Protection and enforcement of second medical use claims: a review of Polish jurisprudence


Marta Koremba

National courts have a degree of discretion when deciding on claims directed to the second use of a known substance. Various approaches to interpretation of claims may result in significant differences in each country.

Polish Intellectual Property Law (IPL) implements standard international rules regarding patent protection. Accordingly, patents shall not be granted in respect of methods of treatment. Nevertheless, inventions concerning the use of a substance for application in a specifi c disease can be patented in the form of the so-called ‘second medical use’ claims.

Second medical use inventions are assessed according to general patentability requirements, ie, novelty, inventive step and industrial applicability. However, a careful glance at Polish case law reveals certain peculiarities in the process of assessing the patentability of such inventions.

In order to meet the condition of sufficiently clear and complete disclosure, the patent description of a second medical application of a known substance shall indicate not only the pharmacokinetic and pharmacodynamic characteristics of the substance, but also the disease treated by the substance, as well as the group of subjects to which the therapy is directed.

Medical use claims, Polish jurisprudence