Affiliation:
1. EpicentRx, Torrey Pines, San Diego, California, USA
Abstract
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Applied Microbiology and Biotechnology,Bioengineering,Biotechnology
Reference65 articles.
1. Surh Y.J.; The 50-year war on cancer revisited: Should we continue to fight the enemy within? J Cancer Prev 2021,26(4),219-223
2. Hinkson I.V.; Madej B.; Stahlberg E.A.; Accelerating therapeutics for opportunities in medicine: A paradigm shift in drug discovery. Front Pharmacol 2020,11,770
3. Collier R.; Drug patents: The evergreening problem. CMAJ 2013,185(9),E385-E386
4. Gelijns A.C.; Institute of Medicine (US) Committee on Technological Innovation in Medicine Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine 1989
5. Berndt E.R.; Nass D.; Kleinrock M.; Aitken M.; Decline in economic returns from new drugs raises questions about sustaining innovations. Health Aff 2015,34(2),245-252
Cited by
4 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献