ABSTRACT
Despite the therapeutical benefits of dosage regimes, being granted and securing patent protection for these types of inventions has always been difficult. Historically dosage regimes have generally been excluded from patent law as these were held to either lack industrial application or were caught by the medical methods exclusions arguing that these inventions unjustifiably imited the medical profession’s choice of clinical practices. In 2010, the Enlarged Board of Appeal of the European Patent Office however held that dosage regimes are no longer excluded as such under the European Patent Convention 2000. In the post-EPC 2000 era the challenge is instead for dosage regimes to fulfill the requirements of novelty and inventive step. In seeking to bring greater clarity to the field of dosage regimes, this article aims at establishing what is required in order to be granted and enforce dosage regimes patents in Europe. In order to offer strategies to practitioners and potential patentees in regards to litigation as well as Research & Development tailoring, this article additionally contributes to the existing literature by providing for the first time, an empirical study of dosage regime patent decisions of the European Patent Office.