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