Merck wins ruling on negative SPCs in Europe
08 December 2011
Simon Crompton, London
The Court of Justice of the EU has ruled that member states can grant negative supplementary protection certificates (SPCs), which will help pharma companies win six-month research extensions
The ruling followed a referral by Germany's Federal Patent Court in a case involving a diabetes drug sold by Merck Sharp & Dohme.
As with other aspects of SPCs, courts around Europe had disagreed on whether a negative SPC was possible. Bulgaria, the Netherlands, and the UK granted Merck the SPC; Greece granted a zero term SPC; various other states, including Germany, refused to grant any SPC at all.
SPCs enable manufacturers of pharmaceutical and veterinary products to gain up to five years extra exclusivity in the EU to compensate for the time taken in gaining marketing approval.
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