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ISSN (Print): 1872-2083
ISSN (Online): 2212-4012

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Review Article

Patent and Marketing Exclusivities 101 for Drug Developers

Author(s): Bryan Oronsky*, Scott Caroen, Franck Brinkhaus, Tony Reid, Meaghan Stirn and Raj Kumar

Volume 17, Issue 3, 2023

Published on: 18 January, 2023

Page: [257 - 270] Pages: 14

DOI: 10.2174/1872208317666230111105223

Price: $65

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Abstract

Despite an ever-increasing need for newer, safer, more effective, and more affordable therapies to treat a multitude of diseases and conditions, drug development takes too long, costs too much, and is too uncertain to be undertaken without the conferment of exclusionary rights or entry barriers to motivate and sustain investment in it. These entry barriers take the form of patents that protect intellectual property and marketing exclusivity provisions that are provided by statute. This review focuses on the basic ins and outs of regulatory and patent exclusivities for which new chemical entities (NCEs), referring to never-before approved drugs with an entirely new active ingredient, are eligible and uses RRx-001, a small molecule aerospace-derived NCE in development for the treatment of cancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3 (NLRP3) inflammasome, as a “real world” example. This is intended as a ‘101-type’ of primer; its aim is to help developers of original pharmaceuticals navigate the maze of patents, other IP regulations, and statutory exclusivities in major markets so that they can make proper use of them.

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