Maxx-Studio / Shutterstock.com
For those involved in the development of biological drugs, the prospects of getting what would seem to be a ‘fair reward’ may not have improved much, says Jaap Mannaerts.
In a long series of judgments and orders, starting with the Medeva case, the Court of Justice of the European Union (CJEU) has given guidance on the exact requirements for the grant of supplementary protection certificates (SPCs) for medicinal products in the EU. It seems that the matter is finally settling after last December’s judgments in the Actavis, Georgetown II and Eli Lilly cases, in a manner that appears generally acceptable, but that may not be the case when it comes to biologicals.
Background
With the Medeva (C-322/10) judgment, the CJEU caused turmoil by ruling that an active pharmaceutical substance could be considered protected by a basic patent only if it was ‘identified in the wording of the claims’. The case arose out of a situation where a patent had been obtained for certain antigens that had been developed into a vaccine containing additional antigens.
You need a subscription to continue reading this content.
Start a subscription today to access the LSIPR website.
To access the full archive, digital magazines and special reports you will need to take out a paid subscription.
News stories up to a week old and feature articles on the day of publication are accessible with a BASIC FREE ACCOUNT.
Register here for free content, or subscribe for access to archive.
If you have already subscribed please login.
If you have any technical issues please email tech support.
For access to the complete website, archive, and to receive print publications, choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial with full access, select ‘TWO WEEK FREE TRIAL’; and for basic access to the latest news on the website and weekly email news alerts choose the 'BASIC FREE ACCOUNT' registration.
Medeva, SPC, biologicals, CJEU
