Novartis AG v Dexcel-Pharma Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Floyd,THE HON MR JUSTICE ARNOLD,MR JUSTICE ARNOLD |
| Judgment Date | 03 March 2009 |
| Neutral Citation | [2008] EWHC 1266 (Pat),[2009] EWHC 336 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC 08 C00896 |
| Date | 03 March 2009 |
[2008] EWHC 1266 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Hon Mr Justice Floyd
Mr Daniel Alexander And Mr Mark Chacksfield (instructed By Bristows) For The Claimant
Mr Simon Thorley and Mr Justin Turner (instructed by Howrey LLP) for the Defendant
Hearing date: June 4 th 2008
Mr Justice Floyd :
Novartis AG (“Novartis”) is the proprietor of UK Patent No 2 222 770 (“the Patent”). Novartis seeks an interim injunction to restrain Dexcel-Pharma Limited (“Dexcel”) from marketing a cyclosporin-containing formulation which it alleges infringes the patent. Novartis' product made in accordance with the Patent is recognised as a significant breakthrough in the treatment of transplant patients. The case is unusual because the Patent has been the subject of previous judicial consideration. Dexcel says that, on the construction previously arrived at, there is no serious question to be tried on the issue of infringement. Dexcel raises no novelty/obviousness challenge to validity, but Dexcel has indicated it may seek to raise an insufficiency squeeze if so advised.
The patent
The Patent is entitled “Pharmaceutical compositions containing cyclosporins”. The cyclosporins are a class of drugs possessing immunosuppressive activity. Cyclosporins are important in the treatment of transplant patients, to prevent the rejection of transplanted tissue. A problem with cyclosporins is their poor solubility in aqueous media leading in turn to poor bio-availability.
The Patent proposes a novel cyclosporin formulation in the form of “a micro-emulsion pre-concentrate”. Claim 1 claims
“A pharmaceutical composition comprising a cyclosporin as active ingredient,
) a hydrophilic phase,
2) a lipophilic phase, and
3) a surfactant
which composition is an “oil-in-water micro-emulsion pre-concentrate”.
The reference to an “oil-in-water micro-emulsion pre-concentrate” refers to the fact that what is claimed in claim 1 is a concentrate which, when added to water, either in a glass so that it can be drunk, or in the human body from a capsule, forms a micro-emulsion. An important feature of a micro-emulsion mentioned in the Patent is that its particles are less than 200 nanometres in diameter.
The previous litigation
In the previous litigation to which I have already referred ( Novartis v Ivax [2006] EWHC 2506 (PAT); [2007] EWCA Civ 971), Pumfrey J held the Patent to be valid, but not infringed by the formulation intended to be marketed by the generics company Ivax. The Court of Appeal upheld the finding of non-infringement. Two issues of construction and non-infringement arose. The first was that Ivax claimed that its cyclosporin was largely contained in particles which were larger than 200 nm. Jacob LJ, who gave the leading judgment, said
“If one asks what the fundamental teaching of this patent is, the answer is clear: avoid the problems of the prior art emulsion formulation by carrying the cyclosporin in the micro-emulsion size particles.”
So later he said:
“If one reads the claim as a whole and with purpose in mind the right way to read it is that the active ingredient of the composition is to be carried by the “oil-in the-water micro-emulsion.” It is not enough for there simply to be present cyclosporin and a micro-emulsion. The latter is for carrying the former.”
On that basis the IVAX formulation was outside the claim. That was enough to dispose of the appeal. Nobody questions that construction in the present case. But Pumfrey J had held that the Ivax composition did not infringe on a further ground. The second point was whether the Ivax product had a lipophilic phase. Novartis alleged that the lipophilic phase was constituted by polyglycerol-3-oleate (Pg3o). The hydrophilic phase was ethanol. Pg3o is soluble in ethanol, at least in the relative amounts present in the composition.
A particular problem with the allegation of infringement in the Ivax case was that the ingredient in question was also a surfactant, which is another feature of the claim. There were other surfactants present apart from Pg3o. Pumfrey J held at [36]:
“The claim calls for distinct hydrophobic and hydrophilic phases and a surfactant. If one surfactant is to be taken to be the hydrophobic phase, why not the other two also? They will form aggregates in aqueous medium in which the active ingredient is held: but they will all act together as Professor Attwood emphasised.”
So there was no basis for distinguishing between the surfactant alleged to be the lipophilic phase and the surfactant alleged to be the surfactant. The surfactant certainly could not do the job of the lipophilic phase and the surfactant in the aqueous medium at the same time. It is significant that in this passage Pumfrey J is looking ahead to what will happen to the component in the aqueous medium.
The learned Judge went on to say:
“I conclude that it is artificial and incorrect to construe the word “lipophilic” otherwise than as meaning substantially immiscible with the hydrophilic phase and destined to form the dispersed phase in the resulting oil-in-water micro-emulsion.”
In that passage the Judge is again, at least in part, looking ahead to the function of the lipophilic phase as the dispersed or oil phase in the aqueous micro-emulsion.
Support for Pumfrey J's construction is to be found at page 15 of the specification where it is said that
“Suitable components for use as lipophilic phase include any pharmaceutically acceptable solvent which is non-miscible with the selected hydrophilic phase…. Such solvents will appropriately be devoid or substantially devoid of surfactant function.”
Ivax's formulation thus fell outside the claim for this second reason, because there was no “separately identifiable” lipophilic phase. And it seems this was so in pre-concentrate and aqueous medium alike.
The Court of Appeal also briefly dealt with this second ground. Jacob LJ dealt with the point in this way:
“The answer to the problem is found, as it so often is, when construing a patent claim, by asking: what is the claim element for? What in this case is a lipophilic phase for? The answer is that it is there for two reasons: to carry the insoluble cyclosporin and to form the micro-emulsion, the oil phase. It cannot do the latter if it is amphiphilic [as the Pg30 was].”
Thus far Jacob LJ was saying that a component like Pg3o could not be the lipophilic phase because it would not do the job expected of that phase in the patent. He went on to deal with the passage in the patent cited above about the miscibility of the lipophilic phase and the hydrophilic phase, rejecting a submission that the passage was not dealing comprehensively with the purpose of the lipophilic phase:
“Mr Alexander invites us to say that the skilled man would read that as saying the lipophilic phase need not be non-miscible with the hydrophilic phase. He tries to get that out of the word “include”. But that is to read the passage acontextually and without regard to the evident purpose of the lipophilic phase.”
The Court of Appeal was accordingly considering whether the “lipophilic phase” claim element was apt to cover a material which was eminently unsuitable to fulfil the purpose of that element, and which was in fact suited to fulfil the purpose of a different and contrasting claim element, the surfactant. It was in this context that the Court held there must a distinct lipophilic phase. It is important to note that neither Pumfrey J nor the Court of Appeal were, so far as I can see, directing their minds specifically to the question of when the two phases must appear: it does not appear that that was how the argument was presented. To the extent that there is material in the judgments touching this question, it seems to me that they were looking forward to the function of the required phases in the aqueous micro-emulsion.
The effect of previous findings of construction of a patent
It is sometimes said that a finding about the correct construction of a given patent specification is a question of law, binding on a subsequent court according to the rules of precedent. Terrell on Patents (16 th edition) at paragraph 16.43 puts it in this way:
“The Court of Appeal has considered itself bound, in a subsequent action on the same patent, by its own previous judicial construction.”
Two nineteenth century cases are cited for this proposition. In Edison v Holland (1889) 6 RPC 243 at 276, Cotton LJ had been a minority dissentient in the Court of Appeal in a previous case on the construction of the same patent. He said:
”.. I consider myself bound by the decision of the Court on that point, and in my opinion, except on questions of fact, which, of course, must be decided by the evidence in this action, the Court ought to consider itself bound by the previous judgment.”
That judgment was given in February 1889. Three months later in May 1889, in Automatic Weighing Machine v The Combined Weighing Machine (1889) 6 RPC 367 at 370, a Court of Appeal which included Cotton LJ refused to allow a patentee to reargue the construction of a patent it had previously construed, holding the alleged infringement not to be materially different from that considered in the previous case.
In SmithKline Beecham v Apotex [2004] FSR 26; [2003] EWHC 2939 Pumfrey J was faced with a patent which had previously been construed by the Court of Appeal. He held at [12] that the findings of the Court of Appeal had no bearing on his case, “save on questions of construction”. He said:
“But it has to be remembered that the construction of the documents is not the end of the question. Their disclosure is still a question of fact, upon which evidence is...
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