Authorisation of generic medicines - Advocate General favours pragmatic approach to EU 'carve-out' rule for still patented indications and dosage forms
In her Opinion issued on 4 October 2018, Advocate General (AG) Kokott invites the EU Court of Justice (ECJ) to endorse a pragmatic application of the 'carve-out' for indications and dosage forms still under patent when Member States authorise generic human medicines. In particular, the generic applicant should be allowed to introduce a 'subsequent carve-out' after the marketing authorisation has been granted, but before the generic product is actually placed on the market (C-423/17, Warner-Lambert Company).
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- Where the originator enjoys patent protection only in relation to certain indications or dosage forms, EU law allows the marketing of generic medicines for the unpatented indications and dosage forms (after the data exclusivity period for the reference product has expired).
- To avoid patent right infringements, generic manufacturers are allowed to introduce a 'carve-out' as foreseen in Article 11 of the Human Medicines Directive (2001/83). This ensures the deletion of the still patented indications or dosage forms from the published summary of the product characteristics (SmPC) of the generic medicine.
- The AG favours a pragmatic application of the carve-out mechanism allowing the generic manufacturer not only to introduce the carve-out at the stage of the authorisation application ('initial carve-out'), but also, where necessary, to introduce the carve-out after the marketing authorisation has been granted, but before the generic product is actually placed on the market ('subsequent carve-out').
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Background
The case originated in the Netherlands where the pharmaceutical company, Aurobindo, applied for a marketing authorisation for a generic version of the human medicine Lyrica, which can be used to treat epilepsy, generalised anxiety disorder and neuropathic pain.
As the company sought authorisations in several Member States, it made use of the decentralised authorisation procedure. The indication for neuropathic pain was still patented at the time in the Netherlands. However, the company's application submitted in the decentralised procedure did not contain any carve-out in that regard, as foreseen in Article 11 of the Human Medicines Directive.
The company introduced the carve-out in the Netherlands only after the marketing authorisation had been granted, but before the generic medicine had been placed on the market. The company notified the regulator of the carve-out and requested the removal of the patented indication from the published summary of the product characteristics (SmPC), in accordance with the subsequent carve-out.
The Dutch regulator rejected that request and published the complete SmPC, including the still patented indication. The position of the Dutch regulator is that the carve-out must be part of the initial application for authorisation. This led the originator, Warner-Lambert Company, to initiate court proceedings in the Netherlands for alleged infringement of its patent rights.
It is in the context of these national proceedings that the ECJ has been asked to clarify the application of the EU carve-out rule and in particular to consider the possibility of a subsequent carve-out after the marketing authorisation has been granted.
The AG's Opinion
In her Opinion of 4 October 2018, the AG agrees with the EU Commission that a generic manufacturer must be allowed to introduce a subsequent carve-out.
In the AG's view, this reading is the only possible means to ensure that generic medicines can be authorised in a single procedure in all or several Member States, and, at the same time, to accommodate the patent rights of the originator which may differ in the various Member States (in the absence of a uniform EU-wide patent protection).
This reading is further supported, according to the AG, by the need to ensure that the marketed version of a medicine always corresponds to the authorised version, as described in the SmPC.
On the basis that the notification of a subsequent carve-out limits the scope of a previously granted marketing authorisation, the AG concludes that national regulators, having been notified of a carve-out, must refrain from publishing the full label version of the SmPC, including the patented indication or dosage form affected by the carve-out.
The judgment of the ECJ is still to be handed down and it remains to be seen whether the ECJ will follow the AG's proposed reading reconciling the law on medicinal products and patent law.
Depending on the final outcome of the case, one or more national regulators may have to re-visit their approach to subsequent carve-outs, which will certainly include the Netherlands.
