Durán-Corretjer SLP

The English High Court has taken a decision requiring that prescriptions of a pharmaceutical product protected by a second medical use patent be prescribed using the Trade Mark of the Patent holder when said pharmaceutical is prescribed to treat the disease  protected by the second medical use Patent. The case concerns a dispute between the companies Warner-Lambert and Actavis in connection with the drug comprising the active ingredient pregabalin. Said drug has three different medical indications. For two of those indications patent protection has already expired. However, for the third one (pain treatment) Warner-Lambert has protection through second medical use Swiss-type claims (EP0934061).

PROBLEM: Most prescriptions made by doctors in the UK refer generically to the active ingredient without specific mention of the specific drug prescribed (Trade Name / Trade Mark). In such cases, the pharmacist usually provides the generic drug, which is cheaper.

This approach collides directly with the situation described above in which a drug has three indications, two of them of public domain and a third one being Patent protected, risking that the generic drug is the one provided by the pharmacist both for the indications that are public domain and the Patent protected indication.

SOLUTION: The judge has forced the NHS (National Health Service) to issue guidelines indicating doctors that in the present case they should proceed as follows:

•    If the medical indication to be treated is neuropathic pain, pregabalin should only be prescribed under the Trade Mark name Lyrica® (marketed by the company Warner-Lambert), unless non-advisable due to medical contraindications or special medical needs. In such cases, neither Lyrica® nor pregabalin should prescribed.

•    If the medical indication to be treated is not pain, prescription using the generic name pregabalin should continue.