The decision effectively nullifies a supplementary protection certificate which was awarded to MSD Animal Heath (known as Merck in the North America) in 2014 and extended the term of their PD vaccine patent, preventing other suppliers from gaining access to the market until 2020.
As a result, other suppliers are now able to offer alternative vaccines against PD, something that Pharmaq – which had already developed its own PD vaccine – has been desperate to achieve. Indeed the Supreme Court’s decision upheld Pharmaq’s argument that the supplementary protection certificate should not have been awarded to MSD.
In its ruling, the Norwegian Appeals Court considered the comparative efficacy and stated that "[t]he Court of Appeal's overall assessment of the research data presented and the other evidence is that there are significant differences in vaccine efficacy, and that PHARMAQ's vaccine in actual practice has a significantly better effect against SAV-3 infection than Intervet's vaccine. The differences are consistent and systematic."
"This decision is no surprise, we always knew our vaccine was significantly more effective for pancreatic disease in salmon in Norway and we are pleased that the Supreme Court has confirmed the decision from the Appeal Court and denied MSD the supplementary protection certificate," says Pharmaq President Morten Nordstad.
Since 2004, Pharmaq has launched 28 fish vaccines, providing protection against a broad range of diseases, and helping to almost eliminate the use of antibiotics in the Norwegian aquaculture industry.
