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.
Keywords:
Patents, regulatory exclusivities, RRx-001, NLRP3 inhibitor, radioprotection, anticancer.
Graphical Abstract
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