Pronova BioPharma ASA announced that the U.S. District Court for the District of Delaware ruled in Pronova's favour in the patent litigation involving U.S. Patent Nos. 5,656,667 (the "'667 patent") and 5,502,077 (the "'077" patent") covering Lovaza.
"We are very pleased that all of our challenged patents have been fully upheld in this ruling", says CEO of Pronova BioPharma ASA Morten Jurs. "We have been confident in our intellectual property rights and have spent considerable resources on defending our patents in the USA. We look forward to continue building the Lovaza brand in our largest market".
The U.S. market represents approximately half of total revenues.
The Court found Pronova's patent claims are valid, enforceable and would be infringed by Teva Pharmaceutivals USA, Inc. and Par Pharmaceutical Inc. In a written ruling, the Court found: "that Pronova has met its burden to prove infringement of the '667 and '077 patents by a preponderance of the evidence; defendants have not proven that the asserted claims of either patent are invalid by clear and convincing evidence; and defendants have not proven, by clear and convincing evidence, that either patent is unenforceable due to inequitable conduct."
The Lovaza patents are owned by Pronova and licensed to GlaxoSmithKline in the United States and Puerto Rico, and cover compositions and methods of using omega-3 fatty acids. The '667 patent expires in April 2017 and the '077 patent expires in March 2013. Pronova, via its wholly owned subsidiary Pronova BioPharma Norge AS, filed the patent infringement lawsuits against Teva and Par in April 2009.