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
Friday, 29 June 2012
Mike and Michael acknowledge that, on the face of it, the opinion appears to be good news for the innovative pharmaceutical industry. However, their analysis of the opinion highlights some potentially serious side-effects that may throw the SPC system out of balance in a way that is detrimental to the long-term interests of the industry. In particular, they point to the fact that the solution proposed by the Advocate General would inadvertently sever an important link in the legislation (a link between a high regulatory hurdle and the award of an SPC) and lead to not only inconsistencies with certain statements of principle from the authors of the original legislation but also to a proliferation of SPCs based upon almost any kind of marketing authorisation (and therefore almost any degree of regulatory hurdle).
Mike and Michael therefore question whether, when reaching their judgment later this year, the Court of Justice of the EU may wish to consider alternative "cures" that have fewer side-effects but that still avoid the harsh result for Neurim that is reached through strict application of the prior case law of that court.
You can read Mike and Michael's article in full here.