Limitations on patentability for biologic medicines mean data exclusivity and market exclusivity can be the primary protection for originator biologic medicines which is most evident in the USA.
National Regulation Authority (RNA) needs to be satisfied that the product is safe and manufactured to a sufficient quality. The studies, preparation and data required are time consuming and expensive to produce meaning competitors rely on original sponsor’s clinical studies for relevant follow on products.
Where a patent has not or cannot be obtained another form of protection (data exclusivity) is essential to give incentives to bring new drugs to market. In some territories there are additional restrictions on competitors’ products entering the market to allow a period of market exclusivity to the original sponsor.