,,ii #aafth ,,congress #ast ,session ,s4 #bchg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ca1 #bjai ,mr4 ,van ,hollen 7for himself and ,mr4 ,scott of ,florida7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a process by which reasonable drug prices may be determined1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,we ,protect ,american ,investment in ,drugs ,act or the ,we ,,paid ,act4 #b4 ,findings ,congress finds the following3 7#a7 ,in addition to spurring economic growth1 the ,national ,institutes of ,health supports some of the most significant breakthroughs in biomedical innovation1 including some that are commercialized into new pharmaceutical products4 7#b7 ,the ,national ,institutes of ,health funding contributed1 either directly or indirectly1 to the development of all #baj new molecular entities approved by the ,food and ,drug ,administration between #bjaj and #bjaf1 according to an analysis published in the ,proceedings of the ,national ,academy of ,sciences4 7#c7 ,in fiscal year #bjai1 ,congress provided #ci1ajj1jjj1jjj in funding for the ,national ,institutes of ,health4 7#d7 ,according to a ,kaiser ,family ,foundation health tracking poll in ,february #bjai-- 7,a7 nearly #hj percent of people in the ,united ,states say that the cost of prescription drugs is unreasonable and only #be percent trust pharmaceutical companies to price their products fairly2 and 7,b7 one-fourth of people in the ,united ,states say it is difficult to afford their prescription drugs1 and #c in #aj say they have not taken their medications as prescribed due to costs4 7#e7 ,according to a ,september #bjah report from the ,,aarp-- 7,a7 between #bjaf and #bjag1 retail prices for #bfg widely used brand name prescription drugs increased by #h4d percent after #e straight years of double-digit average annual price increases2 7,b7 brand name drug prices increased #d times faster than general inflation in #bjag2 and 7,c7 retail prices increased in #bjag for #hg percent 7#bca of #bfg7 of the widely used brand name prescription drugs reviewed1 and all but #e such increases exceeded the rate of inflation4 7#f7 ,in #bjaf1 prescription drug spending in the ,united ,states was #dgg1jjj1jjj1jjj1 according to an estimate from the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services4 7#g7 ,prescription drugs account for nearly #a out of every #e in overall spending under the ,medicare program1 as well as #ba percent of ,medicare beneficiaries' out-of-pocket health spending1 not including premiums4 7#h7 7,a7 ,a drug's list price has a significant impact on what payors and patients pay to purchase prescription drugs4 7,b7 ,in prescription drug plans under ,medicare part ,d1 and a growing number of commercial health plans1 seniors' and other beneficiaries' cost-sharing is based on a percentage of a drug's list price4 ,as a result1 higher drug list prices mean higher out-of-pocket costs for ,medicare beneficiaries for their retail prescriptions4 7,c7 ,for prescription drugs covered under ,medicare part ,b1 beneficiaries are responsible for paying #bj percent of the ,medicare-approved amount for the drug1 and the part ,b deductible also applies4 ,this can be a significant burden for high-cost part ,b drugs4 7,d7 ,a drug's list price is a factor in determining the amount of the rebate paid to ,state ,medicaid plans by the drug's manufacturer under the ,medicaid ,drug ,rebate ,program1 and an increase in the drug's list price may result in increased ,medicaid costs4 7,e7 ,in the private health insurance market1 pharmacy benefit manager and wholesaler fees are based on a percentage of the list price4 ,higher list prices increase costs in this part of the distribution chain4 7,f7 ,from #bjjg through #bjag1 enrollment in high-deductible health plans with a health savings account 7#d4b percent to #ah4i percent7 and without a health savings account 7#aj4f percent to #bd4e percent7 increased among adults between ages #ah and #fd with employment-based coverage1 while enrollment in traditional plans decreased1 according to the ,centers for ,disease ,control and ,prevention4 ,individuals with high-deductible health plans pay more out of pocket for medical expenses until their deductible is met1 making high-cost drugs challenging to afford4 7,g7 ,a larger share of prescription drug plans under ,medicare part ,d charged a deductible in #bjai than in #bjah 7#ga percent in #bjai1 and #fc percent in #bjah71 according to the ,kaiser ,family ,foundation4 ,fifty-two percent of prescription drug plans will require enrollees to satisfy the standard deductible of #dae in #bjai4 #c4 ,definitions ,for purposes of this ,act3 7#a7 ,applicable drug ,the term applicable drug means a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 that-- 7,a7 is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 is subject to section #ejc7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 and 7,c7 is covered by a qualifying patent on the drug1 on a method of using such drug1 or on a method or machine used to manufacture or administer such drug with respect to which the drug sponsor retained the title to any subject invention under section #bjb of title #ce1 ,united ,states ,code1 or entered into a licensing agreement after the date of enactment of this ,act4 7#b7 ,conflict of interest ,the term conflict of interest means an association1 including a financial or personal association1 or past employment1 that has the potential to bias or have the appearance of biasing an individual's decisions in matters related to the ,drug ,affordability and ,access ,committee or the conduct of other activities under this ,act4 7#c7 ,manufacturer list price ,the term manufacturer list price means the national price for a prescription drug established by the manufacturer or licensee found in a catalogue or other public source that is the price from which market discounts and price concessions are calculated4 7#d7 ,period of market exclusivity ,the term period of market exclusivity means any period of market exclusivity granted with respect to a prescription drug under clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e771 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f7 of such ,act1 section #ebg of such ,act 7#ba ,u4,s4,c4 #cfj;cc71 or section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g771 and any extension of such period granted under section #eje;,a or #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;f74 7#e7 ,qualifying patent ,the term qualifying patent means any patent-- 7,a7 held by the ,federal ,government2 or 7,b7 which the applicant with respect to the patent was required to disclose under section #bjb7;c77#f7 of title #ce1 ,united ,states ,code1 in the application for the patent4 7#f7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 #d4 ,national ,academy of ,medicine study on determining a reasonable drug price 7a7 ,in general ,not later than #fj days after the date of enactment of this ,act1 the ,secretary shall seek to enter into a contract with the ,national ,academy of ,medicine 7referred to in this section as the ,academy7 under which the ,academy agrees to study-- 7#a7 how best to determine the reasonableness of a drug's manufacturer list price and retail price and develop at least #a framework for determining the reasonableness of a drug's manufacturer list price and retail price taking into consideration-- 7,a7 affordability of the drug to payers1 purchasers1 and patients across wide market segments in a manner that ensures equitable access2 7,b7 investment by the ,national ,institutes of ,health or any other ,federal ,government entity in the development of the drug2 7,c7 inclusion of research funded by the ,national ,institutes of ,health or other ,federal ,government entity in the development of the drug2 7,d7 manufacturer research and development costs as shown on the manufacturer's ,federal tax filing under sections #da and #agd of the ,internal ,revenue ,code of #aihf2 7,e7 investment and the rate of return needs for the drug manufacturer2 7,f7 market for the drug2 7,g7 the cost of production and distribution of the drug2 7,h7 the price of the drug in other similar1 industrialized countries2 7,i7 estimated global and domestic sales of the drug2 7,j7 gross and net expenditures by public payers for coverage of the drug under ,federal health programs1 to the extent available2 and 7,k7 any additional information the ,academy determines appropriate2 7#b7 an appropriate timeline for the submission of information to the ,drug ,affordability and ,access ,committee required under section #f7;a77#b7 to determine the reasonableness of a drug's manufacturer list price and retail price2 and 7#c7 an appropriate timeline for the ,drug ,affordability and ,access ,committee to determine the reasonableness of a drug's manufacturer list price and retail price to be in effect the second year after coming to market4 7b7 ,report ,any contract between the ,secretary and the ,academy under this section shall include a requirement that the ,academy submit a report on the results of the study described in subsection 7a7 to the ,secretary1 the ,drug ,affordability and ,access ,committee1 and ,congress4 #e4 ,drug ,affordability and ,access ,committee 7a7 ,establishment ,there is hereby authorized to be established a nonprofit corporation to be known as the ,drug ,affordability and ,access ,committee 7referred to in this section as the ,committee71 which is neither an agency nor establishment of the ,united ,states ,government4 ,the ,committee shall be headed by an ,executive ,director4 7b7 ,purpose ,the purpose of the ,committee is to determine a reasonable manufacturer list price and retail price for each applicable drug4 7c7 ,board of ,directors 7#a7 ,in general ,the ,committee shall have a ,board of ,directors1 which shall be composed of ex officio and appointed members in accordance with this subsection4 ,all appointed members of the ,board shall be voting members4 7#b7 ,ex officio members ,the non-voting ex officio members of the ,committee shall be the following individuals or their designees3 7,a7 ,the ,secretary of ,health and ,human ,services4 7,b7 ,the ,director of the ,national ,institutes of ,health4 7,c7 ,the ,commissioner of ,food and ,drugs4 7,d7 ,the ,director of the ,agency for ,healthcare ,research and ,quality4 7,e7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,f7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7,g7 ,the ,assistant ,secretary for ,planning and ,evaluation4 7#c7 ,appointed members 7,a7 ,in general ,ten additional members shall be appointed to the ,committee by the ,comptroller ,general of the ,united ,states not later than #ahj days after the date of enactment of this ,act4 ,such members shall include-- 7i7 #b patient and consumer representatives not affiliated with any organization that receives funding from pharmaceutical manufacturers2 7ii7 #c provider representatives1 including #a hospital representative and #a pharmacist representative2 7iii7 #a health services researcher2 7iv7 #a health care economist2 7v7 #a representative of a sponsor of a health plan or health insurance coverage2 7vi7 #a pharmacy benefit management services representative2 and 7vii7 #a drug manufacturer representative4 7,b7 ,duration of terms ,members appointed to the ,committee under subparagraph 7,a7 shall be appointed to serve #e-year terms1 which shall be staggered for the members first appointed4 7,c7 ,term limits ,members appointed to the ,committee under subparagraph 7,a7 may not be so appointed for more than #b terms4 7,d7 ,conflicts of interest 7i7 ,in general ,in appointing members under subparagraph 7,a71 the ,comptroller ,general of the ,united ,states shall consider and disclose any potential conflicts of interest4 ,members of the ,board shall recuse themselves or be recused from relevant ,committee activities in the case where the member 7or an immediate family member of such member7 has a conflict of interest4 7ii7 ,disclosure of conflicts of interest 7,i7 ,in general ,a conflict of interest or potential conflict of interest shall be disclosed1 as applicable-- 7aa7 by the ,committee1 in appointing members to an advisory committee and for employment as staff on the ,committee2 and 7bb7 by the ,comptroller ,general of the ,united ,states1 in appointing members of the ,committee4 7,,ii7 ,manner of disclosure ,conflicts of interests shall be disclosed as soon as practicable on the internet websites of the ,committee and of the ,government ,accountability ,office4 ,the information so disclosed shall include the type1 nature1 and magnitude of the interests of the individual involved1 except to the extent that the individual recuses himself or herself from participating in the consideration of activity in which the potential conflict exists4 7,e7 ,confidentiality ,the ,committee shall maintain the confidentiality of any information provided to the ,committee under this section that is a trade secret or confidential information4 7,f7 ,vacancies ,vacancies on the ,board shall be filled in the same manner as the original appointment was made4 ,any vacancy in the membership of the ,board shall not affect the power of the remaining members to execute the duties of the ,board4 7,g7 ,compensation ,while serving on the business of the ,committee 7including travel time71 a member of the ,committee shall be entitled to compensation at the per diem equivalent of the rate provided for level ,,iv of the ,executive ,schedule under section #ecae of title #e1 ,united ,states ,code1 and while so serving away from home and the member's regular place of business1 a member may be allowed travel expenses1 as authorized by the ,chairman of the ,committee4 7,h7 ,no ,federal employees ,no employee of the ,federal ,government shall be an appointed member of the ,committee4 7d7 ,executive director 7#a7 ,appointment ,the ,board shall appoint an ,executive ,director who shall serve at the pleasure of the ,board4 ,the ,executive ,director shall be responsible for the day-to-day operations of the ,committee and shall have such specific duties and responsibilities as the ,board shall prescribe1 including to identify1 recruit1 and hire staff4 7#b7 ,compensation ,the compensation of the ,executive ,director shall be fixed by the ,board4 7#c7 ,conflicts of interest and confidentiality ,the ,executive ,director and all staff of the ,committee shall be subject to the same conflict of interest and confidentiality requirements as the ,board members1 as described in subparagraphs 7,d7 and 7,e7 of subsection 7c77#c74 7e7 ,initial meeting ,the initial meeting of the ,committee shall take place within #fj days of all members being appointed4 ,in the initial meeting1 the ,committee shall-- 7#a7 incorporate the ,committee2 7#b7 designate a ,chair2 and 7#c7 appoint the ,executive ,director4 7f7 ,duties and authorities ,the duties and authorities of the ,committee are as follows3 7#a7 ,administrative duties ,the ,committee shall establish administrative guidelines for the ,committee1 including-- 7,a7 establishing bylaws for the ,committee that are published in the ,federal ,register and made available for public comment2 7,b7 establishing policies for the selection of officers1 employees1 agents1 and contractors of the ,committee2 7,c7 establishing policies that would subject all employees1 fellows1 and trainees of the ,committee to the conflict of interest standards under subsection 7c77#c77;,d72 7,d7 specifying a process for annual ,board review of the operations of the ,committee2 7,e7 establishing specific duties of the ,executive ,director2 7,f7 evaluating the performance of the ,executive ,director2 and 7,g7 carrying out other necessary activities regarding the functioning of the ,committee4 7#b7 ,process1 methodology1 and timeline for determining reasonable prices 7,a7 ,in general ,not later than #b years after receipt of the report of the ,national ,academy of ,medicine under section #d1 the ,committee shall-- 7i7 outline the process and methodology by which the ,committee will determine1 based on such report1 whether the manufacturer list price and retail price is reasonable for each applicable drug2 7ii7 outline the timeline under which the manufacturer1 based on such report1 is required to submit the information required under section #f7;a77#b7 to the ,committee2 7iii7 outline the timeline under which the ,committee is required to determine1 based on such report1 whether the manufacturer list price and retail price is reasonable for each applicable drug2 and 7iv7 publish such proposed process1 methodology1 and timeline on the internet website of the ,committee4 7,b7 ,public input ,not later than #fj days after publication of the proposed process1 methodology1 and timeline under subparagraph 7,a71 the ,committee shall hold a minimum of #b public stakeholder meetings to solicit feedback on such proposed process1 methodology1 and timeline4 7,c7 ,publication of final process1 methodology1 and timeline ,not later than #cj months after receipt of the report under section #d1 the ,committee shall publish a final process1 methodology1 and timeline on the ,committee's internet website4 7,d7 ,updates to process1 methodology1 and timeline ,the ,committee may make changes and updates to the final process1 methodology1 and timeline as necessary4 ,any such changes or updates shall be published on the internet website of the ,committee4 7#c7 ,issuance of reasonable pricing determination 7,a7 ,determinations ,the ,committee shall issue a reasonable pricing determination for each applicable drug that-- 7i7 is based on a review of the information submitted under section #f7;a72 and 7ii7 uses the process1 methodology1 and timeline developed by the ,committee under paragraph 7#b74 7,b7 ,timeframe ,the ,committee shall issue a reasonable pricing determination under subparagraph 7,a7 for a drug that1 upon approval of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 will be an applicable drug1 taking into consideration the recommended timeframe under section #d7;a77#b74 7,c7 ,reports to drug manufacturers ,for each reasonable pricing determination made under subparagraph 7,a71 the ,committee shall submit a report in writing to the applicable drug manufacturer outlining such determination4 ,each such report shall be made public1 excluding any proprietary information4 7#d7 ,appointment of advisory committees ,the ,committee may appoint permanent or ad hoc advisory committees as determined appropriate to assist in the work of the ,committee4 ,all members of any such advisory committee shall be subject to the same conflict of interest requirements as ,committee members4 7g7 ,annual reports ,the ,committee shall submit an annual report to ,congress and to the ,secretary1 and shall make the annual report available to the public4 ,each such report shall include-- 7#a7 a description of the activities conducted under this ,act2 7#b7 the budget of the ,committee for the following year2 and 7#c7 any other relevant information1 including information on the membership of the ,board1 advisory committees1 and the executive staff of the ,committee1 any conflicts of interest with respect to such individuals1 and any bylaws adopted by the ,board during the preceding year4 #f4 ,requirements for entering into a licensing agreement 7a7 ,in general ,upon retaining the title to any subject invention under section #bjb of title #ce1 ,united ,states ,code1 or entering into a partial or exclusive licensing agreement relating to an applicable drug1 the drug manufacturer shall agree to-- 7#a7 beginning one year after an applicable drug first comes to market1 limit the annual price increase on such drug to the percentage by which the medical care consumer price index detailed expenditure category for all urban consumers for that year exceed such index for the preceding calendar year2 7#b7 submit to the ,drug ,affordability and ,access ,committee1 on a good faith timeline that is consistent with the recommendation under section #e7;f77#b77;,a77ii7-- 7,a7 the manufacturer list price for the drug2 7,b7 the retail price for the drug2 7,c7 information on expenditures1 including-- 7i7 the total annual expenditures of the manufacturer on materials and manufacturing for the drug2 7ii7 the total expenditures of the manufacturer on acquiring patents and licensing for the drug1 including expected royalty payments2 7iii7 the total expenditures of the manufacturer on research and development as shown on the manufacturer's ,federal tax returns under sections #da and #agd of the ,internal ,revenue ,code of #aihf2 7iv7 the amount of the manufacturer's total expenditures derived from any ,federal funding source1 including tax deductions or credits claimed2 and 7v7 total expected expenditures for marketing and advertising for the drug in the first #c years that the drug is on the market2 7,d7 the anticipated number of patients who will be treated with the drug2 7,e7 a copy of the application submitted under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 and any subsequent information or data requested by1 or submitted to1 the ,food and ,drug ,administration during the approval process2 7,f7 any additional information requested by the ,drug ,affordability and ,access ,committee2 and 7,g7 any additional information the manufacturer chooses to provide related to drug pricing decisions2 7#c7 submit the manufacturer list price and retail price of an applicable drug to the ,drug ,affordability and ,access ,committee for a reasonable price determination2 and 7#d7 beginning one year after an applicable drug first comes to market1 not exceed the reasonable price1 as determined by such ,committee1 for the drug's manufacturer list price4 7b7 ,penalties 7#a7 ,loss of period of market exclusivity ,in the case of a drug manufacturer subject to this section who increases the price of an applicable drug to an amount that exceeds the amount under subsection 7a77#a7 or exceeds the reasonable price as required under subsection 7a77#d71 any period of market exclusivity with respect to the applicable drug shall be deemed expired1 effective on the date of such price increase or launch price4 7#b7 ,prohibition on entering into future licensing agreements ,if a drug manufacturer fails to adhere to the limit on annual price increases under subsection 7a77#a71 such drug manufacturer1 and its president1 chief executive officer1 chief operating officer1 and general counsel employed at the time of the violation1 shall be ineligible for future licensing agreements for qualifying patented technology4 7#c7 ,prohibition on entering into future licensing agreements ,if a drug manufacturer fails to adhere to the reasonable price as required under subsection 7a77#d71 the drug manufacturer1 and its president1 chief executive officer1 chief operating officer1 and general counsel1 shall be ineligible for future licensing agreements for qualifying patented technology4 7#d7 ,failure to submit information or submitting false information to the ,drug ,affordability and ,access ,committee ,any manufacturer that fails to submit information required under subsection 7a77#b7 to be submitted to the ,drug ,affordability and ,access ,committee1 or who submits false information to such ,committee shall be subject to a civil monetary penalty of #ejj1jjj and if a violation is not corrected within #cj days following notification of such violation1 #a1jjj1jjj for each day that the violation continues after such period until the violation is corrected4 7#e7 ,excessive price in the first year of launch ,if a drug manufacturer's launch price in the first year for an applicable drug is at least #ej percent higher than the reasonable price as required under subsection 7a77#d7 to be in effect for the second year1 the drug manufacturer shall be subject to a civil monetary penalty of the cost of the drug in excess of #ej percent multiplied by the number of doses of the drug sold in the ,united ,states in the first year on the market4 7#f7 ,distribution of payments to the national institutes of health 7,a7 ,in general ,each fiscal year1 there shall be transferred1 out of funds in the ,treasury not otherwise obligated1 to the ,director of the ,national ,institutes of ,health1 an amount equal to the amount collected in civil penalties under this subsection during the previous fiscal year1 unless the amount otherwise appropriated to the ,national ,institutes of ,health for the fiscal year in which such transfer would occur is less than the amount so appropriated for the previous fiscal year4 7,b7 ,delayed distribution ,if1 in accordance with clause 7i71 the ,secretary of the ,treasury does not transfer amounts under such clause during any portion of a fiscal year1 and1 at a later date in such fiscal year1 the appropriations to the ,national ,institutes of ,health becomes equal to or greater than the amount of appropriations for the previous fiscal year1 such ,secretary shall transfer such amount at any time in such fiscal year4 #g4 ,proper disclosure of government support 7a7 ,definitions ,in this section-- 7#a7 the term contractor-- 7,a7 has the meaning given the term in section #bja of title #ce1 ,united ,states ,code2 and 7,b7 includes an assignee of a contractor to the extent that the assignee is the entity that files an application described in section #bjb7;c77#f72 7#b7 the term covered contractor means a contractor that-- 7,a7 is a party to a funding agreement that contains an appropriate provision to effectuate the requirement under section #bjb7;c77#f72 and 7,b7 files a ,united ,states patent application with respect to a subject invention that the contractor conceived or first actually reduced to practice in the performance of work under the funding agreement described in subparagraph 7,a72 7#c7 the term covered patentee means the patentee with respect to a patent issuing from an application described in paragraph 7#b77;,b72 7#d7 the term drug has the meaning given that term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#e7 the terms funding agreement and subject invention have the meanings given the terms in section #bja of title #ce1 ,united ,states ,code2 7#f7 the term patentee has the meaning given the term in section #ajj of title #ce1 ,united ,states ,code2 and 7#g7 the term section #bjb7;c77#f7 means section #bjb7;c77#f7 of title #ce1 ,united ,states ,code4 7b7 ,actions for failure ,to disclose government support 7#a7 ,private right of action 7,a7 ,in general ,a person 7including a government entity7 may bring a civil action in an appropriate district court of the ,united ,states against a covered patentee-- 7i7 on the ground that the application for the patent with respect to which the covered patentee holds title failed to comply with the requirement under section #bjb7;c77#f72 and 7ii7 if the person is injured by the failure to comply described in clause 7i74 7,b7 ,scope ,in an action brought under subparagraph 7,a71 if the court finds by a preponderance of the evidence that the application described in that subparagraph failed to comply with the requirement under section #bjb7;c77#f71 the court shall cancel as unpatentable any claim of the patent issuing from that application4 7#b7 ,inter partes review ,section #caa of title #ce1 ,united ,states ,code1 is amended by striking subsection 7b7 and inserting the following3 7b7 ,scope ,a petitioner in an inter partes review may request to cancel as unpatentable #a or more claims of a patent-- 7#a7 7,a7 on a ground that could be raised under section #ajb or #ajc2 and 7,b7 on the basis of prior art consisting of patents or printed publications2 or 7#b7 on the ground that the application with respect to the patent was subject to the requirement in section #bjb7;c77#f7 and failed to comply with that requirement4 4 7c7 ,disclosure of grants ,section #aaa7;a77#b7 of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in subparagraph 7,b71 by striking and at the end2 7#b7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,d7 with respect to a drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 covered by a qualifying patent on the drug1 on a method of using such drug1 or on a method or machine used to manufacture or administer such drug1 a disclosure of any ,federal grant received in the #aj-year period prior to submitting the application1 in which the applicant is listed as the principal investigator or co-investigator with respect to the grant4 4 7d7 ,,gao report ,not later than #e years after the date of enactment of this ,act1 and once every #e years thereafter1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct a study that reviews-- 7,a7 the compliance by covered contractors with the requirement under section #bjb7;c77#f72 and 7,b7 the effectiveness of the ,national ,institutes of ,health in conducting oversight of the extent to which covered contractors are complying with the requirement under section #bjb7;c77#f72 and 7#b7 submit to ,congress the results of each study conducted under paragraph 7#a71 which shall include1 in each case1 recommendations for additional practices and policies to improve the effectiveness of the requirement under section #bjb7;c77#f71 including any mechanism to better enforce that requirement4