Sec. 3. Definitions
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In this Act: The term biological product has the meaning given to that term in section 351 of the Public Health Service Act (42 U.S.C. 262). The term Director means the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. The term dormant therapy means a medicine designated as a dormant therapy under section 4(a). The term drug has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
The term medicine means a biological product or a drug. The term protection period , with respect to a dormant therapy, means the period that— begins on the date on which the Secretary first approves an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) for the dormant therapy for any indication; and ends on the date that is 15 years after the date of such approval.
The term Secretary means the Secretary of Health and Human Services. The term sponsor , with respect to a dormant therapy, is the person who takes responsibility for the designation and development of the dormant therapy. The sponsor may be a single entity or an entity collaborating with one or more other entities.
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