Laboratoires Servier v Apotex Inc.
| Jurisdiction | England & Wales |
| Judge | Lord Justice Jacob,Lord Justice Lloyd,The Lord Chief Justice of England and Wales |
| Judgment Date | 09 May 2008 |
| Neutral Citation | [2008] EWCA Civ 445 |
| Docket Number | Case No: A3/2007/1715 |
| Court | Court of Appeal (Civil Division) |
| Date | 09 May 2008 |
[2008] EWCA Civ 445
The Lord Chief Justice Of England And Wales
Lord Justice Jacob
Lord Justice Lloyd
Case No: A3/2007/1715
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 Pumfrey HC 06 C03050
Royal Courts of Justice
Strand, London, WC2A 2LL
Iain Purvis QC (instructed by Messrs Bristows)for the Claimants/Appellants
Antony Watson QC and Colin Birss (instructed by Messrs Taylor Wessing) for the Defendants/Respondents
Hearing date: 28 April 2008
Lord Justice Jacob (giving the first judgment at the invitation of the Lord Chief Justice):
This is an appeal from one of the last first instance decisions of the late Lord Justice Pumfrey. He held that Servier's EP (UK) 1 296 947 was invalid for lack of novelty and obviousness, but that if the patent had been valid, Apotex's product would have infringed. He gave permission to appeal applying the Pozzoli test ( [2007] FSR 37 at [10]). But he also refused to continue an interim injunction pending appeal on the grounds that he considered there was no real prospect of success. An application to this court for continuation of the injunction was refused on the same basis, [2007] EWCA Civ 783.
Undaunted, and doubtless because much money is at stake, Servier persisted in the appeal. Following Mr Purvis QC's opening of the appeal, we decided that it was unnecessary to hear Mr Watson QC for Apotex. These are my reasons for dismissing the appeal.
The priority date of the patent is 6 th July 2000. It is for a particular crystalline form of the tert-butylamine salt of perindopil, a process for making it and for pharmaceutical compositions containing it. The patent, using its own nomenclature, calls this particular crystalline form of salt, the a form. It claims that the a form “especially exhibits valuable characteristics of filtration, drying and ease of formulation.” It does not say with what other crystalline form the comparison is being made or why this form is “especially valuable.” When asked about this, Mr Purvis could provide no answer.
The first and basic patent for perindopril and its tert-butylamine salt (without any indication or specification of crystalline form) was EP 0 049 658. It had a priority date 2 nd October 1980. Servier's pharmaceutical compositions containing the salt have been on the market since the late 1980's (the first, French, marketing authorisation was June 1988). The basic patent was effectively extended by a supplementary protection certificate which expired on 21 st June 2003. The market for the product is vast; UK sales alone are about £70m per annum at Servier's patent protected price. It is not surprising that Servier have sought to exploit the patent system as far as possible to protect that vast income stream.
Servier sought and obtained additional protection for perindopril and the tert-butylamine by way of EP 0 380 341 (“341”) filed on 16 th September 1988, expiring on 16 th September 2008. This is for “the industrial synthesis of perindopril” and covers a process for making it and its tert-butylamine salt. There has been no investigation of the validity of this patent, and it does not matter for present purposes.
Finally Servier sought yet further protection for the tert-butylamine salt of perindopril by applying for three patents on 6 th July 2000, covering the only three crystalline forms (called by Servier a, ß and ?) which, to date, have ever been found. We were shown the patent for the ß form. It claims that that form too “especially exhibits valuable characteristics for formulation” without saying what these are supposed to be. The Judge describes the fact that there were simultaneous applications for the other two forms “curious.” That was perhaps a kind way of saying that Servier were simply trying to extend their monopoly in the salt.
The Judge held this about the three crystalline forms at [10]:
Professor Motherwell [Servier's expert] accepted that it seems that form a is the stable form of perindopril and, absent special circumstances, it follows that any process for producing perindopril from ethyl acetate will produce this form in the absence of impurities. The ß form, identified in the patent to which I have referred, is not stable and is created by special crystallisation techniques. Professor Motherwell said that eventually it reverts to the a form. The ? form is not produced by recrystallisation from ethyl acetate and is accordingly irrelevant.
So you need special conditions for making the ß and even if you do, it will revert to a.
The upshot of all this is that were the patent valid, Servier's monopoly in practice would last until 2020. But, as the Judge held and we confirm, it is invalid. And very plainly so. It is the sort of patent which can give the patent system a bad name. I am not sure that much could have been done about this at the examination stage. There are other sorts of case where the Patent Office examination is seen to be too lenient. But this is not one of them. For simply comparing the cited prior art ('341) with the patent would not reveal lack of novelty and probably not obviousness. You need the technical input of experts both in the kind of chemistry involved and in powder X-ray diffraction and some experimental evidence in order to see just how specious the application for the patent was. The only solution to this type of undesirable patent is a rapid and efficient method for obtaining its revocation. Then it can be got rid of before it does too much harm to the public interest.
It is right to observe that nothing Servier did was unlawful. It is the court's job to see that try-ons such as the present patent get nowhere. The only sanction (apart, perhaps, from competition law which thus far has had nothing or virtually nothing to say about unmeritorious patents) may, under the English litigation system, lie in an award of costs on the higher (indemnity) scale if the patent is defended unreasonably.
I turn back to the patent. As I have said the only citation against it is '341, itself acknowledged in the patent. '341 discloses in detail a process said and claimed to be “for the industrial synthesis” of the salt. I have to say I have never seen a patent claim which contains a limitation “for the industrial synthesis”. I do not know what it adds. It is not as though it is suggested that the chemistry is any different on a laboratory or any other scale. The reacting or crystallising molecules do not know about the size of the pot they are in.
After the description of the process of making the acid, '341 goes on to describe the process for making the salt (Stage 3D). It says:
“Place in reactor approximately 140 litres of ethyl acetate and 10kg [of the acid]. Add gradually approximately 2.20 kg of ter-butylamine, heat to reflux until all has dissolved; filter. Cool, filter off and dry. Yield 95%”
It does not say anything about the nature of the crystallisation which takes place during cooling, or indeed explicitly that the product is crystalline at all. But no one disputes that you will get crystals – there is no suggestion that the salt has an amorphous form.
The patent in suit is a little more specific about the crystallisation process said to produce the a form. In its widest form the process claim (original claim 2) merely said that a solution of the salt in ethyl acetate “is heated at reflux and is then cooled gradually until crystallisation is complete.” That differs from what was said in '341 only in the qualification “gradually”.
By a proposed amendment the rate of cooling was more specific, saying “cooled to a temperature of from 55 to 65 º at a rate from 5 to 10 º C/hour then to ambient temperature until crystallisation is complete.” This was the subject of original claim 5 and is based on a passage in the body of the specification saying that such conditions were “advantageous” but without saying why. It is not suggested that the more general original teaching is wrong – so although the claim has this limitation, it is not one which is meaningful technically – just a limitation in scope. It is not surprising that the judge held the proposed amendment did not save the claim, amounting as it does to merely technically arbitrary limitations.
The Judge's finding of obviousness was based a short piece of cross-examination of Servier's witness, Professor Motherwell. To understand it one needs to know that Servier had used the specified cooling conditions since 2000. It went like this:
Q. When you talk about commercial batches, you are including the post 2000 method as well?
[clarification from the judge]
A. In as much as they all cool, filter and dry, they are all the same (inaudible). Generally speaking, I observed linear cooling regimes both in Apotex and in Servier. The degree may have changed. I think later on, if I remember correctly, it may have been slightly more rapid, but that may not be true.
Q. But taking all the regimes, both pre 2000 and post 2000, they are all obvious ways of implementing the instruction, cool, filter and dry?
A. In the most general terms, yes. It is not as sophisticated as 947 [the Patent] but…
Q. Now, we saw that dropping from 76 to 55 there was a range of 1:4, one hour or four hours. Are you suggesting that there is anything unusual in adopting a linear cooling regime where you drop the...
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