II Calendar No. 129 116th CONGRESS 1st Session S. 440 IN THE SENATE OF THE UNITED STATES February 12, 2019 Mr. Cotton (for himself, Ms. Ernst , and Mr. Toomey ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary June 28 (legislative day, June 27), 2019 Reported by Mr. Graham , with an amendment Strike out all after the enacting clause and insert the part printed in italic A BILL To amend title 35, United States Code, to provide that a patent owner may not assert sovereign immunity as a defense in certain actions before the United States Patent and Trademark Office, and for other purposes.

1. Short title This Act may be cited as the Preserving Access to Cost Effective Drugs Act or the PACED Act . 2. Abrogation of sovereign immunity (a) In general Title 35, United States Code, is amended— (1) in section 135, by adding at the end the following: (g) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) a derivation proceeding instituted under subsection (a); or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any proceeding described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States. ; (2) in section 296— (A) in the section heading, by striking and State officials and inserting , State officials, and Indian tribes ; and (B) by adding at the end the following: (c) Abrogation of tribal sovereign immunity (1) Definitions In this subsection— (A) the term covered claim means any claim, counterclaim, or third-party claim that arises under— (i) this title relating to infringement of a patent; or (ii) section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation In any action that involves a covered claim that is otherwise within the jurisdiction of a court of the United States, an Indian tribe may not assert sovereign immunity as a defense. ; (3) in section 305— (A) in the first sentence, by striking After the and inserting the following: (a) In general After the ; and (B) by adding at the end the following: (b) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) any reexamination proceeding under this section, including any appeal to the Patent Trial and Appeal Board; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any proceeding described in paragraph (2)(A), the Office or the Patent Trial and Appeal Board, as applicable, shall determine whether the patent owner is immune from the jurisdiction of the Office or the Patent Trial and Appeal Board, as applicable, in accordance with chapter 97 of title 28 as if the Office or the Patent Trial and Appeal Board, as applicable, were a court of the United States. (4) Limitation This subsection shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States. ; (4) in section 316, by adding at the end the following: (f) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) an inter partes review instituted under this chapter; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any review described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States. ; and (5) in section 326, by adding at the end the following: (f) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) a post-grant review instituted under this chapter; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any review described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States. . (b) Amendments to the Tariff Act of 1930 Section 337 of the Tariff Act of 1930 ( 19 U.S.C. 1337 ) is amended by adding at the end the following: (o) Abrogation of tribal sovereign immunity (1) Definitions In this subsection— (A) the term covered person — (i) means a person; and (ii) includes— (I) an Indian tribe; and (II) any other person that claims immunity on account of the sovereign status of an Indian tribe; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation In any proceeding under this section, no covered person may assert as a defense the sovereign immunity that is accorded to an Indian tribe. . (c) Technical and conforming amendment The table of sections for chapter 29 of title 35, United States Code, is amended by striking the item relating to section 296 and inserting the following: 296. Liability of States, instrumentalities of States, State officials, and Indian tribes for infringement of patents. .

1. Short title This Act may be cited as the Preserving Access to Cost Effective Drugs Act or the PACED Act . 2. Abrogation of sovereign immunity (a) In general Title 35, United States Code, is amended— (1) in section 135, by adding at the end the following: (g) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) a derivation proceeding instituted under subsection (a); or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any proceeding described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection— (A) shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States; and (B) shall not apply with respect to— (i) any State of the United States; or (ii) any institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ), that is a public institution in a State of the United States. ; (2) in section 296— (A) in the section heading, by striking and State officials and inserting , State officials, and Indian tribes ; and (B) by adding at the end the following: (c) Abrogation of tribal sovereign immunity (1) Definitions In this subsection— (A) the term covered claim means any claim, counterclaim, or third-party claim that arises under— (i) this title relating to infringement of a patent; or (ii) section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation In any action that involves a covered claim that is otherwise within the jurisdiction of a court of the United States, an Indian tribe may not assert sovereign immunity as a defense. ; (3) in section 305— (A) in the first sentence, by striking After the and inserting the following: (a) In general After the ; and (B) by adding at the end the following: (b) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) any reexamination proceeding under this section, including any appeal to the Patent Trial and Appeal Board; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any proceeding described in paragraph (2)(A), the Office or the Patent Trial and Appeal Board, as applicable, shall determine whether the patent owner is immune from the jurisdiction of the Office or the Patent Trial and Appeal Board, as applicable, in accordance with chapter 97 of title 28 as if the Office or the Patent Trial and Appeal Board, as applicable, were a court of the United States. (4) Limitation This subsection— (A) shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States; and (B) shall not apply with respect to— (i) any State of the United States; or (ii) any institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ), that is a public institution in a State of the United States. ; (4) in section 316, by adding at the end the following: (f) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) an inter partes review instituted under this chapter; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any review described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection— (A) shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States; and (B) shall not apply with respect to— (i) any State of the United States; or (ii) any institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ), that is a public institution in a State of the United States. ; and (5) in section 326, by adding at the end the following: (f) Sovereign immunity (1) Definitions In this subsection— (A) the term foreign state has the meaning given the term in section 1603(a) of title 28; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation of sovereign immunity Except as provided in paragraph (3), and subject to paragraph (4), a patent owner may not assert sovereign immunity, including the sovereign immunity accorded to an Indian tribe, as a defense in— (A) a post-grant review instituted under this chapter; or (B) a review by a court of the United States with respect to a decision reached in a proceeding described in subparagraph (A). (3) Immunity of foreign states If a patent owner is a foreign state, for the purposes of any review described in paragraph (2)(A), the Patent Trial and Appeal Board shall determine whether the patent owner is immune from the jurisdiction of the Patent Trial and Appeal Board, in accordance with chapter 97 of title 28 as if the Patent Trial and Appeal Board were a court of the United States. (4) Limitation This subsection— (A) shall apply only to the extent permitted under the 11th amendment to the Constitution of the United States; and (B) shall not apply with respect to— (i) any State of the United States; or (ii) any institution of higher education, as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ), that is a public institution in a State of the United States. . (b) Amendments to the Tariff Act of 1930 Section 337 of the Tariff Act of 1930 ( 19 U.S.C. 1337 ) is amended by adding at the end the following: (o) Abrogation of tribal sovereign immunity (1) Definitions In this subsection— (A) the term covered person — (i) means a person; and (ii) includes— (I) an Indian tribe; and (II) any other person that claims immunity on account of the sovereign status of an Indian tribe; and (B) the term Indian tribe has the meaning given the term in section 4(e) of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304(e) ). (2) Abrogation In any proceeding under this section, no covered person may assert as a defense the sovereign immunity that is accorded to an Indian tribe. . (c) Technical and conforming amendment The table of sections for chapter 29 of title 35, United States Code, is amended by striking the item relating to section 296 and inserting the following: 296. Liability of States, instrumentalities of States, State officials, and Indian tribes for infringement of patents. .

June 28 (legislative day, June 27), 2019 Reported with an amendment