08 October 2020 - Authored by:Lars Braams
Medice is the marketing authorisation (MA) holder of the medicinal product Amfexa, used for the treatment of ADHD. A third party successfully requested the Dutch Medicines Agency to publish the marketing authorisation dossier on the basis of the Dutch Open Government Law.
Medice unsuccessfully opposed the publication of its MA application. The MA application concerned a bibliographical application which consist of a collection of (public) articles and studies, rather than clinical trials (as required for a so-called full MA application). Albeit bibliographical, Medice estimated the application costs were 1800 man-hours over a period of more than 3 years (literature screening, reviewing, interpretation and drawing scientific conclusions).
The scientific conclusions drawn by Medice on the basis of public sources were rendered illegible by the agency prior to publication, because competitors could gain disproportionate advantages by gaining access (and being able to of copy) to those conclusions. The remaining part of the MA application was not rendered illegible.
Medice invoked database rights and copyright protection to prevent publication of its application.
On 30 September 2020, the highest administrative court in the Netherlands ruled that, for a database to be protected, a substantial investment is required. Medice’s investments were aimed at drafting and submitting the MA application and obtaining and maintaining a registration for Amfexa. It is only in the course of that activity that Medice prepared bibliographies as part of the clinical and nonclinical overviews of its application. Such “spin-off” database is only protected if there is also a substantial investment for obtaining the data and including it in the database. This is not the case here, because the actual investments were not for that purpose.
Unfortunately the highest administrative court does not answer whether the (selection of information in the course of drafting the) registration dossier is copyright protected.
In case of disproportionate harm, publication of competitive relevant information can be avoided under the Open Government Law (a so called relative ground for refusal). However, the mere fact that a third party could benefit from Medice’s investment does not mean that Medice would suffer disproportionate harm. Competitors are allowed to use Medice’s “summary of public information” (quoting the court), but need to draw their own scientific conclusions for their own bibliographic applications.
The highest administrative court considers it relevant in this respect that a bibliographical application is based on public sources which are not covered by the Open Government Act and that the conclusions drawn by Medice were rendered illegible.
The judgment can be found here.