-
Janssen Pharmaceuticals, Inc., et al. v. Tolmar, Inc. DC CAFC
- 1:21-cv-01784
- D. Del.
- Judge: William C. Bryson +1
- Filed: 12/21/2021
- Closed: 03/13/2024
- Latest Docket Entry: 04/24/2024
- PACER
- Docket updated daily
2
Plaintiffs
4
Defendants
5
Accused
Products
1
Patent-in-Suit
814
Days in
Litigation
-
Janssen Pharmaceuticals, Inc., et al. v. Tolmar, Inc. DC CAFC
- 1:21-cv-01784
- D. Del.
- Judge: William C. Bryson +1
- Filed: 12/21/2021
- Closed: 03/13/2024
- Latest Docket Entry: 04/24/2024
- PACER
- Docket updated daily
Assigned Judge
Outcome Summary
- Patent Information
-
Validity & Enforceability
Claim # | Claim Text | Outcome |
---|---|---|
1 |
A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising (1) administering intramuscularly in the deltoid of a patient
view more
|
Valid
Entry 169 |
2 |
The dosing regimen of claim 1 wherein after administration of the first maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150 mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of
view more
|
Valid
Entry 169 |
3 |
The dosing regimen of claim 1 wherein the sustained release formulation is an aqueous nanoparticle suspension.
|
Valid
Entry 169 |
4 |
A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for psychotic disorder comprising (a) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about
view more
|
Valid
Entry 169 |
5 |
The dosing regimen of claim 4 wherein the sustained release formulation is an aqueous nanoparticle suspension.
|
Valid
Entry 169 |
6 |
The dosing regimen of claim 4 wherein the psychiatric patient is in need of treatment for psychotic disorder wherein the psychotic disorder is schizophrenia.
|
Valid
Entry 169 |
7 |
The dosing regimen of claim 4 wherein the psychiatric patient is in need of treatment for a psychotic disorder wherein the psychotic disorder is schizoaffective disorder.
|
Valid
Entry 169 |
8 |
A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising (a) administering intramuscularly in the
view more
|
Valid
Entry 169 |
9 |
The dosing regimen of claim 8 wherein after the first maintenance dose, subsequent maintenance doses of from about 25 mg-eg. to 150 mg-eg. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of treatment of monthly
view more
|
Valid
Entry 169 |
10 |
The dosing regimen of claim 8 wherein the sustained release formulation is an aqueous nanoparticle suspension.
|
Valid
Entry 169 |
11 |
A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment for psychotic disorder comprising (a) administering intramuscularly in the deltoid of a renally impaired psychiatric patient in
view more
|
Valid
Entry 169 |
12 |
The dosing regimen of claim 11 wherein the sustained release formulation is an aqueous nanoparticle suspension.
|
Valid
Entry 169 |
13 |
The dosing regimen of claim 11 wherein the psychiatric patient is in need of treatment for of a psychotic disorder wherein the psychotic disorder is schizophrenia.
|
Valid
Entry 169 |
14 |
The dosing regimen of claim 11 wherein the psychiatric patient is in need of treatment for a psychotic disorder wherein the psychotic disorder is schizoaffective disorder.
|
Valid
Entry 169 |
15 |
The dosing regimen of claim 4 wherein after administration of the first maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150 mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of
view more
|
Valid
Entry 169 |
16 |
The dosing regimen of claim 11 wherein after administration of the first maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150 mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of
view more
|
Valid
Entry 169 |
17 |
The dosing regimen of claim 1, 4, 8 or 11 wherein the formulation is an aqueous nanoparticle suspension comprises (a) from 3 to 20% (w/v) of the paliperidone palmitate having an average particle size (d50) of from about 1600 nm to about 900 nm; (b)
view more
|
Valid
Entry 169 |
18 |
The dosage regimen of claim 17 wherein the concentration of paliperidone palmitate is 156 mg/ml in the aqueous nanoparticle suspension.
|
Valid
Entry 169 |
19 |
The dosing regimen of claims 1, 4, 8 or 11 wherein the sustained release depot formulation is an aqueous nanoparticle suspension consists essentially of (a) 156 mg/ml of the paliperidone palmitate having an average particle size (d50) of from about
view more
|
Valid
Entry 169 |
20 |
The dosage regimen of claim 19 wherein in the buffering agents contained in the aqueous nanoparticle suspension are citric acid monohydrate, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium hydroxide.
|
Valid
Entry 169 |
21 |
The dosage regimen of claim 19 wherein in the pH of the aqueous nanoparticle suspension is in the range of pH 7 to 7.5.
|
Valid
Entry 169 |
-
Infringement
Tolmar Incorporated
- 1 Detail
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Generic paliperidone palmitate extended-release injectable suspension, 117 mgGeneric paliperidone palmitate extended-release injectable suspension, 156 mgGeneric paliperidone palmitate extended-release injectable suspension, 234 mgGeneric paliperidone palmitate extended-release injectable suspension, 39 mgGeneric paliperidone palmitate extended-release injectable suspension, 78 mg | US 9,439,906 B2 |
1, 2, 3, 4, 5, 6, 7, 15, 17, 18, 19, 20, 21
|
Infringement
Entry 169
|