On 8 May 2019, the Dutch Medicines Agency (CBG/MEB) published a revised policy on generic manufacturers’ ability to carve out patented indications from their product information (that is, leaflet and summary of product characteristics). This new policy is a direct result of the CJEU’s preliminary ruling in Staat der Nederlanden v Warner-Lambert Company LLC (Case C-423/17) (see our previous blog post: “ECJ: notification of carve-out for the patented indications in SmPC and PIL by a generic Producer limits the scope of the MA.”)
Product information lists the specific set of indications for which a medicine can be used. Such indications can however still be patented by third parties (generally originators). In the past, the CBG published full product information about a medicine on its website despite the generic manufacturer having carved out the patented indication(s). If a generic manufacturer now applies for national marketing authorisation (MA) without the patented indication, the CBG will grant the MA without the patented indication. If a national MA is already granted and the manufacturer wishes to remove a patented indication it can do so by submitting a so-called variation request. After approval, the indication will no longer be part of the MA or be mentioned in the production information.
To protect the interests of patients and prescribers, safety information, even with respect to patented indications that are not mentioned, must be maintained. If a patented indication is deleted from the product information, the generic manufacturer has to use the following standard wording: “[product name] contains the [active ingredient], which can also be used to treat other conditions not mentioned in this leaflet. Contact your doctor or pharmacy with any questions.” A similar policy applies for MAs granted or applied for via the decentralised procedure or mutual recognition procedure. If patent protection ends, the policy describes how generic manufacturers can add the indication to the product information. A variation request is required for national registered products. For products registered via the decentralised procedure or mutual recognition procedure, a notification to the CBG is sufficient if the indication is mentioned in the common EU text. If that is not the case, a variation request is required.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2019 Issue (Thomson Reuters).