Updates

VALUE ADDED SPCs - CJEU CLARIFIES BROAD SCOPE OF PROTECTION

09 March 2012

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 Court's judgement is that an SPC granted for Product A may be used to prevent a competitor from marketing any authorised product that contains A (e.g. A+B) after the basic patent's expiry and whilst the SPC is in force.

The application of this logic to the facts of the Novartis v Actavis case should mean that Novartis' SPC in which the product is defined as valsartan (only) can be used to oppose the launch of generic versions of not only:
-  Diovan® (Novartis' valsartan-only medicine); but also
-  combination products containing valsartan (such as Diovan HCT®, a medicine containing both valsartan and hydrochlorothiazide (HCTZ)).

The English High Court however is yet to render a judgement following issuing of the CJEU's Reasoned Order.

More broadly, it should mean that generic manufacturers will now need to delay launch of their versions of combination products until the time that, in the country of proposed launch, all SPC protection has expired (or has been invalidated) in respect of:
(a) each individual active ingredient present in the innovator product; and
(b) any (sub-)combination(s) of active ingredients present in the innovator product for which SPCs may have also been obtained.

Please therefore contact us if you would like to discuss in detail the implications of this ruling and the ways in which it could effect either your SPC portfolio or your plans to launch any combination products.

If you require any further information, please contact John Miles or Michael Pears of our SPC & Regulatory group.

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