Generics (UK) Ltd v Daiichi Pharmaceutical Company Ltd (Costs)
| Jurisdiction | England & Wales |
| Judge | Lord Justice Lloyd,Lord Justice Ward |
| Judgment Date | 02 July 2009 |
| Neutral Citation | [2009] EWCA Civ 646 |
| Docket Number | Case No: A3/2008/2889 |
| Court | Court of Appeal (Civil Division) |
| Date | 02 July 2009 |
[2009] EWCA Civ 646
Before: The Rt Hon Lord Justice Ward
The Rt Hon Lord Justice Jacob
and
The Rt Hon Lord Justice Lloyd
Case No: A3/2008/2889
HC 07 C00988
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Kitchin
Henry Carr QC and Michael Tappin QC (instructed by Taylor Wessing LLP)for the Appellant/Claimant
Andrew Waugh QC and Thomas Hinchliffe (instructed by Herbert Smith LLP)for the Respondents/Defendants
Hearing dates: 9/10 June 2009
Lord Justice Jacob (giving the first judgment at the invitation of Lord Justice Ward):
This appeal is from a judgment of Kitchin J, [2008] EWHC 2413 (Pat), of 15 th October 2008. He held that Daiichi's by then expired patent EP (UK) No. 0206283 was valid and that the supplementary protection certificate based on it no. SPC/GB97/085 (“the SPC”) was also valid.
Before Kitchin J validity of the patent was attacked on a mass of grounds: lack of novelty over Daiichi's earlier patent EP 0,047,005 and/or Drugs of the Future and/or a Bayer patent application (this point took the form of a dispute about the priority date of the Patent, for if priority was lost, Bayer anticipated), obviousness over either of the first two of those citations or over at least one of four further prior disclosures (about one of which there was an issue of availability to the public), added matter and insufficiency. A total of 9 attacks which, with the sub-issue of availability, gave the Judge 10 issues relating to validity to decide.
Perhaps eventually realising that a court is unlikely to be impressed where a party takes masses of points (the natural initial and strong impression is that the party does not feel it has a real killer) the appellants (“GUK”) confine their appeal on validity of the patent to a single point, obviousness over “Gerster IP”. This was a poster which had been displayed for a couple of hours by a Dr Gerster in a Symposium in Toronto in 1982, some three years before the priority date. They also appeal on the SPC point. So we have two points before us, obviousness over Gerster IP and the validity of the SPC. If the patent was invalid, there could be no valid SPC; if it was valid, there could, but only if the criteria for an SPC were satisfied.
Validity of the Patent
We turn first, therefore, to validity of the patent. It is for a chiral antimicrobial compound called levofloxacin, the name of the S(-) enantiomer of a compound whose racemic form is known as ofloxacin. (For anyone coming for the first time to the basic science and terminology of stereochemistry, a good explanation is to be found in [12–15] of Kitchin J's judgment in Generics v Lundbeck, [2007] EWHC 1040 (Pat), [2007] RPC 729).
The structure of levofloxacin looks like this:
The asterisk is by the chiral carbon atom.
Claim 2 of the Patent (the only claim we have to consider) is to levofloxacin. It is common ground that the claim does not extend to ofloxacin – such would be an absurd construction given the fact that the patent acknowledges that ofloxacin is old, having been disclosed in the '005 patent (see how Kitchin J dealt with an identical point in the Lundbeck case at [51–64], upheld in this court, [2008] EWCA Civ 311 at [8–13] per Lord Hoffmann and at [50] per Jacob LJ – the point did not arise in the House of Lords, [2009] UKHL 12, [2009] RPC 407).
Uncontroversial Matters
I turn to set out matters which were always uncontroversial or are now unchallenged on appeal.
Ofloxacin was a known compound in 1985. It was disclosed in the '005 patent along with a way of making it. The patent says nothing about chirality and the method of synthesis disclosed produces the racemic compound.
Ofloxacin is a member of the class of compounds called quinolones. The Judge sets out their structures at [41–43] and there is no need to repeat that here. For present purposes it is sufficient to note that at the priority date, “a large number of quinolones of very different structures had been shown to display antibacterial activity” (Judgment [44). The Judge describes the history in helpful detail at [55–81]. It is sufficient to record the following findings of the Judge:
i) By 1985 a number of quinolones were known. These included nalidixic acid (discovered in the late 50s), oxolinic acid (1966), cinoxacin, miloxacin, flumequine and pipemidic acid (1970s), norfloxacin (1979), perfloxacin (1979) enoxacin (1980), ofloxacin (1982), amifloxacin (early 1980s) and ciprofloxacin (1983).
ii) In 1985 this last compound, ciprofloxacin was seen to be the “class leader”.
iii) The structures of quinolones varied – some were bi-cyclic and some tri-cyclic. You could put a wide variety of substituents onto the varied basic structures. Research was being done to find out if a better product resulted.
iv) In 1985 quinolones were seen as a field well worth researching further, the hunt being on for better molecules. “It was a time of excitement and optimism.”
v) A particular reason for looking for new compounds was the avoidance of a compound to which bacteria had developed resistance.
So the general position was, as the judge found:
[110] Overall, I think a relatively clear picture emerges. The quinolone field was unusual in that workers recognised the need for and perceived an opportunity to discover new chemical entities of ever greater efficacy. The discovery of norfloxacin, ofloxacin and ciprofloxacin put great pressure on researchers to identify new quinolones having even better bacterial profiles. It was here their energies were primarily directed. Hundreds of chemists were making new compounds each year and, not surprisingly, they would opt not to make a compound if its synthesis was difficult. Compounds which were difficult to make would get a low priority in the laboratory. This was not an environment conducive to the investigation of stereochemistry. Resolution of a racemate might result in a twofold increase in activity, at best, and it could be a good deal worse. It was quite possible that activity might lie more in one enantiomer than the other, but not greatly so. Moreover, resolution might prove very difficult to achieve. As a result, for many chemists, including those at Sterling-Winthrop, I am satisfied that resolution of racemates was something that would simply not have occurred to them at all. For others, it plainly did. But it was not a routine path to follow and, for the ordinary chemist, I believe it was something which he might well not have considered and, if he did, then it would not have been a high priority, absent some particular reason for doing so.
GUK do not challenge any of that. Nor do they challenge the finding that stereochemistry was not discussed at the time in any of the major review articles about quinolones – a good indication of the skilled workers' lack of interest in stereochemistry. There were potentially richer pickings to be had in the field of new compounds than in the field of stereoisomers.
By 1985 flumequine was not considered important. It had been overtaken by other quinolones, including ofloxacin and particularly ciprofloxacin. The Judge put Prof. Wentland's view this way:
[167] … It must be remembered that flumequine had been known since 1973 and was recognised as an important advance as of that time. However, by 1985, its properties were considered unexceptional and it had made only limited progress as a human therapeutic. Consequently it was no longer an influential compound.
At [170] the Judge said he preferred that view to that of GUK's expert, Dr Spargo – perhaps hardly surprising since Dr Spargo was not only not in the quinolone field at the time (he was just completing his PhD) but he never became a quinolone man later, whereas Prof Wentland was, both in 1985 and thereafter, such a man.
Moreover it was the view of Prof. Wentland, accepted by the Judge, that:
flumequine and ofloxacin were different compounds and that the medicinal chemist could not take information from one to the other [169]
By 1985 ofloxacin was of some importance for it was in that year it received regulatory approval. It was of more interest then than in 1982 when the Gerster IP poster was briefly displayed in Toronto. But it was not as important as ciprofloxacin.
Generally if one wanted a pure enantiomer of a chiral compound, there were a number of general methods known. These might or might not work. The Judge describes them at [92–97]. A starting point would be to attempt a resolution from the racemate itself. As the Judge put it at [140] in the context of ofloxacin:
all the experts agreed that the obvious starting point would have been ofloxacin itself. Dr Spargo accepted this would have been the skilled person's 'first port of call'. Dr Newton agreed with Professor Davies that if the final product was available and could be made then typically the skilled person would try and resolve that first.
It was not GUK's case that resolution from the final product could be readily achieved. So the skilled man would find, on investigation, that the “first port of call” was closed to him.
In 1985 the incentive to investigate the enantiomers of ofloxacin was limited. So the incentive to obtain them was correspondingly limited. The Judge found the position to be as follows:
[139] … Weighing the evidence as a whole against the background of the common general knowledge, I have...
To continue reading
Request your trial
-
Swarovski-Optik KG v Leica Camera AG and Another
...to substitute the words "generally regarded as a good basis for further action".'" … 110 In the Court of Appeal in that case [2009] EWCA Civ 646, [2009] RPC 23, Jacob LJ quoted the passage I have cited from Raychem and commented at [25]: "Of course material readily and widely to hand can be......
-
KCI Licensing Inc. and iothers v Smith & Nephew Plc and Others
...as a matter of routine before embarking on the problem to which the patented invention provides the solution. 109 In Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2008] EWHC 2413 (Pat), [2009] RPC 4, Kitchin J quoted passages from Pumfrey J's judgments in Novartis v Ivax and Glaxo Grou......
-
Verathon Medical V. Aircraft Medical
...which the defender had given Professor Denyer and Dr Muirhead on this matter. [38] In Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] RPC 23, Jacobs LJ (at paragraph 27) emphasised the restrictions of, and the importance of unimaginativeness and the lack of inventive capacity in, t......
-
Garmin (Europe) Ltd v Koninklijke Philips N.v (a company existing under the laws of the Kingdom of the Netherlands)
...sought or applied in any given circumstance is a separate question.” 94 This principle was considered by Jacob LJ in Generics v. Daiichi [2009] RPC 23 at 25: “Of course material readily and widely to hand can be and may be part of the common general knowledge of the skilled person – stuff h......
-
Court Of Appeal Confirms Invalidity Of Patent For EXELON Because It Was Obvious To Resolve Racemate Using Standard Techn
...obvious because the resolution of the enantiomers was difficult or uncertain (Generics (UK) Limited v. Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646) or the skilled person simply didn't know how to resolve the enantiomers at the priority date (H Lundbeck A/S v. Generics (UK) Limited [20......
-
Obviousness In The United Kingdom - Levofloxacin From Daiichi Is Not Obvious
...benefit. Only a curmudgeon would say there was no invention here." In his judgement, delivered on 2nd July 2009, in Generics v Daiichi [2009] EWCA Civ 646 Jacob LJ began by noting that validity of the patent had been attacked at first instance on many grounds. He once again warned that it i......
-
IP Snapshot - August 2009
...of the CTM. For the full text of the decision, click here. PATENTS Generics (UK) Limited v Daiichi Pharmaceutical Co Ltd and another [2009] EWCA Civ 646, 2 July 2009 The Court of Appeal has dismissed an appeal from the High Court's decision that both a patent on Levofloxacin (an anti microb......