On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In practice, this prevents the competent authorities from publishing a complete SmPC, showing all indications associated with the innovator product, on their website.
Today’s judgment will be welcomed by innovative companies seeking to ensure the effectiveness of their second medical use patents.
When assessing a generic medicinal product, as a general rule, the competent authorities require the same information to appear in the summary of product characteristics (SmPC) and other product information of the generic medicine, as in the SmPC of the original, reference medicine. However, Article 3(3)(b) of Regulation 726/2004/EC (the Regulation) and Article 11 of Directive 2001/83/EC (the Directive) permit a generic applicant to “carve-out” from the SmPC any indications or dosage forms that are protected by patents; this is known as “skinny labelling”. This allows the generic medicinal product to be placed on the market even if individual indications or dosage forms of the reference medicinal product are still patented.
This case concerned the actions of the Dutch authority with respect to the skinny label for a generic version of pregabalin, marketed by Pfizer as Lyrica, which was protected by a second medical use patent for one of its indications. In particular, the Dutch authority had a practice of posting the full label version of the SmPC for the product on its website, instead of the carved-out version. The questions referred to the Court related to how the deletion of a still patented indication or dosage form of the reference medicinal product from the SmPC of the generic medicinal product affects the scope of the marketing authorisation for the generic product, and whether the action of the Dutch authority was in line with the correct interpretation of the Directive and Regulation.
Decision of the Court
The Court concludes that it does not matter if the carve out is made as part of the initial marketing authorisation, or after the authorisation is initially granted, but that both result in limitation of the scope of the marketing authorisation. This is in line with a fundamental principle of pharmaceutical law, according to which, the version of a medicinal product placed on the market must be identical to the authorised version of that medicinal product as described in the SmPC. The Court agreed with the Advocate General’s opinion that if an authorisation holder was able to place a medicinal product on the market with a SmPC that was modified compared with the authorised version, this would jeopardise the effectiveness of the authorisation procedure, as well as legal certainty and transparency for healthcare professionals and patients.
Contrary to the Netherland’s Government claims, the Court found that this interpretation is not inconsistent with the fact that the generic marketing authorisation holder must request a variation of the authorisation when, upon expiry of the relevant patent, they wish to add that indication to their already authorised products.
As the first question was answered positively, the Court did not answer the second and third questions, which related to the practice of the Dutch authority. However, in line with the Advocate General’s opinion, the implication is that competent authorities should not be permitted to publish the full label version of the SmPC of a generic product where the marketing authorisation holder has notified the authority of a carve-out. Article 21(3) of the Directive states that the competent authorities must make publicly available the SmPCs for each medicinal product they have authorised. It follows that if a carve-out limits the scope of the marketing authorisation, and the marketing authorisation and the SmPC thus have the same scope, there is no reason to publish a SmPC going beyond the scope of the marketing authorisation. Allowing such discrepancy between the scopes of the marketing authorisation, the SmPC and the package leaflet, would introduce a risk of confusion.