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Santen Judgment Raises Questions Over Whether Spc Regulation Is Fit for Purpose (IAM)

Life sciences innovators in Europe are no longer entitled to patent term extension rights for new indications of drugs previously approved for other uses, following last week’s Santen judgment in which the CJEU in effect overturned its own 2012 decision in Neurim.


“I think the Regulation needs a completely new start,” comments Maiwald’s Dirk Buehler. “In general, the Regulation as it is today has moved a pretty long way from the original motives for putting it in its place – to foster innovation. A common theme is that certain types of research are discriminated against, such as research into second medical indications and [because of other decisions relating to Article 3(a)] innovative discoveries relating to principle of very broad application. The explanatory memorandum originally said that all types of research should be fostered and should receive SPC protection.”


This text is a report from iam. The full text version of the article can be found here: