Medical treatment methods, medical indication claims and patentability: A quest into the rationale of the exclusion and patentability in the context of the future of personalised medicine

This contribution discusses the thorny issue of the rationale of the exclusion from patentability of medical treatment methods and the patentability of medical indications. This quest is the consequence of our earlier findings that medical indication patents present a real life risk for many players in the medical chain, i.e. the generic manufacturer, the clinician and the pharmacist of patent infringement (see to that effect our contribution at [2016] I.P.Q., 151). We come to the conclusion that the rationale for the exclusion from patentability of medical treatment methods is not very clear and can be interpreted very broadly. It has changed over time but seems now to be based on a rather wide socio-ethical rationale, aiming at protecting healthcare, which, even if justified, seems to be so broad that not only medical treatment methods but also the very patentability of pharmaceutical products can be subsumed under it. We also conclude that the rationale for allowing medical indication patents is equally not very clear, and their allowability was most definitely not a "love at first sight" affair with the legislature. It is submitted that certain medical indication patents sit very close to the activities of clinicians, which makes the argument that medical indication patents do not directly touch the physician not always correct. It is argued that, looking at the historical rationale of both the exclusion from patent protection of medical treatment methods and the patentability of medical indication inventions, there is some force in arguing that medical indication patents are not desirable. We formulate a number of possible solutions. It is argued that abolishing the exclusion from patentability of medical treatment methods, even though feasible if accompanied by the introduction of a therapeutic freedom exemption, is in view of the historical rationale of the exclusion, at least in EPC territories, not very likely to find support. It is further also argued that abolishing medical indication patents could be such a drastic action that it might come at the detriment of at least some genuine innovation in medicinal research, and would require further reflection.