General IP Notice © Copyright [business name] [year eg 2022]. All rights reserved. [Trade mark]® is a [registered] trade mark of [business name]. [business name] is the proprietor or licensee (‘rightsholder’) of all intellectual property rights in relation to this work or works including but not limited to copyright, trade and brand names, trade marks and get-up. If no permission is given by [business name] to the use of any of them, such use may constitute an infringement of the rightsholder’s rights. All other trade marks, brand names, product names and titles, copyright and other intellectual property rights used in this work or works are trade marks, brand names, product names, copyright or other intellectual property rights of their respective rights holders. Permission to copy, reproduce or distribute such material must be obtained from the relevant rights holders concerned. No part of this work or works may be translated, reprinted or reproduced or utilised in any material form either in whole

This Practice Note discusses the various intellectual property (IP) rights that can be used to protect a digital health product. It also addresses other IP considerations, such as protection as a trade secret, the use of open source software, potential ownership disputes with employees and contractors, IP licences, and the protection of patient data. The Practice Note also considers IP strategy during digital health product development, from conception and initial research to advertising, marketing and sale and future developments and improvements. What is digital health? Digital heath falls at the intersection between healthcare IT and medical devices and covers the use of data to assist in the diagnosis, treatment, prevention and monitoring of diseases, as well as providing for healthcare practitioner support. The use of digital health devices to monitor patients can improve accessibility to healthcare services without substantially increasing costs. Digital health devices often have the capacity to feedback to medical professionals on a real-time basis, such that any abnormal changes or inconsistencies can be quickly detected and appropriate

Changes to intellectual property (IP) law from 1 January 2021 Before discussing how intellectual property (IP) law specifically applies to medical devices, it is important to note the changes that occurred on 31 December 2020 (IP completion day). The main change relates to EU trade marks (EUTMs) and registered Community designs (RCDs). On 1 January 2021, holders of EUTMs and RCDs which were already registered and published automatically obtained a comparable registered and enforceable UK registration (UK comparable rights). Essentially, the EUTMs and RCDs on the EU Intellectual Property Office (EUIPO) register were ‘cloned’ onto the corresponding UK Intellectual Property Office (UKIPO) register. The UK comparable rights were generated automatically and free of charge to the rights holder. The new UK comparable rights retained the filing and, if applicable, priority date of the original EUTM or RCD. The new UK comparable rights are separate from the original EUTM and RCD rights and can be assigned or licensed independently from the EU rights. Renewal fees

What is meant by ‘personalised medicines’? The term ‘personalised medicine’, or sometimes ‘targeted medicine’, is generally used to describe treatments for rare diseases. As this Practice Note explains, such medicines are typically small molecule drugs repurposed for new indications or sub-populations of existing patient groups that share a predictive biomarker for disease. They may also be biological drugs defined by functional features. These types of medicine raise particular issues for patenting and patent enforcement, some of which remain to be resolved by the English courts. This Practice Note also explains the limits of patent and supplementary protection certificates (SPCs) for these forms of treatment and other rights that may be relevant to research in the area, including the protection provided by data and market exclusivity. What are rare diseases? Rare diseases are those that affect a small minority of the population. In the US, a rare disease is defined by the Orphan Drug Act as a disease or condition that impacts fewer than 200,000 people in the US. In

1 Definitions 1.1 In this Agreement: Assigned Intellectual Property Rights means the Intellectual Property Rights detailed in Schedule [insert schedule number]; Assignment has the meaning given in clause 2.1; [Intellectual Property Rights means copyright, rights related to copyright such as moral rights and performers rights, patents, rights in inventions, rights in confidential information, know-how, trade secrets, trade marks, geographical indications, service marks, trade names, design rights, rights in get-up, database rights, databases,[ data exclusivity rights,] [ approvals,] [ utility models,] domain names, business names, rights in computer software,[ mask works,] [topography rights,] the right to sue for infringement, unfair competition and passing off, and all similar rights of whatever nature wherever in the world arising and, in each case: (a) whether registered or not, (b) including

This Practice Note explains the intellectual property rights (IPRs) that may exist in a website and the extent to which these can be used to protect the components of a website and prevent unlawful conduct by other parties, including competitors. It considers how website owners can secure IPRs as part of the website development and the challenges faced by owners in attempting to protect their intellectual property, particularly in the advent of technological advances such as generative artificial intelligence (AI). This Practice Note includes a brief discussion about internet service provider (ISP) liability, but for a more detailed explanation of the relevant issues in the UK and the EU respectively, see Practice Notes: The liability exemptions/defences under the E-Commerce Regulations 2002 and The liability exemptions/defences under the EU Digital Services Act. This Practice Note does not consider issues arising in relation to registration, use or protection of domain names. For more on this, see: Domain names—overview. Court of Justice judgments This Practice Note includes reference to Court of Justice judgments. For guidance on whether judgments

How to use this Checklist This Checklist is designed to highlight issues that commonly need to be addressed when drafting long-form and short-form licences of intellectual property rights (IPRs) in an asset purchase scenario, and is to be used with the following Precedents: • Intellectual property licence (asset purchase) (long form) • Intellectual property licence (asset purchase) (short form) For assignments of IPRs in an asset purchase scenario, see: • Precedent: Assignment of intellectual property rights (asset purchase) (long form) • Precedent: Assignment of intellectual property rights (asset purchase) (short form) • Assignment of intellectual property rights (asset purchase)—checklist For copyright licences, consider: • Precedent: Copyright licence—pro-licensee • Precedent: Copyright licence—pro-licensor • Copyright licence—checklist For licences of design rights, consider: • Precedent: Design licence—pro-licensee • Precedent: Design licence—pro-licensor • Licence of designs—checklist For patent licences, consider Precedents: • Patent licence—pro-licensee • Patent licence—pro-licensor For trade mark licences, consider: • Precedent: Trade mark licence—pro-licensee • Precedent: Trade mark licence—pro-licensor • Trade mark licence—checklist For further information on issues raised by this Checklist, see the following Practice Notes: • Licensing intellectual property rights • Sub-licensing

1 Definitions clause 1.1 In this Agreement: [Intellectual Property Rights means copyright, rights related to copyright such as moral rights and performers rights, patents, rights in inventions, rights in confidential information, know-how, trade secrets, trade marks, geographical indications, service marks, trade names, design rights, rights in get-up, database rights, databases,[ data exclusivity rights,] [ approvals,] [ utility models,] domain names, business names, rights in computer software,[ mask works,] [topography rights,] the right to sue for infringement, unfair competition and passing off, and all similar rights of whatever nature wherever in the world arising and, in each case: (a) whether registered or not, (b) including any applications to protect or

Climate change and loss of biodiversity are significant and urgent challenges. There is an important role for innovation in trying to address them, for example through the development of new technologies and products relating to climate change mitigation, renewable energy, reduction of pollution, sustainable use of resources and recycling of waste. This Practice Note considers the ways in which IP rights including patents, trade marks, designs, copyright and database rights, can be used to protect innovative products and services. It also examines the interaction of IP rights with new practices such as upcycling, retrofitting and repairing products, and the issues that brand owners will need to consider, to ensure that they minimise the risk of greenwashing. It also considers the issues that need to be taken into account when collaborating on and exploiting new technologies. Innovation and the environment It is becoming increasingly clear that the effective use of IP rights will play an important role in addressing the environmental challenges faced by the world. For example: • the World Intellectual Property Organization (WIPO) explained

ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note tracks key IP developments and guidance specifically related to Brexit. Jump to: • General IP Brexit developments • Copyright and databases • Trade marks • Designs • Patents and SPCs • Geographical indications This Practice Note does not track general Brexit developments, for which see Practice Note: Brexit timeline [Archived]. To track the progress of UK legislation which was introduced as part of the legislative preparation for the UK’s withdrawal from the EU, see Practice Note: Brexit legislation tracker [Archived]. On 31 January 2020 (exit day), the UK ceased to be an EU Member State and lost its entitlement to participate in the political institutions and governance structures of the EU. In accordance with the transitional arrangements provided in Part 4 of the Withdrawal Agreement, exit day marked the commencement of an 11-month implementation period during which the UK was treated by the EU as a Member State for many purposes. The implementation period ran until 11 pm on 31

This Practice Note focuses primarily on the civil remedies available for infringement of trade marks, design rights and copyright in the UK, pursuant to statute and common law. These remedies include: injunctions; damages or an account of profits; erasure/delivery up/destruction of infringing items and items used to make them; dissemination of judgments; and costs. Additionally, it considers declaratory relief and interim remedies, as well as contempt of court for failure to comply with remedies, and civil restraint orders. It also considers the remedies available in claims or counterclaims for invalidity, revocation or unjustified threats and covers practical matters such as drafting an order, dealing with new technologies and considering settlement. It also touches on the remedies available in respect of criminal offences relating to trade marks, designs and copyright. This Practice Note does not consider remedies in patent disputes. For a patent-focused guide to remedies, see Practice Note: Remedies in patent proceedings. Trade marks, designs and copyright Trade marks, designs and copyright are a form of personal moveable property. Their legal nature determines what English law remedies are available

Part of an organisation’s overall attributes which enables it to minimise any risks to nuclear safety in all aspects of its undertaking.