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.

Während die Bestechung und Bestechlichkeit von, in öffentlichen Krankenhäusern angestellten Ärzten, als Folge des „Herzklappenskandals“ und der darauf beruhenden Reform des Korruptionsstrafrechts bereits seit 1997 nach den §§ 331 ff. StGB strafbar sind, unterfielen niedergelassene Vertragsärzte auch nach der Rechtsprechung des Großen Strafsenats bis zum Inkrafttreten der §§ 299a ff. StGB am 04.06.2016 nicht den Korruptionsdelikten. Thematisch damit verbunden war und ist die Frage, ob Vorteilsgewährungspraktiken in diesem Bereich vom Tatbestand der Untreue erfasst sein könnten. Ihrer Beantwortung dient der erste Teil der Arbeit. Der zweite Teil fokussiert die Relevanz der Korruptionsvorschriften für das gewählte Arbeitsthema. Die Einbettung der Gesamtthematik in den Kontext der Korruptionsdelikte führt die Ausgangsbetrachtungen zur Untreue fort und ergänzt diese durch eine Bewertung nach den neuen Gesetzesregelungen. Das gewählte Arbeitsthema zeigt, wie wesentlich die Beschäftigung mit den relevanten Normen des Rechts der Gesetzlichen Krankenversicherung für die strafrechtlichen Bewertungen in diesem Bereich ist. Dies gilt umso mehr, wenn mit sozial- und beziehungsweise oder berufsrechtlichen Verstößen strafrechtliche Konsequenzen einhergehen und die fehlerhafte Anwendung der einschlägigen Rechtsnormen anderer Rechtsbereiche zwangsläufig auch zu falschen strafrechtlichen Schlussfolgerungen führt. Dieser Kritik sieht sich auch die Rechtsprechung des Bundesgerichtshofes zur sogenannten Vertragsarztuntreue ausgesetzt. Auch hier wurden die Besonderheiten des Sozialversicherungsrechts nicht mit der notwendigen Sorgfalt eruiert und stattdessen eine - seit mehreren Jahren - nicht mehr vertretene Rechtsprechung des Bundessozialgerichts zur Grundlage der strafrechtlichen Bewertungen gemacht. Dass dies weder den Anforderungen des Bundesverfassungsgerichts entspricht, noch mit den sozial- und strafrechtlichen Vorgaben vereinbar ist, zeigen die Ausführungen der Arbeit. In der Form eines kritischen Ausblicks werden abschließend, die Grenzen zulässiger verordnungsbezogener Vergütungen durch die Krankenkassen aufgezeigt und deren strafrechtliche Relevanz eingeordnet. Letzteres erfolgt am Beispiel eines Vertrags zur Förderung sog. biosimilarer Arzneimittel durch die Zahlung einer prozentualen Einsparbeteiligung als Gegenleistung für deren bevorzugte Verordnung. Die Konstellation verdeutlicht, dass auch die monetäre Einflussnahme der Krankenkassen auf das Verordnungsverhalten der Vertragsärzte strafrechtsrelevante Wirkung haben kann, wenn sie zu unberechtigten Wettbewerbsverzerrungen führt. / As a consequence of the so-called “heart valve scandal”, and the reform of the German criminal law on corruption that followed in the wake of the scandal, it has been a criminal offence under sections 331 et seqq. of the German Criminal Code [Strafgesetzbuch – StGB] since 1997 to give bribes to medical practitioners employed in public hospitals, or for such medical practitioners to take bribes. However, until sections 299a et seqq. StGB entered into force on 4 June 2016, acts committed by medical practitioners in private practices were not deemed to be corruption offences under the Criminal Code. This was also affirmed by the case-law of the Grand Criminal Panel of the German Federal Court of Justice [Großer Senat für Strafsachen]. A topic that has been repeatedly discussed in connection with the aforementioned issue is whether the practice of granting benefits in healthcare might constitute an offence of embezzlement. The first part of this dissertation provides an answer to that question. The second part focuses on the significance that corruption provisions have for the topic discussed herein. Following the initial analysis of the issue of embezzlement mentioned, this issue is expanded by a discussion of the overall topic in the context of corruption offences, supplemented by an assessment of the topic in the light of new legislation introduced. An analysis of the topic chosen for this dissertation shows how important it is to study the relevant legal provisions of the law on statutory health insurance in order to be able to carry out an assessment of the topic from the perspective of criminal law. This applies all the more so in cases where a breach of social law and/or the law of professional rules and regulations might have consequences under criminal law, and the faulty application of applicable legal rules from legal areas outside criminal law would inevitably also lead to wrong conclusions being drawn on the basis of criminal law. The case-law of the German Federal Court of Justice [Bundesgerichtshof] on so-called “embezzlement by medical practitioners in private practice” [Vertragsarztuntreue] has been criticised in this respect. The Federal Court of Justice did not take account of the specifics of German social security law in a sufficiently diligent manner, and instead used outdated case-law of the German Federal Social Court [Bundessozialgericht] as a basis for its criminal-law assessment—precedents that were overruled by the Federal Social Court itself many years ago. This dissertation shows that this does not meet the requirements of the German Federal Constitutional Court [Bundesverfassungsgericht] and that such an approach is incompatible with requirements under social and criminal law. Finally, the limits of admissible prescription-related remuneration by health insurances are discussed and demonstrated from a critical, future-oriented perspective, together with the significance these limits have from a criminal law perspective. The significance of such limits is discussed using as an example a selective-agreement model designed to promote so-called “biosimilar medicines” by paying medical practitioners a percentage of the savings achieved in return for practitioners prescribing such medicines rather than more expensive ones. The circumstances discussed illustrate that the monetary influence that health insurances exert over the way in which medical practitioners in private practice prescribe such things as medicines may have consequences under criminal law if such influence may lead to competition being distorted. In the light of the above, health insurances should not be provided with additional criminal-law-related exceptional provisions that would enable them to exert further influence over the neutrality of decision-making in the area of medical prescriptions.