Value Added SPCs - CJEU Clarifies Broad Scope Of Protection

Author:Mr John Miles, Mike Snodin and Michael Pears
Profession:Potter Clarkson
 
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Following hot on the heels of important SPC decisions issued in late 2011, the Court of Justice of the European Union (CJEU) has now issued a reasoned order in the Novartis v Actavis case (C-442/11).

SPCs

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation. The purpose of SPCs is to compensate patent holders for at least part of the delay in commercialising a patented active ingredient (or combination of active ingredients) caused by the need to conduct trials on safety and efficacy (and thereafter to obtain regulatory approval).

The CJEU Ruling

The CJEU held that an SPC granted for a product consisting of a single active ingredient should confer the same rights as those conferred by the basic patent for that product in the form of a medicinal product. In other words, an SPC proprietor should be able to oppose any regulatory approved use of that single active ingredient, including its use in combination with other active ingredients, provided that the same action could have been taken under the basic patent.

This ruling effectively confirms the interpretation of SPC scope set out in the Medeva and Georgetown University et al. cases (see our IP Updates Nos 165 and 167). This confirmation means that all national patent offices and courts are now formally bound to use this interpretation, which affords SPCs a broader scope than some had previously believed.

Commentary

Although the Court has answered the question in terms of SPCs for products which are single active ingredients, we anticipate that the same would hold true for products which are combinations of active ingredients. Thus an SPC for A+B in our view would be infringed by a medicinal product containing A+B+C, in the same way that an SPC for A would be infringed by a medicinal product containing A+B (and a medicinal product containing A+B+C). The rationale behind the decision supports both scenarios.

Practical Consequences

The upshot of the...

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