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Friday, 9 May 2008

Servier perindopril "try-on" slammed

The IPKat has just caught the scent of the publication on BAILII of this morning's decision in Les Laboratoires Servier and Servier Laboratories Limited v Apotex Inc, Apotex Pharmachem Inc Apotex Europe Limited and Apotex UK Limited [2008] EWCA Civ 445, a ruling of the Court of Appeal for England and Wales (Lord Phillips, Lord Chief Justice, Lords Justices Jacob and Lloyd) on an appeal against the decision of Pumfrey J (noted here by the IPKat).

Right: "This should be good for protection till at least the year 2020!"

To summarise, Servier had a patent for "a new α crystalline form of perindopril tert-butylamine salt, a process for its preparation and pharmaceutical compositions containing it" (perindopril being an ACE inhibitor used in the treatment of hypertension). This patent claimed priority from a 2000 French application, but the original perindopril compound was patented in the early 1980s and another earlier patent for the compound patent for "the industrial synthesis of perindopril" from the late 1980s. The patent was lucrative: Servier's turnover in the UK alone was £70 million and generics manufacturer Apotex had sold £4 million worth of perindopril in the short period before Servier, alleging infringement, secured interim injunctive relief. Apotex challenged the validity of the patent, while Servier sought leave to amend it. Pumfrey J dismissed Servier's application to amend the patent, which he revoked. On the evidence, the patent's claims had been anticipated by, and lacked inventive step because of, one of the earlier patents: the proposed amendments couldn't remedy this deficiency.

This morning the Court of Appeal dismissed Servier's appeal in no uncertain terms. Giving the judgment of the Court, Lord Justice Jacob made some pretty pointed comments before he even considered the legal niceties of the appeal -- these being just the sort of things that give the appellant a hunch that things are not going to go in his favour:

"This is an appeal from ... 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 ... [b]ut he also refused to continue an interim injunction pending appeal on the grounds that he considered there was no real prospect of success. ...

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 6th 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 2nd 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 21st 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 16th September 1988, expiring on 16th 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 6th 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 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.

Left: Purr-indopril has always been a popular treatment for hypertension in the cat community

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".

A release from Apotex's lawyers Taylor Wessing says:
"This judgment is likely to have ramifications in the pharmaceutical industry, which has long had a policy of "ever-greening" and seeking to obtain as much second and tertiary patent protection as possible."
The IPKat suspects that the ramifications may go no further than the award of costs on an indemnity basis which Jacob LJ mentions -- which would be a small proportion of the value of the patent even if the fees were clocked up on the Allen & Overy Scale. And every day the patent is in contention is another day the proprietor derives some market benefit from it. Merpel mischievously speculates as to whether some sort of account of profits couldn't be conjured up, though he notes that this sort of relief is only ordered against infringers, not naughty patent owners who act within the law.

2020 here and here
Living with hypertension here
Dying with hypertension here

3 comments:

YA76OO said...

I love this blog, again.

Anonymous said...

Hard to reconcile this robust and brutally swift Jacobian dispensing of justice in Europe with the piece in this month's "Managing Intellectual Property" magazine from two members of the German litigation firm Krieger, which states (page 75) "To put it in a nutshell: German patent courts are the first choice worldwide for patent litigation" When the waiting period for a revocation decision from the BGH (appeal instance) is FIVE WHOLE YEARS, that assertion in MIP is simply laecherlich. Why do they need to make such laughable assertions? But where are the articles in MIP from proponents of patent litigation in England? Fact is: litigation in Duesseldorf is ADR beefed up with injunctions, not adversarial litigation with exposure of the real facts.

Anonymous said...

Perindopril is not going any where.
Servier has already moved on from different crystalline forms of the erbumine salts [debated in your blog post] to a completely new salt [Perindopril Arginine].
They are also fighting an opposition at EPO against this new salt.

So, looks like Perindopril litigation will continue for some time to come.

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