,,ii #aahth ,,congress #ast ,session ,s4 #gi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #be1 #bjbc,mr4 ,durbin 7for himself1 ,mr4 ,tillis1 ,mr4 ,grassley1 and ,mr4 ,coons7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to amend title #ce1 ,united ,states ,code1 to establish an interagency task force between the ,united ,states ,patent and ,trademark ,office and the ,food and ,drug ,administration for purposes of sharing information and providing technical assistance with respect to patents1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the 8,interagency ,patent ,coordination and ,improvement ,act of #bjbc04 #b4 ,findings ,congress finds the following3 7#a7 ,decisions by the ,united ,states ,patent and ,trademark ,office relating to patents may implicate1 or have relevance to1 information housed at or involving other ,federal agencies4 7#b7 ,entities submitting patent applications to the ,united ,states ,patent and ,trademark ,office may also submit information to1 or share information with1 other ,federal agencies1 necessitating accuracy and consistency in those representations4 7#c7 ,research has shown that patent examiners may benefit from additional information that is housed at1 or is available to1 ,federal agencies other than the ,united ,states ,patent and ,trademark ,office in order to assess prior art and the state of science and technology4 7#d7 ,the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office is encouraged to work with other ,federal agencies4 #c4 ,report by ,united ,states ,patent and ,trademark ,office ,not later than #d years after the date of enactment of this ,act1 the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office shall submit to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives a report that contains-- 7#a7 a description of the frequency with which-- 7,a7 information is provided by the ,food and ,drug ,administration to the ,united ,states ,patent and ,trademark ,office through the ,interagency ,task ,force on ,patents established under section #ae of title #ce1 ,united ,states ,code1 as added by section #d7;a7 of this ,act1 or under processes established by that ,task ,force2 and 7,b7 the information described in subparagraph 7,a7 is used in patent examinations2 7#b7 an identification of which methods of providing information1 as described in paragraph 7#a77;,a71 and types of information so shared1 are most useful to patent examiners2 7#c7 any recommendations for changes to be made by ,congress to the mandate1 funding1 or operations of the ,task ,force described in paragraph 7#a77;,a72 and 7#d7 an identification of other ,federal agencies with which the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office should explore opportunities for coordination that are similar to those undertaken with the ,food and ,drug ,administration through the activities of the ,task ,force described in paragraph 7#a77;,a74 #d4 ,interagency ,task ,force on ,patents 7a7 ,in general ,chapter #a of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in section #b7;c71 by adding at the end the following3 7#f7 7,a7 ,in exercising the ,director's powers and duties under this section relating to patents1 and decisions or actions involving patents1 for human drugs and biological products1 the ,director shall1 through the ,interagency ,task ,force on ,patents established under section #ae1 consult with the ,commissioner of ,food and ,drugs in the manner described in that section4 7,b7 ,for purposes of subparagraph 7,a71 the term decisions or actions involving patents means decisions or actions taken with respect to patents under this title4 2 and 7#b7 by adding at the end the following3 #ae4 ,interagency ,task ,force on ,patents 7a7 ,establishment ,there is established an interagency task force1 to be known as the ,interagency ,task ,force on ,patents 7referred to in this section as the task force71 to coordinate efforts between the ,director and the ,commissioner of ,food and ,drugs 7referred to in this section as the ,commissioner7 regarding communication about1 evaluation of1 and effective implementation of the activities of the ,office and the ,food and ,drug ,administration with respect to patents1 and decisions or actions involving patents 7as defined in section #b7;c77#f77;,b771 for human drugs and biological products4 7b7 ,memorandum of understanding ,the ,director and the ,commissioner shall enter into a memorandum of understanding1 or update an existing memorandum of understanding1 for the purposes of implementing and carrying out the duties of the task force4 7c7 ,membership ,the task force shall be comprised of employees of the ,office1 who shall be appointed by the ,director1 and employees of the ,food and ,drug ,administration1 who shall be appointed by the ,commissioner1 who have appropriate expertise and decision-making authority regarding operational1 administrative1 technical1 medical1 pharmacological1 clinical1 and scientific matters to carry out the functions of the task force4 7d7 ,activities ,the task force shall carry out the following functions regarding interagency coordination to promote reciprocal access of information3 7#a7 ,sharing information on the general processes of the ,office and the ,food and ,drug ,administration1 what each such agency considers in its respective review of applications1 and how each such agency evaluates those applications1 which may be undertaken through routine and ongoing meetings1 workshops1 and training sessions4 7#b7 ,sharing information on new approvals of patents1 human drugs and biological products1 new technologies and prior art 7as appropriate on a case-by-case basis71 and scientific trends and developments4 7#c7 ,establishing a process that requires-- 7,a7 the ,director to request from the ,commissioner 7and the ,commissioner to provide to the ,director1 upon receiving such a request7-- 7i7 appropriate information for use by employees of the ,office with responsibility to examine patent applications under section #aca 7referred to in this section as patent examiners7 regarding when certain information relating to a human drug or biological product approval1 which may include updates to a label or newly approved indications1 is made publicly available1 including when such information is posted online2 and 7ii7 appropriate access for patent examiners to relevant sources of product application1 approval1 patent1 and labeling information or communications between the ,food and ,drug ,administration and the human drug or biological product sponsors that may not currently be subject to public disclosure1 as appropriate and only to the extent necessary for the ,office to carry out the responsibilities of the ,office1 such as ensuring accurate representations and access to information on whether the claimed invention that would be the subject of the patent was on sale before the effective filing date of the claimed invention1 as described in section #ajb7;a77#a72 and 7,b7 the ,office to assist the ,food and ,drug ,administration in its ministerial role of listing patents4 7#d7 ,establishing a process to ensure that1 in appropriate circumstances1 at the request of the ,director1 the ,commissioner shall consult with or otherwise furnish specific1 available information to the ,office with respect to certain applications1 responses1 or affidavits after rejections in order to assist patent examiners in carrying out the duties of those patent examiners4 7e7 ,rule of construction ,nothing in subsection 7d77#c77;,b7 shall be construed as-- 7#a7 directing the ,office to interfere with1 delay1 or supersede the ministerial function of the ,food and ,drug ,administration of listing patents2 7#b7 indicating the position of the ,office regarding the ability to assert a patent in infringement litigation2 or 7#c7 changing the ministerial function of the ,food and ,drug ,administration of listing patents4 7f7 ,confidentiality 7#a7 ,in general ,with respect to any record or other information of the ,food and ,drug ,administration or the ,office that is confidential1 either such agency may share any such information with the other agency in furtherance of the activities described in this section1 which shall remain subject to such protections as if the information were held by the ,food and ,drug ,administration4 7#b7 ,protocols 7,a7 ,in general ,the task force shall establish appropriate protocols to safeguard confidentiality and prevent the inappropriate disclosure of information when sharing information between the ,office and the ,food and ,drug ,administration4 7,b7 ,contents ,the protocols established under subparagraph 7,a7 shall provide that-- 7i7 before sharing any information described in paragraph 7#a71 the sponsor of the human drug or biological product to which that information relates shall be provided notice of that sharing by the applicable agency and with a period of #cj days to consult with the agency sharing that information2 and 7ii7 the ,director shall1 in order to protect against the inadvertent disclosure of information1 maintain any information shared with the ,director by the ,commissioner separate from pending patent applications and establish procedures for the identification of confidential information4 7,c7 ,potential remedies ,in establishing protocols under this paragraph1 the task force shall identify appropriate remedies for any potential injury suffered when confidential information is made available1 including inadvertently1 through the sharing of information described in this subsection4 7#c7 ,rule of construction ,nothing in this subsection may be construed as superseding any other remedy available for the unauthorized disclosure of confidential information4 4 7b7 ,technical and conforming amendment ,the table of sections for chapter #a of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 #ae4 ,interagency ,task ,force on ,patents4 4