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 21 § _55 FOOD AND DRUGS
 notice made uoder psragrsph (2XBXi) h received, ne _ction may be brought
 under sec_n 2201 of TMe 28 for a declaratory judgment _th respect _ the
 paten_ A_uy action brought under section 2201 sha|| be brought _ the
 judiciu| district where the defend_z_t has it principal p|_ce of business or a
 . regu_" and est_bl_hed place of bushuess.
 (|v) If the appfi_at_on ¢ontair_ a certification described in subchuse (IV)
 paragraph (2)_AXvii) and is for a drug for which a presJous app|icatien has been
 submitted under this subsection continuing such a _r_Scatio_, the app|ication
 shMl be made effec_ve not ear|ier tha_ one h_xudred and eighW days afte_
 {I) the date _ Sec_tary receive_ no_ from the applic_a_t under the
 predot_ application of _e first commereia_ marketing of the drug under
 the predous application, or
 _II) the date of a dec_ion of a court in _ ac_o_ described in clause (i_i)
 holding the patent which _ the subject of the cer_f_catkm to be _nvalid OF
 not infringed,
 w_chever _ eater.
 (C} If the Secretary decides to disapprove an appl_cat_on,, the Secretary shall give
 the applicant notice of an opporturdty fop a hearing before the Secretary on the
 question of whether such appl_ca_on _s apprvvab|e. If the applicant e_ec_ to accept
 the opportunity fop hearing by written request within thh-t_- days after such notice,
 such heaMng shal_ commence not more than ninety days after the expL_t_o_ of such
 thirty days unless the Secretary and the applicant otherwise agree. Any such
 heaz_ng sha_| thereafter be conducted on an expedited b_s_s and the Secret,_ry's
 order t_ereo_ _halI be issued _thin ninety days after _e date fixed by the Secretary
 for filing final briefs.
 (DX_) If an spp]i_t_on (other than an abbreviated new drug application) sub_
 mitred under subsection _) of this secgon for a drug, no active ingredient (including
 any ester or _alt of the ac_ve hgredient} of which h_s been approved in any other
 application under subsection (b) of this section, was .approved du_ng the period
 " beginning ,lanuar] L 1952, and ending on September 24_ 1984_ the Secretary may not
 make the approval of an applica_o_ submitted under th_ subsection which refers to
 the drug for which the subsection _b) application was submitted effective before the
 expir_.g_n of ten years from the date of the approval of the application under
 _ubsec_on (b) of this section.
 ([i) If an appI_cat_on submitted under _ubeection (b) of this section for • drug, no
 active i_gred_ent (ine|uding any ester or _]t of the scth'e ingredient) of which has
 ....... been approved in any other applicat_or_ under subsection {b) of this sections
 approved after September _ 1984, no application _ay be subm_ttod under this
 subsection which refe_ ts the drug for which the subsection {b) appl_ca_on was
 submitted before the exp_ra_on of five years from the date of the approval of the
 appl_cstion trader subsec_on (b) of this section, except that such an application may
 • be submitted under _ subsection after the expiration of _our years from the date
 of the approval of the subsection _) application _ it ecn_ns a cer_f_cat_on of patent
 h_d_ty or noninfringement deacMbed _n subelau_e GV) of paragraph (_){AXvii)o
 ..... The sppr_va| of such an sppficagon _ha]] be made effecl_ve _n accordance with
 subparagraph {B) except that, if an action for paten¢ infringement _ commenced
 during the one-yeaR period beginning forty-eight months after the date of the
 apprvva_ of the subsection _b) appl_cation, the thirtyomonth pe_od referred to
 subp_'sgr_ph _K_h') shall be extended by _uch amount o:_ time (_ any) wh_h is
 reqsi.r_d for _even and one-half years to have elapeod from the date of approval of
 the subsection (b) spp'_cat_o_
 (lfi) _f s_ app_icatk_a _ubm_tted under subsec_on {b) of this sectiou for a drug,
 which h_clude_ an active _ngzed_e_t (_neludh_g any e_er or ,an of the active
 _gred_e_t) that h_ been app_ved _ another application _ppmved under subsec_on
 (b) of this section_ _ approved after September _, 19_4, and if ,ueh _pp_icstion
 contains reports of new clinical iavesgga_or_ (other than bioavaflabi_ty studies)
 essentml to the approval of the applica_on and cooduct_d or sponsored by the
 applicant, the Secretary may _ot make the approved of an app|icat_n submitted
 under the subsection fop the conditions of approval of such drug m the subsection
 Co) appllcat_on effec_ve b_fo_ the expiration of th,re_ ye_ frem the date of the
 ....... approva_ of the application under sub_ec_on (b) o_ th_ _tion for such _:h*ug.

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