Several generic pharmaceutical companies have prevailed in the UK Supreme Court in a patent dispute testing the practical bounds of patent protection for dosing regimens: Actavis Group PTC EHF & Ors v ICOS Corporation & Anr  UKSC 15 (27 March 2019).
Actavis, Teva and Generics challenged the validity of ICOS Corporation's European patent (EP(UK)1173181) (the patent). The patent claims protection for a low level dosing regimen for tadalafil (the active ingredient in ICOS' licensee's Eli Lilly's CIALIS medicine) for use in treating erectile dysfunction (ED).
The first instance judge found that, in light of prior published information, at the priority date of the patent it would have been obvious to investigate tadalafil as a treatment for ED. However, the judge concluded that the claimed "up to" 5mg daily dose as a treatment for ED was not obvious. This was because although the skilled team would "very likely" test a 5mg daily dose in the course of clinical trials, they would not do so with a reasonable expectation that 5mg would produce a clinically relevant effect at all nor one with minimal side effects.
The Court of Appeal disagreed with the judge, concluding that he had erred and the patent was invalid, albeit for slightly different reasons expressed in three separate judgments of the sitting Lord Justices.
The UK Supreme Court review of the law of obviousness
The case proceeded to the Supreme Court, where Lord Hodge took the opportunity to address the law regarding obviousness generally. His judgment is therefore likely to be the starting point in all assessments of obviousness undertaken by the courts for the foreseeable future.
Lord Hodge's view was that the focus of an obviousness assessment should be the inventive concept of the relevant claim, whether adopting the approach to assessment conventionally employed by the English Courts (Windsurfing/Pozzoli) or the "problem-and-solution" approach conventionally employed by the European Patent Office (EPO). However, neither formula should distract the court from the statutory question, this being whether the invention is "obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art".
Lord Hodge confirmed that a question of obviousness must be considered on the facts of each case, the court weighing the balance of factors in light of all the relevant circumstances.
While the Enlarged Board of Appeal of the EPO has held...