In Fisher & Paykel v ResMed EWHC 2748 (Ch) Richard Meade QC, sitting as a Deputy High Court Judge, has delivered the second substantive High Court judgment to consider the Supreme Court's decision in Actavis v Eli Lilly, following hot on the heels of Arnold J's decision last month in Mylan v Yeda III (For a brief analysis of Mylan, see here). In a ground-breaking decision, Actavis departed from the former approach to determining the scope of claims by purposive construction and introduced a two-stage approach – at least for infringement – involving (i) - determining (through the eyes of the notional skilled person) the "normal interpretation" of the claims and if a variant does not fall within the claims as a matter of normal interpretation moving on to (ii) - considering infringement by way of the principle of equivalents utilising a three-step, reformulated Improver test.
In this case, Fisher & Paykel sought revocation of ResMed's patent relating to the configuration of a continuous positive airway pressure mask used to treat obstructive sleep apnoea. ResMed counterclaimed for infringement (cf Actavis (declarations of non-infringement only) and Mylan (revocation only)) but in reality the main issue was validity (given Fisher & Paykel's primary position on claim scope).
The Judge provided some views on the effects of Actavis, but decided that as matters stand (and with no other higher decision yet) he should follow the approach of Arnold J in Mylan. Furthermore, as in Mylan, he considered that the approach taken made little difference to the outcome of the case.
The Judge suggested that in light of Actavis it may be preferable to refer to "claim scope" rather than "claim construction" to indicate that it is no longer permissible to use the one-stage purposive construction approach from Kirin-Amgen (at least for the purposes of deciding whether a claim extends to equivalents in relation to infringement). The Judge referred to the exercise of determining claim scope for a variant and the secondary three-step approach which should be considered in the context of the Supreme Court's judgment as a whole. Additionally he referred to the Supreme Court's discussion of the need to consider the inventive concept of the patent beyond the strict language of its claims and the knowledge that the skilled person should be taken to have when considering any variants, which led to the re-formulation of the Improver questions.
Based on this, the Judge summarised that the overall exercise for the Court is to first determine what the "normal" meaning is and only move on to the three questions if the variant is not within it. The Judge indicates that in his view the Supreme Court equated "normal" with "literal" - recall that in Actavis, the Supreme Court used "literal meaning" rather than "normal meaning" in reformulated questions 1 and 3, having used the term "normal interpretation" for the first stage of the approach. However, the Judge considered he should follow Mylan and that the Court should apply purposive not literal construction for the "normal interpretation". On that basis, it may follow that when there is a need to consider the three second-stage questions, the reference to "literal meaning" in questions 1 and 3 refers to the "normal interpretation" determined in the first stage and not something different. However, neither the Judge here nor Arnold J in Mylan discusses this.
The Judge confirms that at all stages in the Actavis approach (including the first-stage determination) the Court should have regard to what the invention is and that Actavis makes clear that this determination is not limited to what is in the claims but should include consideration of the broader teaching in the specification.
As to the burning issue of whether a claim can be anticipated by equivalence (i.e. "is a claim invalid if it would cover something in the prior art that is outside the "normal" meaning, but would (if done after grant) infringe only by the application of the Actavis questions?"), the Judge did not express a view. Prior to Actavis, the established law was that claim scope must be the same for invalidity and infringement and in this case Fisher & Paykel submitted that the position remained the same (ResMed not really dissenting) i.e. that anticipation in this way was possible. The Judge noted that Arnold J's reasoning in Mylan that this was not possible was brief and obiter since he had held the patent invalid for obviousness. The lack of clarity on this issue arises since in Actavis the Supreme Court was only dealing with infringement and consequently the decision was framed only in those terms.
In conclusion, the Judge held the patent invalid for anticipation and obviousness in the light of both pieces of prior art, but that there would have been infringement had the patent been valid. As in Mylan the outcome of the case here was not really affected by the above issues, in part because, as the Judge observed, the specification, unusually, included "little or nothing of significance" to assist in determining the invention "beyond a large number of consistory clauses and the preferred embodiments". Moreover, the Judge did not consider the literal and purposive meanings of the claim to be significantly different. Like Arnold J, the Judge commented that the important issues discussed above are arguable and would need to be considered at a higher level. The Judge's comments again illustrate the urgent need for clarification of the law by the Court of Appeal, in the first instance, given that these issues will prove crucial in some cases, albeit not this one.