The Court of Justice of the European Union (CJEU) has handed down a ruling that ends uncertainty as to the duration of Supplementary Protection Certificates (SPCs)
Biopharmaceutical companies herald court decision that lengthens term of SPC protection
SPCs are critical intellectual property rights granted to biopharmaceutical and agrichemical innovators whose path to market for innovative products is delayed by essential regulatory processes leading to the grant of marketing approvals.
The European SPC system seeks to compensate patentees by granting these standalone rights which last for a maximum period of five years after patent expiry.
Mike Gilbert, partner at Marks & Clerk Solicitors, said: “The CJEU’s decision is to be applauded because both common and commercial sense has prevailed.
“The SPC system was expressly set up to compensate innovators whose products could not be placed on the market without first undergoing an often lengthy and expensive regulatory procedure.
“These processes limit the effective patent protection for products because the 20 year period of patent protection is dramatically cut short by the delays in bringing the product to market.
“The CJEU’s decision recognises the compensatory effect of SPCs as a fundamental principle of the SPC system.
“While the effect of the decision might be seen as extending the duration of SPCs by only a few days at most, those few days can amount to many millions of Euros of sales of valuable products when assessed across all EU Member States where SPCs are in force.
“The decision will have wide ramifications for innovators and generic manufacturers alike, providing greater commercial certainty.”