A sense of relief: enforcing second medical use patents

Owners of second medical use patents may need to think outside the box in terms of the relief they seek for infringement, says Katie Hutchinson of Bristows.

In the last year the English courts have produced several judgments on infringement of second medical use claims as part of the continuing litigation between Warner-Lambert (Pfizer) and Actavis and Mylan. While there are still questions to be answered on determining infringement of second medical use patents, there are some practical steps which patentees and future competitors can consider taking that may assist in trying to reach a non-contentious solution before the launch of any potentially infringing medicine. There is also some guidance from the courts on what relief patentees can expect the courts to provide if an infringement action relating to a second medical use patent is successful. 

As an obvious first step in advance of any potentially infringing launch, it is essential that a patentee looks to the summary of product characteristics of its future competitor’s medicine and reviews the therapeutic indications which the competitor medicine lists as approved. If the medicine has listed a patent-protected indication (a so-called full label) as an indication, it seems foreseeable that the competitor’s medicine will be intentionally used for the patented indication. At this time, a patentee should therefore consider writing to the competitor company to notify it of the second medical use patent and to request that the protected indication is removed from the medicine’s label.

However, even if the protected indication is removed (creating a so-called skinny label), this will not be enough in the UK to ensure that the competitor medicine, once launched, will not be prescribed, dispensed and used for the patent-protected indication. This is because: