Pregabalin – France

Pregabalin – France

On Dec 02, 2016, the Court of First Instance of Paris rendered a decision in permanent injunction case in Pregabalin (Lyrica), initiated by Warner-Lambert (the patentee) and licensees Pfizer against 9 groups of generic companies (the defendants).

All defendants are on the market with marketing authorizations which comprise the two open indications (epilepsy and generalized anxiety disorders), but do not comprise the still-patented indication (a specific type of pain).
WARNER LAMBERT asserts that the defendant companies would commit infringement by supply of means by knowingly and in bad faith marketing generic Pregabalin as a proprietary medicine protected by patent EP0934061 for pain indication. The majority of the pregabalin products are prescribed for the pain indication (83.8% of the sales in France, according to the patentee).

The defendant companies respond that WARNER LAMBERT cannot collectively criticise them for infringement by supply of means, that it must prove for each defendant, commission of the criticised acts, which it fails to do, that they have complied with all prescriptions on limiting sales of Pregabalin exclusively to those indications for which they have obtained a market authorisation, specifying said specialisms on the instructions for use enclosed with the product and that they have informed municipal and hospital pharmacists and physicians that Pregabalin may not be substituted when used to treat neuropathic pain.

The decision is interesting on many aspects covering skinny label, second medical use claims and contributory infringement.
First, the decision confirms that Swiss type claims, as the ones of the opposed patent (use of pregabalin for the preparation of a pharmaceutical composition to treat pain) are to be considered as process claims, and not product claims and the medicines are not manufactured in France, there can be no direct infringement.

Second, contributory infringement was dismissed for two main reasons: not only the marketing authorizations were limited to the two indications in the public domain, but above all there has been a widely spread information to relevant health professionals about the specificities of the generic pregabalin launched.

Third, the request of the patentee was considered unlawful. The patentee requested to jointly forbid all defendants to sell more than 16.2% of the pregabalin market (representing the market share of the public domain indications in France), as well as to summon defendants to share with him information allowing to understand the origin and the distribution channels of the products.

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