Generics v Daiichi note available

The Current Intelligence note by Bratin Roy ((McDermott Will & Emery UK LLP) on the Court of Appeal (England and Wales) decision in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Another [2009] EWCA Civ 646 (2 July 2009), Court of Appeal, England and Wales (noted here on The SPC Blog), published in this month's Journal of Intellectual Property Law & Practice, is available in full at no charge from that journal's weblog here.

No further UK appeal over levofloxacin

According to a news item this morning on the UKSCblog, which focuses on the activities of the new Supreme Court for the United Kingdom which took over the appellate functions of the House of Lords this autumn, the Supreme Court has refused permission to appeal in Generics (UK) Ltd v Daiichi Pharmaceuticals [2009] EWCA Civ 646 (noted here on The SPC Blog). Generics (now known as Mylan) wanted to appeal against the decision of the Court of Appeal that that Daiichi's by then expired patent antibacterial levofloxacin and the supplementary protection certificate based upon it were valid.

This news item has been picked up by Zenopa here. It does not however appear on the Supreme Court's own website or on any of the usual internet news channels.

No curmudgeons in the Court of Appeal

Now for a bit more on last week's Court of Appeal for England and Wales ruling in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2009] EWCA Civ 646 (see previous post for links to the full text of the judgment and to earlier comments).

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".

Court dismisses Levofloxacin appeal

The Court of Appeal for England and Wales has just given its judgment today in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and Daiichi Sankyo Co Ltd [2009] EWCA Civ 646. The Court, in a judgment delivered on behalf of all their Lordships by Lord Justice Jacob (sitting with Ward and Lloyd LJJ), upheld the decision of Mr Justice Kitchin of 15 October 2008 that Daichi's levofloxacin patent and the SPC which was based upon it were both valid (see notes on the earlier decision here and here).

Having held that the original patent was valid, the Court of Appeal reviewed the validity of the SPC grant at great length (at paras 46 to 83) before upholding it.

The SPC Blog looks forward to discussing this case in greater depth once it has had the chance of reading it carefully. In the meantime, readers should feel free to post their observations below.

Daiichi decision -- a commercial footnote

Nearly a fortnight ago, in "Mirror, mirror on the wall, what is the first marketing authorization for this enantiomer?" (here), this blog reviewed the judgment of Mr Justice Kitchin in the Patents Court for England and Wales decision in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2008] EWHC 2413 (Pat). In that case the court showed how the UK courts deal with the issue of whether the marketing authorization for a racemic product counts as the first marketing authorization as required by Article 3(d) of the SPC Regulation.

I've just spotted that this decision has also been noted by a staff reporter for the Pharmaceutical Business Review in an article, "UK court upholds Daiichi Sankyo's levofloxacin SPC". This article doesn't add much to what we already know, but it does add some business background, mentioning that Daiichi Sankyo has granted an exclusive licence to Sanofi-Aventis to make, use and sell pharmaceutical preparations containing levofloxacin in the UK and that Sanofi-Aventis markets levofloxacin products in the UK under the trade name Tavanic.