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台灣報紙產品市場競爭行為分析(1988-1999)譚士屏 Unknown Date (has links)
本研究從產業經濟學的「結構-行為-績效」架構與寡占理論中汲取對競爭行為的認知。將研究焦點鎖定在報紙產品市場最普遍也最主要的三種競爭行為:內容競爭、價格競爭與促銷競爭三者進行研究。研究對象則是以台灣報業市場中九家主要報紙,分屬三種不同屬性:綜合性報紙(中國時報、聯合報、自由時報、中央日報、台灣日報)、經濟專業性報紙(經濟日報、工商時報)、大眾娛樂性報紙(民生報、大成報),除此之外內容上相同屬性的報紙,彼此之間還有特性上的差異,以利研究不同屬性與特性報紙在競爭行為上的差異。
本研究認為,台灣報紙產品市場競爭行為,在報禁後產生大幅變化,主要原因有四:(1)報業開放後市場結構改變,造成市場競爭行為轉趨激烈:(2)報紙消費者消費型態轉變,變相加強了報業市場的競爭行為;(3)市場趨同性,造成報業市場競爭行為日漸普及;(4)台灣報業市場產品同質性漸高,以競爭行為建立有限差異性。
而在觀察各報競爭行為的發展與不同屬性特性報紙在競爭行為上的異同時。本研究發現,報紙產品市場競爭行為發展,深受外在市場環境、報紙本身特性屬性與市場內競爭者市場行為三者因素的牽制與制約。因此在不同市場環境下,不同特性屬性報紙在面對市場上形形色色的市場競爭者時,會在市場競爭行為上有不同的反應。
最後,本研究整理報禁開放後台灣報紙產品市場競爭行為走向,梳理出其大致發展趨勢為二:(一)市場導向;(二)「強者愈強、弱者愈弱」。
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中國大陸財政地方分權對各省市地區房地產價格的影響 / The influence of fiscal decentralization on the real estate price in China林婷婷, Lin, Ting Ting Unknown Date (has links)
近年來,隨著中國大陸經濟快速的成長,中國大陸房地產市場也隨之蓬勃發展,然而,近期中國大陸房地產價格的節節高漲,產生了房地產過熱的警訊,而區域間房地產價格的差異與不均,也成為各地區經濟發展的重要阻礙。所以,如何合理的調控房地產價格,使房地產市場能穩定成長並與經濟發展相輔相成,成為中國大陸中央政府必須持續關注與適時妥善處理的問題。
本文運用1999年至2010年中國大陸31個省市地區商品房平均銷售價格和影響房價的經濟相關變數的追蹤資料,運用雙因子固定效果模型進行實證研究。研究結果發現:中國大陸各地區財政分權程度對各地區房地產價格為非線性的關係,呈現U型的曲線。意即,存在一個財政分權的臨界值可以使房價達到最小的情況。建議中央政府應透過調整各地區的財政分權程度,來避免因財政分權不均而產生財政資源不均問題,造成房地產價格的波動。並加強對地方政府的財政預算與財政收入的監督與管制,以抑止「土地財政」的行為。 / With the economic growth, the real estate market is booming in China recently. But the overheating real estate price and the difference of real estate price between region and region become the important impediment to regional economic development in China. Therefore, the central government how to control the real estate price is an immense problem.
By using the panel data of average selling price of commercialize buildings and the economic variables of 31cities in China between 1999 and 2010, the study uses two-way fixed effects model to investigate the effect of fiscal decentralization on the real estate price in China.
The empirical analysis’ result shows that the fiscal decentralization provides a non-linear effect on the real estate price, it presents the U-shaped curve. In other words, there are a degree of fiscal decentralization can make the real estate price to reach the minimum. According to results, we propose to take some policies. The central government should adjust the degree of fiscal decentralization in each region, in order to avoid the local government financial problem to lead to rise the real estate price.
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整體經驗模態分解在台灣期貨市場與選舉預測市場的應用 / Applications of ensemble empirical mode decomposition to future and election prediction markets in Taiwan鄭緯暄 Unknown Date (has links)
金融市場常常受到政治、經濟與社會環境等因素所影響,所得到價格為眾多變數交互作用的結果,包含了許多雜訊。本文引進一套數據處理方法「整體經驗模態分解」(Ensemble Empirical Mode Decomposition,EEMD)來分析「期貨市場」以及「預測市場」。第一個實證利用EEMD處理台股期貨,分析對台股指數的解釋能力,並同時與原始台股期貨預測台股指數,比較預測結果;第二個實證利用EEMD來分析預測市場,判別是否能有效的消除雜訊,準確預測選舉結果。
第一個實證結果發現,EEMD能有效地過濾期貨市場的雜訊,另外,在最後到期日前十二天或者是前九天,以週期為6.5日經EEMD處理的台股期貨對台股指數的預測較原始台股期貨預測準確;第二個實證結果指出,直接利用EEMD處理預測市場得到的長期趨勢「剩餘訊號」(Residue)來預測選舉並無優於原始預測市場,主因為預測市場參與者不只在乎長期趨勢,亦在乎短期事件的衝擊,故直接利用剩餘訊號預測選舉結果會有所失真,而將剩餘訊號由低頻率之「本質模態函數」(Intrinsic Modes Function,IMF)合併至週期為6日與12日的IMF,得到了EEMD週趨勢價格,分成選前一天和選前十天的資料並與原始預測市場以及民調預測做比較,從不同的準則來看,發現以EEMD週趨勢價格來做選舉預測,準確度較原始預測市場與民調預測的結果更好。根據中選會2012年初選前對選罷法做成的解釋,未來事件交易所在選前十日亦須停止交易,我們可將EEMD運用在日後的選舉預測,把預測市場的合約價格以EEMD處理,應可提高選舉預測的準確度。 / The financial markets are usually affected by political, economic and social environment factors, and thus the volatilities of asset prices in these markets are subject to a lot of noises and shocks. To filter out noises and quantify shocks, this paper applies a data processing method, Ensemble Empirical Mode Decomposition (EEMD), and demonstrates its improved prediction to the futures and election prediction markets.
While the first empirical application shows that the EEMD effectively filters out the noises in the futures market, the second one indicates that the Taiwanese election prediction using EEMD “residue” is not as accurate as that by original data from the prediction market. The reason why the residue cannot serve as a good predictor is that the market participants consider not only the long-term trend, but also shocks, especially those right before the elections. We then attempt to predict the election outcomes by the week trend series processed by EEMD. The prediction by the week EEMD trend series turns out to be more accurate than that by the poll and original prediction market. Based on this study, we can apply the EEMD to the next election prediction and improve its accuracy.
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影響市地重劃抵費地標售價格因素之研究-以新北市林口新市鎮第三期為例 / Exploring Factors of The Price for Cost Equivalent Land - A Case Study of Lin-Kou New Town Urban Land Readjustment in New Taipei City.李浩榕 Unknown Date (has links)
市地重劃係依照都市發展趨勢及都市計畫規劃內容,將一定範圍內畸零細碎不規則之土地,依據法令加以重新整理,重劃區內土地除配合公共設施興建後,其餘可建築用地依原位次分配原則、調整分配原則並留設抵費地後,重新分配予原土地所有權人,其最終目的是地權的調整,而地權調整屬於交易行為,有交易便會有成本,而價格是交易成本的剩餘,在市地重劃開發的過程及後續標得抵費地的土地利用行為中存在交易成本,交易成本的降低可帶來抵費地價格的提升。
重劃完成後各宗抵費地的區位條件與個別條件均不相同,傳統地價影響因素研究多著重於宗地的條件,例如宗地面積、公設可及性、使用分區等,對於土地建築利用與產權整合並無太多著墨,本研究從重劃後建築開發的角度切入,探討以公辦重劃方式所留設的抵費地,其宗地個別條件、土地使用管制、區位、規模及相鄰土地整合難易度,對於交易成本及開發績效有何影響,研究影響抵費地標售價格的因素。
本研究蒐集了林口新市鎮第三期市地重劃區抵費地及相關土地資訊,透過是否建築作為條件篩選,並以189筆合併建築之案例為樣本,運用特徵價格模型,以每平方公尺抵費地標售單價作為應變數,選取13個可能影響抵費地標售價格的應變數,進行實證分析研究。實證結果顯示抵費地的容積率、所面臨最大路寬、面臨主要道路面寬、至學校距離及標售時間等5個因素對於抵費地標售價格呈現正向影響;而抵費地的面積、鄰地權屬複雜度、深度、寬深比等4個因素對於抵費地標售價格呈現負向影響。
公辦市地重劃政府具有土地分配的規劃及主導權,在抵費地面積有限的情況下,倘能了解抵費地的區位、規模與效益之關係,在訂定分配原則及抵費地劃設時考量上述影響抵費地標售價格的因素,以降低交易成本,即可望降低地主共同負擔或創造盈餘以留供重劃區內建設與管理維護,提升開發效益。 / A urban land readjustment (ULR) project follows the trend of urban development and the urban planning, it readjusts all fragmental and irregular land in the area. After building the land of public in the area, the rest of buildable land will be allocated to landlords and reserve the cost equivalent land by distribution principle. The final purpose of ULR is to adjust the property of land. That way of adjustment is a transaction which comes with the cost, and the residual of transaction cost is price. There is transaction cost in the process of ULR project and in the use of cost equivalent land. The reduction of the transaction cost will rise the price of cost equivalent land.
The area and individual condition of all the cost equivalent land is different after URL project. The traditional research of land price focus on the condition of land, for example, the area of the land, the accessibility of public facilities and the land use zoning , but less attention in the using of building and the conformity of property. In this research, we discuss the cost equivalent land with the point of building development by ULR, and the effect of the transaction cost to develop performance by analyzing individual condition, land using constrain, area, size, conformity of land. We also study on the factor of the price of cost equivalent land.
In this research, we gather the cost equivalent land of Lin-Kou New Town URL and other related information of land. We use the data screened by purpose to build to integrate 189 lands for the base of experimental research, and using the Hedonic Price Method to set the model in which the unit price of cost equivalent land (per square meter ) as the dependent variable and thirteen impact factors as independent variables.。The experiment result shows that five factors including the floor area ratio of cost equivalent land, the maximum width of neighbor road, the width of neighbor, the distance from school and the time for sale have positive impact to the price of the cost equivalent land. On the other hand, the four factors including the area of the cost equivalent land, the complexity of neighbor property, the depth of land and the ratio of width to depth have negative impact to the price of the cost equivalent land.
The government has dominant and plan of land distribution by URL-led by the government, for a limited area of cost equivalent land, if we can realize the relationship among region, size and efficiency of cost equivalent land which effect the price of cost equivalent land, it can reduce the transaction cost when we set up the rule of land and cost equivalent land distribution. We can reduce average burden of landlords or make surplus for construction and management for URL, and also promote the efficiency of development.
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優步公司訂價演算法關於價格聯合行為爭議之研究─以美國休曼法為中心 / A Study on Price-Fixing Controversies over Uber's Pricing Algorithm Focusing on U.S. Jurisprudence of Sherman Act劉穎蓁 Unknown Date (has links)
近來共享經濟商業模式崛起,對各國既有相關市場皆造成不少之衝擊,當中,優步公司用以計算車資之「訂價演算法」,於美國實務亦引起許多爭議。美國司法案例中其中一個重要爭議即為優步公司單方制定之「訂價演算法」與其採行之「高峰動態訂價法」究否構成價格聯合行為。於美國實務近來2起與價格聯合行為相關之案例,即包含Meyer v. Kalanick案與Chamber of Commerce & RASIER, LLC v. City of Seattle案(以下簡稱「City of Seattle案」)中,皆可見Uber企圖正當化其價格聯合行為,以免於競爭法審查下有違法之嫌。而美國對於價格聯合行為之規範,載明於休曼法第1條;依據休曼法第1條規定,若原告擬主張被告行為違反卡特爾行為,則應證明系爭卡特爾行為符合合意主體要件、具合意或共謀行為,與造成限制性之競爭效果等三項要件。由於上述二案皆仍於訴訟前階段,判決尚未出爐,因此,此議題值得吾等分析之。本文擬以美國實務判決為基準,彙整相關爭議,進而探討Uber所採訂價演算法是否構成價格聯合行為。
本文發現,雖然此等訂價演算法究否構成價格聯合行為尚未有定論,然由於訂價演算法中之高峰動態訂價法可提高駕駛於尖峰時段中提供載客服務之誘因,將有助於調節市場機制與促進競爭。此外,Uber亦可利用其訂價演算法與設置平台所奠立之優勢,使其得以潛在破壞市場秩序之形式,創造競爭優勢。據此,Uber除可克服既有行政管制下市場進入之劣勢外,亦得使相關市場交易效率大幅提升、市場更加競爭。因此,於探討Uber價格聯合行為合法與否時,亦應將此等因素納入考量。 / The rapid expansion of sharing economy enterprises around the world has led to many challenges. And among these enterprises, one of the most disruptive examples is Uber because of its algorithm. In the United States, the lawsuits regarding Uber's algorithm has also gained massive attention. One of the controversial issues of the complaints relies upon whether Uber's algorithm which set by Uber, and “surge pricing” model do constitute an illegal price-fixing in violation of Section 1 of the Sherman Act. In 2 recent high-profile cases, Meyer v. Kalanick & Chamber of Commerce & RASIER, LLC v. City of Seattle, Uber has tried to justify its price fixing to avoid antitrust scrutiny. There are three specific facts that the Plaintiff must prove to establish its antitrust claim in Section 1 of the Sherman Act: 2 or more entities entering into an agreement, conspiracy, and unreasonably restrains competition. Analysis regarding Uber's algorithm is significant because the trials are ongoing. Therefore, the thesis examines whether Uber's algorithm do constitute an illegal price-fixing in violation of Section 1 of the Sherman Act by exploring the potential problems with regard to the elements based on U.S. judicial decisions.
The thesis believes that Uber's algorithm can enhance the efficiency of transaction and has pro-competitive effects, leading to the impact of Uber's surge pricing on providing the incentives for drivers during peak hours. Establishing platform and Uber's algorithm create Uber's strengths and advantages. By having disrupted the existing industry, Uber's algorithm serves pro-competitive purposes.
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多重市場競爭與價格離散之關聯 : 以美國境內航空市場為例 / Does multimarket contact matter for price dispersion in the airline industry?劉亭彣, Liou, Ting-Wun Unknown Date (has links)
本文以美國境內航空市場為例,探討多重市場接觸與價格離散的關聯,並研究大型航空公司併購案前後多重市場接觸對航空公司競爭策略的影響。本研究發現:(一) 相互容忍說於併購案發生前後皆成立。(二) 相較於考量擴大市場的市佔率,航空公司更應該關注與競爭者間的競爭關係。(三) 併購案發生前後,航空公司的訂價行為都深受競爭對手的競爭策略影響。(四) 併購案發生前,因競爭者多,市場上航空公司平均市佔率的大小是航空公司可採取競爭手段重要因素之一。在最大的1000 個市場中,雖然每家航空公司的市場力量不大,航空公司仍可採取價格競爭,然若是對手間聯合懲罰,則航空公司不敢採取激進手段,且多重市場接觸越多,價格離散程度越大。而在次要競爭的市場中,則因航空公司的平均市占率是最大的1000 個市場的兩倍,因此航空公司並未有明顯競爭行為。但若考量競爭對手間的碰面次數,則多重市場接觸與不同分位價格關係為正,且多重市場接觸越多,價格離散程度越低。併購案發生後,因航空公司間彼此箝制力量大,與競爭對手間的碰面次數越多,越傾向隱性勾結,且高價位的價格上升較低價位價格多,使價格離散程度越大。 / In this paper, we discuss whether multimarket contact matters for price dispersion in the U.S. airline industry, and compare the influence of multimarket
contact on airlines’ competition strategies before and after airline mergers and acquisitions. We find that: (a) Before and after the mergers, mutual forbearance exists. (b) In contrast to an airline‘s market share, the relationship between airlines and itself plays a more important role in its pricing strategy.(c) Before and
after the mergers, airline companies’pricing strategies are significantly affected by their competitors’strategies. (d) Before the mergers, because of the intense competition, it is the size of the competitors‘ market share that the company decide whether to take aggressive strategies. In the top 1000 competitive markets,airline companies will take aggressive actions to get more passengers for the punishment from its competitor is an incredible threat, however, if competitors collude together, airline companies will hardly dare to cut price. And the
effect of an increase in multimarket contact on price dispersion is positive and significant. In the second competitive markets, since the average market share
is twice bigger than in the top 1000 markets, airlines prefer not to participate in cut-throat competition. However, if competitors collude, then airline companies
will cooperate together, and the effect of an increase in multimarket contact on price dispersion is negative and significant. After the mergers, increase in contacts
with competitors would facilitate mutual forbearance and increase price dispersion and higher-percentile prices will increase more than lower-percentile prices.
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成分股調整之價量關係及新聞報導效果-以臺灣中型100指數為例 / The Effects of Index Revision and News Coverage on Stock Price and Volume :Evidence from Taiwan Mid-Cap 100紀勛虔 Unknown Date (has links)
本研究旨在探討臺灣中型100 指數成分股調整事件之價量關係以及新聞報導效果。研究樣本分為純粹納入股、向下納入股、純粹剔除股以及向上剔除股,並分別以成份股調整之宣告日與執行日作為事件日,採用事件研究法,分析事件前後之價量變化,同時,進一步探討,宣告日至執行日期間,新聞報導對於成分股調整效果之影響。實證結果顯示,純粹納入(剔除)股於宣告日當天以及執行日前一天具有顯著的正(負)向異常報酬,且短期內皆有反轉的現象產生;向下納入(向上剔除)股,在宣告日與執行日前一交易日享有負(正)向異常報酬,且執行日後五日旋即反轉;此外,此四類個股於宣告日以及執行日附近,皆有異常週轉率生。在新聞效果部分,本研究將純粹納入(剔除)股分為有利多(空)新聞之組別以及無新聞之組別,探討其異常報酬現象。實證結果發現,有利多(空)新聞之純粹納入(剔除)股,相較於無新聞之純粹納入(剔除)股享有較高的正(負)向異常報酬率,顯見在成分股調整事件中,新聞報導亦會影響股價表現。 / This paper examines the effects of Taiwan mid-cap 100 index revision and news coverage on stock price and volume. Using event study method, the sample of this study is divided into four groups: pure additions, downward additions, pure deletions, upward deletions to analyze the changes of stock prices and volume on the announcement day and effective day. Furthermore, the effects of news coverage between announcement day and effective day are also investigated. Results of our analysis suggests that there are significantly positive (negative) abnormal returns (ARs) for pure additions (deletions) on announcement day and the day before effective day but transitory. For downward additions and upward deletions, there are significantly negative ARs for the former and significantly positive ARs for the latter. However, both ARs reverse within five days. Besides, there are abnormal volumes in the entire sample. As for the effects of news coverage, pure additions (deletions) are divided into two groups to examine the existence of ARs, one group with bullish (bearish) news and one group without. Results show that pure additions (deletions) with bullish (bearish) news have higher ARs than those without news coverage, supporting our hypothesis that in the event of index revision, news coverage do affect stock prices
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訂房網站行銷策略與顧客忠誠度之研究 / Marketing strategy of online travel agencies and customer loyalty楊宇平 Unknown Date (has links)
近年來國人旅遊風氣盛行,旅遊產業規模日益增大也帶動了住宿業的商機。根據中華民國交通部觀光局的統計,2015年國人國內平均旅遊次數為8.5次,國外旅遊平均為0.56次。與2014年相比,國內旅遊總旅次成長了14.25%,國外總旅次則成長11.3%;旅遊總費用亦有可觀的成長,其中住宿又是主要的支出項目,約占旅遊總支出的33%。隨著網際網路的發達,消費者對旅遊規劃的自主性提高,帶動自由行的風潮,也讓訂房網站得以快速擴張。然而訂房網站面對的是一群價格敏感度較高的消費者,同時產業內多元的競爭者也讓網站業者面臨更激烈的價格競爭,大多以強調低價為主要的行銷手段。本研究欲探討訂房網站行銷4P策略,特別是價格策略,對顧客滿意度與忠誠度之影響,以及影響訂房網站滿意度之消費者心理因素。
本研究透過文獻探討決定研究變數並建立研究架構,再以問卷調查的方式蒐集初級樣本資料,共蒐集295份有效問卷,並以敘述性統計及迴歸分析等方法進行假設驗證。
研究結果發現低價策略及價格/非價格促銷策略皆無法讓消費者同時達到行為及態度忠誠。網站品質、關係行銷策略以及主打經驗性的品牌形象可以透過提升滿意度進而達到顧客忠誠。然而本研究發現當消費者有安全或隱私風險的疑慮時,會對常態性低價策略及短期的價格促銷的滿意度造成不同的影響。本研究認為訂房網站必須跳脫價格競爭的泥淖,做出差異化的策略,同時保障消費者個資以及交易安全,才能確保永續經營的優勢。 / The expansion of tourism industry has thrived the online accommodation reservation market. The increased popularity of Internet has lowered the cost of information search and inspired people to become more willing to arrange their tours online. Consumers who reserve accommodation online are considered more price sensitive than those who do so through the offline channel. In order to attract consumers, online travel agencies (OTA) use different marketing tools, and put special emphasis on providing price incentives such as EDLP strategy or temporary price discount. In this study, we investigate how OTAs’ marketing strategies (including product attributes, price strategy, website quality, promtions and brand image) influence customer satisfaction and loyalty. Also, we will find out whether consumers’ perceived risk will influence the effectiveness of OTAs’ pricing strategy.
A total number of 295 samples were obtained through Internet questionnaire conducted by the study. It was found that
1. EDLP has significantly positive effect on satisfaction while temporary price promotion doesn’t. However, both pricing strategies aren’t able to achieve complete customer loyalty, which is comprised of behavioral and attitual dimension.
2. The loyalty program of OTA has significantly negative effect on satisfaction.
3. Enhancing website quality, conducting relationship marketing and creating experiential brand image have significantly positive effect on both satisfaction and loyalty.
4. Consumers’ perceived risk will pose different effect on EDLP and temporary price promotion.
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臺灣有線電視價格管制上限有效性之探討 / A study of the effectiveness of the price cap in the Taiwan's Cable TV industry蔡國棟, Tsai, Guodung Unknown Date (has links)
從2000年費率主管機關公布有線電視基本頻道收視費用之每月每戶上限為新臺幣600元,並逐年核定其價格上限。本研究透過超越對數成本函數及需求函數,探討我國有線電視2004年至2008年間經營概況,實證結果得知:
一、我國實施價格上限管制法,管制有線電視基本頻道收視費用之機制是具有效性,且費率主管機關近年來價格管制,是增加消費者剩餘方向前進。
二、在每年所核價格上限下,系統經營者平均每戶約新臺幣107元獲利空間;系統經營者對於將所節省的成本反應至收視費用上,是不積極的。
三、有線電視產業之價格需求彈性為-0.8107,顯示有線電視服務已逐漸成為國人生活上的常用品,符合目前社會經濟現象。
四、有線電視產業之家戶所得需求彈性為0.6951,顯示有線電視服務為正常財。
五、有線電視平均成本隨著訂戶數逐年增加而下降趨勢,顯示有線電視產業具有規模經濟特性,其平均成本下降原因主要來自於固定成本下降。
六、系統經營者之邊際成本隨著年度增加而趨向新臺幣300元至400元間集中或收斂。以組織結構來看,各集團5年平均邊際成本在新臺幣348元至405元間。以整體有線電視來看,5年平均值約為新臺幣367元。
七、以組織結構來看,各集團5年平均成本在新臺幣417元至470元間。以整體有線電視來看,5年平均值約為新臺幣438元。
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由學名藥侵權訴訟評估均等論在生物相似藥侵權訴訟的影響—以美國為例 / A Study of the Doctrine of Equivalence on Biosimilars Based on the Patent Infringement in the context of Generics –From U.S. Perspectives沈雅慧, Shen , Yea Huei Unknown Date (has links)
BPCIA在2010年三月生效後,生物相似藥廠商開始可以利用簡化的文件向美國食品和藥物管理局(FDA)申請藥品許可證,這個新醫療法賦予FDA決定如何落實法案的權力。基於不同生物製劑之間缺乏比較性這個已知的事實,加上公眾安全的考量,在還沒有累積大量經驗可以歸納出哪些是比較分析必要的資訊之前,FDA會保守的要求生物相似藥廠商以BPCIA提出申請時,必須提供臨床試驗資料來證明與參照藥品之間沒有臨床上有意義的差異。
雖然BPCIA給出了解決專利糾紛的框架,俗稱專利舞蹈(patent dance),依照目前聯邦巡迴上訴法院對BPCIA的解釋,認為BPCIA法案不強制生物相似藥申請者遵循其規定之專利糾紛解決程序,雖然就目前的最新發展來看,迴避專利舞蹈可以避免一些程序上的麻煩,但真正參照藥品廠商和生物相似藥公司的輸贏仍是在訴訟戰場上見真章。
美國FDA在2015年3月6日核准了的一個生物相似藥-Zarxio( filgrastim-sndz),目前尚不清楚均等論這種不確定性在生物相似藥上影響的程度,但藉由簡化新藥申請上市的小分子藥物所涉入的侵權訴訟做有限度的推論可以發現,小分子藥物的均等謬論案件是牽涉到外圍專利,當專利不再提供足夠的誘因去激勵專利權人時,學名藥廠商就會贏得均等論謬論案件。因為生物製劑是一種製程決定的產物,因此其專利通常是集中在製程。以BPCIA和專利法為框架來分析過去的相關侵權訴訟,可以預測生物相似藥廠商在轉化前步驟、轉化步驟、調劑、或包裝做改變,其成功的機會較大,而在細胞培養會純化步驟做改變,成功的機會最小。然而,最終還是要看法院將來如何解決生物相似藥的侵權問題,各方都要意識到科學與法律議題的複雜性,及妥適解決侵權訴訟的重要性。
台灣廠商要進入生物相似藥的領域,是困難重重的。生物相似藥的開發及法規成本,不如想像中低,鑒於蛋白質藥『產能』一直被看作是市場發展受阻的主要原因,藥廠委外合作(CRO、CMO或NRDO) 的模式能快速與國際藥廠接軌,逐步奠定台灣在藥物開發的供應鏈合作利基並提昇國際知名度。 / The Biologics Price Competition and Innovation of 2009 was activated on March in 2010. Now the US Food and Drug Administration (FDA) can approve biosimilars and was empowered to how to practice. Given the known issues with lack of comparability between different biologics preparations, and the Agency’s strong interest in protecting public safety, it is probable that, until it has developed a body of experience with regards to the amount and kind of data needed to make comparability evaluations, the FDA will adopt a conservative approach and require at least some clinical studies before approving biologics under BPCIA.
Though BPCIA provide the frame for resolving patent issues, that is so-called patent dance, Federal Circuit said that parties were not compelled to dance. Thus the law uncertainty was shifted to patent infringement.
FDA approved the first biosimilar, Zarxio (filgrastim-sndz), on 6, March, 2015. It is unclear how biosimilar will be treated in court based on doctrine of equivalence. Based on the experience from generics, courts tends to adjust the scope of equivalents to improve the correspondence between patent scope and desired patent incentives. In contrast, biologics is path depended. That is to say process decided what biologics would be. Both the BPCIA and patent law guide the shape of infringement suits. Follow-on biologics companies will be most successful when they make a change in the pretransformation process, the transformation process, the formulation, or the packaging. They will be least successful when they make a change in the cell culture conditions or the purification process. It remains to be seen how courts will address issues of infringement for follow-on biologics, but all parties should be aware of the complexity of the scientific and legal issues and the importance of addressing them properly.
The cost for development and the complexity of regulation in biosimilars were tremendously high. Thus it is difficult for biopharmaceutical industries in Taiwan to enter this field. In the light of unmet production capacity in protein drug, pharmaceutical industries in Taiwan could apply the mode of CRO, CMO or NRDO to integrate into global biopharmaceutical community.
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