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Tris Pharma Inc. v. Actavis Laboratories FL Inc. DC CAFC
- 1:14-cv-01309
- D. Del.
- Filed: 10/15/2014
- Closed: 12/04/2020
- Latest Docket Entry: 08/15/2022
- Judge: Colm F. Connolly
- PACER
1
Plaintiff
6
Defendants
1
Accused
Product
6
Patents-in-Suit
2,243
Days in
Litigation
-
Tris Pharma Inc. v. Actavis Laboratories FL Inc. DC CAFC
- 1:14-cv-01309
- D. Del.
- Filed: 10/15/2014
- Closed: 12/04/2020
- Latest Docket Entry: 08/15/2022
- Judge: Colm F. Connolly
- PACER
Market Sector
Biotech and Pharma
Court
Assigned Judge
Outcome Summary
Patent Information
-
Validity & Enforceability
| Claim # | Claim Text | Outcome |
|---|---|---|
| 6 |
The suspension according to claim 1, wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for d-methylphenidate has an area under the curve (AUC)<sub>0-∞</sub> of about 114 ng-hr/mL to about 180
view more
|
Invalid (103)
Entry 161 |
| 13 |
The suspension according to claim 1, wherein said suspension contains at least about 80% of water by weight based on the total weight of the suspension.
|
Invalid (103)
Entry 161 |
| 16 |
The suspension according to claim 1, wherein the suspension contains about 10 to about 30 parts by weight of methylphenidate as provided in the immediate release component and to about 70 to about 90 parts by weight of sustained release
view more
|
Invalid (103)
Entry 161 |
| 18 |
The suspension according to claim 17, wherein the buffering agent is a mixture of sodium citrate and anhydrous citric acid.
|
Invalid (103)
Entry 161 |
| 20 |
The method according to claim 19, wherein the suspension which has a pH from about 4 to about 4.5.
|
Invalid (103)
Entry 161 |
| 25 |
The powder blend according to claim 24, wherein the surfactant in the diluent granules comprises a poloxamer.
|
Invalid (103)
Entry 161 |
| 30 |
The methylphenidate aqueous extended release oral suspension according to claim 29, which has less than about 3% loss in potency over a period of at least about 4 months of storage at room temperature.
|
Invalid (103)
Entry 161 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 4 |
The suspension according to claim 1, wherein said suspension contains at least about 80% of water by weight based on the total weight of the suspension.
|
Invalid (103)
Entry 161 |
| 10 |
The method according to claim 9, wherein the suspension which has a pH from about 4 to about 4.5.
|
Invalid (103)
Entry 161 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 15 |
The suspension according to claim 14 which comprises about 10 to about 30 parts by weight of methylphenidate as provided in the immediate release component and to about 70 to about 90 parts by weight of methylphenidate as provided in the sustained
view more
|
Invalid (103)
Entry 161 |
| 16 |
The suspension according to claim 1, wherein said suspension contains at least about 80% of water by weight based on the total weight of the suspension.
|
Invalid (103)
Entry 161 |
| 20 |
The suspension according to claim 3, wherein the suspension has less than about 5% loss in potency over a period of at least about 4 months at room temperature.
|
Invalid (103)
Entry 161 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 12 |
The methylphenidate aqueous extended release oral suspension according to claim 11, wherein the hydrophilic polymer is polyvinylpyrrolidone.
|
Invalid (103)
Entry 161 |
| 22 |
The methylphenidate aqueous extended release oral suspension according to claim 19, which has less than about 5% loss in potency over a period of about 4 months of storage at room temperature.
|
Invalid (103)
Entry 161 |
| 23 |
The methylphenidate aqueous extended release oral suspension according to claim 19, which has less than about 1% of threo-α-phenyl-2-piperidineacetic acid hydrochloride impurity after a period of about 4 months of storage at room temperature.
|
Invalid (103)
Entry 161 |
| 25 |
The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a therapeutically effective plasma profile for methylphenidate for about 12 hours following a single oral administration of an
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|
Invalid (103)
Entry 161 |
| 26 |
The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a single mean average plasma concentration peak for methylphenidate following a single oral administration of an aqueous suspension
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|
Invalid (103)
Entry 161 |
| 27 |
The methylphenidate aqueous extended release oral suspension according to claim 17, wherein said suspension provides a therapeutically effective amount of methylphenidate within 45 minutes after administration following a single oral administration
view more
|
Invalid (103)
Entry 161 |
| 33 |
The methylphenidate aqueous extended release oral suspension according to claim 17, wherein the barrier coating comprises ethylcellulose.
|
Invalid (103)
Entry 161 |
-
Infringement
Actavis Laboratories FL Incorporated
- 3 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| 5mg/ml Methylphenidate hydrochloride extended release oral suspension | US 8,465,765 B2 |
6, 20
|
Infringement
Entry 204
|
| 5mg/ml Methylphenidate hydrochloride extended release oral suspension | US 8,563,033 B1 |
4, 10
|
Infringement
Entry 204
|
| 5mg/ml Methylphenidate hydrochloride extended release oral suspension | US 8,778,390 B2 |
15, 16, 20
|
Infringement
Entry 204
|