Yesterday’s unanimous judgment of the Supreme Court in Actavis v ICOS (27 March 2019) emphasised that the question of whether an invention is obvious under the statutory test must be approached by using a fact specific assessment. The statutory test ultimately requiring a single question to be answered: was it obvious to the skilled but unimaginative addressee in light of the prior art and the common general knowledge to make a product or carry out a process falling within the claim?
In giving the leading judgement, Lord Hodge followed Lord Sumption in Generics v Warner-Lambert in emphasising the overarching principle of the patent bargain under which the monopoly bestowed by the patent system must be is balanced and justified against a patent’s technical contribution. This maintains the “balance or symmetry in patent law”. When considering how to approach the statutory test, Lord Hodge highlights the following key points:
- In a fact specific assessment, the relevance and weight of various factors depends on the individual factual circumstances. If the obvious to try test is an appropriate factor, then the relevant likelihood of success also depends on the particular facts of the case.
- It is wrong to apply the Pozzoli test or the EPO’s “problem-solution approach” in a mechanistic way in which you adopt a literalistic approach to the wording of the claim in identifying the inventive concept.
- Although the skilled person has no inventive capacity, this does not mean that the skilled person has no skill to take forward in an uninventive way the teaching of the prior art.
- Patent law cannot disregard work that the skilled person would need to carry out after the priority date in order to implement the teaching of the prior art.
- There is no general proposition that the product of well-established or routine enquiries cannot be inventive.
In this case, Lord Hodge identified 10 relevant factors that should be considered in the assessment of obviousness, the last of which was the nature of the invention. The invention in question was a dosage patent with claims in the Swiss-form or EPC 2000 form. Lord Hodge dismissed the suggestion that there is a different approach or standard to assessing such patents, as there is “no policy reason why a novel and inventive dosage regime should not be rewarded by a patent. A fortiori, efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests.” However, he also concluded that it was “no mystery” why Jacob LJ had concluded in Actavis v Merck that “nearly always such dosage regimes will be obvious – it is standard practice to investigate appropriate dosage regimes”. It is because the target of the skilled person’s research “is in large measure predetermined”. In these circumstances, finding additional benefits, such as the reduced side effects in this case, in the dose ranging studies did not prevent the identification of the appropriate dose from being obvious.
The judgment of the Supreme Court emphasises a flexible, fact specific approach to the statutory question of obviousness under which the relevance and weight of various factors can change. This approach is designed to ensure that the assessment to obviousness keeps in mind the patent bargain and the technical contribution made by the patentee. The Supreme Court affirms that there is no prejudice against empirical based inventions or policy reasons against dosage regime patents, but nevertheless revoked the patent in this case. For dosage regime patents, the routine nature of the research arising out of regulatory requirements remains a relevant factor. Given this and the inability to rely on added (or surprising) benefits if these inevitably arise out such research that needs to be undertaken, it will be necessary to have several other relevant factors that point against that dosage regime being obvious.