One year on – the impact of Actavis v Eli Lilly in the UK courts

A year ago we reported on what is undoubtedly the most important decision in UK patent law in recent years: the Supreme Court’s decision in Actavis v Eli Lilly [2017] UKSC 48 (‘Actavis’). In this update we consider how the lower courts have begun to interpret the Supreme Court’s decision and what unanswered questions remain.

The Supreme Court’s decision in Actavis

As detailed in our article last autumn, the key issue in Actavis related to claim scope and direct infringement. In summary, the Supreme Court defined how the scope of protection could be widened beyond the normal interpretation of the claim when considering infringement by variants. In particular, instead of only purposively construing the claims it considered infringement using a new two part test:

1. Does the variant infringe any of the claims as a matter of normal interpretation? If not,
2. Does the variant nonetheless infringe because it varies from the invention in a way which is immaterial?

The second limb of the Supreme Court’s new approach involves applying the reformulated Improver questions (now renamed the ‘Actavis’ questions). Of particular note, the notional addressee of the patent is now imbued with the knowledge that the variant does indeed work when considering whether it would have been obvious that it achieved the same result in the same way.

Prior to this case, it was a settled legal principle of UK patent law since the House of Lords’ judgement in Synthon v SmithKline Beecham [2005] UKHL 59 (‘Synthon’) that claims should be interpreted in the same way when considering either validity or infringement: the approaches mirrored one another. However, the Supreme Court has now stressed that there should be a clear distinction between the concepts of claim interpretation when assessing novelty and the issue of scope of protection afforded by the claims when considering infringement.

As the Supreme Court only considered claim construction for the purposes of infringement, there has been much speculation in recent months as to how far the doctrine of equivalents would apply to novelty when validity is being assessed. In recent months the High Court has had to consider the issue of whether an equivalent, or variant, in the prior art would be enough to destroy novelty and overturn the patent in question. Some of these cases are discussed briefly below.

What is meant by ‘normal interpretation’?

In Generics & Ors v Yeda & Ors [2017] EWHC 2629 (Pat) (‘Generics’), the claimants sought revocation of a patent concerning a dosage regime of glatiramer acetate used in the blockbuster drug Copaxone. The claimants argued that a piece of prior art disclosed an equivalent regime that anticipated the claims and so destroyed novelty. The defendants’ position was that settled law meant that the claim would only lack novelty if the subject matter disclosed by the prior art fell within the claim as purposively construed.

In his judgement, Mr. Justice Arnold considered the first limb of the Supreme Court’s test and what was meant by a ‘normal interpretation’ and whether this required a new approach to claim construction. However, he concluded that the Supreme Court had intended the first limb to still require the claim to be construed in order to determine what the person skilled in the art would have understood (i.e. purposive and not literal construction).

Mr. Justice Arnold then went on to consider the question of whether equivalents should be taken into account when assessing novelty.  The defendants had advanced three arguments: firstly, that following Synthon, the infringement test for novelty did not extend to anticipation by equivalents as Synthon had been decided before Actavis; secondly, that the Guidelines for Examination at the EPO (based on decisions of the Technical Boards of Appeal) state that a claim is not to be deprived of novelty by an obvious equivalent in the prior art; and thirdly, that the Supreme Court’s decision in Actavis was based on Article 2 (relating to infringement) of the Protocol on the Interpretation of Article 69 EPC and so did not concern validity in any event.

Mr. Justice Arnold ultimately found favour with the defendants’ submissions, and that the new doctrine of equivalents should not be taken into account when assessing validity.  However, in case he was wrong on this point he considered in the alternative and concluded that the claim would have lacked novelty if equivalents were taken into consideration.  Mr. Justice Arnold also remarked that ultimately it will require another decision of the Supreme Court to provide a definitive answer on the approach to be taken.

Further cases

The High Court has since agreed with the approach taken by Mr. Justice Arnold in Generics in a number of further cases, including: Fisher & Paykel v ResMed [2017] EWHC 2748 (Ch) (‘Fisher’); Illumina v Premaitha [2017] EWHC 2930 (‘Illumina’);  L’Oréal v Ventures [2018] EWHC 173 (‘L’Oréal’); and Olaplex v L’Oréal [2018] EWHC 1394 (‘Olaplex’).

In Fisher, the High Court considered Actavis in a case concerning revocation of patents relating to masks used to treat obstructive sleep apnoea. The claimants argued that the claims had a broad scope of protection and so were anticipated by the prior art, whilst the defendants argued for a narrower interpretation in the hope of avoiding the prior art and upholding their patents. Infringement was not in dispute as had the patents been valid, then they would have been infringed by the claimants’ devices.

In his judgement, Richard Meade QC, sitting as Deputy High Court Judge, stated that in the absence of a decision of a higher court, the approach taken by Mr. Justice Arnold in Generics was correct and that the ‘normal interpretation’ required by the first limb of the test requires purposive construction. In addressing the second limb and the Actavis questions, the Judge stated that in his view the Supreme Court had equated ‘literal meaning’ with ‘normal meaning’ for the purpose of the reformulated questions. He also suggested that in light of the Supreme Court’s decision in Actavis it may be preferable to refer to ‘claim scope’ rather than to ‘claim construction’, to indicate that (at least for the purposes of deciding whether a claim extends to equivalents in relation to infringement) it is no longer permissible to use the one-stage purposive construction familiar from Kirin-Amgen v Hoechst Marion Roussel [2004] UKHL 46 (‘Kirin-Amgen’). The Judge did not give a view on whether a claim can actually be anticipated by a variant, except to say that it was an arguable view which he expects will be considered by a higher court in due course.

In conclusion, the Judge held ResMed’s patent to be both anticipated by the prior art and obvious. However, he also stated that there would have been infringement had the patent been valid. The outcome of this case, as in Generics, was not in the end materially affected by Actavis and the new law concerning equivalents. However, it is only a matter of time before a case presents where these issues prove critical.

Is the prosecution history now relevant?

To what extent should the prosecution history be considered by the UK courts when dealing with issues of infringement or claim interpretation?  Prior to Actavis it was widely discouraged with Lord Hoffman famously stating in Kirin-Amgen that “life is too short” to consult the file for the limited assistance it may provide.  Now, following Actavis the door has been pushed gently ajar.  The Supreme Court concluded that reference would be appropriate in a small number of cases, but only where: (a) the point at issue is truly unclear if one confines oneself to the specification and claims of the patent, and the contents of the file unambiguously resolve the point; or (b) it would be contrary to the public interest for the contents of the file to be ignored.  Following Actavis, in both Illumina and L’Oréal, the High Court has stated that reference to the prosecution history of a patent should very much be the exception and not the rule.

Further clarity has now been given in the recent case of Icescape v Ice-World International [2018] EWCA Civ 2219 (‘Icescape’).  In this case, the Court of Appeal held that if the appellants are permitted to run a case based on equivalents then the respondents should, provisionally, be permitted to rely upon the prosecution history of the patent.  Ultimately, in Icescape the Court of Appeal held that the correspondence fell well below the threshold set by the Supreme Court and did not unambiguously resolve the issues.  As such, the Court viewed this as a good illustration of why it is usually unhelpful to consider the file.  However, now that there is more clarity on when the prosecution history may be relevant, it will be interesting to see if it ever proves determinative when considering issues of infringement or claim interpretation in future cases.  Certainly, the increased likelihood of the Court considering the prosecution history may lead to increased caution during European and UK patent prosecution in the future.

Looking ahead

Foretelling how a claim may eventually be construed during any future litigation is an important consideration many years earlier during patent prosecution.  The Supreme Court’s judgement has clearly provided a wider scope of protection to patentees when considering equivalents and infringement. To date, only alleged infringers have attempted, albeit unsuccessfully, to take advantage of the change to the law when pursuing revocation actions and challenging novelty. However, the High Court has so far stated that purposive claim construction still applies to the assessment of validity. Interestingly, the Court of Appeal has in both Icescape, and Actavis v ICOS [2017] EWCA 1671 (currently awaiting the decision of the Supreme Court) also stated that the approach to normal construction has not changed in light of the Supreme Court’s decision and that the question remains “what the person skilled in the art would have understood the patentee to be using the language to mean”.

The apparent divergence between the approaches taken to interpret claims for the purposes of novelty and infringement will, ultimately, need to be addressed by the Supreme Court.  But until then it will be interesting to follow how case law continues to develop in this area.