Patenting of Biosimilars?

The title chosen for the present chapter might be surprising to some skilled experts and IP professionals. The two terms ‘patenting’ and ‘biosimilars’ are hardly ever used within the same context and it seems to be a contradiction in itself. True, the ‘classic’ approach to the concept of biosimilars is one of follow-on drugs or generics, which profit from the fact that patent protection of the original drug has already expired, and from simplified procedures for market authorization. This approach does not include any patent-related issues such as the scope of a patent claim, patent infringements, or the risk of being copied at all. However, patent-related questions do arise by slightly shifting the perspective and questioning whether a biotechnological invention, in which the pioneer manufacturer has invested high research costs, could – with minor changes or amendments – be brought to the market as a new product by an imitating competitor. The following chapter investigates this broader understanding of ‘biosimilars’ and presents some thought-provoking points without claiming to provide a final response to all the questions raised.