The Court of Justice of the European Union (CJEU) has confirmed that where a generic company has omitted - ‘carved out’ - patented indications or dosage forms from the Summary of Product Characteristics (SmPC) and product labelling in order to avoid patent infringement, this has the effect of limiting the generic’s marketing authorisation. This is good news for patent owners as it makes it clear on the record that the generic is not licensed to produce and sell the patented products for the patented indications or dosage forms.
A company wishing to put a generic product onto the market in the EU may obtain a marketing authorisation under the ‘abridged procedure’ relying on clinical trials and tests carried out by the original marketing authorisation holder, provided that certain conditions are met and that 10 years have elapsed since the original authorisation. The generic company will also need to wait until patent protection for the original product (the reference product) has run out. In cases where there are secondary patents on the original product relating to new therapeutic uses or dosage forms which could be infringed by the generic, these may be omitted from the SmPC and the package leaflet supplied to the patient in order to make it clear that the generic is not intended for these uses and forms. This is often referred to as ‘skinny’ labelling.
The case related to Warner Lambert (WL)’s blockbusting analgesic, Lyrica (pregabalin), and was referred to the CJEU by the Dutch court. At the time of the proceedings WL had authorisation for Lyrica in respect of epilepsy, generalised anxiety disorder (GAD) and neuropathic pain. Use in relation to epilepsy and GAD was no longer patent protected, thus enabling generic companies to come into the market for these indications. However, WL still had patent protection for neuropathic pain (expiring 17 July 2017). In such a situation it was the practice of the Dutch Medicinal Product Evaluation Board (CBG) to publish full details of the reference product (i.e. in this case Lyrica), including the patented indications, even though the generic had informed them of its intention to omit the patented information from its SmPC and product labelling. WL objected to this on the basis that full publication would encourage general practitioners to prescribe generic versions for indications which were still covered by patents. The view of the Dutch court, on the other hand, appears to have been that failure to publish the full details might be incompatible with CBG’s duty of care.
The CJEU, agreeing with WL, held that when the generic company notifies the ‘skinny’ SmPC to the competent authority (as it is obliged to do) this constitutes a request to limit the scope of the marketing authorisation for the generic medicine in question. As a result, the record of the generic authorisation on the website of the national authority should reflect the ‘skinny’ label. When patent protection for an indication or dosage form expires, it will be up to the generic company to request a variation of its marketing authorisation.
Case C-423/17 Staat der Nederlanden v Warner Lambert Company LLC 14.02.2019