Further medical use patents are directed to a new therapeutic use of a known active pharmaceutical ingredient. Clinical trials are often conducted to confirm therapeutic efficacy of the claimed medical use. A sponsor of a clinical trial is obliged to publish information on the trial. Already the protocol of the trial, i.e., the fact that patients with a specified disease are recruited for a clinical trial, wherein these patients are treated by administering a specified amount of a specified drug according to a specified dosage regimen, is regularly published before the first results are available.
Applicants for further medical use patents are therefore often caught in a dilemma. If the patent application is filed before the results of the clinical trials are available, there is a risk that the claimed teaching may be considered to have been insufficiently disclosed. If the patent application is based on the results of the clinical trial, the prior publication of the protocol will be considered in the assessment of inventive step.
In two recent decisions the German Federal Court of Justice (FCJ) confirmed patentability of further medical use patents in view of prior publications disclosing a trial protocol (X ZR 165/23 and X ZR 72/24, which both relate to the use of Fampridine for treating multiple sclerosis). Key considerations of the FCJ provided in these decisions will be explained and placed into the context of respective decisions of Boards of Appeal of the EPO confirming or denying patentability of further medical use patents in view of clinical trial protocols. On this basis, strategies for navigating the minefield will be outlined.
Albrecht von Menges
Dr. von Menges heads the Biotechnology team of Uexküll & Stolberg and advises European and international clients on patent cases related to inventions in the fields of pharmaceuticals, life sciences and biotechnology. Dr. von Menges has over than 20 years of experience as a German and European Patent Attorney and has represented clients in proceedings before all instances of the European Patent Office and in patent related litigation before German courts.