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UNITARY PATENT

In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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Obviousness Test

The UK Court has never embraced the problem-solution analysis for inventive step used by the European Patent Office. There has been much debate about whether the European Patent Convention requirement for there to be an "inventive step" calls for a higher level of inventive activity than the UK requirement that the invention must not be "obvious". The Court of Appeal has picked up the issue, and we have drawn up a point-by-point comparison from the Court's decision.


The case in question (Actavis v Novartis) was for a sustained-release formulation of the well-known statin, fluvastatin. At the time of the invention, fluvastatin was typically administered in 40mg capsules twice a day. Patients would comply more with their doctors' prescriptions if the drug could be administered in 80mg doses once a day.

It was thought (so the patent said) that the drug did not lend itself to sustained release (over 3 to 30 hours) because it was highly soluble in water. To produce a sustained-release formulation might require large amounts of slow release binding matrix or complex semi-permeable membranes or the like. Novartis described a working formulation and claimed the combination of the active ingredient with a matrix or membrane (or combination of the two) that releases the active ingredient over more than 3 hours. They did not claim a novel sustained release mechanism. They merely claimed sustained release fluvastatin thereby encompassing known mechanisms, with their justification being that this was contrary to what a skilled person would have thought possible.

On an application by Actavis for revocation of the patent, the lower court found the invention obvious. The Patents Court judge thought it was a finely balanced case. Novartis appealed. The Court of Appeal had no reservations about upholding the decision.

The case largely hinged on the evidence of the solubility of fluvastatin. The patent said "surprisingly" fluvastatin sodium shows particularly favourable release characteristics, but the evidence presented to the Patents Court showed that the solubility was high but not very high, and that this might limit the choices of release mechanism but would otherwise not be seen as a serious problem. The problem presented in the patent was "illusory".  It was a non-problem because fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form. Once the basis for the invention was destroyed by the evidence, no re-formulation of the "problem" could save it. 

Lord Justice Jacob considered the UK Court's long-established approach to the law on obviousness as set out in Pozzoli v BDMO, which is a 2007 re-statement of the 1985 decision in Windsurfer v Tabur Marine, and he also considered the EPO problem-solution approach. He would have reached the same result using either approach (there were objective reasons why a skilled person would seek a slow-release formulation of fluvastatin, and such formulation would occur to the skilled person who put his or her mind to the objective problem). Jacob LJ's comments give an interesting comparison between the two approaches, and point towards instances in which different results might be reached. Our summary of his comparison is in the table opposite.

Comment

Jacob LJ is our most eminent patent judge and his ruling has come in for criticism, principally for entrenching perceived differences between the EPO approach and the UK Patent Court approach, rather than grasping an opportunity to show how the approaches are (or should be) very similar.

The two examples cited in favour of the UK approach are less than perfect illustrations of the points attempting to be made.

The "Anywayup Cup" was not an example of a "problem invention" (not that Jacob LJ is necessarily saying it is, though he says identifying the problem is halfway to the solution). In that case, the problem was known, but remarkable commercial success tipped the balance in favour of recognizing an inventive step. The EPO Guidelines recognize that fulfilling a long-felt need can be an indication of inventive step (C-IV, 11.10.3).
The 5 ¼ inch plate need not be a paradox under the Problem-Solution Approach. If the problem is defined in terms of a smaller (or larger) table calling for a different size of place setting, or the size of a washing machine requiring a different sized plate, it would have been obvious to choose a particular size. The problem need not be real, so long as it is objective.

The problem with the Court of Appeal's "multi-factorial" approach is that one cannot readily give an accurate prediction of which way a particular case will go.