Importance of patents and data exclusivity in fixed-dose combination medicinal products

The efficacy of an active compound can be advantageously improved when combined with other active compounds. Medicinal products for a particular indication(s) that contain combination of two or more active compounds in a fixed dose ratio is so called fixed-dose combination medicinal products or FDCs. FDCs are beneficial for patients’ adherence to the treatment because of the simplified drug regimen. They are used in the treatment of a wide range of medical conditions especially in the treatment of chronic illnesses including AIDS, type 2 diabetes, and many cardiovascular diseases. FDCs as other medicines are subject to variety of intellectual property rights protection (IPRs), including patents and data protection. Different jurisdictions worldwide have different standards when determining the eligibility of FDCs for patent and/or data protection. They can vary from 1) cases with lower standards for assessing the inventive step, where FDCs are given additional combination patent rights, 2) cases where FDCs is given status of new chemical entities thus allowing supplementary protection certificates and 3) cases where additional data protection for FDCs of already known active compounds is allowed. In this study, we have assessed the national standards among different jurisdictions of developing and developed countries. A comparison of their approaches in respect to their benefits and deficiencies related to the originators, patient accessibility and public health policies has been made. Key words: Fixed-dose combination medicinal products, patents, data exclusivity