`
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US008685930B2
`
`(12) United States Patent (cid:9)(12) United States Patent (cid:9)
`
`lI2j United States Patent
`
`Acheampong et al. (cid:9)Acheampong et al. (cid:9)
`et al.
`Acheampong
`
`(Io) Patent No. :
`
`(10) Patent No.: (cid:9)(10) Patent No.: (cid:9)
`(45) Date of Patent:
`
`(45) Date of Patent: (cid:9)(45) Date of Patent: (cid:9)
`
`US 8,685,930 B2
`
`US 8,685,930 B2 US 8,685,930 B2
`*Apr. 1, 2014
`
`*Apr. 1, 2014 *Apr. 1, 2014
`
`(54) METHODS OF PROVIDING THERAPEUTIC
`
`(54) METHODS OF PROVIDING THERAPEUTIC (54) METHODS OF PROVIDING THERAPEUTIC
`EFFECTS USING CYCLOSPORIN
`
`EFFECTS USING CYCLOSPORIN EFFECTS USING CYCLOSPORIN
`
`COMPONENTS COMPONENTS
`COMPONENTS
`
`Inc., Irvine, CA (US)
`(71) Applicant: Allergan, Inc., Irvine, CA (US) (71) Applicant: Allergan, Inc., Irvine, CA (US)
`
`(71) Applicant: Allergan,
`
`(72) (72)
`
`(72)
`
`
`Inventors: Andrew Acheampong, Irvine, CA (US); Inventors: Andrew Acheampong, Irvine, CA (US);
`Irvine, CA(US);
`Inventors: AndrewAcheampong,
`Diane D. Tang-Liu, Las Vegas, NV
`
`Diane D. Tang-Liu, Las Vegas, NV Diane D. Tang-Liu, Las Vegas, NV
`
`(US); James N. Chang, Newport Beach, (US); James N. Chang, Newport Beach,
`(US); James N. Chang, Newport Beach,
`CA (US); David F. Power, Hubert, NC
`
`CA (US); David F. Power, Hubert, NC CA (US); David F. Power, Hubert, NC
`
`(US) (US)
`(US)
`
`Inc., Irvine, CA (US)
`(73) Assignee: Allergan, Inc., Irvine, CA (US) (73) Assignee: Allergan, Inc., Irvine, CA (US)
`
`(73) Assignee: Allergan,
`( * ) Notice:
`
`Notice: (cid:9)Notice: (cid:9)
`
`* ) * )
`
`the term of this
`
`Subject to any disclaimer, the term of this Subject to any disclaimer, the term of this
`Subject to any disclaimer,
`
`patent is extended or adjusted under 35 patent is extended or adjusted under 35
`is extended or adjusted under 35
`patent
`U.S.C. 154(b) by 0 days.
`
`U.S.C. 154(b) by 0 days. U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-This patent is subject to a terminal dis-
`dis-
`to a terminal
`is subject
`This patent
`
`claimer. claimer.
`claimer.
`
`(21) Appl. No.: 13/961,828 (21) Appl. No.: 13/961,828
`
`(21) Appl. Noz 13/961,S2S
`
`(22) Filed: (cid:9)(22) Filed: (cid:9)
`
`Filed:
`(22)
`
`Aug. 7, 2013 Aug. 7, 2013
`
`Aug. 7, 2013
`
`(65) (cid:9)(65) (cid:9)
`
`(65)
`
`Prior Publication Data
`Prior Publication Data Prior Publication Data
`
`Dec. 19, 2013
`US 2013/0338082 Al
`US 2013/0338082 Al (cid:9)US 2013/0338082 Al (cid:9)
`
`Dec. 19, 2013 Dec. 19, 2013
`
`
`Related U.S.Application Data
`Related U.S. Application Data Related U.S. Application Data
`
`(63) Continuation of application No. 11/897, 177, filed on
`
`(63) Continuation of application No. 11/897,177, filed on (63) Continuation of application No. 11/897,177, filed on
`
`Aug. 28, 2007, now Pat. No. 8,618,064, and a Aug. 28, 2007, now Pat. No. 8,618,064, and a
`Aug. 28, 2007, now Pat. No. 8,618,064, and a
`continuation of application No. 10/927, 857, filed on
`
`continuation of application No. 10/927,857, filed on continuation of application No. 10/927,857, filed on
`
`Aug. 27, 2004, now abandoned. Aug. 27, 2004, now abandoned.
`Aug. 27, 2004, now abandoned.
`
`(60) Provisional application No. 60/503,137, filed on Sep. (60) Provisional application No. 60/503,137, filed on Sep.
`application No. 60/503, 137, filed on Sep.
`(60)
`Provisional
`15, 2003.
`
`15, 2003. 15, 2003.
`
`(2006.01)
`(2006.01) (2006.01)
`
`
`Int. Cl.
`
`(51) Int. Cl. (51) Int. Cl.
`(51)
`zl 61K38/13
`
`A61K 38/13 (cid:9)A61K 38/13 (cid:9)
`(52) U.S. Cl.
`
`(52) U.S. Cl. (52) U.S. Cl.
`
`USPC (cid:9)USPC (cid:9)
`USPC
`(58) Field of ClassiTication Search
`
`(58) Field of Classification Search (58) Field of Classification Search
`A61K 38/13
`
`
`CPC (cid:9)CPC (cid:9)
` A61K 38/13 A61K 38/13
`CPC .........................................
`
`See application file for complete search history. See application file for complete search history.
`See application file for complete search history.
`
` 514/20.5 514/20.5
`
`514/20. 5
`
`(56) (56)
`
`(56)
`
`References Cited References Cited
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`DE DE
`DE
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`EP EP
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`
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`U.S. PATENT DOCUMENTS
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`
`(Continued) (Continued)
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`(Continued)
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`
`
`Primary Examiner — Marcela M Cordero Garcia Primary Examiner — Marcela M Cordero Garcia
`Primary Examiner
`Marcela M Cordero Garcia
`Joel B.
`Laura L. Wine;
`(74) Attorney, Agent, or Firm
`
`(74) Attorney, Agent, or Firm Laura L. Wine; Joel B. (74) Attorney, Agent, or Firm Laura L. Wine; Joel B.
`German; Debra D. Condino
`
`German; Debra D. Condino German; Debra D. Condino
`
`ABSTRACT ABSTRACT
`
`ABSTRACT
`(57) (cid:9)(57) (cid:9)
`
`(57)
`Methods of treating an eye of a human or animal
`
`Methods of treating an eye of a human or animal include Methods of treating an eye of a human or animal include
`include
`to an eye of a human or animal a composition
`
`administering to an eye of a human or animal a composition administering to an eye of a human or animal a composition
`administering
`in the form of an emulsion including water, a hydrophobic
`
`in the form of an emulsion including water, a hydrophobic in the form of an emulsion including water, a hydrophobic
`
`component and a cyclosporin component in a therapeutically component and a cyclosporin component in a therapeutically
`in a therapeutically
`and a cyclosporin component
`component
`effective amount of less than 0.1'zo by weight of the compo-
`
`effective amount of less than 0.1% by weight of the compo-effective amount of less than 0.1% by weight of the compo-
`ratio of the cyclosporin component
`
`sition. The weight ratio of the cyclosporin component to the sition. The weight ratio of the cyclosporin component to the
`sition. The weight
`to the
`is less than 0.8.
`
`hydrophobic component is less than 0.8. hydrophobic component is less than 0.8.
`component
`hydrophobic
`
`36 Claims, No Drawings 36 Claims, No Drawings
`
`36 Claims, No Drawings
`
`MYLAN - EXHIBIT 1001
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
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`
`
`US 8,685,930 B2
`US 8,685,930 B2 US 8,685,930 B2
`
`Page 2
`
`Page 2 Page 2
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`2005/0014691 Al
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`11/2010 (cid:9) Morgan et al. 11/2010 (cid:9) Morgan et al.
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`1/2011 (cid:9) Schiffman 1/2011 (cid:9) Schiffman
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`Schiffman
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`12/2011 (cid:9) Morgan et al. 12/2011 (cid:9) Morgan et al.
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`10/2012 (cid:9) Chang et al. 10/2012 (cid:9) Chang et al.
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`
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS FOREIGN PATENT DOCUMENTS
`
`
`
`EP (cid:9)EP (cid:9)
`EP
`
`EP (cid:9)EP (cid:9)
`EP
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`WO (cid:9)WO (cid:9)
`WO
`
`
`0547229 (cid:9)0547229 (cid:9)
`0547229
`0760237
`
`0760237 (cid:9)0760237 (cid:9)
`95-31211
`
`95-31211 (cid:9)95-31211 (cid:9)
`00-00179
`
`00-00179 (cid:9)00-00179 (cid:9)
`01-32142
`
`01-32142 (cid:9)01-32142 (cid:9)
`01-41671
`
`01-41671 (cid:9)01-41671 (cid:9)
`02-09667
`
`02-09667 (cid:9)02-09667 (cid:9)
`02-49603
`
`02-49603 (cid:9)02-49603 (cid:9)
`03-030834
`
`03-030834 (cid:9)03-030834 (cid:9)
`03-053405
`
`03-053405 (cid:9)03-053405 (cid:9)
`
`I/1993
`
`1/1993 1/1993
`
`3/1997 3/1997
`3/1997
`
`11/1995 11/1995
`11/1995
`
`1/2000 1/2000
`I/2000
`
`5/2001 5/2001
`5/2001
`
`6/2001 6/2001
`6/2001
`
`2/2002 2/2002
`2/2002
`
`6/2002 6/2002
`6/2002
`
`4/2003 4/2003
`4/2003
`
`7/2003 7/2003
`7/2003
`
`OTHER PUBLICATIONS
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`OTHER PUBLICATIONS OTHER PUBLICATIONS
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`in (cid:9)in (cid:9)
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`Steroid-Resistant (cid:9) Atopic Steroid-Resistant (cid:9) Atopic
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`Keratoconjunctivitis, Ophthalmology, 2004, 476-482, 111. Keratoconjunctivitis, Ophthalmology, 2004, 476-482, 111.
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`...........
`
`5,916,589
`
`5,916,589 A 5,916,589 A
`5,929,030
`
`5,929,030 A 5,929,030 A
`5,951,971
`
`5,951,971 A 5,951,971 A
`5,962,014
`
`5,962,014 A 5,962,014 A
`5,962,017
`
`5,962,017 A 5,962,017 A
`5,962,019
`
`5,962,019 A 5,962,019 A
`
`5,977,066 A 5,977,066 A
`5,977,066
`5,981,479
`
`5,981,479 A 5,981,479 A
`5,981,607
`
`5,981,607 A 5,981,607 A
`
`5,998,365 A 5,998,365 A
`5,998,365
`
`6,004,566 A 6,004,566 A
`6,004,566
`
`6,007,840 A 6,007,840 A
`6,007,840
`
`6,008,191 A 6,008,191 A
`6,008, 191
`
`6,008,192 A 6,008,192 A
`6,008, 192
`
`6,022,852 A 6,022,852 A
`6,022, 852
`6,024,978
`
`6,024,978 A 6,024,978 A
`
`6,046,163 A 6,046,163 A
`6,046, 163
`
`6,057,289 A 6,057,289 A
`6,057,289
`6, 159,933
`
`6,159,933 A 6,159,933 A
`l
`6, 197,335
`
`6,197,335 Bl 6,197,335 Bl
`Bl
`
`6,254,860 Bl 6,254,860 Bl
`6,254, 860
`Bl
`
`6,254,885 Bl 6,254,885 Bl
`6,254, 885
`Bl
`
`6,267,985 Bl 6,267,985 Bl
`6,267,985
`Bl
`
`6,284,268 Bl 6,284,268 Bl
`6,284,268
`Bl
`
`6,294,192 Bl 6,294,192 Bl
`6,294, 192
`Bl
`
`6,306,825 Bl 6,306,825 Bl
`6,306,825
`Bl
`
`6,323,204 Bl 6,323,204 Bl
`6,323,204
`Bl
`6,346,511
`
`6,346,511 Bl 6,346,511 Bl
`B2
`
`6,350,442 B2 6,350,442 B2
`6,350,442
`Bl
`6,413,547
`
`6,413,547 Bl 6,413,547 Bl
`B2
`
`6,420,355 B2 6,420,355 B2
`6,420,355
`B2
`6,468,968
`
`6,468,968 B2 6,468,968 B2
`Bl
`6,475,519
`
`6,475,519 Bl 6,475,519 Bl
`B2
`
`6,486,124 B2 6,486,124 B2
`6,486, 124
`B2
`6,544,953
`
`6,544,953 B2 6,544,953 B2
`B2
`
`6,555,526 B2 6,555,526 B2
`6,555,526
`B2
`
`6,562,873 B2 6,562,873 B2
`6,562,873
`B2
`
`6,569,463 B2 6,569,463 B2
`6,569,463
`6,582,718
`B2
`
`6,582,718 B2 6,582,718 B2
`B2
`
`6,656,460 B2 6,656,460 B2
`6,656,460
`B2
`
`6,872,705 B2 6,872,705 B2
`6,872,705
`B2*
`
`6,984,628 B2 * 6,984,628 B2 *
`6,984,628
`B2
`
`7,202,209 B2 7,202,209 B2
`7,202,209
`B2
`
`7,276,476 B2 7,276,476 B2
`7,276,476
`B2
`
`7,288,520 B2 7,288,520 B2
`7,288,520
`B2
`7,297,679
`
`7,297,679 B2 7,297,679 B2
`B2
`7,501,393
`
`7,501,393 B2 7,501,393 B2
`8,211,855
`B2
`
`8,211,855 B2 8,211,855 B2
`B2
`
`8,288,348 B2 8,288,348 B2
`8,288,348
`Al
`
`2001/0003589 Al 2001/0003589 Al
`2001/0003589
`Al
`
`2001/0014665 Al 2001/0014665 Al
`2001/0014665
`Al
`
`2001/0036449 Al 2001/0036449 Al
`2001/0036449
`Al
`
`2002/0012680 Al 2002/0012680 Al
`2002/0012680
`Al
`
`2002/0013272 Al 2002/0013272 Al
`2002/0013272
`Al
`
`2002/0016290 Al 2002/0016290 Al
`2002/0016290
`Al
`
`2002/0016292 Al 2002/0016292 Al
`2002/0016292
`Al
`
`2002/0025927 Al 2002/0025927 Al
`2002/0025927
`Al
`
`2002/0045601 Al 2002/0045601 Al
`2002/0045601
`Al
`
`2002/0107183 Al 2002/0107183 Al
`2002/0107183
`2002/0119190
`Al
`
`2002/0119190 Al 2002/0119190 Al
`Al
`
`2002/0165134 Al 2002/0165134 Al
`2002/0165134
`Al
`
`2003/0021816 Al 2003/0021816 Al
`2003/0021816
`Al
`
`2003/0044452 Al 2003/0044452 Al
`2003/0044452
`Al
`
`2003/0055028 Al 2003/0055028 Al