Dutch State v Warner Lambert Company (Gerechtshof Den Haag, 200.185.962/01, 2017)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

In interim proceedings between the Dutch State, acting for the Dutch medicines authority (CBG), and the holder of a second medical use patent for pregabalin in the treatment of pain, The Hague Court of Appeal referred three questions on Article 11 of Directive 2001/83 to the Court of Justice of the European Union (paras 2.18 and 3.1). The issue is whether a generic company’s notice that it is carving out patented indications amounts to a request to limit the marketing authorisation and, if not, whether the authority may publish online the full summary of product characteristics (SmPC) and leaflet, patented indications included (para 2.18). The court took the provisional view that such publication is neither direct nor indirect infringement by the CBG, while reserving its decision on that point (para 2.6). The stake is whether a carve-out works when the authority circulates the full label.

Facts and procedure

WLC belongs to the Pfizer group, which markets Lyrica (pregabalin) for indications including neuropathic pain (para 2.2.1). WLC holds EP 0 934 061 B3, centrally limited to pregabalin, which claims its use for treating pain and remains in force until 17 July 2017 (paras 2.2.3 and 2.2.4). Since mid 2009 the CBG has published the generic’s full SmPC and leaflet in its database even where the authorisation holder has notified a carve-out (para 2.2.8). In 2015 several generic companies, including Aurobindo, obtained authorisations for pregabalin; the CBG refused Aurobindo’s request to publish the carved-out version (para 2.2.9). The information service of the Dutch pharmacists’ association (KNMP) told a pharmacist that generic pregabalin could be dispensed for neuropathic pain, as that indication appeared in the published SmPCs (paras 2.2.10 and 2.2.11). The interim relief judge rejected infringement but held that the CBG had breached its duty of social care and ordered publication of the carved-out versions for pregabalin (para 2.5.4). The State appealed and WLC cross-appealed on infringement (paras 2.5.5 and 2.5.6).

The applicable law

Article 11 of Directive 2001/83 relieves a generic applicant from including those parts of the reference product’s SmPC that refer to indications or dosage forms still covered by patent law when the generic is marketed; Article 21(3) requires the authority to publish the SmPC and leaflet (para 2.8). They are implemented by the Geneesmiddelenwet and its implementing regulation (paras 2.3.1 and 2.3.2). In the Netherlands, prescriptions are in principle written by substance name and generally do not state the indication (paras 2.4.1 to 2.4.3).

Question

Does a carve-out notice limit the marketing authorisation and, if not, does EU law preclude the authority from publishing the generic’s full label, given that the authorisation holder must refer to the authority’s website in the printed leaflet?

Decision

The court considered that the interpretation of Article 11 is not obvious and does not follow from the case law of the Court of Justice, that the dispute raises a matter of principle, and that the imminent expiry of the patent does not make an answer irrelevant, if only for costs; it noted that the CBG is the only authority in the Union refusing to publish carved-out versions (para 2.11). The interim nature of the proceedings is no bar, since the measures ordered at first instance remain enforceable during the reference (para 2.12). The first question concerns the effect of a carve-out notice on the scope of the authorisation; the second, in the alternative, whether publishing the full label is compatible with Articles 11 and 21(3); the third, the relevance of the mandatory reference to the authority’s website in the leaflet (para 2.18). The court declined to ask about Article 59 of the Directive, as no claim targeted the reference requirement itself (para 2.16). All further decisions were stayed on both the appeal and the cross-appeal (paras 3.1 to 3.3).

Key points for practice

• Publication of the full label by the authority is provisionally not infringement, which moves the debate to medicines law and tort (paras 2.6 and 2.7).
• National prescribing by substance name, without the indication, bears on whether a carve-out is effective (paras 2.4.1 to 2.4.3 and 2.10).
• Practical point: the holder of a second medical use patent should monitor not only the generic’s label but also what the authority publishes and the sources pharmacists consult (paras 2.2.10 and 2.2.11).

Provisions applied

Directive 2001/83/EC

Arts 6, 10, 11, 21(3) and 59

National law

Articles 40, 42, 43, 46 and 50 Geneesmiddelenwet; Articles 3.7, 3.16d, 4a.2 and 6.11 Regeling Geneesmiddelenwet; Article 1019h Rv

Prepared by Dhenne Avocats from the text of the decision (rechtspraak.nl, Dutch text), consulted on 11 October 2026. Only the official text is authoritative.