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Event Report

30.3.2015

What’s the CJEU said this time? A review of the latest SPC musings from Luxembourg

Speakers: Daniel Wise (Carpmaels), Michael Lubienski (UCB) and Edward Oates (Carpmaels)

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Monday night saw AIPPI’s latest event on recent SPC judgments from the CJEU, hosted by Carpmaels & Ransford LLP.  Justin Watts (AIPPI President - Freshfields) chaired the event, with insightful and topical presentations by Mike Lubienski (UCB) and Daniel Wise & Ed Oates (Carpmaels), focussing on Actavis v Boehringer (C-577/13) and Forsgren (C-631/13).  Over 70 SPC enthusiasts from across the industry attended the event, which concluded with a drinks reception providing the opportunity for a chat with the speakers and other attendees. 

 

Actavis v Boehringer (reported on the IPKat here) was discussed against the backdrop of the earlier cases in Medeva (C-322/10), Actavis v Sanofi (C-443-12) and Georgetown II (C-484/12).  In Actavis v Boehringer, an earlier SPC had been obtained for a ‘mono’ product (telmisartan), and the SPC applicant sought a second SPC based on the same patent but a later marketing authorisation to a combination product (telmisartan and hydrochlorothiazide).  According to the CJEU, the parties had agreed that telmisartan “is the sole subject-matter of the invention”, and it followed that the claim to the combination was not the subject-matter of the invention.  Based on this logic, the CJEU held that the combination SPC was invalid.  It was discussed at the event which test should be used for determining the “subject-matter of the invention”.  Must each substance in the combination product (e.g. hydrochlorothiazide), when taken in isolation, constitute the “subject-matter of the invention”, or can the combination itself be the “subject-matter of the invention” if it is inventive in its own right?  Unfortunately for patent practitioners, the CJEU never considered the second question, which asked whether it is allowable to base an SPC on a basic patent that has been amended after grant.  This question is relevant in view of European opposition amendment practice, as well as recent CJEU case law suggesting that active ingredients must be adequately specified in the claims.  We should therefore expect questions on this point being referred to the CJEU in the future.

 

Forsgren (reported on IPKat here) dealt with combinations of a different kind, namely where substances are present in a medicinal product not side by side but covalently linked to each other.  According to the CJEU, an active ingredient (here, protein D) can indeed be the subject of a SPC even where it is covalently linked to another substance (here, pneumococcal saccharides), but the active ingredient must produce an effect “of its own”, and that effect must be “covered” by the therapeutic indications of the marketing authorisation.  The potential practical implications of this judgment were discussed, as well as the many questions that it opens up.  What happens if the marketing authorisation is varied to include new indications?  And how does the decision align with the Plant Protection Regulation and the definition of an “active substance” in the recent Bayer CropScience case (C-11/13)? 

 

In summary, this was a stimulating meeting of practical relevance, and we look forward to more of its kind.

 

Reported by Natalia Wegner-Cribbs (Carpmaels)