1 Our regular Patent and Pharma update aims to keep you informed of recent developments in United Kingdom and European law relating to patents and the pharmaceutical industry. 1. Developments in the Doctrine of Equivalents Fisher and Paykel Healthcare Ltd v ResMed Ltd  EWHC 2748 Regeneron Pharmaceuticals Inc v Kymab Ltd  EWCA Civ 671 L’Oréal Société Anonyme v RN Ventures Ltd  EWHC 173 Since Actavis v Lilly transformed the UK’s approach to patent infringement, there have been only a handful of cases which have grappled with the new three-step equivalents test. This article briefly outlines the developments in the law since our last update. While these cases do not introduce any substantive developments, there are some interesting obiter dicta which provide insight into how the new equivalents law might develop or be limited in the future. In Fisher and Paykel Healthcare Ltd v ResMed Ltd  EWHC 2748, Mr Richard Meade QC sitting as Deputy Judge of the High Court held that, when interpreting claim scope, you must first determine the normal meaning of the claims (applying purposive claim interpretation) and only move on to the threequestion Actavis test if the variant is not within the normal meaning. In this case, Mr Meade QC found on proper purposive interpretation that the prior art anticipated the relevant patent claims, which made it unnecessary to consider anticipation by equivalence. However he stated obiter that the same logic which led to this finding would also lead to anticipation by equivalence, if the law permitted it (though he does note that in Generics v Yeda  EWHC 2629 (Pat), Arnold J expressed the view that there cannot be anticipation by equivalence as a matter of law). In L’Oréal v RN Ventures Carr J was asked to decide whether L’Oréal’s European patent for an electronic facial skin care device was infringed by RN Ventures’ pore-cleansing devices. As an alternative to direct infringement, L’Oréal argued that the patent was infringed because the “shear” mode of action (which was used by the defendant’s pore-cleansing device) was equivalent to the tension/compression mode of action claimed. In order to defend itself, RN Ventures relied on the German doctrine of ‘deliberate selection’. It argued that there is no patent infringement by equivalence if the description discloses several possibilities as to how a technical effect can be achieved, but only one of those possibilities is included within the claims of the patent. L’Oréal submitted that this approach was not adopted by the Supreme Court in Actavis v Lilly and should not be followed. Carr J found that the “shear” mode of action falls within the scope of the claims, so RN Ventures’ products infringed L’Oréal’s patent applying the normal claim interpretation. However when considering equivalents (obiter), Carr J noted that L’Oréal chose to exclude the “shear” mode from the claims and that “the skilled person would have assumed he intended to do so, possibly in the light of prior art cited during the course of prosecution”. Accordingly, Carr J would have concluded that it was not an equivalent, PATENT AND PHARMA UPDATE JULY 2018 London Table of contents 1. Developments in the Doctrine of Equivalents 1 2. SPC update 2 3. Do the English Courts have jurisdiction to hear applications for a DNI for non-UK designations of a patent? 3 4. Damages v account of profits and carved-out preliminary injunction – Edwards Lifesciences v Boston 3 5. The Court rejects jurisdictional challenge to determine a global FRAND licence 5 6. Unified Patent Court – where are we? 6 7. Brexit and IP 6 8. Table of Recent UK Court Decisions on patents 9 9. Contacts 21 Related links IP at Herbert Smith Freehills Previous Patent and Pharma update (November 2017) Our dedicated UPC and UP hub Our IP blog Our Brexit Hub PATENT AND PHARMA UPDATE 2 but he reaches no conclusion as to whether this German doctrine should be applied generally to equivalents in the UK, given there was no need to do so. Carr J clarifies that his “conclusion on equivalents is based upon a consideration of the specification of the Patent in this case, and does not establish any wider proposition”. In Regeneron Pharmaceuticals Inc v Kymab, the Court of Appeal heard limited arguments on infringement by equivalents. Infringement was found as a matter of normal interpretation, and so the Court did not consider the Actavis v Lilly test. However, the Court did set out the test as being a matter of considering, first, the normal claim interpretation and, second, considering equivalents. It will be interesting to see whether the statements made in obiter dicta will result in tangible developments to the test for infringement by equivalents in the UK. Emma Sherratt, Associate (New Zealand) 2. SPC update Sandoz Ltd & Anor v G.D. Searle LLC & Anor  EWCA Civ 49 Opinion of Advocate General Wathelet, Case C-121/17 Teva v Gilead (25 April 2018) In our last Patent and Pharma update we reported on the three pending references to the CJEU in relation to the SPC Regulation; two references regarding the interpretation of Article 3(a) and one regarding Article 3(d). Since these references, there have been two key developments concerning Article 3(a) of the SPC Regulation: firstly, an additional reference on Article 3(a) has been made by the English Court of Appeal to the CJEU, and secondly, in the case of Teva v Gilead (C-121/17), the Advocate General has issued his preliminary opinion to the CJEU on the interpretation of Article 3(a). In its decision in Sandoz v Searle  EWCA Civ 49, the Court of Appeal essentially asks what the correct test is for determining whether a “product” is protected by a patent in accordance with Article 3(a) in the case of a claim containing a Markush formula that defines a class of compounds. We reported on the first instance decision here, and even though the first instance judge considered the SPC to be valid no matter what the correct test for Article 3(a) was, the matter was not so clear to the Court of Appeal. The Court of Appeal has asked the CJEU: “where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?” In C-121/17 (Teva v Gilead), Advocate General Wathelet (the “AG”) provided his opinion on the interpretation of Article 3(a) of the SPC Regulation (reported here). The AG rejected the suggestion of the English referring court that the concept of the “core inventive advance” was a relevant consideration in determining whether a “basic patent” protects an active ingredient (ie product) within the meaning of Article 3(a). Instead, the AG concluded that a “product” is protected by a patent in accordance with Article 3(a) of the SPC Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. The AG’s rejection of the “core inventive advance” test is in contrast to the approach recommended by the Max Planck Institute for Innovation and Competition, which in May 2018 published a Study on the Legal Aspects of Supplementary Protection Certificates in the EU that suggested adopting such a test. It will be interesting to see how the CJEU decides C-121/17 and whether the decision in that case will be broad enough to dispose of the other pending references on Article 3(a). SPC developments from the European Commission Another recent development, this time Brexit-related, in the area of SPCs was the publication by European Commission in April 2018 of a notice to stakeholders discussing consequences arising from the withdrawal of the UK from Europe. As of the withdrawal date, the SPC Regulation will no longer apply to the UK and, as a result of this, an authorisation to place a product on the market granted by a UK competent authority will not be considered a first authorisation to place the product on the market in the EU for the purposes of the SPC Regulation. On 28 May 2018 the European Commission announced its proposal for an SPC export manufacturing waiver (reported here). The waiver would allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the PATENT AND PHARMA UPDATE 3 term of the certificate if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. The SPC-protected medicine will retain full market exclusivity in Europe. The proposal raises interesting questions regarding the ability of SPC holders to effectively police the compliance of manufacturers with the mandatory labelling and notification requirements. Alex Freelove, Senior Associate 3. Do the English Courts have jurisdiction to hear applications for a DNI for non-UK designations of a patent? Eli Lilly & Co & Ors v Genentech Inc  EWHC 3104 (Pat) Eli Lilly & Co v Genentech Inc  EWHC 75 (Pat) In December last year, the High Court refused Genentech’s application to set aside claims for declarations of non-infringement (“DNIs”) for non-UK designations of its European patent. Early this year, the Court accepted an undertaking from Genentech that it would bring infringement proceedings relating to the non-UK designations, and has ordered Lilly to clarify its position with regards to validity. Eli Lilly & Co & Ors v Genentech Inc  EWHC 3104 (Pat) The dispute concerns Lilly’s monoclonal antibody product Taltz (ixekizumab), designed to treat psoriasis. Lilly claimed a DNI for its Taltz product and a revocation of the UK designation of Genentech’s patent. Lilly also sought DNIs in relation to French, German, Spanish, Italian and Irish designations of Genentech’s patent (referred to as the “Related Claims” involving the “Related Patents”). Lilly was granted leave to serve proceedings regarding the Related Claims on Genentech out of jurisdiction relying on service gateway in PD6B §3.1(4A), arguing that the Related Claims arose out of the same or closely connected facts as the DNI for the UK designation. Genentech applied to set aside this service on the three grounds listed below, but the application was refused. Ground 1: Genentech challenged the Court’s jurisdiction to serve out under PD6B §3.1(4A). The Court disagreed and held that there was a sufficiently ‘close’ connection between the first “anchor” claim and the Related Claims. It made practical sense to try the claims together as they involved common issues of fact and the defendant was already properly subject to the Court’s jurisdiction. Ground 2: Genentech also argued that the English court was required to cede jurisdiction under Art 24(4) of the recast Brussels I Regulation, as the proceedings involving the Related Patents were “concerned with” the validity of the non-UK patents and could only be heard in the relevant Member States. The Court again disagreed, saying that the challenge to the validity of the UK designation was not, in form or substance, a challenge to the validity of the foreign designations. The Court was free to decide questions of infringement of foreign designations of a European patent. However, if it became clear that validity of the Related Patents would be put in issue, for example if Genentech counterclaimed for infringement of the Related Patents in response to which Lilly would claim invalidity, Article 24(4) would be engaged and the Court would have to decline jurisdiction. At this point there was sufficient uncertainty for the High Court to proceed. Ground 3: Finally, the Court held that England was the appropriate forum to hear the dispute in this instance. Eli Lilly and Co v Genentech Inc  EWHC 75 (Pat) Following the 2017 decision, Birss J accepted an undertaking offered by Genentech that they would counterclaim for infringement of the Related Patents. This made it reasonably arguable that Lilly might challenge validity in response. As such, Birss J set a date by which Lilly would have to decide whether or not it wished to retain the ability to challenge the validity of the Related Patents, in the UK or abroad, during the pendency of the English proceedings at first instance. To proceed with the Related Claims in the UK, Lilly would have to give an undertaking that it would not challenge validity. Comment Following on from Actavis v Lilly, this case further signals the shift by the English Courts to hear and determine cross-border patent cases in certain situations and, in particular, to decide questions of infringement regarding other European designations of a UK patent-in-suit. However, in line with Article 24(4), the Court will not consider the validity of non-UK designations. If it becomes likely that validity may be put in issue, following Actavis and Eli Lilly v Genentech, it appears that the Court will require certainty from the parties (eg in the form of an undertaking) that validity will not be put in issue for the UK proceedings to continue. Natasha Daniell, Associate 4. Damages v account of profits and carved-out preliminary injunction – Edwards Lifesciences v Boston Edwards Lifesciences LLC v Boston Scientific  EWHC 664 (Pat) PATENT AND PHARMA UPDATE 4 Edwards Lifesciences LLC v Boston Scientific  EWHC 1256 (Pat) In an interim judgment on quantum, HHJ Hacon refused the claimant to advance its case on an account of profits and inquiry into damages in parallel. In the further instalment of the dispute, Arnold J decided the terms on the final injunction in the matter allowing for a 12-month stay of the injunction and a carve-out in respect of a group of patients for whom no alternative treatment was available. Background The main proceedings concerned Boston’s heart valve patents, with Edwards claiming revocation and Boston counterclaiming for infringement. In the first instance decision, HHJ Hacon found one of Boston’s patents valid and infringed and Boston’s other allegedly infringed patent invalid ( EWHC 405 (Pat)). The appeal ( EWCA Civ 673) has since been dismissed. Quantum dispute Boston became aware in the first instance proceedings that the infringing Edwards entities had transferred a substantial part of their profits derived from the infringement into other group companies which were not party to the proceedings. One of those companies was a Singaporean entity and the other was a US entity. Boston sought permission to advance three alternative cases on the quantum at trial, in default of which it sought permission to have a trial on a preliminary issue of the deductibility of transfer pricing for the purpose of an account of profits. The three alternative cases were as follows: • Boston is entitled to an account of profits of all the Edwards entities to whom UK profits from the infringing activities had flowed – including the Singaporean and US entity. • Boston is entitled to an account of profits from the original infringing parties, and from the US and Singaporean entities as joint tortfeasors. • In the alternative, Boston is entitled to claim damages (based on the level of royalties payable under a hypothetical armslength licence agreement). Edwards opposed Boston’s running its third case, arguing that the law was intended to allow for a claimant’s informed election between an action for damages or an account of profits, but not to give it certainty as to the relative benefits of either choice. It also submitted that the added costs from running a joint inquiry into damages and account of profits would amount to a sum between £1.25 million and £1.5 million. HHJ Hacon held that the question was one of case management and that an order of parallel inquiry into damages and account of profits would only be appropriate in very unusual circumstances. The judge placed weight on the fact that running both enquiries in parallel would add significantly to the costs and the time taken by the court and reiterated that there is always an inherent risk in electing to take an account of profits. That risk is somewhat reduced by the patentee’s ability to seek certain financial information from the infringer before the election needs to be made but, ultimately, it is the patentee that bears the risk. HHJ Hacon refused a trial of a preliminary issue proposed by Boston, namely, whether transfer pricing or profit shifting within a group of companies comprises a legitimate deduction for the purpose of an account of profits, because it would increase costs and delay the proceedings. In exercising its case management powers, the Court was reluctant to commit the resources of both parties and its own to guarding a claimant in an infringement action against the uncertainties in its own case. Form of preliminary injunction awarded As reported in our blog, Arnold J delivered a judgment on the form of final relief. His starting point was that a patentee would ordinarily be entitled to a final injunction when a finding of infringement is made. However, the patentee’s interests must be balanced against the public interest in ensuring that patients receive appropriate treatment. In conducting the balancing exercise, he took into account the following: • for a limited but growing group of patients, the only available treatment required the infringing device (Sapien 3); • there was a large body of clinical opinion, but little hard data, suggesting that for a larger group of patients Sapien 3 was superior to the alternatives available on the market; and • the clinicians currently using the infringing device would need re-training if the injunction was granted. In light of this, he granted an initial stay of the injunction for a 12-month period to allow enough time for all relevant clinicians to be re-trained to use alternative devices, with permission to apply for an extension if required. With regard to those patients for whom no alternative to Sapien 3 was available, he granted an exception to the injunction, requiring that the responsible clinicians for those patients provide declarations certifying that each patient falls within this exception. Although this exception was not timelimited, Arnold J gave Boston permission to apply to terminate the exception should alternative treatments become available. PATENT AND PHARMA UPDATE 5 This case demonstrates the willingness of English Courts to adopt a flexible and tailored approach to final relief by allowing both a stay and exception to a final injunction so that it accounted for the public interest in ensuring patients could continue to receive appropriate treatment. Monika Klajn, Associate and Riina Luha, Trainee Solicitor 5. The Court rejects jurisdictional challenge to determine a global FRAND licence Conversant Wireless Licensing v Huawei Technologies  EWHC 808 (Pat) Conversant Wireless Licensing v Huawei Technologies  EWHC 1216 (Ch) Carr J has rejected Huawei’s and ZTE’s jurisdictional challenge to Conversant’s claim seeking a determination of FRAND terms for its global portfolio of standard-essential patents (“SEPs”). Conversant Wireless owns a portfolio of patents covering technologies used in a wide range of mobile communications and devices, including SEPs in over 40 countries. Conversant commenced proceedings alleging infringement of four of its European patents and seeking a determination of the global FRAND rate for its global portfolio of SEPs. A similar determination was sought and provided in the hallmark case of Unwired Planet v Huawei  EWHC 2988 by Birss J on which we reported here. The defendants, Huawei and ZTE, challenged the UK court’s jurisdiction to make such determination on the ground that it would, in effect, be deciding on claims for infringement of foreign patents. Additionally, the defendants contended that the validity of Conversant’s Chinese patents was important for determining any global FRAND claim, which the English court had no jurisdiction to consider. In the alternative, the defendants argued that China, not England, would be the appropriate forum to hear this dispute given the “China-centric” nature of their business. China is their major sales market where most profits are generated and where manufacture takes place. By contrast, the UK accounted for 1% of worldwide sales for Huawei and 0.07% turnover for ZTE group. There were also ongoing proceedings in China commenced by Huawei China and ZTE China seeking to establish invalidity and non-infringement of Conversant’s Chinese patents as well as seeking DNIs and determinations of FRAND royalty terms in respect of Conversant’s Chinese patents. In rejecting Huawei’s and ZTE’s arguments, the Court followed the reasoning of Birss J in Unwired Planet. It disagreed with defendants’ characterisation of Conversant’s case as a claim for infringement of foreign patents and held that the claims in this case related to infringement of four UK patents and English court was an appropriate forum to hear this dispute and to impose a global FRAND licence by way of relief. Carr J emphasised that the FRAND regime would be frustrated if one court could not determine the terms of a FRAND licence on a global basis. It would require Conversant to seek licences on a country-by-country basis which would be undesirable and would undermine the judgment given by Birss J in Unwired Planet. The Court followed Unwired Planet and reiterated that in any global FRAND dispute, the English court is not concerned with determining the validity of non-UK patents. The Court accepted that, in any event, the Chinese proceedings would be concluded before a global FRAND trial was heard and decided in the UK and so the resulting validity or invalidity of the Chinese patents could then be taken into account in the royalty calculation. Even if proceedings have not been determined by then, a global FRAND licence will have a mechanism for reflecting the results of such proceedings. In relation to the forum non conveniens argument, the Court concluded that Chinese courts do not have jurisdiction to determine issues of essentiality and infringement of non-Chinese patents and FRAND rates in respect of non-Chinese patents without agreement of both parties and it is unclear if they would exercise such jurisdiction even if such agreement was given. Carr J concluded that China was not an alternative available forum for this case. Carr J accepted Huawei’s and ZTE’s arguments that Conversant’s service of claim on two UK companies of the defendants’ groups was not valid service on the Chinese counterparts but gave permission to serve out under CPR 6B PD 3.1(2). Carr J subsequently ( EWHC 1216 (Ch)) granted leave to appeal from the decision that the Chinese-domiciled defendants were subject to jurisdiction of the English court but refused to stay the proceedings pending appeal as that would cause further and significant delay and cause prejudice to the claimant. The Court held that the order granting permission to appeal ought to record that subsequent steps in the action did not constitute a submission to the jurisdiction by the Chinese-domiciled defendants. The approach adopted by the Court in Conversant Wireless reflects the English courts’ willingness to accept jurisdiction relating to disputes involving non-UK patent designations provided it does not determine the validity of non-European patents. The case emphasises the importance of having such disputes determined by a single court. This is consistent with the English courts’ attitude towards determination of pan-European DNIs, on which see our commentary on Eli Lilly v Genentech  EWHC 3104 (Pat) above. Monika Klajn, Associate PATENT AND PHARMA UPDATE 6 6. Unified Patent Court – where are we? On 26 April 2018 (World IP Day), the UK ratified the UPC Agreement. The move came as a surprise to many as it had been thought that ratification would be used as a negotiation tool to enhance the likelihood of the UK being able to remain part of the UPC arrangements post-Brexit, if and when the new system actually commences. Read our commentary on this development here. The UK, along with France and Germany, is one of three signatory states which must ratify before the Agreement can come into force. France ratified long ago (2014), so German ratification is all that is now needed. Ratification by Germany has been held up by challenges to the legislation which was passed to allow Germany to ratify in both the Bundestag and the German Constitutional Court. Neither has yet been resolved. Fifteen other countries have already ratified the UPC Agreement. Once Germany ratifies, the Agreement will come into force on the first day of the fourth month after the month of that last required ratification. Assuming the constitutional challenges fail, German ratification will likely be timed to coordinate with the new Unitary Patent Court being ready to operate. Once in effect, the UPC will operate across all current EU states except Croatia, Poland and Spain which have not signed up to the Agreement. A European patent with unitary effect (otherwise known as a unitary patent) will be available, covering all the participating states, once the UPC is established. Unitary patents will be enforced through the UPC which will also have jurisdiction over European patents which have not been opted out of the new system. For more on the UPC Agreement including the other states which have ratified already see the UPC Agreement section of our UPC hub (www.hsf.com/upc). Rachel Montagnon, Professional Support Consultant 7. Brexit and IP Draft Withdrawal Agreement indicates some areas of IP agreed IP rights which are designated as applying across the EU (EU trade marks, Community plant variety rights, Community registered designs and Community unregistered designs) and those, qualification for which involves activity within the EU (such as database rights), are all at risk of termination in relation to the territory of the UK once the definition 'EU' no longer includes the UK. However, since our first edition of this Legal Guide to Brexit, the Commission and the UK Government have agreed at negotiator level (as published on 19 March 2018 and subsequently, 19 June 2018) certain sections in the withdrawal agreement including provision of replacement rights for those registered rights thus affected and for the UK Government to provide replacement rights for UK registered rights. In the latest draft of the withdrawal agreement (19 March 2018) and the joint statement issued on 19 June 2018, the UK Government and European Commission negotiators appear to have agreed text providing for the replacement of EU-wide IP rights having effect in the UK with equivalent UK rights at the end of the transition period post-Brexit (until 31 December 2020) if such a transition period is agreed. Further, during the transition period, EU-wide rights will still apply to the UK due to the effect of Article 122 which provides that EU law will be applicable to the UK during the transition period and that it will produce the same legal effects in respect of and in the UK as those which is produces within the EU and its Member States and shall be interpreted and applied in accordance with the same methods and general principles, and that during the transition period, any reference to Member States in EU law shall be understood as including the UK. Other IP related measures include provision for dealing with: exhaustion of rights, pending applications, international registrations designating the EU and the effect of invalidity proceedings that are 'on foot' at the end of the transition period, (see Articles 50-57 of the withdrawal agreement). Certain provisions (highlighted in green in the 19 March 2018 version) are stated to be agreed between negotiators, whilst others are still just proposals from the Commission (those un-highlighted) including those on GIs, and who pays the administration costs involved in providing replacement rights. The provisions on the treatment of pending applications for SPCs were not agreed in the 19 March draft but have now been listed as agreed at negotiator level, as set out in the joint statement of 19 June 2018. There are still unresolved issues for those who hold IP rights in the EU and those who license (in or out) EU-wide IP rights or have agreements linked to the 'EU' as territory. Despite the areas of current agreement, there remains the possibility of a 'no deal' scenario in relation to the whole agreement, in which case none of the areas agreed would stand (although the UK Government could make separate arrangements to create equivalent rights at the moment of Brexit). Anything agreed between the Commission and the UK under a withdrawal agreement needs European Council approval and then European Parliament approval. Thus, although a good start has been made on agreeing the post-Brexit fate of EU-wide IP rights currently having effect in the UK, the final arrangements are still far from certain. Indeed, if a withdrawal agreement is not accepted then there will be no transition period at all and a 'hard' Brexit will come into effect on 30 March 2019, with all that implies for IP rights (see our comments from January 2017 here). PATENT AND PHARMA UPDATE 7 Licensing Although there is provision in the draft withdrawal agreement for the EU to be 'understood' as including the UK in any interpretation of EU law during the transition period, the same does not directly apply to individual contractual and other arrangements and nothing is agreed as to how to approach this post-Brexit. The effect of the territory of a licence being specified as the 'EU' or whether a licence of EU-wide right covers the replacement right in the UK post-transition, will be a matter of contractual interpretation. For clarity, those who license (in or out) EU-wide IP rights or have the EU as a designated territory in any agreement where the UK is a key territory, should take every opportunity to ensure that all parties are in agreement as to what this means during the transition period and importantly beyond. New agreements should provide specifically for the effect of Brexit. Patents European patents and UK national patents: UK designated European patents (EPs) will continue to apply in the UK and will still be able to be applied for at the European Patent Office. UK entities will be able to apply for European patents as normal for any designations. Nationally granted UK patents will also be available. The UPC: The main impact on patent litigation will be the establishment on the Unified Patent Court (UPC) and whether the UK can continue to be part of this new patent litigation system for European patents and the new unitary patent, post-Brexit. The UK has now ratified the UPC Agreement so all that is needed for the new system to commence is for Germany to ratify also. Germany's ratification has been delayed by a complaint about the UPC Agreement in the German Constitutional Court. Opinions vary on whether the UK could continue as part of the UPC system once it is no longer an EU Member State, but this is largely dependent on whether the CJEU would accept a non-EU state's involvement and whether the UK would accept the role of the CJEU in relation to references from the UPC on EU law matters. Pan-European enforcement post- Brexit: Even if the UK is not in the EU (and not in the UPC system), UK businesses with European patents designated to participating EU Member States will still be able to use the new UPC system (unless they have chosen to opt these patents out of its jurisdiction), and will of course be able to apply for UPs – although the latter will not cover the non-participating States listed above, nor any non-EU European Patent Convention States (eg Turkey, Switzerland, Norway), for which European patents will still be available but which will all need to be litigated nationally as they will be outside the jurisdiction of the UPC. The UPC has advantages (central enforcement) and disadvantages (central revocation) for patentees and their competitors alike. Assuming that the UPC does go live, UK businesses with UPs and EPs will still be able to use the UPC for enforcement in other EU participating countries, whether the UK is in or out of the EU. However given concerns about how the UPC will operate in the early years and the quality of the early decisions made by it, some patent proprietors will choose to opt-out their European patents from the UPC system. As a result, business is still likely to pursue litigation in countries across Europe (including the UK) outside of the UPC system. See the jurisdiction and opt-out page of our UPC and UP hub on our website for more information on the UPC and our article on considerations for opt-out published in Managing IP Magazine, as well as our PLC Magazine article on preparing your patent portfolio for the advent of the UPC and the UP. Pan-European enforcement strategies will remain important post-Brexit and post the introduction of the UPC. Indeed, current or future pan-European patent litigation strategy will still involve multiple courts and supranational management of disputes, whether or not the UPC goes ahead and with or without the UK’s participation; Spanish, Polish and Croatian designated European patents will also be outside its jurisdiction (as explained above) and UPs will not have effect in these jurisdictions. Further, nationally granted patents must be litigated locally. It will still be critical to have advisers who are expert in handling multiple cross-border disputes and managing local lawyers in jurisdictions within Europe or beyond. Unitary patents: Once the UPC is established, applications for unitary patents (UPs) will be able to be made via the EPO system (a designation of unitary effect will be able to be requested at the time of grant). Should the new system be established before the UK has left the EU or whilst it is still effectively part of the EU legal systems through some transitional arrangement, the unitary patents will cover the UK during that period. However once any Brexit transition period is over (or at Brexit if no transition agreement is in place), then any granted UPs will no longer apply to the UK. In such circumstances it is likely that the UK Government would provide some sort of replacement right, as is planned currently under the draft withdrawal agreement for the other registered rights (see above). There is no provision made in the draft of the withdrawal agreement for creating equivalent rights should the UP be in effect prior to the end of the transition period. The UPC needs to be in place before UPs can be granted. It seems that UPs have not been included in the withdrawal agreement as it is far from clear that the new patent system will be up and running before the end of the transition period, the German ratification being dependent on both constitutional court and parliamentary decisions, as well as the fact that the UK had not ratified the UPC Agreement at the time the 19 March 2018 draft of the withdrawal agreement was PATENT AND PHARMA UPDATE 8 issued. It may also be that these issues are better dealt with along with any negotiations on the UK remaining in the UPC system generally. The EMA: With the UK no longer in the EU, the European Medicines Agency (EMA) is moving from London. However, even if the EMA is relocated, it is crucial that the UK and the rest of the EU remain in step in terms of the ability to get pharmaceutical and medicinal products to market efficiently, whilst relying upon common clinical study data, as well as monitoring patient safety. Supplementary Protection Certificates: Supplementary Protection Certificates (SPCs) are UK national rights granted by the Intellectual Property Office (IPO) under rules determined by an EU Regulation. It is anticipated that the Withdrawal Act, once enacted, will have the effect that all EU law applying to the UK at the day before Brexit will remain as UK law going forward unless and until this is changed by the Government or Parliament. This will mean that SPCs on UK designated patents can continue and can be granted by the IPO post-Brexit, although transitional arrangements are expected. Post-Brexit, the UK will be able to award SPCs on the same or some other basis as under the, by then, parallel EU system. The UK will need to decide whether any changes to the EU SPC regime, several of which are in the pipeline, would be introduced into the UK's then independent regime. For more on Brexit and IP see the Intellectual Property section of the Herbert Smith Freehills Brexit Legal Guide 2018. Rachel Montagnon, Professional Support Consultant PATENT AND PHARMA UPDATE 9 8. Table of Recent UK Court Decisions on patents Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Astrazeneca Produtos Farmaceuticos EP 0 521 471 Teva Pharma – Produtos Farmaceuticos Rosuvastatin English Court of Appeal (Civil Division) Jackson, Sales and Flaux LJJ Whether a general release clause in a settlement agreement covered any claims brought in relation to an SPC as extended by a paediatric extension. Appeal allowed. Held that the paediatric extension was just an extension of the SPC, and did not confer a different kind of right that was outside the scope of the general release of rights by the patentee.  EWCA Civ 2135 (14 December 2017) Atlas Elektronik GmbH and ECS Special Projects Limited EP (UK) 2 482 576 EP (UK) 2 483 861 Saab Seaeye Limited Underwater mine clearance devices English Court of Appeal (Civil Division) Kitchin and Floyd LJJ Whether the first instance judge was right to construe certain claims in the ‘861 patent by reference to dictionary definitions in upholding validity and whether the judge was right in finding the ‘576 patent obvious based on the judge’s own proposed claim construction between the parties’ positions. Appeal allowed in part. The conclusion of obviousness in relation to the ‘576 patent was upheld albeit on the defendant’s broader claim construction, but the appeal in relation to the ‘861 patent was allowed. The judge was entitled to inform his judgment by reference to dictionary definitions, but having considered the dictionary meaning, a judge should consider what a skilled person would have understood from the patent specification and drawings.  EWCA Civ 2175 (19 December 2017) Cubist Pharmaceuticals LLC EP (UK) 2 264 047 Hospira UK Limited Method of purification of antibiotic daptomycin English Court of Appeal (Civil Division) Lewison and Kitchin LJJ Whether the first instance judge’s assessment of the skilled team’s expectation that daptomycin was a surfactant capable of forming micelles at the priority date was correct and whether the judge was right to hold that the skilled team would have tried an obvious Appeal dismissed because the first instance judge had sufficient evidential basis to reach his findings and had made no error in principle.  EWCA Civ 12 (18 January 2018) PATENT AND PHARMA UPDATE 10 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome purification step for daptomycin with a “fair expectation of success”. G.D. Searle LLC (patentee) Janssen Sciences Ireland UC (exclusive licensee) EP (UK) 0 810 209 SPC/GB07/038 Sandoz Limited and Hexal AG Darunavir English Court of Appeal (Civil Division) Lewison, Kitchin and Floyd LJJ Whether the active ingredient, which falls within a claim’s Markush formula, but is otherwise never specifically referred to in the patent claims, is a “product” protected by a “basic patent” under Article 3(a) of the SPC Regulations. Appeal stayed and the SPC issue was referred to the CJEU.  EWCA Civ 49 (25 January 2018) Boston Scientific Scimed Inc EP (UK) 2 749 254 EP (UK) 2 926 766 Edwards Lifesciences LLC Edwards Lifesciences Corporation Edwards Lifesciences AG (also known as Edwards Lifesciences SA) Replacement heart valves English Court of Appeal (Civil Division) Kitchin, McCombe and Floyd LJJ Edwards appealed the finding that the ‘766 patent was valid and infringed, asserting that the invalidating prior art of the ‘254 patent rendered the ‘766 patent obvious as well. Boston appealed the finding that the ‘254 patent was obvious, arguing that the judge made an error of principle in declining to accept unchallenged evidence given by one of their expert witnesses. Both appeals dismissed. Floyd LJ was convinced that the expert witness had had a “fair opportunity” to comment on conflicting expert evidence from the other side and did not have to be individually crossexamined.  EWCA Civ 673 (28 March 2018) Regeneron Pharmaceuticals, Inc EP (UK) 1 360 287 EP (UK) 2 264 163 Kymab Limited Novo Nordisk A/S Production of human antibodies using transgenic mice English Court of Appeal (Civil Division) Arden, Kitchin and Floyd LJJ Issues concerning the form of the final injunction order. The Court of Appeal ordered the destruction / delivery up of the infringing mice, cell lines and antibodies produced using the patented method, but not the antibody-generating cells or antibodies, which were being kept for the purpose of a medicinal product assessment. Kymab was allowed to PATENT AND PHARMA UPDATE 11 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome keep its mice in order to render them non-infringing and to preserve any technology unrelated to the inventions of the patents in suit. The Court of Appeal refused Regeneron’s request for disclosure relating to products in jurisdictions where it did not have a valid patent. The court also refused to order Kymab to publicise the decision given it was likely to have reached the relevant sector of the public already. The Court also apportioned the costs payable by the parties on various issues of validity and infringement.  EWCA Civ 1186 (23 May 2018) ICOS Corporation (patentee) Eli Lilly & Company (licensee) EP (UK) 1 173 181 Actavis Group PTC EHF Actavis UK Limited Teva UK Limited Teva Pharmaceutical Industries Limited Generics (UK) Limited (t/a Mylan) Tadalafil English High Court (Patents Court) Carr J Whether Eli Lilly was entitled to an interim injunction based on a patent that had been invalidated by the Court of Appeal, pending determination of its application for permission to appeal to the Supreme Court. Carr J refused the injunction, because there was no realistic prospect that the appeal would succeed. In any case, Lilly had not established that it would suffer unquantifiable damage without the injunction, and on balance, the unquantifiable loss to Actavis and the other generics, if an injunction were to be granted, considerably outweighed any unquantifiable loss to Lilly.  EWHC 2880 (Pat) (10 November 2017) Stanford University Chinese University of Hong Kong Verinata Health, Inc Premaitha Health Plc Premaitha Limited TDL Genetics Limited The Doctors Non-invasive prenatal diagnosis (“NIPD”) for the sex of the foetus, Down’s syndrome and other genetic conditions. English High Court (Patents Court) Carr J Obviousness, sufficiency, enabling disclosure and priority date of EP (UK) 0 994 963; whether the ‘963 patent relates to a discovery as such; whether All but one of the claims of the ‘963 patent were found to be invalid. While one aspect of Ariosa’s Harmony prenatal test was found not to infringe any valid claims, the other was found PATENT AND PHARMA UPDATE 12 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Sequenom, Inc Illumina, Inc EP (UK) 0 994 963 EP (UK) 1 981 995 EP (UK) 2 385 143 EP (UK) 2 183 693 EP (UK) 2 514 842 Laboratory Limited Ariosa Diagnostics, Inc TDL/Ariosa’s product Harmony infringes the ‘963 patent; whether Premaitha’s IONA test and/or two proposed alternative methods infringe the ‘963 patent; and whether Illumina was an exclusive licensee under the ‘963 patent. Obviousness, sufficiency, and added matter of EP (UK) 1 981 995 and EP (UK) 2 385 143, and additional issues around whether the claimants had standing to bring these proceedings. Obviousness, priority and infringement by Premaitha’s IONA test of EP (UK) 2 183 693and EP (UK) 2 514 842, and additional issues around whether the claimants had standing to bring proceedings. to infringe so far as it is used for sex determination. The ‘995 and ‘693 patents and their divisionals, asserted against Premaitha, were found to be valid and infringed. The court applied the principles for assessing the scope of protection (the doctrine of equivalence) from the Supreme Court decision in Actavis v Eli Lilly, when considering infringement, stating that “[n]ormal interpretation means purposive interpretation” at .  EWHC 2930 (Pat) (21 November 2017) Magnesium Elektron Limited EP (UK) 1 444 036 Neo Chemicals & Oxides (Europe) Limited Zibo Jia Hua Advances Material Resources Co LTD Neo International Corp. Neo Performance Materials (Singapore) PTE LTD Neo Chemicals And A method of producing zirconium-cerium-based mixed oxides English High Court (Patents Court) Mr Daniel Alexander QC (Sitting as a Deputy Judge of the High Court) Whether further disclosure in respect of work-up towards experiments conducted was justified (“Mayne Pharma disclosure”) and whether permission should be given to conduct testing on certain confidential (intermediate) samples obtained from a process inspection and to admit further experts into an inner confidentiality club. No additional disclosure of experimental work-up, legal advice or draft expert reports was merited. An additional expert was allowed to be included to the confidentiality club, but the testing of the confidential intermediate samples was not allowed.  EWHC 2957 (Pat) (24 November 2017) PATENT AND PHARMA UPDATE 13 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Oxides LLC Unwired Planet International Ltd EP (UK) 2 229 744 EP (UK) 2 119 287 EP (UK) 2 485 514 EP (UK) 1 230 818 EP (UK) 1 105 991 EP (UK) 0 989 712 Huawei Technologies Co. Ltd Huawei Technologies (UK) Co. Ltd Unwired Planet LLC Telecommunications SEPs related to poll triggers, self-configuring networks, inter-RAT handover and Hadamard codes and a non-SEP patent (‘712) related to network messaging. English High Court (Patents Court) Birss J Final resolution of the confidentiality aspects arising out of the non-technical trial on the FRAND issues of the Unwired v Huawei  EWHC 711 (Pat) decision of 5 April 2017 Decision of the Court, setting out the draft Patent Licence Agreement with the accepted redactions to be applied to the trial judgment.  EWHC 3083 (Pat) (30 November 2017) Unwired Planet International Ltd EP (UK) 2 229 744 EP (UK) 2 119 287 EP (UK) 2 485 514 EP (UK) 1 230 818 EP (UK) 1 105 991 EP (UK) 0 989 712 Huawei Technologies Co. Ltd Huawei Technologies (UK) Co. Ltd Unwired Planet LLC Telecommunications standard essential patents related to poll triggers, self-configuring networks, inter-RAT handover and Hadamard codes and a non-SEP patent (‘712) related to network messaging. English High Court (Patents Court) Birss J Final public form of the Unwired Planet v Huawei judgment in the non-technical trial on the FRAND issues, following the resolution of the confidentiality issues. Final public form of the non-technical trial judgment, handed down confidentially on 5 April 2017 as  EWHC 705 (Pat) and as a first redacted public version as  EWHC 711 (Pat)  EWHC 2988 (Pat) (30 November 2017) Genentech Inc EP 1 641 822 Eli Lilly and Co IL-17A/F Heterologous Polypeptides English High Court (Patents Court) Birss J Whether English courts have jurisdiction to consider claims for declarations of non-infringement in respect of non-UK patent designations. Application to set aside claims refused. The English court considering claims of non-infringement and validity in respect of the UK designation of a European patent could also consider non-infringement claims in respect of non-UK designations of the patent so long as no issues of validity were brought into question.  EWHC 3104 (Pat) (6 December 2017) PATENT AND PHARMA UPDATE 14 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Oxford Nanopore Technologies Ltd and Harvard College EP (UK) 1 192 453 Pacific Biosciences of California, Inc Molecular and Atomic Scale Evaluation of Biopolymers English High Court (Patents Court) David Stone (Sitting as a Deputy High Court Judge) Whether a licence is an “exclusive licence” under the Patents Act 1977 if a third party has an option to take a licence under the patent, but has not done so. A licence was still an “exclusive licence” within the meaning of s. 130(1) of the Patents Act 1977 where a third party had an option to take a licence under a patent but had not yet done so.  EWHC 3190 (Pat) (14 December 2017) Genentech Inc EP 1 641 822 Eli Lilly and Co IL-17A/F Heterologous Polypeptides English High Court (Patents Court) Birss J The Court had to decide the form of order following its decision in  EWHC 3104 (Pat) above. The court required the claimants to undertake not to challenge the patent’s validity until the conclusion of the proceedings.  EWHC 75 (Pat) (11 January 2018) Stanford University Chinese University of Hong Kong Verinata Health, Inc Sequenom, Inc Illumina, Inc EP (UK) 0 994 963 EP (UK) 1 981 995 EP (UK) 2 385 143 EP (UK) 2 183 693 EP (UK) 2 514 842 Premaitha Health Plc Premaitha Limited TDL Genetics Limited The Doctors Laboratory Limited Ariosa Diagnostics, Inc Non-invasive prenatal diagnosis (“NIPD”) for the sex of the foetus, Down’s syndrome and other genetic conditions. English High Court (Patents Court) Carr J Costs apportionment in separate but related proceedings where the claimants were partially successful on infringement, but some of the defendants had been partially successful in invalidating certain patent claims. The successful claimant was awarded its costs, less deductions for issues on which it had not succeeded. The defendants were held to be severally liable for the costs ordered and an interim payment of 60% was ordered.  EWHC 180 (Pat) (23 January 2018) L’Oréal Société Anonyme and L’Oréal (UK) Limited EP (UK) 1 722 699 RN Ventures Limited Electronic facial skin care devices English High Court (Patents Court) (as Carr J Whether a patent and two designs were valid and infringed. The patent was valid and infringed. One of the registered designs was also held to be infringed. PATENT AND PHARMA UPDATE 15 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome part of the Shorter Trials Scheme) Carr J was appreciative of the Shorter Trials Scheme, albeit noting that parties should ensure that all nonsubstantive issues, such as procedural disputes, are resolved before the trial.  EWHC 173 (Pat) (5 February 2018) L’Oréal Société Anonyme and L’Oréal (UK) Limited EP (UK) 1 722 699 RN Ventures Limited Electronic facial skin care devices English High Court (Patents Court) (as part of the Shorter Trials Scheme) Carr J Whether an infringing defendant was entitled to a deduction in costs payable to the claimants under s. 68 of the Patents Act 1977 because the exclusive licence between the claimants was only registered four years after it had been concluded. Although the claimants were part of the same corporate group and were jointly and severally liable for all legal costs, the defendant was entitled to a deduction on costs payable because most of the infringement had occurred before the exclusive licence was registered. The exclusive licensee was therefore not entitled to its costs preregistration under s.68.  EWHC 391 (Ch) (19 February 2018) ARC Medical Design Limited EP (UK) 2 575 590 GB 2 478 081 Cantel Medical (UK) Limited Cantel (UK) Limited Colonoscope cuffs English High Court (Patents Court) Hacon HHJ (Sitting as a High Court Judge) Cantel sought revocation and/or declarations of non-infringement of ARC’s patents. The defendant’s European and UK patents, as amended, were valid and had been infringed by the claimants’ colonoscope cuff.  EWHC 345 (Pat) (23 February 2018) Stanford University Chinese University of Hong Kong Verinata Health, Inc Sequenom, Inc Premaitha Health Plc Premaitha Limited TDL Genetics Limited The Doctors Laboratory Limited Non-invasive prenatal diagnosis (“NIPD”) for the sex of the foetus, Down’s syndrome and other genetic conditions. English High Court (Patents Court) Carr J Whether a patent infringement claim against the same defendants who had already been sued in relation to other patents relating to the same subject (the prenatal tests) should be struck The claim was not struck out as an abuse of process as the claimants had not known that they had a cause of action in respect of the patent when starting the earlier proceedings, they were not seeking to re-litigate lost PATENT AND PHARMA UPDATE 16 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Illumina, Inc EP (UK) 1 524 321 Ariosa Diagnostics, Inc out as an abuse of process under the principles laid down in Henderson v Henderson  2 Hare 100. claims, and had not deliberately held back the new claim.  EWHC 615 (Pat) (19 March 2018) Boston Scientific Scimed, Inc EP (UK) 2 749 254 EP (UK) 2 926 766 Edwards Lifesciences LLC Edwards Lifesciences Corporation Edwards Lifesciences AG (also known as Edwards Lifesciences SA) Replacement heart valves English High Court (Patents Court) Hacon HHJ (Sitting as a High Court Judge) In exercise of the court’s case management powers, whether the patentee was entitled to a joint damages inquiry and an account of profits from the infringer, even after the latter had provided the former with financial information for the purpose of the patentee’s election. The patentee’s application for a joint damages inquiry and an account of profit was refused although most of the infringers’ profits had been transferred to connected companies. Section 61 of the Patents Act requires the patentee to make a choice between damages and an account of profits and the patentee needs to bear any risk arising from this election. From a case management perspective, running both options would be undesirable due to the additional court time required and expenses involved.  EWHC 664 (Pat) (27 March 2018) Conversant Wireless Licensing S.A.R.L Portfolio of (alleged) SEPs in more than 40 countries Huawei Technologies Co. Ltd Huawei Technologies (UK) Co. Ltd ZTE Corporation ZTE (UK) Limited SEPs for mobile phone manufacturing English High Court (Patents Court) Carr J Whether the English court had jurisdiction to determine FRAND terms for Conversant’s global SEP portfolio in the event that the patents were indeed valid SEPs and the defendants infringed them. The court decided that it had jurisdiction to determined FRAND terms on a global SEP portfolio, with England held to be the forum conveniens. Conversant was granted permission to serve out on the defendants based in China.  EWHC 808 (Pat) (16 April 2018) Anan Kasei Co Ltd (now named Solvay Special Molycorp Chemicals & Oxides (Europe) LTD Ceric Oxide and method for production thereof and English High Court Roger Wyand QC (Sitting as Whether the patent was valid in light of inventive step and Patent held valid and infringed in its unamended form. PATENT AND PHARMA UPDATE 17 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Chem Japan) (patentee) Rhodia Operations S.A.S (exclusive licensee) EP 1 435 338 (now named as Neo Chemicals and Oxides (Europe) Ltd) catalyst for exhaust gas clarification (Patents Court) a Deputy High Court Judge) insufficiency challenges and whether Neo infringed the patent.  EWHC 843 (Pat) (23 April 2018) Freebit AS EP (UK) 2 177 045 Bose Corporation Bose Limited Hearing aid devices English High Court (Patents Court) Robert Wyand QC, (Sitting as a Deputy High Court Judge) Whether the patent is valid in light of anticipation (prior publication based on the sale of the patentee’s own product), inventive step and other challenges and whether the defendants infringe the patent. Patent held invalid in its granted form and in light of proposed amendments, and the defendants’ products would not infringe even if the patent were valid.  EWHC 889 (Pat) (24 April 2018) Conversant Wireless Licensing SARL Portfolio of (alleged) SEPs in more than 40 countries Huawei Technologies Co. Ltd Huawei Technologies (UK) Co. Ltd ZTE Corporation ZTE (UK) Limited SEPs for mobile phone manufacturing English High Court (Chancery Division) Carr J Permission to appeal against a decision that the infringement claims against the defendants were justiciable in the UK and that UK was the forum conveniens, and against the judge’s decision to allow amendments to the Particulars of Claim. Stay of the technical trial and FRAND proceedings pending appeal also sought. Permission to appeal on the points of justiciability and forum conveniens granted, but permission to appeal against the judge’s decision to allow amendments to the Particulars of Claim refused; stay refused.  EWHC 1216 (Ch) (8 May 2018) Qualcomm Incorporated Qualcomm (UK) Limited (wholly owned subsidiary) EP (UK) 1 264 506 EP (UK) 1 192 749 EP (UK) 1 791 286 EP (UK) 1 774 822 EP (UK) 2 217 031 Apple Retail UK Limited Apple Distribution International Apple Operations Europe Apple GmbH Apple Retail Germany B.V. & CO. KG SEPs for mobile devices English High Court (Patents Court) Morgan J Whether Apple’s claim of contractual breach against Qualcomm UK under the ETSI’s IPR policy should be struck out. Whether Apple’s claim of exhaustion of rights under all EP (UK) patents owned by Qualcomm Incorporated could be served within the jurisdiction under CPR 63.14. The court struck out the contractual breach claim against Qualcomm UK because it had no real prospect of success and there was no compelling reason why it should proceed to trial. The court was not satisfied that Apple’s further claims against Qualcomm Incorporated fell within the jurisdictional gateways pleaded, but allowed further submissions from PATENT AND PHARMA UPDATE 18 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Apple Inc Whether further claims against Qualcomm Incorporated (ie, other than the technical patent invalidity claims) could be served out of the jurisdiction by relying on the CPR Practice Direction 6B “gateways”. Whether the UK was the proper forum to determine Apple’s claim that Qualcomm Incorporated had abused its dominant position in the market (Article 102 TFEU). Apple as to why loss was suffered in the UK, in order to potentially satisfy Gateway 9. In the event that Apple succeeded, the court found that the UK would be the forum conveniens to hear the claim under Article 102 TFEU.  EWHC 1188 (Pat) 22 May 2018 Koninklijke Philips NV EP (UK) 1 440 525 Asustek Computer Incorporation Asustek (UK) Limited ASUS Technology Pte. Ltd HTC Corporation HTC Europe Co. Ltd SEPs in High Speed Packet Access (HSPA) operations in mobile telecommunications systems. English High Court (Patents Court) Arnold J Whether the patent was obvious over cited prior art. Arnold J found the patent valid and infringed (the defendants did not dispute infringement).  EWHC 1224 (Pat) (23 May 2018) Boston Scientific Scimed Inc EP (UK) 2 749 254 EP (UK) 2 926 766 Edwards Lifesciences LLC Edwards Lifesciences Ltd Edwards Lifesciences SA Edwards Lifesciences (Singapore) Pte Ltd Replacement heart valves English High Court (Patents Court) Arnold J The terms of the final injunction. Balancing public interest with the patentee’s own monopoly rights, the Court stayed the injunction for 12 months (with a financial remedy accruing for the period of the stay) to allow for clinicians to re-train to use non-infringing heart valves and qualified the injunction so that clinicians would still be able to use the infringing replacement heart values in patients where no alternatives could be used.  EWHC 1256 (Pat) (24 May 2018) PATENT AND PHARMA UPDATE 19 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome Liqwd Inc Olaplex LLC (exclusive licensee) GB 2 525 793 L’ORÉAL (UK) Limited L’ORÉAL SA Keratin treatment formulations and methods English High Court (Patents Court) Birss J Whether the patent was valid in light of cited prior art and prior use, and whether L’Oreal infringed the patent. The unamended patent claims were found invalid, but one of the claims as unconditionally amended was found valid and infringed.  EWHC 1394 (Pat) (11 June 2018) TQ Delta LLC Two patents from an alleged SEP portfolio Zyxel Communications UK Limited Zyxel Communications A/S SEPs related to digital subscriber line (DSL) technologies. English High Court (Patents Court) Carr J Whether TQ Delta could limit access to certain licence documents to “external eyes only” and exclude access to parties’ representatives entirely in a Confidentiality Club Agreement. Noting that an “external eyes only” designation in a confidentiality club could be used in exceptional circumstances or if the parties agreed to this, Carr J refused the application for a blanket external eyes only restriction since it would impact Zyxel’s ability to understand the case against it, instruct its lawyers appropriately and participate at trial.  EWHC 1515 (Ch) (13 June 2018) OOO Abbott Godfrey Victor Chasmer (co-proprietors) EP (UK) 1 816 931 Design & Display Limited Eureka Display Limited Slatted display panels IPEC Hacon HHJ Whether Design & Display was entitled to the deduction of certain overheads from its account of profits payable to Abbott. To the extent they related to the infringing business, Design & Display was entitled to deduct salaries, wages and national insurance contributions from its account of profits.  EWHC 2975 (IPEC) (22 November 2017) Smart Reamer Drilling Systems Ltd Two GB patents Nov Downhole Eurasia Ltd Tools used for widening and measuring boreholes IPEC Hacon HHJ Whether the defendant was entitled to specific disclosure of a licence agreement under the patents-in-issue between the patentee and a third party. Disclosure was ordered as it would likely assist in advancing settlement negotiations, whereas there was only a tenuous possibility of potential damage to the patentee due to the disclosure.  EWHC 1265 (IPEC) (30 April PATENT AND PHARMA UPDATE 20 Patentee / Patent no. Other party/ies Subject matter / product (active ingredient) Court Judge/s Legal issue Outcome 2018) 21 9. 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