Actavis Group PTC EHF and Actavis UK Limited v. Sanofi, High Court of Justice, Chancery Division, Patents Court, London, UK, 20 September 2012, [2012] EWHC 2545 (Pat)
The Patents Court referred two questions of interpretation on the Supplementary Protection Certificate (SPC) Regulation to the CJEU for a preliminary ruling.
Sanofi was the proprietor of European Patent (UK) No. 0454 511 which covered the anti-hypertensive drug, irbesartan (marketed under the name Aprovel). The patent had expired on 20 March 2011 but Sanofi had obtained two SPCs based on the patent. The first, SPC GB98/07 (the Irbesartan SPC), had expired on 14 August 2012 and the second, SPC GB99/008 (the Combination SPC) was due to expire on 14 October 2013. The Combination SPC covered a fixed dose of irbesartan and hydrochlorothiazide and was marked by Sanofi under the trade name, CoAprovel.
Actavis intended to market generic versions of Aprovel and CoAprovel and applied to revoke the Combination SPC.
Mr Justice Arnold decided to refer two questions to the CJEU regarding the SPC Regulation. The first related to the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation. The second related to the meaning of Article 3(c) of the Regulation regarding the number of SPCs which can be granted in respect of a single basic patent. Mr Justice Arnold has requested the parties to provide submissions regarding the precise wording of the questions to be referred to the CJEU.
Read the judgment in English here.
Head note: Rob Fitt
The Patents Court referred two questions of interpretation on the Supplementary Protection Certificate (SPC) Regulation to the CJEU for a preliminary ruling.
Sanofi was the proprietor of European Patent (UK) No. 0454 511 which covered the anti-hypertensive drug, irbesartan (marketed under the name Aprovel). The patent had expired on 20 March 2011 but Sanofi had obtained two SPCs based on the patent. The first, SPC GB98/07 (the Irbesartan SPC), had expired on 14 August 2012 and the second, SPC GB99/008 (the Combination SPC) was due to expire on 14 October 2013. The Combination SPC covered a fixed dose of irbesartan and hydrochlorothiazide and was marked by Sanofi under the trade name, CoAprovel.
Actavis intended to market generic versions of Aprovel and CoAprovel and applied to revoke the Combination SPC.
Mr Justice Arnold decided to refer two questions to the CJEU regarding the SPC Regulation. The first related to the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation. The second related to the meaning of Article 3(c) of the Regulation regarding the number of SPCs which can be granted in respect of a single basic patent. Mr Justice Arnold has requested the parties to provide submissions regarding the precise wording of the questions to be referred to the CJEU.
Read the judgment in English here.
Head note: Rob Fitt
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