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The Medicines Company v. Mylan Inc. et al DC CAFC
- 1:11-cv-01285
- N.D. Ill.
- Judge: Amy J. St. Eve
- Filed: 02/23/2011
- Closed: 10/27/2014
- Latest Docket Entry: 11/01/2017
- PACER
- Docket updated daily
1
Plaintiff
3
Defendants
1
Accused
Product
2
Patents-in-Suit
1,343
Days in
Litigation
-
The Medicines Company v. Mylan Inc. et al DC CAFC
- 1:11-cv-01285
- N.D. Ill.
- Judge: Amy J. St. Eve
- Filed: 02/23/2011
- Closed: 10/27/2014
- Latest Docket Entry: 11/01/2017
- PACER
- Docket updated daily
Market Sector
Biotech and Pharma
Assigned Judge
Outcome Summary
- Patent Information
-
Validity & Enforceability
Claim # | Claim Text | Outcome |
---|---|---|
1 |
Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6
view more
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
2 |
The pharmaceutical batches of claim 1, wherein the maximum impurity level of Asp<sup>9</sup>-bivalirudin does not exceed about 0.4% as measured by HPLC.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
3 |
The pharmaceutical batches of claim 2, wherein the maximum impurity level of Asp<sup>9</sup>-bivalirudin does not exceed about 0.3% as measured by HPLC.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
7 |
The pharmaceutical batches of claim 1, wherein the batches have a maximum level of <smallcaps>D</smallcaps>-Phe<sup>12</sup>-bivalirudin that does not exceed about 2.5% as measured by HPLC.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
8 |
The pharmaceutical batches of claim 1, wherein the pharmaceutically acceptable carrier comprises one or more of a bulking agent or a stabilizing agent.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
9 |
The pharmaceutical batches of claim 8, wherein the bulking agent is a sugar.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
10 |
The pharmaceutical batches of claim 9, wherein the sugar is mannitol.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
17 |
The pharmaceutical batches of claim 1, wherein the base is sodium hydroxide.
|
Enforceable and Valid (101 and 102 and 103 and 112)
Entry 615 Entry 590 |
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Infringement
Bioniche Pharma USA LLC
- 2 Details
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Proposed bivalirudin drug | US 7,582,727 B1 |
1, 2, 3, 7, 8, 9, 10, 17
|
Infringement
Entry 615Entry 590 |
250 mg/vial generic bivalirudin intravenous injection | US 7,598,343 B1 |
1, 2, 3, 7, 8, 9, 10, 11
|
No infringement
Entry 615Entry 308 |
Mylan Incorporated
- 2 Details
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Proposed bivalirudin drug | US 7,582,727 B1 |
1, 2, 3, 7, 8, 9, 10, 17
|
Infringement
Entry 615Entry 590 |
250 mg/vial generic bivalirudin intravenous injection | US 7,598,343 B1 |
1, 2, 3, 7, 8, 9, 10, 11
|
No infringement
Entry 615Entry 308 |
Mylan Pharmaceuticals Incorporated
- 2 Details
Accused Product | Patent # | Claim # | Outcome |
---|---|---|---|
Proposed bivalirudin drug | US 7,582,727 B1 |
1, 2, 3, 7, 8, 9, 10, 17
|
Infringement
Entry 615Entry 590 |
250 mg/vial generic bivalirudin intravenous injection | US 7,598,343 B1 |
1, 2, 3, 7, 8, 9, 10, 11
|
No infringement
Entry 615Entry 308 |