UCB Pharma, Gmbh et al. v. Cipla Limited et al.
Infringement action filed 26 Aug 2021 in the United States District Court for the District of Delaware and closed 27 May 2026, with 4 patents asserted. Recorded basis of termination: judgment on the merits for plaintiff.
Case record
- Patents involved
- US9687495B2US9289432B2US8217033B2US8809322B2
- Case no.
- 1:21-cv-01229
- Verdict cause
- Infringement action
- Court
- D. Del.
- Court level
- District Court
- Case region
- Delaware
- Chief judge
- Jennifer L. Hall
- Trial level
- First instance
- Filed – Closed
- 26 Aug 2021 – 27 May 2026
- Duration
- 1735 days
- Basis of termination
- Judgment on the merits for Plaintiff
- Products & marks
- Midazolam nasal spray (5mg) · NAYZILAM®
Check this patent against your own product
Prior art, claim scope, infringement exposure and design-around routes. Every answer cites the records behind it.
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- 02Claim-level comparisonAgainst your own product
- 03Legal statusAcross 174 jurisdictions
Methods and systems for the delivery of a therapeutic agent
The present invention provides a liquid pharmaceutical composition comprising a therapeutic agent and an alkoxy-polyethylene glycol, for example, methoxy-polyethylene glycol, for administration of the therapeutic agent to the mammal. The compositions can be applied to a membrane, for example, a nasal membrane during intranasal administration. The invention also provides methods of administering such compositions to a mammal.
- Legal status
- Active
- Granted
- 27 Jun 2017
- Earliest priority
- 19 Jan 2007
- Est. expiry
- 18 Jan 2028
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- GIZURARSON, SVEINBJORN
- Classification
- A61K31/55A61K47/10A61K31/5513A61K9/00A61K31/5517A61K9/12
- Prosecution counsel
- KAGAN BINDER, PLLC
- Examiner
- RICCI, CRAIG
Methods and compositions for the delivery of a therapeutic agent
The present invention provides a liquid pharmaceutical composition comprising a therapeutic agent and an alkoxy-polyethylene glycol, for example, methoxy-polyethylene glycol, for administration of the therapeutic agent to the mammal. The compositions can be applied to a membrane, for example, a nasal membrane during intranasal administration. The invention also provides methods of administering such compositions to a mammal.
- Legal status
- Active
- Granted
- 22 Mar 2016
- Earliest priority
- 19 Jan 2007
- Est. expiry
- 18 Jan 2028
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- GIZURARSON, SVEINBJORN
- Classification
- A61K31/55A61K31/5513A61K9/00A61K31/5517A61K47/10A61K9/12
- Prosecution counsel
- KAGAN BINDER, PLLC
- Examiner
- RICCI, CRAIG
Also asserted in this case
2 moreThe docket lists 4 asserted patents. Full bibliographic detail, drawings and prosecution history for the remaining 2 asserted patents are one query away in Eureka.
Parties of record
UCB Pharma, Gmbh
- Core tech
- Not recorded
- Counsel
- Alexa R. Hansen · David S. Denuyl · George F. Pappas · Jack B. Blumenfeld · Kaveh V. Saba · Megan Elizabeth Dellinger · Melissa Keech
- Firm
- Morris, Nichols, Arsht & Tunnell LLP
- Also named
- University of Iceland · UCB Biopharma, SRL · Hananja EHF
Cipla Limited
- Core tech
- Not recorded
- Counsel
- Anil H. Patel · Cortlan S. Hitch · Harold M. Storey · Jenna Bruce · Kenneth Laurence Dorsney · Peter L. Giunta
- Firm
- Morris James LLP
- Also named
- CIPLA USA, Inc.
Counsel of record
| Attorney | For | Role |
|---|---|---|
| Alexa R. Hansen | UCB Pharma, Gmbh | Plaintiff |
| David S. Denuyl | UCB Pharma, Gmbh | Plaintiff |
| George F. Pappas | UCB Pharma, Gmbh | Plaintiff |
| Jack B. Blumenfeld | UCB Pharma, Gmbh | Plaintiff |
| Kaveh V. Saba | UCB Pharma, Gmbh | Plaintiff |
| Megan Elizabeth Dellinger | UCB Pharma, Gmbh | Plaintiff |
| Melissa Keech | UCB Pharma, Gmbh | Plaintiff |
| Anil H. Patel | Cipla Limited | Defendant |
| Cortlan S. Hitch | Cipla Limited | Defendant |
| Harold M. Storey | Cipla Limited | Defendant |
| Jenna Bruce | Cipla Limited | Defendant |
| Kenneth Laurence Dorsney | Cipla Limited | Defendant |
| Peter L. Giunta | Cipla Limited | Defendant |
Basis of termination
From the record · verbatim“This action, having been tried before the Court from October 2–5, 2023, Honorable Jennifer L. Hall presiding, the evidence and testimony of witnesses of each side having been heard and a decision having been rendered; IT IS HEREBY ORDERED AND ADJUDGED this ______ day of May 2026, for the reasons set forth in the May 15, 2026 Opinion (D.I. 199), that: 1. Judgment is entered in favor of Plaintiffs UCB Inc., UCB BioPharma SRL, Hananja EHF, and the University of Iceland, and against Defendants Cipla Limited and Cipla USA Inc. (together, “Cipla”) on Plaintiffs’ claim that Cipla’s filing of Abbreviated New Drug Application No. 216048 (“Cipla’s ANDA”) infringed Claim 13 of the ’033 Patent and Claim 10 of the ’322 Patent and that the commercial manufacture, use, sale or offer for sale in the United States, or importation into the United States, of the product that is the subject of Cipla’s ANDA (“Cipla’s ANDA Product”) would infringe Claim 13 of the ’033 Patent and Claim 10 of the ’322 Patent. 2. Judgment is entered in favor of Plaintiffs and against Cipla on Cipla’s counterclaims for invalidity of Claim 13 of the ’033 Patent and Claim 10 of the ’322 Patent. 27th Case 1:21-cv-01229-JLH Document 202 Filed 05/27/26 Page 1 of 3 PageID #: 19025 2 3. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any final approval by the Food and Drug Administration of Cipla’s ANDA No. 216048 shall be a date that is not earlier than the date of expiration of the ’033 Patent and the ’322 Patent, and any additional periods of exclusivity to which Plaintiffs have or may become entitled. 4. Pursuant to 35 U.S.C. § 271(e)(4)(B), Cipla and each of its officers, agents, servants, employees, successors, and attorneys, and all persons and entities acting in concert or participation with them, are enjoined, until the expiration of the ’033 Patent and the ’322 Patent from commercially manufacturing, using, selling or offering for sale in the United States, or importing into the United States, Cipla’s ANDA Product. * * * Any motion for attorneys’ fees and/or costs, including but not limited to any motion that this case is exceptional under 35 U.S.C. § 285, or a bill of costs pursuant to D. Del. LR 54.1, shall be considered timely if filed and served within thirty (30) days after the issuance of a mandate from the Federal Circuit, if any appeal is filed, or the time for appeal to the Federal Circuit expires, if no appeal is filed. Any oppositions to any such motion shall be considered timely if filed and served within thirty (30) days after the motion is filed.”
Case 1:21-cv-01229 · D. Del. · closed 27 May 2026
Related cases
Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.
Frequently asked questions
What is case 1:21-cv-01229?
1:21-cv-01229 is a patent infringement action brought by UCB Pharma, Gmbh against Cipla Limited, filed on 26 Aug 2021 in the United States District Court for the District of Delaware. The case closed on 27 May 2026.
Which patents were asserted in 1:21-cv-01229?
US9687495B2 (“Methods and systems for the delivery of a therapeutic agent”), assigned to HANANJA EHF, currently active; US9289432B2 (“Methods and compositions for the delivery of a therapeutic agent”), assigned to HANANJA EHF, currently active; US8217033B2 (“Methods and compositions for the delivery of a therapeutic agent”), assigned to HANANJA EHF|UNIVERSITY OF ICELAND; US8809322B2 (“Methods and compositions for the delivery of a therapeutic agent”), assigned to HANANJA EHF|UNIVERSITY OF ICELAND. The record also lists Midazolam nasal spray (5mg) and NAYZILAM®.
How was case 1:21-cv-01229 terminated?
The recorded basis of termination is judgment on the merits for plaintiff. The termination text reads: “This action, having been tried before the Court from October 2–5, 2023, Honorable Jennifer L. Hall presiding, the evidence and testimony of witnesses of each side having been heard and a decision having been rendered; IT IS HEREBY ORDERED AND ADJUDGED this ______ day of May 2026, for the reasons set forth in the May 15, 2026 Opinion (D.I. 199), that: 1. Judgment is entered in favor of Plaintiffs UCB Inc., UCB BioPharma SRL, Hananja EHF, and the University of Iceland, and against Defendants Cipla Limited and Cipla USA Inc. (together, “Cipla”) on Plaintiffs’ claim that Cipla’s filing of Abbrevi
What does judgment on the merits mean?
A judgment on the merits decides the substance of the claims, as opposed to ending the case on procedural grounds.
How long did case 1:21-cv-01229 take?
1735 calendar days, from filing on 26 Aug 2021 to closure on 27 May 2026.
Who were the attorneys and the judge in 1:21-cv-01229?
Chief Judge Jennifer L. Hall presided. Alexa R. Hansen, David S. Denuyl, George F. Pappas, Jack B. Blumenfeld, Kaveh V. Saba, Megan Elizabeth Dellinger and Melissa Keech are recorded as counsel for plaintiff UCB Pharma. Anil H. Patel, Cortlan S. Hitch, Harold M. Storey, Jenna Bruce, Kenneth Laurence Dorsney and Peter L. Giunta appear for defendant Cipla.
Disclaimer. This page reproduces publicly available court docket data for case 1:21-cv-01229 and is provided for general information and reference only. It is not legal advice and must not be relied upon as such.
Docket data has limits. Records are drawn from a snapshot and may lag the live docket. Sealed filings, amended complaints, counterclaims and post-closure motions may not be reflected. Party names, attorney names and firm affiliations are reproduced as recorded and may contain omissions. Where a field is absent from the record, this page marks it as not recorded rather than inferring a value.
No characterisation of the parties or the outcome. This page reports what the record contains. Nothing here should be read as an assertion that any party infringed, that any patent is valid or invalid, that any settlement occurred, or that any party prevailed.
No FTO or validity opinion. Nothing on this page constitutes a freedom-to-operate, novelty, validity or infringement opinion. Any decision touching a live patent dispute should be verified independently and reviewed with qualified patent counsel.