Comparison of Claim 1
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`1. A monolithic transdermal drug
`delivery system for estradiol,
`consisting of
`
`1. A monolithic transdermal drug
`delivery system for estradiol,
`consisting of
`
`(i) a backing layer,
`
`(i) a backing layer,
`
`(ii) a single adhesive polymer
`matrix layer defining an active
`surface area and,
`
`(ii) a single adhesive polymer
`matrix layer defining an active
`surface area and,
`
`optionally, (iii) a release liner,
`
`optionally, (iii) a release liner,
`
`wherein the single adhesive
`polymer matrix layer comprises an
`adhesive polymer matrix
`comprising estradiol as the only
`drug,
`wherein the adhesive polymer
`matrix layer has a coat weight of
`greater than 10 mg/cm2 and
`includes greater than 0.156 mg/cm2
`estradiol,
`and the system achieves an
`estradiol flux of from 0.0125 to
`about 0.05 mg/cm2/day,
`
`wherein the single adhesive
`polymer matrix layer comprises an
`adhesive polymer matrix
`comprising estradiol as the only
`drug,
`wherein the adhesive polymer
`matrix layer has a coat weight of
`greater than about 10 mg/cm2 and
`includes greater than 0.156 mg/cm2
`estradiol,
`and the system achieves an
`estradiol flux of from about 0.0125
`to about 0.05 mg/cm2/day,
`
`based on the active surface area.
`
`based on the active surface area.
`
`Noven Pharmaceuticals, Inc.
`EX2024
`Mylan Tech., Inc., v. Noven Pharma., Inc.
`IPR2018-01119
`
`1
`
`
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`1. A monolithic transdermal drug
`delivery system for estradiol,
`consisting of
`
`1. A monolithic transdermal drug
`delivery system for estradiol,
`consisting of
`
`(i) a backing layer,
`
`(i) a backing layer,
`
`(ii) a single adhesive polymer
`matrix layer defining an active
`surface area and,
`
`(ii) a single adhesive polymer
`matrix layer defining an active
`surface area and,
`
`optionally, (iii) a release liner,
`
`optionally, (iii) a release liner,
`
`wherein the single adhesive
`polymer matrix layer comprises an
`adhesive polymer matrix
`comprising estradiol as the only
`drug,
`wherein the adhesive polymer
`matrix layer has a coat weight of
`greater than 10 mg/cm2 and
`includes greater than 0.156 mg/cm2
`estradiol,
`and the system achieves an
`estradiol flux of from 0.0125 to
`about 0.05 mg/cm2/day,
`
`wherein the single adhesive
`polymer matrix layer comprises an
`adhesive polymer matrix
`comprising estradiol as the only
`drug,
`wherein the adhesive polymer
`matrix layer has a coat weight of
`greater than about 10 mg/cm2 and
`includes greater than 0.156 mg/cm2
`estradiol,
`and the system achieves an
`estradiol flux of from about 0.0125
`to about 0.05 mg/cm2/day,
`
`based on the active surface area.
`
`based on the active surface area.
`
`Noven Pharmaceuticals, Inc.
`EX2024
`Mylan Tech., Inc., v. Noven Pharma., Inc.
`IPR2018-01119
`
`1
`
`
`
`Comparison of Claim 2
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`2. The transdermal drug
`delivery system of claim 1,
`
`2. The transdermal drug
`delivery system of claim 1,
`
`wherein the adhesive polymer
`matrix comprises a polymer
`blend comprising
`an acrylic adhesive,
`
`wherein the adhesive polymer
`matrix comprises a polymer
`blend comprising
`an acrylic adhesive,
`
`a silicone adhesive,
`
`a silicone adhesive,
`
`and soluble PVP.
`
`and soluble PVP.
`
`2
`
`
`
`Comparison of Claim 3
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`3. The transdermal drug
`delivery system of claim 1,
`
`3. The transdermal drug
`delivery system of claim 1,
`
`wherein the adhesive polymer
`matrix comprises about 2-
`25% by weight acrylic
`adhesive,
`about 45-70% by weight
`silicone adhesive,
`
`wherein the adhesive polymer
`matrix comprises about 2-
`25% by weight acrylic
`adhesive,
`about 45-70% by weight
`silicone adhesive,
`
`about 2-25% by weight
`soluble PVP,
`about 5-15% penetration
`enhancer,
`and about 0.1-10% by weight
`estradiol,
`all based on the total dry
`weight of the adhesive
`polymer matrix.
`
`about 2-25% by weight
`soluble PVP,
`about 5-15% penetration
`enhancer,
`and about 0.1-10% by weight
`estradiol,
`all based on the total dry
`weight of the adhesive
`polymer matrix.
`
`3
`
`
`
`Comparison of Claim 4
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`4. The transdermal drug
`delivery system of claim 3,
`
`4. The transdermal drug
`delivery system of claim 3,
`
`wherein the penetration
`enhancer comprises oleyl
`alcohol.
`
`wherein the penetration
`enhancer comprises oleyl
`alcohol.
`
`4
`
`
`
`Comparison of Claim 5
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`5. The transdermal drug
`delivery system of claim 3,
`
`5. The transdermal drug
`delivery system of claim 3,
`
`wherein the penetration
`enhancer comprises
`dipropylene glycol.
`
`wherein the penetration
`enhancer comprises
`dipropylene glycol.
`
`5
`
`
`
`Comparison of Claim 6
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`6. The transdermal drug
`delivery system of claim 3,
`
`6. The transdermal drug
`delivery system of claim 3,
`
`wherein the penetration
`enhancer comprises oleyl
`alcohol and dipropylene
`glycol.
`
`wherein the penetration
`enhancer comprises oleyl
`alcohol and dipropylene
`glycol.
`
`6
`
`
`
`Comparison of Claim 7
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`7. The transdermal drug
`delivery system of claim 3,
`
`7. The transdermal drug
`delivery system of claim 3,
`
`wherein the acrylic adhesive
`and silicone adhesive are
`present in a ratio of from
`about 1:2 to about 1:6,
`based on the total weight of
`the acrylic and silicone
`adhesives.
`
`wherein the acrylic adhesive
`and silicone adhesive are
`present in a ratio of from
`about 1:2 to about 1:6,
`based on the total weight of
`the acrylic and silicone
`adhesives.
`
`7
`
`
`
`Comparison of Claim 8
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`8. The transdermal drug
`delivery system of claim 1,
`
`8. The transdermal drug
`delivery system of claim 1,
`
`wherein the adhesive polymer
`matrix comprises an amount
`of estradiol effective to
`deliver a therapeutically
`effective amount of estradiol
`over a period of time selected
`from the group consisting of
`at least 1 day,
`at least 2 days,
`
`wherein the adhesive polymer
`matrix comprises an amount
`of estradiol effective to
`deliver a therapeutically
`effective amount of estradiol
`over a period of time selected
`from the group consisting of
`at least 1 day,
`at least 2 days,
`
`at least 3 days,
`
`at least 3 days,
`
`at least 4 days,
`
`at least 4 days,
`
`at least 5 days,
`
`at least 5 days,
`
`at least 6 days and
`
`at least 6 days and
`
`at least 7 days.
`
`at least 7 days.
`
`8
`
`
`
`Comparison of Claim 9
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`9. The transdermal drug
`delivery system of claim 1,
`
`9. The transdermal drug
`delivery system of claim 1,
`
`wherein the adhesive polymer
`matrix comprises an amount
`of estradiol effective to
`deliver an amount of estradiol
`selected from the group
`consisting of about 0.025,
`
`wherein the adhesive polymer
`matrix comprises an amount
`of estradiol effective to
`deliver an amount of estradiol
`selected from the group
`consisting of about 0.025,
`
`0.0375,
`
`0.05,
`
`0.075 and
`
`0.1 mg/day.
`
`0.0375,
`
`0.05,
`
`0.075 and
`
`0.1 mg/day.
`
`9
`
`
`
`Comparison of Claim 10
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`10. The transdermal drug
`delivery system of claim 1,
`
`10. The transdermal drug
`delivery system of claim 1,
`
`wherein the system achieves
`an estradiol flux of 0.0125
`mg/cm2/day,
`
`wherein the system achieves
`an estradiol flux of about
`0.0125 mg/cm2/day,
`
`based on the active surface
`area.
`
`based on the active surface
`area.
`
`10
`
`
`
`Comparison of Claim 11
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`11. The transdermal drug
`delivery system of claim 1,
`
`11. The transdermal drug
`delivery system of claim 1,
`
`wherein the system achieves
`an estradiol flux of 0.0133
`mg/cm2/day,
`
`wherein the system achieves
`an estradiol flux of about
`0.0133 mg/cm2/day,
`
`based on the active surface
`area.
`
`based on the active surface
`area.
`
`11
`
`
`
`Comparison of Claim 12
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`12. The transdermal drug
`delivery system of claim 1,
`
`12. The transdermal drug
`delivery system of claim 1,
`
`wherein the system achieves
`an estradiol flux of about
`0.015 mg/cm2/day,
`
`wherein the system achieves
`an estradiol flux of about
`0.015 mg/cm2/day,
`
`based on the active surface
`area.
`
`based on the active surface
`area.
`
`12
`
`
`
`Comparison of Claim 13
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`13. The transdermal drug
`delivery system of claim 1,
`
`13. The transdermal drug
`delivery system of claim 1,
`
`wherein the system achieves
`an estradiol flux of about
`0.0167 mg/cm2/day,
`
`wherein the system achieves
`an estradiol flux of about
`0.0167 mg/cm2/day,
`
`based on the active surface
`area.
`
`based on the active surface
`area.
`
`13
`
`
`
`Comparison of Claim 14
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`14. The transdermal drug
`delivery system of claim 1,
`
`14. The transdermal drug
`delivery system of claim 1,
`
`wherein the system achieves
`an estradiol flux of about
`0.0175 mg/cm2/day,
`
`wherein the system achieves
`an estradiol flux of about
`0.0175 mg/cm2/day,
`
`based on the active surface
`area.
`
`based on the active surface
`area.
`
`14
`
`
`
`Comparison of Claim 15
`
`U.S. 9,833,419
`
`U.S. 9,724,310
`
`15. The transdermal drug
`delivery system of claim 1,
`
`15. The transdermal drug
`delivery system of claim 1,
`
`wherein the adhesive polymer
`matrix comprises about 1.6%
`by weight estradiol,
`
`wherein the adhesive polymer
`matrix comprises about 1.6%
`by weight estradiol,
`
`based on the total dry weight
`of the adhesive polymer
`matrix.
`
`based on the total dry weight
`of the adhesive polymer
`matrix.
`
`15
`
`
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