A Sequel to a Relatively Unusual and Complex Patent Situation

Re-purposing of medicines for their newer indications is a routine procedure undertaken in drug discovery, so that if successful, the regulatory approval for marketing the new use or new indication of the drug could be obtained with certainty. After the patent expiry of the older indication, generic manufacturers can begin manufacturing and marketing their version of the product for its off-patented use, if it is appropriate to do so in the country of concern. However, in certain countries, unwittingly, these generic products could also be put to a certain amount of controlling use, which is patent-protected by the innovator, in that country. When there is substantial revenue derived for the innovator from a patent for the controlling use of a drug, a relatively unusual and complex patent situation could arise. This article traces the sequel to the events in the United Kingdom covering the patented second medical indication of the drug, Pregabalin.