1 ABSTRACT SPECIFIC OF PATENT LAW IN PHARMACEUTICAL INDUSTRY This thesis scopes on particularities of patent law with regard to pharmaceuticals. It describes the basics of patent law while focusing mainly on international treaties, in particular on systems established by EPC and TRIPS. The patent system in USA and in the Czech Republic is also noted. This thesis is divided into seven chapters. In the first chapter named sources of law international institutions, treaties and situation in European union, USA and Czech Republic are described here. This chapter also deals with basic legal instruments such as patent, corporate invention or utility model. The next chapter is focused on individual conditions that need to be met in order to grant a certain patent - the most basic are novelty, inventive step and industrial applicability. The following chapter deals with problems associated with costly development of new drugs and the need of companies to get the longest possible protection for their inventions. A special chapter addresses exceptions to the stiff patent regulation. Described in the next chapter is the compulsory license, a legal instrument not very particular in the Czech Republic but relevant in some developing countries used in order to secure better availability of drugs to society. Other...

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

In recent years, patent aggregation and patent trolling activities have received growing attention from all over the world because of the controversial nature of such activities. Somehow it becomes a global obsession to presume that such activities or even the existence of PAEs are problematic by nature and need to be redressed via government intervention, partly due to the unpromising situation in the US. This article seeks to explore the nature of such issue and find out the most appropriate way for China to deal with such issue. The author believes that while such activities might at first sight seem problematic, in fact they are legal commercial practice in general, or more specifically, they are merely strategic uses of patents. This article also argues that there are available remedies under both EU and Chinese legal framework to catch the real problematic conducts derived from such activities. Hence it would seem to the author that even though the quantity of such activities is meant to increase in China, there is neither justification nor need to intervene such activities: the existing legal framework is enough to address certain misconducts; and the market is capable of ensuring its own equilibrium.

The point of conflict between competition law and patent law is mainly on the objectives of these two policies. Whereas competition law encourages market pluralism, patent law promotes exclusive exploitation of patented-technology by patent holders. Despite this asymmetrical purposes both policies compliment each in promoting innovation, dissemination of technology, and developmentof a vibrant economy. The interface between these two should be treated cautiously since a preferential treatment of one over the other can have adverse consequences in the development of the economy. Admittedly competition law is very crucial in regulating anti-competitive conduct by cartels and monopolies that will affect the interests of the society. On the flip side, the enforcement of anti trust policies should not be overly applied to the extent of eroding the spirit of innovation and investment in beneficial technology. In the face of this aggressive global market, promotion of innovation and competition law are crucial in maintaining a competitive edge. Wherefore a balance must be struck!

制定專利法的本意，不僅是給予發明人在一定期限內擁有一定限度的獨占權，以鼓勵發明人揭露新穎發明，亦在於提升科技發展、提高經濟成長，使社會大眾可從既有發明中再進行卓越科技研發，以節省社會研發成本。專利法賦予專利權人禁止任何未經授權之他人製造、使用、販賣、為販賣之要約，以及為上述目的進口該專利權技術之排他權利。但為達促進產業進步的目的，各國專利法並增列研究、實驗的免責條款(experimental use exception)來平衡專利權人及社會大眾的利益。研究實驗免責的前提必須對專利權人權益造成微量或是最低限度的干擾(de minimums)，即是希望對專利權人的權益造成最小傷害，同時又可以達到促進產業發展及鼓勵更多研發工作進行的目的。 我們將實驗免責條款分為二類，一種是純為好奇心，僅針對專利技術內容作實驗，研究如何改善該發明，此為狹義的實驗免責；第二種則是應用於醫藥產業，此類實驗並非改善發明內容，而是重覆實施其發明，再進行其他研究及實驗，可視為廣義的實驗免責，此即美國在1984年修正Hatch-Waxman法案之醫藥產業的實驗免責條款，只要是為提交FDA之相關實驗資料時，則可主張實驗免責，目的為使已享受二十年專利期之發明儘快成為公共財，以供大眾利用。 研究工具專利的實施方法即作為研究及實驗目的，醫藥產業上可以是生物材料，亦可以是篩選新藥方法。由於具有研究及實驗的特性，若在研究實驗免責條款下，非專利權人企圖以研究實驗免責方式來規避其侵權行為時，專利權人行使權利時，則可能遭遇不少困難。若研究工具專利又被主張為提交FDA相關資料之實驗免責時，此行為對於專利權人權益並非造成微量或是最低限度的損失，發明人未因該專利而獲益，又無法實施專利權，則會降低申請專利的意願。 專利權的效力，應給予專利權人較大權利使發明人願意揭露技術、促進社會科技進步，抑或是應給予較大實驗免責範圍，使研發機構不會受到專利權限制而阻礙社會科技發展的動力，此二種考量方向，如同位於天平的兩端，呈現兩難局面。目前法院實務案例則以執行研究工具專利會落入藥物開發之實驗免責規範為主要認定，但筆者認為應就實施研究工具專利的行為、內容、目的作一探討及了解，並顧及公平性，才是評估研究工具專利是否適用實驗免責條款之依據。 因此，專利權人應如何管理或應用其研究工具專利，並可真正執行專利權而不至落入實驗免責條款? 可由數個方向進行：一、產品形式保護研究工具專利：將研究工具的執行方式以產品形式包覆，以銷售產品的方式跳脫實驗免責之框架，未必需要經由專利授權的方式來取得利益；二、進行全球化佈局：於申請研究工具專利之前，分析其發明深度及可能競爭對手，並在可能進行製造、使用、行銷、及進口相關於此發明技術之國家申請專利，以未來如何執行及如何獲利作為考量全球佈局之策略；三、成立契約研發中心(contrast research organization，CRO)：當研究工具專利在執行專利權有困難，不易跳脫實驗免責範圍，則可使用營業秘密 (Trade Secret) 方式保護其發明，不以公開技術方式，而是應用研究工具成為新藥篩選中心，提供研發服務；四、授權國家單位：即是採用類似NIH之OTT模式，將研究工具專利權直接授權給政府，由政府支出其授權金並可擴展至更多研發機構。 至於非專利權人，如一般之研發機構，應如何利用研究工具專利，且不落入專利侵權的疑慮? 除了取得專利授權外，亦可採用：一、從已授權國家單位取得技術：即如同NIH之OTT模式，由已取得研究工具專利授權之政府單位進行非專屬授權，該發明具較合理之授權金，並可被更多研發機構善加利用；二、落入實驗免責範疇：針對研究工具專利之實質發明內容進行改良及應用，再利用其方式以進行其新藥研發實驗，則可適用於實驗免責的規定；三、交互授權(Cross-license)：使用研究工具專利之研發機構與原本專利權人合作，經由交互授權方式成為合作伙伴，則可達到雙贏；四、成立開放社群，共同分享技術：如多數國家成立之GenBank，或BIOS (Biological Innovation for Open Society)社群之概念，收集對人類具有重大意義之研究工具，如基因序列等，以開放原始碼(Open source)之社群相互分享，使後續研發工作更加快速及順暢。 除了上述方法外，專利法可仿照著作權法，增定合理使用（fair use）之相關規定，亦即除了試驗例外、第三人繼續使用權、私人領域內之非營利性使用外，賦予第三人一般而全面性的專利權合理使用範圍，或以自願性參與集體授權機制（voluntary collective rights licensing）以支付合理權利金，促進社會公益。實驗免責條款可使得發明人願意持續公開其發明，同時使新穎發明公諸於世，兼顧社會公益，促使社會經濟及產業的進步，使國家社會整體因研發創新而真正獲益。 / The original purpose of the patent law not only offers the exclusivity to the inventors in a limited periods and in a limited rights in order to inspire the inventors to disclose more novel inventions, but also encourages the development of the technology and increases the growth rate of economics to the publics. The more new inventions the inventors provide, the more cost of R&D will be saved in whole society. The right of the exclusivity for the patentee is when someone without authority from the patentee, he can’t makes, uses, offers to sell, or sells any patented inventions, within the countries, or imports into the countries. But in order to enliven the industrial growth, the experimental use is added as a legal exception in many countries to balance the benefits of the patentee and the public interests. We should minimize interference to the patentee’ rights when the experimental use exception of the patents is claimed. We can divide the experimental use exception into two classes. One is the narrowly-defined experimental use exception only for the curiosity, for testing the content of the patents. The use aims to find out how to improve the inventions. The broadly-defined experimental use exception that is applied in the medical industry. This kind of use does not improve the technology of the invention, but repeat the invention again without changing any content. Such kind of broadly-defined experimental use exception is created after Hatch and Waxman Act in 1984. The experimental use exception in the medical industry is described that if the result of the experience is for submitting the drug information for the FDA examination, it is claimed non-infringement of the patent and protected by “safe harbor” of 35 USC 271 (e)(1). The purpose is to practice the inventions of the patents earlier and save the cost of R&D through public use. Research tool patent are used for the purpose of research and experiment and improves the speed of the experiment. In the medical industry, the research tool patent may be the biological material or the method of screening the new drug. Because of the experimental characteristics, the non-patentee may claim the experimental use exception and cause persecutions to the patentee. This kind of experimental use exception is not fair to the patentee and damage patentee’s benefit, especially in the research tool patentee. The patentee will not be able to receive the royalty from the non-patentee who claims the experimental use exception. As a result, it would reduce the will of filing such kind of patents. Should the effect of the patent right grant the patentee a broader right to patentees to encourage the inventors to release new technology which benefits the social and scientific progress? Or it should offer a large range of the experimental use exempt for the research institutes to encourage the using in the experimental use exception? It is difficult to judge which direction is better than the other one. The court are taking the side of the range of experimental use exception, allowing the research tool patents in the pre-clinical tests or experiment for submitting to FDA. This thesis proposes that there should be more criteria other than FDA, such as the purpose and the practical condition of use. Only when the whole situation and justice are taken into consideration will there be a suitable explanation of the experimental use exception. This thesis offers some suggestions concerning the management and application of research patent tools for the patentee and the non-patentee. It also assert that regulations about the fair use, such as experimental use exception, non-profit private use, voluntary collective rights licensing with rational royalty, can be added to the patent law to urge the patents to be put into practice. The reasonable experimental use exception can encourage the inventors to release his invention and the R&D departments to improve the technology more aggressively, realizing social and industrial advancement through the patent applications.

專利權人在權利保護期間享有法律保障之排他性，而智慧財產權之制度設置，必須兼顧個人權利與社會公益，藉由保護權利人進而促進社會公益，但專利權制度中，專利權濫用之現象，對於專利發展中國家而言，尤其是外國專利強權企業利用專利奪取私益已達浮濫程度，造成私益與公益之間的矛盾與衝突，因此專利公益訴訟是平衡兩者之利益的一個手段。而因專利要件審查難以完善，造成許多具有無效事由的專利被授予專利權，這些專利權的存在侵害公眾利益甚鉅，中國大陸的對策為：提起專利公益訴訟使瑕疵專利無效，鼓勵任意第三人對專利之有效性提出挑戰，請求專利管理機關重新進行專利有效性的審查，維護公眾的合法利益；本文比較我國目前具有瑕疵之專利權，仍由民間企業基於非公共利益之商業利益考量而提出專利舉發，分析兩岸的制度及案例，檢視我國專利公益訴訟提出之可能，期使舉發專利無效之制度得以更臻健全。 / The purpose of the study was to analyze the public interest with regards to patent litigation cases in China. Public interest litigation is litigation for the protection of the public interest. Patentees have the exclusive right to prevent others from exploiting the invention without the patentees' consent during the legal protection. However, intellectual property rights are set up to protect not only rights of patentee but also that of social welfare. To reconcile the contradictions between private interest and public welfare, the study focuses on the phenomenon of abuse of patents discussed in the patent systems and the merits of public interest in patent litigation. Furthermore, the study examines China public interest patent litigation to invalidate defected patent system and encourage any third party to challenge the validity of the patent. Under the comparative legal study approach, the study can provide different perspective for our legal system to improve more beneficially our Patent law system.

Le droit des brevets a pour objet l’appropriation d’enseignements techniques nouveaux afin d’encourager le développement de la recherche dans le domaine de la technique. Ainsi, la technicité constitue une condition fondamentale de l’apparition du droit de brevet. Cependant, la définition de ce qu’est la technique en droit des brevets exige, au préalable, de déterminer quelle est sa fonction normative. Cette fonction varie selon la conception de la propriété retenue. L’approche matérialiste de la propriété en fait une limite à l’appropriation tandis que l’approche idéaliste en fait un critère d’appropriation de la chose. Selon la première approche, la propriété ne concerne que des choses corporelles et des droits. L’invention est alors confondue avec une chose corporelle dont elle autorise la réalisation. La technicité est le critère de la corporéité, c’est une limite à l’appropriation. Cette approche se traduit par l’établissement d’un domaine de la brevetabilité défini par une énumération des choses non appropriables et par une appréciation de la technicité au niveau d’une chose corporelle que la réalisation de l’invention permet. Selon la seconde approche, qui emporte notre conviction, la propriété peut porter sur des choses corporelles et sur des choses incorporelles. La technicité constitue un critère de l’appropriation. Cette approche se traduit par la suppression du domaine de la brevetabilité et par une appréciation de la technicité au niveau de la chose incorporelle de l’invention. / The object of patent law is the appropriation of novel technical teachings in order to support technological development. Thus, the technicality is a fundamental condition of the patent right appearance. However, the definition of what technique is in patent law demands, at first, to fix what its normative function is. This function varies depending on the property conception retained. The materialist approach of property views it as a limit to appropriation, while the idealist views it as a criterion of appropriation.According to the first approach, the property only concerns corporal things and rights. Then the invention is mixed up with a corporal thing that its realization allowed. The technicality is the criterion of corporality, it is a limit to the appropriation. This approach is realized by the establishment of the domain of patentability, which is defined by a list of objects that are not appropriable and by the assessment of the technicality of the invention at the latest stage of realization the invention allows.According to the second approach, which we are defending, the property can concern either corporal or incorporal things. Then the invention is an incorporal thing. The technicality is a criterion of the appropriation. This approach is realized by the suppression of the domain of patentability and by the assessment of the technicality of the invention at the non-tangible stage.

L’évolution d’une économie industrielle vers une économie de la connaissance et du savoir a propulsé la propriété intellectuelle sur le devant de la scène. Désormais les droits intellectuels s’intègrent à tous les domaines de la vie moderne. De ce fait, le besoin de les protéger efficacement par des règles juridiques appropriées et d’inciter en conséquence les créateurs à produire de nouvelles créations est devenu une nécessité de premier ordre. Cependant, la spécificité de la nature de l’œuvre protégée par la propriété intellectuelle exige la prise en considération de multiples intérêts antagonistes. C’est pourquoi le législateur a cherché, au nom de l’intérêt général, à créer un juste équilibre interne entre les principaux intérêts présents au sein du régime de la propriété intellectuelle. Or, l’exercice des prérogatives octroyées par le régime de propriété intellectuelle effectué par le titulaire de droit a généré une importante expansion de ses intérêts au détriment des autres intérêts concurrents – présents dans la matière. Cette situation a provoqué, en conséquence, une rupture de l’équilibre interne de ce système, préétabli en amont par le législateur. Or, l’intérêt général peut jouer un rôle central dans le rétablissement d’un équilibre en la matière. Dans cette perspective, le juge peut, grâce à son pouvoir créateur de règles jurisprudentielles, se servir de l’intérêt général comme d’une ligne directrice servant à rétablir ce juste équilibre dans le système de la propriété intellectuelle. L’intérêt général justifie donc, tout autant que les limites intrinsèques aux droits de la propriété intellectuelle, les limites extrinsèques à ces droits / The evolution of the industrial economy towards the economy of knowledge has propelled intellectual property to the forefront. Intellectual property has become integrated in all the domains of the modern life. As a result, it has become a necessity to protect it effectively through appropriate legal rules that encourage creators to continue to provide new creations. However, the specificity of the nature of the work protected by intellectual property requires the consideration of multiple conflicting interests. As such, the legislator has sought, in the name of the general interest, to create a fair internal balance between the main interests present within the system of intellectual property rights. Nevertheless, the exercise of the prerogatives granted by the intellectual property system, carried out by the owner of intellectual property, has caused an important expansion of the interests of this owner, to the detriment of other concurrent interests. This has consequently caused a break in the internal balance of the system, instigated by the legislator. Nonetheless, the general interest can play a key role in restoring balance through the application of external rules to the intellectual property regime. In this perspective, the judge can, by using his creative power of jurisprudence, use the general interest as a guideline to restore balance in the intellectual property system. The general interest justifies thus, as well as the intrinsic limits to intellectual property rights, the extrinsic limits to these rights

This Diploma thesis, called "Comparison of patent law in the EU countries", deals with legislation of invention patents and their protection in selected countries such as Germany and the Czech Republic. Within Europe there is an attempt to harmonize the legislation in the field of intellectual property rights in all member countries and to create a unified legal system. A patent is the most important object in protection of industrial property. The secondary objective of this thesis is focused on the identification of the re-sponsible authorities and to determine the financial and time requirements for obtaining a patent. Next major objective is the evaluation of the use of the patent protection within the Czech and German universities, research organizations and private companies and then their transfer of technologies. The practical part contains the analysis of both selected countries from the per-spective of patent law, valid legislation, the responsible institutions and patent statistics for the last ten years. Additional chapter discusses the results of research and development in the university environment at three universities in the Czech Republic and Germany. The analysis is focused in particular on the procedure of obtaining a patent, then also the influence of the local authorities. The comparison of these two countries has revealed some certain similarities, but also striking differences between them. The Czech Republic is currently also slowly dis-covering the benefits of patent protection, but the results can be evaluated only after some time interval.

No description available.