Introduction
The English Court of Appeal has suggested that the "Problem and Solution" (PSA) approach, much used by the EPO when considering obviousness, should be considered to be an "administrative tool" only which does not necessarily lead to the "correct" answer.
Obviousness in the Courts and at the EPO
In Actavis v Novartis [2010] EWCA Civ 82, 17th February 2010 the English Appeal Court considered the decision making process of the EPO when determining if an invention is obvious. In this case, the English courts concluded that the claims of European patent (UK) No. 0948320 of Novartis were obvious. In upholding the judgement of the lower court, the Court of Appeal considered the proper test for obviousness, and concluded that the Problem and Solution (PSA) approach used in the EPO had problems.
The claims of the patent related to sustained release pharmaceutical compositions comprising a water soluble salt of fluvastatin as an active ingredient. The claims required that the active ingredient be released from the sustained formulation over more than three hours. The prior art showed that fluvastatin was a known statin. Fluvastatin sodium was also known, and the concept of sustained release was well known and well understood.
Obviousness in the English courts
In giving judgement, Jacob LJ considered the law of obviousness and explained the structured approach which is generally to be used. This was set out in the earlier case, Pozzoli v BDMO [2007] FSR 37, which provides four steps, as follows:
(1)(a) Identify the notional "person skilled in the art"
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
Obviousness in the EPO
In the EPO, and as set out in their guidelines, an Examiner should normally apply the PSA, which has three main stages, as follows:
(1) Determine the "closest prior art",
(2) Establish the "objective technical problem" to be solved, and
(3) Consider whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.
Whilst the PSA is not the only way to consider obviousness, for this particular case, Jacob LJ thought the approach was useful.
Stage 1 of the PSA is simply a tool to assist the EPO. In the EPO there may be a very large number of individual items of prior art. Therefore, in practice, it was extremely useful, perhaps even essential, to identify, and focus on, just a single prior art document. However, as the inventor may not have been aware of that single prior art document at the outset, the "objective technical problem" solved by the invention as compared to that prior art will need to be established, meaning that the problem may have to be reformulated. The European guidelines acknowledge that the problem may not appear in the patent and may have to be reformulated.
Jacob LJ commented:
"For myself, I think the re-formulation – which really means retrospective construction - of a problem is perhaps the weakest part of the PSA. It will be noted that with the Pozzoli/Windsurfing approach, once one has finished the orienting step 3, the question is simply left open: is the invention obvious? There is no attempt to force the question into a problem/solution."
"Another aspect of obviousness which is not readily answered by the PSA is illustrated by the 5¼ inch plate paradox. This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.
What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive."
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