Our client, Chrysalis Pharma, had a new pharmaceutical grade formulation for soft gelatin capsules containing fish oil-derived omega-3 fatty acids in free acid form. The product was called Epanova® and we secured trademark and patent protection for the product around the world, including one patent family claiming the formulation containing a particular gelatin in the capsule shell.
The European patent was opposed by three parties. All three parties were involved in the manufacture and commercialisation of Seacor® which is the European equivalent to Lovaza®. At the time, Lovaza® was the only omega-3 product approved by the US Food and Drug Administration (FDA) for use in lowering very high triglyceride levels with annual US sales estimated at just under $1 billion (2011).
The oppositions came at a commercially sensitive time. Chrysalis had licensed Epanova® to Omthera Pharmaceuticals which was involved in clinical trials demonstrating the efficacy of Epanova® for severe hypertriglyceridaemia. At the time of the oppositions, Omthera was looking for a potential investor interested in commercialising Epanova® worldwide. Losing the European patent would have been a significant blow to these commercial aspirations.
Due to the importance of the case and the number of issues we faced, it had been decided to have two partners from Beck Greener, James Stones and John Hull, present the case at the hearing. We worked closely with Omthera and their US counsel to prepare our defence.
We prepared thoroughly and meticulously for the hearing. As part of those preparations, we met the day before the hearing with representatives for the client and for Omthera, and with our technical expert, to discuss the case. The US counsel for Omthera assumed the role of the opponent and tested our arguments. By the end of the day, we knew the case backwards.
Our preparations and attention to detail paid off handsomely. One of the opponents attempted to run an attack at the hearing based on an obscure combination of teachings. However, we spotted immediately that the teachings were technically incompatible and the attack failed. Indeed, we came out of the hearing having won on every point and, more importantly, with the patent intact.
Within a year of the hearing, AstraZeneca acquired Omthera and its licence to commercialise Epanova®. In May 2014, the FDA approved Epanova® for severe hypertriglyceridaemia.
“Before the hearing, I was worried that we could lose this patent which would have been a body blow to our plans. Having worked closely with James Stones on many projects for well over 10 years, I knew I could trust him to be on top of the situation. However, the Beck Greener team exceeded my expectations. They seemed somehow to be ahead of the opponents at every step. The combination of their careful preparation and fluid presentation under pressure clearly was the deciding factor. It was exactly the result we needed.”
Roly Bufton | Chairman | Chrysalis Pharma AG