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CORPORATE CRIME

This Practice Note outlines the law concerning criminal recklessness. The subjective test for recklessness Certain statutory and common law offences allow the prosecution to prove mens rea through ‘recklessness’. Put simply, recklessness is where the accused takes an unjustified risk that results in unlawful harm or damage. The House of Lords in R v G reaffirmed the subjective approach to recklessness. Before R v G, two distinct tests were used, depending on the offence charged: Subjective recklessness from R v Cunningham: the prosecution had to establish that the accused personally foresaw the risk. Objective recklessness from R v Caldwell: the prosecution only needed to show that the risk would have been obvious to a reasonable person, without proving the accused themselves foresaw it. In R v G, the House of Lords concluded that the objective test could operate unfairly where a defendant did not foresee the

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DISPUTE RESOLUTION

This Practice Note examines the remedy of rescission, explaining when and in what manner a contract can be unwound (at common law, in equity and under statute) and thereby terminated and brought to an end. It covers the consequences and effects of rescission, the principal grounds for setting aside an agreement (misrepresentation, mistake, undue influence, duress, non‑disclosure, fiduciary misdealing and bribery) and the main obstacles to claiming rescission—affirmation, the intervention of third‑party rights and the impossibility of restitution. For further guidance on rescission in the context of misrepresentation, see Practice Note: Misrepresentation—rescission as a remedy. There are many ways in which a contract may reach its end; see: Terminating contracts—how and when a contract ends—overview for a brief and accessible summary, with links to the related further practical guidance, including Practice Note: Termination and expiry of contracts. For a table

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DISPUTE RESOLUTION

What is a res judicata? A res judicata is a determination by a court or tribunal with jurisdiction over the cause of action and the parties, which finally disposes of the issues decided so they cannot be litigated again by those bound, save on appeal. Final judgments entered by default or by consent fall within this concept, whereas rulings on purely procedural points and any decision lacking finality do not. The doctrine’s aim is to bring litigation to an end and shield parties from being harassed by the same dispute twice. in personam—binds the parties and their privies in rem—binds all persons, privy or otherwise (ie a judgment binding the whole world) A party may rely on res judicata: as an estoppel to defeat an opponent’s claim or defence; and/or as the basis of their own claim or

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CORPORATE CRIME

The offence of causing grievous bodily harm with intent Wounding or causing grievous bodily harm (GBH) with intent can be tried solely in the Crown Court on indictment. Elements of the offence Under the Offences against the Person Act 1861 (OATPA 1861), the prosecution must establish that the defendant unlawfully and maliciously: wounded with the intention of causing GBH, or caused GBH with that intention, or wounded intending to resist or prevent the lawful arrest or detention of any person, or caused GBH intending to resist or prevent the lawful arrest or detention of any person ‘Unlawfully’ and ‘maliciously’ Unlawfully The wounding or causing of GBH must be unlawful. Such conduct may be lawful if used: in self-defence in defence of another in defence of property for the prevention of crime where the victim gave express or implied consent For further information on these defences, see below:

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PRACTICE NOTES

ARCHIVED : This Practice Note has been archived and is not maintained. This Practice Note reviews the approach to the recognition and enforcement of judgments as it will operate from the UK’s exit from the EU on 31 January 2020 through to the end of the implementation period, which the EU describes as the transition period. It explores whether that implementation period could be extended, evaluates if the enforcement framework under the Brussels regime—including Regulation ( EU) 1215/2012, Brussels I (recast)—is in force during the implementation period, as well as setting out the position after the implementation period concludes. For a quick reference Brexit research aid that answers key questions on Brexit and provides useful Brexit updates, research tips and resources, see: Brexit Bulletin—key updates, research tips and resources......

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PRACTICE NOTES

ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note monitors major IP developments and guidance that relate specifically to Brexit. Jump to: General IP Brexit developments Copyright and databases Trade marks Designs Patents and SPCs Geographical indications This Practice Note does not follow wider Brexit developments; for those, see Practice Note: Brexit timeline. To follow the progress of UK legislation introduced as part of the legislative preparation for the UK’s departure from the EU, see Practice Note: Brexit legislation tracker. On 31 January 2020 (exit day), the UK ceased to be an EU Member State and relinquished its right to participate in the EU’s political institutions and governance frameworks. Under the transitional arrangements in Part 4 of the Withdrawal Agreement, exit day signalled the start of an 11‑month implementation period during which, for many...

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PRACTICE NOTES

Johnson & Johnson/ Novartis ( Fentanyl) ( COMP/39.685) [ Archived] CASE HUB ARCHIVED – this hub reflects the position at the date of the 10 December 2013 decision and is no longer maintained. See the timeline, commentary and related cases for further details. Case facts Outline European Commission investigation under Article 101 TFEU into Johnson & Johnson and Novartis regarding Fentanyl (case number COMP/39.685). Latest developments The Commission imposed fines of €10.798m on Johnson & Johnson (and subsidiaries) and €5.493m on Novartis (and subsidiaries). Parties Johnson & Johnson (including subsidiaries) Novartis (including subsidiaries) Market(s) Pharmaceuticals (pain-relief medicines). The medicine concerned is Fentanyl, a painkiller around 100 times stronger than morphine. Its primary use is pain relief for people with cancer......

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PRACTICE NOTES

General Throughout the duration of an agreement (and sometimes afterwards), one or more of the parties may wish to notify third parties about particular matters relating to the existence of the agreement, its subject matter, or developments arising from the operation of the agreement. The kind of information envisaged is that typically found in public announcements or press releases issued by one or more of the parties (eg to brief investors, prospective investors, the media, potential customers, or regulatory authorities). Such announcements are usually distinct from information generated through the performance of the agreement itself (eg in a consultancy arrangement, the consultant might produce routine reports on the tasks undertaken and supply that information to its client and, in some cases, to third parties). Nevertheless, the parties will not wish to permit each other to disclose information to third parties without restraint and will...

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PRACTICE NOTES

This Practice Note reviews service of the claim form where a contract between the parties sets out an agreed method for serving court documents. It explains the requirements for service of the claim form under CPR 6.11. For guidance on: contractually agreed methods of service, see Practice Note: Contractually agreed methods of service methods of service in the jurisdiction, see Practice Note: Service in England and Wales—a guide for dispute resolution practitioners methods of service out of the jurisdiction, see Practice Note: Cross-border service—methods of effecting service The claim form— CPR 6.11 requirements CPR 6.11 addresses situations where the parties have contractually agreed a method of service or a place for service of the claim form. The following must be observed: Requirement: the claim must be solely in respect of that contract. Judgment: this was considered in Taberna Europe CDO II PLC v...

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PRACTICE NOTES

CASE HUB ARCHIVED – this archived case hub reflects the position at the date of the judgment of 30 January 2020; it is no longer maintained. See also the timeline, commentary, and related or relevant cases. Case facts Outline Case C‑307/18, Generics ( UK) Ltd and Others v Competition and Markets Authority — a UK reference on the application of Articles 101 and 102 TFEU to pay‑for‑delay patent settlement agreements. Latest developments On 30 January 2020, the Court of Justice delivered its ruling. Echoing Advocate General Kokott’s opinion, the Court confirmed, among other matters, that these agreements may amount to a restriction of competition by object or effect and/or an abuse of a dominant position. Parties Applicants: Generics ( UK) Ltd ( GUK) Glaxo Smith Kline plc ( GSK) Xellia Pharmaceuticals Ap S ( Xellia) Alpharma LLL (formerly Zoetis Products LLC) ( Alpharma) Merck KGa A (...

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PRACTICE NOTES

CASE HUB ARCHIVED – this archived case hub records the position as at the decision of 23 January 2018 and is no longer updated. For further details see: timeline, commentary, and related/relevant cases Case facts Outline A national reference was made by the Consiglio di Stato ( Italian Council of State) to the Court of Justice for a preliminary ruling under Article 267 TFEU, seeking guidance on how the regulatory regime for placing medicinal products on the market intersects with EU competition law. In particular, the Court of Justice was asked to clarify to what degree, and on which grounds, legal uncertainty surrounding the lawfulness of prescribing and marketing a medicine aimed at ‘off-label’ use, and the scientific risks tied to such use, should be taken into account when applying Article 101 TFEU......

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PRACTICE NOTES

ARCHIVED: This Practice Note has been archived and is not maintained. At 11pm ( GMT) on 31 December 2020, the Brexit transition/implementation period concluded, following the UK’s exit from the EU. From that moment—termed ‘ IP completion day’ in UK law—core transitional measures ceased and major alterations started to apply across the UK’s legal framework. Set out below is a maintained list and overview of News Analysis articles that explore the effects of the UK’s withdrawal from the EU on the life sciences sector. For broader guidance, see Practice Note: What does IP completion day mean for Life Sciences? [ Archived]. 22 September 2022 — Brexit Bulletin— Retained EU Law ( Revocation and Reform) Bill introduced, LNB News 22/09/2022 78. On 22 September 2022, the government laid before Parliament the Retained EU Law ( Revocation and Reform) Bill 2022....

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PRACTICE NOTES

ARCHIVED : This Practice Note is archived and no longer maintained. It reviews how the settlement rules apply from the UK’s exit from the EU on 31 January 2020 through to the end of the implementation period, which the EU describes as the transition period. It also examines whether that period can be extended, whether the settlement framework in the Mediation Directive 2008/52/ EC and the European Directive 2013/11/ EU on ADR operates during the implementation period, and the position thereafter. For a quick-reference Brexit research aid answering key Brexit questions and offering useful updates, research tips and resources, see: Brexit Bulletin—key updates, research tips and resources. Definitions This Practice Note uses a number of definitions: European Union ( Withdrawal) Act 2018— EU( W) A 2018 European Union ( Withdrawal Agreement) Act 2020— EU( WA) A 2020 exit day—defined in EU( W) A 2018, s...

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PRACTICE NOTES

ARCHIVED : This Practice Note has been archived and is not maintained. This Practice Note sets out guidance on the implementation period and its impact on EU law and UK legislation drawn from EU measures. It covers: Retained EU law—what it comprises and when it operates. The significance of Court of Justice rulings for UK courts throughout the implementation period. For context on the European institutions cited, see Practice Note: Structure and functions of EU institutions and bodies. For advice on the consequences of the implementation period’s conclusion, see Practice Note: Brexit post implementation period—considerations for dispute resolution practitioners. Brexit timeline For the latest on the Brexit process and related preparations, see Practice Note: Brexit timeline. Withdrawal Agreement 2020—implementation period The 2020 Withdrawal Agreement between the UK and the EU is dated 24 January 2020 and is available here......

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PRACTICE NOTES

ARCHIVED : This Practice Note has been archived and is not maintained. It examines the impact of Brexit on contractual boilerplate provisions ahead of IP completion day. For information on the effect of IP completion day on boilerplate clauses, see Practice Note: What does IP completion day mean for contract clauses? The United Kingdom’s departure from the European Union on exit day, the implementation period, and the period thereafter each carry implications for the drafting, negotiation, and enforcement of contracts governed by English law. This Practice Note focuses specifically on the effect of Brexit on boilerplate clauses. ‘ Boilerplate’ refers to those provisions within an agreement that govern its operation and address legal points relevant to most transactions. Such terms are typically found at the beginning and the end of an agreement. Although often viewed as standard or...

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PRACTICE NOTES

ARCHIVED This Practice Note is archived and is not maintained or updated. It examines how Brexit could affect businesses’ contractual rights and duties for a business, and explores what Brexit means for managing contract risk in advance of IP completion day. For further information and guidance on the impact of IP completion day on contracts and, more generally, on commercial law, see Practice Notes: What does IP completion day mean for contract clauses? and What does IP completion day mean for Commercial? The Note evaluates the effects of Brexit on companies’ contractual rights and obligations and addresses the ramifications of Brexit for contract risk management in practice. It offers practical step-by-step guidance on identifying contractual risk to businesses arising from Brexit and on conducting a Brexit risk-management contract audit and contract review process. See also: Brexit risk management: contract...

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PRACTICE NOTES

STOP PRESS From 24 February 2025, the core provisions of the Procurement Act 2023 ( PA 2023) have come into effect. Any procurement launched on or after that date must follow PA 2023, whereas those started under the prior regime must continue to be run and overseen under that framework. Earlier legislation includes: Public Contracts Regulations 2015 Utilities Contracts Regulations 2016 Concession Contracts Regulations 2016 Defence and Security Public Contracts Regulations 2011 The Cabinet Office has also refreshed its standard contract document collections, templates and guidance for the government’s Model Services Contract, Mid- Tier Contract and Short Form Contract. These updated materials were released to coincide with the PA 2023 ‘go-live’ on 24 February 2025. This Practice Note will be revised shortly to reflect these changes. In the meantime, see News Analysis: Procurement Act 2023 ‘go live’—what happens next?, and...

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PRACTICE NOTES

This Practice Note outlines which biotechnological inventions may and may not be patented. It cites Directive 98/44/ EC (commonly called the Biotechnology Directive) and Schedule A2 to the Patents Act 1977 ( PA 1977), which allow patents for biotechnological inventions while setting key exceptions. Those exceptions have been interpreted by the Court of Justice in cases including Oliver Brüstle v Greenpeace and Monsanto v Cefetra. The Note also reviews exclusions from patentability under Article 52(b) of the European Patent Convention ( EPC) and pertinent European Patent Office ( EPO) decisions, Tomatoes I, Tomatoes II and Broccoli II. It also takes account of the 2017 European Commission Notice on biotechnological inventions. Patenting biotechnological inventions As a general rule, biotechnological inventions are patentable. Although neither PA 1977 nor the EPC imposes a blanket prohibition, specific provisions control when such inventions can be protected (see: The...

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PRACTICE NOTES

This Practice Note sets out what are termed ‘biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations ( MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration ( FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court ( UPC), together with the scope for development of its jurisprudence concerning biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is...

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PRACTICE NOTES

The legal technology landscape is changing at pace, spawning a fresh vocabulary of AI-related terms and expressions. For those who are not product developers or software engineers, it is useful to clarify what these phrases mean. This Practice Note is intended to help legal professionals gain a clearer grasp of key Artificial Intelligence ( AI) concepts. For further detail on the technology underpinning AI, see Practice Note: Artificial intelligence and machine learning—an introduction to the technology. The Basics Algorithm: a coded series of instructions within software that resolves a problem or executes a computation. Artificial Intelligence ( AI): computer software and systems capable of exhibiting human intelligence. They can learn, plan, reason, or handle natural language as they operate, rather than relying only on pre-programmed tasks; for example, speech recognition, computer vision, translation between natural languages, and other mappings of inputs. In the UK and EU,...

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PRACTICE NOTES

ARCHIVED This Practice Note is archived and is not maintained. It tracks EU life sciences developments and updates on coronavirus ( COVID-19). For UK life sciences coronavirus developments, see Practice Note: Coronavirus ( COVID-19)— UK life sciences tracker [ Archived]. Jump to: Research and development of medicines and vaccines IP waiver Clinical trials Regulation of medical devices Regulation of vaccines, medicinal products and blood Post-authorisation vigilance of medicines and vaccines Supply of vaccines, medicines and medical products Actions on falsified and unlicensed medicines, off-label use of medical devices EU coronavirus certificates m Health and data protection Research and development of medicines and vaccines What’s happening? When? Find out more European Medicines Agency backs the International Coalition of Medicines Regulatory Authorities and World Health Organisation statement to support healthcare professionals in strengthening public confidence in coronavirus vaccines — 17 May 2022. The European Medicines Agency ( EMA) endorsed a joint ICMRA– WHO statement on how coronavirus vaccines are...

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ARCHIVED: This Practice Note is archived and is no longer maintained. It charted the progress of UK primary legislation introduced as part of the legislative preparations for the UK’s exit from the EU during the 2017–19 Parliament. Following the prorogation of the 2017–19 Parliament on 8 October 2019, the Brexit Bills moving through Parliament that had not yet secured Royal Assent fell, namely: Agriculture Bill Financial Services ( Implementation of Legislation) Bill [ HL] Fisheries Bill Immigration and Social Security Co-ordination ( EU Withdrawal) Bill Trade Bill For further reading, see: Brexit Bulletin—key Bills fall away on prorogation of Parliament, LNB News 09/10/2019 64......

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PRACTICE NOTES

ARCHIVED This Practice Note is archived and no longer maintained. It contains closed legislative proposals, published judgments and concluded consultations that are no longer listed in the current Life sciences tracker— UK and Life sciences tracker— EU because they are not from the current year. To monitor the progress of current legislative proposals, relevant cases and consultations in life sciences, see Practice Notes: Life sciences tracker— UK and Life sciences tracker— EU. Jump to: Legislation Judgments— Patents Judgments— Supplementary protection certificates Judgments— Medical devices and medicinal products Judgments— Access to documents Judgments— Trade marks Consultations For up-to-date items in life sciences, consult Practice Notes: Life sciences tracker— UK and Life sciences tracker— EU. For key developments and guidance on Brexit within the life sciences sector, including the timeline for relocating the European Medicines Agency ( EMA), see Practice Note: Life...

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PRACTICE NOTES

ARCHIVED: This Practice Note is archived and is no longer maintained. It previously monitored the progress of UK legislative proposals and consultations relevant to the life sciences sector from 2019–2022, separate from matters specifically linked to the coronavirus ( COVID-19) pandemic and Brexit in that timeframe, which have their own archived trackers. To follow current UK legislative proposals, consultations and developments, as well as notable cases, relevant to the life sciences sector, see Practice Notes: Life sciences tracker— UK and Life sciences cases tracker— UK. To follow current EU legislative proposals, consultations and developments, as well as significant cases, relevant to the life sciences sector, see Practice Notes: Life sciences tracker— EU and Life sciences cases tracker— EU. For older archived materials on developments in life sciences, or those relating to the coronavirus ( COVID-19) pandemic or Brexit, see: ...

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When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

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This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

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Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

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I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...

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