,i #aacth ,,congress #ast ,session ,h4 ,r4 #caaf ,,in ,,the ,,house ,,of ,,representatives ,september #ag1 #bjac,mr4 ,lance 7for himself1 ,mr4 ,roskam1 ,mr4 ,guthrie1 ,mr4 ,paulsen1 ,mr4 ,rangel1 ,mr4 ,runyan1 ,ms4 ,schwartz1 ,mr4 ,king of ,new ,york1 ,mr4 ,mc,caul1 ,mr4 ,walden1 ,mr4 ,tiberi1 ,mr4 ,loebsack1 ,mr4 ,ben ,ray ,lujn of ,new ,mexico1 ,mr4 ,ellison1 ,mr4 ,jones1 and ,mr4 ,long7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means and the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to promote the development of meaningful treatments for patients4 #a4 ,short title ,this ,act may be cited as the ,modernizing ,our ,drug ,diagnostics ,evaluation and ,regulatory ,network ,cures ,act of #bjac or the ,,moddern ,cures ,act of #bjac4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,sec4 #c4 ,findings4,sec4 #d4 ,definitions4,title ,i--,advancing diagnostics for patients,sec4 #aja4 ,developing a common lexicon to facilitate progress on diagnostics4,sec4 #ajb4 ,creating incentives for innovative diagnostics4,sec4 #ajc4 ,promoting the development of innovative diagnostics4,title ,,ii--,capturing lost opportunities for patients,sec4 #bja4 ,dormant therapies4,sec4 #bjb4 ,study regarding new indications for existing therapies4 #c4 ,findings ,the ,congress makes the following findings3 7#a7 ,more than #acc million ,americans1 or #de percent of the population1 have at least one chronic condition4 ,a quarter of ,americans have multiple chronic conditions4 7#b7 ,chronic diseases have become the leading cause of death and disability in the ,united ,states4 ,seven out of every #aj deaths are attributable to chronic disease4 ,chronic diseases also compromise the quality of life of millions of ,americans4 7#c7 ,despite #hj billion spent annually on research and development1 many diseases and conditions lack effective treatments4 7#d7 ,many commonly used drugs are effective in only #ej to #ge percent of the patient population1 which can lead to devastating long-term side effects1 resulting in the potential risks outweighing the benefits for some patients4 7#e7 ,advanced and innovative diagnostic tests have the potential to dramatically increase the efficacy and safety of drugs by better predicting how patients will respond to a given therapy4 7#f7 ,despite their promise1 many drugs and diagnostics may go undeveloped due to uncertain regulatory and reimbursement processes1 among other reasons4 7#g7 ,in addition1 there is reason to believe that potential treatments with tremendous value to patients are never developed or are discontinued during research and development due to insufficiencies in the intellectual property system4 7#h7 ,it is in the public interest to address the hurdles that may be precluding new treatments from reaching patients and to remove the disincentives for the development of therapies for these unmet needs4 #d4 ,definitions ,in this ,act3 7#a7 ,the term biological product has the meaning given to that term in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,the term drug has the meaning given to that term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#c7 ,the term medicine means a biological product or a drug4 7#d7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 ,i ,advancing diagnostics for patients #aja4 ,developing a common lexicon to facilitate progress on diagnostics 7a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall establish within the ,department of ,health and ,human ,services the ,advanced ,diagnostics ,education ,council 7in this section referred to as the ,council74 7b7 ,duties 7#a7 ,in general ,the ,council shall promote an improved understanding of key concepts related to innovative diagnostics by recommending standard terms and definitions for use by patients1 physicians1 health care providers1 payers1 and policymakers4 7#b7 ,guide ,the ,secretary shall publish and disseminate a guide regarding such recommended terms and definitions for patients1 physicians1 health care providers1 payers1 and policymakers4 7#c7 ,report ,not later than #ab months after the establishment of the ,council1 the ,secretary shall prepare and submit a report to the ,congress and to the public on the ,council's deliberations1 activities1 and determinations with respect to meeting its duties described in paragraphs 7#a7 and 7#b74 7c7 ,chairperson ,the ,secretary1 or the ,secretary's designee1 shall serve as chairperson of the ,council4 7d7 ,members ,in addition to the ,secretary1 the ,council shall consist of the following3 7#a7 ,the head of each of the following agencies 7or a designee thereof73 7,a7 ,the ,national ,institutes of ,health4 7,b7 ,the ,centers for ,disease ,control and ,prevention4 7,c7 ,the ,food and ,drug ,administration4 7,d7 ,the ,agency for ,healthcare ,research and ,quality4 7,e7 ,the ,centers for ,medicare ,medicaid ,services4 7,f7 ,the ,department of ,defense4 7,g7 ,the ,department of ,veterans ,affairs4 7,h7 ,the ,health ,resources and ,services ,administration4 7,i7 ,the ,substance ,abuse and ,mental ,health ,services ,administration4 7,j7 ,the ,indian ,health ,service4 7#b7 ,seven members appointed by the ,secretary from among individuals who collectively-- 7,a7 represent a broad range of perspectives2 and 7,b7 have expertise in-- 7i7 basic and translational research1 including with respect to molecular biology and genetics2 7ii7 bioinformatics2 7iii7 the discovery1 development1 and commercialization of in vitro diagnostics2 and 7iv7 law and ethics4 7#c7 ,four members appointed by the ,secretary who are each a chief medical or scientific officer of a patient advocacy organization4 7e7 ,public input ,in carrying out its duties1 the ,council shall solicit input from relevant stakeholders and the public4 7f7 ,termination ,the ,council shall terminate after publishing the guide required by subsection 7b77#b7 and submitting the report required by subsection 7b77#c71 or later at the discretion of the ,secretary4 #ajb4 ,creating incentives for innovative diagnostics 7a7 ,improvements ,to process for determining fee schedule amounts for new tests 7#a7 ,clarifying factors for rate-setting ,in determining the payment amount under gapfilling procedures 7as described in section #dad4ejh7;b7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation to such section7 for new clinical diagnostic laboratory tests under section #ahcc7;h77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h771 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall take into account1 as applicable and available1 the following factors with respect to such a new test3 7,a7 ,impact on patient care ,the impact of the new test on patient care1 patient management1 or patient treatment4 7,b7 ,technical characteristics ,the technical characteristics of the new test1 and the resources required to develop1 validate1 and perform the new test4 7,c7 ,claims data ,data from claims for which payment is made under part ,b of title ,,xviii of the ,social ,security ,act4 7,d7 ,laboratory charges ,amounts charged by laboratories to self-pay patients for the new test4 7,e7 ,private insurance rates ,amounts paid to laboratories for such new test under private health insurance coverage offered in the group market and the individual market4 7,f7 ,advisory panel recommendations ,the findings and recommendations of the independent advisory panel convened under paragraph 7#b7 with respect to that new test and any comments received during the open meeting of the advisory panel4 7,g7 ,additional factors ,such other factors as the ,secretary may specify4 7#b7 ,input from patients1 clinicians1 and technical experts 7,a7 ,requirement for independent advisory panel ,the ,secretary shall convene an independent advisory panel from which the ,secretary shall request information and recommendations regarding any new test 7as referred to under subparagraph 7,a7 of section #ahcc7;h77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7h77#h777 for which payment is made under such section1 including technical1 clinical1 and quality information4 7,b7 ,composition of independent advisory panel ,subject to subparagraph 7,d71 the independent advisory panel shall be comprised of #ai members1 including-- 7i7 #g individuals with expertise and experience with clinical diagnostic laboratory tests including expertise in the technical characteristics of the new test as well as expertise in the requirements to develop1 validate1 and perform the new test2 7ii7 #c representatives of patients1 including a patient representative for rare disorders2 7iii7 #c clinicians who use results of the new test in patient care2 7iv7 #b laboratorians2 7v7 #b individuals with expertise in the area of pharmacoeconomics or health technology assessment2 and 7vi7 #b individuals with expertise on the impact of new tests on quality of patient care1 including genetic counselors4 7,c7 ,terms ,subject to subparagraph 7,d71 a member of the panel shall be appointed to serve a term of #f years1 except with respect to the members first appointed1 whose terms of appointment shall be staggered evenly over #b-year increments4 7,d7 ,temporary appointment of experts ,insofar as the ,secretary determines with respect to a new test that there are an insufficient number of members of the panel with expertise with respect to that specific test1 the ,secretary may appoint individuals who have expertise pertaining to the new test involved to serve on the panel4 7,e7 ,open meetings ,the ,secretary shall receive or review the findings and recommendations of the independent advisory panel with respect to the new tests described in subparagraph 7,a7 involved during a meeting open to the public and provide opportunity for public comment4 7,f7 ,clarification of authority of secretary to consult carriers ,nothing in this section shall be construed as affecting the authority of the ,secretary to consult with appropriate ,medicare administrative contractors4 7#c7 ,justification for payment determinations 7,a7 ,initial justification ,with respect to decisions regarding payments made under the clinical laboratory fee schedule for new clinical diagnostic laboratory tests1 the ,secretary shall publicly provide a justification for the payment basis and payment rate determination1 including a detailed summary of the information submitted to1 or obtained by1 the ,secretary regarding the factors specified in paragraph 7#a71 such that interested stakeholders can readily understand the ,secretary's rationale for the payment basis and rate determinations4 7,b7 ,reconsideration period ,after providing such justification for a payment basis and payment rate determination1 the ,secretary shall provide for a reasonable period of reconsideration to receive any appeal of the determination and to evaluate any additional information received regarding the justification and the factors specified in paragraph 7#a74 7,c7 ,final determination ,after the period of reconsideration the ,secretary shall make a final payment basis and payment rate determination and provide a justification for such final determination explaining what additional information was evaluated during the reconsideration and how such information was taken into account with respect to the final determination4 ,nothing in this paragraph shall be construed as authorizing the ,secretary to reveal proprietary information which is otherwise prohibited from disclosure under law4 7b7 ,process for assignment of temporary codes for diagnostic tests ,the ,secretary shall establish a process for application for the assignment of a temporary national ,,hcpcs code to uniquely identify a diagnostic test until a permanent national ,,hcpcs code is available for assignment to that test4 ,assignments of a temporary national ,,hcpcs code shall occur on a quarterly basis4 ,the ,secretary shall provide public notice through the ,centers for ,medicare ,medicaid ,services ,web site of applications made for such temporary national ,,hcpcs codes4 ,upon assignment of a temporary code under this process1 the ,secretary shall treat such test as a new test for purposes of section #ahcc7;h77#h7 of the ,social ,security ,act4 7c7 ,development of further improvements in rate-,setting processes ,the ,secretary shall analyze the process used for the gapfilling procedure used in determining payment amounts for new clinical diagnostic laboratory tests under section #ahcc7;h77#h7 of the ,social ,security ,act4 ,taking into account the changes made by this section1 the ,secretary shall identify further changes to improve the accuracy and appropriateness of resulting rates and the openness1 transparency1 and predictability of the process4 ,the ,secretary shall examine what and how many entities should perform gapfilling1 under contract or otherwise1 and how to ensure that the process is informed by appropriate expertise and proceeds in a transparent and accountable manner4 ,the ,secretary shall implement improvements in the process1 insofar as these are possible under the law through regulations1 after public notice and opportunity for comment4 ,for changes the ,secretary determines would require a change in law1 the ,secretary shall transmit recommendations to the ,speaker of the ,house and the ,president of the ,senate not later than ,july #a1 #bjad4 7d7 ,definitions ,for purposes of this section3 7#a7 ,new clinical diagnostic laboratory tests ,the term new clinical diagnostic laboratory test means a clinical diagnostic laboratory test-- 7,a7 that is assigned a new or substantially revised code on or after ,january #a1 #bjac2 or 7,b7 for which a temporary national ,,hcpcs code is granted under subsection 7b7 on or after ,january #a1 #bjad4 7#b7 ,self-pay patient ,the term self-pay patient means1 with respect to a health care item or service1 an individual who pays out of pocket for such item or service and who does not have health insurance coverage for such item or service4 7e7 ,effective date 7#a7 ,in general ,subject to paragraph 7#b71 this section shall take effect on the date of enactment of this ,act and shall apply with respect to new clinical diagnostic laboratory tests4 7#b7 ,application of justifications to current rate determinations ,subsection 7a77#c7 shall apply to payment basis and payment rate determinations made on or after ,january #a1 #bjac4 #ajc4 ,promoting the development of innovative diagnostics 7a7 ,determination 7#a7 ,request ,the manufacturer or sponsor of a medicine may request the ,secretary to determine that-- 7,a7 a diagnostic test has been developed by1 or with the participation of1 the manufacturer or sponsor of the medicine2 and 7,b7 use of the diagnostic test1 as demonstrated through valid scientific information such as peer-reviewed literature-- 7i7 provides for or improves the identification of a patient population for which the medicine will or will not be used in accordance with its approved indications2 7ii7 provides for or improves the determination of the most appropriate treatment option for a patient population with the medicine in accordance with its approved indications2 or 7iii7 provides for the detection of a qualifying pathogen 7as defined in section #eje;,e7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;f774 7#b7 ,response by ,secretary ,not later than #cj days after the submission of a request under paragraph 7#a71 the ,secretary1 shall-- 7,a7 make the requested determination and publish a notice of such determination and any extension under this section resulting from such determination2 or 7,b7 provide an explanation to the manufacturer or sponsor submitting the request of why the determination is not warranted4 7b7 ,applicable extension period ,for purposes of subsections 7c7 and 7d71 the applicable extension period is-- 7#a7 with respect to a diagnostic test developed 7as described in subsection 7a77#a77;,a77 contemporaneously with the development of the medicine involved1 #ab months2 and 7#b7 with respect to a diagnostic test developed otherwise1 #f months4 7c7 ,extension for drugs ,if1 at the request of the manufacturer or sponsor of a drug1 the ,secretary makes the determination described in subsection 7a77#a7 with respect to such drug and a diagnostic test1 then-- 7#a7 the four- and five-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 the three-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 of such section #eje1 or the seven-year period described in section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc71 as applicable1 shall be extended by the applicable extension period2 7#b7 if the drug is the subject of-- 7,a7 a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77ii7 or 7j77#b77;,a77vii77,,ii7 of such section #eje2 or 7,b7 a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iii7 or 7j77#b77;,a77vii77,,iii7 of such section #eje1 then the period during which an application may not be approved under subsection 7c77#c7 or 7j77#e77;,b7 of such section #eje shall be extended by the applicable extension period after the date the patent expires 7including any patent extensions72 and 7#c7 if the drug is the subject of a listed patent for which a certification has been submitted under subsection 7b77#b77;,a77iv7 or 7j77#b77;,a77vii77,,iv7 of such section #eje1 and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed1 the period during which an application may not be approved under subsection 7c77#c7 or 7j77#e77;,b7 of such section #eje shall be extended by the applicable extension period after the date the patent expires 7including any patent extension74 7d7 ,extension for biological products ,if1 at the request of the manufacturer or sponsor of a biological product1 the ,secretary makes the determination described in subsection 7a77#a7 with respect to such biological product and a diagnostic test1 then the #ab-year period described in subsection 7k77#g77;,a7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 the #d-year period described in subsection 7k77#g77;,b7 of such section #cea1 and the #g-year period described in section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc71 as applicable1 shall be extended by the applicable extension period4 7e7 ,relation to pediatric exclusivity ,any extension under subsection 7c7 or 7d7 of a period shall be in addition to any extension of the period under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 with respect to the medicine4 7f7 ,limitations ,extensions under this section may apply-- 7#a7 not more than twice with respect to the same medicine2 and 7#b7 not more than once with respect to the same indication to be treated by the same medicine4 ,,ii ,capturing lost opportunities for patients #bja4 ,dormant therapies 7a7 ,designation as dormant therapy ,the ,secretary shall designate a medicine as a dormant therapy if-- 7#a7 the sponsor of the medicine submits a request for such designation meeting the requirements under subsection 7b71 and the request has not been withdrawn under subsection 7d77#a72 and 7#b7 the ,secretary determines that-- 7,a7 the medicine is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs2 7,b7 a suitable clinical plan for such investigations of the medicine has been developed by the sponsor2 7,c7 the sponsor intends to file an application pursuant to 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 for approval or licensing of the medicine for an indication described in subparagraph 7,a72 and 7,d7 the request for designation was made on or before the date of submission of any application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for the approval or licensure of commercial marketing or use of a medicine that in the case of a drug shares an active moiety that is the same as1 and in the case of a biologic contains an active moiety that is highly similar to1 an active moiety in the medicine for which designation is being requested4 7b7 ,requirements for request for designation as dormant therapy ,a request under subsection 7a77#a7 with respect to a medicine may only be made by the sponsor of the medicine and shall contain each of the following3 7#a7 ,a listing of all patents and applications for patents under which the sponsor has rights and that may be reasonably construed to provide protection for the medicine4 7#b7 ,a waiver of patent rights to the extent required under subsection 7c7 to take effect1 if at all1 as provided under subsection 7c77#c74 7#c7 ,such additional information as the ,secretary may require by regulation in order to determine eligibility for designation under subsection 7a74 7c7 ,waiver of patent rights expiring after the protection period ends 7#a7 ,patent waiver 7,a7 ,in general ,subject to subparagraph 7,b71 the request under this subsection shall include a waiver of the right to enforce or otherwise assert any patent described in subsection 7b77#a7 7or any patent issued on the basis of an application described in subsection 7b77#a771 which may expire after the end of the protection period for the dormant therapy1 against any applicable product described in paragraph 7#b74 ,the waiver shall be made by the owner of the patent or application for patent1 as the case may be4 7,b7 ,limitations on patent waiver ,any patent waiver provided pursuant to this section1 should it become effective-- 7i7 shall have no effect during the protection period for the medicine to which the waiver relates2 and 7ii7 shall have no effect with respect to the subject matter of a claimed invention in a patent that does not provide any protection for such medicine with respect to an applicable product described in paragraph 7#b74 7#b7 ,applicable products described ,an applicable product is described in this paragraph only if-- 7,a7 it is approved or licensed pursuant to an application that-- 7i7 is filed under section #eje7;b77#b7 or #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b71 7j77 or section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7ii7 references or otherwise relies upon the approval or licensure of the dormant therapy to which the waiver relates2 and 7,b7 the approval of the product occurs after the expiration of the protection period applicable to the medicine to which the request under subsection 7a77#a7 relates4 7#c7 ,effective date of waiver ,a waiver under subsection 7b77#b7 with respect to a patent shall take effect1 if at all1 on the date the ,director publishes the notice required under subsection 7e77#b77;,f7 relating to the patent4 7d7 ,withdrawal of request for designation1 revocation by the secretary 7#a7 ,in general ,the sponsor of a medicine may withdraw a request for designation under subsection 7a77#a7 with respect to a medicine unless the medicine has been approved or licensed under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,the ,secretary shall deny a designation request or revoke any designation granted if at any time the ,secretary finds that the sponsor is not in compliance with subsections 7c77#a7 and 7g77#a74 7#b7 ,effects of withdrawal of request or revocation of designation ,if the sponsor of a medicine withdraws a request under subsection 7b7 or the ,secretary denies a designation request or revokes a designation with respect to the medicine-- 7,a7 any patent waiver submitted under this section with respect to the medicine1 but not yet effective1 is canceled and deemed a nullity2 7,b7 any patent waiver that has taken effect under this section with respect to the medicine shall remain in effect2 7,c7 any patent term extension granted by the ,director under subsection 7e77#b7 with respect to the medicine shall be canceled1 except that the ,director shall maintain the patent term extension for one patent1 to be selected by the sponsor of the medicine1 for the period of extension that would have been applicable under section #aef of title #ce1 ,united ,states ,code2 and 7,d7 the designation1 if made1 otherwise shall be treated as never having been requested or made or having effect4 7#c7 ,basis for revocation ,the ,secretary may revoke a designation made under subsection 7a71 but only based upon a finding by the ,secretary under paragraph 7#a74 7e7 ,guaranteed protections for dormant therapies 7#a7 ,applications filed during the protection period ,during the protection period for a dormant therapy1 notwithstanding any other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47-- 7,a7 absent a right of reference from the holder of such approved application for the dormant therapy1 the ,secretary shall not approve an application filed pursuant to section #eje7;b77#b7 or section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b71 7j77 or section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 referencing or otherwise relying on the approval or licensure of the dormant therapy2 7,b7 the ,secretary shall not approve-- 7i7 an application filed pursuant to such section #eje7;b77#b7 or #eje7;j7 that references or otherwise relies on the approval or licensure of a medicine that is not the dormant therapy1 was approved subsequent to the approval of the dormant therapy1 and contains the same active moiety as the active moiety in the dormant therapy 7or if the dormant therapy contains more than one active moiety1 all of the active moieties are the same72 or 7ii7 an application filed pursuant to such section #cea7k7 that references or otherwise relies on the approval or licensure of a medicine that is not the dormant therapy1 was approved subsequent to the approval or licensure of the dormant therapy1 and contains an active moiety that is highly similar to the active moiety in the dormant therapy 7or if the dormant therapy contains more than one active moiety1 all of the active moieties are highly similar72 and 7,c7 the ,secretary shall not approve an application filed pursuant to section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 for a drug that contains the same active moiety as the active moiety in the dormant therapy 7or if the dormant therapy contains more than one active moiety1 all of the active moieties are the same71 or an application filed pursuant to section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 for a biological product that contains an active moiety that is highly similar to the active moiety in the dormant therapy 7or if the dormant therapy contains more than one active moiety1 all of the active moieties are highly similar71 unless-- 7i7 the information provided to support approval of such application is comparable in scope and extent1 including with respect to design and extent of preclinical and clinical testing1 to the information provided to support approval of the application for the dormant therapy under section #eje7;b7 of the ,federal ,food1 ,drug 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;a772 and 7ii7 if such clinical testing had not commenced before the approval of the application for the dormant therapy1 the clinical testing establishes clinical superiority in the form of a significant therapeutic advantage over and above that provided by the dormant therapy in one or more of the following ways3 7,i7 ,greater effectiveness on a clinically meaningful endpoint4 7,,ii7 ,greater safety in a substantial portion of the target populations4 7,,iii7 ,where neither greater safety nor greater effectiveness has been shown1 a demonstration that the drug otherwise makes a major contribution to patient care4 7#b7 ,patent term alignment with data package protection period 7,a7 ,in general ,notwithstanding any provision of title #ce1 ,united ,states ,code1 a sponsor of a medicine designated as a dormant therapy under subsection 7a77#a71 upon the approval or licensure thereof under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 and in lieu of filing a patent term extension application under section #aef7;d7 of such title #ce1 shall be entitled to patent term extensions in accordance with this paragraph4 7,b7 ,submission of final listing of patents and applications for patents following approval 7i7 ,submission ,the sponsor of the dormant therapy1 within a period to be set by the ,director of not less than #b months beginning on the date the ,secretary approves or licenses the dormant therapy1 shall submit to the ,director-- 7,i7 the listing of patents and applications for patents provided to the ,secretary under subsection 7b77#a72 7,,ii7 any revisions to such listing as may be required for compliance with subsection 7b77#a72 and 7,,iii7 any documentation the ,director may require from the patentee or patent applicant 7as the case may be7 of the waiver of patent rights required under subsection 7b77#b74 7ii7 ,failure to provide sufficient documentation of waiver ,if the ,director determines that the sponsor has not complied with the waiver requirements under subsection 7c71 after providing the sponsor the opportunity to remedy any insufficiency1 the ,director shall so notify the ,secretary that the patent waiver requirements for designation have not been satisfied4 7,c7 ,extension of patents 7i7 ,in general ,unless the ,director has notified the ,secretary of a determination under subparagraph 7,b77ii71 for each patent identified in a submission pursuant to subparagraph 7,b77i71 and for each patent issuing based upon an application for patent so identified1 the ,director shall1 within the #c-month period beginning on the date of the submission1 extend the patent to expire at the end of the protection period for the dormant therapy1 if the patent would otherwise expire before the end of the protection period4 ,if the ,director has so notified the ,secretary under subparagraph 7,b77ii71 the ,director shall extend one such patent1 selected by the sponsor1 for the period that would have been applicable had an application for extension been filed under section #aef of title #ce1 ,united ,states ,code1 with respect to such patent4 7ii7 ,application of certain provisions ,during the period of an extension under clause 7i7-- 7,i7 the rights under the patent shall be limited in the manner provided under section #aef7;b7 of title #ce1 ,united ,states ,code2 and 7,,ii7 the terms product and approved product in such section #aef7;b7 shall be deemed to include forms of the active moiety of the dormant therapy and highly similar active moieties that might be approved by the ,secretary based upon an application filed under section #eje7;b77#b7 or #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b71 7j77 or under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 that references or otherwise relies upon the dormant therapy4 7,d7 ,interim patent extensions ,notwithstanding any provision of title #ce1 ,united ,states ,code1 with respect to any patent listed 7or patent issuing on an application listed7 under subsection 7b77#a7 that would otherwise expire before the sponsor could make a submission under subparagraph 7,b71 the ,director1 upon application of the patentee1 shall grant to the patentee an interim extension of such patent1 subject to the limitations in section #aef7;d77#e77;,f7 of such title #ce1 for such period as may be necessary to permit the sponsor to submit the listing under subparagraph 7,b7 and1 if the patent is therein listed1 to extend the patent as provided under subparagraph 7,c74 ,the ,director may require1 for any patent extended under this subparagraph1 that the sponsor of the dormant therapy to which the patent relates provide periodic certifications that development of the dormant therapy is continuing4 ,the ,director may terminate any interim extension for which a required certification has not been made4 7,e7 ,notice of extension ,for each patent that is extended under this paragraph1 the ,director shall publish a notice of such extension and issue a certificate of extension described in section #aef7;e77#a7 of title #ce1 ,united ,states ,code4 7,f7 ,notice of waiver ,for each patent identified in a submission under subparagraph 7,b77i71 and each patent issuing based upon an application for patent so identified1 that expires after the end of the protection period for the dormant therapy1 the ,director shall publish a notice that the patent is subject to the limited waiver of the right to enforce described in subsection 7c77#a74 7f7 ,certain ,,fda protections inapplicable ,if a medicine has been designated as a dormant therapy under subsection 7a71 the protections otherwise applicable with respect to such medicine under sections #eje;,a1 #eje;,e1 and #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;f1 #cfj;cc7 shall not apply4 ,the preceding sentence shall not be construed to affect any protections applicable with respect to a drug1 including a drug designated under section #ebf of such ,act 7#ba ,u4,s4,c4 #cfj;bb7 for a rare disease or condition1 under provisions other than such sections #eje;,a1 #eje;,e1 and #ebg4 7g7 ,development certifications 7#a7 ,in general ,the ,secretary shall require that the sponsor of a dormant therapy provide periodic certifications that development of the dormant therapy to address one or more unmet medical needs is continuing4 7#b7 ,determination of noncompliance ,if the ,secretary concludes that the sponsor has not complied with paragraph 7#a71 after providing the sponsor the opportunity to remedy any insufficiency1 the ,secretary shall1 for purposes of subsection 7d77#a71 determine that the sponsor is not in compliance with the certification requirement under paragraph 7#a74 7h7 ,collaboration ,nothing in this section shall be construed as preventing a sponsor from collaborating with other entities in developing a dormant therapy or applying for a dormant therapy designation4 7i7 ,definitions ,for purposes of this section3 7#a7 ,the term address one or more unmet medical needs refers to-- 7,a7 addressing a need for medicines for the treatment of one or more life-threatening or other serious diseases or conditions for which no therapy exists2 or 7,b7 if one or more therapies are available for the treatment of such a disease or condition1 demonstrating through clinical investigations-- 7i7 one or more improved effects on serious outcomes of the disease or condition that are affected by alternative therapies1 such as superiority of the medicine used alone or in combination with other therapies in an active controlled trial assessing an endpoint reflecting serious morbidity2 7ii7 one or more effects on serious outcomes of the disease or condition not known to be affected by alternative therapies1 such as progressive disability in multiple sclerosis when alternative therapies have shown an effect on exacerbations but have not shown an effect on progressive disability2 7iii7 an ability-- 7,i7 to provide one or more benefits in patients who are unable to tolerate or are unresponsive to alternative therapies1 such as an antipsychotic agent that is effective in people failing standard therapy2 or 7,,ii7 to be used effectively in combination with other critical agents that cannot be combined with alternative therapies2 7iv7 an ability to provide one or more benefits similar to those of alternative therapies while-- 7,i7 avoiding serious toxicity that is present in alternative therapies2 or 7,,ii7 avoiding less serious toxicity that is common in alternative therapies and causes discontinuation of treatment of a life-threatening or serious disease2 or 7v7 an ability to provide one or more benefits similar to those of alternative therapies but with improvement in some factor1 such as compliance or convenience1 that is shown to lead to improved effects on serious outcomes4 7#b7 ,the term ,director means the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office4 7#c7 ,the term dormant therapy means a medicine designated as a dormant therapy under subsection 7a74 7#d7 ,the term protection period for a dormant therapy means the period that-- 7,a7 begins on the date on which the ,secretary first approves 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;a77 for the dormant therapy for any indication2 and 7,b7 ends on the date that is #ae years after the date of such approval4 7#e7 ,the term sponsor for a dormant therapy is the person who takes responsibility for the designation and development of the dormant therapy4 ,the sponsor may be a single entity or an entity collaborating with one or more other entities4 #bjb4 ,study regarding new indications for existing therapies ,not later than one year after the date of the enactment of this ,act1 the ,secretary shall enter into an arrangement with the ,institute of ,medicine 7or1 if the ,institute declines1 another appropriate entity7-- 7#a7 to conduct a study on intellectual property laws and their impact on therapy and diagnostic development in order to formulate recommendations on how to facilitate the clinical evaluation and development of therapies currently available on the market for new potential indications2 and 7#b7 not later than #ah months after such date of the enactment1 to submit a report to the ,secretary and the ,congress containing the results of such study4