Patologìâ (Dec 2019)
Features of legal protection of medical inventions: present and future
Abstract
The modern legal doctrine of intellectual property practically does not investigate the terms of legal protection of inventions in medical practice. Aim. Therefore, the purpose of the article is to clarify the features of the legal protection of medical inventions, the prospects for its improvement. Materials and methods. The study of the peculiarities of the legal protection of inventions in medical practice is based on a systematic approach, in particular, a critical analysis of the state of modern patent law in Ukraine and the prospects for its improvement through the implementation of European legislation in the field of medical inventions. Through comparative legal method the analysis of the Specialized Database of Ukrpatent “Inventions (Utility Models) in Ukraine” concerning the identification of patents for medical discoveries has been carried out. Results. Inventions within medical practice have a specific feature that is manifested in their industrial suitability (sphere of application – medicine) and possibility of fair use only after examination, in particular, medical and biological or clinical trials (experiments) involving human being. Types of inventions in medical practice are: methods of human treatment, devices for the treatment and diagnosis of a person, medicines, strains of microorganisms used to diagnose a person’s disease or for treatment, biotechnological inventions. Conclusions. The peculiarity of medical inventions is as follows: they have their own distinctive division due to the scope of invention’s application (the method of treatment, diagnosis, etc.); must undergo medical and biological or clinical trials (experiments); they must meet ethical requirements. It is established that it requires legislative consolidation at the level of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”: Ethical Requirements Regarding Biotechnological Inventions; balance of interests, rights of patients and patent holders; the grounds and conditions for granting a compulsory license for medical inventions; the implementation of Directive 98/44/EC of the European Parliament and Council of 07/06/1998 on the legal protection of biotechnological inventions.
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