```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 440 Reported in Senate (RS)]

<DOC>

                                                       Calendar No. 129
116th CONGRESS
  1st Session
                                 S. 440

 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.

_______________________________________________________________________

                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Preserving Access to Cost 
Effective Drugs Act'' or the ``PACED Act''.</DELETED>

<DELETED>SEC. 2. ABROGATION OF SOVEREIGN IMMUNITY.</DELETED>

<DELETED>    (a) In General.--Title 35, United States Code, is 
amended--</DELETED>
        <DELETED>    (1) in section 135, by adding at the end the 
        following:</DELETED>
<DELETED>    ``(g) Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `foreign state' has the 
                meaning given the term in section 1603(a) of title 28; 
                and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) a derivation proceeding instituted 
                under subsection (a); or</DELETED>
                <DELETED>    ``(B) a review by a court of the United 
                States with respect to a decision reached in a 
                proceeding described in subparagraph (A).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Limitation.--This subsection shall apply 
        only to the extent permitted under the 11th amendment to the 
        Constitution of the United States.'';</DELETED>
        <DELETED>    (2) in section 296--</DELETED>
                <DELETED>    (A) in the section heading, by striking 
                ``and State officials'' and inserting ``, State 
                officials, and Indian tribes''; and</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
<DELETED>    ``(c) Abrogation of Tribal Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `covered claim' means any 
                claim, counterclaim, or third-party claim that arises 
                under--</DELETED>
                        <DELETED>    ``(i) this title relating to 
                        infringement of a patent; or</DELETED>
                        <DELETED>    ``(ii) section 351 of the Public 
                        Health Service Act (42 U.S.C. 262); 
                        and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (3) in section 305--</DELETED>
                <DELETED>    (A) in the first sentence, by striking 
                ``After the'' and inserting the following:</DELETED>
<DELETED>    ``(a) In General.--After the''; and</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
<DELETED>    ``(b) Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `foreign state' has the 
                meaning given the term in section 1603(a) of title 28; 
                and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) any reexamination proceeding under 
                this section, including any appeal to the Patent Trial 
                and Appeal Board; or</DELETED>
                <DELETED>    ``(B) a review by a court of the United 
                States with respect to a decision reached in a 
                proceeding described in subparagraph (A).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Limitation.--This subsection shall apply 
        only to the extent permitted under the 11th amendment to the 
        Constitution of the United States.'';</DELETED>
        <DELETED>    (4) in section 316, by adding at the end the 
        following:</DELETED>
<DELETED>    ``(f) Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `foreign state' has the 
                meaning given the term in section 1603(a) of title 28; 
                and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) an inter partes review instituted 
                under this chapter; or</DELETED>
                <DELETED>    ``(B) a review by a court of the United 
                States with respect to a decision reached in a 
                proceeding described in subparagraph (A).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Limitation.--This subsection shall apply 
        only to the extent permitted under the 11th amendment to the 
        Constitution of the United States.''; and</DELETED>
        <DELETED>    (5) in section 326, by adding at the end the 
        following:</DELETED>
<DELETED>    ``(f) Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `foreign state' has the 
                meaning given the term in section 1603(a) of title 28; 
                and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) a post-grant review instituted under 
                this chapter; or</DELETED>
                <DELETED>    ``(B) a review by a court of the United 
                States with respect to a decision reached in a 
                proceeding described in subparagraph (A).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Limitation.--This subsection shall apply 
        only to the extent permitted under the 11th amendment to the 
        Constitution of the United States.''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(o) Abrogation of Tribal Sovereign Immunity.--</DELETED>
        <DELETED>    ``(1) Definitions.--In this subsection--</DELETED>
                <DELETED>    ``(A) the term `covered person'--
                </DELETED>
                        <DELETED>    ``(i) means a person; 
                        and</DELETED>
                        <DELETED>    ``(ii) includes--</DELETED>
                                <DELETED>    ``(I) an Indian tribe; 
                                and</DELETED>
                                <DELETED>    ``(II) any other person 
                                that claims immunity on account of the 
                                sovereign status of an Indian tribe; 
                                and</DELETED>
                <DELETED>    ``(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)).</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``296. Liability of States, instrumentalities of States, State 
                            officials, and Indian tribes for 
                            infringement of patents.''.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preserving Access to Cost Effective 
Drugs Act'' or the ``PACED Act''.

SEC. 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.''.
                                                       Calendar No. 129

116th CONGRESS

  1st Session

                                 S. 440

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                June 28 (legislative day, June 27), 2019

                       Reported with an amendment
```