Amendment of policy for usage patents and publication from Dutch MEB

15 February 2016

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK