II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Preserving Access to 

3 Cost Effective Drugs Act’’ or the ‘‘PACED Act’’. 

4 SEC. 2. ABROGATION OF SOVEREIGN IMMUNITY. 

5 (a) IN GENERAL.—Title 35, United States Code, is 

6 amended— 

7 (1) in section 135, by adding at the end the fol8 lowing: 

9 ‘‘(g) SOVEREIGN IMMUNITY.— 

10 ‘‘(1) DEFINITIONS.—In this subsection— 

11 ‘‘(A) the term ‘foreign state’ has the mean12 ing given the term in section 1603(a) of title 

13 28; and 

14 ‘‘(B) the term ‘Indian tribe’ has the mean15 ing given the term in section 4(e) of the Indian 

16 Self-Determination and Education Assistance 

17 Act (25 U.S.C. 5304(e)). 

18 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

19 Except as provided in paragraph (3), and subject to 

20 paragraph (4), a patent owner may not assert sov21 ereign immunity, including the sovereign immunity 

22 accorded to an Indian tribe, as a defense in— 

23 ‘‘(A) a derivation proceeding instituted 

24 under subsection (a); or 


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1 ‘‘(B) a review by a court of the United 

2 States with respect to a decision reached in a 

3 proceeding described in subparagraph (A). 

4 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat5 ent owner is a foreign state, for the purposes of any 

6 proceeding described in paragraph (2)(A), the Pat7 ent Trial and Appeal Board shall determine whether 

8 the patent owner is immune from the jurisdiction of 

9 the Patent Trial and Appeal Board, in accordance 

10 with chapter 97 of title 28 as if the Patent Trial and 

11 Appeal Board were a court of the United States. 

12 ‘‘(4) LIMITATION.—This subsection shall apply 

13 only to the extent permitted under the 11th amend14 ment to the Constitution of the United States.’’; 

15 (2) in section 296— 

16 (A) in the section heading, by striking 

17 ‘‘and State officials’’ and inserting ‘‘, 

18 State officials, and Indian tribes’’; and 

19 (B) by adding at the end the following: 

20 ‘‘(c) ABROGATION OF TRIBAL SOVEREIGN IMMU21 NITY.— 

22 ‘‘(1) DEFINITIONS.—In this subsection— 

23 ‘‘(A) the term ‘covered claim’ means any 

24 claim, counterclaim, or third-party claim that 

25 arises under— 


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1 ‘‘(i) this title relating to infringement 

2 of a patent; or 

3 ‘‘(ii) section 351 of the Public Health 

4 Service Act (42 U.S.C. 262); and 

5 ‘‘(B) the term ‘Indian tribe’ has the mean6 ing given the term in section 4(e) of the Indian 

7 Self-Determination and Education Assistance 

8 Act (25 U.S.C. 5304(e)). 

9 ‘‘(2) ABROGATION.—In any action that involves 

10 a covered claim that is otherwise within the jurisdic11 tion of a court of the United States, an Indian tribe 

12 may not assert sovereign immunity as a defense.’’; 

13 (3) in section 305— 

14 (A) in the first sentence, by striking ‘‘After 

15 the’’ and inserting the following: 

16 ‘‘(a) IN GENERAL.—After the’’; and 

17 (B) by adding at the end the following: 

18 ‘‘(b) SOVEREIGN IMMUNITY.— 

19 ‘‘(1) DEFINITIONS.—In this subsection— 

20 ‘‘(A) the term ‘foreign state’ has the mean21 ing given the term in section 1603(a) of title 

22 28; and 

23 ‘‘(B) the term ‘Indian tribe’ has the mean24 ing given the term in section 4(e) of the Indian 


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•S 440 RS

1 Self-Determination and Education Assistance 

2 Act (25 U.S.C. 5304(e)). 

3 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

4 Except as provided in paragraph (3), and subject to 

5 paragraph (4), a patent owner may not assert sov6 ereign immunity, including the sovereign immunity 

7 accorded to an Indian tribe, as a defense in— 

8 ‘‘(A) any reexamination proceeding under 

9 this section, including any appeal to the Patent 

10 Trial and Appeal Board; or 

11 ‘‘(B) a review by a court of the United 

12 States with respect to a decision reached in a 

13 proceeding described in subparagraph (A). 

14 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat15 ent owner is a foreign state, for the purposes of any 

16 proceeding described in paragraph (2)(A), the Office 

17 or the Patent Trial and Appeal Board, as applicable, 

18 shall determine whether the patent owner is immune 

19 from the jurisdiction of the Office or the Patent 

20 Trial and Appeal Board, as applicable, in accordance 

21 with chapter 97 of title 28 as if the Office or the 

22 Patent Trial and Appeal Board, as applicable, were 

23 a court of the United States. 


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1 ‘‘(4) LIMITATION.—This subsection shall apply 

2 only to the extent permitted under the 11th amend3 ment to the Constitution of the United States.’’; 

4 (4) in section 316, by adding at the end the fol5 lowing: 

6 ‘‘(f) SOVEREIGN IMMUNITY.— 

7 ‘‘(1) DEFINITIONS.—In this subsection— 

8 ‘‘(A) the term ‘foreign state’ has the mean9 ing given the term in section 1603(a) of title 

10 28; and 

11 ‘‘(B) the term ‘Indian tribe’ has the mean12 ing given the term in section 4(e) of the Indian 

13 Self-Determination and Education Assistance 

14 Act (25 U.S.C. 5304(e)). 

15 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

16 Except as provided in paragraph (3), and subject to 

17 paragraph (4), a patent owner may not assert sov18 ereign immunity, including the sovereign immunity 

19 accorded to an Indian tribe, as a defense in— 

20 ‘‘(A) an inter partes review instituted 

21 under this chapter; or 

22 ‘‘(B) a review by a court of the United 

23 States with respect to a decision reached in a 

24 proceeding described in subparagraph (A). 


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1 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat2 ent owner is a foreign state, for the purposes of any 

3 review described in paragraph (2)(A), the Patent 

4 Trial and Appeal Board shall determine whether the 

5 patent owner is immune from the jurisdiction of the 

6 Patent Trial and Appeal Board, in accordance with 

7 chapter 97 of title 28 as if the Patent Trial and Ap8 peal Board were a court of the United States. 

9 ‘‘(4) LIMITATION.—This subsection shall apply 

10 only to the extent permitted under the 11th amend11 ment to the Constitution of the United States.’’; and 

12 (5) in section 326, by adding at the end the fol13 lowing: 

14 ‘‘(f) SOVEREIGN IMMUNITY.— 

15 ‘‘(1) DEFINITIONS.—In this subsection— 

16 ‘‘(A) the term ‘foreign state’ has the mean17 ing given the term in section 1603(a) of title 

18 28; and 

19 ‘‘(B) the term ‘Indian tribe’ has the mean20 ing given the term in section 4(e) of the Indian 

21 Self-Determination and Education Assistance 

22 Act (25 U.S.C. 5304(e)). 

23 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

24 Except as provided in paragraph (3), and subject to 

25 paragraph (4), a patent owner may not assert sovVerDate Sep 11 2014 21:06 Jun 28, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S440.RS S440

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1 ereign immunity, including the sovereign immunity 

2 accorded to an Indian tribe, as a defense in— 

3 ‘‘(A) a post-grant review instituted under 

4 this chapter; or 

5 ‘‘(B) a review by a court of the United 

6 States with respect to a decision reached in a 

7 proceeding described in subparagraph (A). 

8 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat9 ent owner is a foreign state, for the purposes of any 

10 review described in paragraph (2)(A), the Patent 

11 Trial and Appeal Board shall determine whether the 

12 patent owner is immune from the jurisdiction of the 

13 Patent Trial and Appeal Board, in accordance with 

14 chapter 97 of title 28 as if the Patent Trial and Ap15 peal Board were a court of the United States. 

16 ‘‘(4) LIMITATION.—This subsection shall apply 

17 only to the extent permitted under the 11th amend18 ment to the Constitution of the United States.’’. 

19 (b) AMENDMENTS TO THE TARIFF ACT OF 1930.— 

20 Section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) 

21 is amended by adding at the end the following: 

22 ‘‘(o) ABROGATION OF TRIBAL SOVEREIGN IMMU23 NITY.— 

24 ‘‘(1) DEFINITIONS.—In this subsection— 

25 ‘‘(A) the term ‘covered person’— 


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1 ‘‘(i) means a person; and 

2 ‘‘(ii) includes— 

3 ‘‘(I) an Indian tribe; and 

4 ‘‘(II) any other person that 

5 claims immunity on account of the 

6 sovereign status of an Indian tribe; 

7 and 

8 ‘‘(B) the term ‘Indian tribe’ has the mean9 ing given the term in section 4(e) of the Indian 

10 Self-Determination and Education Assistance 

11 Act (25 U.S.C. 5304(e)). 

12 ‘‘(2) ABROGATION.—In any proceeding under 

13 this section, no covered person may assert as a de14 fense the sovereign immunity that is accorded to an 

15 Indian tribe.’’. 

16 (c) TECHNICAL AND CONFORMING AMENDMENT.— 

17 The table of sections for chapter 29 of title 35, United 

18 States Code, is amended by striking the item relating to 

19 section 296 and inserting the following: 

‘‘296. Liability of States, instrumentalities of States, State officials, and Indian 

tribes for infringement of patents.’’. 

20 SECTION 1. SHORT TITLE. 

21 This Act may be cited as the ‘‘Preserving Access to Cost 

22 Effective Drugs Act’’ or the ‘‘PACED Act’’. 


pamtmann on DSKBFK8HB2PROD with BILLS
10 

•S 440 RS

1 SEC. 2. ABROGATION OF SOVEREIGN IMMUNITY. 

2 (a) IN GENERAL.—Title 35, United States Code, is 

3 amended— 

4 (1) in section 135, by adding at the end the fol5 lowing: 

6 ‘‘(g) SOVEREIGN IMMUNITY.— 

7 ‘‘(1) DEFINITIONS.—In this subsection— 

8 ‘‘(A) the term ‘foreign state’ has the mean9 ing given the term in section 1603(a) of title 28; 

10 and 

11 ‘‘(B) the term ‘Indian tribe’ has the mean12 ing given the term in section 4(e) of the Indian 

13 Self-Determination and Education Assistance 

14 Act (25 U.S.C. 5304(e)). 

15 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

16 Except as provided in paragraph (3), and subject to 

17 paragraph (4), a patent owner may not assert sov18 ereign immunity, including the sovereign immunity 

19 accorded to an Indian tribe, as a defense in— 

20 ‘‘(A) a derivation proceeding instituted 

21 under subsection (a); or 

22 ‘‘(B) a review by a court of the United 

23 States with respect to a decision reached in a 

24 proceeding described in subparagraph (A). 

25 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat26 ent owner is a foreign state, for the purposes of any 


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•S 440 RS

1 proceeding described in paragraph (2)(A), the Patent 

2 Trial and Appeal Board shall determine whether the 

3 patent owner is immune from the jurisdiction of the 

4 Patent Trial and Appeal Board, in accordance with 

5 chapter 97 of title 28 as if the Patent Trial and Ap6 peal Board were a court of the United States. 

7 ‘‘(4) LIMITATION.—This subsection— 

8 ‘‘(A) shall apply only to the extent per9 mitted under the 11th amendment to the Con10 stitution of the United States; and 

11 ‘‘(B) shall not apply with respect to— 

12 ‘‘(i) any State of the United States; or 

13 ‘‘(ii) any institution of higher edu14 cation, as defined in section 101 of the 

15 Higher Education Act of 1965 (20 U.S.C. 

16 1001), that is a public institution in a 

17 State of the United States.’’; 

18 (2) in section 296— 

19 (A) in the section heading, by striking 

20 ‘‘and State officials’’ and inserting ‘‘, 

21 State officials, and Indian tribes’’; and 

22 (B) by adding at the end the following: 

23 ‘‘(c) ABROGATION OF TRIBAL SOVEREIGN IMMU24 NITY.— 

25 ‘‘(1) DEFINITIONS.—In this subsection— 


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•S 440 RS

1 ‘‘(A) the term ‘covered claim’ means any 

2 claim, counterclaim, or third-party claim that 

3 arises under— 

4 ‘‘(i) this title relating to infringement 

5 of a patent; or 

6 ‘‘(ii) section 351 of the Public Health 

7 Service Act (42 U.S.C. 262); and 

8 ‘‘(B) the term ‘Indian tribe’ has the mean9 ing given the term in section 4(e) of the Indian 

10 Self-Determination and Education Assistance 

11 Act (25 U.S.C. 5304(e)). 

12 ‘‘(2) ABROGATION.—In any action that involves 

13 a covered claim that is otherwise within the jurisdic14 tion of a court of the United States, an Indian tribe 

15 may not assert sovereign immunity as a defense.’’; 

16 (3) in section 305— 

17 (A) in the first sentence, by striking ‘‘After 

18 the’’ and inserting the following: 

19 ‘‘(a) IN GENERAL.—After the’’; and 

20 (B) by adding at the end the following: 

21 ‘‘(b) SOVEREIGN IMMUNITY.— 

22 ‘‘(1) DEFINITIONS.—In this subsection— 

23 ‘‘(A) the term ‘foreign state’ has the mean24 ing given the term in section 1603(a) of title 28; 

25 and 


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1 ‘‘(B) the term ‘Indian tribe’ has the mean2 ing given the term in section 4(e) of the Indian 

3 Self-Determination and Education Assistance 

4 Act (25 U.S.C. 5304(e)). 

5 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

6 Except as provided in paragraph (3), and subject to 

7 paragraph (4), a patent owner may not assert sov8 ereign immunity, including the sovereign immunity 

9 accorded to an Indian tribe, as a defense in— 

10 ‘‘(A) any reexamination proceeding under 

11 this section, including any appeal to the Patent 

12 Trial and Appeal Board; or 

13 ‘‘(B) a review by a court of the United 

14 States with respect to a decision reached in a 

15 proceeding described in subparagraph (A). 

16 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat17 ent owner is a foreign state, for the purposes of any 

18 proceeding described in paragraph (2)(A), the Office 

19 or the Patent Trial and Appeal Board, as applicable, 

20 shall determine whether the patent owner is immune 

21 from the jurisdiction of the Office or the Patent Trial 

22 and Appeal Board, as applicable, in accordance with 

23 chapter 97 of title 28 as if the Office or the Patent 

24 Trial and Appeal Board, as applicable, were a court 

25 of the United States. 


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•S 440 RS

1 ‘‘(4) LIMITATION.—This subsection— 

2 ‘‘(A) shall apply only to the extent per3 mitted under the 11th amendment to the Con4 stitution of the United States; and 

5 ‘‘(B) shall not apply with respect to— 

6 ‘‘(i) any State of the United States; or 

7 ‘‘(ii) any institution of higher edu8 cation, as defined in section 101 of the 

9 Higher Education Act of 1965 (20 U.S.C. 

10 1001), that is a public institution in a 

11 State of the United States.’’; 

12 (4) in section 316, by adding at the end the fol13 lowing: 

14 ‘‘(f) SOVEREIGN IMMUNITY.— 

15 ‘‘(1) DEFINITIONS.—In this subsection— 

16 ‘‘(A) the term ‘foreign state’ has the mean17 ing given the term in section 1603(a) of title 28; 

18 and 

19 ‘‘(B) the term ‘Indian tribe’ has the mean20 ing given the term in section 4(e) of the Indian 

21 Self-Determination and Education Assistance 

22 Act (25 U.S.C. 5304(e)). 

23 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

24 Except as provided in paragraph (3), and subject to 

25 paragraph (4), a patent owner may not assert sovVerDate Sep 11 2014 21:06 Jun 28, 2019 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6203 E:\BILLS\S440.RS S440

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1 ereign immunity, including the sovereign immunity 

2 accorded to an Indian tribe, as a defense in— 

3 ‘‘(A) an inter partes review instituted under 

4 this chapter; or 

5 ‘‘(B) a review by a court of the United 

6 States with respect to a decision reached in a 

7 proceeding described in subparagraph (A). 

8 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat9 ent owner is a foreign state, for the purposes of any 

10 review described in paragraph (2)(A), the Patent 

11 Trial and Appeal Board shall determine whether the 

12 patent owner is immune from the jurisdiction of the 

13 Patent Trial and Appeal Board, in accordance with 

14 chapter 97 of title 28 as if the Patent Trial and Ap15 peal Board were a court of the United States. 

16 ‘‘(4) LIMITATION.—This subsection— 

17 ‘‘(A) shall apply only to the extent per18 mitted under the 11th amendment to the Con19 stitution of the United States; and 

20 ‘‘(B) shall not apply with respect to— 

21 ‘‘(i) any State of the United States; or 

22 ‘‘(ii) any institution of higher edu23 cation, as defined in section 101 of the 

24 Higher Education Act of 1965 (20 U.S.C. 


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1 1001), that is a public institution in a 

2 State of the United States.’’; and 

3 (5) in section 326, by adding at the end the fol4 lowing: 

5 ‘‘(f) SOVEREIGN IMMUNITY.— 

6 ‘‘(1) DEFINITIONS.—In this subsection— 

7 ‘‘(A) the term ‘foreign state’ has the mean8 ing given the term in section 1603(a) of title 28; 

9 and 

10 ‘‘(B) the term ‘Indian tribe’ has the mean11 ing given the term in section 4(e) of the Indian 

12 Self-Determination and Education Assistance 

13 Act (25 U.S.C. 5304(e)). 

14 ‘‘(2) ABROGATION OF SOVEREIGN IMMUNITY.— 

15 Except as provided in paragraph (3), and subject to 

16 paragraph (4), a patent owner may not assert sov17 ereign immunity, including the sovereign immunity 

18 accorded to an Indian tribe, as a defense in— 

19 ‘‘(A) a post-grant review instituted under 

20 this chapter; or 

21 ‘‘(B) a review by a court of the United 

22 States with respect to a decision reached in a 

23 proceeding described in subparagraph (A). 

24 ‘‘(3) IMMUNITY OF FOREIGN STATES.—If a pat25 ent owner is a foreign state, for the purposes of any 


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•S 440 RS

1 review described in paragraph (2)(A), the Patent 

2 Trial and Appeal Board shall determine whether the 

3 patent owner is immune from the jurisdiction of the 

4 Patent Trial and Appeal Board, in accordance with 

5 chapter 97 of title 28 as if the Patent Trial and Ap6 peal Board were a court of the United States. 

7 ‘‘(4) LIMITATION.—This subsection— 

8 ‘‘(A) shall apply only to the extent per9 mitted under the 11th amendment to the Con10 stitution of the United States; and 

11 ‘‘(B) shall not apply with respect to— 

12 ‘‘(i) any State of the United States; or 

13 ‘‘(ii) any institution of higher edu14 cation, as defined in section 101 of the 

15 Higher Education Act of 1965 (20 U.S.C. 

16 1001), that is a public institution in a 

17 State of the United States.’’. 

18 (b) AMENDMENTS TO THE TARIFF ACT OF 1930.—Sec19 tion 337 of the Tariff Act of 1930 (19 U.S.C. 1337) is 

20 amended by adding at the end the following: 

21 ‘‘(o) ABROGATION OF TRIBAL SOVEREIGN IMMU22 NITY.— 

23 ‘‘(1) DEFINITIONS.—In this subsection— 

24 ‘‘(A) the term ‘covered person’— 

25 ‘‘(i) means a person; and 


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1 ‘‘(ii) includes— 

2 ‘‘(I) an Indian tribe; and 

3 ‘‘(II) any other person that claims 

4 immunity on account of the sovereign 

5 status of an Indian tribe; and 

6 ‘‘(B) the term ‘Indian tribe’ has the mean7 ing given the term in section 4(e) of the Indian 

8 Self-Determination and Education Assistance 

9 Act (25 U.S.C. 5304(e)). 

10 ‘‘(2) ABROGATION.—In any proceeding under 

11 this section, no covered person may assert as a defense 

12 the sovereign immunity that is accorded to an Indian 

13 tribe.’’. 

14 (c) TECHNICAL AND CONFORMING AMENDMENT.—The 

15 table of sections for chapter 29 of title 35, United States 

16 Code, is amended by striking the item relating to section 

17 296 and inserting the following: 

‘‘296. Liability of States, instrumentalities of States, State officials, and Indian 

tribes for infringement of patents.’’. 


pamtmann on DSKBFK8HB2PROD with BILLS

pamtmann on DSKBFK8HB2PROD with BILLS
Calendar No. 129 

116TH CONGRESS 

1ST SESSION S. 440 

A BILL 

To amend title 35, United States Code, to provide 

for other purposes. United States Patent and Trademark Office, and munity as a defense in certain actions before the that a patent owner may not assert sovereign imJUNE 28 (legislative day, JUNE 27), 2019 

Reported with an amendment 


pamtmann on DSKBFK8HB2PROD with BILLS