nuvolanevicata / Shutterstock.com
Orphan medicinal products in Europe benefit from a range of incentives, but the greatest of these is the promise of receiving a ten-year period of true market exclusivity, says Trevor Cook of Wilmer Cutler Pickering Hale and Dorr.
Since 2001, the EU has had under Regulation No. 141/2000 a modified regulatory regime that provides incentives to develop orphan medicinal products—those that treat rare diseases with patient populations of generally less than 250,000—within the EU.
The regime has been a success, with the number of marketing authorisations (MAs) for orphan medicinal products increasing at a faster rate than new MAs generally. It has attracted little controversy, and litigation has usually focused on whether medicinal products meet the eligibility criteria to be designated as an orphan medicinal product, as in cases CSL Behring v European Commission (T-264/07) and Now Pharma v European Commission (T-74/08).
One of the regime’s incentives is a special market exclusivity system, which has now become the subject of litigation. The first decision on this, given by the EU General Court in a case brought by Teva, has confirmed its strength.
To continue reading this article and to access our full archive, digital magazines and special reports you will need a subscription.
If you have already subscribed please login.
For multi-user price options, or to check if your company has an existing subscription we can add you into, please email Atif at email@example.com
If you have any technical issues please email tech support.
For access to the complete website and archive choose '12 MONTH SUBSCRIPTION'. For a free, two-week trial select ‘TWO WEEK FREE TRIAL’.
market exclusivity, Novartis, CML, EMA, Teva, Gilvec,