Generics (UK) Ltd v H Lundbeck A/S
| Jurisdiction | England & Wales |
| Judge | LORD JUSTICE JACOB,LORD JUSTICE NEUBERGER,LORD JUSTICE CHADWICK,Lord Hoffmann,Lady Justice Smith,Lord Justice Jacob |
| Judgment Date | 10 April 2008 |
| Neutral Citation | [2008] EWCA Civ 311,[2006] EWCA Civ 1261 |
| Docket Number | B6/2006/0879,Case No: A3/2007/1326 05CO3689 / 06CO0457 / 06CO2767 |
| Court | Court of Appeal (Civil Division) |
| Date | 10 April 2008 |
[2006] EWCA Civ 1261
Lord Justice Chadwick
Lord Justice Neuberger
Lord Justice Jacob
B6/2006/0879
IN THE SUPREME COURT OF JUDICATURE
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION
PATENTS COURT
(MR JUSTICE PUMFREY)
Royal Courts of Justice
Strand
London, WC2
MR A WAUGH QC and MR J TURNER (instructed by Messrs Simmons and Simmons, LONDON EC2Y 9SS), appeared on behalf of the Appellant.
MR M TAPPIN (instructed by Messrs Taylor Wessing, LONDON EC4Y 0DX), appeared on behalf of the Respondent.
Judgement
Lundbeck own European Patent UK 0347066. It has six product claims and a single process claim, claim 6. For present purposes it is sufficient to say that the product claims cover the (+) enantiomer of a pharmaceutical compound called citalopram. The enantiomer is escitalopram. The process claim covers a way of making citalopram.
Generics started an action against Lundbeck for revocation of the patent. Lundbeck responded by denying invalidity. A defence was filed. Part of that defence is an allegation that it was obvious to separate out the (+) enantiomer from the racemic mixture.
Lundbeck applied to amend the defence to add a counterclaim for infringement against Generics. The proposed amendment includes a claim for infringement of process claim 6 on the basis that the product which Generics intends to deal is "a product obtained directly from" that process (see section 60(1)(c) of the Patents Act 1977). The proposed amendment also includes bringing in as second defendants to the counterclaim the Indian company ("X") from which Generics intends to buy its product. The proposed pleading claims that X is a joint tortfeasor along with Generics.
Pumfrey J refused to allow the amendment to the extent that it alleged infringement of the process claim or to allow service out of the jurisdiction upon X as a second defendant. He allowed the amendment solely so far as it alleged infringement of certain of the product claims; the judgment is [2006] EWHC 804 (Ch).
Lundbeck appeal. They say they have reasonable prospects of success on two points:
a. Infringement of claim 6 by Generics;
b. Against X as a joint tortfeasor with Generics as an infringer of both the product claims and the process claim.
It is common ground that we can test the matter by the reasonable prospects of success test. That applies both to the question of allowing the amendment to allege infringement of the process claim and for service out of the jurisdiction. I need not spell out the route by which that common ground position was reached. The authorities go into it in various ways. Sometimes other expressions are used, but nothing turns on that here.
Claim 6, the Process Claim
In their proposed pleading Lundbeck simply say this:
"In support of the allegation that escitalopram was obtained directly from a process claimed in claim 6 of the Patent the Part 20 Claimant [i.e. Lundbeck] will aver that escitalopram is a new product and rely upon s.100(1) of the Patents Act 1977."
S.100(1) says this:
"If the invention from which a patent is granted is a process for obtaining a new product, the same product produced by a person other than the proprietor of the patent or a licensee of his shall, unless the contrary is proved, be taken in any proceedings to have been obtained by that process."
Thus, submits Mr Waugh QC for Lundbeck, escitalopram is new. So the burden shifts to Generics and X to prove the claim process is not being used. That burden has not been discharged to the point where one can say there are no reasonable prospects of success. In effect, Mr Waugh is saying that the only way in which the presumption of section 100 can be rebutted is by a full trial. That cannot be right. All the section does is to provide a presumption. It may be that that presumption can be rebutted only by a full trial or it may be that it can be rebutted to the standards for strike out or refusal or permission to serve out of the jurisdiction. It is only a presumption.
The defendants answer Mr Waugh in this way. First they say there is powerful evidence rebutting it, so powerful that there is no reasonable prospect of it being overcome. The judge accepted this. A second point was taken by the respondent's notice to the effect that the presumption did not arise in the first place because the product was not new. Mr Tappin wisely did not pursue that rather difficult area.
Before a medicinal product can be sold in the United Kingdom, regulatory approval must be given. For this purpose the regulatory authorities require information as to the process by which the product will be made. It is a criminal offence to supply false information; more than that, perhaps, is that it will be commercial suicide to do so. Information was supplied to the regulatory authorities in two parts. A general reaction scheme was supplied by Generics. That does not contain any of the details of the reaction used to make the product. It does contain some detail as to the impurities. By another document some detail as to their amounts was also supplied. X also supplied direct to the regulatory authorities the details of its process. That has not been supplied to Generics or anyone else so far as I know. It is common ground that the disclosed process, if carried out, is not that covered by claim 6.
Lundbeck suggest that X has or may have seriously misled the regulatory authorities. It suggests that in reality X will not be using the disclosed process but the process of claim 6; or at least if it is not using the disclosed process the presumption would bite so that there will be a presumption that claim 6 was used. Lundbeck has not of course seen X's process being carried out; one of its avowed objectives is, indeed, to obtain an order for inspection one way or another. Nor have Lundbeck had a sample of X's products. What Lundbeck rely upon is indirect evidence by inference, not so much that the claim 6 process is in fact being used but that the process disclosed to the authorities cannot be the one that is being used. The idea is to cast doubt on what has been disclosed to the regulatory authorities such that, somehow or other, the presumption comes back into play.
What was done was to conduct some experiments broadly in accordance with X's process as disclosed to the authorities, which has been disclosed in its general form but not in detailed form under conditions of confidence to Lundbeck. The impurities in the resulting product were analysed as to their presence and as to their amounts. The suggestion is that these are inconsistent with the impurities and their amounts as disclosed to the authorities.
Even in chief the evidence was thin. Dr Petersen said no more than that:
"The description of these impurities in the written process X description makes me doubt whether the process described is the process which X either have or intend to carry out."
Of that statement the Judge said this:
"That is a remarkable piece of logic since he accepts that not all of the possible impurities need in fact appear in any performance of the reaction scheme. He also accepts that the substance of his objection comes down to an impurity which he labels elsewhere as 'impurity B'. From his discussion of his own repetition of the process carried out by X, it is clear that successive purification steps are removing large quantities of this material. Dr Petersen does not suggest that the impurities stated in the DMF [i.e. the materials supplied to the Regulator] are in fact in any way indicative of infringement."
Astonishingly, Lundbeck would not allow Dr Peterson's evidence to be put to X. So X, accused of dishonesty, have had no opportunity of commenting on the accusation. Lundbeck's reason, advanced by its solicitor, for its extraordinary and, to my mind, unreasonable stance is that if X is told of the details in advance of any inspection "it is possible that steps could be taken to obscure the discrepancies". There is no material to suggest that X is in any way dishonest or that they would take such steps. Be that as it may, the value of the evidence in the absence of any chance to comment on it is at best considerably diminished.
On top of that, however, Generics have provided the comments of an independent expert, Dr Latham, on what Dr Petersen says. He has a number of criticisms. Perhaps of most importance is the fact that Dr Petersen necessarily could not reproduce the precise conditions in fact used by X. His answer, "I have done my best to select reasonable conditions", implicitly accepts this is so. In reply Dr Latham answered the points made by Dr Petersen. I do not go through them all here. It is sufficient to refer to paragraph 8 where Dr Latham says:
"In my opinion Impurity 4 could not be derived from the cyano-route [i.e. that of claim 6]. Its presence is a likely impurity from X's … route."
The upshot of all this is the experimental evidence provided to support the suggestion that X will not use the process it told the regulators it will use is weightless. We have therefore this position, that there is the presumption of section 100 and compelling evidence rebutting it. It is compelling because of both legal and commercial reasons why the evidence should be true.
Lundbeck did advance an alternative suggestion – that the process described could not be carried out economically. But no attempt was made to address the fact that the process will be carried out in India where costs are very different. The point is hopeless.
The judge dealt with it this way:
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