On 12 March 2015, the Court of Justice of the European Union (the "ECJ") ruled on a question referred to it by the High Court of Justice (England and Wales), Chancery Division (Patents Court), after Boehringer had amended its basic patent to include a new claim relating to a combination of the protected active ingredient with another substance and had obtained an SPC for that combination (Case C-577/13, Actavis Group PTC and Actavis UK v. Boehringer).
On 20 May 1998, Boehringer had been granted a basic patent for numerous molecules, one of them being telmisartan. On the basis of that patent and a marketing authorisation Boehringer obtained for a product containing telmisartan, Boehringer was granted a first Supplementary Protection Certificate ("SPC") for that active ingredient.
Boehringer then filed an application to amend its basic patent by inserting a new claim relating to a pharmaceutical combination of telmisartan and hydrochlorothiazide. After it was granted, Boehringer obtained an SPC for the combination of these two active ingredients (the "Combination SPC") as well.
Actavis, which mainly produces generic medicinal products, brought an action before the High Court against Boehringer claiming that the Combination SPC was invalid.
As some of the issues raised by the parties pertained to the interpretation of Regulation 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products, the High Court referred different questions to the ECJ for a preliminary ruling. The ECJ was asked whether a basic patent including a claim to a product comprising an active ingredient for which the holder of that patent has already obtained an SPC, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, is a sufficient basis to obtain a second SPC for that combination.
The ECJ first noted that it could not accept that any subsequent marketing of an active ingredient in conjunction with an unlimited number of other active ingredients (which are not covered by the patent) would confer entitlement to multiple SPCs. It held that such a finding would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health.
The Court then examined the meaning of the expression 'as such' contained in Article 1(c) of Regulation 469/2009 as it considered that this expression was at the centre of the issue at hand. Indeed, an SPC will only be granted for products protected by a basic patent in force, such patent only protecting a product 'as such'.
Relating this to the active ingredient, the ECJ held that, in order for a basic patent to protect 'as such' an active ingredient within the meaning of articles 1(c) and 3(a) of Regulation 469/2009, that active ingredient must be covered by that patent.
As a consequence, the ECJ found that the holder of a patent may not obtain an additional SPC for a combination of two substances, only one of which constitutes the subject-matter of the invention protected by that patent, for which the holder of that patent has already obtained an SPC.
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