It is extraordinarily important for drug development teams to understand the foundation and rules around additional exclusivity for new indications, new populations etc. I recently reviewed a paper by Nicole Stakleff a Pepper Hamilton Intellectual Property Partner that uses a judges decision (Braeburn Decision) to teach us about the standards regarding the grant of exclusivity. It is a very well written, thoughtful and timely article that should help all drug developers to better understand the regulatory exclusivity landscape.
From the article:
"Clinical Investigation Exclusivity
Clinical investigation exclusivity is a three-year period of marketing exclusivity awarded to a drug containing previously approved active moiety when new clinical investigations were conducted by a sponsor that were essential to the approval of the drug. It is often awarded for the development of a new dosage form, a new route of administration or a new indication. If a first-approved drug is awarded such clinical investigation exclusivity, the FDA may not approve an application for the “same conditions of approval” of a drug containing the same active moiety before the expiration of three years from the date of approval of the first-approved drug."
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