{"id":153754,"date":"2026-10-30T12:00:08","date_gmt":"2026-10-30T12:00:08","guid":{"rendered":"https:\/\/www.legal500.com\/guides\/?post_type=comparative_guide&#038;p=153754"},"modified":"2026-11-02T11:06:56","modified_gmt":"2026-11-02T11:06:56","slug":"united-kingdom-patent-litigation","status":"publish","type":"comparative_guide","link":"https:\/\/www.legal500.com\/guides\/chapter\/united-kingdom-patent-litigation\/","title":{"rendered":"United Kingdom: Patent Litigation"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-153754","comparative_guide","type-comparative_guide","status-publish","hentry","guides-patent-litigation","jurisdictions-united-kingdom"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Carpmaels &amp; Ransford LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/www.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2020\/10\/carpmaels-ransford.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Carpmaels &amp; Ransford LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/www.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2020\/10\/carpmaels-ransford.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Patent Litigation laws and regulations applicable in United Kingdom<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the forum for the conduct of patent litigation?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Claims under the UK Patents Act 1977 (the \u201cPatents Act\u201d) must be brought in specialist courts. These consist of the Patents Court, which is part of the Business and Property Courts of the High Court of Justice, and the Intellectual Property Enterprise Court (\u201cIPEC\u201d). In both courts, claims are heard by judges with many years of experience in intellectual property law from their time in practice. The most experienced patents judges hear the most technically complex patents cases. In addition, we are increasingly seeing a number of our most experienced barristers and solicitors sitting as Deputy High Court judges giving the courts increased capacity. Appeals are possible, as set out below.<\/p>\n<p>The idea behind having two specialist first instance courts is that the IPEC will generally deal with more straightforward cases of lower monetary value (cases brought in the IPEC must have a value less than \u00a3500,000 unless waived by agreement of the parties). This cap applies to damages and account of profits. Costs recovery in the IPEC is also (with very limited exceptions) capped at \u00a360,000 for proceedings concerning the final issue of liability and \u00a330,000 for proceedings concerning damages or account of profits. This provides parties with a more cost-effective way of commencing less complex patent claims, thus incentivising the enforcement of patents by SMEs. Patent revocation claims may also be brought before the Comptroller-General of Patents (the UK Intellectual Property Office), however such claims are relatively rare.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the typical timeline and form of first instance patent litigation proceedings?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Where both infringement and validity of a patent are in suit, they are typically heard together; proceedings are not bifurcated and issues of claim construction are considered during trial in the main proceedings. Regardless of the content of a claim, pleadings are exchanged in accordance with deadlines set by the Civil Procedure Rules (\u201cCPR\u201d). Around 1-2 months after close of pleadings, the court holds a Case Management Conference (\u201cCMC\u201d) with the parties to set directions in the case. The resulting Directions Order sets out deadlines for key case preparation milestones in the run up to trial. Parties can, in certain circumstances as set out in the CPR, agree an extension of time to complete a particular action. Such extensions may require the court\u2019s permission. An extension will not be granted if it would threaten critical timings such as the trial date. Once fixed, a trial date will not generally be moved unless there are exceptional circumstances.<\/p>\n<p>There is the option in patent trials to request an expedited trial. The decision to grant expedition, and the extent to which a trial is expedited, is essentially at the discretion of the judge when applying various factors, for example whether the applicant has shown a good reason for expedition and whether expedition would prejudice the other parties to the case.<\/p>\n<p>There is also a streamlined procedure known as the \u201cShorter Trials Scheme\u201d (\u201cSTS\u201d). The STS is designed to achieve shorter and earlier trials at a reasonable and proportionate cost. This is achieved via a docketed judge setting tightly controlled case management directions with limited evidence and disclosure. Costs capping in the STS has been introduced by a new pilot scheme (PD 51ZD), which operates from 1 January 2024 until 31 December 2026 and which applies to all claims issued in the STS in the Patents Court during this period. The pilot scheme has introduced a cap of \u00a3500,000 costs for proceedings concerning the final issue of liability and \u00a3250,000 for proceedings concerning damages or account of profits. If the STS is used, the trial date (or window) should be fixed to be heard within eight months of the CMC.<\/p>\n<p>Even without expedition or streamlining via the STS, the court will aim, where possible, to list a trial in the court\u2019s diary within 12 months of the claim being issued. However, the extent to which this is achievable in practice depends on a number of factors, such as the availability of the court and the parties\u2019 barristers. Recently, some patents judges have expressed a willingness to list trials outside of the normal court term dates (for example, in September) in order to achieve this aim.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Can interim and final decisions in patent cases be appealed?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Matters heard by the Comptroller-General of Patents in the UK Intellectual Property Office may be appealed to the Patents Court.<\/p>\n<p>Decisions of the IPEC and the Patents Court may be appealed with permission to the Court of Appeal. Decisions of the Court of Appeal may be appealed with permission to the Supreme Court. Appeals to the Supreme Court have tended to arise relatively infrequently for patent cases on the whole, although a number of very notable appeals covering a broad range of legal issues have been subject to the scrutiny of the Supreme Court over the last few years, such as: infringement under the Doctrine of Equivalents (<em>Actavis v Eli Lilly<\/em> [2017] UKSC 48); plausibility and the infringement of second medical use patents (<em>Warner-Lambert Company LLC v Generics (UK) Ltd t\/a Mylan and Anor <\/em>[2018] UKSC 56); obviousness (<em>Actavis Group PTC EHF v ICOS Corporation <\/em>[2019] UKSC 15); sufficiency (<em>Regeneron Pharmaceuticals Inc v Kymab Ltd<\/em> [2020] UKSC 27); and the grant of licences on FRAND terms (<em>Unwired Planet International v Huawei Technologies (UK) <\/em>[2020] UKSC 37). In 2026, the Supreme Court has ruled on the patentability of software and AI inventions (<em>Emotional Perception<\/em> <em>v <\/em><em>Comptroller-General of Patents <\/em>[2026] UKSC 3) and jurisdiction over FRAND licensing disputes concerning patent pools (<em>Tesla v InterDigital <\/em>[2026] UKSC 27), with a further judgment on FRAND licence terms expected in the coming months in the appeal of the rate determination in <em>Optis v Apple<\/em> <a href=\"https:\/\/caselaw.nationalarchives.gov.uk\/ewca\/civ\/2025\/552\">[2025] EWCA Civ 55<\/a>2.<\/p>\n<p>An appeal will only be allowed where there is a real prospect of success or there is some other compelling reason for the appeal to be heard. Furthermore, appeals will only be heard by the Supreme Court if they raise an arguable point of law of general public importance which ought to be heard by the Supreme Court at that time.<\/p>\n<p>The original application for appeal is made to the lower court, but if that court does not give permission, a further written application may be made to the appeal court. Appeals themselves take the form of a review, not a rehearing. This means that it is rare for new evidence to be considered. For new evidence to be heard on appeal it must be shown that the evidence could not, with reasonable diligence, have been obtained at trial, that it would have an important influence on the case, and that it is credible. For this reason, the court hearing the appeal will rarely depart from the findings of fact made at first instance. This is because appeals are reviews on points of law and therefore the judge at first instance is often best placed to determine factual matters in dispute. An appeal judge would have to give good reasons for substituting their own finding of fact for that of the trial judge. This is particularly relevant in the context of findings of (non-)obviousness, where the judge at first instance will have had the benefit of hearing all of the expert evidence first-hand.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which acts constitute direct patent infringement?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>As set out in section 60(1)(a) Patents Act, a product claim is directly infringed if a person, without the consent of the patent proprietor, carries out any of the following acts in the UK while the patent is in force: makes the product; disposes of or offers to dispose of the product; uses the product; imports the product; or keeps the product, whether for disposal or otherwise.<\/p>\n<p>As set out in section 60(1)(b) Patents Act, a process claim is directly infringed if a person, without the consent of the patent proprietor, uses the process in the UK while the patent is in force. A person would also infringe if they offer the process for use in the UK where they know, or it would be obvious to the reasonable person in the circumstances, that its use there without the proprietor\u2019s consent would constitute infringement.<\/p>\n<p>As set out in section 60(1)(c) Patents Act, a process claim would be directly infringed if a person, without the consent of the patent proprietor, carries out any of the following acts in the UK while the patent is in force: disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process; or keeps any such product whether for disposal or otherwise.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Do the concepts of indirect patent infringement or contributory infringement exist? If so, what are the elements of such forms of infringement?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>As set out in sections 60(2) and 60(3) Patents Act, indirect infringement in the UK occurs when a person other than the patent proprietor, while the patent is in force and without the proprietor\u2019s consent, supplies or offers to supply a person not entitled to work the invention with the means, relating to an \u201cessential element\u201d of the invention, for putting the invention into effect. What constitutes an \u201cessential element\u201d will depend on the facts of each case. For indirect infringement to be made out, the supply or offer to supply must be in the UK and the invention must be put into effect in the UK, i.e. there is a double territorial requirement.<\/p>\n<p>There is also a knowledge requirement. Indirect infringement will only be established where the alleged infringer knew, or it was obvious to the reasonable person in the circumstances, that the means were suitable for putting the invention into effect in the UK and they were intended to put the invention into effect. This will also depend on the facts of each case and will be the subject of expert or fact evidence. There is no concept of divided infringement under UK patent law. Where different acts are performed by different actors, they may be liable for infringement as joint tortfeasors, i.e. where two (or more) persons act \u201cin furtherance of a common design\u201d. This is also known as contributory infringement. \u201cMere assistance\u201d is not enough to make a second party a joint tortfeasor \u2013 they must join or share in the commission of the tort to an extent that is more than <em>de minimis<\/em>. Such \u201ccommon design\u201d can be a tacit or explicit agreement to perform an act. There is no need to prove that the common design was intended to infringe. If a party is liable as a joint tortfeasor, their liability is for the whole act \u2013 not just their part in the common design.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">How is the scope of protection of patent claims construed?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The court applies a purposive construction of the claims, to arrive at an interpretation which reflects the inventor\u2019s purpose, as understood by the skilled person at the relevant filing or priority date. While claim construction is ultimately a matter for the court to decide, it is common for parties in patent cases to rely on expert evidence in support of a particular claim construction. That expert evidence will relate to the way in which the person skilled in the art would have understood the claims, read in light of the specification as a whole, and also the common general knowledge as at the filing or priority date of the patent.<\/p>\n<p>In 2017 the Supreme Court introduced the doctrine of equivalents in <em>Actavis v Eli Lilly<\/em> [2017] UKSC 48, setting out a new three question test to determine whether a variant would infringe even in the absence of \u201cnormal\u201d or \u201cliteral\u201d infringement. The questions are:<\/p>\n<ol>\n<li>Does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?<\/li>\n<li>Would it be obvious to the person skilled in the art, reading the patent at the priority date but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way?<\/li>\n<li>Would the skilled reader have concluded that the patentee nonetheless intended that strict compliance with the literal reading of the relevant claims was an essential element of the invention?<\/li>\n<\/ol>\n<p>For infringement under the doctrine of equivalents to be made out the first two questions must be answered \u201cyes\u201d and the last question \u201cno\u201d. Since the Supreme Court\u2019s judgment in <em>Actavis v Eli Lilly<\/em> we have seen a number of lower court decisions applying the doctrine of equivalents across a range of different technical areas. A notable recent example is <em>Formycon v Regeneron<\/em> [2025] EWHC 2527 (Pat) concerning patents for a liquid formulation of aflibercept (Eylea). Meade J held that the allegations of infringement by equivalence failed, as the inventive concept of the claims in issue was held to be narrow. Comparing the variant with the invention at the same level of generality as the claim, the biosimilar formulations (which substituted claimed excipients) achieved stability in a different way. Therefore, the equivalence case failed at Q1.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the key defences to patent infringement?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Defences to patent infringement include: invalidity (an invalid patent cannot be infringed); non-infringement (no infringing acts were carried out in the UK); and exhaustion (where a product is placed on the market within the EEA with the patentee\u2019s consent, it \u201cexhausts\u201d its IP rights to prevent further movement or resale of those goods). Note that, owing to the legal framework established following the UK\u2019s departure from the European Union, UK IP rights are still exhausted when a product is placed on the market within the EEA with the patentee\u2019s consent.<\/p>\n<p>In addition, there are a number of statutory exemptions to patent infringement as set out in section 60(5) Patents Act, including private use, experimental use, extemporaneous preparation in a pharmacy of a prescribed medicine, use on a ship or aircraft temporarily in UK territorial waters or airspace, certain permitted agricultural uses, and prior use.<\/p>\n<p>Importantly, we have a \u201cBolar-like\u201d exemption to patent infringement in the UK, which was introduced in 2005 following the amendments to Directive 2001\/83\/EC (on the Community code relating to medicinal products for human use), and which was broadened in the UK in 2014 to exempt anything done in, or for the purposes of, a medicinal product assessment which would otherwise constitute infringement of a patent.<\/p>\n<p>Limitation may be a defence to patent infringement where the infringement occurred more than six years prior to the claim.<\/p>\n<p>Recent cases have confirmed the availability of the <em>Formstein <\/em>defence to patent infringement in the UK. Under this defence, if there is a finding of infringement under the doctrine of equivalents, but the consequence of the broader claim scope by virtue of the doctrine of equivalents means the relevant claims are invalid, then the claim scope must be limited to the normal interpretation.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the key grounds of patent invalidity?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The key grounds for patent revocation are set out in section 72(1) Patents Act:<\/p>\n<p style=\"padding-left: 40px\">a) the invention is not a patentable invention \u2013 the invention must comply with the patentability requirements set out in the Patents Act. It must be new (novel) over the \u201cstate of the art\u201d at the priority date; it must have been non-obvious to the person skilled in the art as at the priority date, having regard to the state of the art and to their common general knowledge; it must be capable of industrial application; and it must not be excluded subject matter. Excluded subject matter includes: (i) a discovery, scientific theory or mathematical method; (ii) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever; (iii) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer; (iv) the presentation of information; and (v) methods of treatment or diagnosis for the human or animal body.<\/p>\n<p style=\"padding-left: 40px\">b) the patent was granted to a person not entitled \u2013 a person who should have been granted a patent, but was not, may bring entitlement proceedings, but will have to discharge the burden of proof to establish why the patent should have been granted to them.<\/p>\n<p style=\"padding-left: 40px\">c) insufficiency \u2013 the specification of the patent must disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.<\/p>\n<p style=\"padding-left: 40px\">d) added matter \u2013 the matter disclosed in the granted patent specification must not extend beyond that disclosed in the original application as filed.<\/p>\n<p style=\"padding-left: 40px\">e) post-grant claim broadening \u2013 the claim scope must not be extended by non-permissible claim amendments.<\/p>\n<p>The assessment of how these grounds apply in practice has led to a great deal of judge-made law. For example, the single ground of insufficiency under s72(1)(c) is now commonly thought of as three types of objection: classical insufficiency (or undue burden); Biogen insufficiency (or excessive claim breadth); and uncertainty insufficiency (also referred to as conceptual uncertainty). Further, the concept of plausibility (although not mentioned in s72(1) Patents Act) often features in cases concerning insufficiency and\/or obviousness.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">How is prior art considered in the context of an invalidity action?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>When seeking to invalidate a patent, the claimant must set out the prior art on which it relies in its Grounds of Invalidity and state whether each is being pleaded for lack of novelty or inventive step. Prior art is usually written material but might be an oral description if appropriate evidence is submitted to prove such a \u201cpublication\u201d. There are no geographical limitations on material that might be considered prior art as long as it can be shown to have been made available to the public. A piece of prior art may be used in respect of multiple grounds of invalidity, provided it is a document made available to the public before the priority date of the patent. If the document was made available after the priority date but before the filing date it may be cited in circumstances where there is a priority challenge to the patent. If this challenge is successful, it will be considered as \u201cfull\u201d prior art. Such a document may also, in certain limited circumstances, be considered as \u201cnovelty only prior art\u201d, in which case it will not be taken into account for the purposes of inventive step. Prior art documents may be combined only if there is a clear reason to do so on the face of the documents but not in other circumstances. This is a strict rule and documents cannot be readily mosaiced in UK patent litigation. It is, however, necessary to read the prior art in the light of the common general knowledge. It is the combination of the common general knowledge and the prior art that will be said to form the \u201cstate of the art\u201d against which the questions of novelty and inventive step will be judged. It is also possible (although relatively uncommon) to run an invalidity attack based solely on common general knowledge. The common general knowledge is typically evidenced as part of an expert witness statement, supported by review articles and textbooks etc. The courts increasingly ask parties in litigation to prepare and seek to agree statements on common general knowledge or a primer setting out the background technology of the patent.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Can a patentee seek to amend a patent that is in the midst of patent litigation?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Patent claims may be amended during infringement or invalidity proceedings. The patentee must make an application by way of application notice, which must be served on all parties and the Comptroller (the UK Intellectual Property Office) within seven days of it being filed. The notice must give details of the amendment, the grounds on which it is being sought, and whether the applicant will claim that the patent claims prior to amendment were valid. The Comptroller will, unless the court orders otherwise, advertise the application. A person may, during this time, inform the court of their opposition, which the court may take into account when determining the application. Typically amendment applications made during the course of litigation will be heard during the full trial of the matter.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is some form of patent term extension available?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p><em>SPC Regulation <\/em><\/p>\n<p>Patent term extensions (known as supplementary protection certificates or \u201cSPCs\u201d) are available for certain human and veterinary medicinal products and result in up to five years of additional exclusivity once the relevant patent (known as the \u201cbasic patent\u201d) has expired. This five-year term is extendable by a further six months if a \u201cpaediatric extension\u201d is available. So-called \u201cnegative term\u201d SPCs are also available. These SPCs would themselves have a negative term under the usual rules governing SPC duration, but they can be valuable now that a paediatric extension may also be sought.<\/p>\n<p>Regulation (EC) No 469\/2009, as amended, sets out the regime for human and veterinary medicinal products (the \u201cSPC Regulation\u201d) and Regulation (EC) No 1610\/96 governs SPCs for plant protection products (the \u201cPlant SPC Regulation\u201d). Article 7 of the SPC Regulation states that SPCs must be applied for within six months of the date on which marketing authorisation for the relevant medicinal product has been granted. Alternatively, where the authorisation is granted before the basic patent, SPCs may be applied for within six months of the date on which the basic patent has granted.<\/p>\n<p>Article 3 of the SPC Regulation sets out a number of conditions which must be satisfied in order to obtain an SPC:<\/p>\n<p style=\"padding-left: 40px\">a. the product must be \u201cprotected by\u201d a basic patent and that patent must be in force;<\/p>\n<p style=\"padding-left: 40px\">b. a valid authorisation to place the relevant medicinal product on the market must be granted. Importantly, such an authorisation must meet the requirements of the legislation which sets out the criteria for the approval of the relevant human or veterinary medicinal product;<\/p>\n<p style=\"padding-left: 40px\">c. the product must not already be the subject of an SPC; and<\/p>\n<p style=\"padding-left: 40px\">d. the authorisation (in the second bullet point above) must be the first to place the product on the market.<\/p>\n<p>SPCs are most frequently attacked on the basis that the conditions for the grant of an SPC under Article 3 have not been satisfied and\/or the underlying basic patent is not valid. The Article 3 conditions have been subject to a high degree of scrutiny before the national courts in Europe, including a large volume of cases before the UK courts. Since the SPC Regulation and Plant SPC Regulation are instruments of European Union (\u201cEU\u201d) law, many of these disputes have involved references for a preliminary ruling from the Court of Justice of the European Union (the \u201cCJEU\u201d).<\/p>\n<p>The UK left the EU on 31 January 2020, and the relevant transition period under the Withdrawal Agreement came to an end on 31 December 2020. The SPC Regulation and Plant SPC Regulation are nevertheless retained EU legislation (strictly speaking \u201cassimilated law\u201d now pursuant to the Retained EU Law (Revocation and Reform) Act 2023) and govern new SPCs filed in the UK after the transition period. However, it is no longer possible for the UK courts to make references to the CJEU regarding the interpretation of the SPC Regulation or the Plant SPC Regulation.<\/p>\n<p>SPC applicants should keep in mind certain post-Brexit differences concerning the deadline for filing new SPC applications, the calculation of SPC term and the territorial scope of these SPCs. Whilst paediatric extensions and the SPC manufacturing waiver were retained following Brexit, there is an important aspect of asymmetry in each case. Under the UK system, for example, applicants will not need to provide evidence of corresponding authorisations in all EEA member states in order to obtain a paediatric extension (which is still a requirement under the equivalent EU scheme). This change to the UK regime potentially allows for paediatric extensions to be granted in the UK, in circumstances where that would not previously have been possible for products that were not approved in all EEA member states. (Paediatric extensions are also available in Switzerland.)<\/p>\n<p>Decisions of the CJEU which pre-date 1 January 2021 are binding on the UK Courts as assimilated case law (although the Court of Appeal and Supreme Court may depart from them). CJEU rulings and reasoned orders that were decided on or after that date are not, however, raising the prospect of the UK and EU regimes diverging. The prospect of such divergence in the SPC arena arose in <em>Merck Serono SA v Comptroller-General of Patents, Designs and Trade Marks<\/em> [2023] EWHC 3240 (Ch). This case concerned the grant of an SPC for a second medical use and the impact of the CJEU\u2019s decision in Case C-673\/18 Santen (which was decided during the Brexit transition period). Merck Serono\u2019s SPC application was rejected by the UK Patents Court under Article 3(d) SPC Regulation. On appeal, the Court of Appeal decided that there was no reason to depart from the CJEU\u2019s decision in Santen, favouring the coherence and legal certainty that Santen had restored to the SPC regime (see <em>Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks<\/em> [2025] EWCA Civ 45).<\/p>\n<p>Two recent Patents Court decisions have further developed the UK\u2019s SPC case law, in each case considering the central question of how the \u201cproduct\u201d or \u201cactive ingredient\u201d should be identified under Article 1(b) of the SPC Regulation. In <em>Accord Healthcare Ltd v Novartis AG<\/em> [2026] EWHC 2127 (Pat) concerning the SPC protecting Novartis\u2019s Entresto product, the court held that the \u201cproduct\u201d was the combination of the active ingredients valsartan and sacubitril, rather than valsartan and sacubitril in co-complex form. On that basis, the requirements of Articles 3(a) and 3(b) of the SPC Regulation were satisfied and the validity of the SPC was upheld.<\/p>\n<p>In <em>Aristo Pharma &amp; STADA Arzneimittal v Takeda<\/em> [2026] EWHC 2414 (Pat), the court upheld the validity of Takeda\u2019s SPC for Elvanse which is authorised for treating ADHD.\u00a0Elvanse contains the prodrug lisdexamfetamine, which is metabolised after administration to a patient to dexamfetamine. The UK court rejected the claimants\u2019 contentions that the active ingredient was the previously authorised dexamfetamine product. The court noted in particular that lisdexamfetamine (not dexamfetamine) had been identified as the \u201cactive substance\u201d within the meaning of the Medicinal Products Directive, and it follows that lisdexamfetamine is also the \u201cactive ingredient\u201d or \u201cproduct\u201d as defined by Article 1(b) of the SPC Regulation. Consequently, the claimants\u2019 attacks under Article 3(d) therefore failed, as the marketing authorisation for the medicinal product Elvanse, as relied upon by Takeda, was the first authorisation to place the relevant \u201cproduct\u201d (i.e. lisdexamfetamine) on the market.<\/p>\n<p><em>SPC Manufacturing Waiver <\/em><\/p>\n<p>The SPC Regulation has been amended to introduce an \u201cSPC manufacturing waiver\u201d, which sets out two exceptions to infringement in the UK for third party acts that would otherwise be protected by an SPC. In summary, it allows a third party to:<\/p>\n<p style=\"padding-left: 40px\">a. Manufacture a product for the purpose of export to countries outside the UK and EU; and<\/p>\n<p style=\"padding-left: 40px\">b. Manufacture and store a product during the last six months of SPC term for sales in the UK and EU after SPC expiry.<\/p>\n<p>Both exceptions require the third party to provide certain information to the SPC holder three months before manufacture, by way of advanced notification. In a recent case concerning aflibercept, the active ingredient in Eylea, the UK courts had the opportunity to consider the SPC manufacturing waiver for the first time (see <em>Regeneron &amp; Bayer v Alvotech &amp; Fisher<\/em> [2025] EWHC 3050 (Pat) following an expedited trial in November 2025). Mr Justice Meade held that the third party notification was valid, even though it did not initially include the marketing authorisation number for the intended country of export, provided that number is supplied once publicly available. In the context of a separate dispute concerning ustekinumab, the active ingredient in Stelara, the Danish court has referred questions to the CJEU seeking to clarify the interpretation of the scope and formalities required by the SPC manufacturing waiver. This reference for a preliminary ruling (see C-371\/26 Janssen Biotech) was lodged earlier this year and remains pending.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">How are technical matters considered in patent litigation proceedings?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Proceedings before the UK courts are adversarial and it is usual in patent litigation proceedings in the Patents Court for the evidence of expert witnesses to be relied on by parties to support their case. This expert evidence is a very important part of proceedings in the UK courts.<\/p>\n<p>Prior to trial a party will serve their pleadings, witness statements including expert reports, and skeleton arguments. As mentioned above, the UK courts increasingly ask parties in litigation to prepare and seek to agree statements on common general knowledge or a primer setting out the background technology of the patent. While these documents are important to the proceedings, the claim will not be determined on the papers alone. An exception is in the IPEC in the event that both parties agree to a trial on the papers.<\/p>\n<p>At trial, a witness statement will ordinarily stand as evidence in chief. Therefore, witnesses will not give oral evidence in chief at trial. However, witnesses will be cross-examined by the other side\u2019s barrister. Oral cross-examination of experts is a crucial part of UK patent proceedings. Cross-examination need not be confined to the contents of the witness statement and they may be questioned on any document, fact or issue which arises in the case. At the conclusion of cross-examination, the barrister representing the party who called that witness has the option of re-examining the witness, although there is no obligation that they do so.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is some form of discovery\/disclosure and\/or court-mandated evidence seizure\/protection (e.g. saisie-contrefa\u00e7on) available, either before the commencement of or during patent litigation proceedings?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Disclosure<\/p>\n<p>Fact-finding in UK patent litigation is most often achieved through disclosure. Relevant documents are disclosed to the other side, who may then inspect all documents which are not privileged. In the Patents Court parties must provide \u201cinitial disclosure\u201d of documents they have relied upon and key documents necessary to enable the other party to understand the case it has to meet when filing their pleadings. This is then followed by disclosure of any known adverse documents (before any searches are carried out) that undermine a party\u2019s case. A party may also seek extended disclosure of further documents, based on a number of different \u201cmodels\u201d differing in scope. When ordering extended disclosure, the court will seek to ensure that disclosure is directed towards the issues in dispute and that the scope of disclosure is not wider than is reasonable and proportionate in order to fairly resolve the issues. Parties are required to conduct a reasonable search for disclosable documents, taking into account the number of documents which may be involved, the nature and complexity of proceedings, ease and expense of document retrieval, and the significance of any document which is likely to be found. The underlying principle is one of proportionality. Disclosure is also limited to documents which are, or have been, in a party\u2019s control. The duty of disclosure is one which continues throughout the proceedings. If a party fails to disclose a document, or allow its inspection, then they may not rely on it in proceedings unless the court gives permission. In the Patents Court, disclosure will usually be limited to a window, two years either side of the earliest claimed priority date of the patent. Further, disclosure will usually be restricted to those issues in relation to which the disclosure would have real probative value. The courts do not, for example, typically order disclosure in relation to inventive step.<\/p>\n<p>Where patent infringement is in issue, the alleged infringer can (and typically does) elect to provide a confidential product and\/or process description instead of giving documentary disclosure relating to the products or processes they are alleged to infringe.<\/p>\n<p>In proceedings in the IPEC, the normal expectation is that disclosure will not be ordered. If parties wish for disclosure to be given, they will have to make out a case that it would be appropriate. Again, if an order for disclosure is granted by the court it is likely to be restricted to only some of the issues in dispute. Disclosure in the STS is also significantly curtailed and, in general, cases which require extensive disclosure will not be suitable for the STS. Under PD 57AB, each party is generally only required to disclose the documents on which it relies, together with any specific documents that another party has requested in advance of the CMC, and which the court has ordered or the parties have agreed to produce.<\/p>\n<p>Evidence Seizure<\/p>\n<p>If a party is concerned that evidence such as infringing articles may be destroyed or concealed, then they may apply for a search order. If a search order is granted it allows a party\u2019s solicitors to enter the other party\u2019s property in order to search for and seize the property specified in the order. Search orders are draconian in nature, given that they breach, albeit justifiably, private property rights. There are therefore safeguards in place to protect the interests of the party who is the subject of the order. A court, before granting a search order, will need to be satisfied:<\/p>\n<ul>\n<li>That the applicant has an extremely strong prima facie case. A prima facie case must be extremely strong since otherwise the injustice done to the respondent by the execution of the search order would not be justifiable. Any potential or actual damage would be very serious for the applicant.<\/li>\n<li>There is clear evidence that the respondent has in their possession an incriminating document or incriminating goods.<\/li>\n<li>There is a real possibility that the defendants may destroy such material before an application is made on notice.<\/li>\n<li>The harm likely to be caused by the execution of the search order will be in proportion to the legitimate object of the order.<\/li>\n<\/ul>\n<p>The applicant also has a duty to make full and frank disclosure, as is the norm in applications made without notice to the other party. A search order application should always be made without notice since to act otherwise would defeat the object of the order. A claimant may apply for a search order at any stage of proceedings, including before issue of the claim. A defendant may only apply after filing an acknowledgement of service or defence unless the court orders otherwise. In either case, the application should be made as soon as possible.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there procedures available which would assist a patentee to determine infringement of a process patent?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In patent infringement proceedings the alleged infringer will typically provide a confidential product and\/or process description instead of giving disclosure relating to the products or processes they are alleged to infringe. In the case of a process, this will set out the process being used by the alleged infringer. Section 100 Patents Act provides for a reverse burden of proof where the invention for which a patent is granted is a process for obtaining a new product. In such circumstances where that product is produced by another party, it will be taken to have been obtained by the patented process unless it can be proved that was not the case.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there established mechanisms to protect confidential information required to be disclosed\/exchanged in the course of patent litigation (e.g. confidentiality clubs)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The courts have developed rules designed to encourage parties to honour their disclosure commitments without fear that confidential information will be put at risk. The CPR state that documents which have been disclosed may only be used for the purpose of the proceedings in which they are disclosed. If disclosed documents are used for other purposes this would constitute a contempt of court. This prevents use of disclosed confidential documents for ulterior motives. Schemes, known as confidentiality clubs, may also be set up in order to supplement the protection afforded by the CPR. In a confidentiality club any documents which are confidential are identified as such and their access and use by the receiving party will be restricted. Any pleadings or documents based on documents contained in the confidentiality club will themselves become subject to the same restrictions. Ordinarily, even if documents are part of a confidentiality club, documents will cease to be confidential if they are read out or referred to in open court. However, patent judges are mindful of confidentiality issues which may arise and can keep information confidential by:<\/p>\n<ul>\n<li>Making an interim order restricting or prohibiting use of a confidential document even if it is read out or referred to in open court. This order can be made permanent at the conclusion of proceedings.<\/li>\n<li>Not stating confidential information in public, which sometimes may involve sitting in private for part of the case. A private hearing will only include members of the confidentiality club. The courts will limit private hearings to those situations where sitting in private would be absolutely necessary in order to achieve justice between the parties. The degree of privacy must be kept to a minimum and a private hearing is only likely to be ordered, for example, in circumstances where commercially valuable confidential information is in issue.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a system of post-grant opposition proceedings? If so, how does this system interact with the patent litigation system?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>No post-grant oppositions can be raised before the UK Intellectual Property Office following the grant of national patents in the UK. However, there is a nine-month window available in which to file an opposition to the grant of a European patent at the EPO. While these proceedings remain pending at the EPO, a patentee subject to a revocation action in the UK may apply for a stay of the national litigation. The law in the UK regarding the grant of stays for these reasons was revisited and recast by the Court of Appeal in <em>IPCom v HTC Co Europe<\/em> [2013] EWCA Civ 1496. One notable change in approach since then is that, if there are no other factors, a stay of the national proceedings is the default option, and it is for the party resisting the grant of the stay to show why it should not be granted. However, the factors that the court will bear in mind when deciding whether to grant a stay have remained broadly consistent including, importantly, the extent to which commercial certainty would be achieved at a considerably earlier date in the case of the national proceedings than at the EPO. The court will also take into account additional factors such as the spin-off value of UK judgments when pursuing a settlement across Europe, for example, and the risk of wasted costs if no stay is granted. However, the issue of costs will normally be outweighed by commercial factors which favour early resolution, as described above, which means that stays are not often granted unless the patentee offers undertakings that would minimise the resulting commercial uncertainty (see e.g. <em>Actavis v Pharmacia<\/em> [2014] EWHC 2265 (Pat); [2014] EWHC 2611 (Pat) where the patentee agreed to seek expedition of the parallel proceedings at the EPO, amongst other things). Whether the court will grant a stay is discretionary, and the Supreme Court has recently emphasised that this discretion is to be exercised by the Patents Court, not the Court of Appeal.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">To what extent are decisions from other fora\/jurisdictions relevant or influential, and if so, are there any particularly influential fora\/jurisdictions?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The UK courts are not bound by foreign national decisions. They may treat foreign decisions as persuasive, however, and take them into account when considering cases arising on similar or identical facts, in particular where the law is also similar. Nonetheless, the UK courts will depart from foreign decisions where they disagree with the reasoning. For example, in <em>Regeneron v Alvotech<\/em>, the Patents Court declined to follow a German decision on the SPC manufacturing waiver, aligning itself instead with decisions from the Dutch and Belgian courts. In <em>Aristo Pharma GmbH v Takeda<\/em> [2026] EWHC 2414 (Pat), the Patents Court disagreed with the German Federal Patent Court\u2019s view of the law and its nullity decision, instead upholding the validity of Takeda\u2019s SPC for lisdexamfetamine. Both of these cases are discussed in more detail under question 11 above.<\/p>\n<p>Although central revocation of the patent-in-suit by the EPO Boards of Appeal has effect <em>ex tunc<\/em> in all designated contracting states, case law of the EPO is not binding in the UK. UK courts are, however, generally encouraged to follow the case law of the EPO Boards of Appeal where a consistent approach to a particular point of law has been established. While this consistency of approach was endorsed in <em>Human Genome Sciences v Eli Lilly<\/em> [2011] UKSC 51, the extent to which it is observed in practice can and does vary.<\/p>\n<p>We have seen the UK courts consider with interest decisions from the UPC in parallel proceedings concerning the same subject-matter. However, even in circumstances where the court has ultimately come to the same conclusion as the UPC in these parallel proceedings, it has been emphasised that the UPC decision was not necessary to arrive at this conclusion (see for example <em>Samsung Bioepis UK Ltd v Alexion Pharmaceuticals Inc<\/em> [2025] EWHC 1240 (Pat)).<\/p>\n<p>Following the CJEU\u2019s ruling in Case C-339\/22 <em>BSH Hausger\u00e4te GmbH v Electrolux AB <\/em>in early 2025, we have seen both the national courts in Europe and the UPC exercise so-called \u201clong-arm\u201d jurisdiction over defendants domiciled in their respective territories to grant cross-border injunctions covering, among other countries, the UK. It will be interesting to see how the UK courts respond to these recent developments.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">How does a court determine whether it has jurisdiction to hear a patent action? And in what circumstances will a court anti-suit to preserve its jurisdiction.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The UK courts have the jurisdiction to hear matters relating to the infringement and validity of UK national patents and the UK designations of European patents. While they can, and have, in some instances been prepared to rule on the non-infringement of foreign patents (for example in <em>Actavis v Lilly<\/em> [2017] UKSC 48), they lack the jurisdiction to hear invalidity challenges relating to foreign patents. Questions of jurisdiction are largely determined according to the provisions of the Patents Act, and the common law depending on the issue in dispute. Following the end of the post-Brexit transition period, the Brussels Recast Regulation is no longer in force (subject to certain post-transition separation provisions which provide that the Brussels Recast Regulation will apply in respect of legal proceedings instituted before the end of 2020). However, the UK recently ratified the Hague Judgments Convention 2019, which came into force in the UK in 2025.<\/p>\n<p>The UK courts have the discretionary power to grant anti-suit injunctions to prevent the institution or continuation of proceedings in a foreign court where it is necessary in the interests of justice to do so. In general, they may be granted either to restrain proceedings in a foreign court where such proceedings would be in breach of an exclusive jurisdiction clause in an agreement between the parties, or where such proceedings are \u201cvexatious or oppressive\u201d (an example would be seeking to obstruct or having the effect of obstructing pending proceedings in England &amp; Wales) in circumstances where England &amp; Wales is clearly the more appropriate forum. However, the UK courts will have regard to the principles of international comity when considering whether to exercise their discretion. Recently, the Patents Court issued an anti-anti-suit injunction in <em>Amazon v InterDigital<\/em> [2025] EWHC 2708 (Pat) restraining InterDigital from pursuing certain steps in other jurisdictions, including at the UPC, which the court considered would interfere with its ability to determine final (F)RAND terms in those proceedings.\u00a0This was in response to InterDigital obtaining an \u2018anti-interim-licence injunction\u2019 from the UPC, which was intended to limit the relief that Amazon could seek in the UK (see further discussion of interim FRAND licences under question 31).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the options for alternative dispute resolution (ADR) in patent cases? Are they commonly used? Are there any mandatory ADR provisions in patent cases?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In the UK there are no rules that would fetter the parties\u2019 ability to take advantage of any method of ADR \u2013 nor are there mandatory ADR provisions in patent cases, save that the advisors to the parties do have an obligation to consider the appropriateness of ADR with their clients and with each other. In practice, in patent cases ADR is used less frequently than in other commercial disputes.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the key procedural steps that must be satisfied before a patent action can be commenced? Are there any limitation periods for commencing an action?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Generally speaking, there are no specific procedural pre-requisites to commencing an action for patent revocation or infringement in the UK. Where a person is seeking a declaration of non-infringement under section 71 Patents Act, however, a declaration may only be made if it is shown that the person seeking such a declaration has written to the patentee for a written acknowledgment to the effect of the declaration sought and provides the patentee with full particulars of the act in question. If the patentee refuses or fails to give any such acknowledgment, a declaration may then be sought. A patent action is commenced when a claim form is issued. The Limitation Act 1980 provides a defence to an alleged infringer in respect of acts committed six years before the claim form is issued.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which parties have standing to bring a patent infringement action? Under which circumstances will a patent licensee have standing to bring an action?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Section 61 Patents Act provides that an infringement claim may be brought by a patentee. If there are multiple owners, then a claim may be brought by just one of them without the need for the consent of their co-owners. In that scenario, section 66 Patents Act requires that the co-owners must be joined as defendants to the action, although they would not be liable for costs unless they take part in those proceedings.<\/p>\n<p>Under section 67 Patents Act an exclusive licensee has the same rights as the patentee to bring proceedings for infringement after the date of the licence. If an exclusive licensee brings a claim but the patentee does not consent to being joined as a claimant, they must be joined as a nominal defendant, although the patentee would not be liable for costs unless they take part in those proceedings. It is worth noting that an \u201cexclusive licence\u201d has a particular meaning under the Patents Act, namely a licence which confers the right upon the licensee to work the relevant invention to the exclusion of all other persons, including the patentee themselves.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Who has standing to bring an invalidity action against a patent? Is any particular connection to the patentee or patent required?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Under section 72 Patents Act \u201cany person\u201d can bring an action to revoke a patent. There is no need for that person to have been sued for infringement (or under threat of an infringement action) before commencing a revocation action or to otherwise establish standing. Where the revocation of a patent is sought on the basis that the patent was granted to a person not entitled to be granted the patent (section 72(1)(b) Patents Act), however, the requirements are different. In addition to a time constraint on bringing these proceedings, section 72(2) Patents Act provides that such an action may only be commenced by a person who has already satisfied the UK court (or Comptroller) that they should be entitled to be granted that patent, or a part of the matter comprised in the specification.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are interim injunctions available in patent litigation proceedings?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Preliminary (interim) injunctions are available. The UK courts have jurisdiction to grant an interim injunction where it is just and convenient to do so, but they are an equitable (i.e. discretionary) remedy. An interim injunction will be granted by the court if the conditions as laid down in <em>American Cyanamid v Ethicon<\/em> [1975] AC 396 are satisfied. This is a four-stage test, under which the court will consider in turn:<\/p>\n<ol>\n<li>Whether there is a serious issue to be tried. This is not usually a high hurdle for an applicant seeking a preliminary injunction to overcome. They need only show that they have an arguable case which is not frivolous or vexatious.<\/li>\n<li>Whether damages would not be an adequate remedy for the applicant. Merely showing loss of sales is not ordinarily enough since such loss can be remedied financially. The applicant must instead demonstrate some kind of intangible or unquantifiable harm which has been or may be caused. Several decisions in recent years in the life sciences sector have highlighted that the evidential burden on the patentee to demonstrate such irrecoverable and unquantifiable losses is substantial (see e.g. <em>Neurim and Anor v Generics (UK) and Anor<\/em> [2020] EWHC 1362 (Pat); [2020] EWCA Civ 793) and <em>Novartis and Anor v Teva and Ors<\/em> [2022] EWHC 959 (Ch)).<\/li>\n<li>Whether damages (on a cross-undertaking in damages given by the patentee) would be an adequate remedy for the defendant.<\/li>\n<li>Where the \u201cbalance of convenience\u201d lies, if there is doubt as to the adequacy of damages for either side.<\/li>\n<\/ol>\n<p>Factors which the court will use to determine whether the balance of convenience lies in favour of granting or dismissing the application for a preliminary injunction will vary from case to case, but can include the extent to which the defendant could and should have sought to \u201cclear the way\u201d (by proactively bringing a revocation action in respect of the relevant patent or seeking a declaration of non-infringement in respect of their product). This can be particularly relevant in life sciences cases. If all matters seem balanced, the court will attempt to preserve the <em>status quo<\/em>. This was seen in practice in a decision handed down last year, where an interim injunction was granted after the UK Court of Appeal concluded that there was real doubt as to the adequacy of damages for either side, but overall the balance of convenience favoured the grant of the injunction and preservation of the status quo (<em>AstraZeneca AB &amp; Anor v Glenmark Pharmaceuticals Europe Ltd<\/em> [2025] EWCA Civ 480).<\/p>\n<p>In urgent cases an application for an interim injunction may be made without notice. If making a without notice application, the applicant has a duty of full and frank disclosure.<\/p>\n<p>Recently, we have seen confirmation from the UK courts that, where an injunction has been wrongly granted, damages under a cross-undertaking are compensatory in nature, and an account of profits is not available as a remedy (<em>Sandoz AG &amp; Ors v Bayer Intellectual Property GmbH &amp; Ors<\/em> [2025] EWHC 2201 (Pat); [2025] EWHC 2533 (Pat)).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What final remedies, both monetary and non-monetary, are available for patent infringement? Of these, which are most commonly sought and which are typically ordered?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The UK courts have a number of remedies available following a finding of patent infringement. These include:<\/p>\n<ul>\n<li>Injunctions to restrain further patent infringement. A finding of actual infringement is normally considered by the court to be enough to evidence a threat of further infringement.<\/li>\n<li>Damages are awarded so as to put the patentee in the position they would have been in but for the infringement, so long as the loss that is alleged was foreseeable and caused by the infringement. The court may also award interest on damages.<\/li>\n<li>An account of profits, as an alternative to damages. The successful claimant may choose between damages or an account of profits.<\/li>\n<li>An order for delivery up or destruction of the infringing articles. The claimant may choose between these remedies.<\/li>\n<li>An order for the circulation or dissemination of the court\u2019s judgment. This is done at the expense of the unsuccessful party. However, this order is not necessarily made. For example in <em>Regeneron Pharmaceuticals, Inc v Kymab Ltd &amp; Anor<\/em> [2018] EWCA Civ 1186 it was held that publication of the judgment would serve no proper purpose. The Court of Appeal took the view that, given the subject-matter of the dispute (transgenic mice), the relevant public was so specialised and relatively small it was highly unlikely that they would not already be aware of the judgment and its effect.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">On what basis are damages for patent infringement calculated? Is it possible to obtain additional or exemplary damages?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>As outlined above, the successful claimant may choose between seeking damages and an account of profits. This election is made after the trial on the merits of the case in a separate damages enquiry. As also stated above, damages are awarded so as to put the patentee in the position they would have been in but for the infringement, so long as the loss that is alleged was foreseeable and caused by the infringement. Where the patentee does not have a product of its own on the market and is not in a position to demonstrate its loss, the UK courts tend to determine damages on a reasonable royalty basis. The notional royalty rate to be determined by the court would typically be that which a potential licensee would pay.<\/p>\n<p>It is not possible to obtain exemplary or punitive damages in the UK. \u201cSpringboard\u201d damages may be available, however, if the infringer has given themselves a head start in the market after patent expiry.<\/p>\n<p>The Court of Appeal recently clarified in <em>Lufthansa v Astronics<\/em> [2026] EWCA Civ 964 that, where a patentee elects for an account of profits, it must prove both factual causation and legal causation. Where profits were generated by multiple causes, legal causation involves distinguishing between those causes, with apportionment being an established tool for this purpose.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">How readily are final injunctions granted in patent litigation proceedings?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Final injunctions are readily granted but they are, like preliminary injunctions, an equitable (discretionary) remedy rather than available as of right. The UK courts should only grant an injunction where it is \u201c<em>just and convenient to do so<\/em>\u201d, so the grant or otherwise of a final injunction will ultimately depend on the particular facts of the case. While an injunction is a discretionary remedy, the court must also assess whether the grant of an injunction is proportionate.<\/p>\n<p>In exercising its discretion, the courts are willing to consider the impact of public interest factors, such as patient health, to justify the refusal of, or a carve-out from, a final injunction. Based on the case law to date, however, the discretion of a judge to refuse (or qualify) an injunction is used sparingly and public interest factors are only likely to be engaged in the context of treatments for serious, perhaps only life-threatening, conditions. In <em>Evalve v Edwards Lifesciences <\/em>[2020] EWHC 513 (Pat), for example, the judge was prepared to carve-out from the scope of the final injunction the treatment of certain patients with the allegedly infringing medical device, but only in circumstances where the patentee\u2019s own device had already been tried on these patients and was unsuccessful.<\/p>\n<p>The court will receive evidence from the parties at a \u201cForm of Order\u201d hearing and also consider the precise wording of an injunction in the event that one is granted. In the event that such an injunction is not granted, then the court will exercise its discretion to ensure that another suitable remedy (e.g. damages) is considered to be appropriate. Where life-saving treatments are involved, patentees have themselves elected not to pursue injunctive relief at all. For example, in <em>Merck Sharp &amp; Dohme v Ono Pharmaceutical Co<\/em> [2015] EWHC 2973 (Pat) the patentee indicated that, even if it succeeded on infringement at trial, it would not seek an injunction provided that an appropriate royalty was agreed between the parties or awarded by the court.<\/p>\n<p>Where a SEP is subject to a FRAND undertaking, this can affect the remedies available to the patentee for infringement, including the availability of injunctive relief. A \u2018FRAND injunction\u2019 may be granted where an implementer is found to infringe a SEP: the injunction takes the normal form to restrain infringement of the relevant patent, but includes a proviso that it will cease to have effect if the defendant enters into a FRAND licence that has been settled by the court.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there provisions for obtaining declaratory relief, and if so, what are the legal and procedural requirements for obtaining such relief?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In the UK a person may request a declaration of non-infringement under section 71 Patents Act or the court\u2019s inherent jurisdiction. Under statute, someone who is doing an act or intending to do a certain act may seek a declaration from the court that the act would not infringe a specified UK patent. Section 71 therefore covers hypothetical acts. The party seeking a declaration must set out particulars of the act and the relevant patent. They must also first write to the patentee, seeking acknowledgement to the effect of the declaration sought. If the patentee refuses to give acknowledgement, the applicant may seek a declaration. In order to be granted a declaration under the court\u2019s inherent jurisdiction, the applicant must show that the declaration would serve a useful purpose. Normally they must show they have a real commercial interest in knowing whether an act would infringe.<\/p>\n<p>Arrow declarations are available in the UK and have been the subject of recent case law. Arrow declarations are in essence a declaration that a person\u2019s product or a process that they have used was obvious at the filing or priority date. If the subject matter of the declaration sought is obvious, it cannot infringe the relevant patent. The conditions under which an Arrow declaration may be granted will be assessed in detail by the court and particular scrutiny will be given to the extent to which the grant of such a declaration will serve a useful purpose. The full list of points to be considered by the court when exercising its discretion is as follows: justice to the claimant; justice to the defendant; whether the declaration will serve a useful purpose; and whether or not there are any other special reasons why the court should or should not grant the declaration.<\/p>\n<p>The UK is still one of only a few jurisdictions around Europe that has granted such declarations. The fact that the Patents Court has shown that it is willing in certain circumstances to grant Arrow declarations and assist litigants in obtaining commercial certainty in this way is continuing to attract yet further litigation, as companies seek to test the boundaries and the circumstances in which the courts will be prepared to exercise their discretion. For example, in <em>Sandoz AG &amp; Ors v Biogen MA Inc<\/em> [2024] EWHC 2567 (Pat), the claimant essentially sought a declaration that a PCT application did not disclose an <em>in vitro<\/em> assay clearly enough and completely enough for the skilled person to perform it in order to determine the risk of a patient developing a particular disease. Although characterised by the claimant as \u201cArrow\u201d relief, this was disputed by the defendant. Ultimately the court declined to grant the declaration sought, as the court held that it effectively amounted to a declaration of insufficiency and hence that the PCT could not give rise to a valid patent, which risked usurping the function of the EPO.<\/p>\n<p>The requirement that such declarations must serve a \u201cuseful purpose\u201d is strictly applied. For example, a recent decision from the UK Court of Appeal emphasised that, where there are no remaining patent rights covering the UK and hence no commercial uncertainty in the UK, it will be difficult to persuade the court to grant an Arrow declaration in this scenario. In particular, the potential \u201cspin off\u201d value of such a declaration for use in foreign courts was held not to be a legitimate reason to grant declaratory relief under these circumstances (<em>Teva UK Ltd &amp; Anor v Novartis AG<\/em> [2022] EWCA Civ 1617). The requirement that the declaration must serve a \u201cuseful purpose\u201d was subsequently underlined in <em>Philip Morris Products SA &amp; Anor v Nicoventures Trading Ltd &amp; Anor<\/em> [2023] EWHC 2616 (Pat), where it was held that the Arrow declaration sought had not been formulated with sufficient clarity and was therefore refused.<\/p>\n<p>Declarations relating to an interim FRAND licence are discussed under question 31 below.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the costs typically incurred by each party to patent litigation proceedings at first instance? What are the typical costs of an appeal at each appellate level?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The costs in UK actions can vary considerably, depending on the forum, the number of patents in a case, the complexity of the issues involved, the length of the trial, the extent of disclosure, the number of experts and the way the litigation is conducted \u2013 for example, costs might be significantly higher for cases involving multiple parties or additional causes of action, or which require extensive witness and expert evidence. First instance costs in the IPEC might vary from a minimum of \u00a3100,000 to \u00a3500,000 or more, and in the Patents Court from around one up to several million pounds. Appeal costs again vary, but would generally be expected to range from \u00a3500,000 to \u00a31,000,000, depending on the number and complexity of issues under appeal.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Can the successful party to a patent litigation action recover its costs?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Under the CPR the general principle is that the losing party will pay the winner\u2019s costs, in a proportion that takes into account how successful the winning party was at trial and on which issues. A party who has been successful on all issues raised may typically expect to recover in the region of 70-80% of their costs, or even higher in some cases. When determining what type of costs order to make the UK courts will also take into account factors such as the parties\u2019 conduct, money paid into court, and any offers to settle which have been made. When considering a party\u2019s conduct the court will consider whether it was reasonable for a party to raise, pursue or contest a particular issue, as well as the manner in which the party contested that issue. For example, a successful party who exaggerated their claim or unreasonably pursued a point they knew to be weak, is likely to receive a lower proportion of their costs.<\/p>\n<p>Costs recovery is capped in the IPEC, and proceedings issued in the STS in the Patents Court are subject to the costs capping pilot scheme described under question 2 above. Otherwise, costs recovery is not generally capped in the Patents Court.<\/p>\n<p>Costs will be awarded, at the court\u2019s discretion, on either the standard basis or the indemnity basis. Costs will not be allowed if they were unreasonably incurred or are unreasonable in amount. If costs are assessed on the standard basis they must also have been proportionate. Any doubts as to proportionality or reasonableness of costs when assessed on the standard basis will be resolved in favour of the paying party. For indemnity costs, any doubts as to reasonableness will be resolved in favour of the receiving party.<\/p>\n<p>Where the court orders a party to pay costs subject to detailed assessment, it will order that party to pay a reasonable sum on account of costs unless there is good reason not to do so (CPR 44.2(8)). This is typically dealt with at the form of order hearing following judgment.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the biggest patent litigation growth areas in your jurisdiction in terms of industry sector?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Patents Court has continued to see a mix of industry sectors represented at trial, the most prevalent sectors being pharmaceuticals, biotechnology, telecoms and medical devices. Based on the parties named in the current court list we see no indication that this balance of technology areas is likely to change in the coming year.<\/p>\n<p>Overall, the number of cases we are seeing in the Patents Court is broadly consistent, and at the time of writing (October 2026) the number of cases is approximately the same in 2026 as it was at the equivalent point in 2024 and 2025. \u00a0As noted above, we are now seeing many disputes running in parallel in the UPC and before the UK courts.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What do you predict will be the most contentious patent litigation issues in your jurisdiction over the next twelve months?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Supreme Court\u2019s decision in <em>Unwired Planet v Huawei<\/em> [2020] UKSC 37 indicated that the UK courts are ready and willing to determine global FRAND disputes, and the UK continues to see high numbers of patent cases involving SEPs and FRAND issues. Following the recent Supreme Court decision accepting jurisdiction over a dispute as to whether the licensing rates offered by a patent pool are FRAND (<em>Tesla v InterDigital <\/em>[2026] UKSC 27), we can expect to see more cases of implementers proactively bringing proceedings in England and Wales to challenge SEP platform or pool licensing rates.<\/p>\n<p>We also anticipate that there will be further evolution of the UK&#8217;s interim FRAND licence jurisprudence. Decisions of the Court of Appeal in <em>Panasonic v Xiaomi<\/em> [2024] EWCA Civ 1143 and <em>Lenovo v Ericsson<\/em> [2025] EWCA Civ 182 established that the UK courts may grant a declaration that willing licensors\/licensees would enter into an interim licence pending a final FRAND determination (and may set the terms of that interim licence on a broad-brush, mid-point basis). Such declarations are intended to preserve the position of the parties while FRAND rate determination proceedings are pending, including where one party seeks injunctive relief in another jurisdiction. As noted above under question 18, this jurisprudence has led to emerging jurisdictional conflict with other fora, such as the UPC, where patentees may pursue enforcement proceedings in parallel with UK proceedings.<\/p>\n<p>In the life sciences sector, the concept of plausibility continues to be a contentious issue in UK patent cases. The UK courts continue to apply the plausibility standard set by the Supreme Court in <em>Warner Lambert v Generics (UK) Ltd <\/em>[2018] UKSC 56. Decisions from the Court of Appeal in <em>Sandoz and Teva v BMS<\/em> [2023] EWCA Civ 472 (considering for the first time in the UK the decision of the Enlarged Board of Appeal in <em>G 2\/21<\/em>), and <em>Generics (UK) Ltd &amp; Ors v AstraZeneca AB<\/em> [2025] EWCA Civ 903 held patents invalid for failing to meet the <em>Warner Lambert <\/em>threshold. However, the most recent UK judgment on plausibility, <em>Accord v Novartis<\/em> [2026] EWHC 2127 (Pat), upheld the validity of the patent and SPC protecting Novartis&#8217;s Entresto product, finding that the disclosure of the patent met the &#8220;<em>modest standard for plausibility<\/em>&#8221; without the inclusion of \u201c<em>numerical results<\/em>\u201d.<\/p>\n<p>There have also been further recent and notable decisions relating to the grant of preliminary injunctions in life sciences cases. Following the <em>Neurim <\/em>series of cases we have seen a number of other decisions which evaluate the <em>American Cyanamid<\/em> principles (see question 23) in the context of different factual scenarios in the life sciences sector (see for example <em>Bayer Intellectual Property GmbH &amp; Ors v Aspire Pharma Ltd &amp; Ors<\/em> [2024] EWHC 711 (Pat), <em>AstraZeneca AB &amp; Anor v Glenmark Pharmaceuticals Europe Ltd<\/em> [2025] EWCA Civ 480 and <em>Dr Reddy&#8217;s v Boehringer Ingelheim<\/em> [2025] EWHC 2834 (Pat)). Interestingly, in the case of <em>Novartis and Anor v Teva and Ors<\/em> [2022] EWHC 959 (Ch), the Court held that it had jurisdiction to grant an interim injunction before the relevant patent had been granted, although it declined to do so in this particular case.<\/p>\n<p>The UK approach to software and AI inventions has been fundamentally reshaped by the recent Supreme Court decision in <em>Emotional Perception <\/em><em>v <\/em><em>Comptroller-General of Patents <\/em>[2026] UKSC 3. For the past 20 years, the UK has used the <em>Aerotel<\/em> test to assess patent eligibility and whether a claim falls within the statutory exclusion to patentability. In a significant departure, the Supreme Court ruled that the <em>Aerotel<\/em> approach should be replaced by the \u201c<em>any hardware<\/em>\u201d approach of the EPO set out by the Enlarged Board in G 1\/19, under which claims containing at least one hardware feature, such as a computer processor, are not excluded from patentability. Following <em>Emotional Perception<\/em>, the UK courts must also follow the EPO\u2019s approach to excluded subject matter when assessing inventive step.\u00a0It will be for the UKIPO and UK courts to determine how to implement this new approach in combination with the UK\u2019s existing test for inventive step set out in <em>Pozzoli<\/em>.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the biggest challenges and opportunities confronting the international patent system?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p><em>The UPC<\/em><\/p>\n<p>In Europe, the advent of the UPC is leading to a more consistent approach to validity and enforcement across UPC member states. At the time of writing, the UPC has been open for over three years and over 1200 cases have been filed, with more than 400 appeals\/requests reaching the Court of Appeal. Caseload numbers have continued to grow year on year, as the UPC has attracted users with its streamlined procedures and high-quality decisions. Engagement with the UPC across all sectors, including the pharma and biotechnology industries, appears to be high. Nearly half of all preliminary injunction proceedings that have been decided concerned the healthcare sector.<\/p>\n<p>The UPC Court of Appeal in Luxembourg has now handed down a body of guidance on key procedural and substantive issues, including claim construction, the grant of preliminary injunctions, the UPC\u2019s approach to added matter and inventive step, and the exercise of the UPC\u2019s long-arm jurisdiction (following the CJEU\u2019s decision in <em>BSH Hausger\u00e4te<\/em>).<\/p>\n<p>Outcomes have so far been fairly evenly balanced. At first instance, patentees have succeeded on the merits in roughly half of all infringement actions. Where a counterclaim for revocation has been brought, around 75% of patents have been upheld, either as granted or in amended form. Of the preliminary injunction applications decided at first instance, just over half have succeeded. On appeal, around half of the first instance decisions considered to date have been overturned. Even so, patentees\u2019 overall success rates in preliminary injunction and merits proceedings remain broadly similar once appeals are taken into account.<\/p>\n<p>As the UK sits outside the UPC, parallel UK and UPC proceedings are now common, and the interaction between the two systems (including the UPC\u2019s willingness to grant relief covering the UK, discussed under question 17) will be a defining feature of European patent litigation in the coming years.<\/p>\n<p><em>EU Pharma Package<\/em><\/p>\n<p>The next couple of years will bring major changes for the European life sciences sector, as the EU Pharma Package regulatory reform (comprising a new Pharmaceutical Directive and Regulation, the compromise text of which was published in March 2026) reshapes the regulatory landscape in Europe. Formal adoption of this legislation is expected in late 2026, with full application anticipated two years later, in late 2028.<\/p>\n<p>Changes to the length and scope of regulatory protection available (including e.g. the reduced period of automatic market protection from two years to one year) will enhance the importance of patent and SPC protection for innovators and may impact on future litigation strategies. The package also substantially broadens and harmonises the Bolar-like exemption: these changes are likely to narrow the type of pre-launch activities on which patentees can secure injunctive relief at the UPC and before the national courts in Europe.<\/p>\n<p><em>FRAND\/SEP Disputes <\/em><\/p>\n<p>In the technology sector, competition between fora in global FRAND\/SEP disputes continues to present a risk of jurisdictional conflict and inconsistent outcomes. As noted under question 18, there has recently been friction between the UK courts hearing FRAND rate determination claims and jurisdictions where SEP holders are seeking to enforce their rights, including the UPC and Germany. This has led the different courts to issue conflicting anti-suit-type injunctions. We have also seen SEP owners seeking injunctive or exclusionary relief in jurisdictions such as Brazil, Colombia, India (in the Delhi High Court) and the US International Trade Commission. The risk of divergent outcomes is illustrated by <em>Samsung v ZTE<\/em>, in which the UK courts, the Chongqing Intermediate People&#8217;s Court in China, the Munich I Regional Court in Germany and the UPC\u2019s Mannheim Local Division arrived at different FRAND rates and settlement proposals.<\/p>\n<p>Going forward, we may see de-escalation through appellate guidance and consideration of international comity, or perhaps due to greater use of arbitration in FRAND disputes (for example, in the UPC\u2019s Patent Mediation and Arbitration Centre). In <em>Acer Incorporated &amp; Ors v Nokia Technologies Oy<\/em> [2026] EWCA Civ 564, the English Court of Appeal endorsed arbitration as an acceptable means of dispute resolution for resolving global FRAND disputes, where arbitration is sought by the SEP owner. In another notable development, China withdrew its policy of issuing anti-suit injunctions in SEP disputes (reported in April 2026), after a WTO ruling found the measures breached global IP rules.<\/p>\n<p><em>AI<\/em><\/p>\n<p>Finally, a further set of challenges, cutting across sectors, arises from the growing use of AI in research and development and the way the global patent system is responding to this.<\/p>\n<p>Following the DABUS test case brought by Dr Thaler in the UK, it is settled that an AI system cannot be named as an inventor, as an inventor must be a\u00a0natural person (<em>Thaler v Comptroller-General of Patents, Designs and Trade Marks<\/em> [2023] UKSC 49). This ruling is consistent with the outcome of the DABUS litigation in most other major jurisdictions. However, this leaves open the question of whether, and to whom, patents may be granted for inventions generated with substantial AI involvement.<\/p>\n<p>The UK\u2019s alignment with the EPO\u2019s approach to excluded subject matter in <em>Emotional Perception<\/em> (see question 31) promotes alignment on patentability, though the impact of AI on the assessment of inventive step remains unresolved. In particular, as AI tools become increasingly part of the skilled person&#8217;s ordinary toolkit, courts and patent offices will need to consider whether this raises the bar for inventiveness, and what the skilled person&#8217;s common general knowledge should include. Divergent answers to these questions in different jurisdictions could result in inconsistent outcomes, highlighting the need for close cooperation between the leading patent jurisdictions on these issues.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">12647<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/www.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/153754","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/www.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/www.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=153754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}