-
SHIRE LLC et al v. AMNEAL PHARMACEUTICALS, LLC DC CAFC
- 2:11-cv-03781
- D.N.J.
- Judge: Stanley R. Chesler
+2
- Filed: 06/30/2011
- Closed: 07/22/2014
- Latest Docket Entry: 08/30/2016
- PACER
3
Plaintiffs
8
Defendants
1
Accused
Product
19
Patents-in-Suit
1,119
Days in
Litigation
-
SHIRE LLC et al v. AMNEAL PHARMACEUTICALS, LLC DC CAFC
- 2:11-cv-03781
- D.N.J.
- Judge: Stanley R. Chesler
+2
- Filed: 06/30/2011
- Closed: 07/22/2014
- Latest Docket Entry: 08/30/2016
- PACER
Cause of Action
Willful Patent Infringement
Market Sector
Biotech and Pharma
Court
Referred Judges
Assigned Judge
Outcome Summary
- Patent Information
-
Validity & Enforceability
| Claim # | Claim Text | Outcome |
|---|---|---|
| 3 |
L-lysine-d-amphetamine mesylate.
|
Valid (102 and 103)
Entry 699 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 1 |
Crystalline lisdexamphetamine dimesylate.
|
Valid (102 and 103)
Entry 699 |
| 2 |
The crystalline lisdexamphetamine dimesylate of claim 1, wherein the crystalline lisdexamphetamine dimesylate exhibits an X-ray powder diffraction pattern substantially as shown in <figref idref="DRAWINGS">FIG. 77</figref>.
|
Valid (102 and 103)
Entry 699 |
| 3 |
The crystalline lisdexamphetamine dimesylate of claim 1, wherein the crystalline lisdexamphetamine dimesylate exhibits an X-ray powder diffraction pattern having at least one peak in degrees 2Θ±0.2 2Θ selected from 4.5, 9.0, 12.0, 15.7, and 16.3.
|
Valid (102 and 103)
Entry 699 |
| 4 |
The crystalline lisdexamphetamine dimesylate of claim 3, wherein the dimesylate exhibits an X-ray powder diffraction pattern having at least two peaks in degrees 2Θ±0.2 2Θ selected from 4.5, 9.0, 12.0, 15.7, and 16.3.
|
Valid (102 and 103)
Entry 699 |
| 5 |
The crystalline lisdexamphetamine dimesylate of claim 4, wherein the dimesylate exhibits an X-ray powder diffraction pattern having peaks in degrees 2Θ±0.2 2Θ at 4.5, 9.0, 12.0 and 15.7.
|
Valid (102 and 103)
Entry 699 |
| 6 |
The crystalline lisdexamphetamine dimesylate of claim 1, wherein the crystalline lisdexamphetamine dimesylate has a melting point onset as determined by differential scanning calorimetry at about 194.7° C.
|
Valid (102 and 103)
Entry 699 |
| 7 |
The crystalline lisdexamphetamine dimesylate of claim 1, wherein the crystalline lisdexamphetamine dimesylate exhibits a single crystal X-ray crystallographic analysis at 150 K with crystal parameters that are approximately equal to the
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|
Valid (102 and 103)
Entry 699 |
| 8 |
Crystalline lisdexamphetamine dimesylate particles having at least one of: (a) a d<sub>10 </sub>ranging from about 1 to about 10 μm; (b) a d<sub>50 </sub>ranging from about 8 to about 40 μm; and (c) a d<sub>50 </sub>particle size ranging from about
view more
|
Valid (102 and 103)
Entry 699 |
| 9 |
The crystalline lisdexamphetamine dimesylate particles of claim 8, wherein the crystalline lisdexamphetamine dimesylate has a d<sub>90 </sub>particle size ranging from about 25 to about 90 μm.
|
Valid (102 and 103)
Entry 699 |
| 10 |
The crystalline lisdexamphetamine dimesylate particles of claim 8, wherein the crystalline lisdexamphetamine dimesylate has a d<sub>50 </sub>ranging from about 8 to about 40 μm.
|
Valid (102 and 103)
Entry 699 |
| 11 |
A pharmaceutical composition comprising crystalline lisdexamphetamine dimesylate of claim 1 and a pharmaceutically acceptable additive.
|
Valid (102 and 103)
Entry 699 |
| 12 |
The pharmaceutical composition of claim 11, wherein the pharmaceutical composition comprises at least about 95% by weight of crystalline lisdexamphetamine dimesylate, based upon 100% total weight of lisdexamphetamine dimesylate in the pharmaceutical
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|
Valid (102 and 103)
Entry 699 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 1 |
The compound, L-lysine-d-amphetamine dimesylate.
|
Valid (102 and 103)
Entry 699 |
| 2 |
A compound as defined in claim 1, having a water content of about 0% to about 5% by Karl Fischer analysis.
|
Valid (102 and 103)
Entry 699 |
| 3 |
A compound as defined in claim 1, having a water content of about 0.1% to about 3% by Karl Fischer analysis.
|
Valid (102 and 103)
Entry 699 |
| 4 |
A compound as defined in claim 1, having a water content of about 0.25% to about 2% by Karl Fischer analysis.
|
Valid (102 and 103)
Entry 699 |
| Claim # | Claim Text | Outcome |
|---|---|---|
| 4 |
The method of 3, wherein the salt is a mesylate salt of L-lysine-d-amphetamine.
|
Valid (102 and 103)
Entry 699 |
-
Infringement
Actavis Elizabeth LLC
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Actavis LLC
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Amneal Pharmaceuticals, LLC
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Johnson Matthey Incorporated
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703
|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Johnson Matthey Pharmaceutical Materials
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703
|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Mylan Incorporated
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Mylan Pharmaceuticals Incorporated
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Roxane Laboratories Incorporated
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
Sandoz Inc.
- 4 Details
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| Generic lisdexamfetamine dimesylate oral capsules | US 7,105,486 B2 |
4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,655,630 B2 |
1, 2, 3, 4
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,659,253 B2 |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Infringement
Entry 703Entry 699 |
| Generic lisdexamfetamine dimesylate oral capsules | US 7,662,787 B2 |
3
|
Infringement
Entry 703Entry 699 |
| Accused Product | Patent # | Claim # | Outcome |
|---|---|---|---|
| US 7,659,254 B2 |
2, 3, 4, 5, 6, 7, 8
|
No infringement
Entry 699
|
|
| US 7,662,788 B2 |
1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 25, 26, 27, 28, 30, 31, 32, 33, 34, 35, 37, 38, 39, 40, 41, 42, 44, 45, 46, 47
|
No infringement
Entry 699
|
|
| US 7,678,770 B2 |
19, 20, 21, 22, 23, 24
|
No infringement
Entry 699
|
