In a long awaited decision, the UK Supreme Court (Lord Hodge giving the speech on behalf of a unanimous panel) has dismissed ICOS’s appeal against the Court of Appeal’s decision holding that its patent for a low dosage regimen for tadalafil for the treatment of erectile dysfunction was invalid for obviousness. Ultimately, the Supreme Court concluded that, under the specific circumstances of this case, a skilled team would have arrived at the claimed low dosage regimen without using inventive skill, as a result of conducting routine clinical experimentation. This is therefore an important decision for innovators seeking to obtain patent protection for new medical dosage regimen.
The Supreme Court had two principal issues to decide – first, the application of the obviousness test to dosage regimen patents and secondly, whether the Court of Appeal was entitled to reverse Birss J’s first instance decision holding claim 7 to have been inventive.
On the first issue, the Supreme Court comprehensively reviewed the UK and EPO approaches to obviousness. Lord Hodge held that neither the UK approach (Pozzoli) and the EPO (problem solution) should be applied mechanistically. Indeed, it is clear that a far more nuanced approach should be adopted, which, according to Lord Hodge, includes consideration of the following factors:- (1) is something obvious to try; (2) was the research of a routine nature; (3) what was the burden and cost of the research programme; (4) what value judgements during the research would the skilled team have had to make; (5) were there alternative or multiple paths of research; (6) what was the skilled person motivated to do; (7) were the results of the research surprising; (8) hindsight must be avoided; (9) is the claimed invention an added benefit when the claimed innovation is obvious for another purpose; (10) the possibility that dosage regimen patents may be valid has been recognised by the EPO and courts in the UK.
The Supreme Court accepted that the Court of Appeal had been correct to overturn the first instance decision. In essence, both the Court of Appeal and the Supreme Court held that the first instance judge had erred in principle by not appreciating the logical consequences of his finding as to whether the skilled team would continue tests on low doses of tadalafil and thus arrive at the claimed dose. In so doing, the Supreme Court adopted the step by step nuanced approach on the facts of the case, correctly leaving factual determinations made by the first instance judge untouched. In those circumstances, the Supreme Court held that the Court of Appeal was entitled to have overturned the first instance ruling.
There were some other noteworthy aspects of the decision:
- The Supreme Court found that parallel decisions from foreign courts did not assist in the determination of the issues.
- Various interveners (including industry associations) sought clarification on the general approach to obviousness. Further, the interveners also sought clarification as to whether specific criteria should be applied when dealing with selection patents and “improvement” patents. These queries were addressed in the decision.
The Supreme Court decision makes it clear that the step by step nuanced approach on the facts of the specific case is the correct approach for courts to adopt. The Supreme Court also clarified some of the views expressed in the Court of Appeal judgments. Of key importance to innovators is Lord Hodge’s statement that “efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests”. Furthermore, as regards selection patents and improvement patents, Lord Hodge said this:- “The use of well-known research tests of itself does not render such selections and improvements obvious”.
It is hoped that these words will allay some fears, which may have otherwise arisen from the decision, that the use of routine and standard experiments conducted during medicinal discovery and clinical research cannot lead to patentable inventions. The guidance given by Lord Hodge will also be a helpful guide in preparing appropriate expert evidence for use in revocation actions brought before the UK courts.