Patent and Pharma Update - December 2015

1 ` PATENT AND PHARMA UPDATE 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. Court of Appeal overturns the Patents Court and finds that Leo Pharma's psoriasis patents are not obvious Teva UK Ltd & Anor v Leo Pharma A/S [2015] EWCA Civ 779, 28 July 2015 • The Court of Appeal reversed the judge's finding that two of Leo Pharma's patents for a psoriasis ointment were invalid for obviousness. • The key issue was whether a particular solvent in the ointment would have been obvious to the skilled formulator, especially in light of teaching in an earlier US patent. • The judgment provides useful guidance on the notional person skilled in the art. It also reminds parties that in the context of the "obvious to try" test, a "fair expectation of success" requires more than the fact that a compound is worth including in a research programme. Further, it emphasises the importance of taking commercial considerations and a "long-felt want" into account when assessing obviousness. Leo Pharma sells an ointment for the treatment of psoriasis that is marketed as Dovobet. The ointment contains, amongst other things, two active ingredients (calcipotriol and betamethasone) and a non-aqueous solvent called Arlamol E. Leo Pharma was appealing the decision of Birss J in the Patents Court, who had found that two patents protecting this formulation (EP 1 178 808 and EP 2 455 083) were invalid for obviousness. Calcipotriol and betamethasone have different beneficial effects, and both were well-established as the sole active ingredient in separate psoriasis creams before the priority date. Although patients were often prescribed both creams, they were warned by clinicians that they could not be applied at the same time. The two active ingredients are stable at different pHs and each needed to be applied separately in an appropriately-buffered cream. Having to apply creams separately meant that some patients, especially those with less serious psoriasis, failed to comply with their treatment regime. Therefore, even before the priority date, clinicians had voiced a need for a combination product containing both calcipotriol and betamethasone. A dual product would need a non-aqueous solvent (rather than the DECEMBER 2015 London Table of Contents 1. Court of Appeal overturns the Patents Court and finds that Leo Pharma's psoriasis patents are not obvious 1 2. Further Developments in the Lyrica patent dispute 2 3. Novartis Europharm v Commission 3 4. Construction of numerical ranges 4 5. The Court of Appeal has set aside a declaration of noninfringement in respect of the UK, French, Italian and Spanish designations of a European Patent, refusing to hold that there was no indirect infringement. 5 6. The High Court has invalidated a patent in the third action by Hospira which is part of ongoing efforts to clear the way for their launch of a biosimilar of trastuzumub. 6 7. High Court gives ruling on strike out of competition law defence to patent infringement 6 8. High Court decides not to transfer a patent licence dispute to the Patents Court 7 9. Teva succeeds in obtaining interim injunction, as Actavis fails to "clear the path" 8 10.Court of Appeal upholds invalidity of Rovi's patent 9 11.Flynn Pharma can assert its trade mark to prevent the parallel importation of re-branded Epanutin 9 12.High Court considers the requirement of plausibility in relation to a Swiss Form Patent 10 13.Ono's Swiss Form patent is plausible and valid 11 14.Disclosure published on same day that a patent is filed is not prior art 11 15.Use of HMPC as a capsule material in a dry powder inhaler for the delivery of tiotropium bromide was considered obvious. 11 16.CJEU finds that the notification of the grant of a centralised MA is the relevant date for calculating the term of an SPC 12 17.Key points from featured UK decisions 13 18.Contacts 16 RELATED LINKS > Herbert Smith Freehills > The Unified Patent Court and the Unitary Patent 2 aqueous solvents used in the creams) so that both active ingredients could be stable in the same formulation. The key question was whether Arlamol E would have been obvious as an appropriate non-aqueous solvent to the skilled formulator at the relevant priority date. The key piece of prior art, US 4,083,974, already disclosed Arlamol E as a non-aqueous solvent for a betamethasone alone. However, since it was primarily used in cosmetics, it did not form part of the common general knowledge (CGK) of the skilled formulator. Birss J was held to have erred in various points of principle at first instance, allowing the Court of Appeal to reconsider obviousness de novo: • First, it was wrong to distinguish between the notional person skilled in the art and a real person skilled in the art. Birss J had found that the former would be less conservative and more likely to test unfamiliar solvents. Jacob LJ emphasised that the notional person skilled in the art would have all the prejudices and practices of a real person skilled in the art, as in Dyson v Hoover [2002] R.P.C. 22. Therefore, if the real skilled formulator would have omitted Arlamol E from their research project because it was unfamiliar and not part of the CGK, so would the notional skilled formulator. • Secondly, it was wrong to find that Arlamol E was obvious simply because it would have been included in a research project to find an appropriate solvent. Jacob LJ emphasised that, following Conor v Angiotech [2008] UKHL 49 and St. Gobain v Fusion Provida [2005] EWCA (Civ) 17, a claimed invention will only be "obvious to try" if the person skilled in the art has a fair expectation that such trying will succeed. Just because a compound is worth testing does not necessarily mean it carries a fair expectation of success. On the facts, there was no such expectation – Arlamol E was no more likely to succeed than any other non-aqueous solvent. Indeed, Teva's own expert admitted that finding the right solvent would be "a real problem…and it would require a lot of work to solve it". • Thirdly, the trial judge should have taken into account (i) that there had been a long-felt want for a dual product, (ii) that DOVOBET was the desired solution and (iii) that there was no explanation of why that solution had not been found earlier. Jacob LJ held that this was the "classic sort of case where the courts have found invention over the years". The Court of Appeal also rejected Teva's arguments on insufficiency and added matter and therefore held, in line with the EPO's Opposition Division, that both patents were valid. 2. Further Developments in the Lyrica patent dispute Warner-Lambert Company LLC and (1) Actavis Group PTC EHF, (2) Actavis UK Limited, (3) Cadecus Pharma Limited and (4) Pfizer Limited and Secretary of State for Health [2015] EWHC 2548 (Pat) ("Warner-Lambert V") In an e-bulletin published on 17 September 2015, we reported that the High Court has set out a framework for dealing with enforcement of second medical use claims. Generic companies might be able to avoid infringement of such claims when marketing products for non-patented indications by using a "skinny" label and assisting prescribers/dispensers to only use the generic product for non-patented indications. On the particular facts of the above case, Arnold J found that there was no infringement because at the time of manufacture of the generic product it was not foreseeable to Actavis that the product would be used for the patented indication. Read more Warner-Lambert Co LLC v Sandoz GmbH, Sandoz Ltd and Lloyds Pharmacy Ltd [2015] EWHC 3153 (Pat) Warner-Lambert sought a continuation until trial (or further order) of the injunctions which it had obtained on an urgent basis before Birss J against (1) Sandoz from dealing in full label generic pregabalin; and (2) Lloyds from dispensing the Sandoz full label product. Arnold J noted that although he had made declarations of invalidity in relation to certain claims of WarnerLambert's pregabalin patent in Warner-Lambert V, the patent remains in force pending the appeals arising from that decision. Following Warner-Lambert IV [2015] EWHC 485, the NHS issued guidance that pregabalin should only be prescribed for the treatment of neuropathic pain by reference to the Warner-Lambert brand name "Lyrica", but that when the prescription is for anything other than pain it should be by reference to generic pregablin. A number of generic suppliers, including Sandoz, had launched generic pregablin with 'skinny' label marketing authorisations for epilepsy and general anxiety. Despite indicating that it would provide seven days' notice to Warner-Lambert prior to any launch of a generic pregabalin product, on 2 October 2015 Sandoz confirmed that it had started to supply its full label pregabalin product. On 3 October Birss J made an order restraining the supply of this product. On 4 October Sandoz disclosed that approximately 90,000 packs of its product had been supplied to Lloyds and on 6 October Birss J. made an order that the products should not be dispensed by Lloyds. Both Birss J. and Arnold J. criticised the Defendants and noted that in such circumstances prior notice should have been given which would have enabled the dispute to be resolved in an orderly manner. In addition, the proper course for a generic supplier would have been to commence proceedings for a declaration of non-infringement to 'clear the path' prior to launch of its full label product. In granting a continuation of the injunctions, Arnold J. held that there was a greater risk of Warner-Lambert suffering irremediable harm if the injunction was refused than that suffered by Sandoz if it was granted and that there was a strong case for preserving the status quo pending trial (or the decision of the Court of Appeal in Warner-Lambert V). The loss to the patent owner would be difficult to quantify as the generic competition would lead to price depression which would be difficult to reverse. 3 Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Company LLC [2015] EWHC 3370 (Pat) In Warner-Lambert V, claim 3 (amongst others) of the pregablin patent was held to be invalid for insufficiency. This decision has been appealed by Warner-Lambert. In case the appeal is unsuccessful, Warner-Lambert also made a conditional application to amend the patent, including an application to re-write claim 3. The amendment was opposed by Actavis and Mylan on the basis that it would amount to an abuse of process of the court requiring a second trial as it lacks clarity, adds subject matter and does not cure the invalidity of claim 3. Claim 3 provides for the use of pregabalin for the preparation of a pharmaceutical composition for the treatment of neuropathic pain. The proposed amendment consists of adding the words "caused by injury or infection of peripheral sensory nerves". The basis for this is [0006] of the patent specification, which included a sentence to this effect. An issue that arose in Warner-Lambert V was the meaning of "neuropathic pain". Actavis and Mylan took this term to include both "central neuropathic pain" and "peripheral neuropathic pain", and therefore argued that claim 3 was insufficient as the patent did not contain data from models in relation to both forms of neuropathic pain. Warner-Lambert argued that the data models contained in the patent related to "central sensitisation" and were appropriate for any types of pain that had this as a component (i.e. neuropathic pain). However, Actavis and Mylan argued that there were certain types of central neuropathic pain that did not have a central sensitisation component, such as pain caused by stroke or multiple sclerosis. The amendment sought by Warner-Lambert therefore seeks to narrow claim 3 to "peripheral neuropathic pain" only, thereby avoiding the insufficiency argument. Arnold J. held that the amendment would amount to an abuse of process because it would require a second trial. If the application to amend claim 3 had been made at trial, Mylan and Actavis would have been entitled to adduce evidence on the point. Therefore the clarity objection that they raised could not be fairly determined without allowing them to adduce evidence. A minor additional point was that there was a risk that allowing the amendment would delay the overall resolution of the dispute as a second trial may not be concluded before the appeals to Warner-Lambert V. Arnold J. noted that as per Samsung Electronics Co Ltd v Apple Retail UK Ltd [2014] EWCA Civ 250, [2015] RPC 3, it would not be an abuse of the process for a patentee to make a central limitation application pursuant to EPC 2000 Articles 105a- 105c, even if it would be an abuse for the patentee to apply to make the same amendment under section 75 Patents Act 1977 following the trial in English proceedings. Warner-Lambert argued that, even if a second trial were required, the application does not amount to an abuse of process since it is the victim of procedural unfairness as a result of Actavis and Mylan not raising the point about "central neuropathic pain" earlier. It was their contention that this was first raised in cross-examination of Warner-Lambert's expert witness. This argument was rejected by Arnold J. who held that it should have been apparent from Actavis and Mylan's statement of common general knowledge that they were proceeding on the basis that neuropathic pain included both central neuropathic pain and peripheral neuropathic pain. Alternatively, it should have been apparent from their first expert report or their second expert report and was made crystal clear in their skeleton argument. Even at trial Warner-Lambert made no complaint that it had been taken by surprise in this regard. 3. Novartis Europharm v Commission [2015] EUECJ T-67/13 [Re Hospira UK Ltd] and [2015] EUECJ T-472/12 [Re Teva Pharma BV] • The Court of Justice of the European Union (the "EUECJ") has dismissed Novartis' applications for annulment of decisions to grant marketing authorisations (MAs) to Teva and Hospira for generic versions of Novartis' ACLASTA, zoledronic acid for non-oncology indications. • Novartis claimed that, by referring to data in Novartis' Aclasta MA application, the generics had infringed its data exclusivity rights for Aclasta, which were to last for 10 years from the MA grant date in April 2005. • However, the Commission successfully argued that their decision to grant the generic MAs was correct as the data protection period had ended by the time the generics made their MA applications. The data was no longer protected, because the MA for Aclasta was included in the global MA granted to Novartis in March 2001 for ZOMETA, a zoledronic acid product with different indications and strength. • The decision shows that the Court will be strict in its application of the rule that new therapeutic indications, new doses, administration routes and new pharmaceutical forms of an original medicinal product do not enjoy an independent data exclusivity period. In March 2001, Novartis received an MA for Zometa, intravenous zoledronic acid for oncology indications. Through further research Novartis developed Aclasta which extended the use of zolderonic acid to non-oncology indications and was of a different strength appropriate for these new uses. The MA for Aclasta was granted in 15 April 2005. In 2012, the European Commission granted Teva and Hospira MAs for their respective generics of Aclasta. In their applications, both Teva and Hospira referred to data in the files submitted by Novartis with their MA applications for Zometa and Aclasta. Novartis launched actions against the Commission to annul the grant of the MAs to Teva and Hospira. Teva and Hospira were granted leave to intervene in support of the Commission. Novartis argued that the granting of the generic MAs was 4 unlawful because it infringed the data exclusivity rights in respect of Aclasta, which was to last until April 2015, 10 years from the date of the MA grant. The Commission submitted that it was free to grant the MAs as Teva and Hospira had been free to use the data. Under the regulations, the Aclasta MA was included in the global MA for Zometa, so any data exclusivity rights had expired in March 2011, 10 years after grant of the Zometa MA, and before the generic MA applications were made. The issue for the Court was whether Aclasta was covered by the same global MA as Zometa, so that the data exclusivity period expired with the data exclusivity period for Zometa, or by a separate global MA, so that it had an independent data exclusivity period through to April 2015. The General Court held that: • The Commission was correct to conclude that, even though Novartis could obtain an MA for Aclasta using the centralised procedure, Aclasta could not be granted an independent global MA or a new regulatory data exclusivity period given the existing MA for Zometa. • Aclasta constituted an additional strength and a variation of Zometa and therefore the MA for Aclasta was included in the global MA for Zometa. • When the Commission granted the generic Aclasta MAs to Teva and Hospira, Novartis' data exclusivity period had ended. The Commission was therefore correct to conclude that the MAs could be granted. The action was dismissed and Novartis was ordered to pay its own costs and those incurred by the Commission, Teva and Hospira. 4. Construction of numerical ranges Smith & Nephew plc v Convatec Technologies Inc [2015] EWCA Civ 607, 24 June 2015 and Smith & Nephew plc v Convatec Technologies Inc [2015] EWCA Civ 803, 30 July 2015 • The Court of Appeal allowed an appeal against a finding of non-infringement on the ground that the High Court wrongly construed the numerical range in the claims of a patent. ConvaTec owns European Patent (UK) No 1,343,510 (the "Patent") which claims a process for the silverisation of gel-forming fibres used in wound dressings. One of the stages of the process involves subjecting the gel-forming fibres to an agent, such as a chloride salt, which facilitates the binding of the silver to the polymers. The relevant claim states that the binding agent must be present in a concentration of “between 1% and 25% of the total volume of treatment”. In earlier proceedings, Smith & Nephew sought revocation of the Patent to clear the path for a new range of products which they wished to sell under the brand name Durafiber Ag. The revocation claim was rejected at first instance and the decision was upheld on appeal. By this time Smith & Nephew had obtained a CE mark to sell products made in accordance with their process (the "Original Process") in the European Union, and there was a risk that it might be found to infringe the Patent. Therefore they developed a new process (the "Modified Process") with a concentration of binding agent of no more than 0.77%, and in January 2013 they began proceedings for a declaration of non-infringement. ConvaTec counterclaimed that both the Original Process and the Modified Process, used in various experiments to develop the process and obtain regulatory approval, infringed the Patent. The experiments that were in issue at trial used a concentration of binding agent of 0.93% to 0.97%, (depending on how it was calculated). On the numerical range issue ConvaTec argued that conventional rounding should apply such that the claim encompassed all concentrations in the range 0.5% - 25.5%. Smith & Nephew argued that the claimed range was concentrations of 1% - 25% precisely. Birss J held that the skilled person would look at the limits in terms of significant figures and therefore the claim included concentrations in the range 0.95% to 25.5%.Therefore, the Modified Process did not infringe the Patent, but the Original Process did. Smith & Nephew appealed the decision In determining the issue of the numerical range claimed, the Court of Appeal considered two questions. First, whether the skilled person would believe the patentee intended the values of 1% and 25% to be taken as exact values or whether they would understand that a standard number convention had been used to express the limits of the claim to a lesser degree of accuracy and so include within the claim concentrations falling within the range when expressed with the same degree of precision. In deciding that the patentee did not intend for the range claimed to be exact, the following points were said to be material: (i) in the field, the concentration of the binding agent can be measured to a high degree of accuracy (i.e. to 2 decimal places) – had the patentee wanted to express the range to a higher degree of accuracy, he could have; (ii) numerical values are expressed to two decimal places elsewhere in the Patent; and (iii) One of the examples teaches that the concentration of the binding agent can be in the range 0.01 – 50% - therefore, the concentration range given in the claim is not critical to the method of the invention. The second question considered was whether the skilled person would understand the numbers to be expressed in terms of whole numbers (zero decimal places), i.e. 0.5% - 25.5%, or in terms of significant figures, i.e. 0.95% to 25.5%. In deciding that the skilled reader would understand that the patentee had chosen limits to an accuracy of zero decimal places, Kitchin LJ considered it material that the application of significant figures to the claimed range (and to any range containing number 1 or any power of the number 10) created an asymmetry or "mathematical quirk". Since the claim embraced all concentrations of binding agent ≥ 0.5% and < 25.5% Smith & Nephew's Modified Process infringed the patent. 5 In judgment of the Court of Appeal, Kitchin LJ also provides a review of UK and EPO case law concerning numerical ranges in patents and the following pointers for construction: • The scope of any such numerical claim must be exactly the same whether one is considering infringement or validity. • There can be no justification for using rounding or any other kind of approximation to change the disclosure of the prior art or to modify the alleged infringement. • The meaning and scope of a numerical range in a patent claim must be ascertained in light of the common general knowledge and in the context of the specification as a whole. • It may be the case that, in light of the common general knowledge and the teaching of the specification, the skilled person would understand that the patentee has chosen to express the numerals in the claim to a particular but limited degree of precision and so intends the claim to include all values which fall within the claimed range when stated with the same degree of precision. • Whether that is so or not will depend upon all the circumstances including the number of decimal places or significant figures to which the numerals in the claim appear to have been expressed. In the same case, following the decision the Court of Appeal refused permission to appeal, and Smith & Nephew appealed directly to the Supreme Court on the basis that the Court of Appeal decision raised a significant point of general public importance. The Patent was also subject to EPO proceedings. A decision to revoke the Patent was issued on 16 December 2014. This was appealed by ConvaTec and a hearing before the TBA is due to take place by April 2016 – a few months after the application for permission to appeal to the Supreme Court is resolved. Smith & Nephew applied to stay the injunction pending the decision of the TBA, arguing that if declined they will suffer severe and irreparable harm as an injunction would devastate the market for Durafiber Ag. The Court of Appeal, noting that this is an unusual case since the Patent has now been revoked and the TBA decision will be issued only a few months after the Supreme Court decision, held that the balance of justice lies in favour of suspending the injunction at least until the Supreme Court decision on whether to allow an appeal. 5. The Court of Appeal has set aside a declaration of non-infringement in respect of the UK, French, Italian and Spanish designations of a European Patent, refusing to hold that there was no indirect infringement. Actavis UK Ltd and others v Eli Lilly & Co [2015] EWCA Civ 555, 25 June 2015 • In May 2014, the High Court held that Actavis UK Ltd would not infringe Eli Lilly’s European patent by launching a generic pemetrexed product – relying on both the prosecution history of the patent and amendments made to the patent during prosecution to determine how broadly the claim could be interpreted. • The Court of Appeal found it was not appropriate for Arnold J to place so much weight on the prosecution history and confirmed that the doctrine of file wrapper estoppel used in the US does not apply in the UK. • Despite upholding Arnold J’s findings that there was no direct infringement, the Court of Appeal reversed his findings in relation to indirect infringement. • The Court of Appeal also clarified the position regarding declarations of non-infringement and Rome II by confirming that the conditions for applying for declarations of non-infringement are procedural and therefore are subject to English law as the lex fori. Lilly held a basic patent for their cancer treatment drug pemetrexed expiring in December 2015 (extended by SPC) as well as a patent for the use of pemetrexed disodium in combination with vitamin B12, expiring in June 2021. Actavis sought to use other pemetrexed salts in their generic product and sought from the UK court declarations of non-infringement (‘DNI’) over not only the UK designation, but also French, Spanish and Italian designations of the use patent. Direct and indirect infringement Article 69(1) of the European Patent Convention, and the Protocol on the Interpretation of Article 69, states that the extent of the protection conferred by a European patent/application is determined by the claims. In the High Court, it was held that the patent claim, which here referred to pemetrexed disodium in combination with vitamin B12, excluded the equivalent active ingredients which Actavis were seeking to launch, namely pemetrexed diacid, ditromethamine or dipotassium. While Floyd LJ in the Court of Appeal agreed that the claim would not cover the equivalents listed above, it would still cover solutions containing sodium ions and pemetrexed ions with at least a 2:1 ratio. Finding that where a pharmacist reconstituted or diluted the Actavis products in saline, there would be a stage when “pemetrexed disodium” would be present - as required by Eli Lilly's claim. Accordingly, while there was clearly no direct infringement, this would still amount to indirect infringement. The use of prosecution history Despite not having any effect on the outcome, Floyd LJ did not accept the trial judge's use (and corresponding reasoning) of the prosecution history of the patent in considering how broadly the claim could be interpreted. He argued that Arnold J's approach assumed that a skilled reader will always read the prosecution history – which he felt would not necessarily be the case given the "limited value it was generally recognised to have". He also went on to say that it will only be in the rarest of cases that "the story told by the prosecution history of how the claims came to be drafted as they were will assist the court in 6 preventing abuse of the system". Other points A particularly significant aspect of the original judgment (which was not set aside) was that it confirmed that the UK courts would hear non-infringement actions in relation to multiple European jurisdictions in a single court action. Conclusion and the next stages In view of the finding of indirect infringement, the Court of Appeal concluded that Actavis was not entitled to a declaration of non-infringement. In their post-appeal submissions, Actavis suggested that they could specify that their product should be reconstituted in dextrose solution rather than saline solution. However, it was held that the issue of whether there would be indirect infringement in doing this should be a matter for the Patents Court – and the case has been remitted back accordingly. 6. The High Court has invalidated a patent in the third action by Hospira which is part of ongoing efforts to clear the way for their launch of a biosimilar of trastuzumub. Hospira UK Ltd v Genentech Inc [2015] EWHC 1796 (Pat), 24 June 2015 • The court held that Genentech's patent relating to the use of trastuzumab with a taxane to treat HER2-positive breast cancer was invalid for obviousness. • The judge concluded that upon reading the prior art a skilled person motivated to find a cure for HER2-positive breast cancer would have carried out trials based on its contents and would in the process discover the invention. This meant that the invention was obvious. Hospira sought to rely on lack of novelty and on obviousness as grounds for invalidity due to the existence of the prior art, Baselga et al, "HER2 overexpression and Paclitaxel Sensitivity in Breast Cancer: Therapeutic implications" (Baselga 97). The report gave results from Phase II studies, stating that they had led to a Phase III study being designed which would trial trastuzumab combined with a taxane. Results of the Phase III study were not included in Baselga 97. However, Genentech summarised those results in its patent, and went on to claim that the combination of trastuzumab and a taxane was clinically beneficial, which is what was indicated by the Balsega 97 Phase III results. The question therefore arose as to whether the mention of the Phase III trial in the prior art was enough to anticipate a claim of a specified therapeutic effect? In other words: was Genentech's claim novel? Arnold J stated that the fact the mere existence of a trial is mentioned will not alone anticipate a claim of a specified therapeutic effect revealed by the results of that trial, if those results were not themselves disclosed. This was the case unless a reader could ascertain this therapeutic effect "directly and unambiguously" from the disclosure of the trial alone. Arnold J concluded that a reader of Baselga 97 would not have known that this clinical benefit would be obtained and therefore Genentech's patent did not lack novelty. Hospira failed on this ground. As regards Hospira's arguments on obviousness, Arnold J had to consider whether it would have been obvious to a skilled reader of Baselga 97 to try to perform the invention described in Genentech's patent. The judge considered MedImmune v Novartis [2012] EWCA Civ 1234, stating that the test to apply was whether a skilled person would have a "fair expectation of success" if he were to try the process claimed. In considering whether this test was met, Arnold J considered how motivated a skilled reader would be to find the treatment, whether carrying out a Phase III trial to discover the clinical benefit would a heavy burden, and the context in which Baselga 97 would be read. He concluded that a skilled person would be motivated to carry out further trials having read Baselga 97, and in doing so would discover Genentech's invention. This meant that the invention was obvious and the patent was therefore invalid. 7. High Court gives ruling on strike out of competition law defence to patent infringement Unwired Planet International Ltd v Huawei Technologies Co Ltd & Others [2015] EWHC 2097 (Pat), 21 July 2015 An earlier ruling in this case on an application for summary judgment in relation to whether Unwired had offered to licence patents on fair, reasonable and non-discriminatory (FRAND) terms was reported in our June update. This relates to a different aspect of the case. • The court considered an application to strike out allegations of breaches of competition law as part of a defence to a claim for patent infringement. • Ericsson applied to have allegations that they had breached Article 101 of the Treaty on the Functioning of the European Union (TFEU) struck out or decided summarily. Samsung brought three claims in relation to the allegation and the court considered whether each one was required to be heard at trial. 7 Ericsson transferred several standard essential patents (SEPs) to Unwired under a Master Sale Agreement (MSA). Under the MSA, Ericsson was entitled to a share of the revenue earned by Unwired from licensing those patents. Unwired brought proceedings against Samsung and other defendants for patent infringement and offered to licence the relevant SEPs to them. Amongst other points, Samsung raised competition arguments as part of their defence. They alleged that: • The MSA breached Article 101 TFEU and was therefore void meaning that Unwired had no title to the patents and could not sue for infringement. • Unwired breached Article 102 TFEU by offering to license the patents on terms that were not FRAND. The second of these issues was the subject of an application for summary judgment by the defendants which was refused. See our previous report on this case from our June update. Ericsson was joined to the proceedings and applied to have the allegations of breach of Article 101 struck out or for summary judgement on these claims. Each of the breaches claimed by the defendants was considered in turn. Breach 1 – transfer of FRAND obligation The defendant submitted that the terms of the MSA did not compel Unwired to licence on FRAND terms and that even if it had so compelled Unwired, the obligation would not be enforceable by any third party. After concluding the MSA, Unwired made a FRAND declaration to the European Telecommunications Standards Institute (ETSI). The court held that this claim should be struck out. Under the MSA, Unwired was bound to make a FRAND undertaking and did so. Unwired had no ability under the MSA to contract on non-FRAND terms and by making the declaration to ETSI, Unwired had rendered this obligation enforceable by any third party seeking a license from Unwired. Breach 2 – division of patent portfolio Samsung alleged that the transfer of the SEPs out of Ericsson's portfolio to Unwired infringed Article 101 as Ericsson retained the right to a share of the revenue generated and could transfer further patents to Unwired in the future and because Unwired is a patent assertion entity. They argued that these factors would encourage Unwired to charge a higher price for the license to cover the royalties payable to Ericsson. The court felt that this claim should go to trial as it was impossible to say that this point would have no real prospect of forming a successful argument that the object and/or effect of the MSA was to restrict or distort competition. Breach 3 – terms of the MSA Samsung argued that two particular clauses of the MSA were examples of hard core restrictions and a form of price fixing. These were a clause stating that Ericsson was entitled to a minimum royalty payment regardless of what rate Unwired agreed with the licensee and a clause restricting the terms on which Unwired is able to license the SEPs. The judge felt it was arguable that these terms could create an anti-competitive incentive for Unwired to charge higher royalties and that it should be considered fully in context. This claim was also not struck out. 8. High Court decides not to transfer a patent licence dispute to the Patents Court Medical Research Council v Celltech R&D Ltd [2015] EWHC 2139 (Ch), 7 July 2015 The court refused to transfer a dispute concerning non-payment of royalties under a patent licence to the Patents Court because the complex technical questions of patent construction were not being raised by either party at this stage of the proceedings. • The court held that the fact that patent judges have more expertise in dealing with construction of patent licences is not in itself sufficient to warrant a transfer to the Patents Court which would have the effect of taking scarce judicial resource. • The court noted, obiter, that the list in CPR 63.2(1) which sets out types of claims to be heard by the Patents Court or the Intellectual Property Enterprise Court is non-exhaustive as concluding otherwise would be inconvenient in practice. The Medical Research Council ("MRC") brought an action against Celltech R&D Limited ("Celltech") for non-payment of royalties due to MRC under a licence granted to Celltech in 1987 (the "Winter Licence"). The Winter Licence related to a number of patents in the field of recombinant antibodies and methods for production and required Celltech, in broad terms, to pay royalties on sales of products which would, but for the Winter Licence, infringe the licensed patent portfolio. Celltech applied to transfer the dispute to the Patents Court. It put forward a number of arguments to support its application: • MRC, in order to succeed in the licensing dispute, would have to demonstrate that the products in question would, but for the Winter Licence, infringe the licensed patent portfolio which raises the spectre of a patent infringement dispute. • Issues of construction of patent licences would be much more securely and easily determined by a judge of the Patents Court with patents experience. • It may be necessary for the court to determine foreign patent law issues which the judges of the Patents Court are used to doing. • Further issues relating to case management, what particulars should be given and the scope of the pleadings would be better dealt with by the judges of the Patents Court. 8 The court accepted that infringement questions may materialise at trial which would raise complex technical issues that should more appropriately be determined by the Patents Court. However, Nugee J accepted MRC's argument that even if such questions do arise in the future, they are not before the court at this stage. Nugee J further stated that transferring the dispute to the Patents Court would have the practical effect of taking that quite scarce judicial resource and devoting it to a case where it may well turn out at the end of the day to be quite unnecessary. He accepted that while judges who have regularly practiced in the field may find it easier, quicker and sounder to construe patent licences, that in itself is insufficient to warrant a transfer. The judge refused the application without prejudice to Celltech's ability to try again at a later stage if it becomes apparent that there will be an active dispute regarding complex technical issues. The judge commented obiter that the list in CPR 63.2(1) which sets out the types of claims which must be started in the Patents Court or in the IPEC should be treated as non-exhaustive. A result to the contrary would lead to some seriously inconvenient practical consequences and preclude highly technical cases being heard by the judges with appropriate expertise. 9. Teva succeeds in obtaining interim injunction, as Actavis fails to "clear the path" Teva Pharamceutical Industries Limited v. Actavis UK Limited [2015] EWHC 2604 (Pat), 9 September 2015 • Arnold J in the Patents Court granted Teva's interim injunction application to restrain Actavis from allegedly infringing one of its patents for ragasaline citrate and its use for the treatment of Parkinson's. • In establishing that there is a serious question of validity to be tried, the court rejected Actavis' Gillette defence and accepted Teva's argument that the precise processes disclosed in the prior art that Teva sought to rely on need to be considered in detail and with great care. • On irreparable harm, Arnold J was guided by Actavis' failure to clear the path by means of an application for revocation or a declaration of non-infringement. Teva commenced the proceedings immediately after it learnt that Actavis had launched a generic ragasaline product on 25 August 2015. The active ingredient in Actavis' product was ragasaline tartrate, as opposed to the citrate disclosed in Teva's patent, EP (UK) 2 246 321 (321 Patent). However, Teva's contention was that due to the presence in Actavis' product of citric acid as an excipient, together with sources of water, salt exchange will take place between the ragasaline tartrate and the citric acid to form ragasaline citrate. Teva submitted an expert report containing details of the analysis of samples of Actavis' product. Arnold J had earlier rejected an application by Actavis contending that this expert report was inadmissible. On the assumption that the expert report was admissible, Actavis accepted that it establishes a serious question to be tried in relation to infringement. However, Actavis disputed there was a serious question to be tried overall on the basis of a Gillette defence i.e. if there was infringement of the 321 Patent, it was inevitable that the Patent was invalid over prior art. In this connection, Teva sought to rely on PCT application WO2008/019871 (the "Application") which refers to the fact that ragasaline is a known substance which is used in particular to treat Parkinson's. The Application lists citric acid as one of the stabilisers that may be contained in the pharmaceutical compositions according to the invention. The Application describes at least two formulation processes involving water. Against this background, Actavis contended that if its tartrate product can be said to infringe the 321 Patent by way of salt exchange, it is inevitable that the same will occur if the directions in the Application are followed. Arnold J rejected Actavis' argument and concluded that there is a serious question to be tried on validity, primarily based on the following contentions made by Teva: • The Application came into the case only on the day before the hearing. Neither side had an opportunity to serve expert evidence in relation to the disclosure of the Application. Teva argued that in the circumstances, the court has to be particularly cautious before concluding that the case on invalidity is so strong that Teva can be said to have no real prospect of success. • While the infringement case makes it likely that the citrate will be formed, it is not inevitable that it will be formed. The precise process will have to be further considered before any conclusion is made on whether the salt exchange will definitely take place. • It was necessary for Actavis to establish that there was disclosure of all features of Claim 15 of the 321 Patent, including use for the purpose of treating Parkinson's. Prima facie, the Application fails to do that. On the question of irreparable harm, Arnold J saw merit in Teva's contention that even if it is successful at trial, it does not follow that it will be able to bring its prices back up to the monopoly price. He noted that there is "no evidence of any instance where a pharmaceutical company which has sought injunction in circumstances such as these has been successful in raising its prices after refusal of the interim injunction but success at trial." Other companies had already been granted MAs, and Arnold J acknowledged that they were waiting in the wings to launch their products. From Actavis' point of view, Arnold J considered that the "most important form of unquantifiable harm" is the "loss of the first mover advantage". Having said that, he noted that the advantage is likely to be short-lived in any event since it was clear from the facts that other generic companies had been granted MAs and one of them (Glenmark) had, in its response to a letter from Teva, expressly stated that while it undertakes to provide Teva with notice of an intended launch in the UK, it reserved the right "to reconsider its position pending the outcome of the injunction application against Actavis." Arnold J, however, accepted that that the result of an injunction against Actavis will deprive it of first mover advantage for at least a 9 period of time. Arnold J noted that he "faces the familiar dilemma that, on both of the contrasting hypothesises, one side is going to suffer harm which will be difficult to quantify". Relying on Smith Kline Beecham vs. Apotex, he noted that it is a well-established principle for the court to maintain the status quo in "cases of doubt". In that connection, he placed importance on Actavis' failure to "clear the path". He noted that Actavis did not attempt to have the 321 Patent revoked nor did it seek a declaration of non-infringement. There was no evidence produced by Actavis to say that it was unaware of the 321 Patent or that the allegation of infringement put forward by Teva has come as a surprise to it. Actavis noted that the evidence in Teva's expert report did not attempt to quantify the amount of citrate present in the Actavis product. In the circumstances, it may be that only a "comparatively tiny" amount of citrate may be present and that would result in the injunction to restrain the marketing of the entire Actavis product having a disproportionate effect. Arnold J, rejected this de minimis argument, noted that this contention is no more than the "familiar one that defendant could have achieved the same commercial objective without infringement." 10. Court of Appeal upholds invalidity of Rovi's patent Rovi Guides Inc v Virgin Media Ltd & Others [2015] EWCA Civ 1214 Rovi appealed the decision of Mann J that claim 3 (and corresponding process claim 28) of its UK patent No. 0 862 833 were invalid due to lack of inventive step. The invention concerned viewer-controlled selection of programming information which informs the viewer in real time of events available currently or in the future by displaying a prompt or icon on the screen thereby avoiding the delay caused by having to scroll through the information. The system operates by two signals. First an identification signal indicates that information is available and causes an icon or text to be displayed on screen, if the user responds to the identification signal via the remote control then an information signal is processed and the information is displayed on screen. Claim 3 provides: A. A system according to claim 2, wherein said first identification signal comprises: B. (i) Data indicating the availability of said first information signal; C. (ii) (a) data defining an icon or textual matter alerting a viewer to the availability of information or (b) data enabling access to such an icon or textual matter as may be already stored on said computer; and D. (iii) data defining said preselected times and said predetermined time increments. The prior art relied upon by Virgin Media in its counterclaim to infringement at first instance was a PCT application by Apple Inc. ("Florin") which contained a passage entitled "Home Shopping Interface". This described a blinking select icon shown in a graphic overlay panel on the viewer's screen which enabled them to access additional information relating to the item being sold on the programme. Virgin argued that implementation of the teaching of Florin using the common general knowledge would lead the skilled team to construct a system that fell within the claims. Mann J. held that claim 2 was obvious in light of Florin but that a critical feature of claim 3 was C(ii) The parties agreed that C(ii)(a) was not obvious, however the claim could still be invalid if the second alternative, feature C(ii)(b) was obvious. Rovi, relying on the specification, argued that this feature was not obvious as it required that the data in the identification signal contained a 'pointer' to the icon which appeared on screen. This argument, which had not been given much emphasis throughout the trial or in Rovi's skeleton, was rejected by Mann J. He held that the relevant integer was to be construed in the sense that the data in the identification signal must trigger the icon. There was no requirement for a pointer in the signal. Claim 3 was therefore obvious and invalid. In dismissing the appeal, Floyd L J. noted that the process of construction is rarely assisted by taking paraphrases of the words of the claim. Mann J. had correctly concluded that there was no justification for substituting the more specific word 'pointer' for the general words of the claim 'data enabling access'. He also approved of Virgin Media's citing of the approach in Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Ltd [2009] EWCA Civ 1062 that "the inventor's purpose is not the beall and end-all. One is still at the end of the day concerned with the meaning of the language used." He therefore held that the skilled person would infer that the patentee had chosen entirely general language which was capable of encompassing the arrangement described in the specification, but was not limited to it. A further principle of construction was also referred to: that dependent claims would normally be expected to add technical subject matter to the claims on which they depend. On the facts of the case it was agreed that integer C(iii) of claim 3 was not implicit in claim 2, therefore it was immaterial that C(ii)(b) did not add anything to the substance of claim 2. 11. Flynn Pharma can assert its trade mark to prevent the parallel importation of re-branded Epanutin Flynn Pharma Ltd v Drugsrus Ltd and Tenolol Ltd [2015] EWHC 2759 (Ch) The Defendants' proposed use of 'Phenytoin Sodium Flynn' was trade mark use since 'Flynn' is not a word associated with medicines. • A disclaimer in the packaging small print is insufficient to counteract infringing trade mark use. 10 • The BMS criteria do not apply when the product is placed on the market in another member state by a different entity to the one seeking to prevent the parallel import. In 2012, Flynn Pharma acquired from Pfizer the rights to market and sell phenytoin sodium capsules, an anti-epileptic drug, in the UK. As a requirement for transferring the marketing authorisation, the Medicines and Healthcare products Regulatory Agency (MHRA) required that the generic product be called 'Phenytoin Sodium Flynn' and also that a communication plan was followed for notifying patients and healthcare professionals of the name change. Apart from one other supplier, NRIM, the only other source of phenytoin sodium capsules in the UK is in the form of parallel imports from other EU Member States, where the product continues to be marketed under the Pfizer brand Epanutin. The Defendant Tenolol holds product licences for such parallel imports. Drugsrus is a related company that imports and sells parallel imported drugs using licences held by Tenolol. The Defendants sought to market the imported products under the generic name 'Phenytoin Sodium Flynn' rather than Epanutin; this would widen their use as it would enable them to be used by pharmacists to fulfil prescriptions written for 'Phenytoin Sodium' rather than just those issued for Epanutin. Flynn Pharma argued that the Defendants' proposed use of the 'Flynn' mark amounted to an infringement pursuant to section 10(1) of the Trade Marks Act (equivalent to Art. 5(1)(a) of the Trade Mark Directive 2008/95 (the Directive)) because it was use of the identical sign for identical goods. The Defendants relied on section 11(2)(b) of the Trade Marks Act (Art.6(1)(b) of the Directive) and said that they were not using the mark as a trade mark but only as a description of the goods. In dismissing the Defendants' argument, Rose J held that its proposed use of 'Phenytoin Sodium Flynn' was clearly trade mark use of the word 'Flynn'. Since 'Flynn' is not a word associated with medicines or ingredients or otherwise denoting the qualities or characteristics of the medicine, it would be perceived by consumers as a mark of origin denoting Flynn Pharma as being the entity responsible for the quality of the goods. The Defendants also sought to rely on a disclaimer that it proposed including on the outside of the pack and in the patient information leaflet a statement that the product is not distributed by Flynn Pharma. Rose J did not find the disclaimer sufficient to clarify the relationship between the product and the Claimant, stating: "The use of a word in naming a product where the word is clearly a brand name is not gainsaid by small print explaining that the product has not been made or marketed by the entity which owns the rights to use that name." In Bristol-Myers Squibb v Paranova [1997] FSR 102 ("BMS"), the CJEU held that a trade mark owner could not legitimately enforce its trade mark if the national court found that five conditions were met. The first BMS condition was most relevant to the current case: "…where the owner has put an identical pharmaceutical product on the market in several Member States in various forms of packaging, and the repackaging carried out by the importer is necessary in order to market the product in the Member State of importation…" Rose J agreed with the Claimants that a pre-condition for the owner to be able to prevent such importation was that the products were placed on the market in the exporting Member State by the same entity trying to prevent its import into another Member State. The Defendants' could not establish that the Epanutin that they were seeking to import into the UK was placed on the market in the exporting member state by Flynn Pharma - the entity trying to prevent its import. Neither could the Defendants establish that there was a sufficient link, either at a corporate or contractual level, between the entity that had control over the production of Epanutin capsules in the exporting state (Pfizer) and of the Phenytoin Sodium Flynn capsules in the UK (Flynn Pharma). Therefore the pre-condition for the application of the five BMS conditions could not be met. Having found that Flynn Pharma was entitled to prevent the relabeling of the parallel imported product by the Defendants, Rose J went on to consider whether, if the BMS criteria had been engaged in this case, the Defendants would have established the second aspect of the relevant condition - that it was necessary for them to re-brand imports of Epanutin as Phenytoin Sodium Flynn in order to market the product in the UK. On the facts, she held that the condition would have been satisfied. The remaining 4 conditions of BMS were not considered. 12. High Court considers the requirement of plausibility in relation to a Swiss Form Patent Actavis Group PTC EHF and another v Eli Lilly and Company [2015] EWHC 3294 (Pat), 16 November 2015 To clear the path for a generic product for the treatment of ADHD Actavis sought revocation of Lilly's second medical use patent for atomoxetine. Actavis alleged that the patent makes no more than a bald assertion that atomoxetine is effective and safe for the treatment of ADHD and therefore the disclosure lacks plausibility and is insufficient or obvious on the basis of lack of technical contribution. The Court considered whether the standard of “plausibility” is the same for obviousness and sufficiency (i.e. that the skilled person should be able to make a fair prediction that the alleged invention will, not might, succeed). Carr J noted that it is relevant to bear in mind that plausibility does not form a separate ground of objection to the validity of a patent. A plausible invention may nonetheless be shown to be insufficient. He also noted that plausibility does not apply only as a check on overbreadth of claims of wide scope. Whether an invention is plausible is fact sensitive and will depend upon the nature of the invention, the scope of the claim, the disclosure of the specification and the common general knowledge. 11 Carr J further noted that the policy considerations underlying plausibility for sufficiency and obviousness are different, which indicates that the standard for assessment is not the same. For obviousness, a fair expectation of success is required because the denial of patent protection based upon the “obvious to try” criterion alone would provide insufficient incentive for research and development. He held that, for sufficiency, the test of plausibility is a threshold test which is satisfied by a disclosure which is “credible”, as opposed to speculative. On the facts, the patent was plausible. 13. Ono's Swiss Form patent is plausible and valid Merck Sharp & Dohme Limited v Ono Pharmaceutical Co. Limited & another [2015] EWHC 2973 (Pat) Merck contended that Ono's patent, for the use of anti-PD-1 antibodies for the treatment of cancer, was invalid and therefore not infringed by its own an anti-PD-1 antibody product, pembrolizumab (brand name Keytruda). Merck alleged that the patent lacked plausibility as part of its priority, sufficiency and obviousness attacks. Birss J confirmed that the requirement for plausibility was part of the law of priority. In relation to enablement of Swiss Form claims the question is whether the patentee has shown, for example by appropriate experiments, that the product has an effect on a disease process so as to make the claimed therapeutic effect plausible. The scope of the mental element of the Swiss Form claim makes no difference to the analysis. In relation to sufficiency, the assertion that the invention will work across the scope of the claim must be plausible or credible. Birss J dismissed Merck's argument that the patent was only plausible for treatment of tumour cells expressing PD-L1 and that it was not plausible that anti-PD-1 antibodies could treat all cancers. He therefore held that the claims were plausible at the priority date and the patent valid. 14. Disclosure published on same day that a patent is filed is not prior art Unwired Planet International Ltd v Huawei Technologies Co Ltd & Ors [2015] EWHC 3366 (Pat), 23 November 2015 The patent, for an efficient polling system for a wireless communication network, was obtained by Ericsson and subsequently acquired by Unwired. It had been declared essential to the 4G telecommunications system. Huawei and Samsung contended that the patent is invalid and therefore not infringed. In relation to priority Unwired Planet argued that the fact that a claim was wider in scope than a specific embodiment described in the priority document did not mean priority was lost. Section 5(2) of the 1977 Patents Act provides that an invention is entitled to priority from a priority document filed before the patent application if it is supported by matter disclosed in the priority document. The equivalent provision in the EPC is Art 87(1) which provides that the right of priority arises as long as the priority document is in respect of the “same invention” requires the skilled person to be able to derive the subject matter of the claim directly and unambiguously using common general knowledge from the priority document as a whole. The Court agreed that EPO case law on added matter had a role to play, since "clearly and unambiguously derivable" is the added matter test. However, to maintain priority a claim must also satisfy the principle that its scope is commensurate with the relevant technical contribution. On the facts, the relevant claims were entitled to priority. In relation to novelty the Court considered whether a piece of enabling disclosure formed part of the state of the art. The relevant document ('The Ericsson TDoc') had been uploaded on 8 January 2008 (European time) to a publicly accessible server for consideration at an ETSI Working Group Meeting. The priority document for Unwired's patent was filed at the United States Patent Office (USPTO). This occurred when the date at the USPTO was 8 January 2008. Unwired argued that in certain parts of the world, such as Hawaii, the date on which the relevant document became available would have been 7 January 2008. As per s2(2) of the 1977 Act and Art 54(1) EPC the state of the art comprises everything made available to the public before the priority date. To first establish the priority date, the Court noted that at any given moment, the time and date around the world are different. Thus the priority date has to be based on some frame of reference. The only frame of reference which makes sense is the one at the patent office at which the priority document was filed. Neither the EPC nor the Patents Act required knowledge of the time at which the document was filed. On the facts, the frame of reference corresponded to the location of the United States Patent Office (Eastern Standard Time) so the priority date was the 8 January 2008. The Ericsson TDoc was made available to the public at 02.36 8 January 2008 EST. Therefore it was not made available to the public before the priority date. The fact that this time was 7 January in some places in the world such as Hawaii is irrelevant. 15. Use of HMPC as a capsule material in a dry powder inhaler for the delivery of tiotropium bromide was considered obvious. Teva UK Ltd v Boehringer Ingelheim Pharma GMBH & Co KG [2015] EWHC 2963 (Pat) This case concerned capsules intended to be used in a dry powder inhaler for the purpose of delivering tiotropium bromide to patients suffering from chronic obstructive pulmonary disease, or asthma. Teva sought a declaration of invalidity and revocation order on the grounds of lack of an inventive step, claiming two pieces of prior art and common general knowledge. Teva claimed that there was no disclosure in the patent so show technical benefit, certain integers in the claims were 12 arbitrary, there was not data in the patent to show the capsules plausibly solved a technical problem and the patent did not disclose the invention clearly enough to enable performance by a skilled person. Teva's case focused on a number of new claims as considered below. Claims 5, 6, 6A and 6B were considered. It was found that the invention was not to be considered part of the common general knowledge of a formulation scientist at the time the patent was filed, but that to consider the use of HPMC as a potentially suitable capsule material would have been obvious. Claims 5 and 6 of the patent were considered by the judge to be obvious, with no inventive step and it was suggested that these conclusions apply also to claims 6A and 6B. The specification of specific moisture levels by certain integers in the aforementioned claims was deemed arbitrary. Further issues in relation to these claims were not considered in the judgment. Amendments to introduce claims 5 and 6 were not allowed. Judgment in relation to claim 1 of the patent was adjourned by request of the Defendant, Boehringer, to allow them to file evidence in relation to it. The case will continue to enable the judge to hear submissions on other issues raised and proposed orders. 16. CJEU finds that the notification of the grant of a centralised MA is the relevant date for calculating the term of an SPC Seattle Genetics Inc. v Österreichisches Patentamt (Case C 471/14) Following a reference from the Higher Regional Court of Vienna, the CJEU has issued a decision in Seattle Genetics Inc. v Österreichisches Patentamt (Case C‑471/14) clarifying the meaning of "date of the first authorisation to place the product on the market in the [European Union]" in the SPC Regulation (Regulation 469/2009). The CJEU held that the date on which a centralised marketing authorisation ("MA") holder is notified of the grant of that MA is the relevant date for calculating the term of a Supplementary Protection Certificate ("SPC"), and not the earlier date of the decision to grant that MA. This agrees with the conclusion of Advocate General Jääskinen's Opinion, and confirms the approach to the calculation of an SPC's term previously followed by the UK-Intellectual Property Office and several other national Patent Offices. Read more 13 17. Key points from featured UK decisions Patentee(s) / patent no. Other party/ies Product Court Judge Legal issue Outcome Decisions related to pharmaceutical patents Leo Pharma A/S, Leo Laboratories Limited Teva UK Ltd, Teva Pharmaceutical Industries Ltd ointment to treat psoriasis Court of Appeal Kitchen and King LJJ, Sir Robert Jacob Whether the High Court was correct to find that Leo's patent was invalid for obviousness. Appeal allowed. Patent valid. Warner-Lambert Company LLC EP (UK) 0 934 061 Generics (UK) Ltd (t/a Mylan), Actavis Group PTC EHF, Actavis UK Limited, Caduceus Pharma Ltd, Pfizer Ltd Secretary of State for Health (intervenor) LYRICA (pregabalin to treat pain) High Court (Patents Court) Arnold J Whether it was foreseeable that a skinny label product would be intentionally administered for a patented indication. Patent not infringed. Sandoz GmbH, Lloyds Pharmacy Ltd High Court (Patents Court) Birss J Whether to order a continuation of urgent injunctions until trial. Continuation of injunctions granted. Generics (UK) Ltd (t/a Mylan) High Court (Patents Court) Arnold J Whether allowing an amendment to the patent would require a second trial and amount to an abuse of process. Application to amend patent refused. ConvaTec Technologies Inc. EP (UK) 1 343 510 Smith & Nephew plc Silverised wound dressing Court of Appeal Kitchen, Briggs, Christopher Clarke LJJ Whether the High Court was correct to find non-infringement. Whether to stay the order for an injunction and delivery up pending the Supreme Court's decision on leave to appeal. Appeal allowed. The High Court had wrongly construed the numerical range in the claims of the patent. Eli Lilly & Co Actavis UK Ltd and others Pemetrexed disodium in combination with vitamin B12 to treat cancer Court of Appeal Longmore, Kitchen and Floyd LJJ Whether the High Court was correct to grant Actavis a declaration of noninfringement. Appeal allowed. Declaration of noninfringement overturned. 14 Patentee(s) / patent no. Other party/ies Product Court Judge Legal issue Outcome Genentech Inc Hospira UK Ltd trastuzumab in combination with a taxane (to treat breast cancer) High Court (Patents Court) Arnold J Whether Genentech patent relating to the use of the breast cancer drug, a chemotherapeutic agent, Patent invalid as obvious over a prior art publication. Medical Research Council Celltech R&D Ltd recombinant antibodies and methods for their production High Court (Chancery) Nugee J Application to transfer a case relating to the construction of a US patent licence from the Chancery Division General List to the Patents Court. Application refused. Teva Pharmaceutical Industries Ltd EP (UK) 2 246 321 Actavis UK Ltd Pagasaline citrate for the treatment of Parkinson's. High Court (Patents Court) Arnold J Whether to grant an interim injunction to restrain Actavis from allegedly infringing Teva's patent Interim injunction granted. Eli Lilly & Co Actavis Group PTC EHF use of atomoxetine for the treatment of ADHD High Court (Patents Court) Carr J Whether the patent was invalid for obviousness or insufficiency. Patent valid. Ono Pharmaceutical Co. Limited Merck Sharp & Dohme Limited use of anti-PD-1 antibodies for the treatment of cancer High Court (Patents Court) Birss J Whether the patent was invalid on the grounds of priority, obviousness or insufficiency. Patent valid. Boehringer Ingelheim Pharma GMBH & Co KG EP (UK) 1 379 220 Teva UK Ltd tiotropium bromide capsules for use in asthma inhalers High Court (Patents Court) Morgan J Whether the patent was invalid on the grounds of lack of inventive step. Patent invalid in part. Decisions related to patents other than pharmaceutical patents Unwired Planet International Ltd; Unwired Planet Inc, Unwired Planet LLC EP (UK) 1 230 818, EP (UK) 2 229 744, EP (UK) 2 119 287, EP (UK) 2 485 514, and EP (UK) 1 105 991 Huawei Technologies Co Ltd, Huawei Technologies (UK) Co Ltd, Samsung Electronics (UK) Ltd, Google Inc, Google Ireland Ltd, Google Commerce Ltd 4G wireless telecommunications High Court (Patents Court) Birss J A patent dispute in which alleged breach of competition law was raised as a defence. Struck out in part. 15 Patentee(s) / patent no. Other party/ies Product Court Judge Legal issue Outcome Unwired Planet International Ltd EP (UK) 2 229 744 Huawei Technologies Co Ltd 4G wireless telecommunications High Court (Patents Court) Birss J Whether disclosure published on same day that a patent is filed is prior art. Disclosure published on same day that a patent is filed is not prior art. 16 18. Contacts Clare Blendis (Senior Associate, London) T +44 20 7466 2165 [email protected] Christopher Sharp (Senior Associate, London) T +44 20 7466 2591 [email protected] Grace Pead (Associate, Australia) T +44 20 7466 7518 [email protected] If you would like to receive more copies of this briefing, or would like to receive Herbert Smith Freehills briefings from other practice areas, or would like to be taken off the distribution lists for such briefings, please email [email protected] © Herbert Smith Freehills LLP 2015 The contents of this publication, current at the date of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action based on the information provided herein.