For those interested in UKIPO decisions, here is a link to a recent decision (BL O/117/16) from the IPO which looks at 2 specific points:
(i) Can the End of Procedure Communication from the RMS as part of the Decentralised Procedure (DCP) for granting MAs act as means to show that a valid authorisation has been granted for the medicinal product – as required by Art 3(b) of the SPC regulation; and
(ii) can an SPC for a combination, based on the same patent but later MA, be granted when the SPC for the monoproduct has already been granted using an Earlier MA but the same basic patent. Recent CJEU case law was considered (Sanofi, C-433/12, and Boehringer, C-577/13) to work out if more than one SPC can be granted based on same patent.
Click here for the decision.
If you are the type of person who turns to the end of a novel first to find out "whodunnit" then the answers to these questions are:
(i) No; and
(ii) Yes
This case arose because - with only one day left to patent expiry - the patentee only had the "End of Procedure Communication", but not the MA.
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