§360cc. Protection for drugs for rare diseases or conditions

(a) Exclusive approval, certification, or license

Except as provided in subsection (b) of this section, if the Secretary-

(1) approves an application filed pursuant to section 355 of this title,

(2) issues a certification under section 357 of this title, or

(3) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare disease or condition, the Secretary may not approve another application under section 355 of this title, issue another certification under section 357 of this title, or issue another license under section 262 of title 42 for such drug for such disease or condition for a person who is not the holder of such approved application, of such certification, or of such license until the expiration of seven years from the date of the approval of the approved application, the issuance of the certification, or the issuance of the license. Section 355(c)(2) of this title does not apply to the refusal to approve an application under the preceding sentence.

(b) Exceptions

If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition, if a certification is issued under section 357 of this title for such a drug, or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval, of the issuance of the certification under section 357 of this title, or of the issuance of the license, approve another application under section 355 of this title, issue another certification under section 357 of this title, or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application, of such certification, or of such license if-

(1) the Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application, of such certification, or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or

(2) such holder provides the Secretary in writing the consent of such holder for the approval of other applications, issuance of other certifications, or the issuance of other licenses before the expiration of such seven-year period.

(June 25, 1938, ch. 675, §527, as added Jan. 4, 1983, Pub. L. 97–414, §2(a), 96 Stat. 2050 ; amended Sept. 24, 1984, Pub. L. 98–417, title I, §102(b)(6), 98 Stat. 1593 ; Aug. 15, 1985, Pub. L. 99–91, §§2, 3(a)(3), 99 Stat. 387 , 388; Aug. 13, 1993, Pub. L. 103–80, §3(v), 107 Stat. 778 .)

Amendments

1993-Subsec. (b). Pub. L. 103–80 struck out extraneous comma before "or issue a license under section 262" in introductory provisions and substituted "the" for "The" at beginning of par. (1).

1985-Pub. L. 99–91, §2(3), struck out "unpatented" before "drugs" in section catchline.

Subsec. (a). Pub. L. 99–91, §§2(1), 3(a)(3)(A)–(D), struck out "or" at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out "and for which a United States Letter of Patent may not be issued" after "rare disease or condition", inserted in first sentence ", issue another certification under section 357 of this title," after "section 355 of this title" the second time it appeared, inserted ", of such certification," after "holder of such approved application", and inserted ", the issuance of the certification," after "approval of the approved application".

Subsec. (b). Pub. L. 99–91, §§2(2), 3(a)(3)(E)–(K), struck out "and if a United States Letter of Patent may not be issued for the drug" after "such a drug", substituted ", if a certification is issued under section 357 of this title for such a drug, or if a license" for "or a license", inserted ", of the issuance of the certification under section 357 of this title," after "application approval", struck out ", if the drug is a biological product," before "issue a license", inserted ", issue another certification under section 357 of this title," after "section 355 of this title", inserted ", of such certification," after "holder of such approved application", inserted ", of such certification," after "application" in par. (1), and inserted ", issuance of other certifications," after "other applications" in par. (2).

1984-Subsecs. (a), (b). Pub. L. 98–417 substituted "section 355" for "section 355(b)" wherever appearing.

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.