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FR – Warner-Lambert Company and Pfizer v. Sandoz

30 Mar 2016

Lyrica® in France: Pfizer fails in preliminary injunction proceedings based on EP 0 934 061 covering a second medical use of pregabalin for pain

Warner-Lambert Company & Pfizer v. Sandoz, order of the presiding judge of the tribunal de grande instance de Paris of 26 October 2015, Docket № 15/58725, with thanks to Pierre Véron, Véron & Associés, for providing the judgment as well as a summary and translation in English

The ruling issued on 26 October 2015 by the presiding judge of the tribunal de grande instance de Paris dismisses preliminary injunction proceedings commenced by Warner-Lambert Company and Pfizer against Sandoz in relation with the marketing in France of a drug known as pregabalin.

Pregabalin was covered as such and for its use against epilepsy and anxiety by EP 0 641 330, which lapsed in 2013.

Warner-Lambert owns European patent № 0 934 061 (hereafter “EP 061”), which will lapse on 16 July 2017, covering the use of pregabalin “for the preparation of a pharmaceutical composition for treating pain”: this is a Swiss-type claim for a second medical use.

Pfizer markets pregabalin under the brand name Lyrica® for neuropathic pain, generalised anxiety disorder (“GAD”) and epilepsy (the two indications corresponding to the lapsed patent plus the indication corresponding to EP 061).

Sandoz developed a generic pregabalin and obtained a “carved out” marketing authorization in France covering only the two indications corresponding to the lapsed patent (epilepsy and GAD), but excluding the indication against pain corresponding to EP 061 still in force.

This practice is also known as “skinny labeling” (because it leads to a generic drug label that is “skinnier” than the pioneer drug label).

Sandoz informed French doctors and pharmacists that its pregabalin could not be sold for the treatment of pain.

Warner-Lambert and Pfizer argued that such information was not sufficient to avoid direct or indirect infringement of EP 061 and required that health professionals be provided with further information; they also required an order to limit the sales of Sandoz’ pregabalin to a certain percentage of the French pregabalin market (corresponding to the two indications covered by the lapsed patent) and claimed publication measures.

Parallel proceedings in Europe

In the UK, although EP 061 was held invalid for insufficiency, the High Court of Justice ordered the National Health Service to issue guidance to ensure that doctors would not prescribe generic pregabalin for the treatment of pain.

In Germany, the Landgericht Hamburg enjoined several generic pregabalin manufacturers from proposing discount agreements to health insurance organisations and taking part in invitations to tender which did not exclude the indication for pain treatment.

In Denmark, the Sø- og Handelsretten (Maritime and Commercial Court) issued a preliminary injunction against Danish pharmacists, enjoining them from dispensing a generic of the Lyrica® drug for the pain treatment indication.

French ruling

The presiding judge of the tribunal de grande instance de Paris ruled that, since Sandoz carved out the pain indication covered by EP 061 from its generic’s label and informed more than 50,000 French doctors and pharmacists that its pregabalin should not be prescribed or dispensed for the treatment of pain, it could not reasonably be held liable for either direct or contributory infringement, it being irrelevant that doctors may prescribe and pharmacists may dispense its generic for the patented indication of pain. It, therefore, rejected Pfizer’s claims for further measures.
A copy of the judgment (in French) can be found here.

A copy of the judgment (in English) can be found here.