Hopes rise for a bright future, if the court gets it right ...

"Hopes rise for a bright future for paediatric SPC extensions in the EU" is the title of an article by Mike Snodin (Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. Mike's article, which considers the effects of Advocate General Bot's Opinion in Case C-125/10 Merck,  concludes with the following thoughts.

"The innovative pharmaceutical industry will welcome Mr Bot’s opinion as representing a pragmatic interpretation of the objectives of the legislation governing SPCs and their extension. A particularly important practical aspect of the opinion is that, if followed in the CJEU’s final ruling, there will no longer be a perverse incentive in some cases to delay marketing authorisation issuance in order to obtain a longer patent / SPC monopoly period.

However, the opinion will not allay the concerns of those who obtain marketing authorisation issuance 4 years and 6 months or less after patent filing. This is because this category of patent holder could still be obliged to conduct additional clinical trials in the paediatric population, but would not have the option of using an extended monopoly period to recoup the costs associated with the additional trials.

There may therefore be some in the innovative industry who will be hoping that the CJEU does not follow Mr Bot’s opinion, but instead agrees with the patent office of Greece. If this were to happen, patent holders might be able to obtain a full 6-month period of (extended) SPC monopoly beyond patent expiry, regardless of how short the time between patent filing and marketing authorisation issuance.

As discussed in the 2007 RAJ Pharma article, a uniform reward of a full (additional) 6 months of SPC exclusivity after expiry of a patent meeting the qualifying criteria of the SPC legislation could well be viewed as being consistent with the objectives of the Paediatric Regulation.

In particular, Recital (26) of the Paediatric Regulation indicates that, for those products where the marketing authorisation holder has satisfied the obligations of the Regulation:

“a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92” (emphasis added).

It will be interesting to see what the CJEU make of this point, especially with regard to what “reward” will be granted to those who are able to obtain an SPC having a term of negative 6 months or less".

You can read Mike's article in full here.