An Institutional Examination of the Implications of the Unitary Patent Package for the Morality Provisions: A Fragmented Future too Far?

This article examines the institutional changes created by the unitary patent package (UPP), including the unified patent court (UPCt), in the European patent system. It focuses specifically on the implications of these changes for the morality provisions for biotech inventions: contained in Art. 53(a) EPC and Art. 6 Biotechnology Directive 98/44EC. These provisions were chosen as a site of investigation because of the overlap of substantive EU and EPC laws involved. Furthermore, despite the identical wording of these provisions in the EPC and Directive, the open-textured nature of the morality provisions requires interpretation by the adjudicative bodies in each institutional framework. Hence, institutional influences on adjudicative bodies are heightened. Accordingly, these provisions provide an ideal site to examine the significance of the addition of another adjudicative body, the UPCt to the European patent system. The article examines the implications of having adjudicative bodies operating in differing institutional frameworks in contexts where States have overlapping obligations to international treaties. It argues that the UPCt is not institutionally configured to apply these provisions in the same manner as the generalist CJEU and demonstrates that the UPCt’s openness to refer questions to the CJEU is crucial to ensuring the UPP does not become blinkered to broader issues. Moreover, it argues that the unitary nature of the European Patent with unitary effect (EPUE) is problematic because it fails to accommodate national divergence on the morality provisions and it is unclear whether morality is to be judged at a national, EPC or EU level. A mechanism for maintaining national divergence in this context is proposed

Brexit and the unitary patent package : a further compromised future?

Developing a unitary patent system for Europe has been debated for over 50 years but never achieved. Nonetheless, a unitary patent package (UPP) for the current 25 EU Member States who wish to participate is now within grasp. However, as this system neared completion, the UK voted to leave the EU by referendum on 23 June 2016. The UK subsequently triggered Article 50 TEU on 29 March 2017 commencing its withdrawal from the EU (Brexit) in a process expected to take two years. Beyond the broader legal and political questions which Brexit gives rise to, it raises a key question for patent lawyers, namely, whether, and under what circumstances, the UK can continue to participate in the Unified Patent Court (UPCt) system and European Patent with Unitary Effect (EPUE) when it leaves the EU? In November 2016, despite the Brexit vote, the UK government confirmed its intention to join the Agreement on the Unified Patent Court (AUPC) — and subsequently ratified the AUPC on 26 April 2018. However, this article argues that in light of the complex relationship the UPCt has with the EU, including, the primacy of EU law in the operation of the UPCt and links between the UPCt and the Court of Justice of the European Union (CJEU), joining the AUPC at this point is a curious move and one which is inconsistent with the UK’s previous more general statements on Brexit. In particular, in February 2017 Theresa May while outlining key facets of Brexit stated that the UK would not be subject to the jurisdiction of the CJEU once it leaves the EU. The article highlights the difficulties with ameliorating this position with the UK’s continued participation in the UPP post-Brexit. It argues that Brexit will likely sound the death knell for the UK’s membership of EPUE. Moreover, although UK participation in the UPCt seems more likely there remains considerable challenges to tackle in this respect. Furthermore, the question mark that exists over the UK’s participation in the UPCt and EPUE post-Brexit has attendant consequences for the general feasibility of the UPP. Accordingly, this article argues that instead of focusing on how to keep the UK within the currently devised system, Brexit provides further impetus to pause and consider whether the current proposal is still worthwhile given that it will create a more complex and fragmented European patent landscape at the supranational level. Instead, it echoes calls that a better solution would be to consider ways to modify the current system or redesign a new system to include not just the UK but also other European Patent Convention states which are not in the EU

Should states restrict recipient choice amongst relevant and available COVID-19 vaccines?

Several COVID-19 vaccinations have been authorised worldwide. Whilst some vaccines are contraindicated for certain age groups or health conditions, there are often multiple clinically suitable authorised vaccine brands available. Few states have allowed recipients to choose amongst them, though there are multiple reasons why choice would be valued. We consider the policy justifications for state controls on recipient choice amongst COVID-19 vaccine brands, focusing on European countries and drawing on the UK context as an example. We contrast justifications for not offering choice at the height of the early pandemic crisis, and as some states seek to de-escalate their response and transition towards living with COVID-19. We argue that in the latter context public expectations of choice between available vaccine brands and platforms may rise, but that several considerations may justify continued restrictions on choice. A key factor which states should continue to take into consideration is the global nature of the pandemic. Insofar as offering recipient choice at a national level might exacerbate global inequity in vaccine distribution, states retain a normative and legal justification for restricting choice amongst available and clinically suitable vaccine brands

After the 8th: Ireland, Abortion, and International Law

Although international law did not play a significant role in the lead-up to the referendum which repealed Ireland's constitutional ban on abortion, this article argues that it has a vital role to play in the interpretation of the Health (Regulation of Termination of Pregnancy) Act 2018 and the monitoring of the reformed framework for abortion access in Ireland. This is because Ireland is a party to several treaties which lay out obligations concerning abortion access, and Ireland is legally obliged to adhere to these commitments.Although international law did not play a significant role in the lead-up to the referendum which repealed Ireland's constitutional ban on abortion, this article argues that it has a vital role to play in the interpretation of the Health (Regulation of Termination of Pregnancy) Act 2018 and the monitoring of the reformed framework for abortion access in Ireland. This is because Ireland is a party to several treaties which lay out obligations concerning abortion access, and Ireland is legally obliged to adhere to these commitments

Decision-Makers, Institutional Influences and the Role of Ethical issues in the Patenting of Biotechnological Inventions in Europe: Enter the Unitary Patent System.

This chapter focuses specifically on one long contested area, namely, the role of ethical considerations in patent decision-making for biotechnological inventions in Europe. More specifically, the chapter examines to what extent the introduction of the UPC– and the unitary patent system more generally – has the potential to influence the current interpretative approach for how ethical issues are considered in the patenting of biotechnological inventions in Europe. It puts forward the case for why a renewed conversation is urgently needed around what normative role ethical issues should play in European patent law at this juncture

Gene Patents and the Marginalisation of Ethical Issues.

In 2013 and 2015, the Supreme Court of the United States (US)1 and Australian High Court,2 respectively, rejected the patentability of isolated genes.3 Subsequently, in March 2016 a case in the Federal Court of Canada involving the Children’s Hospital of Eastern Ontario’s (CHEO) challenge to patents on genes related to Long QT syndrome was settled. The settlement provided a licence to CHEO to test for the syndrome. A primary driver of the litigation in all three jurisdictions, was the broader ethical issues posed by such patents, including, the potential healthcare implications of such patents. The European Union adopted tailored legislation to deal with biotechnology patents in 1998, including gene patents. Again, in Europe, a primary concern underlying the drafting of the Directive was the ethical issues posed by biotechnological patents.4 Nonetheless, despite ethical issues driving challenges to, and debates on changes of patent law in such contexts, in practice ethical issues are given limited consideration within patent law cases in each of these jurisdictions. Using gene patents as a case study, this article argues patent law in these jurisdictions, has failed to engage with the broader ethical issues (including potential healthcare implications) of biotechnological patents in any meaningful way. In effect, a marginalisation of ethical issues is evident within patent law. The only exception to this is Canada, where solutions outside patent law, via licensing, have been devised to deliver access to technologies under patent, focusing on the public health issues at stake. The article argues that unless and until we adopt fundamental institutional change within patent law to address broader ethical issues inherent in the grant of patents, it behoves us to take seriously and devise appropriately, solutions outside patent law to address such ethical issues including potential healthcare implications posed by patent use. For such reasons, at a practical level, the solution offered by tailored licensing approaches in the Canadian context, although not without some potential shortcomings, is arguably a preferable solution in the short term. Such licensing approaches should be taken seriously in other jurisdictions

Endoscopic T-tube placement in the management of lye-induced esophageal perforation: Case report of a safe treatment strategy

Esophageal perforation is associated with a significant risk of morbidity and mortality. We report herein a case of lye-induced esophageal perforation managed successfully by employing endoscopic T-tube placement with a successful outcome

Banking (on) the Brain:From Consent to Authorisation and the Transformative Potential of Solidarity

Modern technologies and biomedicine ambitions have given rise to new models of medical research, including population biobanking. One example of biobanking is brain banking, which refers to the collection and storage of brain and spinal cord samples for research into neurological diseases. Obviously, brain banking involves taking brains and tissue from deceased people, a fact which complicates the role of recruiters and makes consent a poor tool for stakeholders. After contextualising brain banking and considering the public health issues at stake, this article explores the legal definitions and demands of, and actual processes around, consent in England/Wales/Northern Ireland and authorisation in Scotland, articulating and evaluating their conceptual and practical differences. It then argues for an expanded but improved operation of ‘authorisation’ in the brain banking (and broader biobanking) setting, adopting ‘solidarity’ as our foundation and the improvement of the ‘public good’ our objective

Patentability and de-extinct animals in Europe: the patented woolly mammoth?

De-extinction is a hot topic within conservation science but the potential patentability of de-extinct animals in Europe has hitherto been unexplored. This article addresses this lacuna, examining the legal, commercial, and ethical implications of patenting de-extinct animals under European patent law. The article is organized into four parts. Part I explores the reasons why patents are relevant and may be applied for in this context. Part II provides an overview of the scientific techniques currently being used in de-extinction projects, setting the foundation for the analysis of patentability which follows. Part III then critically assesses whether recreated animals would qualify as patent eligible subject matter under European patent law. It also investigates the extent to which European patent exclusions such as those on animal varieties, essentially biological processes, and the morality provisions might apply and whether recreated animals would meet the novelty requirement for patentability. Part IV concludes by highlighting the possible ramifications of patenting such animals, elucidating the chasm between the cultural and symbolic significance held by such animals, and their lack of differential treatment in the patent law sphere. It argues that de-extinction reignites questions around the scope of patents, and the role of ethical considerations within patent decision-making which warrant urgent reconsideration