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UCB Pharma v. Annora & MSN – Brivaracetam Patent Litigation | PatSnap
Patent Litigation

UCB Pharma v. Annora & MSN: Brivaracetam Injunction After 1,145-Day ANDA Battle

UCB Pharma GmbH and UCB Biopharma SRL sued ten generic pharmaceutical defendants in Delaware over US Patent No. 6,911,461 covering brivaracetam (Briviact®) tablets. After a four-day bench trial, the court found Claim 5 infringed and not invalid — delivering an injunction against Annora and blocking MSN's ANDA effective date until patent expiry.

Resolution time
1145days
1,145 days from filing to close — a full bench trial ANDA dispute resolved in just over three years
Patents asserted
3
US6911461 — brivaracetam tablets (10–100 mg), anti-epileptic compound patent; 2 further patents also asserted (US6784197, US8492416)
Outcome
Injunction Granted
Court-ordered injunction under 35 U.S.C. §271(e)(4)(B); MSN ANDA effective date deferred to patent expiry
Cost ruling
Bench Trial
Four-day bench trial held November 14–18, 2022; court opinion issued August 16, 2023
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

How UCB Secured an Anti-Generic Injunction for Briviact®

On July 24, 2020, UCB Pharma GmbH and UCB Biopharma SRL filed suit in the District of Delaware against ten generic pharmaceutical defendants — including Annora Pharma, MSN Laboratories, Apotex, Lupin, Zydus, Micro Labs, Sunshine Lake Pharma, and Aurobindo — alleging that their Abbreviated New Drug Application filings for generic brivaracetam tablets (10 mg, 25 mg, 50 mg, 75 mg, and 100 mg) infringed three UCB patents: US6911461, US6784197, and US8492416. The branded product at issue is Briviact®, an anti-epileptic medication.

The case proceeded to a four-day bench trial in November 2022. On August 16, 2023, the court issued its opinion and order finding Claim 5 of US6911461 infringed by MSN's ANDA filings and not invalid. Judgment was entered for UCB and against MSN on both infringement and MSN's invalidity and unenforceability counterclaims. The court enjoined Annora under 35 U.S.C. §271(e)(4)(B) from commercially manufacturing, using, selling, or importing its ANDA products until expiry of the '461 Patent. MSN's ANDA effective date was deferred to no earlier than patent expiry. Claims relating to the two expired patents (US6784197 and US8492416) were dismissed as moot.

The 1,145-day duration reflects the complexity of multi-defendant ANDA litigation with parallel validity challenges. UCB achieved a strong outcome on its core composition patent, though claims on the two expired patents were rendered moot before trial concluded. The disposition of defendants other than Annora and MSN — including Apotex, Lupin, Zydus, Micro Labs, Sunshine Lake, and Aurobindo — is not fully detailed in the available record beyond the verdict text addressing Annora and MSN specifically.

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Case at a glance
CourtDelaware District Court
JudgeN/A
FiledJuly 24, 2020
ClosedSeptember 12, 2023
Duration1145 days
OutcomeInjunction Granted
Verdict causeInfringement Action
BasisInjunction Granted
Prior Art Intelligence
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Case timeline

Filing to Injunction Granted in 1145 days

1,145 days from filing to close — a full bench trial ANDA dispute resolved in just over three years

Case timeline: Complaint filed JUL 24 2020 — 1145 days total Horizontal timeline showing the three key events in UCB Pharma, Gmbh v Annora Pharma Private, Ltd. from filing to resolution. Source: PACER, Delaware District Court. JUL 24 2020 Complaint filed Pre-trial proceedings SEP 12 2023 Injunction Granted 1145 DAYS TOTAL
Patent at issue

US6911461 — Brivaracetam compound and anti-epileptic use

Publication No.US8492416B2
Application No.US13/222477
Patent details
ProductBrivaracetam anti-epileptic compound formulations — Briviact® tablets 10–100 mg
Cited in actionJuly 24, 2020

Publication No.US6911461B2
Application No.US10/693917
Patent details
ProductBrivaracetam anti-epileptic compound (core composition patent)
Cited in actionJuly 24, 2020

Publication No.US6784197B2
Application No.US10/204266
Patent details
ProductBrivaracetam-related pharmaceutical compound or formulation
Cited in actionJuly 24, 2020
Technical brief · sourced from PatSnap patent database
Representative claim (1 of 1 independent)
1. A method for treatment of epilepsy, seizure disorders and convulsions comprising administering to a mammal in need thereof a therapeutically effective amount of (2S)-2-[(4R)-2-oxo-4-propylpyrrolidinyl]butanamide.
Technical background
This is a divisional of Ser. No. 10/20/1,266 filed Aug. 20, 2002, which is a 371 of PCT/EP01/01992 filed Feb. 21, 2001. This application is a continuation application of U.S. application Ser. No. 12/656,808, filed Feb. 17, 2010, now allowed, which is a divisional of U.S. application Ser. No. 12/000,512, filed Dec. 13, 2007, now issued as U.S. Pat. No. 7,692,028, which is a continuation of U.S. application Ser. No. 11/043,176, filed Jan. 27, 2005, now issued as U.S. Pat. No. 7,358,276, which is a divisional of U.S.…
Patent family
288 family members across 49 jurisdictions (MX, DE, MY, EP, IS, ME, SI, IL, ZA, WO, SG, RO)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US6911461 for brivaracetam products?

Any company formulating, manufacturing, or distributing brivaracetam tablets or solutions in the United States — including ANDA applicants and specialty pharma developers — must assess freedom to operate against Claim 5 of US6911461. The Delaware bench trial outcome confirms this claim is enforceable and has survived a coordinated multi-defendant validity challenge. Generic entrants and adjacent anti-epileptic compound developers face non-trivial infringement risk until patent expiry.

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Official verdict

Official order — verbatim text

WHEREAS Defendant Annora Pharma Private Limited ("Annora") filed Abbreviated New Drug Application No. 214831 ("ANDA No. 214831") seeking approval from the U.S. Food and Drug Administration ("FDA") to engage in the commercial manufacture, use, and sale of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg brivaracetam tablets ("Annora's ANDA Product") prior to the expiration of U.S. Patent No. 6,911,461 (the "'461 Patent"); WHEREAS Defendants Apotex Inc. and Apotex Corp. (collectively, "Apotex") filed Abbreviated New Drug Application No. 214875 ("ANDA No. 214875") seeking approval from the FDA to engage in the com1nercial manufacture, use, and sale of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg brivaracetam tablets ("Apotex 's ANDA Product") prior to the expiration of the '461 Patent; WHEREAS Defendants MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (collectively, "MSN") filed Abbreviated New Drug Application Nos. 214921 ("ANDA No. 214921"), 214922 ("ANDA No. 214922"), and 214924 ("ANDA No. 214924") seeking approval from the FDA to engage in the commercial manufacture, use, and sale of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg brivaracetam tablets, 10 mg/ml oral solution, and 50 mg/ml intravenous solution ("MSN's ANDA Products") prior to the expiration of the '461 Patent; WHEREAS the Court held a four-day bench trial on November 14-18, 2022. WHEREAS on August 16, 2023, the Court issued its Opinion (D.I. 246) and Order (D.I. 247) finding that Claim 5 of the '461 Patent is infringed and not invalid; WHEREAS before trial, U.S. Patent No. 6,784,197 and U.S. Patent No. 8,492,416 expired (collectively the "Expired Patents"); IT IS HEREBY ORDERED AND ADJUDGED, for the reasons set forth in the August 16, 2023 Opinion, that: Judgment is entered in of Plaintiff and against MSN on Plaintiffs- claim that MSN's filings of ANDA 214921. 214922, and 214924 infringed Claim 5 ofthe '461 Patent and that the commercial manufacture, use, sale Or for sale in the United States, or importation into the United States, ofMSN's ANDA Products would infringe Claim 5 of the '461 Patent. 2. Judgment is entered in Of plaintiffs and against MSN on MSN's counterclaims for invalidity or unenforceability and non-infringement Claim 5 of the '461 Patent 3. Pursuant to 35 US.C. § the effective date of any final approval of MSN's ANDA Products shall be a date that is not earlier than the date of expiration of the '461 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), Annora 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 '461 Patent from commercially manufacturing, using, selling or offering for sale in the United States, or importing into the United States, Annora's ANDA Products. 5. Plaintiffs' claims for infringement and Annora's counterclaims for invalidity and non-infringement of the Expired Patents are dismissed as moot.
Source: PACER Docket, Case 1:20-cv-00987, Delaware District Court

The August 16, 2023 opinion and order found Claim 5 of US6911461 infringed by MSN's ANDA filings and rejected MSN's invalidity and unenforceability counterclaims after a full bench trial. The court entered judgment for UCB against MSN on all counts and separately enjoined Annora under §271(e)(4)(B). Claims on the two expired patents — US6784197 and US8492416 — were dismissed as moot. The verdict text does not detail the resolution for defendants other than Annora and MSN.

PACER case 1:20-cv-00987 · Public docket record Explore in Eureka ↗
Court ruling

Injunction granted: what the bench trial ruling means for both parties

Legal mechanism

35 U.S.C. §271(e)(4): The ANDA Infringement Remedy Framework

Under 35 U.S.C. §271(e)(4), filing an ANDA with a Paragraph IV certification constitutes an act of infringement. The statute provides two remedies: deferral of the ANDA effective date to no earlier than patent expiry (§271(e)(4)(A)), and injunctive relief against commercial launch (§271(e)(4)(B)). The court applied both here — deferring MSN's ANDA and enjoining Annora — after finding Claim 5 of US6911461 infringed and not invalid.

Statutory ANDA remedy
Patent holder outcome

UCB Retains Briviact® Market Exclusivity Until '461 Patent Expiry

With Claim 5 of US6911461 upheld as infringed and valid, UCB secures continued market exclusivity for Briviact® against both Annora and MSN. Annora faces a hard injunction barring commercial manufacturing, sale, or importation in the US. MSN's ANDA effective date is deferred. UCB also prevailed on MSN's counterclaims of invalidity and unenforceability, strengthening the patent's enforceability posture against remaining defendants.

Market exclusivity preserved
Defendant outcome

Annora Enjoined; MSN ANDA Blocked Until Patent Expiry

Annora is enjoined under §271(e)(4)(B) from commercially manufacturing, using, selling, or importing its ANDA products in the United States until the '461 Patent expires. MSN's three ANDA filings (Nos. 214921, 214922, and 214924) are blocked from receiving effective FDA approval before patent expiry. MSN's invalidity and non-infringement counterclaims were also rejected. The disposition of other defendants — Apotex, Lupin, Zydus, Micro Labs, Sunshine Lake, and Aurobindo — is not detailed in the available record.

Hard injunction and ANDA block
Commercial implications

Claim 5 Validity Upheld: Raised Bar for Generic Brivaracetam Entry

The court's validation of Claim 5 of US6911461 — rejecting invalidity and unenforceability challenges mounted by MSN after a full bench trial — signals a high evidentiary bar for future generic challengers. Any remaining generic filers seeking to launch before patent expiry must now contend with a court-tested, upheld claim. The two expired patents (US6784197 and US8492416) were dismissed as moot, narrowing the forward-looking enforceability landscape to the '461 Patent alone.

Higher generic challenge bar
Legal analysis based on PACER docket records for case 1:20-cv-00987 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffUCB Pharma, GmbhCompany/Search in Eureka ↗
Co-PlaintiffUCB Biopharma, SRLCompanySearch in Eureka ↗
DefendantAnnora Pharma Private, Ltd.Company/Search in Eureka ↗
Co-DefendantMicro Labs USA, Inc.CompanySearch in Eureka ↗
Co-DefendantLupin, Ltd.CompanySearch in Eureka ↗
Co-DefendantApotex Corp.CompanySearch in Eureka ↗
Co-DefendantZydus Pharmaceuticals (USA), Inc.CompanySearch in Eureka ↗
Co-DefendantApotex, Inc.CompanySearch in Eureka ↗
Co-DefendantMicro Labs, Ltd.CompanySearch in Eureka ↗
Co-DefendantMSN Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Co-DefendantMSN Laboratories Private, Ltd.CompanySearch in Eureka ↗
Co-DefendantSunshine Lake Pharma Co., Ltd.CompanySearch in Eureka ↗
Co-DefendantAurobindo Pharma USA, Inc.CompanySearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for UCB Pharma, GmbhSearch in Eureka ↗
Plaintiff counselKaren JacobsAttorneyCounsel for UCB Pharma, GmbhSearch in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for UCB Pharma, GmbhSearch in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting UCB Pharma, GmbhSearch in Eureka ↗
Defendant counselJulie VernonAttorneyCounsel for Annora Pharma Private, Ltd.Search in Eureka ↗
Defendant counselKenneth Laurence DorsneyAttorneyCounsel for Annora Pharma Private, Ltd.Search in Eureka ↗
Defendant counselSaukshmya TrichiAttorneyCounsel for Annora Pharma Private, Ltd.Search in Eureka ↗
Defendant counselTodd S. WernerAttorneyCounsel for Annora Pharma Private, Ltd.Search in Eureka ↗
Defendant law firmMorris James LLPLaw FirmRepresenting Annora Pharma Private, Ltd.Search in Eureka ↗
Presiding judgeJudge N/AJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the brivaracetam and anti-epileptic patent space

Forward-looking patent and R&D intelligence derived from UCB's enforcement of US6911461 against ten generic filers across the SV2A ligand and anti-epileptic compound landscape.

Patent portfolio

UCB's broader SV2A ligand and anti-epileptic patent portfolio

UCB's enforcement of three patents — US6911461, US6784197, and US8492416 — around brivaracetam suggests a layered patent estate strategy in the SV2A ligand space. Mapping UCB's full anti-epileptic filing activity can reveal additional exclusivity barriers for generic developers and signal where UCB is investing in next-generation compound protection.

UCB patent estate
Technology landscape

SV2A ligand patent filing trends in epilepsy therapeutics

Brivaracetam's mechanism — selective SV2A binding — represents a validated anti-epileptic target. Tracking patent filing activity around SV2A modulators and related synaptic vesicle protein ligands can surface emerging competitors or next-generation compound candidates entering the pipeline, signalling where innovation is converging post-Briviact® exclusivity.

SV2A modulator filings
Competitor IP posture

Generic challenger patent activity: Annora, MSN, Apotex, and Lupin

The ten generic defendants in this case — including MSN Laboratories, Apotex, Lupin, and Aurobindo — each maintain their own patent portfolios in pharmaceutical formulation and process technology. Analysing their filing activity in anti-epileptic formulations can reveal design-around efforts or process patent strategies they may be developing for a post-expiry launch of brivaracetam generics.

Generic filer IP strategy
White space

Adjacent R&D opportunities near SV2A-targeting anti-epileptic compounds

With UCB's core brivaracetam composition claim upheld and flanking patents expired, adjacent white space may exist in novel SV2A modulator structures, modified-release formulations, or combination therapy patents not covered by Claim 5 of US6911461. R&D teams can identify these opportunities by mapping claim scope gaps and unpatented formulation territories in the anti-epileptic space.

Anti-epileptic white space
Related litigation

Similar ANDA patent infringement cases in the Delaware District Court

Explore comparable Paragraph IV ANDA pharmaceutical patent disputes litigated in the Delaware District Court involving anti-epileptic and CNS compound patents.

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UCB Pharma, Gmbh patent enforcement history, Delaware District Court case history, UCB Pharma, Gmbh's full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the ANDA pharmaceutical patent IP landscape

UCB's bench trial win on Claim 5 of US6911461 reinforces the value of composition-of-matter claims in anti-epileptic drug patents against multi-defendant ANDA challenges.

Composition claims survive multi-defendant validity assault at bench trial

MSN mounted invalidity and unenforceability counterclaims against Claim 5 of US6911461. The court rejected all of them after a four-day bench trial. For branded pharma IP teams, this outcome reinforces the durability of well-drafted composition claims even under coordinated generic challenge — particularly where multiple ANDA filers pool litigation resources.

Expired patents create mootness risk — prioritise active patent portfolio management

US6784197 and US8492416 expired before trial concluded, resulting in those claims being dismissed as moot. IP teams should monitor patent expiry timelines relative to ANDA litigation schedules. Where expiry is foreseeable during litigation, the enforceability strategy must pivot entirely to surviving active patents to avoid prosecuting moot claims through costly trial proceedings.

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§271(e)(4)(B) injunction scopeRemaining defendant exposureBrivaracetam FTO timeline
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Frequently asked questions

UCB v Annora — key questions answered

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Track brivaracetam patent expiry and ANDA risk with Eureka

Monitor the expiry timeline of US6911461 and map the remaining claim scope against your formulation pipeline. PatSnap Eureka enables real-time FTO analysis and ANDA patent clearance across UCB's full anti-epileptic patent estate.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

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