(12) United States Patent
`Acheampong et al.
`
`(10) Patent N0.:
`
`(45) Date of Patent:
`
`US 9,248,191 B2
`*Feb. 2, 2016
`
`US00924819lB2
`
`(54) METHODS OF PROVIDING THERAPEUTIC
`EFFECTS USING CYCLOSPORIN
`COMPONENTS
`
`(71) Applicant: Allergan, Inc., Irvine, CA (US)
`
`(72)
`
`Invc11tors: Andrew Acheampong, Irvinc, CA (US);
`Diane D. Tang-Liu, Las Vegas, NV
`(US); James N. Chang, Newport Beach,
`CA (US); David F. Power, San
`Clemente, CA (US)
`
`Assig11ee: Allergan, Inc., Irvine, CA (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted 11nder 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`14/222,478
`
`Mar. 21, 2014
`
`Prior Publication Data
`
`US 2014/0206626 A1
`
`Jul. 24, 2014
`
`Related U.S. Application Data
`
`Continuation of application No. 13/961,828, filed on
`Aug. 7, 2013, now Pat. No. 8,685,930, which is a
`continuation of application No. 11/897,177, filed on
`Aug. 28, 2007, now Pat. No. 8,618,064,
`a11d a
`continuation of application No. 10/927,857, filcd on
`Aug. 27, 2004, now abandoned.
`
`Provisional application No. 60/503,137, filed on Sep.
`15, 2003.
`
`4,388,307
`4,614,736
`4,649,047
`4,764,503
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`5,474,919
`5,474,979
`5,496,811
`5,504,068
`5,540,931
`5,543,393
`5,578,586
`
`>>>>>>>>>>>>>>>:>>:>u>u>>>u>:>>u>:>>:>>>
`
`983 Cavanak
`986 Delevallee et al.
`987 Kaswan
`988 VVenger
`989 Andrieu et al,
`989 Kaswan
`990 Horrobin
`991 Kurihara et al.
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`
`§§@Q%EE$&’3“\-"i§§£Q£“<“<EQ“<’@%£Q
`
`>-»—O0\l-EL»)\\\\\
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`19810655
`0448856
`
`9/1999
`10/1991
`
`(Continued)
`
`OTHER PUBLICATIONS
`
`(2006.01)
`(2006.01)
`(2006.01)
`(200601)
`(200601 )
`(2006.01)
`(2006.01)
`(2006.01)
`
`I11t. Cl.
`A61K38/13
`A61K47/02
`A61K 9/00
`A61K 47/44
`A61K 9/107
`A6lK47/I0
`A61K 47/22
`A61K 47/32
`U.S. Cl.
`CPC ............. .. A6IK 47/02 (2013.01); A61K 9/0048
`(2013.01); A61K 9/107 (2013.01); A61K38/13
`(2013.01); A61K 47/10 (2013.01); A61K47/22
`(2013.01); A61K 47/32 (2013.01); A61K47/44
`(2013.01)
`
`Field of Classification Search
`None
`
`See application file for complete search history.
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,278,447 A
`4.347.238 A
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`
`Abdulra7ik, M. et al, Ocular Delivery of Cyclosporin A II. Effect of
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`1 1(6).
`
`(Continued)
`
`Primary Examiner — Marcela M Cordero Garcia
`(74) Attorney, Agent, or Firm—Laura L. Wine; Joel B.
`German; Debra D. Condino
`
`(57)
`
`ABSTRACT
`
`Methods of treating an eye of a human or animal include
`administering to an eye of a human or animal a composition
`in the form of an emulsion including water, a hydrophobic
`component and a cyclo sporin component in a therapeutically
`effective amount of less than 0.1% by weight of the compo-
`sition. The weight ratio of the cyclosporin component to the
`hydrophobic component is less than 0.8.
`
`27 Claims, No Drawings
`
`FAMY CARE - EXHIBIT 1001-0001
`
`

`
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`
`>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
`
`B2
`B2
`B2
`B2
`B2 *
`
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`US 9,248,191 B2
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`

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`
`FAMY CARE - EXHIBIT 1001-0005
`
`

`
`US 9,248,191 B2
`
`1
`METHODS OF PROVIDING THERAPEUTIC
`EFFECTS USING CYCLOSPORIN
`COIVIPONENTS
`
`RELATED APPLICATION
`
`This application is a continuation ofcopending U.S. Appli-
`cation Serial No. 13/961.828 filed Aug. 7, 2013, which is a
`continuation of U.S. application Ser. No. 11/897,177, filed
`Aug. 28, 2007, now issued as U.S. Pat. No. 8,618,064, which
`is a continuation of U.S. application Ser. No. 10/927,857,
`filedAug. 27, 2004, now abandoned, which claims the benefit
`ofU.S. Provisional Application No. 60/503,137 filed Sep. 15,
`2003, which are incorporated in their entirety herein by ref-
`erence.
`
`BACKGROUND OF THE INVENTION
`
`lhe present invention relates to methods of providing
`desired therapeutic effects to humans or animals using com-
`positions including cyclosporin components. More partic11-
`larly, the invention relates to methods including administer-
`ing to an eye of a human or animal a therapeutically effective
`amount of a cyclosporin component to provide a desired
`therapeutic effect, preferably a desired ophthalmic or ocular
`therapeutic effect.
`The use of cyclosporin-A and cyclosporin A derivatives to
`treat ophthalmic conditions has been the subject of various
`patents, for example Ding et al U.S. Pat. No. 5,474,979; Garst
`U.S. Pat. No.