A ‘carve out’ of the patented indications from the Summary of Product Characteristics (SmPC) for a generic product has the effect of limiting its marketing authorisation. In such circumstances the authority should not publish the full label on its website. This is the view expressed by the Advocate General (AG) who advises the Court of Justice of the European Union (CJEU). We now await the CJEU’s ruling on this point, which should ensure consistent practice on this point by the different authorities. The likelihood is that it will follow the AG, but it is not obliged to.
The skinny label
The issue arose in the context of a dispute between Warner Lambert (WL) and the Government of the Netherlands in relation to WL’s blockbuster Lyrica (pregabalin). Lyrica is authorised for epilepsy, generalised anxiety disorder (GAD) and neuropathic pain. After the data exclusivity period had expired in 2015, a number of generics applied for authorisation for their products. At this point, patent protection on the substance itself (pregabalin) had expired, but WL still had patent protection for the indication neuropathic pain as a second medical use. This meant that, in countries where this patent existed, generic companies needed to exclude or ‘carve out’ neuropathic pain from the product descriptions with their packaging in order to avoid patent infringement – the label incorporating the carve out is known as a ‘skinny’ label.
The marketing authorisation
In the case in question the generic producer – Aurobindo – applied to the Netherlands authority under the decentralised procedure with Portugal as the reference Member State and obtained a full-label authorisation. After the marketing authorisation had been granted it notified them that it would introduce a carve-out for neuropathic pain which was patent protected in the Netherlands and asked them to publish the ‘skinny’ SmPC. However, the Netherlands authority published a full label version taking the view that a carve-out subsequent to the grant of the authorisation does not affect the marketing authorisation. WL objected on the grounds that failure to amend the authorisation would encourage generic prescription of the patented indication.
The SmPC should reflect the marketing authorisation
The AG pointed out that there is no obligation to introduce a carve out. The generic manufacturer chooses to do so to avoid patent infringement. However, where there is a carve-out it is important that the authorisation should be consistent with the product description that comes with the medicine (the SmPC) and that this ‘skinny’ version of the label should be published on the website. This reflects the fundamental principle that the version of the product placed on the market must be identical to the authorised version. She acknowledged that this will result in the authorisation being different between countries as there will be patents in some countries but not in others.
The AG makes it clear that where a marketing authorisation applicant or holder notifies the competent authority that it is introducing a carve-out, this should be regarded as a request to limit the marketing authorisation to the remaining indications and it is the skinny label which should be published on the website. When the patent expires the generic must apply to add the indication back into its marketing authorisation. This creates a situation where there can be no confusion about what the generic product is authorised for protecting both the patent holder and the generic. In the interests of transparency it might be felt that patients should be aware that the medicine is also authorised for other conditions, and the AG points out that Member States may require generic manufacturers to include a statement in the package leaflet explaining that the active substance is authorised for other conditions and that patients may ask their doctor or pharmacist if they have questions.
The Opinion: Advocate General Kokott: Case C-423/17 Staat der Nederlanden v Warner Lambert Company LLC