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IP Cases & Commentary – Details

7 March 2012

SPCs for Combination Products - Common Sense Prevails At Last?

Garreth Duncan

Hot on the heels of the Medeva and related decisions late in 2011, the Court of Justice of the European Union (CJEU) has issued its latest order on SPCs for combination pharmaceutical products. The order was issued remarkably quickly, within 8 months of its referral by the UK Patents Court, and will be welcomed by innovator pharmaceutical companies after the confusion caused by the Medeva ruling. It may also bring to an end the long-running dispute between Novartis and generics manufacturers on the valsartan / hydrochlorothiazide combination drug. The ruling of the CJEU is reproduced below:

“Articles 4 and 5 [of the medicinal products SPC Regulation] must be interpreted as meaning that, where a 'product' consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that 'product' in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that 'product' enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the 'product', as a medicinal product, which was authorised before that certificate expired.”

Although the wording of the order is somewhat convoluted, its effect is good news for innovator pharmaceutical companies. If an SPC is granted for a drug containing an active ingredient (A), the ruling would permit the SPC holder to enforce it against a competitor marketing an authorised drug which is a combination of actives (A + B) after expiry of the basic patent for A, unless the claims of the basic patent specifically exclude the presence of another active. It could therefore prevent generics from circumventing an SPC protecting A by marketing a combination of A with another active.

A full article on this case will be available in our April patent newsletter.

Useful links

Full text of decision C-442/11 Novartis v Actavis

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