NEWS - FEBRUARY 2009

Trademarks - Switzerland:

Off-label use of pharmaceuticals and related information.
“Topamax”- The present decision from the Federal Court relates to the ruling of advertising for therapeutic products outside their approved therapeutic indications (published in SIC! 02/2009).

The pharmaceutical product was approved by Swissmedic for the treatment epilepsy and prophylaxis of migraine. The owner of the market authorization (plaintiff) provided information for professionals relating to its use in the treatment of drug-dependency (non-authorized indication). Swissmedic requested the plaintiff to: (i) cease providing information on dosage schemes in relation to the non-authorized indication; (ii) immediately inform doctors about the associated security risks for such a use, and (iii) provide a revised concept of communication.

The plaintiff referred the case to the Federal Court refuting the advertising nature of the documentation. The decision confirmed that advertising addressed to professionals should NOT encourage the abusive or inappropriate use of therapeutic products (Art. 1 I, II, 10 I a, 31 I a, 32 I LPth (Federal law on pharmaceutical products) and Art. 5 I, 2 c, 3, 4 OPMéd (Ordinance on the advertising of medicaments)). A clear distinction has to be made between general information concerning health or diseases which do not refer directly or indirectly to a specific medicament (which do not constitute an advertisement), and direct advertising for specific therapeutic products.

It was stressed that the use of a therapeutic products outside its registered use (off-label-use) is not, in principle, forbidden and information thereon is possible without necessary consisting in an advertisement (Art. 9, 31, 4 I d–f I LPth and Art. 5 I, 4 d OPMéd). However, this information should NOT present the unauthorized use in a unilateral manner (as found in this case) but on the contrary should contain balanced remarks and contributions. Therefore, anybody distributing documentation containing unilateral information with the name of a therapeutic product and proposes a posology for a non-agreed indication is liable for distributing unauthorized publicity for a non-agreed use of a therapeutic product.