The UK High Court has decided to refer further questions to the Court of Justice of the European Union (CJEU) in an attempt to clarify under what conditions a Supplementary Protection Certificate (SPC) may be granted based on a product containing a combination of active ingredients.

At the end of last year, the CJEU issued a number of judgements stating that an SPC should not be granted “relating to active ingredients which are not specified [identified] in the wording of the claims of the basic patent relied on in support of the SPC application”.  However, the meaning of these CJEU judgements has been widely questioned.  In particular, what does “specified/identified” in the claims actually mean?

Mr. Justice Arnold sitting in the UK High Court has now decided to ask the CJEU for clarification in the context of Actavis v Sanofi.

Sanofi are the owners of EP(UK) Patent No. 0 454 511 claiming both irbesartan (an angiotensin II receptor blocker useful for treating hypertension) and a combination of irbesartan and a diuretic.  Sanofi was granted a first SPC for the single product irbesartan (Aprovel®) which has now expired and also a second SPC for a combination of irbesartan and hydrochloridethiazide sold as CoAprovel® which is set to expire 14 October 2013.  Hydrochloridethiazide (HCT) is not specifically mentioned anywhere in the patent but is a well known diuretic.  Actavis challenged the validity of Sanofi’s second SPC for the combination product alleging (1) that the patent did not specify/identify a combination of irbesartan and HCT; and (2) that only one SPC is allowed per patent.

The first question to be referred to the CJEU is:

“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation?”

This is essentially asking for clarification regarding how the phrase “specified/identified in the wording of the claims” should be interpreted.  In Mr. Justice Arnold’s opinion the CJEU “did not answer question 1 in the previous five references and the rulings it did make do not provide a clear test which can be applied to cases such as the present”.  A number of conflicting decisions arising from national courts in France, Germany and the Netherlands are cited as evidence that this is the case.  Interestingly, Mr. Justice Arnold offers a suggested answer to his own question “(i)n the hope that it will assist the Court of Justice to provide a clear answer this time”.  He suggests that an SPC may be based on a product if it “contains an active ingredient, or combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent”.  Only time will tell if the CJEU welcomes or adopts this suggestion.  In the meantime, it is certain to cause further debate.

The second question to be referred is provisionally worded in the same manner as a related question referred to the CJEU by the Dutch Court:

“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?”

The precise wording of the questions may be challenged by either party before being finalised.