Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions. |
Search result: 8 articles
Year 2019 xArticle |
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Journal | Erasmus Law Review, Issue 2 2019 |
Keywords | Medical Device Directive, Medical Device Regulation, regulatory, European Union, reform, innovation, SPCs, policy |
Authors | Magali Contardi |
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Journal | Erasmus Law Review, Issue 2 2019 |
Keywords | property, intellectual creation, open access, copyright |
Authors | Nikos Koutras |
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This article relies on the premise that to understand the significance of Open Access Repositories (OARs) it is necessary to know the context of the debate. Therefore, it is necessary to trace the historical development of the concept of copyright as a property right. The continued relevance of the rationales for copyright interests, both philosophical and pragmatic, will be assessed against the contemporary times of digital publishing. It follows then discussion about the rise of Open Access (OA) practice and its impact on conventional publishing methods. The present article argues about the proper equilibrium between self-interest and social good. In other words, there is a need to find a tool in order to balance individuals’ interests and common will. Therefore, there is examination of the concept of property that interrelates justice (Plato), private ownership (Aristotle), labour (Locke), growth of personality (Hegel) and a bundle of rights that constitute legal relations (Hohfeld). This examination sets the context for the argument. |
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Journal | Erasmus Law Review, Issue 3 2019 |
Keywords | Mercosur, European Union, regionalism, integration, international organisation |
Authors | Ricardo Caichiolo |
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This study is focused on the evaluation of successes and failures of the Common Market of the South (Mercosur). This analysis of Mercosur’s integration seeks to identify the reasons why the bloc has stagnated in an incomplete customs union condition, although it was originally created to achieve a common market status. To understand the evolution of Mercosur, the study offers some thoughts about the role of the European Union (EU) as a model for regional integration. Although an EU-style integration has served as a model, it does not necessarily set the standards by which integration can be measured as we analyse other integration efforts. However, the case of Mercosur is emblematic: during its initial years, Mercosur specifically received EU technical assistance to promote integration according to EU-style integration. Its main original goal was to become a common market, but so far, almost thirty years after its creation, it remains an imperfect customs union. |
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Journal | Erasmus Law Review, Issue 4 2019 |
Keywords | Dutch model BIT, foreign direct investment, bilateral investment treaties, investor-to-state dispute settlement, sustainable development goals |
Authors | Alessandra Arcuri and Bart-Jaap Verbeek |
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In 2019, the Dutch government presented a New Model Investment Agreement that seeks to contribute to the sustainability and inclusivity of future Dutch trade and investment policy. This article offers a critical analysis of the most relevant parts of the revised model text in order to appraise to what extent it could promote sustainability and inclusivity. It starts by providing an overview of the Dutch BIT (Bilateral Investment Treaty) programme, where the role of the Netherlands as a favourite conduit country for global FDI is highlighted. In the article, we identify the reasons why the Netherlands became a preferred jurisdiction for foreign investors and the negative implications for governments and their policy space to advance sustainable development. The 2019 model text is expressly set out to achieve a fairer system and to protect ‘sustainable investment in the interest of development’. While displaying a welcome engagement with key values of sustainable development, this article identifies a number of weaknesses of the 2019 model text. Some of the most criticised substantive and procedural provisions are being reproduced in the model text, including the reiteration of investors’ legitimate expectation as an enforceable right, the inclusion of an umbrella clause, and the unaltered broad coverage of investments. Most notably, the model text continues to marginalise the interests of investment-affected communities and stakeholders, while bestowing exclusive rights and privileges on foreign investors. The article concludes by hinting at possible reforms to better align existing and future Dutch investment treaties with the sustainable development goals. |
Editorial |
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Journal | Erasmus Law Review, Issue 1 2019 |
Keywords | international business courts, justice innovation, justice competition, global commercial litigation, private international law |
Authors | Xandra Kramer and John Sorabji |
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Journal | Erasmus Law Review, Issue 1 2019 |
Keywords | Commercial contracts, Enforcement, Jurisdiction, Specialized courts, India |
Authors | Sai Ramani Garimella and M.Z. Ashraful |
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The liberal globalised order has brought increased focus on the regulation of international commerce, and especially dispute resolution. Enforcement of contracts has been a concern largely owing to the insufficiencies of the legal systems, especially relating to the institutional structure, and it holds true for India as well. The commercial courts mechanism – international and domestic – with innovative features aimed at providing expedited justice is witnessing much traction. India, similar to many other jurisdictions, legislated in favour of specialized dispute resolution mechanisms for commercial disputes that could help improve the procedures for enforcement of contracts. This research attempts to critique the comparable strengths and the reform spaces within the Indian legislation on commercial courts. It parses the status of commercial dispute resolution in India especially in the context of cross-border contracts and critiques India’s attempt to have specialised courts to address commercial dispute resolution. |
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Journal | Erasmus Law Review, Issue 1 2019 |
Keywords | international commercial court, dispute resolution, business court, Brexit, judicial system |
Authors | Alexandre Biard |
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In 2018, in the wake of Brexit, the French legal profession took several important measures to strengthen the competitiveness of France and the French legal system, and to make Paris an attractive go-to-point for businesses when the latter have to deal with international commercial litigation. When taking a closer look at it, Brexit is only the top of the iceberg, and has mostly served as a catalyst. Reasons explaining the development of international commercial courts in France are manifold. They are consequences of long-standing efforts aimed at boosting the French judicial marketplace to adapt it to the requirements of globalization and to the expectations of multinational corporations. The setting-up of the French international business courts has made several procedural adjustments necessary. Although the latter undoubtedly represent clear innovations, they however do not constitute a full-blown revolution. France has indeed decided to maximize already-existing procedural rules, combined with a new organisational format inspired by the Common Law tradition. If it remains too early to draw clear conclusions on the impact of these new developments, it is essential to keep our ears to the ground, and to be forward-looking. We should carefully consider the possible side-effects on the French justice system considered as a whole, and in particular wonder whether these international commercial courts might in the future open the door to broader far-reaching evolutions within the judicial system. Finally, the multiplication of international business courts across Europe nowadays triggers some questions concerning the role and potential added value of an EU initiative in this domain. |
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Journal | Erasmus Law Review, Issue 1 2019 |
Keywords | choice of court, commercial court, lawyers’ preferences, survey on lawyers, international court |
Authors | Erlis Themeli |
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France, Germany, Belgium, and the Netherlands have taken concrete steps to design and develop international commercial courts. Most of the projects claim to be building courts that match the preferences of court users. They also try to challenge England and Wales, which evidence suggests is the most attractive jurisdiction in the EU. For the success of these projects, it is important that their proposed courts corresponds with the expectations of the parties, but also manages to attract some of the litigants that go to London. This article argues that lawyers are the most important group of choice makers, and that their preferences are not sufficiently matched by the new courts. Lawyers have certain litigation service and court perception preferences. And while the new courts improve their litigation service, they do not sufficiently addressed these court perception preferences. |