Bausch & Lomb v. Gland Pharma: Brimonidine Ophthalmic Patent Case Dismissed Without Prejudice
Bausch & Lomb filed suit against Gland Pharma in New Jersey District Court asserting four patents covering brimonidine ophthalmic solution formulations. The parties jointly stipulated to dismiss all claims, defenses, and counterclaims without prejudice after 239 days — each side bearing its own costs.
A stipulated exit: four ophthalmic patents, zero merits ruling
On April 28, 2025, Bausch & Lomb, Inc. filed an infringement action in the District of New Jersey against Gland Pharma, Ltd., a Hyderabad-based generic pharmaceutical manufacturer. The complaint asserted four U.S. patents — US11596600B2, US9259425B2, US11833245B2, and US8293742B2 — all directed to brimonidine ophthalmic solution, an alpha-2 adrenergic agonist widely used in glaucoma and ocular hypertension treatment. The action was triggered by Gland Pharma’s filing of an ANDA or equivalent regulatory pathway seeking approval for a generic version of the branded formulation.
After 239 days of litigation, the parties filed a joint stipulation under Rule 41(a)(1)(ii) and (c), seeking dismissal of all claims, defenses, and counterclaims without prejudice. The court entered an order granting the stipulation, with each party absorbing its own legal costs. A dismissal without prejudice means no merits determination was made — Bausch & Lomb retains the right to reassert these patents against Gland Pharma in future proceedings, and Gland Pharma’s invalidity or non-infringement defenses were not adjudicated.
The 239-day timeline and mutual cost-bearing arrangement is consistent with a negotiated resolution — possibly a licensing agreement, consent judgment, or commercial arrangement reached outside the public record. The absence of any costs award removes one typical signal of a clear winner. The public record does not disclose whether Gland Pharma has delayed or withdrawn its ANDA, or whether Bausch & Lomb granted any license, making the full commercial outcome opaque. IP practitioners monitoring generic entry risk for brimonidine formulations should note that all four patents remain potentially enforceable.
Filing to Dismissed without Prejudice in 239 days
239 days from filing to dismissal — faster than the median ANDA patent dispute in D.N.J.
Dismissed without prejudice: what the stipulated order means for both parties
Rule 41 stipulated dismissal — no court merits finding
Under Federal Rule of Civil Procedure 41(a)(1)(ii) and (c), both parties jointly stipulated to dismiss all claims, defenses, and counterclaims. The court approved the stipulation by order. Crucially, this is not a judgment — no court has ruled on infringement, validity, or enforceability of any of the four asserted patents. The without-prejudice designation preserves Bausch & Lomb’s right to refile identical or similar claims in future litigation.
No merits adjudicationBausch & Lomb retains full enforcement rights on all four patents
Because the dismissal is without prejudice, Bausch & Lomb’s patent portfolio emerges legally intact. None of the four patents was declared invalid, unenforceable, or not infringed. The company can reassert these patents against Gland Pharma or any other generic entrant pursuing brimonidine formulation approval. The mutual cost-bearing term suggests neither side extracted a concession that compelled the other to absorb litigation expense.
Patents remain enforceableGland Pharma avoids adverse ruling but faces unresolved patent exposure
Gland Pharma secured no invalidity finding and no non-infringement declaration from this action. Its ANDA or regulatory filing status is not reflected in the public record. If the underlying approval pathway proceeds, Bausch & Lomb retains the option to reinitiate litigation. The without-prejudice dismissal is not equivalent to clearance — Gland Pharma’s freedom to commercialise a generic brimonidine product in the U.S. remains legally uncertain without a court or licensing determination.
No FTO establishedPrivate resolution likely — four patents still cloud generic brimonidine entry
The rapid, mutually agreed exit within 239 days is consistent with a confidential licensing deal, consent agreement, or commercial settlement that shaped the parties’ ANDA timeline. Other generic manufacturers targeting brimonidine ophthalmic formulations must still contend with all four Bausch & Lomb patents. The case’s lack of any merits ruling means no prior art or claim construction findings are available for competitors to leverage in future invalidity challenges.
Settlement likely signalledFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch & Lomb, Inc. | Company | Ophthalmic pharmaceutical innovator — holder of US11596600B2 and three related brimonidine patentsSearch in Eureka ↗ |
| Defendant | Gland Pharma, Ltd. | Company | Gland Pharma, Ltd. — Hyderabad-based generic injectable and ophthalmic drug manufacturerSearch in Eureka ↗ |
| Plaintiff counsel | J. BRUGH LOWER | Attorney | Counsel for Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William P. Deni | Attorney | Counsel for Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing Bausch & Lomb, Inc.Search in Eureka ↗ |
| Defendant counsel | NOELLE TORRICE | Attorney | Counsel for Gland Pharma, Ltd.Search in Eureka ↗ |
| Defendant law firm | BENESCH FRIEDLANDER COPLAN & ARNOFF | Law Firm | Representing Gland Pharma, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated order dismisses all claims, defenses, and counterclaims without prejudice under Rule 41(a)(1)(ii) and (c). The language is deliberately symmetric — neither party is named a prevailing party, and the mutual cost-bearing clause reinforces that no concession was formally extracted in court. For Bausch & Lomb, the patents survive; for Gland Pharma, no validity or non-infringement shield was obtained. The absence of a 30-month stay expiration reference in the public record leaves the ANDA status and any agreed market entry date undisclosed.
US11596600B2 — brimonidine ophthalmic solution formulation patents
The four asserted patents — US11596600B2, US9259425B2, US11833245B2, and US8293742B2 — cover formulation and composition aspects of brimonidine ophthalmic solution, an alpha-2 adrenergic agonist used clinically to reduce intraocular pressure in glaucoma and ocular hypertension. Application dates span from 2009 (US12/460941) to 2023 (US18/103404), reflecting a multi-generational prosecution strategy that extends portfolio protection across successive formulation innovations and claim refinements.
Brimonidine is a mature active ingredient, making formulation patents the primary IP barrier to generic entry. Bausch & Lomb’s layered portfolio — with granted patents at different prosecution timelines — is a classic lifecycle management strategy in ophthalmic pharma. For competitors developing brimonidine generics, each patent in this stack must be independently evaluated for claim scope, validity, and design-around potential. The 2023 application date on US18/103404 suggests coverage may extend well into the 2040s for at least one family member.
Should your brimonidine product team run an FTO against these four patents?
Any company with an active or planned ANDA, 505(b)(2), or branded NDA for a brimonidine ophthalmic product must assess all four patents in this case. US8293742B2 through US11833245B2 span over a decade of prosecution and likely cover different formulation features — excipient compositions, pH ranges, preservative systems, or delivery parameters. A freedom-to-operate analysis cannot treat these as a single family; each requires independent claim mapping against your specific formulation.
PatSnap Eureka’s FTO Search Agent allows R&D and IP teams to run structured claim-by-claim clearance analysis against each of the four Bausch & Lomb patents simultaneously. By uploading your formulation parameters, Eureka identifies overlapping claim language, suggests design-around opportunities, and flags related continuation or divisional applications that may not yet be in litigation but carry equivalent claim scope. Early-stage FTO here is substantially cheaper than a second infringement action.
Run a freedom-to-operate analysis on US11596600B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman ophthalmic patent cases in D.N.J. and related venues
Explore comparable ANDA-triggered ophthalmic patent infringement actions filed in New Jersey District Court involving brimonidine or related glaucoma formulation patents.
What this case signals for the ophthalmic generics IP landscape
Four unlitigated patents, a fast exit, and mutual cost-bearing — the pattern here carries real implications for generic ophthalmic drug development.
Without-prejudice dismissal is not a green light for generic entry
Gland Pharma obtained no court ruling on infringement or validity. Any generic manufacturer interpreting this dismissal as market clearance for brimonidine formulations takes on significant legal risk. All four Bausch & Lomb patents remain unadjudicated and fully enforceable against any party pursuing a competing ANDA or NDA.
Mutual cost-bearing points to negotiated commercial resolution
In ANDA-linked patent disputes, unilateral cost awards typically signal a winner. The parties’ agreement that each bears its own costs — with no fee-shifting — is a hallmark of settlement or licensing. IP professionals should monitor Gland Pharma’s FDA approval status and any subsequent launch activity as leading indicators of what was agreed.
Bausch v Gland — key questions answered
Bausch & Lomb asserted four patents: US11596600B2, US9259425B2, US11833245B2, and US8293742B2. All four cover aspects of brimonidine ophthalmic solution formulations. The case was filed in the District of New Jersey on April 28, 2025, and dismissed without prejudice on December 23, 2025.
A dismissal without prejudice means no court adjudicated infringement, validity, or enforceability. Bausch & Lomb retains the legal right to refile the same claims against Gland Pharma in future litigation. The four patents remain in force and no non-infringement or invalidity finding was entered, leaving Gland Pharma without formal patent clearance.
Not necessarily. The dismissal without prejudice does not constitute a freedom-to-operate determination or a court ruling that Gland Pharma’s product does not infringe any of the four asserted patents. Market entry would depend on FDA approval status, any private agreement reached between the parties, and the absence of subsequent patent enforcement action.
The stipulated order specifies that each party bears its own costs, attorneys’ fees, and expenses. This symmetric arrangement typically signals a negotiated resolution — such as a licensing agreement or commercial settlement — rather than a clear litigation victory by either side. It avoids the fee-shifting that would follow a finding of exceptional case status under 35 U.S.C. § 285.
Bausch & Lomb was represented by Gibbons PC, with attorneys J. Brugh Lower and William P. Deni on record. Gland Pharma was represented by Benesch Friedlander Coplan & Arnoff, with attorney Noelle Torrice listed as counsel of record.
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