The European Patent Convention (EPC) establishes “a system of law, common to the Contracting States, for the grant of patents for inventions” (article 1) and an organisation, the European Patent Organisation, to administer it. A patent granted under the EPC is called a European patent but takes effect as a bundle of national patents under the laws of the Contracting States in which protection is sought.

Following the 1980 US Supreme Court decision to allow a patent on a living organism, debate has continued on the moral issues involved in biotechnology patents of many kinds and remains a contentious issue for those opposed to the use of biotechnology in industry and agriculture. Attitudes to patenting in the life sciences, including those of the research scientists themselves, are analysed. The relevance of morality to patent law is discussed here in an international context with particular reference (...) to the law of the European Patent Convention administered by the European Patent Office (EPO). The EPO has been the principal forum for opposition to such patents and the few cases under dispute in the EPO are reviewed, including patents for the onco-mouse, human relaxin gene, and the PGS herbicidally resistant plant (gmo). Morality provisions in the European Parliament and Council Directive 98/44/EC are also summarised. (shrink)

Human gene patents are patents on human genes that have been removed from human bodies and scientifically isolated and manipulated in a laboratory. The U.S. Patent and Trademark Office (the USPTO) has issued thousands of patents on such genes, and patents have also been granted by the European Patent Office, (the EPO). Legal and moral justification, however, are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and procedure. (...) So, it is surprising to learn that some people believe that the legal justification of human gene patents can remove the most serious moral objections to them. Yet, those who are well-versed in patent law often believe that confusion over some quite basic legal and scientific facts accounts for moral objections to such patents and, in particular, for the belief that they justify the ownership of one person by another. Once these confusions are removed, they contend, we will see that there is nothing especially alarming about patents on human genes, and no reason to believe them immoral. -/- Such claims seem especially surprising because the morality of an invention is generally supposed to have little role in decisions about whether or not an invention deserves a patent under U.S. law. Although the European Patent Convention’s article 53 (a) prohibits patenting inventions, the publication or exploitation of which would be contrary to public order or morality, it turns out that this clause rarely justifies withholding a patent from an invention that otherwise meets legal criteria. Thus, although more than 320,000 patents have been granted by the EPO since its creation, this clause has never been used successfully to strike down a claim for a patent. Indeed, Ulrich Schatz explains, “Poisons, explosives, extremely dangerous chemical substances, devices used in nuclear power stations, agro-chemicals, pesticides and many other things which can threaten human life or damage the environment have been patented, despite the existence of the public order and morality bar” in almost all European countries. -/- Indeed, this paper shows, while ethical objections to human gene patents are often controversial, they need not be unreasonable, nor need they depend on mistaken assumptions about patent law. Rather, they may reflect familiar ethical concerns about the dominance of commercial imperatives in modern societies; concerns about the disparities in power and wealth amongst individuals and countries; and concerns about the lack of public discussion, transparency and accountability surrounding significant changes in people’s rights, status and opportunities. Hence, I conclude, ethical concerns cannot be easily dismissed and, indeed, point to the need to think harder about the nature and justification of patent law, itself. (shrink)

The term “patent” is an abbreviation of “letters patent”, the open form of document historically issued by the Crown for the purpose of conferring a right or privilege or otherwise communicating the royal will. In contemporary law it denotes the species of intellectual property that is granted as an inducement for the creation and disclosure of novel, inventive and industrially applicable inventions. In the UK that property is conferred under the Patents Act 1977, or with similar effect the (...) European Patent Convention (EPC), and comprises the exclusive right to use and sell a protected invention for up to 20 years. A protected invention may be any subject matter having technical character; a definition derived from the Act’s express exclusion from patentability of (among other things) discoveries, scientific theories, business methods and computer programs “as such”. Also excluded are surgical, therapeutic and diagnostic methods (for lack of industrial applicability), and inventions the commercial exploitation of which would be contrary to public policy or morality. In these and other respects the Patents Act follows the EPC, which it was the explicit purpose of that Act to implement. Patents are territorial, and are thus only valid and infringed in their country of issue. For a UK inventor to obtain protection outside the UK s/he must therefore obtain a patent from that country, either directly by applying under its laws, or if it is a party to the EPC or other intergovernmental agreement, indirectly by applying under that agreement. Inventors seeking protection for an invention in more than one country will often do so by means of the Patent Cooperation Treaty. (shrink)

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It (...) is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years. (shrink)

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It (...) is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years. (shrink)

Generics (UK) Ltd v Lundbeck A/S [2009] UKHL 12 is about the validity of patents for chemical products. It is also about the object of patent protection, and the balance struck by the patent system between the interests of the public and individual inventors. Finally, it is about the development of UK patent law in the era of the Convention on the Grant of European Patents (1973) 13 I.L.M. 268 (European Patent Convention).

This paper addresses the topic of patenting related to the notion of Responsible Research and Innovation (RRI). Focusing on patents in the field of biotechnology, we assess to what extent current patenting practices of the European Patent Organization, and more specifically of its executive body, the European Patent Office (EPO) align with RRI principles. We first argue for including patenting as a relevant topic in the context of RRI and then provide an operationalisation of RRI principles (...) that functions as an analytic tool in the article. We find that the dimensions of RRI currently do not have a strong position in the EPO. Subsequently, we discuss the potential for improving the alignment of the EPO with RRI principles. We conclude the article with some final reflections on the applicability of RRI to the policies and practices of the European Patent Organization. (shrink)

This article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting (...) patent holders a governance like function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over “novel beings”; how issues of “agency” displayed by any “novel beings” would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on “novel beings” or whether changes within patent law may be needed if patents in relation to “novel beings” are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally. (shrink)

The European Parliament rejected in 1995 the European Commission proposal to harmonize legal protection of biotechnological inventions. Although it did not seem initially the most contentious of the many issues involved in the current legal and ethical debate around biomedicine and genetics, patenting is now focusing bioethics in Europe.

Cette contribution examine la pertinence de la Convention européenne des droits de l’homme pour les personnes en situation de handicap. Elle se penche sur les principes de la Convention tels que la dignité humaine, l’autonomie personnelle et l’égalité, qui sont particulièrement importants pour les personnes en situation de vulnérabilité. Le texte aborde ensuite les obligations négatives et positives de l’État à l’égard des personnes handicapées. En ce qui concerne les premières, le texte souligne la nécessité de procéder à (...) des évaluations individualisées dans le cadre des processus décisionnels et de trouver un équilibre entre les droits des personnes et les intérêts de l’État. En ce qui concerne les secondes, l’État est également tenu d’évaluer les besoins réels des personnes handicapées. Il doit fournir une aide suffisante, tout en pouvant prendre en compte des considérations financières légitimes. La Convention européenne est ensuite examinée dans sa relation avec la Convention des Nations Unies relative aux droits des personnes handicapées. La Cour européenne des droits de l’homme s’efforce généralement d’interpréter la Convention européenne en harmonie avec les autres traités internationaux. Si la Convention des Nations Unies a ainsi influencé certains développements dans la jurisprudence de la Cour, il existe également des cas où la Cour a estimé que la Convention européenne n’offrait pas le même niveau de protection que la Convention des Nations Unies. La relation entre les deux conventions reste dynamique, ce qui laisse penser qu’avec le temps, davantage de principes de la Convention des Nations Unies pourraient devenir partie intégrante de l’interprétation de la Convention européenne. (shrink)

We conduct the first comparative analysis of the financial performance of European green, black and conventional mutual funds. Based on a unique dataset of 175 green, 259 black and 976 conventional mutual funds, the investigation contrasts the financial performance of the three dissimilar investment orientations over the 1991–2014 period. Over the full sample period, green mutual funds significantly underperform relative to conventional funds, while no significant risk-adjusted performance differences between green and black mutual funds could be established during the (...) same period. Environmentally friendly investment vehicles display a significant exposure to small cap and growth stocks, while black funds are more exposed to value stocks. Remarkably, the green funds’ risk-adjusted return profile progressively improves over time until no difference in the performance of the green and the conventional classes could be discerned. Further evidence suggests that the green funds are beginning to significantly outperform their black peers, especially over the 2012–2014 investment window. (shrink)

Nearly fifteen years after the Council of Europe first called for a pan‐European convention on issues in bioethics to harmonize disparate national regulations, in November 1996 the council's Committee of Ministers approved the Convention on Human Rights and Biomedicine for formal adoption. The draft convention, released in July 1994, provoked strong public, professional, and governmental debate among European nations, particularly regarding provisions for biomedical research with subjects unable to give informed consent. If ratified, the “bioethics (...) convention” will become the first such document to have binding force internationally. (shrink)

Forced expropriations of immovable property were common during the Communist era in Eastern Europe. Today, many of the former owners or their heirs are interested in regaining legal ownership of such properties, often decades after the ownership has been reallocated to others. Therefore, the conflict between old and new owners is often resolved in favour of the new owners. While this is understandable from a contemporary political perspective, this approach results in a perpetuation of the results of an earlier human (...) rights violation, thereby resulting in a new human rights violation which will have to be measured against the European Convention on Human Rights (ECHR) if the state in question has ratified it prior to deciding how to handle the long-term effects of expropriations. Firstly, in the article we will devote ourselves to the interpretation of the right to property with an emphasis on the problem of expropriation. Above all, we will elaborate on the definition of the term “property” as well as positive and negative obligations of the Member States regarding this right. Finally, we will address the question of expropriations prior to the entry into force of the Convention and just compensation under Article 41 ECHR. Interpretation of the right to property will be supported by the jurisprudence of the European Court of Human Rights. (shrink)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position (...) of certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

The treaty of Lisbon makes European Union (EU) accession to the European Convention on Human Rights (ECHR) an obligation of result. The issue has been intensely discussed for more than thirty years, arguing that such accession is necessary in view of the need to ensure the ECHR standard of fundamental rights protection in Europe. This question again gains prominence as the EU member states and the institutions seek to agree on the negotiation directives of EU accession to (...) the ECHR. The process brings up the difficulties involved in creating a mechanism which would both facilitate the autonomy of the EU legal order and enable individuals to bring claims against the EU to the European Court of Human Rights (ECtHR). This involves the questions how it would be possible to ensure quick access to justice, and whether the ECtHR would continue to apply the doctrine of equivalent protection in relation to EU even after the latter becomes bound by the ECHR. The article argues that EU accession to the Convention is a prominent political step ensuring coherence of human rights protection mechanism in Europe. (shrink)

Benefiting from a widely recognised experience of the field of bioethics, the Council of Europe which represents all the democratic countries of Europe, has embarked on the ambitious task of drafting a European Convention on bioethics. The purpose of this text is to set out fundamental values, such as respect for human dignity, free informed consent and non-commercialisation of the human body. In addition to this task, protocols will provide specific standards for the different fields concerned with the (...) application of biomedical sciences. The convention and the first two protocols (human experiments and organ transplants) are due to be ready for signature by mid 1994. (shrink)

Even though the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) does not explicitly address the rights of asylum seekers and refugees, the case law of the European Human Rights Court (ECtHR) confirms that their rights can be successfully defended under this mechanism. In parallel, in its evolving jurisprudence on asylum the Court of Justice of the European Union (CJEU) refers to the Strasbourg case law, where there is a certain interrelationship between these two (...) jurisdictions, in particular given the recent ECtHR pronouncement on “EU Dublin transfers”. The article aims at evaluating protection available for asylum seekers and refugees under the ECHR, while comparing it with protection of asylum relevant fundamental rights under the EU legal order and the most recent jurisprudence of the CJEU in asylum cases. The authors also analyze which of the two systems is more favourable and what are their limitations. Thus, the article offers to students and practitioners a detailed analysis of ECtHR and CJEU jurisprudence in asylum cases through a comparative perspective, as well as the key problematic aspects arising in both jurisdictions and their junction. The jurisprudence of the ECtHR reveals that despite the most developed protection from expulsion under Article 3 of the ECHR, it does not sufficiently secure status for the concerned persons. Effective remedy requirements under the ECHR allow for filling the gaps of national asylum procedures, while recognition of vulnerability and special status of asylum seekers by the ECtHR assist in addressing still commonly prevailing detention problems of asylum seekers in Europe. In the context of family protection, the recognition of positive obligations by states to reunite the refugee families is still rudimentary, thus, clearly Article 3 protection in expulsion cases takes over Article 8. At the same time, the jurisprudence of the CJEU in asylum cases is still inconsistent, as the court sometimes takes decisions without including human rights into its’ analysis (Kadzoev, Arslan, K.), while in other cases refers to the Charter (MA and others), verifies if its’ own decision is in line with the ECtHR jurisprudence (Elgafaji) or shapes secondary legislation in line with Strasbourg arguments and findings (N.S.). Quite likely, the ECtHR practice will have an important influence on the developments of subsidiary protection in the EU, at least in the context of Articles 2 and 3 of the ECHR, and serve as an important reference for interpretation of various concepts under the EU Qualification and Procedures Directives. The comparative analysis of pros and cons of the two mechanisms demonstrates that the main advantage of the ECtHR is individual justice possibility, which is not yet accessible under CJEU preliminary judgement procedure and its input in developing asylum law concepts, such as non-state agents of persecution, internal protection or even subsidiary protection regime under EU asylum law. Thanks to the ECtHR, the realistic possibility to question the application of certain EU norms has emerged (Dublin Regulation). While the ECtHR does not have such a specific competence over asylum issues as the CJEU and is clearly a slow and seriously overburdened mechanism, the pilot judgement procedure seems to be increasingly capable of providing guidelines to the states concerning systematic problems in their asylum procedures. Thus, both jurisdictions in their own ways contribute to strengthening asylum seekers’ protection while forming a common oasis for these individuals in Europe. (shrink)

In patent law most of the crucial legal questions such as patentability and infringement are linked to the patent claims. The European Patent Office regards patent claims as a set of independent features which are examined separately in a more or less formal way. The author has found that this approach allows for developing a simple mathematical model which treats patent claim features as logical statements and patent claims as compound statements wherein the (...) individual statements are connected by logical connectives. The proposed mathematical model provides a uniform system for examining various legal questions that are dealt with separately under current case law, moreover, it allows for developing an expert system for resolving complex legal situations and for automating the evaluation of a large number of patent claim variants that is currently not possible. (shrink)

The article discusses the certain features of the constitutional doctrine of human rights developed by the Constitutional Court of Lithuania which were influenced by the jurisprudence of the European Court of Human Rights, the role of the European Convention on Human Rights as a legal source in the system of sources of constitutional law. The intersection of the jurisprudences, which came into being due to different assessments of the legal regulation in cases where the same legal act (...) was recognized by the Constitutional Court being in compliance with the Constitution and the European Court of Human Rights recognized that the application of the said act was a cause of the violation of a certain person’s rights protected by the Convention (or vice versa) is one of the most important questions and raises many theoretical and practical problems. Different assessment of the legal acts made by the European Court of Human Rights with regard to their compliance with the Conventionshould not be regarded as such an essential circumstance which could lead to possible repeated review of such legal act at the Constitutional Court, such intersection of the jurisprudences, should be solved by ordinary courts while following the doctrine that in cases where legal acts contain the legal regulation which competes with that established in the international treaty, the international treaty should be applied. (shrink)

The system of the European Convention on Human Rights created in 1950 is still regarded as the most important and effective regional system for the protection of human rights in the whole world. However, the experience of the European Court of Human Rights (ECHR) has clearly showed that the steady growth in the number of cases brought before the ECHR makes it increasingly difficult to keep the length of proceedings within the acceptable limits and to maintain the (...) effectiveness of the ECHR. This aspect is becoming extremely important due to the fact that the European Union (EU) will join the Convention system in the near future. The legal basis for the EU accession to the Convention system has been made possible after the entering into force of the EU Lisbon Treaty on 1 December 2009, and, from the Convention’s perspective, the new Protocol No. 14 to the Convention, which entered into force on 1 June 2010, and which, in Article 17 (amending Article 59 of the Convention), stipulates that the EU may accede to this Convention. (shrink)

Within the Irish government there is a discussion regarding the possibility of limiting the legal protection afforded to the confessional secret. This paper addresses the question of whether this suggestion, if it were to be implemented by the legislature, would be compatible with the right to religious freedom under Article 9 of the European Convention on Human Rights (ECHR). This text will also highlight the role of the confessional secret in canon law and the protection of it under (...) German law. Catholic priests, should this plan that is currently under discussion be implemented, were obliged to disclose the knowledge gained in confession to law enforcement authorities. The canonical consequence of such a breach of the confessional secret would be excommunication. In such cases priests therefore would only have the choice between breaking the law (which would probably also be punishable under criminal law) and excommunication, with all the resulting disadvantages. In this paper, the canonical law rules regarding confession are presented before the provisions relating to the confessional secret in § 53 para. 1 No. 1 of the Code of Criminal Procedure, § 383 para. 1 No. 4 of the Code of Civil Procedure and § 139 para. 2 of the Criminal Code are discussed. Specifically, the question is raised as to whether a duty of priests to co-operate with the law enforcement authorities may be established by law. Here in particular the protection of the confessional secret under the protection of freedom of religion under Article 9 of the European Convention on Human Rights will be discussed. It has to be noted however that the protection afforded by Article 9 of the European Convention on Human Rights extends far less than the scope of § 53 para. 1 No. 1 of the Code of Criminal Procedure, § 129 para. 2 of the Criminal Code and § 383 para. 1 No. 4 of the Code of Civil Procedure, as Art. 9 ECHR only protects the confessional secret as far as it is required from a religious point of view, but not a general pastoral secret. The article then includes a discussion on the limitations of Article 9 ECHR. Limitations of Article 9(1) ECHR on religious freedom under Article 9(2) ECHR are only permitted if they are prescribed by law and necessary in a democratic society for the protection of public order, health, morals or the rights of others. This is discussed against the background of the legislative goal of more effective law enforcement. As a result, a limitation of the protection of confessional secret through normal (sub-constitutional, domestic) laws, despite the understandable goal of more effective law enforcement, is not compatible with Article 9 of the ECHR. (shrink)

The primary function of the European Court of Human Rights is to ensure that administrative and judicial processes in member states effectively conform to pan‐European Convention standards (‘constitutional justice’) rather than seeking to provide every deserving applicant with a remedy for a Convention violation (‘individual justice’). But, in order to do so effectively some core elements of the Convention's constitution require more deliberate articulation and more consistent application. In seeking to show how this might be (...) achieved, this article argues that three primary constitutional principles—the judicial protection of Convention rights (the ‘rights’ principle), the democratic pursuit of the public interest (the ‘democracy’ principle), and the principle of priority to rights (the ‘priority’ principle), each exercised according to the rule of law—can be distinguished from a cluster of secondary principles which support them in a variety of ways. An analysis of the Convention's key provisions shows, in particular, how the ‘priority’ principle can, and should, operate to give the Court's decisions greater coherence and constitutional authority. (shrink)

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to “ordre public” or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human (...) genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention. (shrink)

The article deals with the question whether a state might be held liable for the infringement of the European Convention on Human Rights if its national court of last instance fails to implement the obligation to make a reference for a preliminary ruling to the Court of Justice of the European Union under the conditions laid down in Article 267 of the Treaty on the Functioning of the European Union and developed in the case-law of the (...) Court. Relying on well-established practice that an arbitrary decision not to refer a question for a preliminary ruling theoretically could infringe the right to a fair trial, the author analyses the practical application of the “arbitrariness rule” and discusses whether the European Court of Human Rights has established any specific criteria that national courts are required to bring into play in order to substantiate the decision not to refer. (shrink)

Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison’s intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for (...) ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns. (shrink)

In the present paper we investigate the role of human values in the reception of the Convention on Preventing and Combating Violence Against Women and Domestic Violence (better known as ‘the Istanbul Convention’) within the EU. By establishing a certain relationship between the most important arguments raised in favor of or against the convention and values from Schwartz’s theory of human values, we formulate certain hypotheses about the influence of the importance the people from a given EU (...) member state ascribe to certain values on the decision of that EU member state on whether the convention should be ratified. We also hypothesize that human values have played the role of mediator between the decision in question and the waves of immigrants from the Middle East and North Africa to the EU. All hypotheses are tested using the results from the European Social Survey. These results suggest that: 1) a more positive attitude towards the convention is correlated with higher importance of the value ‘universalism-concern’ and lower importance of the value ‘tradition’; 2) the value ‘universalism-concern’ has played the role of mediator described above. (shrink)

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic (...) drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this “biosimilar gap” has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5. (shrink)

Through an analysis of the European Court of Human Rights’ decisions concerning the practice of veiling, this article problematises the semiotics-architectural structure of article 9 of the European Convention of Human Rights (Freedom of thought, conscience and religion), questioning which representation of the human and the female subject is recognised and therefore protected by secular/liberal and Human Rights law. It argues that the semiotics-architectural structure of article 9, which is based on the distinction between faith and its (...) manifestation, not only relies on a particular ontological understanding of the religious subject as well as a specific notion of religion, but it also reveals a distinct relationship between the individual and sovereign power through the division between the public and the private spheres. In light of this, the western debate surrounding the women’s veiling overlooks how liberal secularism perceives and defines the religious and legal gendered subject in the modern world, and how this understanding is embedded in and reproduced through the law, which emerges as an instrument for regulating minority religious communities. (shrink)

We analyse and evaluate the qualified majority (QM) decision rules for the Council of Ministers of the EU that are included in the Draft Constitution for Europe proposed by the European Convention [5]. We use a method similar to the one we used in [9] for the QM prescriptions made in the Treaty of Nice.

The filing of patent applications by universities remains a debatable issue in Europe more than 25 years after the Bayh Dole Act in the U.S.A. The European Commission and several national governments are currently exerting pressure on universities to take a more active part in the innovation process.The importance of university research as a source of technology is increasing in the knowledge economy, which is characterized by open innovation. The funding of research may eventually be at stake. (...) class='Hi'>Patent applications are essential instruments in the knowledge-transfer process. They enable universities to reconcile their mission of disseminating knowledge with a direct participation in innovation. They contribute to the development of new products, to the funding of more collaborative research with industry, and to the creation of new companies.This article offers guidelines for making the filing of patent applications by universities consistent or even synergistic with their other missions. Yet, despite all these considerations, the propensity of European universities to file patent applications is 5 times lower than in the U.S.A., which is also reflected in the other knowledge-transfer indicators.This article suggests two reasons for this lower propensity: the mindset of the mostly independent European universities based on the Humboldt model and the much less attractive European patent system for universities. (shrink)

This article examines the way in which the organs of the European Human Rights Convention have dealt with cases involving ‘the environment’ in the absence of any environmental (human) right or rights in the Convention. Some theoretical approaches to ‘human rights and the environment’ are examined and the possible formulation of an environmental right or rights, their scope and content are discussed as a preliminary to the examination of the way in which the rights actually stated in (...) the Convention could be or have been used to derive some form of environmental human right(s). It is suggested that the willingness or otherwise of the Court (now) to act in some sense to enforce ‘environmental human rights’ very much implicates the Court's willingness or not to accept a ‘judicial control not always restricted to the legality of administrative acts’. The conclusion is that it is unnecessary to ‘add’ specific environmental human rights to the Convention, and that there can be derived from a Convention that contemplated neither protection of the environment nor of the individual against harm to the environment, substantial legal protection under the Convention against environmental harms. (shrink)

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical (...) concerns actually addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system. (shrink)

The Patent Cooperation Treaty (PCT) is an international treaty that was concluded in 1970 as a special agreement under the 1883 Paris Convention for the Protection of Industrial Property. It establishes an international system for the filing and examination of patent applications and the conduct of “prior art” (technical literature) searches that is administered by a network of national and regional patent offices acting as Receiving Offices, International Searching Authorities and/or International Preliminary Examining Authorities. Its specific (...) purpose is to help inventors obtain a patent for the same invention in two or more PCT countries by allowing them to assert their claim internationally have it subjected to preliminary assessment before committing to one or more local applications. It thus reduces the risk of wasted expenditure by enabling an applicant to postpone the decision to pursue an application to grant until confident of its success. By creating a series of pre-grant procedures with recognised validity in each of the PCT’s nearly 140 countries, it also provides a basis for the harmonisation of patentability standards and facilitates the move toward the creation of an international patent. (shrink)

Property rights are integral part of the freedom and prosperity of every person, although their centrality has often been misprized and their provenance was doubted. Yet, traces of their origin can be found in Magna Carta, signed by the King of England in 1215. It was a turning point in human rights. Namely, it enumerates what later came to be thought of as human rights. Among them was also the right of all free citizens to own and inherit property. The (...) European Convention on Human Rights was heavily influenced by British legal traditions, including Magna Carta. Among other rights, it also guaranties the right to property as a human right. Moreover, the protection of property rights has been extended to intellectual property rights as well. Namely, the European Court of Human Rights has provided protection of intellectual property rights through the adoption of decisions that interpret the right to property, in relation to intellectual property protection claims. It has extended the human rights protection of property to the mere application for registration of the trade mark. This paper has placed its focus on the development and treatment of the right to property starting from Magna Carta to the European Convention on Human Rights, as modern version of Magna Carta. In this sense, the jurisprudence of the European Court of Human Rights and its role and approach in the protection of the right to property will be examined as well. (shrink)

In the course of its preparation, the 1997 convention on human rights and biomedicine adopted by the Council of Europe instigated a widespread debate. This article examines one of the core issues: the notion of the human being as depicted in the convention. It is argued that according to the convention, this being may exist in three different legal categories, namely 'human life', 'embryo', and 'personhood', each furnished with an inherent set of somewhat different rights, yet none (...) of them clearly defined, thus leaving it to domestic law to regulate at what point a human being belongs to which category. While this approach is understandable from a political point of view, it creates a vicious circle, since law thereby has to define its own foundation and, in the case of the convention, to protect a being that it cannot define. It appears that this form of life is seen rather as a given entity, taking precedence over the interests of society and science, and its dignity and identity forming criteria for the subsequent systems of culture, simply because this life is human and nothing else. Thus, the convention approaches a natural law position. (shrink)

The case of Vo v. France represents the latest phase of the European Court of Human Rights’ thinking on the scope of Article 2 of the European Convention on Human Rights (the right to life) in relation to foetal life where a foetus had been lost owing to a medical accident. The Court by a majority decided that, “even assuming” Article 2 applied to the instant case (albeit to the life of the pregnant woman rather than that (...) of the foetus), it had not been violated. While the facts in Vo were extreme and exceptional, the Court will shortly hear the case of D v. Ireland concerning access to abortion for foetal anomaly, an application made under Articles 3, 8, 10 and 14 of the European Convention. If the case of D were declared admissible, the Court would then have to consider whether a denial of access to abortion for foetal anomaly constitutes inhuman and degrading treatment contrary to Article 3, or an interference with a pregnant woman’s right to respect for private life under Article 8 (and if so, how the doctrine of the margin of appreciation applies). The Grand Chamber precedent of Vo displays ambivalence about whether Article 2 should apply to foetal life, and its resort to the “even assuming” formula spared Member States the difficulty of having to justify their various abortion regimes, by reference to this Article. It remains to be seen whether in a case like D that is directly concerned with abortion, the Court will take a more definite stance on the correct balance to be struck between the State’s interest in protecting foetal life and the Convention rights of pregnant women. (shrink)

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent (...) agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells. (shrink)

Nanotechnology has been facing multiple obstacles related to the applicability of patentability criteria. In this article, the authors addressed the novelty requirement in nanotechnology inventions in Iraqi and Malaysian patent acts. First, novelty was discussed to determine its applicability in the field of nanotechnology. Then, problems on nanotechnology patent application were presented along with some suggested solutions. The problems encountered in the patentability of nanotechnology inventions were summarized in two categories. First, the multidisciplinary nature of nanotechnology casts its (...) shadow on the examination process in patent offices. To overcome this problem, the United States Patent and Trademark Office and the European Patent Office created new divisions to examine nanotechnology inventions; thus, this step must be followed by developing countries. In addition, with the existence of larger scaled materials and devices in prior art, three potentials have been introduced to overcome this issue. First, novel properties in nanoinventions can be demonstrated to reach the point of novelty. Second, nanoinventions can be patentable if they are carried out despite scientific problems occurring when materials are shaped in nanoscale. Third, the process of creating nanomaterials can be patentable as the bottom-up approach, which is not used in larger scaled materials. Finally, pre-disclosure must be considered as an enabling disclosure, which enables a skilled man in the art to put the nanoinvention in practice. (shrink)

The objective of this paper is to stimulate academic debate on embryo and fetal research from the perspective of the drafting of a protocol to the European Convention on Biomedicine. The Steering Committee on Bioethics of the Council of Europe was mandated to draw up such a protocol and for this purpose organised an important symposium on reproductive technologies and embryo research, in Strasbourg from the 16th to the 18th of December 1996.

The extension of intellectual property rights into the realm of biology has emerged as an increasing focus of controversy in relation to science,2 biodiversity,3 agriculture,4 health,5 development,6 human rights7 and trade.8 This paper presents the results of a review of international trends in activity for patent protection between 1990-2000 and provisional data to 2004 and 2005 from over 70 national patent offices, four regional patent offices and the World Intellectual Property Organisation using the European Patent (...) Office esp@cenet worldwide database.9 The review employed patent publication counts as an indicator of activity for traditional medicines, pharmaceuticals, agriculture, and biotechnology. The research provides insights into the internationalisation of patent activity in multiple areas of biology. The review emphasises the need to combine the further development of quantitative methods with qualitative analysis of the implications of international patent activity in relation to biological and genetic material for science, society and policy. (shrink)

Controversy often follows when patents are obtained in a pioneering area of technology. Patent filing activity in the field of regenerative medicine and in relation to stem cells in particular has not escaped opprobrium, although it is instructive to compare the nature of the debates that are taking place over the patenting of stem cells in the US and Europe. In the US, debate over the early patent applications made by the Wisconsin Alumni Research Foundation has been intense2, (...) but at least it appears to have been grounded firmly in patent law principles. In Europe, the debate has skewed away from the basic patent law tenets of novelty, inventiveness and industrial utility and has entered something of a twilight zone, with the European Patent Office serving as a diffident forum for difficult moral and ethical arguments about the destruction of human embryos and the commercial exploitation of human life. (shrink)

Name der Zeitschrift: Studies in Logic, Grammar and Rhetoric Jahrgang: 45 Heft: 1 Seiten: 265-276.

A Theory of Interpretation of the European Convention on Human Rights provides a philosophically informed study of the methods of interpretation used by the European Court of Human Rights in Strasbourg. By drawing on Anglo-Americal legal, political and moral philosophy, the book also aims to provide a normative theory of the foundations of the ECHR rights.

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing (...) in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)