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Microsoft word - a one way street to harmony - aug 2009.doc

On 2 July 2009 the UK Court of Appeal handed down its judgement in Generics A one way street (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
pursued.
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
This information has been prepared by Boult Wade Tennant. 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). contact Nienke Lubben or your usual adviser. 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. Boult Wade Tennant

Source: http://www.legal500.com/assets/images/stories/firmdevs/a_one_way_street_to_harmony_-_aug_2009.pdf

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