Świerczyński Marek, Second Medical Use Patents and the Substitution of Medicinal Products

This paper relates to the legal problems of second medical use patents and the substitution of medicinal products. It is inspired by two recent rulings of the English and Dutch courts. These courts have considered whether the sale of generic drugs may be regarded as an infringement of a second medical use patent in case where the facts of the case showed that these drugs have actually been used as in the indications covered by this patent (i.e. off-label use). The author of this paper wishes to give an answer to the following question – whether it is appropriate to limit the scope of the second medical use patent, where medicinal products based on the substance are subject to public reimbursement, in order to provide wider access to these products.