Laboratoires Servier v Apotex Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Norris |
| Judgment Date | 09 October 2008 |
| Neutral Citation | [2007] EWHC 1905 (Ch),[2008] EWHC 2347 (Ch) |
| Docket Number | Case No: HC 06 C03050,Case No: TLC688/06 |
| Court | Chancery Division |
| Date | 09 October 2008 |
[2007] EWHC 1905 (Ch)
Mr Justice Pumfrey
Case No: TLC688/06
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand
London WC2A 2LL
Mr IY Purvis QC appeared on behalf of the Claimant
Mr A Watson QC appeared on behalf of the Defendant
HIS HONOUR JUDGE SEROTA: I am asked whether I should grant permission to appeal in this case. I think the starting point will have to be the observations of Jacob LJ in the Court of Appeal in the case of Pozzoli SPA v BDMO SA [2007] EWCA Civ 588 where he said this:
“Unless the case is very clear and can be understood sufficiently readily in an hour or so, the better course is normally for permission to be granted by the trial judge. For, unlike the trial judge, the Court of Appeal judge(s) who have to decide whether permission should be granted (where the trial judge has refused it) will not be immersed in the technology and evidence in the same way as the trial judge. Faced with but an incomplete understanding and a plausible skeleton argument seeking permission, the Court of Appeal will generally be likely to grant permission, even if it later discerns that the case is indeed clear.”
Mummery LJ and Keene LJ agreed with those observations.
This case raises a problem with this approach in a very acute form. The reason is, I think, threefold. The first reason is that the challenge mounted by the unsuccessful claimant, Servier, to the judgment which is to be delivered is really heavily underpinned by the contention that an incorrect approach has been taken to construction of the claim. It is perhaps difficult without an appreciation of the underlying technology of x-ray diffraction to give a sensible interpretation of the claim and to be in a position to place the unchallenged evidence of Professor Cima, on behalf of the defendant, and the evidence of Dr Tarling, on behalf of the claimant, in their correct context.
However, there are two points on invalidity which, it is forcibly submitted, are essentially unaffected by the correctness or otherwise of the construction placed upon the claim in the judgment. The first point is my finding in paragraph 40 that the prior art when performed in an obvious manner before the priority date will produce a result which, if not inevitably within the claim, is certainly one of the obvious results. That is the meaning of the reference to the assumption that the pilot plant process described in notice experiment 2 does not inevitably fall within the claim. That of course is a reference to a test for anticipation and this is a finding of obviousness. It is not clear to me, this being a finding of obviousness and subject to the difficulties of displacing it which are outlined in the Biogen case and in a long line of authorities on the subject of expert evidence and the weight to be attached to it, that it would be in any way a straightforward matter to persuade the Court of Appeal that this finding is wrong. The problem is that this finding does not depend upon the rightness or wrongness of the interpretation which I placed upon the claim. Essentially, it is whatever the claim means, this result is within it or the process can be operated in an obvious manner which falls within the claim. That is the first point.
The second point and the third point appear in paragraphs 28 and 29 of the judgment. This is an anticipation by a laboratory scale repetition of the same prior art document. It was accepted that both the notice and experiment and repeat were in fact within the claim, although Dr Tarling's evidence had suggested, at least, the contrary. This then turned into a question on onus which I discuss in paragraphs 29, 30 and 31 of the judgment. Again this does not depend upon the correct interpretation of the claim, it is simply a finding that a repetition inevitably produces an alpha structure within the claim on Dr Tarling's view. Dr Tarling's view for this purpose is what I can call the irreducibly minimum width of the claim.
Mr Purvis submits that in fact I should take the experiments together, that is to say, not only experiment 1 but experiments 2, 3, 4, 5 and 6, to show that there is no question here of repeatability, that some of the results of the notice experiments and the repeat were different in the sense that on the narrow construction of the claim the notice did or did not fall within the claim and the repeat did not or did. So, he says, there is no inference from a notice experiment and its successful repetition that the second attempt to repeat will fall within the claim. If that is to be a valid approach to a notice and its repeat where the opposing party has declined to submit any experimental evidence at all, I think this is a matter that ought to be raised with the Court of Appeal and I have formed the view that I cannot, in the light of these two distinct findings on validity, form the view that there is genuinely a real prospect of success on this appeal.
Then the question arises: am I too knowledgeable about the underlying facts of this case in forming this view and do I leave the Court of Appeal in the difficult position which Jacob LJ describes in the paragraph of the judgment in Pozzoli v BDMO to which I have referred? This, I have to say, adds new horror to the problem of granting permission to appeal since I am conscious that there is a deal of evidential material in this case which really does have to be read and assimilated before, I think, a proper and nuanced view of the material which underpins the judgment can be taken.
CPR 52.3 sets out exhaustively the grounds upon which permission to appeal is to be granted. As is well known, by 52.3(6) permission to appeal may be given only where the court considers that the appeal would have a real prospect of success or there is some other compelling reason why the appeal should be heard. I regard the indications given the Court of Appeal in Pozzoli v BDMO as an explanation of special circumstances which indicate that permission should be granted under paragraph (6)(b) where the court nevertheless has the view, based on its more comprehensive view of the facts, that the appeal in fact has no real prospect of success.
In those circumstances and for that reason only I am going to grant permission to appeal. Mr Watson, who appears on behalf of Apotex, the successful defendants, says that if I am to grant leave to appeal on this ground then I should make it clear that I am doing so. That submission I accept. Accordingly, this permission to appeal is granted under paragraph (6)(b) only of CPR 52.3 and is granted having regard to the guidance given to me by Pozzoli
[2008] EWHC 2347 (Ch)
Mr Justice Norris
Case No: HC 06 C03050
IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Iain Purvis QC and Andrew Lykiardopoulos (instructed by Bristows) for the Claimant
Antony Watson QC and Colin Birss QC (instructed by Taylor Wessing) for the Defendant
Hearing dates: 9 -12 and16 June, 28 July 2008.
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Dated…………………………………… Mr Justice Norris……………………………………………
Les Laboratoires Servier (Servier) developed and patented a pharmaceutical known as Perindopril which it sold under the trade mark “Coversyl”. It is an ACE inhibitor which is used to treat hypertension and is a prescription medicine. It obtained patent protection for the original compound in France in 1980, and subsequently patented the process for the industrial synthesis of the product (“the 341 patent”). In July 2000 Servier applied for a further patent covering an allegedly new form of Perindopril described as “Form Alpha” (“the 947 patent”). By 2006 the basic protection for Perindopril had expired, and the 947 patent was a second generation patent the object of which was to enable Servier to maintain its monopoly in Perindopril. The 947 patent was sought in the European Patent Office and was the subject of opposition proceedings (one of the grounds of which was that Form Alpha would inevitably result from practising the prior art 341 patent). On 27 July 2006 the European Patent Office dismissed this opposition and held the 947 patent valid despite the earlier 341 patent. Servier was thereby placed in a position in which it could continue to assert its monopoly.
Apotex Incorporated and its associated companies (“Apotex”) is a manufacturer of generic drugs. Apotex decided to manufacture (and obtained marketing authorisations in respect of) Perindopril produced in a manner which it considered did not use the process of the 341 patent. Apotex took the view that the 947 patent was plainly invalid (since it did no more than claim the product obtained by the 341 patent) and it was prepared to launch its generic product “at risk”. Notification that market authorisation would be forthcoming was given on 24 July 2006 and Mr Darroch of Apotex personally collected the signed copies on 28 July 2006. That day very substantial sales of generic Perindopril were effected. (I should note that Apotex was unaware that opposition to the 947 patent had been dismissed by EPO the preceding day). On 1 August 2006 Servier issued a claim...
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