Bausch & Lomb Inc v. Gland Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bausch & Lomb Inc. (New York); Bausch & Lomb Ireland Limited (Ireland); Eye Therapies, LLC (Delaware)
  • Defendant: Gland Pharma Limited (India)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 3:25-cv-03398, D.N.J., 04/28/2025
• Venue Allegations: Plaintiffs allege venue is proper because Defendant is a foreign corporation, and is therefore subject to suit in any judicial district where it is subject to personal jurisdiction. The complaint further alleges that Defendant conducts business in New Jersey and intends to direct sales of its generic product into the state upon FDA approval.
• 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 related to low-concentration brimonidine formulations for reducing eye redness.
• Technical Context: The technology concerns ophthalmic solutions using a low concentration of the alpha-2 adrenergic agonist brimonidine to achieve vasoconstriction (eye redness relief) while minimizing side effects, such as rebound hyperemia, that are associated with higher concentrations used for glaucoma treatment.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a Notice of Paragraph IV Certification from Defendant concerning its ANDA No. 220091. The asserted patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Plaintiffs' NDA-approved product, Lumify® (brimonidine tartrate, 0.025%).

Case Timeline

Date	Event
2008-08-01	Earliest Priority Date for ’742, ’600, ’245 Patents
2009-12-17	Earliest Priority Date for ’425 Patent
2012-10-23	’742 Patent Issued
2016-02-16	’425 Patent Issued
2017-12-22	FDA Approval of Lumify® (NDA No. 208144)
2023-03-07	’600 Patent Issued
2023-12-05	’245 Patent Issued
2025-04-23	Date of Defendant’s Notice Letter
2025-04-28	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,293,742 - "PREFERENTIAL VASOCONSTRICTION COMPOSITIONS AND METHODS OF USE," issued October 23, 2012 (’742 Patent)

The Invention Explained

• Problem Addressed: The patent describes that commercially available alpha adrenergic agonist eye drops used to treat eye redness (vasoconstriction) often cause undesirable side effects, most notably "rebound hyperemia"—a return or worsening of redness after the drug's effect wears off (’742 Patent, col. 1:7-23). Even brimonidine, a more selective alpha-2 agonist, is associated with this side effect when used at the higher concentrations (0.1%-0.2%) required for glaucoma treatment (’742 Patent, col. 2:1-9).
• The Patented Solution: The invention proposes using a low concentration of a highly selective alpha-2 agonist like brimonidine (specifically, below 0.05%) to achieve effective vasoconstriction for cosmetic redness relief, but at a dose low enough to avoid the rebound hyperemia and other side effects seen at glaucoma-treating concentrations (’742 Patent, col. 2:44-53). The solution is to decouple the cosmetic vasoconstrictive effect from the intraocular pressure-lowering effect, finding a therapeutic window for redness relief alone.
• Technical Importance: The invention identifies a method to repurpose an existing active pharmaceutical ingredient (brimonidine) at a new, lower concentration to create a product with a different therapeutic purpose (cosmetic redness relief) and an improved side-effect profile compared to existing decongestants and higher-strength glaucoma formulations (’742 Patent, col. 2:36-43).

Key Claims at a Glance

• The complaint asserts at least one claim (Compl. ¶27). Independent claim 1 is representative:
• A method for reducing eye redness consisting essentially of:
  • topically administering a composition consisting essentially of brimonidine into ocular tissue;
  • wherein the composition’s pH is between about 5.5 and 6.5;
  • wherein the brimonidine concentration is from about 0.001% to about 0.05% weight by volume; and
  • wherein the composition is formulated as an ocular drop.

U.S. Patent No. 9,259,425 - "COMPOSITIONS AND METHODS FOR EYE WHITENING," issued February 16, 2016 (’425 Patent)

The Invention Explained

• Problem Addressed: Similar to the ’742 Patent, this patent addresses the side effects of conventional eye-redness treatments, such as rebound hyperemia (’425 Patent, col. 1:50-55). It extends the technical problem from merely "reducing redness" to cosmetically "increasing whiteness," noting that whiter eyes are a societal symbol of health and hygiene (’425 Patent, col. 1:39-44).
• The Patented Solution: The invention provides compositions and methods for eye whitening using low concentrations of selective alpha-2 adrenergic agonists like brimonidine (’425 Patent, Abstract). The patent suggests that by causing microvascular vasoconstriction in the sclera (the white layer of the eye), the compositions can increase whiteness beyond simply neutralizing hyperemia, achieving a cosmetic "bleaching" effect (’425 Patent, col. 4:8-19). Figure 5 provides a visual scale for quantifying both hyperemia ("redness") and scleral whitening.
• Technical Importance: This patent frames the technical solution in terms of cosmetic enhancement ("whitening") rather than just therapeutic redness reduction, creating a distinct, market-focused application for low-concentration brimonidine and providing a quantitative scale to measure the effect (’425 Patent, col. 2:25-41).

Key Claims at a Glance

• The complaint asserts at least one claim (Compl. ¶38). Independent claim 1 is representative:
• A method of increasing whiteness of an eye comprising:
  • administering to a subject in need thereof a composition;
  • comprising from between about 0.001% to about 0.05% weight by volume of a selective a-2 adrenergic receptor agonist selected from a list that includes brimonidine;
  • or a pharmaceutically acceptable salt thereof.

U.S. Patent No. 11,596,600 - "VASOCONSTRICTION COMPOSITIONS AND METHODS OF USE," issued March 7, 2023 (’600 Patent)

• Technology Synopsis: This patent addresses the problem of achieving effective vasoconstriction to treat conditions like eye redness without the concomitant side effects, such as rebound hyperemia, caused by less selective or higher-concentration alpha agonists (’600 Patent, col. 1:20-24, col. 2:8-19). The solution is a method of using an ophthalmic solution containing 0.025% brimonidine as the sole active ingredient, at a specific pH range, to reduce eye redness (’600 Patent, Claim 1).
• Asserted Claims: The complaint asserts at least one claim (Compl. ¶49). Independent claims are 1, 15, and 23.
• Accused Features: The accused features are embodied in Defendant's ANDA submission for a generic brimonidine ophthalmic solution that is intended to be bioequivalent to Lumify® (0.025% brimonidine) (Compl. ¶¶13, 17, 50).

U.S. Patent No. 11,833,245 - "VASOCONSTRICTION COMPOSITIONS AND METHODS OF USE," issued December 5, 2023 (’245 Patent)

• Technology Synopsis: This patent is directed to methods of using a specific low-concentration brimonidine formulation for reducing eye redness for cosmetic purposes (’245 Patent, col. 1:20-24). The invention consists of topically administering an ocular drop containing about 0.025% brimonidine as the sole redness-reducing active ingredient, with a pH between 5.5 and 6.5, to reduce ocular hyperemia (’245 Patent, Claim 1).
• Asserted Claims: The complaint asserts at least one claim (Compl. ¶60). Independent claims are 1, 8, 15, 18, and 20.
• Accused Features: The accused features are embodied in Defendant's ANDA submission for a generic 0.025% brimonidine ophthalmic solution (Compl. ¶¶13, 17, 61).

III. The Accused Instrumentality

Product Identification

• Defendant Gland Pharma Limited’s generic Brimonidine Tartrate Ophthalmic Solution, 0.025% (the "Accused Product") (Compl. ¶1).

Functionality and Market Context

• The Accused Product is the subject of ANDA No. 220091 filed with the U.S. FDA (Compl. ¶12). The complaint alleges the product is intended to be a generic version of Plaintiffs’ Lumify® product and is "the same, or substantially the same, as Lumify®" (Compl. ¶¶13, 17). The ANDA submission necessarily contains data to establish the product’s bioequivalence to Lumify® (Compl. ¶16). Upon approval, Defendant intends to engage in the commercial manufacture, use, and sale of the Accused Product in the United States (Compl. ¶13). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’742 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method for reducing eye redness consisting essentially of topically administering... a composition consisting essentially of brimonidine into ocular tissue...	Defendant’s ANDA seeks approval for an ophthalmic solution containing brimonidine tartrate, and its proposed product label will instruct users to topically administer it to the eye to relieve redness.	¶¶13, 17, 28	col. 4:50-55
...wherein pH of said composition is between about 5.5 and about 6.5...	Defendant's ANDA product is alleged to be the same or substantially the same as Lumify®, which requires it to have a pH within a bioequivalent range.	¶17	col. 6:13-15
...wherein said brimonidine concentration is from between about 0.001% and about 0.05% weight by volume...	Defendant’s ANDA product has a brimonidine tartrate concentration of 0.025%, which falls within the claimed range.	¶16	col. 6:8-10
...and wherein said composition is formulated as an ocular drop.	Defendant's ANDA product is an ophthalmic solution intended for topical administration as eye drops.	¶13	col. 6:21-22

’425 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of increasing whiteness of an eye comprising administering to a subject in need thereof a composition...	Defendant’s ANDA product, intended as a generic for Lumify®, will be marketed and labeled for reducing eye redness, which Plaintiffs allege constitutes a method of increasing eye whiteness.	¶¶13, 17, 39	col. 2:4-7
...comprising from between about 0.001% to about 0.05% weight by volume of a selective a-2 adrenergic receptor agonist selected from the group consisting of...brimonidine...	Defendant’s ANDA product contains 0.025% brimonidine tartrate, which is a listed agonist at a concentration within the claimed range.	¶16	col. 5:14-18
...or a pharmaceutically acceptable salt thereof.	The active ingredient in Defendant’s ANDA product is brimonidine tartrate, a pharmaceutically acceptable salt of brimonidine.	¶11, 16	col. 5:1-4

Identified Points of Contention

• Scope Questions: A central question for claims using the phrase "consisting essentially of" (such as in the ’742 Patent) may be whether any unlisted excipients in the Defendant’s formulation "materially affect the basic and novel properties" of the invention, which is the legal standard for this transitional phrase. The complaint does not detail the excipients in the accused product, but this is a common area of dispute in ANDA litigation.
• Technical Questions: For the ’425 Patent, a potential issue is whether the act of "reducing redness," for which the accused product will be labeled, is inherently a method of "increasing whiteness" as claimed. The analysis may turn on whether these are functionally and definitionally equivalent from the perspective of a person of ordinary skill in the art, based on the patent's specification.

V. Key Claim Terms for Construction

• The Term: "consisting essentially of" (’742 Patent, Claim 1)

• Context and Importance: This term is a cornerstone of the claim's scope. Unlike "comprising" (which is open-ended) or "consisting of" (which is closed), "consisting essentially of" permits the presence of unlisted ingredients so long as they do not materially alter the basic and novel characteristics of the invention. The dispute will likely focus on what those "basic and novel characteristics" are (e.g., redness reduction without significant rebound hyperemia) and whether any excipients in Gland's formulation materially affect them.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent focuses on the low concentration of brimonidine as the key to avoiding side effects. A party might argue that as long as no other active vasoconstrictors are present, common pharmaceutical excipients (e.g., buffers, preservatives) do not materially alter this fundamental characteristic.
  • Evidence for a Narrower Interpretation: The specification emphasizes achieving vasoconstriction with "reduced or minimized side effects, such as rebound hyperemia" (’742 Patent, col. 2:41-43). A party could argue that the "basic and novel characteristic" is this specific clinical outcome, and any excipient that affects the formulation's stability, absorption, or local tolerance in a way that increases rebound hyperemia would be a material alteration, thus placing the formulation outside the claim scope.

• The Term: "increasing whiteness of an eye" (’425 Patent, Claim 1)

• Context and Importance: The construction of this term is critical to determining whether a product labeled for "redness relief" infringes. The question is whether "increasing whiteness" is merely a cosmetic description of "reducing redness" or if it requires a distinct, measurable effect beyond the mere absence of hyperemia.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification often discusses redness and whiteness together, suggesting they are two sides of the same coin. The abstract states the invention provides "compositions and methods for whitening of eyes" and that they "utilize low concentrations of selective a-2 adrenergic receptor agonists," the same mechanism used for redness reduction.
  • Evidence for a Narrower Interpretation: The patent introduces a new "redness" scale that explicitly includes levels of "whiteness" beyond "normal," such as "slightly whiter than normal" and "absolute whiteness" (’425 Patent, FIG. 5). A party could argue this demonstrates an intent to claim a cosmetic effect that goes beyond simply returning a red eye to a normal state, requiring proof of a "bleaching" effect.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement and contributory infringement for all asserted patents (Compl. ¶¶29, 40, 51, 62). The factual basis for these allegations is the act of filing the ANDA for a product whose proposed labeling will allegedly instruct medical professionals and patients to administer the drug in a manner that directly infringes the patented methods.
• Willful Infringement: The complaint does not explicitly allege willful infringement. However, the prayer for relief requests a declaration that this is an "exceptional case" under 35 U.S.C. § 285, which can be a predicate for enhanced damages or attorney's fees (Compl., Prayer for Relief ¶8). The basis for knowledge is Defendant's Paragraph IV certification, which acknowledges the existence of the patents-in-suit.

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of claim scope under Hatch-Waxman: Given that the Defendant's product must be bioequivalent to the branded product, the infringement analysis for the later, more specific patents (’600 and ’245) may be straightforward. However, for the earlier patents, the case will likely turn on the construction of key terms. Can the phrase "consisting essentially of" be interpreted to exclude Defendant’s formulation based on its specific combination of excipients, even if the active ingredient and concentration are identical?
• A second central question will be one of infringement by labeling: Does the Defendant's proposed product label, which will seek an indication for redness relief, inherently teach the patented methods of "increasing whiteness" (’425 Patent) or "preferential vasoconstriction" (’742 Patent)? The outcome may depend on whether the court views these as inherent results of redness reduction or as requiring specific intent and outcomes that must be explicitly encouraged by the label.