09 December 2011

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.

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

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