Does an SPC for a Biological Product Cover a Biosimilar? Guidance from Norway
In December 2016 the Norwegian Court of Appeal handed down its decision in Pharmaq v Intervet, which concerns the validity of Intervet's SPC for a viral vaccine for preventing pancreatic disease (PD) in salmonid fish. The case is of general interest in that it relates to the extent to which an SPC for a biological product may be considered to encompass closely-related alternatives such as biosimilars.
For more information, please see our briefing on this topic, here.