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News Articles

Supplementary protection certificates: is a new era beckoning for combination drugs in the EU?

09 August 2011

SCRIP Regulatory Affairs August 2011, 8-9
Authors: Michael Pears and Mike Snodin

This article appeared in the August 2011 edition of SCRIP Regulatory Affairs. It discusses Advocate-General Verica Trstenjak's opinion in joined cases C-322/10 (Medeva) and C-422/10 (Georgetown et al.). In particular, Michael and Mike point to aspects of the opinion that could provide a workable approach for dealing with supplementary protection for combination products. If adopted by the court, that approach could lead to substantial changes in practice in some territories, with resulting benefits for some SPC applicants / holders (increased availability of SPC protection and broader SPCs) and disadvantages for other SPC applicants / holders (possible invalidity of granted SPCs, or refusal of pending applications).

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