Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 3991 To amend title 35, United States Code, to clarify and improve the process for subsection (k) applicants to resolve patent infringement claims for biological products (commonly known as the ‘‘patent dance’’), and for other purposes. IN THE HOUSE OF REPRESENTATIVES JULY 25, 2019 Mr. JOHNSON of Georgia (for himself and Mrs. ROBY) introduced the following bill; which was referred to the Committee on the Judiciary A BILL To amend title 35, United States Code, to clarify and im- prove the process for subsection (k) applicants to resolve patent infringement claims for biological products (com- monly known as the ‘‘patent dance’’), and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Affordable Prescrip- 4 tions for Patients Through Improvements to Patent Liti- 5 gation Act of 2019’’. 6 VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS 2 •HR 3991 IH SEC. 2. TITLE 35 AMENDMENTS. 1 (a) IN GENERAL.—Section 271(e) of title 35, United 2 States Code, is amended— 3 (1) in paragraph (2)(C), in the flush text fol- 4 lowing clause (ii), by adding at the end the fol- 5 lowing: ‘‘With respect to a submission described in 6 clause (ii), the act of infringement shall extend to 7 any patent that claims the biological product, a 8 method of using the biological product, or a method 9 or product used to manufacture the biological prod- 10 uct.’’; and 11 (2) by adding at the end the following: 12 ‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 13 if the sponsor of an approved application for a reference 14 product, as defined in section 351(i) of the Public Health 15 Service Act (42 U.S.C. 262(i)) (referred to in this para- 16 graph as the ‘reference product sponsor’), brings an action 17 for infringement under this section against an applicant 18 for approval of a biological product under section 351(k) 19 of such Act that references that reference product (re- 20 ferred to in this paragraph as the ‘subsection (k) appli- 21 cant’), the reference product sponsor may assert in the 22 action a total of not more than 20 patents of the type 23 described in subparagraph (B), not more than 10 of which 24 shall have issued after the date specified in section 25 351(l)(7)(A) of such Act. 26 VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS 3 •HR 3991 IH ‘‘(B) The patents described in this subparagraph are 1 patents that satisfy each of the following requirements: 2 ‘‘(i) Patents that claim the biological product 3 that is the subject of an application under section 4 351(k) of the Public Health Service Act (42 U.S.C. 5 262(k)) (or a use of that product) or a method or 6 product used in the manufacture of such biological 7 product. 8 ‘‘(ii) Patents that are included on the list of 9 patents described in section 351(l)(3)(A) of the Pub- 10 lic Health Service Act (42 U.S.C. 262(l)(3)(A)), in- 11 cluding as provided under section 351(l)(7) of such 12 Act. 13 ‘‘(iii) Patents that— 14 ‘‘(I) have an actual filing date of more 15 than 4 years after the date on which the ref- 16 erence product is approved; or 17 ‘‘(II) include a claim to a method in a 18 manufacturing process that is not used by the 19 reference product sponsor. 20 ‘‘(C) The court in which an action described in sub- 21 paragraph (A) is brought may increase the number of pat- 22 ents limited under that subparagraph— 23 ‘‘(i) if the request to increase that number is 24 made without undue delay; and 25 VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS 4 •HR 3991 IH ‘‘(ii)(I) if the interest of justice so requires; or 1 ‘‘(II) for good cause shown, which— 2 ‘‘(aa) shall be established if the subsection 3 (k) applicant fails to provide information re- 4 quired under paragraph (2)(A) that would en- 5 able the reference product sponsor to form a 6 reasonable belief with respect to whether a 7 claim of infringement under this section could 8 reasonably be asserted; and 9 ‘‘(bb) may be established— 10 ‘‘(AA) if there is a material change to 11 the biological product (or process with re- 12 spect to the biological product) of the sub- 13 section (k) applicant that is the subject of 14 the application; 15 ‘‘(BB) if, with respect to a patent on 16 the supplemental list described in section 17 351(l)(7)(A) of Public Health Service Act 18 (42 U.S.C. 262(l)(7)(A)), the patent would 19 have issued before the date specified in 20 such section 351(l)(7)(A) but for the fail- 21 ure of the Office to issue the patent or a 22 delay in the issuance of the patent, as de- 23 scribed in paragraph (1) of section 154(b) 24 VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS 5 •HR 3991 IH and subject to the limitations under para- 1 graph (2) of such section 154(b); or 2 ‘‘(CC) for another reason that shows 3 good cause, as determined appropriate by 4 the court. 5 ‘‘(D) In determining whether good cause has been 6 shown for the purposes of subparagraph (C)(ii)(II), a 7 court may consider whether the reference product sponsor 8 has provided a reasonable description of the identity and 9 relevance of any information beyond the subsection (k) ap- 10 plication that the court believes is necessary to enable the 11 court to form a belief with respect to whether a claim of 12 infringement under this section could reasonably be as- 13 serted. 14 ‘‘(E) The limitation imposed under subparagraph 15 (A)— 16 ‘‘(i) shall apply only if the subsection (k) appli- 17 cant completes all actions required under paragraphs 18 (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 19 section 351(l) of the Public Health Service Act (42 20 U.S.C. 262(l)); and 21 ‘‘(ii) shall not apply with respect to any patent 22 that claims, with respect to a biological product, a 23 method for using that product in therapy, diagnosis, 24 VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS 6 •HR 3991 IH or prophylaxis, such as an indication or method of 1 treatment or other condition of use.’’. 2 (b) APPLICABILITY.—The amendments made by sub- 3 section (a) shall apply with respect to an application sub- 4 mitted under section 351(k) of the Public Health Service 5 Act (42 U.S.C. 262(k)) on or after the date of enactment 6 of this Act. 7 Æ VerDate Sep 11 2014 00:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H3991.IH H3991 kjohnson on DSK79L0C42 with BILLS