A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Wednesday 30 January 2019

Recent developments to the SPC manufacturing waiver proposal

As most SPC Blog readers will know, in May 2018, the European Commission published its proposal to amend the SPC Regulation (Regulation (EC) 469/2009) to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals to export outside the EU during the SPC term (see here for SPC Blog post). 

Recently the Council of the European Union has published its final mandate (here) for negotiations with the European Parliament on this proposal. 

Andrew Hutchinson and Nicholas Fischer have summarized where things now stand with this proposal in an article, which can be accessed here.  Thanks Andrew and Nicholas!