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 21 § 355 FOOD AND DRUGS
 (b) Ft_|_ spp|leation_ eon_n_
 (1) Any person may file with the Secretary sn applica_on with _spect to any
 drug subject to the provisio_ of subsec_on (a) of th_ sect/on. Such person shall
 submit to the _cretsxy as a l_ of the application (A) full reports of investi_t_on_
 which have been made to show whether or net such drug is safe for u_e and whether
 such drug is effective in use_ (B) a full lLst of the _'.hcles used as components cf
 such drug; (C) a full _tateme_t of the composition of such dr_ (D) a full
 description of the methods used in, and the facilities snd con_zols u_ for, the
 m&mffacture, processing, and packing cf such chug; (E_ _uch samples of such drug
 and of the articles used as components thereof as the Secretary rasy re:luire_ and (F)
 apecimen_ of the hbe]ing proposed to be used for such dru¢ The appr_cant _hall file
 with the application the patent number and the expiration date of any paint wh/ch
 claims the drug for which the applicant submitted the application sr which clain_ a
 method of using such drug and with respect te which a claim of patent infringement
 could reasonably be asserted _ a person not licensed by the owner engaged in the
 manufscture, use, or sale of the drug. If an application _ filed under this
 subsec_on for a drug and a patent wh/ch cla_rn_ such drug or a method of using such
 drug is issued after the _ing date but before approval of the application, the
 applicant shall amend the application to include the _nfo_r_st/on required by the
 preceding sentence. Upon approva| of the application, the Secretary abel| publish
 fi'fformat_on submitted under the two preceding senta_ceso
 (2) .A_ application submitted under paragraph (I) _er a drug for which the
 _vestigations descry'bed in clause (A) of such paragraph and relied upon by the
 applicant for spprova_ of the app|ication were not conducted by or for the applicant
 and for which the applicant has not obtained a right _f reference or use from the
 person by or for whom the fi_v_stiga_ons were conduc_.ed sha|l also inc]ud_
 (A) a certL_c_t_en, in the opinion of the applicant and to the best of his
 knowledge, _adth respect to esch patent which clainn$ the drug for which such
 investigations were _nducted or which claims a use for such drug fez which the
 applicant is seeking approval under this subsection and for whkh _nforrnat_on is
 required to be f_ed under paragraph (I) or subsection (c) of _ _on_
 (D that auch patent information has _o_ been filed,
 (|t) that such patent h_ expired,
 G_) of the date on which such patent _'ll e_p_'e, or
 (|v} t.hst _uch patent _ invalid or will not be _nfr_nged by the manufa_
 usa, or _le of the new drug for which the appli_on ls subra_tted; and
 (B) if with reapect to the drug for which mvest_ga_ion_ described h pazto
 gr'_ph (lXA) were conducted _nfonnat/on was _ed under para_'_ph _1) or
 subsection (c) of this set,on for a method of use paten_: wh/_h does not claim a
 use for which the appl_nt L_ seeking approva_ under this subsections a s_te-
 ment that the method of use patent doe_ _o_ claim such a use.
 (_)_A) An applicant who makes a certification de,on'bed in paragraph (2){A){iv)
 , shall include m the application _ statement that the app|ica_t will _dve the r_t_ce
 required by subparagraph (B)
 (t) each owner of the patent which is the sub_ec_ of the _rtffic_tion or the
 ropresentat/ve of such owner designated to receive suci_ nonce, _nd
 (_D the ho|der of the approved spplica_on under subsection _) of th_ section
 for the drug wh_h is chimed by the patent or a use of which _ chimed by the
 patent sr the representative of such holder desigr_ated to receive such notice.
 {B) The not.ice referred to _ subpar_,gzaph _A} shall a_te t,bat an app|_tion
 been submitted u_der this subse_t_m for the drug with respect to wh_h the
 certification is made to obtain app_va] to engage h the commerchl manufacture,
 _, or sa|e Of the _Fug befOro the e_r_tio_ O_ the pa._nt referred to _ the
 cert_fica_eno Such notice shall include a _etai|ed statement of the factual and _e_al
 basis of the applica_Fs opinion that the patent _ not va|_ ,)r w'fll not be infringed_
 (C) if an application is _mended to include a cert_ficat_n described in par_ffraph
 (2XA_v)_ the _ot_ce required by subparagraph (B) shall be _,_ven when the amended
 app_cat_on m submit:teA

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