In today's judgment in the Actavis v ICOS case, the Supreme Court has given useful guidance on the English court's approach to the assessment of obviousness. Whilst finding the particular dosage regimen patent (which was the subject of the case) obvious, the Supreme Court has seemingly endeavoured to determine the case in a way which will avoid unforeseen and far-reaching implications beyond the patentability of this patent – something the bioscience industry had expressed concern about.
As we previously reported this case concerned the validity of ICOS's patent which claimed the use of up to a 5mg dose of tadalafil (Cialis) in the treatment of erectile dysfunction (see our earlier blog on the Court of Appeal's decision). Actavis's obviousness challenge was based upon a piece of prior art (Daugan) which specifically disclosed examples of a tablet containing 50mg of tadalafil and the argument that it would be obvious to implement Daugan by taking tadalafil forward into routine dose ranging studies.
Birss J at first instance rejected the challenge that the patent was obvious and, in a finding of fact, which turned out to be critical to the subsequent fate of the patent, determined that the skilled team would conduct dose response studies hoping for a dose response and that following discovery of a plateau starting at 25mg or 10mg, there would very likely be a subsequent dose ranging study which included 5mg. However, Birss J held that the skilled team would not have a reasonable expectation that 5mg would produce a clinically relevant effect and, ultimately found the patent valid. The Court of Appeal overturned Birss J's decision and unanimously found the patent invalid for lack of inventive step.
Supreme Court decision
The Supreme Court has unanimously come to the same conclusion as the Court of Appeal. In so doing, however, and perhaps with the acknowledgement of the need to facilitate expensive pharmaceutical research in mind, the court has decided this case on the specific facts, as well as giving some useful guidance on factors to be taken into account in determining an obviousness case more generally and the weight to be given to them.
Whilst it is clear that obviousness is to be assessed at the priority date, the line of enquiry does not necessarily stop there if the skilled team would subsequently take uninventive steps to implement the prior art and follow the research through to a foreseeable target. However, something is not obvious just because those steps are ones which the skilled team could already do. There are many factors which might be relevant in the assessment of obviousness and need to be taken into account and the Court of Appeal correctly decided that Birss J had wrongly applied weight to a number of these factors. This included the weight given by Birss J to the relevance of whether it is necessary for something to be obvious to try with a reasonable prospect of success. The Supreme Court held that there is no strict requirement that a test ought to work, since this 'would impose a straightjacket which would preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable'. The assessment very much depends on the facts and in this case the lack of an expectation of efficacy at a 5mg dose is a factor of little weight if, as was found, the skilled team would be very likely to study such a dose in the search for a dose response relationship – or as one of the experts put it, it was a 'no brainer' to test such a dose.
The Supreme Court considered both the English courts approach to obviousness based on the Windsurfing/Pozzoli test and the EPO's problem-and-solution approach and warned against applying either in a mechanistic way, commenting that neither require a literalist approach to the wording of the claim in identifying the inventive concept.
Whilst we digest the nuances and implications of the judgment, many in the industry will at least be grateful for the Supreme Court's confirmation that there is no general proposition that the product of well-established or routine enquiries cannot be inventive and that, importantly, efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests.
Nicole Jadeja assisted the UK BioIndustry Association in its application to intervene in this case.