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Understanding Medical Device Patenting and Clinical Trials for Product Leadership

Rekha, Naga G and Arunagiri, Srigowtham and Mathew, Mary (2014) Understanding Medical Device Patenting and Clinical Trials for Product Leadership. In: 2014 PORTLAND INTERNATIONAL CONFERENCE ON MANAGEMENT OF ENGINEERING & TECHNOLOGY (PICMET), JUL 27-31, 2014, Portland Int Ctr Management Engn & Technol, Japan Chapter, Kanazawa, JAPAN, pp. 3598-3604.

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Unmet clinical needs remain the primary driving force for innovations in medical devices. While appropriate mechanisms to protect these innovative outcomes are essential, the performance of clinical trials to ensure safety is also mandated before the invention is ready for public use. Literature explaining the relationship between patenting activities and clinical trials of medical devices is scarce. Linking patent ownership to clinical trials may imply product leadership and value chain control. In this paper, we use patent data from Indian Patent Office (IPO), PCT, and data from Clinical Trials Registry of India (CTRI) to identify whether patent assignees have any role in leading as primary sponsors of clinical trials. A total of 42 primary sponsors are identified from the CTRI database in India. Number of patents awarded to these primary sponsors in the particular medical device, total number of patents awarded to the primary sponsor in all technologies, total number of patents in the specific medical device technology provides an indication of leadership and control in the value chain.

Item Type: Conference Proceedings
Series.: Portland International Conference on Management of Engineering and Technology
Publisher: IEEE
Additional Information: Copy right for this article belongs to the IEEE, 345 E 47TH ST, NEW YORK, NY 10017 USA
Department/Centre: Division of Interdisciplinary Sciences > Management Studies
Date Deposited: 22 Jun 2015 07:36
Last Modified: 22 Jun 2015 07:36
URI: http://eprints.iisc.ac.in/id/eprint/51754

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