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`WHAT IS CLAIMED IS:
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`1.
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`A method for treating pulmonary hypertension, comprising
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`administering to a subject in need thereoftrcprostinil or treprostinil derivative, or a
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`pharmaceutically acceptable salt thereof by a metered dose inhaler.
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`2.
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`The method ofelaim 1, wherein said metered dose inhaler is a
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`pressured metered dose inhaler.
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`3.
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`The method ofclaim 1, wherein said metered dose inhaler is a dry
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`powder inhaler.
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`4.
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`The method of claim 1, wherein said metered dose inhaler is a soft mist
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`inhaler.
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`5.
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`The method ofclaim 4, wherein said treprostinil is formulated in said
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`inhaler as a solution, wherein a solvent of the solution comprises water, ethanol or a
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`mixture thereof.
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`6.
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`The method ofelaim 5, wherein a concentration of the treprostinil in
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`the solution ranges from about 500 gig/ml to about 2500 ugfml.
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`7.
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`The method of claim 6, wherein the concentration of the treprostinil in
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`the solution ranges from about 1000 Itle to about 2000 ptgfml.
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`8.
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`The method of claim 1, wherein a dose of the treprostinil administered
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`during a single event ranges from about 15 Mg to about 100 11g of the treprostinil.
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`9.
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`The method ofclaim 8, wherein the dose ranges from about 30 ng to
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`about 90 ttg of the treprostinil.
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`WASH 18600012
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`UNITED THERAPEUTICS, EX. 2201
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR201T-01622
`Page 1 of 6
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`Atty. Dkt. N0. 080618-0548
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`10.
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`The method of claim 1, wherein said administering does not have a
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`systemic side effect on said subject, wherein the systemic side effect is selected from
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`the group consisting of headache, flush, nausea, and dizziness.
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`I l.
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`The method of claim 1, wherein said administering does not disrupt
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`gas exchange in said subject.
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`12.
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`The method of claim 1, wherein said administering does change heart
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`rate of said subject.
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`l3.
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`The method of claim 1, wherein said administering does not affect
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`systemic arterial pressure and systemic arterial resistance.
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`14.
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`The method of claim 1, wherein said administering comprises a limited
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`number of breaths by said subject.
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`IS.
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`The method of claim 1, wherein said administering lasts less than 5
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`minutes.
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`16.
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`The method of claim 1, wherein said administering lasts less than 1
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`minute.
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`I7.
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`The method of clam I, wherein said subject is a human being.
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`18.
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`The method ofelaim ], further comprising administering to said
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`subject at least one supplementary agent selected from the group consisting of
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`diltiazem, amlodipine, nifedipine, sildenafil, tadalafil, vardenafil, bosentan,
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`sitaxscntan, ambrisenatn, prostacyclin, iloprost, beraprost and pharmaceutically
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`acceptable salts thereof.
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`WASH 18600012
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`Atty. Dkt. No. 080618-0548
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`19.
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`A method of delivering to a subject in need thereof a therapeutically
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`effective amount of treprostinil, or treprostinil derivative or a pharmaceutically
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`acceptable salt thereof comprising administering to the subject the therapeutically
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`effective amount of the treprostinil or treprostinil derivative or a pharrnaceutically
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`acceptable salt thereof using a metered dose inhaler.
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`20.
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`The method of claim 19, wherein said metered dose inhaler is a
`
`pressured metered dose inhaler.
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`21.
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`The method of claim 19, wherein said metered dose inhaler is a dry
`
`powder inhaler.
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`22.
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`The method of claim 19, wherein said metered dose inhaler is a soft
`
`mist inhaler.
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`23.
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`The method of claim 22, wherein said treprostinil is formulated in the
`
`metered dose inhaler as a solution, wherein a solvent of the solution comprises water,
`
`ethanol or a mixture thereof.
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`24.
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`The method ofclaim 23, wherein a concentration ofthc treprostinil in
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`the solution ranges from about 500 pig/ml to about 2500 Mg/ml.
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`25.
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`The method of claim 24, wherein the concentration of the treprostinil
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`in the solution ranges from about 1000 ug/ml to about 2000 tag/ml.
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`26.
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`The method of claim 19, wherein a dose of the treprostinil
`
`administered during a single event ranges from about 15 ug to about 100 ug of the
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`treprostinil.
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`WASH 18600012
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`32
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR201T-01622
`Page 3 of 6
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`27.
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`The method of‘elaim 26, wherein the dose ranges from about 30 Mg to
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`about 90 pg of the treprostinil.
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`Atty. Dkt. No. 080618-0548
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`28.
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`The method ofclaim 19, wherein said administering does not have a
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`systemic side effect on said subject, wherein the systemic side efi‘ect is selected From
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`the group consisting of headache, flush, nausca, and dizziness.
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`29.
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`The method of claim 19, wherein said administering does not disrupt
`
`gas exchange in said subject.
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`30.
`
`The method of claim 19, wherein said administering does change heart
`
`rate of said subject.
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`31.
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`The method ofelaim 19, wherein said administering does not affect
`
`systemic arterial pressure and systemic arterial resistance.
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`32.
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`The method of claim 19, wherein said administering comprises a
`
`limited number of breaths by said subject.
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`33.
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`The method ofclaim 19, wherein said administering lasts less than 5
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`minutes.
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`34.
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`The method of claim 19, wherein said administering lasts less than 1
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`minute.
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`35.
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`The method of clam 19, wherein said subject is a human being.
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`36.
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`A kit for treating pulmonary hypertension, comprising (i) a metered
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`dose inhaler containing a pharmaceutical formulation comprising treprostinil or
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`WASH 18600012
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01622
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`treprostinil derivative, or a pharmaceutically acceptable salt thereof; and (ii)
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`instructions for use of in treating pulmonary hypertension.
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`Atty. Dkt. N0. 080618-0548
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`37.
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`The kit of claim 36, wherein said metered dose inhaler is a pressured
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`metered dose inhaler.
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`38.
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`The kit of claim 36, wherein said metered dose inhaler is a dry powder
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`inhaler.
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`inhaler.
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`39.
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`The kit of claim 36, wherein said metered dose inhaler is a soft mist
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`40.
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`The kit of claim 39, wherein said formulation further comprises water,
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`ethanol or a mixture thereof.
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`41.
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`The kit ofclaim 36, wherein a concentration of the treprostinil in said
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`formulation is from about 500 gig/ml to about 2500 Jig/ml.
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`42.
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`The kit of claim 4], wherein said concentration is from about l000
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`11ng to about 2000 ug/ml.
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`43.
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`The kit of claim 36, further comprising an effective amount of at least
`
`one supplementary agent selected from the group consisting of diltiazcm, amlodipine,
`
`nifedipine, sildenafil, tadalafil, vardenafil, bosentan, sitaxscntan, ambrisenatn,
`
`prostaeyclin, iloprost, beraprost and pharmaceutically acceptable salts thereof.
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`44.
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`A kit comprising a metered dose inhaler containing a pharmaceutical
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`formulation comprising treprostinil or treprostinil derivative, or a pharmaceutically
`
`acceptable salt thereof.
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`WASH 18600012
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`34
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`UNITED THERAPEUTICS, EX. 2201
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017-01622
`Page 5 of 6
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`45.
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`The kit of claim 44, wherein said metered dose inhaler is a pressured
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`metered dose inhaler.
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`Atty. Dkt. No. 080618-0548
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`46.
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`The kit of claim 44, wherein said metered dose inhaler is a dry powder
`
`inhaler.
`
`inhaler.
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`47.
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`The kit of claim 44, wherein said metered dose inhaler is a soft mist
`
`48.
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`The kit of claim 47, wherein said formulation further comprises water,
`
`ethanol or a mixture thereof.
`
`49.
`
`The kit of claim 44, wherein a concentration of the treprostinil in said
`
`formulation is from about 500 gig/ml to about 2500 Jig/ml.
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`50.
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`The kit of claim 44, wherein said concentration is from about 1000
`
`ug/ml to about 2000 itg/ml.
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`51.
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`The kit of claim 44, further comprising instructions for using the
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`metered dose inhaler for inhaling the treprostinil.
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`WASH 18600012
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`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01622
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