智慧財產權為政府鼓勵知識創新者公開其研究成果所給予的獨佔權利。這些公開的資訊便稱之為「智慧財產權資訊」，內含了人類超過90%的智慧結晶。是以企業妥善運用這些資訊可以節省許多研發的時間及金錢，並加快取得智慧財產權的速度。 　　智慧財產權資訊服務的提供可視為一種加值的過程，從數量龐大的原始資料檢索、分析，甚至提供軟體工具的協助，都是內涵相當專業。本研究將其稱之「智慧財產權資訊服務業」。 　　本研究為一初探性研究，企圖藉由廣泛的文獻收集與深度訪談，勾勒本產業在台灣的發展現況、上下游價值鍊、與其他技術商品化服務業的關係、以及未來發展的策略。為有效的觀察六個訪談個案，本研究參照了相關文獻，訂定產品組合與目標市場、價值活動與核心能力、組織與人事管理、專業行銷與客戶管理、策略聯盟與併購五個項目作為觀察指標。 　　本研究之研究個案包括：亞太智慧財產權發展基金會、亞太智財科技服務股份有限公司、連穎科技股份有限公司、元勤科技股份有限公司、識權科技股份有限公司、台灣智財股份有限公司。 　　本研究發現：目前台灣本產業廠商均為近幾年成立的新創企業，屬於知識密集型產業。產業的最上游為各國智慧財產權主管機關的資料庫，本產業部分廠商將其加值提升其方便性、對於重要資料加以翻譯或分析、或是協助廠商監視新增專利。在資料庫獲得加值後，部分廠商提供檢索服務，並以此為基礎提供研究發展、侵權訴訟、技術移轉之用。 　　本研究對於本產業發展的建議為：透過顯示其專業的方式教育使用者，並與相關技術商品化服務業合作以擴大其營業規模。同時本研究也建議政府提升本國智財權資料庫的水準、並協助民間業者使用其他國家之智財權資料庫。 / Intellectual Property Right (IPR) is a monopoly right for a period of time that governments encourage innovators to disclose their innovation. The published information is called “Intellectual Property Right Information” which included over 90% humans’ intellectual innovation, and companies may use the information to save money and time in R&D. 　　The usage of IPR Information can be seen as a value-added process, and it requires professional service providers to search and analyze useful information from IPR database and to design useful tools for their clinets. 　　The aim of this exploratory research is to study the professional service sector in Taiwan by wide data-collecting and interviews. For observing the current status, the value chain, the cooperation with other service providers, and the developing strategy, this research uses product mixes and targeted markets, value-added activities and required knowledge, organization and human resource management, professional marketing, strategic alliance and merger and acquisition as five indexes. 　　The cases in this research include Asia Pacific Intellectual Property Association, Asia-Pacific Technology and Intellectual Property Services, Inc., LearningTech Inc., IP Tech Inc., Su Cheng (Knowing Power) Inc., and IP Era Inc. 　　This research finds out that all the cases are srtart-up, and knowledge-intensive. The most upstream is the databases built by governments and this sector dilutes, monitors and translates these databases, or enhances the convenience. Some companies in this sector provide IPR search and analysis services, and the results may be useful for R&D, IPR lawsuit, or technology transfer. 　　This research suggests that this sector should enlarge the market by educating their customers with professional services and cooperating with other technology commercializing service companies. In the mean time, Taiwanese government may consider to enhance its IPR database and to assist local companies to utilize other IPR databases around the world.

生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。 / Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R＆D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets.