The Court of Justice of the European Union (CJEU) ruled
yesterday in an important case (C-125/10, Merck Sharp &
Dohme Corp. v Deutsches Patent- und Markenamt), relating to
Supplementary Protection Certificates (SPCs). The decision of the
CJEU is binding upon all national patent offices and courts, and
dictates how the term of an SPC is calculated, especially in view
of a 6-month extension of term that may be available.
In essence, the CJEU has approved "Model A" of
an article published on 7 July 2007 by Mike Snodin and John
Miles of this firm, which introduced the revolutionary concept of
zero and negative term SPCs.
That is, the CJEU has decided that SPCs can be granted even if
they initially have a zero or negative term, i.e. if less
than 5 years and 1 day has elapsed between patent filing and
Marketing Authorisation (MA) issuance. This is because, provided
that at least 4 years, 6 months and 1 day has elapsed from between
patent filing and MA issuance, a zero or negative term SPC can
serve as the basis for an extended SPC with a positive term.
The particular factual background to this case is discussed in
our IP
Update no. 153 (relating to the opinion of the Advocate-General
that has effectively been confirmed by the Court). However, the
essential points of the case, as well as possible actions that you
may wish to take, are outlined below.
Legal Principles
SPCs provide additional protection, beyond patent expiry, for
products (medicinal or plant protection) that require a marketing
authorisation.
The "normal" (unextended) duration of an SPC after the
patent expiry is X - 5 years, where X is the period between the
patent filing date and the (subsequent) issuance of the marketing
authorisation. Although the normal duration is capped at a maximum
of 5 years after the patent expiry, this duration can be extended
by 6 months if the product has been the subject of clinical trials
in the paediatric population in accordance with an investigation
plan that has been agreed with the European Medicines Agency.
The question addressed by the CJEU is whether the potential
availability of a 6-month extension of term gives rise to the
possibility of obtaining, as an initial step, an SPC with a normal
term that is either zero or negative. Such zero or negative terms
could arise if less than 5 years and 1 day has elapsed between
patent filing and Marketing Authorisation issuance (i.e. if X in
the paragraph immediately above is less than 5 years and 1
day).
The point of having the potential 6 month extension is to
provide a reward to drug companies for carrying out clinical trials
in the paediatric population. Mike Snodin and John Miles argued in
their article that zero or negative term SPCs should be granted, in
order to maximise the effect of this reward.
CJEU Decision
The CJEU has now decided that SPCs can indeed be granted even in
situations where X is less than 5 years and 1 day, i.e. the normal
term is zero or even negative. For example, if the normal term of
the SPC were to be "minus 2 months" and an appropriate
paediatric trial had been carried out, then the 6 month extension
would mean that the actual term would be 4 months post-expiry of
the patent.
Action points
Please contact us for advice if you have a medicinal product for
which the following criteria apply:
Marketing Authorisation for the medicinal product could be (or
has been) issued in Europe at least 4 years 6 months and 1 day
after the date of filing of a patent protecting the product.
The results from clinical trials in the paediatric population
have been (or will be) submitted to one or more regulatory bodies
in Europe.
If these conditions are met, there could well be a benefit in
applying for Supplementary Protection for the product.
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.
Specific Questions relating to this article should be addressed directly to the author.
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