized for requiring high technology, lots of money, long developing time, and high risk of failure. The strategies pharmaceutical companies token will influence their fate to success or failure. The goal of this thesis is to propose suitable management strategies for Taiwan pharmaceutical industry.
After several drug safety related incidents in recent years, FDA becomes more conservative and blocks new drug approval. More over, it takes more money to investigate a new drug, and the speed of getting new drugs can not catch up the speed of losing patent of blockbuster drugs. Under such huge pressure, international pharmaceutical companies adopt strategies as outsourcing part of drug developing work to achieve cost down. They also conduct strategic alliances and mergers, which can enrich their patents and products portfolio. Generic drug has great market potential because of several blockbuster drugs losing patents and government favoring cheap drugs. Pharmaceutical companies in Taiwan are all small and medium size enterprises. Their research capacity and capital are insufficient. So the first recommended strategy is developing generic drugs. The second strategy is drug repurposing which can minimize the risk of failure. The third strategy is technology transfer and licensing. Complying with the trend of outsourcing, Taiwan companies can adopt technology transfer and licensing strategy and determine proper points to enter and out of the chain of drug development. Licensing-in can resolve the problem of insufficient research capacity. License-out can prevent shortage of money.
If a generic drug company can advance the timing to launch generic drug, it can earn more money. Thus well study of Abbreviated New Drug Applications, patent term expansion and data exclusivity can help plan market schedule. The Supreme Court decision in Merck v. Integra expands the protection of Safe Harbor which exempted from infringement all uses of patented compounds "reasonably related" to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs. Using patented compound in pre-clinical trials is exempted and it encourages drug developer to use patented compound owned by other companies to explore new usage. The patent ruling law experiment exemption in Taiwan needs further discussion and amended. Hope the result of amendment can help drug repurposing strategy in Taiwan. Research oriented company can license out patented result to big pharmaceutical companies, while companies good in clinical trial study can license in patented drug candidate and do clinical trial in Taiwan. Taiwan Government also set rules to encourage pharmaceutical companies to adopt technology transfer and licensing. Having well knowledge relating to drug approval and patent law is a must to run a successful pharmaceutical company.
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原開發藥廠因應學名藥廠競爭之經營模式調整之研究 / The study on the adjustment of research-based pharmaceutical companies’ operating model against generic manufacturers’ competition藍任堯 Unknown Date (has links)
全民健康保險制度在台灣開辦以來已經快二十年了,在全民都有保險、給付的範圍從基礎到複雜的醫療照護完整、合約醫療機構相當普遍、就醫的方便性等,得到大多數台灣民眾的肯定。
但全民健保這一路實施下來卻為台灣帶來的龐大國家赤字。健保局針對於每年五千餘億的健保費用其中的藥品費用(為第二大支出,占了其中的25%)多次長期進行多種的藥費及藥價管控措施,低廉的新藥核價加上每兩年的藥價調查後的藥價調降,國外藥廠除了要配合健保的藥價政策外,還需要面對醫療機構對於現有藥品再降價的要求。長久下來,藥廠利潤逐年下降影響甚劇。
其中以今年七月所要實施二代健保中「藥品三同」對於原開發藥廠藥衝擊最大。衛生署所實施的三同政策,即是針對健保給付超過15年的藥品,實施「同成分」、「同品質」、「同價格」,調整為同價格。此一政策倘若實施,原開發藥廠利潤嚴重下降,可能會導致會放棄台灣市場,民眾只剩下國產學名藥可以選擇。再者,三同政策最大的瑕疵,在於只單方面考慮健保給付的藥價,卻忽略了藥廠製藥成本,此舉明顯不顧成本不同卻硬性規定價格,明顯違反市場機制,也違反健保精神。
專利藥到期的原開發藥藥廠要如何因應以縮小品質及價格的爭端,只著眼於一昧砍藥價來填補健保財務虧損,不仔細思考同成分就一定同品質的問題而將藥品砍至同一價格的健保署藥物品質認定及給付標準。
本研究探討之研究問題包括: 1)在台灣健保逐年調降藥價的政策下藥品三同政策前,原開發藥廠在台的經營模式為何,2)在政府政策培育下的學名藥如何日益茁壯來影響專利藥到期的原開發藥廠市場活動,3)藥品三同政策實施後對專利藥到期的原開發藥廠的衝擊4)主要獲利的專利藥品皆到期的台灣武田藥品公司未來的經營模式從主要價值活動面該如何調整因應。
本研究以Afuah A.(2004)經營模式架構,先從過去健保政策下原開發藥廠的營運模式做說明,再以目前健保政策環境因素的變化,如何影響個案公司的市場行銷活動,而活動又如何影響公司的資源、定位及成本。
本研究發現「藥品三同」對台廠學名藥因具有較佳的成本競爭優勢,對原開發藥廠產生威脅,但因原料的不穩定性讓病患、處方醫師無法信任。所以原開發藥廠除了監督政府長期對學名藥廠品質加以把關、用訴訟延緩學名藥的上市外、另外一方面併購國內學名藥廠,以配合醫療院所對於低價高品質藥品的需求。最後,專利藥到期的原開發藥廠從健保政策中與學名藥廠價格競爭獲得利潤,就必須改變營運模式,首要的就是降低成本。如何從採購及製造方面有效降低成本著手,進一步調整有形、無形資產投入、人員配置培養與組織等策略資源,以及定價、市場區隔等定位修正,是原開發藥廠需要深入思考的問題。 / National Health Insurance (NHI) program has been implemented in Taiwan for almost 20 years. It has earned recognition for the compulsory enrollment for all residents in Taiwan, the benefits covered from basic to complicated medical care, the prevalence of contract medical facility and the convenience of going to doctors.
NHI, however, has caused fiscal deficit for the past few years. Drug cost, among the over 500,000,000,000 NTD health insurance fee, is the second largest expenditure, which takes up 25 percent of health insurance fee. Therefore, Bureau of National Health Insurance has taken measures to manage and control drug cost and drug price multiple times for a long period. Foreign pharmaceuticals have cooperated on the low-priced pricing for new drugs and have lowered drug price after drug price evaluation every two year. However, there is still demand from medical institution for lowering drug price. The profit is therefore significantly affected in the long run.
Among the impacts, the significant one for research-based pharmaceutical companies is “three sameness of drug” in the 2nd generation NHI, which will be implemented in this coming July. This three sameness policy is to adjust those drugs which are covered by NHI for over 15 years and are of the same ingredients and quality to the same price. If this policy is put into practice, the profit of research-based pharmaceutical companies would plunge, which may result in their leave of Taiwan market. The domestic generic drugs, as a result, would be the only choice for the general public. Moreover, the major flaw of this three sameness policy is that it merely considers the drug price NHI covers, not the costs of pharmaceutical companies. That the drug price is set inflexibly without taking costs difference into consideration is against not only market mechanism but also the essence of NHI.
The questions this study aimed to investigate were: 1. What have been the operating models of research-based pharmaceutical companies in Taiwan in the circumstances of drug price drop year by year before “three sameness policy”? 2. How have the government-sponsored generic drugs affected the market activities of drug patent expiration of research-based pharmaceutical companies? 3. What have been the impacts of “three sameness policy” on drug patent expiration of research-based pharmaceutical companies? 4. How should the operating model of Takeda Pharmaceuticals Taiwan, Ltd. adapt to, from the aspect of primary value activities, the condition of drug patent expiration of its profitable drugs?
Based on the framework of operating model by Afuah A.(2004), this study began with the operating model of research-based pharmaceutical companies in former NHI policy. It then elaborated on how changes of the present NHI policy have influenced the marketing activities of the case company and how these activities have influenced the company’s resources, position and costs.
This study reveals that “three sameness policies” is favorable for Taiwanese generic manufacturers for their costs competition. However, the instability of raw materials could not gain the trust of patients and doctors. Therefore, in order to cooperate on the demand for low-price and high-quality drug, researched-based pharmaceutical companies supervise the government’s check on the quality of generic manufacturers, employ litigation to suspend the launch of generic drugs or merge domestic generic manufacturers. If research-based pharmaceutical companies with drug patent expiration would like to compete with generic manufacturers and make a profit in NHI policy, they would have to change their operating model. How to reduce costs of purchase and manufacture and go further to adjust the input of physical and intangible assets, strengthen professional training of personnel and organization and modify strategies for pricing and market segmentation are the main issues worth considering.
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處方藥品試驗資料保護之研究─以資料專屬權為中心 / The Protection for Test Data of Prescription Drugs- an Analysis of Data Exclusivity楊代華, Yang, Tai-Hua Unknown Date (has links)
在歐美國家的強大貿易談判壓力下,我國立法院於民國九十四年一月二十一日完成藥事法第四十條之二的立法,同年二月五日由總統公布實施,進入實施資料專屬權制度的時期。
資料專屬權乃以處方藥品試驗資料為保護對象,由美國首先立法,利用貿易談判、國際協定向外推動的法律制度;美國對於新成分新藥及非新成分新藥、補充申請之試驗資料,分別賦予五年及三年的保護,於此資料專屬權期間內,其他藥廠不得使用或援引試驗資料權利人的試驗資料提出新藥上市申請。本文參酌美國最高法院於EPA v. Monsanto案例之見解,認為資料專屬權制度之法理基礎,乃係對於試驗資料權利人營業秘密之保護,以防止來自其他藥廠之不公平競爭;這項制度之經濟上意義,則在於藉由賦予藥品試驗資料權利人一段資料專屬權期間,要求學名藥廠必須進行其考量本身資力及市場後,不可能自己實施的藥品安全性及有效性試驗,使因而間接獲得市場獨占利益的試驗資料權利人,得到足以回收其藥品試驗資料投資之機會。
TRIPS第三十九條第三項規範保護藥品試驗資料的國際最低標準,它的保護標的限於藥廠為了取得於申請國第一次提出之「新化學成分」藥品之上市許可,所提出其花費相當時間、金錢始取得,而未經揭露之必要試驗或其他資料。會員國對於符合此項條件之資料,負有避免其被不公平商業使用之義務。本文認為所謂「不公平商業使用」,係指未提供藥品試驗資料權利人回收其對於試驗資料所為投資之機會,所為客觀上足以使得他人自其試驗資料獲得商業上利益的一切使用或應用試驗資料的行為;所以如果政府機關於「參考」藥品試驗資料權利人所提出藥品試驗資料時,未提供任何使其得以回收對於試驗資料所為投資之機會,即應認為政府機關此等參考行為,屬於「不公平的商業使用」行為。因此,資料專屬權制度可謂符合TRIPS第三十九條第三項所規範保護藥品試驗資料之標準;但如果會員國能夠建立另外一套賦予藥品試驗資料權利人回收其對於藥品試驗資料所為投資機會之制度,同樣也可以符合TRIPS第三十九條第三項的最低保護標準,並不一定必須採取資料專屬權之保護模式。
我國新修正藥事法第四十條之二採行資料專屬權制度,相關條文規定多有闕漏,本文認為新修正藥事法第四十條之二第一項之保護客體,應以「新成分新藥」之查驗登記申請人本身享有權利,為通過查驗登記所提出,且支付相當成本所取得之尚未公開營業秘密資料為限。第四十條之二第二項、第三項之保護方式,則係規定學名藥品於原廠藥品上市後滿三年,始得引據其查驗登記申請資料提出查驗登記申請,且滿五年之後,始能取得藥品許可證。至於第四十條之二第四項有關外國上市新藥的准用規定,可謂缺乏法理依據及執行可能,且實際上也不會發生任何效用的條文,建議應予刪除。
藥品試驗資料屬於原廠所有無形資產,提供適當保護以維公平競爭,有其正當性,但無論自藥品試驗資料之公益屬性、重複試驗的人道問題、重複試驗與獨占市場缺乏經濟效益等觀點來看,資料專屬權制度都有相當的負面影響,所以一套可以提供藥品試驗資料權利人回收其對於藥品試驗資料所為投資,且可以避免重複試驗或市場壟斷之「補償」制度,應有必要。
依據哈佛大學Aaron教授對於學名藥廠應分擔原廠藥品試驗資料投資之補償金,所提出的可重新調整補償金模式,每個學名藥廠都可以依據當時在市場上的學名藥廠總數,平均分擔其當年度應支付原廠的補償金比例,每個適用這套計算補償金架構的國家,都可以依據其國家學名藥產業及藥品市場的發展狀況,設定適當之參數,本文以為,乃足以替代資料專屬權制度之最佳選擇。
至於應該如何計算藥品試驗資料之成本,本文則提出下列公式:
( S )
C = --------------------------------- x ( N ) + H
S +S1+S2+˙˙˙
C:學名藥廠應分擔原廠試驗資料成本之範圍。
N:原廠於第一個申請上市國家所花費的試驗資料成本。
H:原廠於學名藥申請上市國家所花費的試驗資料成本。
S:學名藥申請上市國家的國民生產毛額(GDP)。
S1+S2+˙˙˙:由主管機關所核定包括第一個申請上市國家的世界主要藥品市場國的GDP總和。
亦即本文認為,發生在學名藥申請上市國家的藥品試驗資料成本,應該全額列入學名藥廠應分擔成本的範圍;發生於第一個申請新藥上市國家的藥品試驗資料成本,則應該由每個學名藥申請上市國家的學名藥廠,依據該國GDP(表彰藥品支出費用)占世界主要藥品市場(包括第一個上市國家)各國GDP總和的比例,分攤其應負擔之部分。
因此,本文認為,以本文建議之計算公式核算各國應分擔之藥品試驗資料成本,並以「可重新調整補償金模式」之公式計算各學名藥廠每年應支付之補償金,應係較佳之保護藥品試驗資料模式。
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專利法及藥事法上實驗例外之研究─以製藥產業為中心 / The Research of Experimental Use Exception on Patent Law and Pharmaceutical Affairs Act -Especially in Pharmaceutical Industry孫小萍, Sun, Hsiao-ping Unknown Date (has links)
專利權具有獨占性,對一國產業發展具有重要影響,為了平衡該權利,各國專利法在給予發明人專利權的同時也加諸某些限制,以我國為例,於專利法第五十七條第一項列舉專利權效力所不及之情形有:(一)為研究、教學或試驗,實施其發明,而無營利行為者。此即所謂之「實驗例外」 (experimental use exception)條款。
實驗例外條款在各國司法實務運作上,最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。因為學名藥廠為了能夠盡早進入市場,不免須在專利期間屆滿前實施原廠專利進行必要之研究、試驗,以符合各國對於藥物上市管理法令之要求。
雖然我國專利法與其他國家一樣也有試驗例外條款,但其中要件嚴格限定為「非營利行為」,從比較法之方式分析,該規定係受美國普通法之影響。美國普通法關於試驗例外係採取嚴格路線,必須行為人之試驗係出於非營利目的,單純追求真相、探求知識理論,或為滿足好奇心,才可主張普通法上之實驗例外,即始係不具營利色彩之公家機關、學術單位從事之試驗,只要背後具有實質的商業目的亦不得主張試驗例外。如此造成要成功適用試驗例外是愈來愈不可能。
國際間對於試驗例外之立法,除美國外,尚存在許多形式值得我國借鏡,以歐洲共同體專利規則草案(Proposal for a Council Regulation on a Community Patent)為例,其區分「私人且非商業性目的之行為」,以及「為試驗目的之行為」,後者要求必須係針對系爭專利技術本身所進行之試驗始非專利權效力所及,若係將該專利技術作為研究工具之用,仍非法之所許。這種區分方法不僅層次分明、無觀念上混淆之虞,判斷上也較具有可預測性。
美國於1984年通過Hatch-Waxman 法案鼓勵學名藥之發展,對於為滿足主管機關關於醫藥品上市要求之試驗,在專利法271(e)(1)明文規定排除在專利權效力之外,即所謂之「Bolar例外」。我國於九十四年二月五日亦增訂藥事法第四十條之二第五項:「新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗」關於Bolar例外之規定。惟或因立法匆促,致法條要件不符合實際狀況,例如限定「申請查驗登記前」之行為,實際上藥廠於提出查驗登記之申請後,往往在主管機關之要求下須進行其他試驗,這些行為均在立法者原欲保護之範圍內,僅因立法用語之不當,造成實務運用之困擾。
筆者最後從法律及商業管理觀點著眼,對國內立法提出下列修法建議,作為本研究之最終成果:
壹、對於專利法第五十七條第一項第一款修法之建議
一、刪除「教學」之行為態樣
二、刪除「而無營利行為」之要件
三、增列關於研究工具之專利則無本條之適用
四、放寬適用範圍為符合主管機關法規要求而實施他人專利亦有實驗例外之適用。
贰、對於藥事法修法之建議
一、刪除「申請查驗登記前」之要件,改以行為目的來限定範圍,即「為通過藥品查驗登記所進行之研究或試驗」,始有本款之適用。
二、明定「物品專利」及「方法專利」均有本條之適用
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論製藥產業之實驗實施免責 / The Experimental Use Exemption of Pharmaceutical Industry張睿麟, Chang, Jui Lin Unknown Date (has links)
隨著醫療科技的進展,人類對於疾病的成因、機轉、病程、及治療,在不斷地研究突破下,有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品,正是人類對抗疾病最關鍵、也最普遍的方式之一,對公共衛生的重要性自不待言。
其中,由於生命科學的本質使然,開發新的藥品對於研究發展的倚賴,遠勝於其他產業,因此,創新研發藥廠對於開發一項新藥的平均投資,已達十三億美元之譜;此外,由於藥物對人體的生理功能、體內恆定能造成極大的影響,因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制,使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間,使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而,因為智慧財產之保護,也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一,亦為世界各國所大力推動。在推動學名藥產業上,實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究,美國普通法上以及成文法上實驗實施免責的探討,我國實驗實施免責之規定與判決之研究,來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題,以及相對應的可能改進方案。
本文第二章本章先行探討製藥產業之特質;第三章討論美國普通法上實驗實施免責之概念,並歸結出美國普通法上實驗實施免責的三項適用要件;第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響;第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定,並由學者論述以及相關判決中,探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題,並提出可能之解決方案。 / With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt.
Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems.
The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.
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