I 11111 11111111 III 11111 11111!1s1 J1j1181151111 1111111111111111111111111111111
`
`USOO8853156B2
`
`(12) United States Patent (cid:9)
`(12) United States Patent
`Dugi et al. (cid:9)
`Dugi et al.
`
`(10) Patent No.:
`(10) Patent No.: (cid:9)
`(45) Date of Patent: (cid:9)
`(45) Date of Patent:
`
`US 8,853,156 B2
`US 8,853,156 B2
`Oct. 7, 2014
`Oct. 7, 2014
`
`(54) TREATMENT FOR DIABETES IN PATIENTS
`(54) TREATMENT FOR DIABETES IN PATIENTS
`INAPPROPRIATE FOR METFORMIN
`INAPPROPRIATE FOR METFORMIN
`THERAPY
`THERAPY
`
`(75) Inventors: Klaus Dugi, Dresden (DE); Eva Ulrike
`(75) Inventors: Klaus Dugi, Dresden (DE); Eva Ulrike
`Graefe-Mody, Biberach (DE); Ruth
`Graefe-Mody, Biberach (DE); Ruth
`Harper, Reading (GB); Hans-Juergen
`Harper, Reading (GB); Hans-Juergen
`Woerle, Munich (DE)
`Woerle, Munich (DE)
`
`(73) Assignee: Boehringer Ingelheim International
`(73) Assignee: Boehringer Ingelheim International
`GmbH, Ingelheim am Rhein (DE)
`GmbH, Ingelheim am Rhein (DE)
`
`( * ) Notice:
`* N '
`ot1ce:
`
`Subject to any disclaimer, the term of this
`S bj
`yd' 1 '
`h
`f hi
`u ect to an 1sc aimer, t e term 0 t s
`patent is extended or adjusted under 35
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 577 days.
`U.S.C. 154(b) by 577 days.
`
`(52) US. Cl.
`(52) U.S. Cl.
`CPC (cid:9)
`A 61K 31/40 (2013.01); A 61K 31/513
`CPC ............. .. A61K 31/40 (2013.01); A61K 31/513
`(2013.01); A61K31/4375 (2013.01); A61K
`(2013.01); A61K 31/4375 (2013.01); A61K
`31/4439 (2013.01); A61K 31/427 (2013.01);
`31/4439 (2013.01); A61K 31/427 (2013.01);
`A61K 31/422 (2013.01); A61K31/403
`A61K 31/422 (2013.01); A61K 31/403
`(2013.01); A61K31/4025 (2013.01); A61K
`(2013.01); A61K 31/4025 (2013.01); A61K
`31/506 (2013.01); A61K31/4985 (2013.01);
`31/506 (2013.01); A 61K 31/4985 (2013.01);
`A61K 31/522 (2013.01); A61K 31/5025
`A61K 31/522 (2013.01); A61K 31/5025
`(2013.01)
`(2013.01)
` 514/6.9; 514/5.9; 514/248; 514/263.2;
`USPC (cid:9)
`USPC ........ .. 514/6.9; 514/5.9; 514/248; 514/263.2;
`514/263.21; 514/263.22
`514/263.21; 514/263.22
`(58) Field of Classi?cation Search
`(58) Field of Classification Search
`CPC combination set(s) only.
`CPC combination set(s) only.
`See application ?le for complete search history.
`See application file for complete search history.
`
`(21) App1.No.:
`(21) Appl. No.:
`
`13/057,295
`13/057,295
`
`(22) PCT Filed:
`(22) PCT Filed:
`
`Aug. 5, 2009
`Aug. 5, 2009
`
`(86) PCT No.:
`(86) PCT No.:
`§ 371 (0X1),
`§ 371 (c)(1),
`(2), (4) Date:
`(2), (4) Date:
`
`PCT/EP2009/060170
`PCT/EP2009/060170
`
`Apr. 15, 2011
`Apr. 15, 2011
`
`(87) PCT Pub. No.: WO2010/015664
`(87) PCT Pub. No.: W02010/015664
`
`PCT Pub. Date: Feb. 11, 2010
`PCT Pub. Date: Feb. 11, 2010
`
`(65)
`(65) (cid:9)
`
`Prior Publication Data
`Prior Publication Data
`
`US 2011/0263493 A1
`US 2011/0263493 Al (cid:9)
`
`Oct. 27, 2011
`Oct. 27, 2011
`
`Related US. Application Data
`Related U.S. Application Data
`
`(60) Provisional application No. 61/086,620, ?led on Aug.
`(60) Provisional application No. 61/086,620, filed on Aug.
`6, 2008, provisional application No. 61/105,915, ?led
`6, 2008, provisional application No. 61/105,915, filed
`on Oct. 16, 2008.
`on Oct. 16, 2008.
`
`(30)
`(30) (cid:9)
`
`Foreign Application Priority Data
`Foreign Application Priority Data
`
`08161989
`Aug. 7, 2008 (EP)
` 08161989
`Aug. 7, 2008 (EP) (cid:9)
` 08166827
`Oct. 16, 2008 (EP) (cid:9)
`Oct. 16, 2008 (EP) ................................... .. 08166827
`
`AU
`AU
`AU
`AU
`CA
`CA
`CA
`CA
`CA
`CA
`CA
`CA
`CA
`CA
`
`(56)
`(56)
`
`References Cited
`References Cited
`
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`
`9/1936 Fourneau
`2,056,046 A (cid:9)
`9/1936 Fourneau
`2,056,046 A
`5/1945 Salvin
`2,375,138 A (cid:9)
`5/1945 Salvin
`2,375,138 A
`2/1953 Krimmel
`2,629,736 A (cid:9)
`2/1953 Krimmel
`2,629,736 A
`1/1956 Sahyun
`2,730,544 A (cid:9)
`1/1956 Sahyun
`2,730,544 A
`6/1956 Krimmel
`2,750,387 A (cid:9)
`6/1956 Krimmel
`2,750,387 A
`3/1960 Leake et al.
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`3/1960 Leake et a1.
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`3/1965 Sterne
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`3/1965 Sterne
`3,174,901 A
`2/1966 Seemuller
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`2/1966 Seemuller
`3,236,891 A
`7/1969 Muth
`3,454,635 A (cid:9)
`7/1969 Muth
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`6/1972 Marxer
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`6/1972 Marxer
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`12/1975 Okada et al.
`3,925,357 A (cid:9)
`3,925,357 A 12/1975 Okada et al.
`(Continued)
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
`
`6/2004
`2003280680 Al
`6/2004
`2003280680 A1
`9/2009
`2009224546 Al
`9/2009
`2009224546 A1
`5/1982
`1123437 Al
`5/1982
`1123437 A1
`5/1995
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`2136288 A1
`2/2002
`2418656 Al
`2/2002
`2418656 A1
`3/2004
`2496249 Al
`3/2004
`2496249 A1
`3/2004
`2496325 Al
`3/2004
`2496325 A1
`(Continued)
`(Continued)
`OTHER PUBLICATIONS
`OTHER PUBLICATIONS
`
`Kanada, S. et al., "Safety, tolerability, pharmacokenetics and
`Kanada, S. et al., “Safety, tolerability, pharmacokenetics and
`pharmacodynamics of multiple doses of BI 1356 (proposed
`pharmacodynamics of multiple doses of BI 1356 (proposed
`tradename Ondero), a dipeptidyl peptidase 4 inhibitor, in Japanese
`tradename Ondero), a dipeptidyl peptidase 4 inhibitor, in Japanese
`patients with type 2 diabetes" Diabetes, vol. 57, No. Suppl. 1, Jun.
`patients with type 2 diabetes” Diabetes, v01. 57, N0. Suppl. 1, Jun.
`2008, p. A158-A159 and 68th Annual Meeting of the American
`2008, p. A158-A159 and 68th Annual Meeting of the American
`Diabetes Association: San Francisco, CA, Jun. 6-10, 2008.
`Diabetes Association: San Francisco, CA, Jun. 6-10, 2008.
`
`(Continued)
`(Continued)
`
`Primary Examiner — Marcela M Cordero Garcia
`Primary Examiner * Marcela M Cordero Garcia
`(74) Attorney, Agent, or Firm — Michael P. Morris; David L.
`(74) Attorney, Agent, 0rFirm * Michael P. Morris; David L.
`Kershner
`Kershner
`
`ABSTRACT
`(57)
`ABSTRACT
`(57) (cid:9)
`The present invention relates to the ?nding that certain DPP-4
`The present invention relates to the finding that certain DPP-4
`inhibitors are particularly suitable for treating and/ or prevent
`inhibitors are particularly suitable for treating and/or prevent-
`ing metabolic diseases, particularly diabetes, in patients for
`ing metabolic diseases, particularly diabetes, in patients for
`Whom metformin therapy is inappropriate due to intolerabil
`whom metformin therapy is inappropriate due to intolerabil-
`ity or contraindication against metformin.
`ity or contraindication against metformin.
`
`25 Claims, No Drawings
`25 Claims, No Drawings
`
`(51) Int. Cl.
`(51) Int. Cl.
`A 61K 38/00 (cid:9)
`A61K 38/00
`A 61K 38/28 (cid:9)
`A61K 38/28
`A 61P 3/10 (cid:9)
`A61P 3/10
`A 61P 7/12 (cid:9)
`A61P 7/12
`C07K 14/62
`C07K 14/62 (cid:9)
`A OIN 43/58 (cid:9)
`A01N 43/58
`A OIN 43/60 (cid:9)
`A01N 43/60
`A 61K 31/50 (cid:9)
`A61K 31/50
`A 61K 31/495 (cid:9)
`A61K 31/495
`A 61K 31/52 (cid:9)
`A61K 31/52
`A 61K 31/513 (cid:9)
`A61K 31/513
`A 61K 31/4375 (cid:9)
`A61K 31/43 75
`A 61K 31/4439 (cid:9)
`A61K 31/4439
`A 61K 31/427 (cid:9)
`A61K 31/427
`A 61K 31/422 (cid:9)
`A61K 31/422
`A 61K 31/403 (cid:9)
`A61K 31/403
`A 61K 31/4025 (cid:9)
`A61K 31/4025
`A 61K 31/40 (cid:9)
`A61K 31/40
`A 61K 31/506 (cid:9)
`A61K 31/506
`A 61K 31/4985 (cid:9)
`A61K 31/4985
`A 61K 31/522 (cid:9)
`A61K 31/522
`A61K 31/5025 (cid:9)
`A61K 31/5025
`
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`Mylan EX 1001, Page 1
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`
`US 8,853,156 B2
`US 8,853,156 B2
`Page 2
`Page 2
`
`(56)
`(56)
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`Mylan EX 1001, Page 2
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`(cid:9)
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`US 8,853,156 B2
`US 8,853,156 B2
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`Page 3
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`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
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`CA
`CA
`CN
`DE
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`DE
`DE
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
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`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
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`EP
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`4/2004
`2498423 Al
`$88:
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`11/2007
`2651089 A1
`11/2007
`2651089 Al
`11/2007
`101234105 A
`8/2008
`2205815 Al
`8/1973
`2758025 A1
`M979
`2758025 Al
`7/1979
`10109021 A1
`9/2002
`10109021 Al
`9/2002
`10117803 Al
`10/2002
`10238243 Al
`3/2004
`102004019540 A1 11/2005
`102004019540 Al
`11/2005
`102004024454 Al
`12/2005
`102004044221 Al
`3/2006
`102004054054 A1
`500%
`102004054054 Al
`5/2006
`0023032 A1
`M981
`0023032 Al
`1/1981
`0149578 A2
`7/1985
`0223403 A2
`5/1987
`0223403 A2
`5/1987
`0237608 A1
`9/1987
`0237608 Al
`9/1987
`0248634 A2
`12/1987
`0389282 A2
`9/1990
`0399285 A1
`11/1990
`0399285 Al
`11/1990
`0400974 A2
`12/1990
`409281 Al
`1/1991
`0412358 A1
`M991
`0412358 Al
`2/1991
`443983 A1
`8/1991
`443983 Al
`8/1991
`0475482 Al
`3/1992
`0524482 A1
`M993
`0524482 Al
`1/1993
`0657454 A1
`6/1995
`0657454 Al
`6/1995
`0775704 Al
`5/1997
`0950658 Al
`10/1999
`1054012 A1 11/2000
`1054012 Al
`11/2000
`1066265 Al
`1/2001
`1333033
`8/2003
`1338595 AZ
`80003
`1338595 A2
`8/2003
`1406873 A2
`4/2004
`1406873 A2
`4/2004
`1500403 A1
`1/2005
`1500403 Al
`1/2005
`1514552 A1
`3/2005
`1514552 Al
`3/2005
`1535906 A1
`6/2005
`1535906 Al
`6/2005
`1537880 A1
`6/2005
`1537880 Al
`6/2005
`1557165 Al
`7/2005
`1557165 A1
`7/2005
`1586571 Al
`10/2005
`1586571 A1 10/2005
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`Mylan EX 1001, Page 3
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`US 8,853,156 B2
`US 8,853,156 B2
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`ES
`ES
`ES
`ES
`ES
`ES
`FR
`FR
`GB
`GB
`HU
`HU
`HU
`HU
`JP
`JP
`JP
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`JP
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`JP
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`KR
`KR
`WO
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`W0
`WO
`W0
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`WO
`W0
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`W0
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`W0
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`WO
`W0
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`WO
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`WO
`WO
`WO
`W0
`WO
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`WO
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`References Cited
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