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Thursday, 4 October 2012

Brief from the AdvoKat: Arnold J asks the CJEU to try again in relation to SPCs on combination product

The AdvoKat
Currently the Court of Justice of the European Union (CJEU) is wrestling with the SPC Regulation, particularly the interpretation of Articles 3(a) and (b) in the context of combination products. As reported on IPKat here, in Actavis v Sanofi ([2012] EWHC 2545 (Pat)) the Patents Court has referred further questions on the issue back to the CJEU.

By way of recap, the problem that has arisen several times is the requirement in Article 3(a) that the product the subject of a Supplemental Protection Certificate (SPC) is “protected by a basic patent in force”. In Medeva, the CJEU said that Article 3(a) of the Regulation:
“must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application."
In the UK, Mr Justice Arnold said in Novartis Pharmaceuticals UK Ltd v MedImmune Ltd [2012] EWHC 181 (Pat) that he was “disappointed” with the CJEU’s judgment. He believes it is far from clear what is meant by “specified in the wording of the claims”. Nor is he alone - both the Court of Appeal in Medeva itself ([2012] EWCA Civ 523) and Warren J in Eli Lilly v Human Genome Sciences ([2012] EWHC 2290 (Pat) have expressed similar sentiments.

Arnold J clearly thinks that the time has come for the CJEU to have another go at answering the Article 3(a) question. So, in Actavis, having noted the divergent rulings in the parallel cases in France, Germany and the Netherlands, he has referred the issue back to the CJEU, asking essentially the same question as was asked in Medeva:
"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?"
The AdvoKat suggests that there are three points of note from this.

First, Arnold J was keen to avoid the kind of convoluted question sometimes asked by the English courts. He has asked a straightforward question. We will have to see if he gets a straightforward answer….

Should the CJEU come back with
a clear answer, the AmeriKat suggests
Mr Justice Arnold crack open
a bottle of his favorite Côte-Rôtie
Second, Arnold J suggested the answer to his question. He proposed that for a product to be protected by a basic patent it must infringe that patent and “infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the ‘inventive advance’ (or technical contribution) of the basic patent”. On this basis, he would have not allowed Sanofi’s SPC, which was to the combination of the anti-hypertensive irbesartan and the diuretic HCT and which is sold by Sanofi as CoAprovel. Sanofi’s inventive advance was irbesartan itself, not the combination of it with HCT. Arnold J was keen to stress that his test was a matter of substance not form which operates independently of the wording of the claims of the basic patent. Because Arnold J had heard a trial on validity of the basic patent, it was easy for him to identify Sanofi’s inventive advance. It is less clear how an industrial property office will assess the inventive advance based upon no more than the basic patent itself. As to the “substance not form” point, this raises the question as to how one reconciles Arnold J’s test with the CJEU in Medeva. Would it result in combinations that are express in the claim wording (and therefore clearly “specified” in it) being denied SPC protection because they do not embody the “inventive advance” of the patent? We will have to see what the CJEU makes of it.

Third, however, there must be a distinct possibility that the CJEU will consider that it has already answered the question in its judgment in Medeva and that any further issues that remain are matters for the national courts to resolve.

Finally, while he was at it, Arnold J decided to clarify the other issue that arose out of the judgment in Medeva. This is whether it was possible to have more than one SPC per patent in a situation where multiple products are protected by the claims of a basic patent. Based on the decision in Biogen, it had been generally thought that it was. However, the judgment in Medeva stated:
“Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28).”
This has been interpreted in two ways. Some, including the UK IPO, have continued with its existing understanding based on Biogen that “one SPC per patent per product” was permissible. Others have interpreted it more literally and applied an absolute limit of one SPC per patent. In this camp is the Dutch Patent Office in case AWB 10/4769 Georgetown University v Octrooicentrum Nederland (11 July 2012). However, like Arnold J, they have also referred the issue to the CJEU. It is to be hoped that the CJEU can clarify the position.

SPC fans therefore have plenty more excitement to look forward to in the coming year.


Anonymous said...

Re your comment: "Because Arnold J had heard a trial on validity of the basic patent....".

Er, not quite. There was some evidence about whether or not HCTZ was an obvious diuretic, with the evidence appearing to be that it was, which led Arnold to conclude that there was therefore no invention in Claim 20. However, there was no invalidity attack by the claimant as against claim 1, and no free-standing invalidity attack against claim 20 either.

Anonymous said...

The points that Mr Justice Arnold mentions raise a lot of issues. An infringement test does not sit well with a technical contribution test which operates independently of the claims. Further technical contribution does of course change if the prior art landscape changes (when new prior art comes to light).

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