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Monday, 6 July 2009
In short, Daiichi owned European Patent (UK) No. 0206283 and supplementary protection certificate no. SPC/GB97/085. The patent related to ofloxacin, the (-) enantiomer of a racemic compound which belonged to the quinolone class of anti-microbial agents. The S(-) enantiomer of ofloxacin was called levofloxacin.
This patent, which claimed priority from three Japanese filings, was applied for on 20 June 1986 and was granted on 27 January 1993. UK marketing authorisations were granted for levofloxacin on 6 June 1997. On 23 October of that year Daiichi applied for the SPC, identifying this patent as the basic patent, levofloxacin as the product and the UK marketing authorisations in respect of levofloxacin as the first authorisations to place the product on the market. The SPC was granted on 13 July 1998. The patent expired on 20 June 2006. The SPC came into force and was due to expire on 19 June 2011.
In this action Generics sought a declaration of invalidity of (or rectification of the register in respect of) the SPC and a declaration that certain claims of the patent were invalid. At trial, Kitchin J found that the skilled man "would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point". He held that Daiichi's patent, which had by then expired, was valid, as was the SPC.
Generics appealed, basing its appeal on a single point relating to the alleged obviousness: as a result of extra information contained in a poster that had been displayed for a couple of hours by a doctor in a symposium in Toronto in 1982, concerning how the enantiomers of flumequine had been made, the skilled man would recognise that the same method would probably work for ofloxacin. The skilled man would therefore follow that lead up by experiment and would then find out that it did indeed have the required result. Generics added that the authorisation to sell ofloxacin was really the first authorisation to sell levofloxacin because levofloxacin was by far the most active component of ofloxacin, and sought to bolster their argument by reference to case-law (using the ECJ BASF and MIT cases and the German Patent Court Fusilade case). Accordingly the date of authorisation for levofloxacin did not count because it was not the relevant first authorisation.
The Court of Appeal dismissed the appeal. In their Lordships' view, the decision that the skilled man "would have considered it worthwhile exploring whether ofloxacin could be resolved, but only to a point" was a perfect example of a judge properly carrying out the balancing task of forming an overall value judgment which trial judges so often had to perform. In doing so, the the trial judge committed no error of principle.
The patent, whilst it had subsisted, had been valid. Daiichi's work had led to a better medicine than ofloxacin, since levofloxacin was not just twice as active as ofloxacin (as one might have expected) but was far more soluble and less toxic than could be predicted. It could also be used in higher dosages than might have been expected, with corresponding medical benefit. As Jacob LJ eloquently put it: "Only a curmudgeon would say there was no invention here".