The Retained EU Law Bill is now an Act of Parliament, having received Royal Assent on 29 June 2023. In our blog, published at the end of last year, we explained the draft Bill’s key features. Since then, the Bill has undergone significant amendment. In this blog we consider key differences between the original Bill and the Act.Continue Reading The Retained EU Law (Revocation and Reform) Act 2023 – Update
Dr Beatriz San Martin
Demystifying the UPC and the Unitary Patent
Answers to Some Common Questions
After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.Continue Reading Demystifying the UPC and the Unitary Patent
Tampering with the packaging? Further EU Court of Justice guidance for parallel traders
In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders
Parallel imports: identicality of products when repackaging
On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer affixes the trade mark of a branded reference medicinal product onto the packaging of a generic product, the brand owner may oppose the placing of that generic product by the parallel importer on the market of a Member State. Though the CJEU provides an exception to this general rule, the authors query whether the exception will ever apply.
Importantly, this case compares: (i) the rules on when a parallel import licence can be obtained (which is a regulatory question), and (ii) when rebranding can legitimately take place for such products (which is an IP question). As set out below, the need for “identicality” is not the same for these two considerations.Continue Reading Parallel imports: identicality of products when repackaging
The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues
Synopsis
On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards only domestically enacted legislation. A revised Bill was published on 29 November 2022 following its first debate in parliament and scrutiny by the Public Bar Committee. If current timelines are maintained, it is anticipated that the Bill would be passed in April or May 2023.
Continue Reading The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues
Demystifying the UPC and the Unitary Patent – answers to some common questions
The Unified Patent Court (UPC) and the unitary patent system are expected to commence on 1 June 2023. Until early December 2022, the UPC was advocating 1 April 2023 as the date of entry into force of the Agreement on a Unified Patent Court (UPCA) with the Sunrise Period commencing on 1 January 2023. The two-month postponement has been implemented to allow users to prepare for “strong authentication” required to access the court’s Case Management System and to sign documents. In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.
Continue Reading Demystifying the UPC and the Unitary Patent – answers to some common questions
Virtual and Digital Health Digest
Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.
Continue Reading Virtual and Digital Health Digest
European Commission launches public consultation on compulsory licensing of patents
Following a call for evidence in April 2022, the European Commission launched a public consultation in July 2022 seeking to revise the framework on compulsory licensing of patents in the EU. The general objective being to create a less fragmented and better-suited compulsory licensing system for EU-wide crises of a health, environmental, nuclear or industrial nature. Nevertheless, the consultation recognises that any system should remain exceptional and a last resort measure, applicable where voluntary agreements are not implemented, and bearing in mind that compulsory licensing may have a significant impact on IP holders.
Continue Reading European Commission launches public consultation on compulsory licensing of patents
AI and IP: Implications for digital health from possible reforms to UK IP law
The use of artificial intelligence (AI) and machine learning is growing at a significant pace and spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind” is no longer limited to creations by a human being. These technological developments mean that the legal framework governing intellectual property (IP) rights such as patents and copyright, which protect “creations of the mind”, may need to be adjusted to address the changes and impacts brought about by the use of AI.
In line with the UK government’s ambition for the UK to be a leader in AI and to better understand the implications AI might have for IP policy, as well as the impact IP might have for AI in the short to medium term, the UK IPO conducted a public consultation at the end of 2020. The aim of the consultation was to seek responses on a range of questions relating to AI and IP rights. The UK IPO received 92 responses from a wide range of stakeholders, including IP rights holders, producers of AI technology and academia. The government’s response to the call for views on AI and IP was published in March 2021, under which reforms to patent and copyright law and policy were discussed.
In this blog, we summarise the UK government’s conclusions from the consultation before considering the potential impact to digital health applications and companies.Continue Reading AI and IP: Implications for digital health from possible reforms to UK IP law
End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU
As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU