SPC export waiver: a long road ahead


Trevor Cook

SPC export waiver: a long road ahead

AnnaElizabethPhotography / iStockphoto.com

The European Commission’s proposed export waiver for supplementary protection certificates is likely to face opposition and may be delayed by EU parliamentary changes, says Trevor Cook of WilmerHale.

On hearing that the European Commission had on 28 May 2018 adopted a proposal for a Regulation to amend Regulation (EC) 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products, many practitioners might have been forgiven for imagining that such proposal sought to deal with what are to them are the most pressing issues with the SPC Regulation—perhaps by seeking to introduce a unitary SPC to accompany the proposed unitary patent, or perhaps by addressing some of the confusion surrounding certain aspects of the SPC Regulation that has led to so many references to the Court of Justice but has resulted in so little clear guidance from that body.

But such practitioners would be disappointed. Instead the proposal seeks to introduce, for medicinal product SPCs granted after its entry into force, what the Commission terms a “manufacturing waiver” to the SPC Regulation, which term is accordingly used in this article, although it is in reality a type of defence. The aim of the proposal is that such waiver apply only to manufacture for export.

The proposal would achieve this by inserting a proviso into article 4 of the Regulation, which at present provides that “within the limits of the protection conferred by the basic patent, the protection conferred by [an SPC] shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the SPC.”

Supplementary Protection Certificates, export waiver, generics, patent protection, European Commission, TRIPS, Trevor Cook, WilmerHale, manufacturing