Time for a review of the SPC regime...

The EU is putting out to tender a project to review the fundamentals of the SPC regime. See here for details. The deadline for reply is the 4th February.  This could get quite interesting.

The EU communication states that:

"The study shall evaluate whether a new European SPC title, in its current scope, or broadened with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.

With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets. The study shall also evaluate some economic aspects of the current SPC framework.

It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.

The results could serve as a basis for an impact assessment for a future proposal by the Commission to create a European SPC title, and complement the recalibration of the existing EU SPC rules".

New UK IPO Decision - can you rely on an "end of procedure" communication under Art 3(b)?

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.