,,ii #aafth ,,congress #ast ,session ,s4 #fei ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #e1 #bjai,ms4 ,collins 7for herself1 ,mr4 ,kaine1 ,mr4 ,portman1 ,mrs4 ,shaheen1 ,mr4 ,braun1 and ,ms4 ,stabenow7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for certain additional requirements with respect to patent disclosures4 #a4 ,short title ,this ,act may be cited as the ,biologic ,patent ,transparency ,act4 #b4 ,patent disclosure requirements 7a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,approved application holder listing requirements 7,a7 ,in general ,beginning on the date of enactment of the ,biologic ,patent ,transparency ,act1 within #cj days of approval of an application under subsection 7a7 or 7k71 the holder of such approved application shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,b7 ,previously approved or licensed biological products 7i7 ,products approved under section #cea of the ,,phsa ,not later than #cj days after the date of enactment of the ,biologic ,patent ,transparency ,act1 the holder of a biological product license that was approved under subsection 7a7 or 7k7 before the date of enactment of such ,act shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7ii7 ,products approved under section #eje of the ,,ffdca ,not later than #cj days after ,march #bc1 #bjbj1 the holder of an approved application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act that is deemed to be a license for the biological product under this section on ,march #bc1 #bjbj1 shall submit a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,c7 ,updates ,the holder of a biological product license approved under subsection 7a7 or 7k7 shall submit to the ,secretary a list that includes-- 7i7 any patent first required to be disclosed 7as described in paragraph 7#c77 after the submission under subparagraph 7,a7 or 7,b71 as applicable1 within #cj days of the earlier of-- 7,i7 the date of issuance of such patent by the ,united ,states ,patent and ,trademark ,office2 or 7,,ii7 the date of approval of a supplemental application for the biological product2 and 7ii7 any patent1 or any claim with respect to a patent1 included on the list pursuant to this paragraph with respect to the biological product subsequently determined to be invalid or unenforceable1 within #cj days of a determination of patent invalidity4 7#b7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,biologic ,patent ,transparency ,act1 the ,secretary shall publish and make available to the public a single1 easily searchable1 list that includes-- 7i7 the official and proprietary name of each biological product licensed under subsection 7a7 or 7k71 and of each biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for the biological product under this section on ,march #bc1 #bjbj2 7ii7 with respect to each biological product described in clause 7i71 each patent submitted in accordance with paragraph 7#a72 7iii7 the date of licensure and application number for each such biological product2 7iv7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7v7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7vi7 any period of any exclusivity under subsection 7k77#g77;,a7 or subsection 7k77#g77;,b7 of this section or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and any extension of such period in accordance with subsection 7m7 of this section with respect to each such biological product1 and the date on which such exclusivity expires2 7vii7 information regarding any determination related to biosimilarity or interchangeability for each such biological product2 and 7viii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7viii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 7#c7 ,patents required to be disclosed ,in this section1 a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection 7a7 or 7k71 or a biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for a biological product under this section on ,march #bc1 #bjbj1 believes a claim of patent infringement could reasonably be asserted by the holder1 or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license1 if a person not licensed by the holder engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of the biological product that is the subject of such license4 4 7b7 ,disclosure of patents ,section #cea7l77#c77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is amended by inserting included in the list provided by the reference product sponsor under subsection 7o77#a7 after a list of patents4 7c7 ,restriction on claims of patent infringement ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 7#g7 ,the owner of a patent that should have been included in the list described in section #cea7o77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7o77#a771 including any updates required under subparagraph 7,c7 of that section1 but was not timely included in such list1 may not bring an action under this section for infringement of the patent4 4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to carry out subsection 7o7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a74 7e7 ,rule of construction ,nothing in this ,act1 including an amendment made by this ,act1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the licensing of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74