United Kingdom Patent Decisions 2015

This report highlights the main UK patent cases from 2015, tracking through second medical use patents, issues of construction, the interpretation of “plausibility” and “obvious to try”, infringement, injunctions, stays, and damages.

2015 was a voluminous year in UK patent jurisprudence, with the Patents Court, Intellectual Property Enterprise Court, and Court of Appeal all deciding a higher number of cases than usual. This report describes some of the most notable of those decisions.
The law surrounding second medical use patents and ''Swiss form claims'' was developed in the on-going, high-stakes dispute over Warner-Lambert's second medical use patent for the use of pregabalin (branded Lyrica) for the treatment of pain, including neuropathic pain. Warner-Lambert was refused an interim injunction against Actavis' generic pregabalin product, Lecaent, in both the Patents Court 1 and Court of Appeal. 2 In successive decisions, Arnold J and Floyd LJ offered extensive (and somewhat conflicting) analyses of when a patent is made ''for'' a patented indication, and associated requirements of intention and foreseeability. These decisions were followed by a book-length first instance trial decision from Arnold J in September 2015, 3 finding no infringement of Warner-Lambert's patent by Actavis and holding, further, that claims relating to certain indications (''all types of pain'', ''central neuropathic pain'', etc.) were invalid for insufficiency. Arnold J's decision involved several departures from Floyd LJ's reasoning on infringement, which may create pressure points at the appeal level. By contrast, Floyd LJ's decision was straightforwardly applied by the newly-appointed Carr J in the separate case of Actavis Group PTC EHF v. Eli Lilly & Co (atomoxetine), 4 holding that Ely Lily's second medical use patent for the use of atomoxetine was valid, because a beneficial effect in treating the patented indication of ADHD was known or reasonably foreseeable to the manufacturer.
In a further Warner-Lambert proceeding, decided between the interim injunction application and the trial, Arnold J adopted a novel approach to the practical problem facing Warner-Lambert. Arnold J relied on the Court's inherent jurisdiction to order the National Health Service to require doctors and pharmacists to only prescribe patented Lyrica, and not generic pregabalin, for neuropathic pain. 5 Though Arnold J claimed at the time that the NHS order, effectively co-opting medical professionals into patent protection, was ''the most efficacious, dissuasive and cheapest solution'', he acknowledged eight months later that the order and guidance had been ''less effective than was anticipated''. 6 In the September trial decision Arnold J also expressed a desire that the NHS provide clearer guidance, informed by patentees, to assist the protection of genuine second medical use patents while also allowing lawful generic competition for non-patented indications. Whether such orders will become more commonly used, the proper legal basis for their issuance, as well as the best ways to incentivise medical research on novel indications more generally, will all be key questions over coming years. Two interesting judgments explored the role of ''plausibility'' in different areas of patent law. 7 Birss J in Merck Sharp & Dohme Ltd v. Ono Pharmaceutical Co Ltd 8 affirmed a strong role for plausibility in sufficiency, but cautioned that it is not a statutorily-derived notion. A similar sentiment was expressed by Carr J in the above-mentioned case of Activis v. Lily (atomoxetine); 9 though plausibility was characterised in that case as a threshold only, giving way to a broader sufficiency assessment. It is worth noting that Justice Henry Carr's robust expertise and his demonstrated willingness to issue clear, bold decisions in his first months on the bench affirms the strength of his 2015 appointment to the Patents Court.
2015 also saw the appeal in the test case of Actavis UK Ltd v. Eli Lilly & Co (pemetrexed). 10 Floyd LJ remitted Arnold J's novel 2014 decision 11 to grant Actavis declarations of non-infringement in relation to French, Italian, Spanish and UK designations of Ely Lilly's patents on its anti-cancer drug pemetrexed disodium. The Court of Appeal differed from the original decision in choosing to rely on ordinary claim construction, rather than on the prosecution history of the patents. This reconfirmed the non-availability of ''file wrapper estoppel'' in UK litigation. Further, the Court held that the provision of a compound's salts in a form requiring reconstitution or dilution involved providing ''means relating to an essential element of the invention'', exposing Actavis to liability for contributory infringement. This finding directly contradicted that of the Düsseldorf Court of Appeal shortly before the decision. 12 In 2016, Actavis continues its fight in the UK, in part through its proposal of an alternative, non-saline reconstitution method that is alleged not to infringe the patent.
The Court of Appeal in the ''numerical limits'' case, Smith & Nephew Plc v. ConvaTec Technologies Inc, 13 held that a concentration range of ''between 1 and 25 %'' for a particular component of a manufacturing method (a binding agent used in a silverisation process) should be understood on a whole number basis (i.e. C0.5 and \25.5 %), rather than through the lower court's application of a significant figures approach (i.e. C0.95 and 25.5 %). The finding was determinative, because the alleged infringer, Smith & Nephew, had adopted a process that involved a concentration of B0.77 % in its binding agent. Separately, the Court accepted an application by Smith & Nephew to stay injunctive relief, pending an application for leave to appeal to the Supreme Court. 14 An opposition case is also being contested in parallel in the EPO Boards of Appeal.
Another finely diced numerical case was Unwired Planet International Ltd v. Samsung Electronics Co Ltd, 15 where the question of anticipation turned on the time-zone of patent filing and the respective publication time of alleged prior art. A document published online at 2:36am in the place of filing, on the same day as the filing, was held not to have anticipated and invalidated the patent.
''Obvious to try'', an old chestnut of UK jurisprudence, was the subject of several interesting decisions, and was used to find the patent at issue in Hospira UK Ltd v. Genentech Inc 16 invalid for obviousness, while the patent was maintained on the basis of the same test in the appeal in Teva UK Ltd v. LEO Pharma A/S. 17 The latter case also helpfully clarified that the law of obviousness attributes to the notional person the real prejudices and practices of persons skilled in the art, not some artificial abstraction.
In the area of procedure, a stay on domestic infringement proceedings, pending parallel EPO opposition proceedings, was refused in the e-cigarette case, Fontem Holdings 1BV v. Ten Motives Ltd. 18 Norris J applied the Court of Appeal's 2013 guidance in IPCom GmbH & Co Kg v. HTC Europe Co Ltd, 19 refusing an application by the patentee's competitor, Ten Motives, to grant a stay. The decision was influenced by the nature and speed of change in the expanding e-cigarette market, which encouraged swift domestic resolution of proceedings, as well as the fact that Ten Motives would have future opportunities to apply for a stay as litigation progressed. The case proceeds to trial in 2016.
Finally, the costs of seeking an interim injunction for a patent that is subsequently invalidated were starkly emphasised in AstraZeneca AB v. Krka dd Novo Mesto. 20 The Court of Appeal upheld the Patents Court's award of £27 million damages (the largest ever such award) from AstraZeneca to companies that lost their first-mover's advantage on using the drug esomeprazole to treat gastric conditions over ten months in 2010-2011, due to an interim injunction obtained before validity was tried in the courts.