Pharmaceutical Patent Term Extensions
All those concerned with the manufacture and sale of generic pharmaceuticals know that one of the most important pieces of information is the knowledge of when the targeted product will be free of its exclusivity…when will the patent expire.
Until not very long ago all that the generic producer had to know was the patent expiry. However, over the past decade or so we have seen the creation of the Pharmaceutical Patent Term Extension. In the USA, it has emerged under the Waxman-Hatch legislation; in Europe, in the form of EU Supplementary Protection Certificate (SPC). Subsequently, many countries throughout the world are following one of these forms to extend cover on their pharmaceutical products. Although this does not apply to all marketed products, most new products will qualify for these extensions.
The reason for this legislation was to reflect a “fairer” use of the allotted patent term. In the past, only about half of patent duration of 20 years was available for the patentee to recoup costs and make “reasonable” profits. All the procedures of testing and authorisation getting the product to market eroded a considerable amount of patent duration. So, legislation was created to give up to an extra five years of exclusivity to originators to compensate for this shortfall.
Those contemplating producing and marketing generic pharmaceuticals need to know when these extension periods expire, even more than patent expiry, particularly if the UK and the European Economic Union is a targeted area.
As business consultants for the pharmaceutical industry, MPA have been providing a business and patent intelligence service for more than 30 years. They have been particularly concerned with the European SPC since its inception in January 1993. Its principal, Martin Paltnoi, is well known on a global level and has addressed many conferences on this subject.
Through business and personal links with Canada, MPA would be keen to assist Canadian pharmaceutical producers, particularly those interested in Europe and the EU, through the quagmire of legislation on the question of pharmaceutical patent term extensions and ensure that they are well equipped with the best intelligence.
For more information contact Martin Paltnoi here.