In Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb the UK High Court has referred two further questions relating to the scope of Supplementary Protection Certificates (SPCs) for pharmaceutical products to the Court of Justice of the European Union (CJEU). The questions relate to the criteria for determining whether a product is ‘protected by a basic patent in force’ and to the situation where multiple products are protected by a single patent.

Sanofi had been granted a second SPC in respect of EP(UK) 0454511, a European patent relating to the antihypertensive drug, irbesartan. This SPC is directed to a combination of irbesartan and hydrochlorothiazide (sold under the trade mark CoAprovel). It was granted in December 1999 and has an expiry date of 14 October 2013. The first SPC based on this patent, for irbesartan alone, expired in August 2012.

Actavis challenged the validity of the second SPC on the grounds that:

  1. the combination of irbesartan and hydrochlorothiazide is not specified or identified in the wording of the claims of the patent; and
  2. the product had already been the subject of an SPC and/or the product had already been the subject of a marketing authorisation before the application for the combination SPC was filed.

The judge decided to refer two questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling

Question 1: What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?

Question 2: 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 first question 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". The second relates to Article 3(c) which specifies that an SPC will be granted only if “the product has not already been the subject of a certificate”. This second question has previously been referred to the CJEU by the Dutch courts in Georgetown University v Octrooicentrum Nederland.

The CJEU has given opinions on a number of issues relating to SPCs recently (see here, for example, as well as the review in our most recent newsletter). In particular, supplementary protection certificates for combination products have been the subject of a number of previous referrals. However, there are still many areas of uncertainty as evidenced by this new referral.