Patenting of Biosimilars?

Heinz Mueller

Patenting biosimilars before the expiration of the original patent might raise several questions for the original manufacturer as well as the biosimilar manufacturer. In general, the most eminent questions are the drafting of the original patent in a way to be protected against a wide range of similar products and for the biosimilar manufacturer to ensure that the similar product is new and inventive. Since so far no case law exists in Europe dealing with biosimilars, both manufactures are somewhat in an unclear and ambiguous situation when it comes to estimate the scope of claims of biopharmaceuticals.