DCT
3:25-cv-18325
Bausch & Lomb Inc v. Granules India Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch & Lomb Inc. (New York); Bausch & Lomb Ireland Limited (Ireland); and Eye Therapies, LLC (Delaware)
- Defendant: Granules India Ltd. (India)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 3:25-cv-18325, D.N.J., 12/09/2025
- Venue Allegations: Venue is based on Defendant being a foreign corporation, which may be sued in any judicial district where it is subject to personal jurisdiction. Plaintiffs allege Defendant conducts business in the United States and that New Jersey is a likely destination for its products.
- Core Dispute: Plaintiffs allege that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Lumify® ophthalmic solution constitutes an act of infringement of four U.S. patents.
- Technical Context: The technology concerns low-concentration brimonidine ophthalmic solutions used for cosmetic eye whitening (reducing redness) while minimizing the side effect of rebound hyperemia.
- Key Procedural History: The litigation was triggered by Defendant's submission of ANDA No. 220937 to the U.S. Food and Drug Administration (FDA) and its subsequent issuance of a Paragraph IV Certification Notice Letter to Plaintiffs, asserting that the Asserted Patents are invalid, unenforceable, or will not be infringed by the proposed generic product. The Asserted Patents are listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) for Lumify®.
Case Timeline
| Date | Event |
|---|---|
| 2008-08-01 | Earliest Priority Date for Asserted Patents |
| 2012-10-23 | U.S. Patent No. 8,293,742 Issues |
| 2016-02-16 | U.S. Patent No. 9,259,425 Issues |
| 2017-12-22 | FDA Approves Lumify® (NDA No. 208144) |
| 2023-03-07 | U.S. Patent No. 11,596,600 Issues |
| 2023-12-05 | U.S. Patent No. 11,833,245 Issues |
| 2025-11-06 | Plaintiffs Receive Defendant's Notice Letter |
| 2025-12-09 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,293,742 - "Preferential Vasoconstriction Compositions and Methods of Use"
The Invention Explained
- Problem Addressed: The patent describes that dilation of small blood vessels in the eye leads to clinically undesirable redness (conjunctival hyperemia). While alpha adrenergic receptor agonists can cause vasoconstriction to treat this, existing formulations, particularly those for glaucoma, use concentrations (e.g., 0.1% to 0.2% brimonidine) that are associated with a high incidence of "rebound hyperemia"—a secondary, often delayed, vasodilation that worsens redness. (’742 Patent, col. 2:3-19).
- The Patented Solution: The invention is based on the discovery that using low concentrations (below 0.05%) of a highly selective alpha-2 adrenergic receptor agonist, such as brimonidine, can induce effective vasoconstriction to reduce eye redness while significantly reducing or minimizing the side effect of rebound hyperemia. (’742 Patent, col. 2:42-49, col. 3:50-55). This approach seeks to find a therapeutic window that provides the desired cosmetic effect without triggering the mechanisms that cause the rebound effect seen at higher doses. (’742 Patent, col. 4:1-6).
- Technical Importance: This technical approach enabled the use of brimonidine for a new indication (cosmetic eye whitening) by identifying a novel, lower-dose regimen that managed a known, dose-limiting side effect, thereby allowing for safe and long-term application. (’742 Patent, col. 2:36-49).
Key Claims at a Glance
- The complaint does not identify any specific claims asserted, alleging infringement of "at least one claim" of the ’742 Patent (Compl. ¶27). Independent claim 1 is representative of the invention's core method.
- Independent Claim 1:
- A method for reducing eye redness consisting essentially of administering brimonidine to a patient having an ocular condition,
- wherein brimonidine is present at a concentration between about 0.001% weight by volume and about 0.05% weight by volume.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,596,600 - "Vasoconstriction Compositions and Methods of Use"
The Invention Explained
- Problem Addressed: Similar to the ’742 Patent, this patent addresses eye redness caused by dilated blood vessels and the rebound hyperemia associated with known alpha agonist formulations. (’600 Patent, col. 2:7-19).
- The Patented Solution: The invention discloses compositions and methods for inducing vasoconstriction using low doses (below 0.05% w/v) of highly selective alpha-2 adrenergic receptor agonists like brimonidine. A key aspect of the solution described in this patent is a formulation with a specific pH range, preferably between about 5.5 and 6.5, to achieve the desired effect with reduced side effects. (’600 Patent, Abstract; col. 6:11-14).
- Technical Importance: This patent refines the formulation parameters for low-dose brimonidine, identifying pH as a variable for optimizing the balance between efficacy in reducing redness and minimizing side effects like rebound hyperemia. (’600 Patent, col. 2:43-46).
Key Claims at a Glance
- The complaint does not identify any specific claims asserted, alleging infringement of "at least one claim" of the ’600 Patent (Compl. ¶49). Independent claim 1 is representative of the invention.
- Independent Claim 1:
- A method for reducing eye redness in a human subject having ocular hyperemia,
- comprising topically administering to an eye of said human in need of said reduction of eye redness an ocular drop comprising about 0.025% weight by volume brimonidine as the sole active ingredient,
- wherein the ocular drop has a pH between 5.5 to 6.5.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,833,245 - "Vasoconstriction Compositions and Methods of Use"
- Technology Synopsis: As a member of the same patent family, the ’245 Patent addresses the problem of achieving effective cosmetic eye whitening without the rebound hyperemia associated with higher-dose alpha agonist treatments. The patent discloses that methods using a specific low concentration of brimonidine (0.025%) as the sole redness-reducing active ingredient can provide effective vasoconstriction with a low incidence of side effects. (’245 Patent, Abstract; col. 2:7-21).
- Asserted Claims: The complaint alleges infringement of "at least one claim" (Compl. ¶60). The patent includes independent claims 1 and 8.
- Accused Features: The accused features are Defendant’s proposed generic 0.025% brimonidine ophthalmic solution and its intended use for reducing eye redness (Compl. ¶9, ¶17, ¶60-61).
- The complaint asserts U.S. Patent No. 9,259,425, however the document was not provided for analysis (Compl. ¶7).
III. The Accused Instrumentality
Product Identification
- Defendant Granules' generic Brimonidine Tartrate Ophthalmic Solution, 0.025%, which is the subject of ANDA No. 220937 (Compl. ¶12, ¶17).
Functionality and Market Context
- The product is an ophthalmic solution intended to be a generic version of Bausch & Lomb’s Lumify® product (Compl. ¶13). As such, its intended function is the reduction of eye redness (Compl. ¶11).
- The complaint alleges the proposed generic product is "the same, or substantially the same, as Lumify®" (Compl. ¶18). The act of filing the ANDA with a Paragraph IV certification is a statutory act of infringement that creates the basis for the lawsuit prior to any commercial sales (Compl. ¶1, ¶14).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart or detailed infringement allegations beyond conclusory statements that Defendant's ANDA submission infringes. The infringement theory is premised on the allegation that the product described in the ANDA, a 0.025% brimonidine ophthalmic solution, will, upon approval and marketing, be used in a manner that practices the methods claimed in the Asserted Patents (Compl. ¶28, ¶39, ¶50, ¶61).
U.S. Patent No. 8,293,742 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for reducing eye redness consisting essentially of administering brimonidine to a patient having an ocular condition... | Defendant's proposed product is intended as a generic version of Lumify®, which is used for reducing eye redness. The proposed product label would instruct this use. | ¶11, ¶13 | col. 4:51-54 |
| ...wherein brimonidine is present at a concentration between about 0.001% weight by volume and about 0.05% weight by volume. | Defendant's proposed product has a brimonidine concentration of 0.025%, which falls squarely within the claimed range. | ¶17 | col. 5:2-10 |
U.S. Patent No. 11,596,600 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for reducing eye redness... comprising topically administering... an ocular drop... | Defendant's product is an ophthalmic solution, or eye drop, intended to be administered topically to the eye for reducing redness. | ¶13, ¶17 | col. 6:17-21 |
| ...comprising about 0.025% weight by volume brimonidine... | Defendant's product is specified to have a brimonidine tartrate concentration of 0.025%. | ¶17 | col. 22:45-48 |
| ...as the sole active ingredient... | The product's established name is "brimonidine tartrate ophthalmic solution, 0.025%," which suggests brimonidine is the only active ingredient. | ¶17 | col. 22:47 |
| ...wherein the ocular drop has a pH between 5.5 to 6.5. | The complaint does not provide sufficient detail for analysis of this element. | N/A | col. 6:11-14 |
Identified Points of Contention
- Factual Questions: A primary point of dispute for the ’600 Patent will be factual: what is the pH of Defendant's proposed formulation as specified in its ANDA? The complaint provides no information on this critical claim limitation. Similarly, the exact composition of the formulation will be scrutinized to determine if brimonidine is indeed the "sole active ingredient."
- Scope Questions: For the ’742 Patent, a central legal question may involve the scope of the term "consisting essentially of." The analysis will question whether any other ingredients in Defendant's formulation materially alter the basic and novel properties of the claimed invention (i.e., vasoconstriction with minimized rebound hyperemia).
V. Key Claim Terms for Construction
The Term: "consisting essentially of" (from ’742 Patent, Claim 1)
Context and Importance: This transitional phrase is a legal term of art that is open to interpretation. Its construction is critical because it will determine whether excipients or other non-brimonidine components in Defendant's formulation could be sufficient to avoid infringement. Practitioners may focus on this term because it defines the boundary between permissible and impermissible additional ingredients.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's focus on brimonidine as the agent responsible for the desired vasoconstrictive effect, and the problem of rebound hyperemia being linked to alpha-1 agonist activity, may support an interpretation where "consisting essentially of" only excludes other ingredients that have alpha-1 agonist or vasoconstrictive properties. (’742 Patent, col. 4:2-10).
- Evidence for a Narrower Interpretation: The patent's general theme of using a simple, low-dose formulation could support an argument that the addition of any component that materially affects the formulation's overall performance, stability, or side-effect profile (even if not a vasoconstrictor) would fall outside the claim's scope.
The Term: "sole active ingredient" (from ’600 Patent, Claim 1)
Context and Importance: This term appears more restrictive than "consisting essentially of" and its definition will be central to the infringement analysis for the ’600 Patent. The case may turn on whether any other component in Defendant's formulation could be characterized as an "active ingredient" under FDA regulations or for its therapeutic purpose.
Intrinsic Evidence for Interpretation:
- Evidence for a Narrower Interpretation: The plain language of the claim strongly suggests that no other therapeutically active substance may be present. The specification supports this by teaching a method that relies on the properties of the low-dose selective alpha-2 agonist alone to achieve the desired outcome. (’600 Patent, col. 2:48-55).
- Evidence for a Broader Interpretation: A party could argue that "active ingredient" refers only to other vasoconstrictors or redness-reducing agents, and that ingredients with other therapeutic purposes (e.g., a lubricant for dry eye) would not negate the "sole" nature of brimonidine with respect to the claimed method of reducing redness.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement and contributory infringement for all asserted patents (Compl. ¶29, ¶40, ¶51, ¶62). In the context of an ANDA case, these allegations are based on the premise that the proposed product labeling will instruct medical professionals and patients to use the generic drug in a manner that directly infringes the asserted method claims.
- Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, the prayer for relief requests a declaration that this is an "exceptional case" under 35 U.S.C. §§ 285 and 271(e)(4), which could entitle Plaintiffs to an award of attorneys' fees (Compl., Prayer for Relief ¶8).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to present two primary categories of questions for the court's determination:
- A central issue will be one of factual proof: for the more recent and specific patents ('600 and '245), does Defendant's ANDA formulation for its generic brimonidine solution meet the explicit claim limitations of having a pH within the range of 5.5 to 6.5 and containing brimonidine as the "sole active ingredient"? The complaint is silent on these technical details, making them immediate targets for discovery.
- A second core issue will be one of definitional scope: for the earlier patent ('742), what is the proper construction of the term "consisting essentially of"? The court's interpretation will determine whether the presence of other non-vasoconstrictive components in Defendant's formulation is sufficient to place the product outside the patent's claims.