Using a comparative methodology the thesis analyses the patentability of pharmaceutical and related inventions in the UK and South Africa. The viewpoint adopted is that of the industry actors, who are engaged in the conception through to the commercialisation of inventions, although this perspective is measured against the concerns of wider stakeholders. Drawing, in particular, on the classical justifications of the patent system, the research identifies the attributes of an optimal patentability standard which can be adjusted as technology and the legislative landscape changes. Framing an optimal patentability benchmark as one that both promote and protect the invention, the thesis considers the elements that ground the judicial patentability decision-making process. As pharmaceutical patenting tends to be an emotive and contentious area, the interplay between the international and respective domestic patentability frameworks is also evaluated in its impact on the inventor within the pharmaceutical chain. The research then turns to investigate four individual patentability limbs as applied in the two jurisdictions. The definition of the invention and excluded subject matter is evaluated in mapping out the pharmaceutical activity and the associated research output that falls within patentable subject matter. The novelty, non-obviousness and industrial application limbs to patentability are then examined, giving particular attention to the tests used by the courts in evaluating whether an invention meets the requisite criteria. The argument is made that the courts in interpreting patentability must apply principles advancing the purpose of the patent system in arriving at decisions. A systematic and robust approach is advanced that improves repeatability and precision in arriving at patentability decisions whilst preventing subjective application of the criteria. It is suggested that the application of the tests whilst aligning with the rationale and policy of the patent system, have to make sense to the scientist working in inventive pharmaceutical activities.

La Convention sur la diversité biologique (CDB, 1992) a établi pour la première fois en droit international un système d’accès aux ressources génétiques (RG) et du partage des avantages qui découlent de leur utilisation (système d’APA). Ce système se base sur la reconnaissance de la souveraineté des États sur leurs ressources naturelles, censée leur permettre d’en contrôler l’utilisation et bénéficier des avantages qui en découlent. La Convention se présentait alors comme un acquis pour les pays du Sud, principaux fournisseurs des RG et par conséquent principaux bénéficiaires de ce système. Deux ans après la conclusion de la CDB, l’Accord sur les aspects de la propriété intellectuelle qui touchent au commerce (l’Accord) a été conclu sous l’égide de l'OMC. Sous l’influence des pays du Nord, cet Accord étend le champ de la brevetabilité à toutes technologies, y compris celles qui étaient auparavant exclues de ce champ par de nombreux pays, notamment du Sud. Les biotechnologies sont les principales technologies visées par cette obligation. À cet égard les pays du Sud ont exprimé leur réticence en considérant que l’ADPIC n’est pas adapté aux exigences du système d’APA de la CDB puisqu’il permet la brevetabilité des RG qui sont à la base des biotechnologies sans prendre en considération ces exigences. Ces pays ont en outre estimé que l’Accord risque de compromettre la mise œuvre de ce système. Dès lors les deux textes se sont retrouvés au centre d’un réel débat, entre les pays du Sud et les pays du Nord que ce soit pour condamner leur incompatibilité ou pour défendre leur synergie. Un débat qui révèle un réel clivage Nord/Sud autour de nombreuses questions. / The Convention on Biological Diversity (CBD), concluded in 1992, has established for the first time in international law a genetic resources (GR) regime on access and benefits sharing arising from their use (ABS system). This system is based on the recognition of the sovereignty of States over their natural resources, supposed allow them the control of their use and reaping the associated benefits. Therefore, the Convention was presented as a gain for South’s countries, the main suppliers of GR and therefore the main beneficiaries of this system. Two years after the conclusion of the CBD, the Agreement on Trade Related aspect of Intellectual Property (TRIPS) was concluded under the aegis of the World Trade Organization (WTO.) Under the influence of North’s countries concerned to shape the international patent system on their own model, this Agreement extend the patentability scope to all technologies, including those which were excluded from this scope by many countries, especially in South. Biotechnologies are the most concerned by this obligation. In this regard, South’s countries have expressed reluctance, considering that TRIPS is not adapted to the requirements of the ABS system of CBD since it allows the patentability of GR which are the base of biotechnologies without regard to these requirements. These countries, moreover, considered that the Agreement could compromise the implementation of this system. Therefore, the two texts found themselves at the center of a real debate between the South and the North whether to denounce their incompatibility or support their synergy. A debate that exposes a real North/South division on numerous question.

<p>Patent law has during time evolved from industrial inventions to also include intellectual inventions. Patentability has as well changed with time. For technology to be patentable it must be considered to be a technical solution to a problem, and today genetic inventions are considered to be such a technical solution. From the beginning plants and animals were not considered as inventions; however, technology progress urged modifications of existing legislation to meet development progress within technology. European as well as international harmonization have been carried out in this field to ensure uniformity.</p><p>The exclusion from patentability for plant and animal varieties can be found in several sources of law; this study focuses on the exclusions in Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions, as well as in Article 53b of the European Patent Convention. After two specific cases from the European Patent Office the scope of the exclusion from patentability for plant and animal varieties was questioned. The two cases ONCO-mouse and Plant Genetic Systems had different outcomes, patent was granted in one case and not in the other; and that raised confusion as to the definition of plant and animal varieties, as both cases concerned genetic modification.</p><p>Although there is no clear definition of plant and animal varieties, case law provides guidance to a certain extent, the reasoning in the case law also gives guidance as to where the judiciary is heading in its interpretation. There is more legislation concerning plant varieties, and the definition of this term might be considered to be clearer. The general opinion seems to be that what is said about plant varieties should be applied mutatis mutandis to animal varieties, and vice versa, however this may be questionable in some cases. The lack of a clear definition of the terms plant and animal varieties might result in a lack of legal certainty in this field, as demonstrated by the questioning of the two contradicting cases mentioned above.</p><p>Rapid developments in the field of biotechnology imply that the patentability of plants and animals will be assessed on other grounds in the future. As biotechnology is an expanding area, the acceptance of new controversial inventions may occur on a more regular basis. Time will tell if this is the case.</p>

Patent law has during time evolved from industrial inventions to also include intellectual inventions. Patentability has as well changed with time. For technology to be patentable it must be considered to be a technical solution to a problem, and today genetic inventions are considered to be such a technical solution. From the beginning plants and animals were not considered as inventions; however, technology progress urged modifications of existing legislation to meet development progress within technology. European as well as international harmonization have been carried out in this field to ensure uniformity. The exclusion from patentability for plant and animal varieties can be found in several sources of law; this study focuses on the exclusions in Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions, as well as in Article 53b of the European Patent Convention. After two specific cases from the European Patent Office the scope of the exclusion from patentability for plant and animal varieties was questioned. The two cases ONCO-mouse and Plant Genetic Systems had different outcomes, patent was granted in one case and not in the other; and that raised confusion as to the definition of plant and animal varieties, as both cases concerned genetic modification. Although there is no clear definition of plant and animal varieties, case law provides guidance to a certain extent, the reasoning in the case law also gives guidance as to where the judiciary is heading in its interpretation. There is more legislation concerning plant varieties, and the definition of this term might be considered to be clearer. The general opinion seems to be that what is said about plant varieties should be applied mutatis mutandis to animal varieties, and vice versa, however this may be questionable in some cases. The lack of a clear definition of the terms plant and animal varieties might result in a lack of legal certainty in this field, as demonstrated by the questioning of the two contradicting cases mentioned above. Rapid developments in the field of biotechnology imply that the patentability of plants and animals will be assessed on other grounds in the future. As biotechnology is an expanding area, the acceptance of new controversial inventions may occur on a more regular basis. Time will tell if this is the case.

"Mémoire Présenté à la Faculté des Études Supérieures en vue de l'obtention du Grade de Maîtrise En Droit Option Recherche" / The past decade has seen an explosion in the availability of genome sequence data from public and private genome projects. Most notably, the complete human DNA genome sequence has been published and the locations of some of the genes have been mapped to individual chromosomes. Commensurate with the growth in sequence information, the biotechnology industry has become firmly established. Gene patents have played an important part in this industry, and there has been a marked increase in patent applications filed in the field of human genetic resource. However, concerns have been raised over the patentability of human genetic material through public protests and international statements, but to little effect. Discussed here are some of these concerns, the patent office's response to them in different jurisdictions, and ways in which to address these issues and to move the debate forward within current legal structures. / Durant la dernière décennie nous avons assisté à une explosion de données génomiques séquentielles provenant de projets publiques et privés. Le séquence complète du génome humain a été publiée ainsi que la localisation certains gènes a été tracée pour des chromosomes individuels. Avec I'accroissement de I'information séquentielle, l'industrie de la biotechnologie s'est sérieusement établie. Le brevets octroyés en regard des gènes a joué un rôle important dans cette industrie, aussi il y a eu une augmentation dans la demande de brevets dans Ie domaine du matériel génétique humaine. Cependant après plusieurs controverses publiques et la créations de règles internationales certains doutes ont été soulevés à propos de la « brevetabilité »du génome humain, mais impact. II sera question dans notre étude ces inquiétudes, de la réponse a ces inquiétudes par les bureaux des brevets différentes juridictions, ainsi que des divers moyens utilisés pour de ces problèmes tout en avançant le présent débat en utilisant les structures légales existantes.

Title: Patentability of biotechnological inventions under European Patent Convention The topic of thesis is the patentability of biotechnological inventions under the European Patent Convention (Munich, 1973) (hereinafter the "EPC") with special emphasis on decision making practices of the European Patent Office. At the beginning, the author deals with general patent law, in particular with fundamental substantive conditions of patentability of inventions, both positive and negative. A brief explanation is then devoted to the definition of biotechnological science and biotechnological invention. In the subsequent part of the thesis, the author discusses the sources of patent law in general and in relation to biotechnological inventions. The chapter is divided into three parts - international, European and national sources. Discussion regarding European sources is split into two subsections dealing with EPC and EU law. The author examines in particular the complicated legislative procedure for the adoption of the Directive 98/44/EC of the European Parliament and of the Council dated 6th July 1998 on the legal protection of biotechnological inventions and its impact on European patent law. National sources address primarily imperfect transposition of Directive 98/44/EC into the Czech law. The next chapter is...

The purpose of the thesis is to analyse exclusions and exceptions from patentability which is a negative requirement for an invention to enjoy a patent protection. It aims to answer the question why the exclusions are needed and whether they should be preserved as some of them proved to be very controversial. The law and practice of the European Patent Office, the Czech Republic and the United Kingdom are compared with the emphasis on the European Patent Convention and the EPO's case law. In the national regulation, mainly the differences and peculiarities to the European approach are pointed out. The work is composed of four chapters. The first chapter explains the basic concepts of patent law and presents justifications for patent protection. The second chapter deals with various patent systems and reviews the most important international tools of harmonization. In the third chapter, the exclusions are introduced and the distinction between Article 52(2) and (3) EPC (exclusions) and Article 53 (exceptions) is clarified whereas it is submitted that the difficulty posed by the exclusions lies in the interpretation of the words "as such" used in Article 52(3) EPC. The main focus of the thesis lies in chapter four which is subdivided into nine subchapters, each discussing one of the exclusions and...

The past decade has seen an explosion in the availability of genome sequence data from public and private genome projects. Most notably, the complete human DNA genome sequence has been published and the locations of some of the genes have been mapped to individual chromosomes. Commensurate with the growth in sequence information, the biotechnology industry has become firmly established. Gene patents have played an important part in this industry, and there has been a marked increase in patent applications filed in the field of human genetic resource. However, concerns have been raised over the patentability of human genetic material through public protests and international statements, but to little effect. Discussed here are some of these concerns, the patent office's response to them in different jurisdictions, and ways in which to address these issues and to move the debate forward within current legal structures. / Durant la dernière décennie nous avons assisté à une explosion de données génomiques séquentielles provenant de projets publiques et privés. Le séquence complète du génome humain a été publiée ainsi que la localisation certains gènes a été tracée pour des chromosomes individuels. Avec I'accroissement de I'information séquentielle, l'industrie de la biotechnologie s'est sérieusement établie. Le brevets octroyés en regard des gènes a joué un rôle important dans cette industrie, aussi il y a eu une augmentation dans la demande de brevets dans Ie domaine du matériel génétique humaine. Cependant après plusieurs controverses publiques et la créations de règles internationales certains doutes ont été soulevés à propos de la « brevetabilité »du génome humain, mais impact. II sera question dans notre étude ces inquiétudes, de la réponse a ces inquiétudes par les bureaux des brevets différentes juridictions, ainsi que des divers moyens utilisés pour de ces problèmes tout en avançant le présent débat en utilisant les structures légales existantes. / "Mémoire Présenté à la Faculté des Études Supérieures en vue de l'obtention du Grade de Maîtrise En Droit Option Recherche"

In writing this dissertation, the aim is to investigate the patentability of computer software - whether it is possible and legally advisable to make way for software patents in South Africa. This is an uncertain and highly debated area in our law. Ultimately, this study is aimed at checking the validity of proposed arguments and suggestions emanating from within the computer software patent debate itself. The Patents Act 57 of 1978 only excludes the patenting of computer software ?as such?. As a result, it is left open for interpretation what it is that the legislature meant by the phrase ?as such? and whether indeed computer software can be patented, since we lack case-law to clarify this point of law. Presently, there are arguments that software patents may possibly fall in line with the required growth and development for our country?s economy. The debate also revolves around the issue whether patents are better suited as legal protection for computer software in contrast to the protection offered under the Copyright Act 98 of 1978. This study will therefore be carried out with an aim to determine and recommend the suitable direction which our law should follow in order to have a competitive stance and facilitate economic growth for our country, specifically in the computer software industry. / Mini Dissertation (LLM)--University of Pretoria, 2016. / Mercantile Law / LLM / Unrestricted

The primary objective of the thesis will be to focus on patent protection of software under the European Patent Convention, by analyzing the different approaches that the European Patent Office has taken into consideration since the mid-1980s. These approaches are derived from the different decisions that emanate from the Technical Boards of Appeal of the European Patent Office. The thesis will examine the most relevant decisions illustrating the juridical tendencies and basis that have been utilized to decide over the patentability of computer programs. The analysis will conclude with the latest approach taken by the Technical Board of the European Patent Office. The study will examine the patentability requirements of inventions in general established within the European Patent Convention. Sources that will be utilized to carry out this research will include case law, legislation, specialized legal commentary; journals and books. The present study sustains that computer programs may be patented as long as they comply with all the general requirements of an invention prescribed under the European Patent Convention together with the condition established by case law called the technical character requirement. Nevertheless, due to the fact that the Technical Boards of Appeal are not bound by previous case law, the current position could keep evolving as it relies on the stance of  the European Patent Office on patentability of computer programs which is seems to be influenced by the changes in the technological world