Legal Practice Notes

Directive 2001/83/ EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation ( MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all. Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection ( RDP). This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering...

Parties often wish to stipulate that the entirety of their contractual relationship is governed by the written agreement they have signed. This is known as an ‘entire agreement clause’. This Practice Note examines why such clauses are used and the principal issues relevant to their operation, including the interplay between entire agreement clauses and implied terms, misrepresentation, fraud and exclusion clauses, non-reliance statements, and broader matters of evidential estoppel and contractual estoppel. For further guidance on construing the scope of parties’ contractual obligations, see Practice Notes: The parol evidence rule in interpreting contracts Contract interpretation—admissibility of surrounding documents and related content What is an entire agreement clause? At its simplest, an entire agreement clause provides that the whole of the parties’ contractual dealings is governed exclusively by the terms contained in their written contract. Consequently, when interpreting the contract, the court is...

Practice Note: The duty of fidelity and fiduciary duties As explained in Practice Note: The duty of fidelity and fiduciary duties, an implied duty of fidelity in every contract of employment will ordinarily prevent an employee from revealing to third parties confidential material learned in the course of their work. In addition, highly sensitive business information, commonly described as trade secrets, is protected by the equitable duty of confidence. Taken together, these obligations have historically shaped the implied responsibility owed by employees in relation to confidential information. The classification of business information is therefore pivotal: during employment, an employee is subject to an implied obligation not to disclose trade secrets and/or confidential information to others; after employment ends, only the implied restraint against revealing trade secrets persists. One exception is that a former employee may be stopped from benefiting,...

This Practice Note sets out the core principles for securing injunctions concerning confidential information and privacy. Although other remedies exist for claimants in breach of confidence matters, stopping publication of the material by injunction is frequently the only remedy of real practical worth to the claimant. It also addresses anonymised injunctions, alongside both interim and final injunctions. In recent years, injunctions touching on confidentiality and privacy have provoked debate. So‑called ‘super‑injunctions’ have drawn media criticism for constraining free expression; yet much of this derives from misunderstanding of what a ‘super‑injunction’ actually signifies and from the false sense that such orders are far more common than they are. This Practice Note explains the overarching principles for obtaining relief in this field. For further material on privacy injunctions, see the following Practice Notes: Privacy law—misuse of private...

This Practice Note This Practice Note has been revised following the introduction of the Arbitration Act 2025 and now points to changes made to the Arbitration Act 1996. For more detail on commencement and transitional arrangements, see Practice Note: Arbitration Act 2025 commencement and transitional provisions. It offers an overview of arbitration and its principal characteristics, concentrating on practice under the law of England and Wales, including the Arbitration Act 1996 ( AA 1996), as modified by the Arbitration Act 2025 ( AA 2025), which obtained Royal Assent on 24 February 2025 and took effect on 1 August 2025. Arbitration is a conclusive and binding method of resolving disputes, overseen by a constituted arbitral tribunal (usually one or three arbitrators) operating in a quasi-judicial way. As a rule, it rests on the parties' agreement (the arbitration agreement) and is supervised and enforced by...

This Practice Note outlines the formal requirements for witnesses, covering who may witness another person’s signature on a document connected to a commercial deal, such as a deed or simple contract, as well as witnessing electronic signatures and the current approach to video witnessing in practice. For guidance on witnessing wills, see Practice Note: Validity of Wills—signature. We have created a collection that serves as a comprehensive, interactive resource to help users recognise and navigate the concepts and frequent issues and pitfalls in executing documents, including the witnessing of signatures. Each stage or phase provides practical guidance, precedent clauses and Q& As relevant to that stage. For further details, see: Execution collection. Witnessing What is the difference between witnessing and attestation? Witnessing is the act of observing the execution of a document. Attestation adds the further step of noting, on the document itself, that the witness has seen the...

This playbook provides guidance for drafting and negotiating a confidentiality agreement (also known as a non-disclosure agreement or NDA) from a pro-discloser position. It sets out preferred stances and alternative fallback options for the clauses most often contested in these agreements. The template suits solicitors representing the discloser, whether operating in-house or working in private practice. Users should adapt and tailor it as needed to address client-specific issues and safeguard the client’s interests in full. The level of risk referenced throughout may vary depending upon the particular client. Be aware it omits fallbacks for boilerplate clauses, for situations where confidential information comprises personal data, and for detailed intellectual property rights provisions. For a complete index of related confidential information materials, see: Confidential information—overview. For the underlying template agreement, consult: Precedent: Confidentiality...

This Practice Note It sets out guidance on applying the Protocol. It covers: when the Protocol operates its objectives and scope typical outcomes of non-compliance how it relates to limitation The Protocol replaced the Pre- Action Protocol for Defamation Claims. For how it differs from that earlier regime, see News Analysis: Pre- Action Protocol for Media and Communications Claims. In addition to defamation, the Protocol extends to a range of other media and communications claims which, before 2019, were not governed by a dedicated pre-action protocol. It formed part of broader reforms to media and communications procedure commencing on 1 October 2019, which also introduced a new CPR 53 and a new practice direction. For more on these changes, see News Analysis: New rules for media and communications claims from 1 October 2019......

A ‘patent’ is a legal instrument that grants an inventor monopoly rights. It safeguards novel inventions and can extend to elements such as the way things function, their composition, and the methods by which they are produced. A UK national patent, or a European patent designating the UK ( EP( UK)), is infringed by carrying out acts in the UK without the permission of the patent proprietor (the patentee). Those infringing acts are prescribed by section 60 of the Patents Act 1977 ( PA 1977) and include making, using, and importing a patented product or process. For detail on patent infringement, see Practice Note: Patent infringement......

This Practice Note outlines what know-how is and identifies the various methods by which it can be safeguarded, before offering guidance on matters connected to licensing know-how, including licensing within a broader research and development ( R& D) arrangement. It covers why know-how is licensed, the principal clauses of a know-how licence, IP considerations in R& D agreements and issues around co-ownership of IP rights. What is know-how? ‘ Know-how’ denotes technical or practical knowledge gained through research or experience and typically concerns how something is carried out. This technical or practical insight may be documented in any format—or retained solely in the mind of an inventor or key employee—and may include operating manuals, drawings, blueprints and other technical material. As it is not always recorded in writing, it can be hard to define. However, Article 1 of Assimilated Regulation ( EU) 316/2014, the...

Background— EU law in the UK Pre-exit day The European Communities Act 1972 ( ECA 1972) was enacted to implement the United Kingdom’s obligations, as a Member State, under the relevant EU treaties and to ensure adherence to EU law. Under ECA 1972, s 2(1), certain EU rights and obligations intended to have direct effect applied in the UK without the need for additional domestic legislation. This encompassed rights under the EU Treaties and EU regulations setting out detailed legal rules. Other forms of EU law took effect via UK regulations made under ECA 1972, s 2(2), or, in some circumstances, through separate Acts of Parliament. This pathway covered EU directives, which stipulate overarching aims or frameworks while leaving each Member State to make its own provision to secure the required legal outcome. In its operation within Member States, EU law is...

When collaborators join forces on creative projects or research and development, knotty questions arise about who owns any resulting IP. Joint ownership can appear a straightforward and equitable answer where efforts were shared and the contributions cannot be disentangled. Yet, without careful thought about how jointly created IP will be owned, organised and exploited, parties may face legal traps, practical hurdles and limits on full commercialisation. In the great majority of cases, it is preferable to put in place an express agreement on joint ownership of IP rather than depend on the default legal position... This Practice Note provides an overview of the law on joint ownership of IP (also known as co-ownership, used interchangeably in this note): Implied joint ownership—basic principles Implied joint ownership—risks and obstacles Joint ownership agreements—key considerations Alternatives to joint ownership of IP ...

Across both advanced and developing nations, the commerce in falsified medicinal products is a global problem. The labels ‘falsified medicines’ and ‘counterfeit medicines’ must not be conflated—falsified medicines are fake items crafted to imitate genuine treatments, while counterfeit medicines are those that breach trade marks or other intellectual property rights. This Practice Note reviews the regulatory changes introduced by Directive 2011/62/ EU on preventing the entry of falsified medicinal products into the legitimate supply chain (the Falsified Medicines Directive, FMD), aimed at addressing the growing incidence of falsified medicines. It first explains the meaning of ‘falsified medicinal product’, then outlines the FMD’s measures, including: tighter oversight of active substances duties placed on participants within the supply chain safety features added to medicinal product packaging a common logo for websites that sell medicinal products This Practice Note also sets out an...

A– B | E– H | I– N | O– P | Q– V. CE marking The CE ( Conformité Européene—meaning European Conformity) symbol is compulsory for certain products, including medical devices, to confirm the device meets all relevant medical device regulations before it can be lawfully marketed within the EEA. It: demonstrates the manufacturer has verified these products satisfy EU safety, health or environmental requirements signals a product’s conformity with EU legislation permits the free movement of products across the EEA In Great Britain ( GB) after Brexit, the UKCA mark is the counterpart to the CE mark, available for medical devices placed on the GB market from 1 January 2021, although Northern Ireland continues to require the CE mark under EU legislation. For existing ‘legacy’ devices on the GB market, the CE mark will keep being recognised for varying periods beyond 30 June 2023 under...

No medicinal product can be marketed until it has obtained approval known as a marketing authorisation ( MA). An MA specifies the authorised indications, the patient population and the dosage, together with any conditions placed on the MA holder ( MAH). The approval framework is regulated by Directive 2001/83/ EC on the Community Code relating to medicinal products for human use (the Pharmaceutical Code). There are several routes to secure an MA for medicinal products: EU centralised procedure ( CP), with medicines approved via the CP often termed centrally authorised products ( CAPs) Mutual recognition procedure ( MRP) Decentralised procedure ( DCP) National procedure The appropriate route is determined by the product’s nature, therapeutic area and the type of licence required (ie where the product is to be sold and whether licences already exist in other EU/ EEA Member States). There are also several different legal bases on which an MA...

Tracker Use this Tracker to confirm if a state is a signatory to the Hague Convention on Choice of Courts Agreements and whether the Convention is already in effect for that jurisdiction. Albania — In force: 1 October 2024. Ratified: 25 June 2024. Signed: 13 February 2024. HCCH website: Albania—the Convention enters into force; HCCH website: Albania signs the Choice of Court Agreements Convention; HCCH notification: Albania ratifies the Choice of Court Agreements Convention. Australia — Signed: No. The Joint Standing Committee on Treaties in 2017 backed accession to the Convention and advised that binding treaty action be undertaken. For information, see Australian Parliament— Convention on Choice of Courts accession. Bahrain — In force: 1 July 2025. Acceded: 13 March 2025. For information, see: Bahrain accedes to the Choice Of Court Convention. China — Approval, ratified or...

A co-operative or community benefit society ( CCBS), previously termed an industrial and provident society ( IPS), is a limited liability corporate body that organisations may use to run a business either as a co-operative serving members’ mutual interests, or as a community benefit society operating for the good of a community. This Practice Note sets out the legal framework, organisational structure and the registration process for these societies. It also makes extensive reference to the FCA’s finalised guidance on registered societies, with sections addressing governing rules, share capital, name, transfer of engagements, conversion, amalgamation, dissolution and winding up. What is a co-operative or community benefit society? A co-operative society or community benefit society (historically called an industrial and provident society) is a registered society—also described as a society—and a corporate body with limited liability that can be used by...

Legal professional privilege ( LPP) This Practice Note examines legal professional privilege, which comprises legal advice privilege and litigation privilege. It sets out the criteria applicable to both categories, including the confidentiality of communications, the dominant purpose and legal context of the material over which privilege is claimed, and the identity of any recipients copied into the correspondence. It explains, for the purposes of asserting privilege, what is meant by client, legal adviser, legal advice and anticipated litigation. It also addresses recognised exceptions, notably the iniquity exception (where fraud or crime is in play), and situations where statute displaces privilege. The treatment of copy documents, and of documents that are collated, selected or extracted, together with translations, is considered. Practical pointers are provided. In this Note, legal professional privilege (often shortened to ‘privilege’) is used as a collective label for legal advice...

Introduction Block exemption regulations offer broadly applicable safe harbours from the EU ban on anti-competitive agreements set out in Article 101(1) TFEU, provided the agreement meets the criteria of the relevant block exemption regulation. Each block exemption rests on the assumption that any restrictive agreement within its scope satisfies the four conditions in Article 101(3) TFEU required for an individual exemption from the application of Article 101(1) TFEU (see further, Article 101(1) TFEU—the prohibition on restrictive agreements and Individual exemptions under Article 101(3) TFEU). Accordingly, every block exemption regulation creates a safe harbour that shields restrictive arrangements from legal challenge under Article 101 TFEU. The former Research & Development Block Exemption Regulation ( EU) 1217/2010 ( R& D 2010), which expired on 30 June 2023, had applied since 1 January 2011. Following a review and engagement with stakeholders, the updated Research &...

Intellectual property laws grant exclusive entitlements to holders of patents, copyright, design rights, trade marks and other protected rights. Owners of intellectual property rights ( IPRs) may stop unauthorised use of their IP and may exploit it, for instance by granting licences to third parties. However, the ability to commercialise does not shield IPRs from scrutiny under competition law. Like any other arrangement, deals involving IPRs (e.g., licences enabling a licensee to use the licensor’s IPRs) must comply with Article 101(1), TFEU. For many would-be licensees and licensors, the initial task in checking whether their arrangements accord with EU competition rules is to consider if a block exemption regulation can apply. The block exemption most commonly relevant to an IP licence is the Technology Transfer Block Exemption Regulation ( TTBE, Regulation 316/2014), the latest iteration of which took effect on 1 May 2014 and...