Our client, Tillotts Pharma AG, markets *ASACOL® in almost 50 countries worldwide. For more than three decades, ASACOL® has been a market leader in the treatment of inflammatory bowel disease worldwide.
Tillotts packages ASACOL® in blister packs for the European market. However, the company was considering entering new geographical markets where packaging with a desiccant would be desirable.
We were aware of a European patent that stood squarely in the way of Tillotts’ plans. The patent mentioned that ASACOL® tablets discoloured over time when stored in a humid environment due to the formation of a particular impurity and suggested preventing the discolouration by packaging the tablets with a desiccant to absorb moisture. Seeking a licence was not an option and therefore grant of the patent had to be opposed.
The Opposition Division unfortunately maintained the patent as granted. They believed that, since the formation of the impurity in question had not been recognised previously in the art, packaging the tablets with the desiccant was inventive. As no further art of any relevance could be found, the challenge was to overturn that decision and have the patent revoked on appeal based on the same art.
James Stones handled the appeal on behalf of Tillotts. Based on his experience before the EPO Boards of Appeal, James realised early on that a different approach would be needed if the appeal was going to succeed and so he assembled a select team of experts to assist in the preparation of the case.
Recognising that thorough preparation is the key to success before the Boards of Appeal, in addition to communicating by email and over the telephone, James made a point of meeting individual members of the team in person in the months before the hearing to discuss and co-ordinate their contributions. James also met with the team the day before the hearing to discuss the case in detail and, based on those discussions, prepared and presented the oral arguments to the Board of Appeal the following day.
The appeal was a complete success as the decision at first instance was reversed and the patent was revoked for lack of inventive step. Since no new art could be found, the deciding factor proved to be the difference in approach when preparing the case.
With the patent revoked, Tillotts was free to move forward with plans to re-package ASACOL® for the new geographical markets.
“The absence of any further relevant prior art could potentially have been a serious problem in this appeal but James’ approach proved to be effective. He quickly understood the science behind our work and guided us in the collection and interpretation of the evidence needed to support the arguments to win the case. We are very pleased with the outcome of the appeal as we are now free to pursue our commercial goals.”
Dr Claudia Hartig | Head of Analytical Department | Tillotts Pharma AG
*Asacol is a registered trade mark of Tillotts Pharma AG and of third parties in the USA, UK, Canada, Switzerland and Italy.