,in the ,senate of the ,united ,states1 ,december #g1 #bjbj4 ,amendment3 ,that the bill from the ,house of ,representatives 7,h4,r4 #aejc7 entitled ,an ,act to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act regarding the list under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and for other purposes41 do pass with the following ,strike all after the enacting clause and insert the following3 #a4 ,short title ,this ,act may be cited as the ,orange ,book ,transparency ,act of #bjbj4 #b4 ,orange ,book modernization 7a7 ,submission of patent information for brand name drugs 7#a7 ,in general ,paragraph 7#a7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended to read as follows3 7b7 7#a7 7,a7 ,any person may file with the ,secretary an application with respect to any drug subject to the provisions of subsection 7a74 ,such persons shall submit to the ,secretary as part of the application-- 7i7 full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use2 7ii7 a full list of the articles used as components of such drug2 7iii7 a full statement of the composition of such drug2 7iv7 a full description of the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of such drug2 7v7 such samples of such drug and of the articles used as components thereof as the ,secretary may require2 7vi7 specimens of the labeling proposed to be used for such drug2 7vii7 any assessments required under section #eje;,b2 and 7viii7 the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture1 use1 or sale of the drug1 and that-- 7,i7 claims the drug for which the applicant submitted the application and is a drug substance 7active ingredient7 patent or a drug product 7formulation or composition7 patent2 or 7,,ii7 claims a method of using such drug for which approval is sought or has been granted in the application4 7,b7 ,if an application is filed under this subsection for a drug1 and a patent of the type described in subparagraph 7,a77viii7 is issued after the filing date but before approval of the application1 the applicant shall amend the application to include the patent number and expiration date4 4 7b7 ,subsequent submission of patent information 7#a7 ,in general ,section #eje7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#b77 is amended-- 7,a7 by inserting before the first sentence the following3 ,not later than #cj days after the date of approval of an application submitted under subsection 7b71 the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subsection 7b77#a77;,a77viii71 except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application4 ,if a patent described in subsection 7b77#a77;,a77viii7 is issued after the date of approval of an application submitted under subsection 7b71 the holder of the approved application shall1 not later than #cj days after the date of issuance of the patent1 file the patent number and the expiration date of the patent1 except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application42 7,b7 in the first sentence following the sentences added by subparagraph 7,a71 by striking which claims the drug for which and all that follows through of the drug4 and inserting described in subsection 7b77#a77;,a77viii742 7,c7 in the second sentence following the sentences added by subparagraph 7,a71 by inserting after could not file patent information under subsection 7b7 because no patent the following3 of the type for which information is required to be submitted in subsection 7b77#a77;,a77viii72 and 7,d7 by adding at the end the following3 ,patent information that is not the type of patent information required by subsection 7b77#a77;,a77viii7 shall not be submitted under this paragraph44 7#b7 ,updating list ,clause 7iii7 of section #eje7;j77#g77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by striking 7b7 or4 7c7 ,listing of exclusivities ,subparagraph 7,a7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7iv7 ,for each drug included on the list1 the ,secretary shall specify any exclusivity period that is applicable1 for which the ,secretary has determined the expiration date1 and for which such period has not yet expired1 under-- 7,i7 clause 7ii71 7iii71 or 7iv7 of subsection 7c77#c77;,e72 7,,ii7 clause 7iv7 or 7v7 of paragraph 7#e77;,b72 7,,iii7 clause 7ii71 7iii71 or 7iv7 of paragraph 7#e77;,f72 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 subsection 7u74 4 7d7 ,orange book updates with respect to invalidated patents 7#a7 ,amendment ,section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7,d7 ,in the case of a listed drug for which the list under subparagraph 7,a77i7 includes a patent for such drug1 and any claim of the patent has been cancelled or invalidated pursuant to a final decision issued by the ,patent ,trial and ,appeal ,board of the ,united ,states ,patent and ,trademark ,office or by a court1 from which no appeal has been1 or can be1 taken1 if the holder of the applicable application approved under subsection 7c7 determines that a patent for such drug1 or any patent information for such drug1 no longer meets the listing requirements under this section-- 7i7 the holder of such approved application shall notify the ,secretary1 in writing1 within #ad days of such decision of such cancellation or invalidation and request that such patent or patent information1 as applicable1 be amended or withdrawn in accordance with the decision issued by the ,patent ,trial and ,appeal ,board or a court2 7ii7 the holder of such approved application shall include in any notification under clause 7i7 information related to such patent cancellation or invalidation decision and submit such information1 including a copy of such decision1 to the ,secretary2 and 7iii7 the ,secretary shall1 in response to a notification under clause 7i71 amend or remove patent or patent information in accordance with the relevant decision from the ,patent ,trial and ,appeals ,board or court1 as applicable1 except that the ,secretary shall not remove from the list any patent or patent information before the expiration of any #ahj-;day exclusivity period under paragraph 7#e77;,b77iv7 that relies on a certification described in paragraph 7#b77;,a77vii77,,iv74 4 7#b7 ,applicability ,subparagraph 7,d7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 as added by paragraph 7#a71 applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this ,act4 7e7 ,review and report ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 solicit public comment regarding the types of patent information that should be included on1 or removed from1 the list under section #ejg7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 and 7#b7 transmit to ,congress a summary of such comments and actions the ,food and ,drug ,administration is considering taking1 if any1 in response to public comment pursuant to paragraph 7#a7 about the types of patent information that should be included or removed from such list4 7f7 ,,gao report to congress 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the patents included in the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 that claim an active ingredient or formulation of a drug in combination with a device that is used for delivery of such drug1 including an analysis of such patents and their claims4 7#b7 ,content ,the ,comptroller ,general shall include in the report under paragraph 7#a7-- 7,a7 data on-- 7i7 the number of patents included in the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug1 and that together claim the finished dosage form of the drug2 and 7ii7 the number of claims with respect to each patent included in the list published under such section #eje7;j77#g7 that claim a device that is used for the delivery of the drug1 but do not claim such device in combination with an active ingredient or formulation of a drug2 7,b7 an analysis of the listing of patents described in subparagraph 7,a77ii71 including the timing of listing such patents in relation to patents described in subparagraph 7,a77i71 and the effect listing the patents described in subparagraph 7,a77ii7 has on market entry of one or more drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act as compared to the effect of not listing the patents described in subparagraph 7,a77ii72 and 7,c7 recommendations about which kinds of patents relating to devices described in subparagraph 7,a77i7 should be submitted to the ,secretary of ,health and ,human ,services for inclusion on the list under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and which patents should not be required to be so submitted in order to reduce barriers to approval and market entry4 7g7 ,conforming amendments ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended-- 7#a7 in subsection 7c77#c77;,e71 by striking clause 7,a7 of subsection 7b77#a7 each place it appears and inserting subsection 7b77#a77;,a77i72 and 7#b7 in subsection 7j77#b77;,a77vi71 by striking clauses 7,b7 through 7,f7 of subsection 7b77#a7 and inserting clauses 7ii7 through 7vi7 of subsection 7b77#a77;,a74 ,secretary