Amendment of policy for usage patents and publication from Dutch MEB
The Netherlands Medicines Evaluation Board (MEB) wants to continue publishing the complete SmPC (Summary of Product Characteristics) and package leaflet of generic medicinal products on the MEB website, even if a patent still rests on an indication.
A new proposal is to mark the patented indication, so that it is clear that this is a patented indication. This proposed policy change will be published on the MEB website for public consultation shortly.
The MEB is proposing this change to the policy following the judge’s ruling in the preliminary injunction proceedings surrounding the usage patent for pregabalin, filed by the company Pfizer (NYSE: PFE). According to the MEB, this makes it possible to combine the interests of good patient information and the disclosure of patents.
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