Test Data Protection, Data Exclusivity and TRIPS: What Options for India

2006 ◽  
Author(s):  
Krishna Ravi Srinivas
Keyword(s):  
Test Data ◽  
Data Protection ◽  
Data Exclusivity

22. Data Protection and Data Exclusivity

2019 ◽  
pp. 497-512
Author(s):  
Justine Pila ◽  
Paul L.C. Torremans
Keyword(s):  
Data Protection ◽  
Patent Protection ◽  
Personal Data ◽  
Pharmaceutical Sector ◽  
Data Exclusivity ◽  
The Law ◽  
Data Subject

This chapter examines the law on data protection and data exclusivity. It focuses on the new GDPR Regulation. It covers rules on lawful processing of personal data, on the security of the processing, on the transparency of the processing, and on promoting compliance. It also discusses the rights of the data subject, the transfer of personal data to third countries, and the period of data exclusivity granted to the pharmaceutical sector independent of any form of patent protection.

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

2019 ◽  
Vol 65 (2) ◽  
pp. 33-38
Author(s):  
Marija Mitkovska ◽  
Katerina Anchevska Netkovska ◽  
Aleksandra Grozdanova ◽  
Ana Poceva Panovska ◽  
Ema Kikovska Stojanovska
Keyword(s):  
Data Protection ◽  
Developed Countries ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Medicinal Products ◽  
Active Compounds ◽  
Intellectual Property Rights Protection ◽  
Data Exclusivity ◽  
Wide Range ◽  
Dose Combination

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

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