Round-up of English Patent Litigation in 2022

After the bumper year of 2021 in terms of the number of patent trials in the English courts, 2022 saw a slight easing off in the level of trial activity, at least in terms of determinations as to patent validity and infringement.¹ 2022 saw, at first instance, in inter partes proceedings in which patent infringement and/or validity was in issue, 16 final decisions in the Patents Court and one in the Intellectual Property Enterprise Court, concerning in total 27 patents. The validity of all but two² of these patents was challenged, successfully so in respect of 18 of them, but infringement was in issue in respect of only 15 patents, of which only five were held to be not infringed at all. Of the 18 patents held to be invalid, 15 were held to be obvious,³ one anticipated and one insufficient. The patentee prevailed, in whole or in part, in relation to seven patents, all of which survived challenges to validity and all of which were held to be infringed, at least in relation to some of the products or processes in issue, apart from four where infringement was admitted.

In summary, in the same way as in previous years, as shown by the following table, most of those cases that got to trial turned primarily on obviousness. Other attacks on validity were rarely successful, and in only relatively few cases did non-infringement arguments, where these were run, succeed.

Despite the relatively large number of Patents Court determinations in 2021 (19 trials concerning 32 patents), 2022 saw only six Court of Appeal decisions in inter partes proceedings concerning validity, all of which upheld such findings at first instance, with infringement not being in issue in any of these. As might be inferred from this statistic, none of these appellate decisions established anything new by way of legal principle, but neither did they involve anything notable in terms of new formulations or summaries of the law. As in 2021, there were no decisions on patent (or indeed any other IP) matters from the UK Supreme Court in 2022, although as noted later, at least one is promised for 2023, and leave to appeal has been given in another.

A summary of all the inter partes decisions on patent infringement and/or validity at first instance and on appeal in 2022 is set out in the Appendix at the end of this article.⁴ But in addition to these final decisions on patent infringement and/or validity, there have been important decisions on damages and threats, as well as numerous decisions on important procedural issues and remedies, such as interim injunctions and ‘Arrow’ injunctions, some of which represent the most significant decisions of 2022.

As in previous years and as emphasized by the above table, by far, the most common successful ground of invalidity in 2022 was traditional (ie non-Agrevo) obviousness. As in 2021, little or no new law as to this was made in 2022, but the cases reviewed not only the assessment of the inventive step itself but also the identity and structure of the skilled team⁵ and the nature of the common general knowledge,⁶ although no decision can be said to have turned on these last two issues.

The judgment by His Honour Judge (HHJ) Hacon in Teva v Novartis⁷ is worth singling out from the various other decisions on inventive step in 2022 for its extensive discussion of a number of aspects of the law of obviousness, including (i) (at [71]) the role of the ‘inventive concept’ of the second and third steps of the traditional Pozzoli approach of the UK courts in analysing obviousness, (ii) the relationship between this and the ‘inventive concept’ for the purposes of the first step in the Actavis v Lilly⁸ equivalence analysis, (iii) a potential but hitherto unrecognized difference between the problem–solution approach of the European Patent Office (EPO) and the Pozzoli approach and (iv) (at [123]) a number of aspects of the final step of the Pozzoli approach, including the relation between a number of earlier cases on obviousness and the list of factors that may be taken into account when considering the inventive step set out in Actavis v ICOS.⁹

Insufficiency has long been a popular attack on validity in the English courts,¹⁰ although it has in practice proved to be much less successful as an attack than obviousness, with which it is generally in tension, unless the obviousness in question is lack of technical contribution, or Agrevo-type obviousness, with which certain types of insufficiency can correspond. In such cases, this can involve analysis of the vexed question of ‘plausibility’—namely, whether it is plausible from the specification as filed that the invention will ‘work’—which issue is also currently under review by the EPO Enlarged Board of Appeal in Pending Referral G 2/21.

2022 saw the UK and EPO case law as to plausibility in the context of both insufficiency and Agrevo-type obviousness reviewed in detail by Meade J in Sandoz & Teva v Bristol-Myers Squibb.¹¹ Having discussed its basis in T-939/92 Agrevo/Triazoles and its most recent development in English law in Warner-Lambert v Generics¹² and FibroGen v Akebia Therapeutics,¹³ he went on thoroughly to analyse by reference to other EPO and UK case law what it means for the invention to ‘work’, which he held (at [68]) ‘is to be determined from the specification where the claim is not explicit’, going on to note that ‘the patentee is not restricted to the most ambitious assertion made. In some cases, the patentee may be able to rely on a more limited contribution, but this must be fact-dependent and will still have to find a basis in the specification’, As to what level of activity was required in determining whether it is plausible from the application that the invention does in fact ‘work’ he observed at [76], having recognized that there is no requirement to file data in an application in order to establish plausibility:

The weight of judicial analysis directed in recent years to what might be termed ‘plausibility insufficiency’ should not, however, distract from other types of insufficiency; both ‘undue burden insufficiency’ and ‘uncertainty insufficiency’ were fully reviewed in 2022 by Michael Tappin KC in Saint-Gobain Adfors v 3m Innovative Properties.¹⁴ The patent was invalidated for the former, but not the latter, which is in practice of narrow application and has no application to ‘puzzles at the edge of the claim’.

In most of the cases in which there was a finding of infringement in 2022, this was on the basis of what has come to known as the ‘normal’ interpretation of the claims, rather than as the result of applying the two-stage approach to determining infringement by equivalents as mandated by the UK Supreme Court in Actavis v Eli Lilly¹⁵—namely, determining first what is the ‘normal interpretation’ of the claim and second whether the alleged infringement an immaterial variant of that, for which in the second stage, it applies a modified version of the three old ‘Improver’ questions. This may in part be attributable to the practice introduced in 2021¹⁶ that infringement by equivalence must be specifically pleaded, requiring that it be raised at the outset. This practice has, however, also had consequences for those cases in which infringement by equivalence is not argued, as observed by Meade J in Siemens Gamesa Renewable Energy v GE Energy at [63]:¹⁷

The judgment in Siemens also considered (at [77]), the relevance of the prosecution history to claim interpretation, but rejected the attempt to rely on it first because the claims were not sufficiently unclear, and secondly because the file did not unambiguously resolve matters—which has usually been the case when the point has been argued.

Even though 2022 saw few cases in which infringement by equivalents featured, the relatively new nature of the law as to this has increased the significance of those cases in which it does play a role. One case in 2022 in which the equivalence argument mattered was Shenzhen Carku...