Federal Supreme Court, Decision 9C_324/2018 of 29 May 2019

10. Juli 2019 – In a recent decision, the Federal Supreme Court held that, although certain provisions of the Health Insurance Act (SR 832.10; Bundesgesetz über die Krankenversicherung) and the Health Insurance Ordinance (SR 832.102; Verordnung über die Krankenversicherung; KVV) are based on patent protection (or its expiry, cf. art. 65e KVV), the KVV does not specify pricing-rules for generics at only partial loss of original’s exclusivity. The Court made clear that protected indications of a multi-indication pharmaceutical – of which some indications had lost exclusivity – cannot be exchanged by a generic. With regards to price-delta between an original with partial loss of exclusivity and generics marketed for non-protected indications only, the Court decided that the Federal Council would have to specify pricing rules for this specific constellation. Without such specification, the general rule applies that the (whole) sales-volume of the original defines the price-delta (cf. art. 65c KVV).