Master thesis is primarily focused on parallel trade with medicinal drugs within European Union. In regard to attractive offer for cooperation with strong supplier of mentioned goods was required to valorise realization possibility and potential of idea. Business plan estimates different variants or realization and progress, describes it in numbers and wide context. Object of thesis is absolutely real case of starting intermediary company in pharmaceutical field specifically in parallel "reexport" of pharmaceutical drugs and accessories between states of European Economic Area. In first two passages study remembers methodology of business plan and passes to bases of legislative frame related with. Subsequently are described market movements, thoroughly analysed its weak points and also strengths and opportunities. Everything is simultaneously reflected with object of our business plan to support reality of whole master thesis. After short marketing passage comes the largest part dealing with financial calculations. Considered are three variants of potential reality and in each of them are calculated costs, revenues, profit and cash flow for single months and whole year. Conclusion summarizes and evaluate project as whole. Considering infestation of input costs against its rentability and potential other opportunities of the pharmaceutical market. Evolution of European market mostly depends on legislation regulations of EU and single countries.

5.Abstract Title: Legal aspects of a parallel trade in drugs within the EU Key words: single market, parallel trade, price regulation, pharmaceuticals Parallel trade is one of the most distinctive benefits of the European single market. In a simplified way, parallel trade is legal importing of drug from one country where it is legally marketed into a second country where the marketing authorization holder also markets that product, but without the consent of the marketing authorization holder. Price regulation of medical products makes parallel trade of drugs questionable. Final price for customer is not result of an independent decision of pharmaceutical company but it is given by relevant authority often regarding the spending power of citizens. Wholesalers are taking advantage of these price differences when they are buying cheap drugs in low-price countries and selling them with profit in countries where drug price are higher. In theory this practice should deliver significant saving for patient and national healthcare insurance system in destination countries due to lower price of parallel traded drugs. However many studies show minimum impact on drug price in these countries since wholesalers retain great part of the financial benefits. On the other hand, negatives of parallel trade are evident. Drug...

<p>Parallel imports often lead to lowered prices and is therefore regarded as good from a consumer's point of view. From a business'point of view this is not always the case. When do parallel imports occur? Is it possible to prevent parallel imports to protect an introduction of a product in another member state? The purpose of this thesis is to present situations where parallel imports occur and to see if it is compatible with competition law to prevent parallel imports. Furthermore I will analyse the future development after the group exemption of vertical restraints enters into force in June 2000. RESULTS: I believe that the group exemption of verical restraints will lead to an increasing amount of businesses setting up in other countries. As a result of the increasing internationalisation, prices will fall which leads to decreasing parallel imports. I also consider that it should be possible to prevent parallel imports for a short time in order to protect an introduction abroad.</p>

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Parallel imports often lead to lowered prices and is therefore regarded as good from a consumer's point of view. From a business'point of view this is not always the case. When do parallel imports occur? Is it possible to prevent parallel imports to protect an introduction of a product in another member state? The purpose of this thesis is to present situations where parallel imports occur and to see if it is compatible with competition law to prevent parallel imports. Furthermore I will analyse the future development after the group exemption of vertical restraints enters into force in June 2000. RESULTS: I believe that the group exemption of verical restraints will lead to an increasing amount of businesses setting up in other countries. As a result of the increasing internationalisation, prices will fall which leads to decreasing parallel imports. I also consider that it should be possible to prevent parallel imports for a short time in order to protect an introduction abroad.

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EU Competition Law and Practices Hindering Market Entry of Drugs This thesis deals with the legality of pharmaceutical companies' practices that hinder market entry of drugs, whether within the intra-brand or inter-brand competition, from the EU competition law perspective. The aim of this thesis is to introduce the reader to the issue of different practices aimed at limiting parallel trade and also at delaying or complete prevention of the market entry of a new competing drug, and also to assess whether the competition authorities have established clear guidance on the performance of these practices, i.e. whether they are clearly set boundaries between acceptable restriction of competition which can be justified and distortion which cannot be allowed. For the purpose of this assessment, the relevant decisions of the European Commission and the CJEU are analyzed, identifying the key factors on which the competition authorities place emphasis when assessing the compliance of such practices with the EU competition law, and general conclusions are drawn from these key factors to determine whether there is a sufficient degree of legal certainty for pharmaceutical companies engaging in these practices. The thesis is divided into six chapters, of which chapters three, four and five form the main part....

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自從美國最高法院在廣達與LGE案中作出解釋後，便將權利耗盡理論亦稱為第一次銷售理論帶往另一個層次。此案已被普遍認為對於美國過去的判例影響甚鉅，對於產業界的商業活動發展更是具有深遠的影響。智慧財產權旨在保護發明及創造公眾利益間取得一平衡點，權利耗盡理論長久以來已被視為專利法中重要的一環，並藉以杜絕專利權人的過當控制。而最高法院對於第一次銷售理論的解釋，則進而撼動專利權人長此以往對限制性銷售策略的仰賴。 即便銷售後限制(Post-sale restriction)確實提供了專利權人避免耗盡其權利的好方法，但專利權範圍則限縮了專利權人所享有的權利控制範圍，換言之，專利權人僅能擁有專利法所賦予的權利，且其加諸於被授權人的購買條件限制僅限於該專利之功能及使用目的。而超越該專利功能及使用目的的過分限制，則可能導致專利權濫用。而在開放WTO框架下，國際貿易的頻繁也使得權利耗盡衍生出了在散佈等方面的相關討論，平行輸入/輸出的議題亦隨著跨國交易的興盛而隨之重要。 故此篇論文的研究目的不僅僅探討權利耗盡理論及其相關議題，更旨在藉由廣達案的啟發，提供台灣的IT產業一有效的專利授權策略，並提供不論專利權人或被授權人於制定授權契約時，能有一更具有策略性的思考方向。 / The Supreme Court’s current decision in Quanta Computer, Inc. v. LG Electronics, Inc. brings the exhaustion doctrine also known as first sale doctrine up to a new phase. This case is believed significantly overcome quite a lot of past precedents and will effectively influent industry business operations in the future. The core goal of intellectual property right aims to find a balance between protecting the incentives to create and innovate, and providing the benefits to public interests. Exhaustion doctrine has been long standing as part of patent law to prevent patentees’ over control. The interpretation made by Supreme Court regarding the first sale doctrine does vibrate the conditional sale strategies long believed by patentees. Now the Supreme Court brings the issue from the phase of patent law down to the contract law level. Subsequently, the litigations of antitrust and fair trade are therefore involved while patentees are tempting to make an “end-run” control over the downstream purchasers. Though applying post-sale restriction provides a way out for intellectual property owner from triggering the exhaustion, however, the scope of the patent claims determine how far the privilege is given to the inventors. A patent owner or licenser can only enforce its patent right while the right is truly granted by the patent law. Subsequently, the restriction set forth to limit the licensees or purchasers must be accordance with the function or feature of the patent claims for. On the contrary, the patentee intends to restrict its purchasers by holding the exclusive right which beyond the scope of the patent granted may result to patent misuse, for instance, the resale price maintenance, prohibition of manufacturing the competing products, the conditional license which incorporates another license, and overwhelming royalties on the price of the whole product instead of the actual usage of the patented article. Under WTO, the concern of intellectual property protection has become more critical in the perspective of international trade, different issues and disputes regarding exhaustion have also been generated. Not alike the traditional domestic exhaustion, the discussion regarding distribution has therefore been derived. Moreover, the issues related to parallel import/export are generated in accordance with the frequent cross-border transaction. The purpose of this research does not merely lead us look into the doctrine and restriction patentees used to impose for avoiding exhaustion. But I intend to further illustrate a guideline based on the inspiration from Quanta and the explanation of the Courts. This guideline should provide both patentees and licensees an orientation while considering making a licensing agreement.