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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 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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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