Is There Anyone Who is Being Tricked?

SPCs are an essential incentive for the research industry to develop and marketing new medicinal products. For many years, generic and biosimilar companies have attempted to change the SPC-regulation to make it possible for these companies to marketing generic and biosimilar medicines rapidly – preferably the day after the SPC-expiration (“Day-1”). In parallel to this, The EU-Commission has found that generic and biosimilar companies increasingly have moved workplaces to countries outside the EU. This is because such a production would constitute an infringement of the original manufacturer’s SPC-rights. In order to stop the moving of workplaces, the EU-Commission proposes a so-called “SPC Export Manufacturing Waiver” – a waiver for production of generic and biosimilar medicines in the EU, if the medicines are produced for export. But what does the EU-Commission’s proposal mean for the balance between the original manufacturer on one side and the generic/biosimilar companies on the other side? Is it now possible to produce to stock (stockpiling), and is it possible to launch from Day-1? Are there any gaps in the EU-Commission’s proposal and is there anyone who is being tricked?

TARGET GROUP
The event is for lawyers, patent agents, persons with interest for IP and commercial relations and other persons who work in the life science industry. Please invite your colleagues and others in your network with interest for the life science industry.

Course certificates will be issued corresponding to 3 lessons and the certificates will be handed out by the end of the event. If you wish to get a course certificate, please write this in connection with your registration for the event.