,,ii #aacth ,,congress #ast ,session ,s4 #ejd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #g1 #bjac ,mr4 ,franken 7for himself1 ,mr4 ,vitter1 ,mr4 ,durbin1 ,mrs4 ,shaheen1 and ,mr4 ,sanders7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure that valid generic drugs may enter the market4 #a4 ,short title ,this ,act may be cited as the ,fair ,and ,immediate ,release of ,generic ,drugs ,act or the ,,fair ,generics ,act4 #b4 #ahj-;,day exclusivity period amendments regarding first applicant status 7a7 ,amendments to ,federal ,food1 ,drug1 and ,cosmetic ,act 7#a7 ,in general ,section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77 is amended-- 7,a7 in clause 7iv77,,ii7-- 7i7 by striking item 7bb72 and 7ii7 by redesignating items 7cc7 and 7dd7 as items 7bb7 and 7cc71 respectively2 and 7,b7 by adding at the end the following3 7v7 ,first applicant defined ,as used in this subsection1 the term first applicant means an applicant-- 7,i7 7aa7 that1 on the first day on which a substantially complete application containing a certification described in paragraph 7#b77;,a77vii77,,iv7 is submitted for approval of a drug1 submits a substantially complete application that contains and lawfully maintains a certification described in paragraph 7#b77;,a77vii77,,iv7 for the drug2 and 7bb7 that has not entered into a disqualifying agreement described under clause 7vii77,,ii72 or 7,,ii7 7aa7 for the drug that is not described in subclause 7,i7 and that1 with respect to the applicant and drug1 each requirement described in clause 7vi7 is satisfied2 and 7bb7 that has not entered into a disqualifying agreement described under clause 7vii77,,ii74 7vi7 ,requirement ,the requirements described in this clause are the following3 7,i7 ,the applicant described in clause 7v77,,ii7 submitted and lawfully maintains a certification described in paragraph 7#b77;,a77vii77,,iv7 or a statement described in paragraph 7#b77;,a77viii7 for each unexpired patent for which a first applicant described in clause 7v77,i7 had submitted a certification described in paragraph 7#b77;,a77vii77,,iv7 on the first day on which a substantially complete application containing such a certification was submitted4 7,,ii7 ,with regard to each such unexpired patent for which the applicant described in clause 7v77,,ii7 submitted a certification described in paragraph 7#b77;,a77vii77,,iv71 no action for patent infringement was brought against such applicant within the #de-;day period specified in paragraph 7#e77;,b77iii72 or if an action was brought within such time period1 such an action was withdrawn or dismissed by a court 7including a district court7 without a decision that the patent was valid and infringed2 or if an action was brought within such time period and was not withdrawn or so dismissed1 such applicant has obtained the decision of a court 7including a district court7 that the patent is invalid or not infringed 7including any substantive determination that there is no cause of action for patent infringement or invalidity1 and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed74 7,,iii7 ,if an applicant described in clause 7v77,i7 has begun commercial marketing of such drug1 the applicant described in clause 7v77,,ii7 does not begin commercial marketing of such drug until the date that is #cj days after the date on which the applicant described in clause 7v77,i7 began such commercial marketing4 4 7#b7 ,conforming amendment ,section #eje7;j77#e77;,d77i77,,iv7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,,iv77 is amended by striking ,the first applicant and inserting ,the first applicant1 as defined in subparagraph 7,b77v77,i714 7b7 ,applicability ,the amendments made by subsection 7a7 shall apply only with respect to an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to which the amendments made by section #aajb7;a7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7,public ,law #ajh-agc7 apply4 #c4 #ahj-;,day exclusivity period amendments regarding agreements to defer commercial marketing 7a7 ,amendments to ,federal ,food1 ,drug1 and ,cosmetic ,act 7#a7 ,limitations on agreements to defer commercial marketing date ,section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b771 as amended by section #b1 is further amended by adding at the end the following3 7vii7 ,agreement by first applicant to defer commercial marketing2 limitation on acceleration of deferred commercial marketing date 7,i7 ,agreement to defer approval or commercial marketing date ,an agreement described in this subclause is an agreement between a first applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the #ahj-;day exclusivity period whereby that applicant agrees1 directly or indirectly1 7aa7 not to seek an approval of its application that is made effective on the earliest possible date under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 7bb7 not to begin the commercial marketing of its drug on the earliest possible date after receiving an approval of its application that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or 7cc7 to both items 7aa7 and 7bb74 7,,ii7 ,agreement that disqualifies applicant from first applicant status ,an agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the #ahj-;day exclusivity period whereby that applicant agrees1 directly or indirectly1 not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the #ahj-;day exclusivity period awarded to another applicant with respect to such drug 7without regard to whether such #ahj-;day exclusivity period is awarded before or after the date of the agreement74 7viii7 ,limitation on acceleration ,if an agreement described in clause 7vii77,i7 includes more than #a possible date when an applicant may seek an approval of its application or begin the commercial marketing of its drug-- 7,i7 the applicant may seek an approval of its application or begin such commercial marketing on the date that is the earlier of-- 7aa7 the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or begin the commercial marketing of such drug1 without regard to any other provision of such agreement pursuant to which the commercial marketing could begin on an earlier date2 or 7bb7 #ahj days after another first applicant begins commercial marketing of such drug2 and 7,,ii7 the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph1 subparagraph 7,f7 of this paragraph1 section #eje;,a1 or section #ebg1 or begin the commercial marketing of such drug1 without regard to any other provision of such agreement pursuant to which commercial marketing could begin on an earlier date1 shall be the date used to determine whether an applicant is disqualified from first applicant status pursuant to clause 7vii77,,ii74 4 7#b7 ,notification of ,,fda ,section #eje7;j7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#aa7 7,a7 ,the holder of an abbreviated application under this subsection shall submit to the ,secretary a notification that includes-- 7i7 7,i7 the text of any agreement entered into by such holder described under paragraph 7#e77;,b77vii77,i72 or 7,,ii7 if such an agreement has not been reduced to text1 a written detailed description of such agreement that is sufficient to disclose all the terms and conditions of the agreement2 and 7ii7 the text1 or a written detailed description in the event of an agreement that has not been reduced to text1 of any other agreements that are contingent upon1 provide a contingent condition for1 or are otherwise related to an agreement described in clause 7i74 7,b7 ,the notification described under subparagraph 7,a7 shall be submitted not later than #aj business days after execution of the agreement described in subparagraph 7,a77i74 ,such notification is in addition to any notification required under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc4 7,c7 ,any information or documentary material filed with the ,secretary pursuant to this paragraph shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code1 and no such information or documentary material may be made public1 except as may be relevant to any administrative or judicial action or proceeding4 ,nothing in this paragraph is intended to prevent disclosure to either body of the ,congress or to any duly authorized committee or subcommittee of the ,congress4 4 7#c7 ,prohibited acts ,section #cja7;e7 of such ,act 7#ba ,u4,s4,c4 #cca7;e77 is amended by striking #eje 7i7 or 7k7 and inserting #eje 7i71 7j77#aa71 or 7k74 7b7 ,infringement of patent ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 7#g7 ,the exclusive remedy under this section for an infringement of a patent for which the ,secretary of ,health and ,human ,services has published information pursuant to subsection 7b77#a7 or 7c77#b7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be an action brought under this subsection within the #de-;day period described in subsection 7j77#e77;,b77iii7 or 7c77#c77;,c7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 7c7 ,applicability 7#a7 ,limitations on acceleration of deferred commercial marketing date ,the amendment made by subsection 7a77#a7 shall apply only with respect to-- 7,a7 an application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 to which the amendments made by section #aajb7;a7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7,public ,law #ajh-agc7 apply2 and 7,b7 an agreement described under section #eje7;j77#e77;,b77vii77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77#a77 executed after the date of enactment of this ,act4 7#b7 ,notification of ,,fda ,the amendments made by paragraphs 7#b7 and 7#c7 of subsection 7a7 shall apply only with respect to an agreement described under section #eje7;j77#e77;,b77vii77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77#a77 executed after the date of enactment of this ,act4