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Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson Laboratories Inc., et al. DC CAFC
- 1:13-cv-01674
- D. Del.
- Judge: Richard G. Andrews
- Filed: 10/08/2013
- Closed: 09/05/2019
- Latest Docket Entry: 02/28/2020
- PACER
- Docket updated daily
3
Plaintiffs
5
Defendants
2
Accused
Products
3
Patents-in-Suit
2,159
Days in
Litigation
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Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson Laboratories Inc., et al. DC CAFC
- 1:13-cv-01674
- D. Del.
- Judge: Richard G. Andrews
- Filed: 10/08/2013
- Closed: 09/05/2019
- Latest Docket Entry: 02/28/2020
- PACER
- Docket updated daily
Market Sector
Biotech and Pharma
Court
Assigned Judge
Outcome Summary
- Patent Information
-
Validity & Enforceability
Claim # | Claim Text | Outcome |
---|---|---|
1 |
A mucosally-adhesive water-soluble film product comprising: an analgesic opiate pharmaceutical active; and at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer; wherein:
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|
Invalid (103)
Entry 453 |
4 |
The film product according to claim 1, further comprising an additional pharmaceutical active.
|
Invalid (103)
Entry 453 |
10 |
A mucosally-adhesive water-soluble film product comprising: an analgesic opiate pharmaceutical active; and at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer; wherein:
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Invalid (103)
Entry 453 |
13 |
The film product according to claim 10, further comprising an additional pharmaceutical active.
|
Invalid (103)
Entry 453 |
Claim # | Claim Text | Outcome |
---|---|---|
1 |
A film dosage composition comprising: a. A polymeric carrier matrix; b. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof; c. A therapeutically effective amount of naloxone or a pharmaceutically
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Invalid (103)
Entry 452 Entry 453 |
3 |
The composition of claim 1, wherein said polymeric carrier matrix comprises at least one polymer in an amount of at least 25% by weight of said composition.
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Invalid (103)
Entry 452 Entry 453 |
6 |
The film dosage composition of claim 1, wherein said buprenorphine is present in an amount of from about 2 mg to about 16 mg per dosage.
|
Invalid (103)
Entry 452 Entry 453 |
15 |
An orally dissolving film formulation comprising buprenorphine and naloxone, wherein said formulation provides an in vivo plasma profile having a Cmax of between about 0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in vivo plasma profile
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Invalid (103)
Entry 452 Entry 453 |
16 |
The formulation of claim 15, wherein said formulation provides a mean AUC of between about 5.431 hr·ng/ml to about 56.238 hr·ng/ml for buprenorphine.
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Invalid (103)
Entry 452 Entry 453 |
17 |
The formulation of claim 15, wherein said formulation provides a mean AUC of between about 102.88 hr·pg/ml to about 812.00 hr·pg/ml for naloxone.
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Invalid (103)
Entry 452 Entry 453 |
18 |
The formulation of claim 15, wherein said formulation comprises about 2 to about 16 mg of buprenorphine or a salt thereof.
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Invalid (103)
Entry 452 Entry 453 |
19 |
The formulation of claim 15, wherein said formulation comprises about 0.5 to about 4 mg of naloxone or a salt thereof.
|
Invalid (103)
Entry 452 Entry 453 |
Claim # | Claim Text | Outcome |
---|---|---|
62 |
A drug delivery composition comprising: (i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one
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Invalid (103)
Entry 453 |
64 |
The drug delivery composition of claim 62, wherein the particulate active has a particle size of 100 microns or less.
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Invalid (103)
Entry 453 |
65 |
The drug delivery composition of claim 62, wherein said variation of drug content is less than 5% by weight per film dosage unit.
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Invalid (103)
Entry 453 |
69 |
The drug delivery composition of claim 62, wherein said taste-masking agent is present in the amount of about 0.1-30% by weight of the drug delivery composition.
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Invalid (103)
Entry 453 |
73 |
The drug delivery composition of claim 62, wherein said active is an opiate or opiate derivative.
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Invalid (103)
Entry 453 |
All Claims |
NA
|
Valid
Entry 446 |
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Infringement
Actavis Laboratories UT Incorporated
- 3 Details
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Buprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mg | US 8,017,150 B2 |
1, 4, 10, 13
|
Infringement
Entry 452Entry 453 |
aloxone hydrochloride sublingual filmBuprenorphine hydrochlorideBuprenorphine hydrochloride 12 mg/3 mgBuprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mgnaloxone hydrochloride sublingual film 12 mg/3 mg | US 8,475,832 B2 |
1, 3, 6, 15, 16, 17, 18, 19
|
Infringement
Entry 452Entry 453 Entry 446 |
Buprenorphine hydrochlorideBuprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mgnaloxone hydrochloride sublingual film | US 8,603,514 B2 |
62, 64, 65, 69, 73
|
Infringement
Entry 452Entry 453 Entry 446 |
Watson Laboratories, Inc. (Connecticut)
- 3 Details
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Buprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mg | US 8,017,150 B2 |
1, 4, 10, 13
|
Infringement
Entry 452Entry 453 |
aloxone hydrochloride sublingual filmBuprenorphine hydrochlorideBuprenorphine hydrochloride 12 mg/3 mgBuprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mgnaloxone hydrochloride sublingual film 12 mg/3 mg | US 8,475,832 B2 |
1, 3, 6, 15, 16, 17, 18, 19
|
Infringement
Entry 452Entry 453 Entry 446 |
Buprenorphine hydrochlorideBuprenorphine hydrochloride and naloxone hydrochloride sublingual filmGeneric buprenorphine hydrochloride in 12 mg/3 mgGeneric buprenorphine hydrochloride in 2 mg/0.5 mgGeneric buprenorphine hydrochloride in 4 mg/I mgGeneric buprenorphine hydrochloride in 8 mg/2 mgnaloxone hydrochloride sublingual film | US 8,603,514 B2 |
62, 64, 65, 69, 73
|
Infringement
Entry 452Entry 453 Entry 446 |