Combination SPCs: more hypertension for the Court of Justice?

Last week Mr Justice Arnold gave judgment in the Patents Court, England and Wales, in Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat). In this action Sanofi was granted a second SPC in respect of European Patent (UK) No 0 454 511, "N-substituted heterocycle derivatives, their preparation, compositions containing them" (this being antihypertensive drug known by its international non-proprietary name of irbesartan).  The first SPC, for the single product irbesartan, expired on 14 August of this year.  The second SPC, granted in December 1999 and with an expiry date of 14 October 2013, is for a combination of irbesartan and hydrochlorothiazide sold under the trade mark CoAprovel.  Actavis challenged this grant and the judge has decided to refer two questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling

The first question for reference relates to Article 3(a) of the SPC Regulation, which states that an SPC shall be granted in respect of a patent when, on the date of the application for it, "the product is protected by a basic patent in force". Arnold J's first question to the CJEU, at [74], is this:

"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 second question is found at [92], where Arnold J states:

"It appears ... that the Dutch Patent Office has adopted the opposite interpretation of [the CJEU's ruling in Case C-322] Medeva to that adopted by the UK Intellectual Property Office, namely that it prohibits the grant of more than one SPC per patent regardless of the number of products claimed in the basic patent. In Case AWB 10/4769 Georgetown University v Octrooicentrum Nederland (11 July 2012), which is a parallel case to the Georgetown case in this country, the Rechtbank 'S-Gravenhage (Judge van Walderveen) held that the correct interpretation of Article 3(c) was unclear and decided to refer a question to the CJEU provisionally worded as follows:

"Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?" ...

Arnold J has provisionally decided to ask this question too.