,,ii #aacth ,,congress #b;d ,session ,s4 #cjjd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #aa1 #bjad ,mr4 ,hatch 7for himself and ,mr4 ,bennet7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to promote the development of meaningful treatments for patients4 #a4 ,short title ,this ,act may be cited as the ,dormant ,therapies ,act of #bjad4 #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 ,definitions4 ,sec4 #d4 ,capturing lost opportunities and creating new cures for patients4 ,sec4 #e4 ,implementation and effect4 #c4 ,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 ,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 section #d7;a74 7#d7 ,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#e7 ,the term medicine means a biological product or a drug4 7#f7 ,the term protection period1 with respect to a dormant therapy1 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#g7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#h7 ,the term sponsor1 with respect to a dormant therapy1 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 #d4 ,capturing lost opportunities and creating new cures for patients 7a7 ,designation as a 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submits a request for such designation meeting the requirements under subsection 7b71 and the request has not been withdrawn under subsection 7d77#a72 and 7#b7 the ,secretary determines that-- 7,a7 the medicine is being investigated or is intended to be investigated for an indication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 at the time the request for designation is made1 the medicine for which designation is being requested contains1 in the case of a drug an active moiety that is not the same as1 and in the case of a biological product an active moiety that is not highly similar to1 an active moiety in a medicine for which an 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 has been submitted4 7b7 ,requirements for request for designation as dormant therapy ,a request under subsection 7a77#a7 with respect to a medicine may be made only by the sponsor of the medicine and shall contain each of the following3 7#a7 ,a listing of all ,united ,states 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 or licensure 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 subsection 7c77#a7 or 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 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 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 licensure of a medicine that is not the dormant therapy1 was licensed subsequent to the 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 qualifying medicine 7or if the qualifying medicine 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 qualifying medicine 7or if the qualifying medicine contains more than one active moiety1 all of the active moieties are highly similar71 unless 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 qualifying medicine 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;a774 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 or licensure 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 or licensed 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 medicine1 including a medicine 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 a certification that the clinical plan under subsection 7a77#b77;,b7 has been completed1 and1 that the initial marketing approval or licensure for the qualifying medicine was based on the investigations set forth in such clinical plan 7including modifications to the initial plan approved by the ,food and ,drug ,administration74 ,prior to receiving such certifications1 the ,secretary shall require periodic certifications that the clinical plan under subsection 7a77#b77;,b7 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 #e4 ,implementation and effect 7a7 ,effective date ,subject to the provisions of this section1 this ,act shall take effect on the date of enactment4 7b7 ,implementing regulations ,the ,secretary1 in consultation with the ,secretary of ,commerce1 shall promulgate such regulations and finalize such guidance as necessary to implement the provisions of section #d4 ,such regulations or guidance shall take effect #ah months after the date of enactment of this ,act4 7c7 ,limitation on determinations and designations ,notwithstanding any provision of section #d1 the ,secretary may not make a determination on a request for designation by a manufacturer or sponsor under section #d7;a7 prior to the effective date of the regulations under subsection 7b7 or #cj months after the date of enactment of this ,act1 whichever occurs first1 and the ,secretary may not designate a medicine under section #d7;a7 unless the requirement under section #d7;a77#b77;,d7 is met for such medicine as of the effective date of the regulations under subsection 7b7 or #cj months after the date of enactment of this ,act1 whichever occurs first4