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

Monday 28 May 2018

European Commission proposal for manufacturing waiver

Today, the European Commission published its proposal to amend Regulation (EC) No 469/2009 on SPCs to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals for export outside the EU during the SPC term. A copy of the proposal is available here.

The results of the studies on the legal aspect of SPCs by the Max Planck Institute (here) and on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (here) were also published on the Commission website today. 

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