Marija MitkovskaAlkaloid AD Skopje, Republic of Macedonia
Title: “Skinny labeling” pathway in Europe: an instrument for circumventing second medical use patents by generic companies
Innovation is driven by the exclusive intellectual property rights named patents. A diverse and complex patent network is seen in the pharmaceutical industry. Each single drug possesses multiple potentially patentable aspects. The structure of the active ingredients, the diverse formulation and technology possibilities, the different therapeutic indications, the different dosage forms and dosage regimes could be subject to a patent protection. Discovering a new therapeutic indication of already known, and most probably, patented drugs is a common practice of originator companies. The incentive for repurposing of known drugs is their eligibility for an additional patent protection via so called second or further medical use patents. Besides to new therapeutic indication of known drugs, medical use patents, also refer to use of previously known indication but for a new patient group, а new dosage form or a new dosage regime. Generally, the purpose of the second medical use patents is to postpone entering of generic drugs on market. In order to avoid such market delays, generic companies can obtain market approval by a pathway called “carving-out” or “skinny labelling”. This pathway allows generics to seek a market approval only for the unpatented medical uses of the originator drugs, instead of waiting а patent expiration or attempting a patent invalidation. Whether the “skinny labelling” pathway is sufficient instrument for circumventing second medical use patents within different jurisdictions in European Union will be shown through case law and examples.
Marija Mitkovska is a manager of the Patent and data exclusivity unit within the Research and development department in Alkaloid AD Skopje, one of the biggest pharmaceutical companies on Balkans. Her experience in the field of intellectual property (IP), predominantly in the field of pharmaceutical patents and data exclusivity matters spans over 14 years. She has graduated in 2009 at the “Institute of Chemistry” at the “Faculty of Natural Sciences and Mathematics” in Skopje. Since 2012 she is a Macedonian IP attorney and holds a LL.M. degree in Intellectual Property, a master studies program organized by WIPO and the University of Turin, Italy. At the moment, she e is a PhD student at the Faculty of Pharmacy, Skopje.