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 FOOD AND DRUGS 21 § 855
 (˘) Pczt_ for mpp_vsl of s_t_on; _r_,_ fort no_ _t_ e_t_o_ of he_ng_ _i_
 for _su_˘_ _' or_ter
 (l) Within one hundred _d eighty days _ft_r the Fling of _n _pp}ic_tion under
 subsection (b) of th_ section, or _uch additional _eH_ _ may be a_r_ed upon by the
 Secretary and the _pplican_ the Secretary _hall either_
 (A) Approve the applic_o_ if he thee f'u_ds _a_ _one of the g_und_ fo_
 de_y_g sppr_v_ specifier in _beec_o_ (d) of this sec_o_ _p:_li_, or
 _B) Give the applicant _ce of sn oppo_nity for _ he_r_ng before the
 Secretly under subsection (d) of _is seett_on on the questiou whether sun
 appl_ee_fio_ is _pprovableo If the applicant elects to _ccept the opporCuni_j for
 heaMag by written request within _h_y dsys a_..er such nonce, such hea,r_ng
 eh_tl_ comz_ence -not more than ninetry days _ter the expir_tio_ of such thirty
 dzys unless _e Secr_t_'y and the applicant otherw_ agree° Any such hearing
 shell _e_ter be conducted on an e_ved_ed basis and the Secretsxy'e order
 thereon sh_l be issued w_thi_ ninety days after the date fixed by the Sec.ret_ry
 for filing finn| b_efs.
 (S) If the pa_t inforr_a_on desezibed _ subsection CO) of _i_ section co_d nol
 be flied wi_ _e suhm/ss_on of sn application under subsect/on Co) of this s_ct_on
 because the apl_lica_on was fled before the patent _forma_o_ w_ required under
 subsection _) of this s_tJon or a patent was issued after _e appI_cst_on w_
 approved under such subsect_o_ the holder of an approved application shall F.h with
 the Secretary the patent number and the expiration dat_ of any pat,ent which claira_
 the drug for which _e app|i_tion was sub_nittted or which claims a |method of u_ng
 such drug and w_th respect to which a cl_im of patent infringement o_u]d _e_onab]y
 be ssserted ff a _er_on not licensed by the owner engaged _n the ma_uf_cture_ _e,
 or sale of the drug. If the holder of _n approved appli_on could not _e paint
 inform_tior_ under sub_e,ztio_ Co) of thLs _ec_ior_ because it w_ not _'equired st the
 time the appliea_/on w_ approved, the herder shall file such i_orrn_on under this
 subeect,io_ not later than thirty days aftor'Septeraber _4_ 198_, and if the holder of
 a_ approved application could _ot file patent infor_t_on under subse:t_o_ {b) of th_
 section because no patent had been issued _hen _ applics_on _s _h_ or approved,
 the holder shall _]e su_ in_ormaUon under this subsection _ot |ater than thirty dsy_
 after the da_ the patent involved _ issued° Upon the _ubm_ssion of paint
 inforr_at_on under this sub_ec_on_ _e Seczetery shall publish" i_
 {$) The approval of _ app|ication filed under subsection _b) of this _ee_on which
 cont_ins a _rtific_o_ requh'ed by p_graph (2) of such subsee_en sh_l be made
 eff_t/ve on the lent app_e_b]e date deterzr_d uoder the following:
 (A) If the applk_tnt on|y nasde a _:/fi_ion desc_bed in clause 6) or (_) of
 subsection Co_2XA) of th/_ section or ia both such chu_e_, the approval _y be
 made effective _unedhttegy.
 .... (_) _f the t_1:_lie_nt rn_de a ecrU. fiction descffbed in cht_e (_h_} of subsection
 CoX2_A) of this _ect_on, the approval rosy be made effective on the date certified
 under clause (_h'L
 (C) If the applicant made a certi.ficaticn described m c_ause (iv) of subsec_on
 (b)_2XA) of thi,_ section, the approval sh_ll be made effec_ve irnmed_tely unless
 an _etion _ brought for L_.fringernent of a patent which is the subject of the
 certification before the expLration of foff:y-fwe days from the date the no_ce
 provided under paragraph {8)(_) _ received. _f such an sctior_ is brought before
 the expiration of such d_ the approval may be made elfscare upon the
 exgir_fion of the t_y-month period beginning on the date of the _c_ipt of the
 notice p_vided ueder par_gr'_ph (3BOB) or such shorter or longer paMod u the
 court may order because either t:_trty to the ac_:k:,n filed to reasorably coope_.
 ate h e_fft_g the :_::ion. except th_b--_
 (|) if be_or_ the exp.ff_o_ of such period _he court dedd_ that _uch
 patent is inva_d or not infringed, the approv.tJ may be made effe_ive on the
 ...... chte of the court decision,
 (ID ff before the e.xpirs_on of such period the cou._, deeidea that sum
 l:nttent has been i_frL_ged, the spprova_ _ty be made effective oa such d,_.te
 as the cotu'_ orders under section 271(eX&_A) of Title 35_ or
 (_) ff before the _r_o_ of such pariod the court grants a pre_in_
 mjunc_on p_'bithg the _ppllc_ng f_m e_g_ghg in the commerc/_tl m_nu-

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