From Takeda to Teva v Merck: are we treading the right path on Combination Product SPCs (Part 2 of 2)?
07 November 2017
In two earlier papers, including Part 1 of this series, we discussed the diminution of SPC term since SPCs were introduced in 1993, how the understanding of the definition of "product" in art. 1(b) of Regulation (EC) No 469/2009 (the SPC Regulation) has developed over time and how various courts within Europe have dealt with the definition of product.
In this article, we look in greater detail at the treatment of chemical combination products within the SPC system. In particular, we consider the key role that combination product cases have played in the development of the law regarding arts. 3(a) and 3(c) of the SPC Regulation. As part of that, we look at whether the CJEU should take the advice of Arnold J in the UK and adopt a "core inventive advance" test into SPC law. We set this discussion within the context of how pharmaceutical companies have applied for combination products in practice since inception of the SPC Regulation and how the average SPC term for combination products has dwindled over time.
To read the full article please click here.
This material was first published by Thomson Reuters and Contributors in Nicola Dagg, Steve Baldwin and Dr Tony Rollins , "From Takeda to Teva v Merck: Are We Treading the Right Path on Combination Product SPCs? (Part 2)", (2017) 39 (11) E.I.P.R. 697-704, and is reproduced by agreement with the Publishers.
This post was originally co-authored by Steven Baldwin.