102 STAT. 3978 PUBLIC LAW 100-670—NOV. 16, 1988

the date the notice made under subsection (n)(2)(B) is received,
no action may be brought under section 2201 of title 28, United
States Code, for a declaratory judgment with respect to the
patent. Any action brought under section 2201 shall be brought
in the judicial district where the defendant has its principal
place of business or a regular and established place of business,
"(iv) If the application contains a certification described in
clause (iv) of subsection (n)(l)(G) and is for a drug for which a
previous application has been filed under this subsection
containing such a certification, the application shall be made
effective not earlier than 180 days after—

"(I) the date the Secretary receives notice from the ap-
plicant under the previous application of the first commer-
cial marketing of the drug under the previous application,
or

"(II) the date of a decision of a court in an action de-
scribed in subclause (III) holding the patent which is the
subject of the certification to be invalid or not infringed,
whichever is earlier.

"(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such ap-
plication is approvable. If the applicant elects to accept the oppor-
tunity for hearing by written request within 30 days after such
notice, such hearing shall commence not more than 90 days after
the expiration of such 30 days unless the Secretary and the ap-
plicant otherwise agree. Any such hearing shall thereafter be con-
ducted on an expedited basis and the Secretary's order thereon shall
be issued within 90 days after the date fixed by the Secretary for
filing final briefs.

"(F)(i) If an application submitted under subsection (b)(l) for a
drug, no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under subsection (b)(l), is approved after the date of the enactment
of this paragraph, no application may be submitted under subsection
(b)(2) which refers to the drug for which the subsection (b)(D applica-
tion was submitted before the expiration of 5 years from the date of
the approval of the application under subsection (b)(l), except that
such an application may be submitted under subsection (b)(2) after
the expiration of 4 years from the date of the approval of the
subsection (b)(l) application if it contains a certification of patent
invalidity or noninfringement described in clause (iv) of subsection
(n)(l)(G). The approval of such an application shall be made effective
in accordance with subparagraph (B) except that, if an action for
patent infringement is commenced during the one-year period
beginning 48 months after the date of the approval of the
subsection (b) application, the 30 month period referred to in
subparagraph (C)(iii) shall be extended by such amount of time (if
any) which is required for seven and one-half years to have elapsed
from the date of approval of the subsection (b) application.

"(ii) If an application submitted under subsection (b)(l) for a drug,
which includes an active ingredient (including any ester or salt of
the active ingredient) that has been approved in another application
approved under such subsection, is approved after the date of enact-
ment of this paragraph and if such application contains reports of
new clinical or field investigations (other than bioequivalence or
residue studies) and, in the case of food producing animals, human