vol1 - Page 26

 21 § 355 FOov _v VRUGS
 fsc_re or san of the drug until the court decides the _ues of patent
 vs_idi_y and _fringement and if the _u_ decides that such _,tent m _nvalid
 @r not inf_g_, the appzova| shall by made effec_ve o_ the date of such
 courlt decision°
 ]n such _n sction_ _ach of the parties _ha|_ _onsbly _ooper_te m expedite
 i
 ing the action° Until the expiration of for_y-five days from _he dane the
 nonce made under paragraph (_XB) _ _ceived_ no action may be bzought
 _der _ec_ion 2201 of Title 28 for a declaratory judgment with respect to the
 pa_nL Any actlon brought under such _s_tion 2201 shad be brought in the
 _udic_l d_trict where the defendant has i_ pr_c_p_d pl_e_ _ bus_n_ or a
 re.far and _tsbl_hed place of business°
 (DXD [f ar_ applica_on (other than sn sbbr_v_ed new drss apportion}
 submitted under su_tio_ _b) of _s section re:: a drug, so _ctive ingredient
 (including any es_r or _It of t_e _.ct_ve mgred_nt) of which h_ been ap1_'oved
 _n _y o_her application under subsection _) of _ sec_o_, w_ _ppmv_d
 during the _r_od beginning J_nu_,ry I, $982° end _mding on Septsmber 2_, 1984,
 the Secretary may not rake the approval of another appl_cs_on for a drug for
 which the _nves_a_ons described in claus (A} of _ubsec_on Co_i) of th_
 section az_d relied upon by the applicant for _pp_al of the appllcatio_ were not
 conducted by or for _e _pp|ic_t and for which the applicant has no_ _bta_z_od s
 right of reference cr use f_m the person by or for whom the _nvestigs_ons
 were conducted efffect_ve before the expiration of ten ye_xs from the dat_ of the
 approval of the application pre_ously approved under sub_ect_on {_) of th_
 _ec_on°
 (ll) _f a_ applics_cn _ubmi_ted under subsec_on _)of this sec_J0n for a drug,
 no active k_gredient (including _y ester or _alt of the active ingredient} of
 which has been approved in shy other appl_eation _nder subs_c_on C_) of this
 _et.ion, _ spproved a_t_r September 2_, 19_4_ no application which _fers to the
 drug f_r which _e subsec_on Co) applica_o_ wa_ subm_t_d and for which the
 investigators described m clause (A) of subsection _b_1) of this section _d
 _elied u_ by the applicant for approva._ of the _pplic_t_on wen not conducted
 by or for the applicant and for which the applicant h_ not ob_ined a right of
 reference _z uae from the person by or for whom hhe inv_tigaficns were
 c_duct_d may be submit_,_d under subsection _b) of this section before the
 expint_on of five years from the date of the approval of the spp_ica_on under
 _ubeect_o_ _b) of this section, exc_ that such an application may be sub.triad.
 under su_on _b) of th_ section gft_r the exp_'_tk_n of fouz y_az_ from the
 d_tW of the approval of the subsection (b) ap_l_t_on _ it cont_i_ a c_r_ific_tion
 of p_t_nt _va]_d_t7 or _o_infr/ngement dese_bed ia clause (iv) of subsection
 _b_2_A) of th_ _ec_ono The approval of _uch sa applicado_ shall be made
 effective _ accordgnce with this l_tr_graph except _hs_ ff _ set_n for paint
 h'_ri_gement _ c_mmencvd during the one_ye_z _rk_d beginvL_g forty.eight
 months _fter the d_t_ of the approval of the subs_c_on (h) applicat/on, the
 thirZy-menth period r_ferr_d to _ subparagraph (C) shall be e_rt_nded by such
 amount ef _me (if _ny) which _ r_qub_d for seven and one_h_If yesxs to have
 elspeod from the _ of _ppmv_l of the subsection (b) sppli_on.
 (rid |f an app]ics_on submi_d under subsect/oz_ _b) o_ this sec_on for a
 drug, which gnc_udes _ sc_vs ingredient (Lac_udLag say e_r or ash of the
 : _ctive ingredient) that k_ be_ _pprovod in another application approved under
 subeeet_on (b) of this _ecfion, m approved _ter September 24, 1984, and ff such
 _pplica_on conS, ha _port_s of _ew eI_iea| mvestigst/o_ (other than bioavL_,-
 b_ty _tudie_) essential to the _ppmvsi of _ application sad conducted or
 spon_o_ by the a_nt_ the S_ez_t_'7 may not m_k_ the approval of
 application submittt_d under subeect_on (_) of this see_on for ths conddtio_ of
 _ppr_v_ of _uch drug is the app_xrved sub|_t_on (b) _ppl_ca_on effective before
 _e e:_pir_o_ of th_ yews from the d_t_ of the spprov_ of _e applicstio_
 ur_der tub_ct_o_ (b} of h_ sec_io_ ff the mvest_gatior_ de_cr_'bed in clause (A)
 of subsect_o_ {b_1) of th_ _ec_on sad _|iod Ul_:_n by '_e applicator for approval
 of the app_cs_on were not co_ductt_:_ by or for the applicant and ff the applic_t
 h_ not obtained s right of _fe_enc_ or are frsm the person by or for whom the
 inves_gatio_s were conduc_do
 (t_) _f • supplement to an _pplicatkm approved under subsection (b) of tht_-
 section _ approved _f_er September _, 19_, _d the supplement contains