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1 August, 2009

On 2 July 2009 the UK Court of Appeal handed down its judgement in Generics (UK) v Daiichi, dismissing the appeal and holding that the patent relates to inventive subject matter. The court endorsed a more balanced approach to assessing obviousness in patent law, wherein factors such as the motive to find a solution to the problem addressed by the patent, the number and extent of alternative avenues of research, the effort involved in pursuing them and the expectation of success should all be considered. This decision reaffirms a recent trend towards harmonising the approach to assessing patentability applied by the UK courts with that of the European Patent Office (EPO) and other national courts in Europe.

The patent in question claims the antibiotic levofloxacin. It is the S (-) enantiomer of a compound whose racemic form was a known antibiotic, ofloxacin, at the filing date of the patent.  During litigation, Generics argued that since ofloxacin was known to contain a mixture of components, it would be obvious to the skilled person to isolate each component and thereby identify which is most active.

High Court
At first instance, it was held that although the skilled person would consider resolving ofloxacin into its individual components, the skilled person would not be motivated to relentlessly pursue the course of action to the point of making the invention, since several other molecules being synthesised at the time were more attractive antibiotic candidates than the individual enantiomers of ofloxacin. Accordingly, the invention was held to be non-obvious over the prior art. The judge emphasised that it was important to weigh up all of the facts of the case to identify, on balance, what the skilled person would have done rather than what he/she could have done. This ‘would not could’ approach is explicitly favoured by the EPO when assessing inventive step. It highlights that the skilled person would not consider the expected benefits of resolving the racemate in isolation, but rather within the context of the potential difficulties they could encounter and any alternative avenues of research that may be pursue.

Court of Appeal
The first instance decision was reaffirmed in the Court of Appeal judgement, in which Lord Justice Jacob emphasised that the only question to be addressed when considering the concept of inventive step is simply whether the claimed invention is obvious to the skilled person in the context of what was known. He referred to Generics v Lundbeck, where Kitchin J stated that:

‘The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.’

Generics v Daiichi therefore highlights the importance of assessing what the skilled person would have done based on the particular circumstances of the case, a refreshingly pragmatic approach that seems to be in line with EPO practice.

Lord Justice Jacob also highlighted that a particular route is only obvious to try if there is a fair expectation of success. In this particular case, it was clear that a number of different avenues were available to the skilled person trying to find a solution to the problem addressed by the patent, some of which appeared more attractive than the solution offered by the patent in suit. The court held that without a fair expectation of success, the motivation of the skilled person may be weak and therefore he/she would not pursue every avenue relentlessly. This rationale is similar in feel to the ‘one way street’ and ‘expectation of success’ tests often applied in EPO proceedings.

The judges also considered the technical effects achieved by the claimed invention. Although these features of the invention did not appear to form part of the overall assessment of obviousness, Lord Justice Jacob stated:

‘I am not sorry to reach this conclusion [that the patent was valid]. Daiichi’s work led to a better medicine than ofloxacin. Levofloxacin is not just twice as active as ofloxacin (which might have been expected) but is a lot more soluble and less toxic than was predictable. It can be used in higher dosages than might have been expected with corresponding medical benefit. Only a curmudgeon would say there was not invention here.’

In light of this, it appears that factors which are not directly related to patentability of the invention may influence the rationale of the court (either subconsciously or consciously). In this case, the presence of a number of non-predictable special technical effects may have provided the court with further evidence of the inventive contribution of the claimed invention, particularly since a number of avenues of research were available to the skilled person.

Whilst indicating that there is only one question to ask when assessing inventiveness, Lord Justice Jacob suggested that the structured approaches to answering the statutory question provided by the Windsurfing/Pozzoli questions and the EPO’s problem and solution approach were the same.  However, in practice, the tests currently applied by the UK courts and the EPO respectively are not completely equivalent, and certainly not identical.  Whilst the problem and solution approach does indeed require identification of the skilled person and his/her common general knowledge, the approach to formulating the problem to be solved (i.e. how to achieve the inventive concept) is not the same as questions 2 and 3 of the Windsurfing/Pozzoli questions. The closest prior art must be selected, the differences between it and the claimed invention identified and the technical effect of these differences used to formulate the problem to be solved.  The UK approach does not apparently lend itself to an assessment of obviousness involving acknowledgement of the effects achieved by the invention (even though the judge did make reference to these).

The judgement is good news for patentees and third parties because it provides specific guidance on the factors that may be taken into account when considering the concept of obviousness in the UK. It favours a more ‘real life’ approach, in which all of the circumstances which could (and would) affect the skilled person’s actions are assessed and also indicates further harmonisation between the approach used in the UK courts and the EPO.