DCT
3:21-cv-16766
Bausch & Lomb Inc v. Slayback Pharma LLC
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: Slayback Pharma LLC (Delaware); and Slayback Pharma India LLP (India)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 3:21-cv-16766, D.N.J., 09/10/2021
- Venue Allegations: Venue is alleged to be proper based on Defendant Slayback Pharma LLC’s principal place of business in Princeton, New Jersey, and its status as having a regular and established place of business within the district.
- Core Dispute: Plaintiffs allege that Defendant Slayback Pharma’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Lumify® eye drops constitutes an act of patent infringement.
- Technical Context: The technology concerns ophthalmic solutions using a low concentration of brimonidine tartrate (0.025%) to reduce eye redness with purportedly fewer side effects than prior art formulations.
- Key Procedural History: The litigation was triggered by Plaintiffs’ receipt of a Notice of Paragraph IV Certification from Slayback on or about August 16, 2021, which stated Slayback’s intent to market a generic brimonidine ophthalmic solution prior to the expiration of the patents-in-suit. The patents are listed in the FDA’s "Orange Book" as covering the Lumify® product.
Case Timeline
| Date | Event |
|---|---|
| 2008-08-01 | Earliest Priority Date for '742 Patent |
| 2009-12-17 | Earliest Priority Date for '425 Patent |
| 2012-10-23 | '742 Patent Issue Date |
| 2016-02-16 | '425 Patent Issue Date |
| 2017-12-22 | FDA Approval of Lumify® New Drug Application (NDA) |
| 2021-08-16 | Plaintiffs Receive Slayback's Paragraph IV Notice Letter |
| 2021-09-10 | 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
The Invention Explained
- Problem Addressed: The patent’s background section identifies a clinical need for a topical vasoconstrictor (a substance that narrows blood vessels) that can be used for extended periods without causing significant side effects, particularly "rebound hyperemia"—a condition where eye redness returns or worsens after a drug's effect wears off ('742 Patent, col. 2:1-30). Conventional alpha agonists were known to cause this, limiting their long-term use ('742 Patent, col. 2:12-16).
- The Patented Solution: The invention proposes a method of using a low concentration (specifically, below 0.05%) of a highly selective alpha-2 adrenergic agonist, brimonidine, to reduce eye redness ('742 Patent, Abstract). The specification posits that this low-concentration, high-selectivity approach provides effective vasoconstriction while minimizing the stimulation of alpha-1 receptors, which are theorized to be associated with rebound hyperemia and other undesirable effects ('742 Patent, col. 4:58-65).
- Technical Importance: This approach provided a method for managing chronic eye redness that could potentially be used more frequently or for longer durations than was advisable with existing over-the-counter decongestants ('742 Patent, col. 2:20-30).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim (Compl. ¶ 29). Independent claim 1 is central.
- 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. 9,259,425 - "Compositions and Methods for Eye Whitening," issued February 16, 2016
The Invention Explained
- Problem Addressed: The patent addresses the same side-effect profile of conventional decongestants as the '742 patent but also frames the issue in cosmetic terms, noting that "whiter eyes are traditionally a societal symbol of natural healthy eyes" (’425 Patent, col. 1:36-39). It identifies a need for methods to improve the cosmetic appearance of eyes beyond simply treating a disease state ('425 Patent, col. 1:56-59).
- The Patented Solution: The invention claims methods for "increasing whiteness of an eye" by administering a low concentration of a selective alpha-2 agonist like brimonidine ('425 Patent, Abstract). The specification suggests this effect may go beyond constricting superficial blood vessels and could involve "microvascular vasoconstriction" of vessels within the sclera (the white of the eye) itself, leading to a "bleaching" effect beyond the baseline whiteness of a healthy eye (’425 Patent, col. 4:6-19).
- Technical Importance: This patent reframes the use of low-dose brimonidine as a cosmetic "eye whitening" treatment, not just a therapeutic redness reducer, which may suggest a broader application and market positioning (’425 Patent, col. 1:56-59).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim (Compl. ¶ 40). Independent claim 1 is representative.
- Independent Claim 1:
- 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 α-2 adrenergic receptor agonist,
- wherein the agonist is selected from a list that includes brimonidine,
- or a pharmaceutically acceptable salt thereof.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Slayback's proposed "generic Brimonidine Tartrate Ophthalmic Solution, 0.025%," which is the subject of ANDA No. 216361 filed with the FDA (Compl. ¶¶ 1, 21).
Functionality and Market Context
The complaint alleges that Slayback’s product is intended to be a generic version of Plaintiffs’ Lumify® ophthalmic solution and is "the same, or substantially the same" as Lumify® (Compl. ¶¶ 22, 26). The ANDA submitted by Slayback allegedly contains data asserting the bioequivalence of its 0.025% brimonidine tartrate solution with the branded product (Compl. ¶ 25). The act of infringement under the Hatch-Waxman Act is the filing of the ANDA itself, which seeks FDA approval to market this generic product before the expiration of the patents-in-suit (Compl. ¶ 29, 40).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The infringement allegations are based on 35 U.S.C. § 271(e)(2), where the filing of an ANDA for a generic drug is a statutory act of infringement if the drug, once marketed, would infringe the patent.
'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 administering brimonidine to a patient having an ocular condition, | Slayback seeks approval to market a generic ophthalmic solution containing brimonidine. The proposed label for this product will instruct patients to administer it for the purpose of reducing eye redness. | ¶29, ¶30 | col. 22:18-20 |
| wherein brimonidine is present at a concentration between about 0.001% weight by volume and about 0.05% weight by volume. | Slayback's ANDA filing specifies that its product is a "brimonidine tartrate ophthalmic solution, 0.025%." This concentration is within the range claimed by the patent. | ¶25 | col. 22:20-22 |
'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 comprising from between about 0.001% to about 0.05% weight by volume of a selective α-2 adrenergic receptor agonist | Slayback’s proposed product is a generic version of Lumify®, which is marketed for reducing redness and whitening eyes. The proposed label will instruct administration of a composition within the claimed concentration range. | ¶40, ¶41 | col. 10:1-5 |
| selected from lofexidine ... brimonidine ... or a pharmaceutically acceptable salt thereof. | Slayback's product contains brimonidine tartrate, which is a listed agonist and a pharmaceutically acceptable salt. | ¶25 | col. 10:6-11 |
- Identified Points of Contention:
- Scope Questions: The '742 Patent uses the transitional phrase "consisting essentially of." A central question may be whether any inactive ingredients (excipients) in Slayback's formulation, which are not detailed in the complaint, "materially affect the basic and novel properties" of the invention (i.e., redness reduction with minimized rebound hyperemia), thereby placing the product outside the claim's scope.
- Technical Questions: A key question for the '425 Patent is whether the act of "reducing eye redness," as would be described on a generic label, is legally and factually synonymous with the claimed method of "increasing whiteness of an eye." The dispute may focus on whether the claimed "whitening" implies a distinct, cosmetic effect beyond simple therapeutic redness reduction, and whether Slayback's product label would induce infringement of that specific method.
V. Key Claim Terms for Construction
The Term: "consisting essentially of" (’742 Patent, Claim 1)
- Context and Importance: This term is a legal term of art that defines the scope of the claimed method. It permits the presence of unlisted ingredients so long as they do not materially alter the basic and novel characteristics of the invention. Practitioners may focus on this term because Slayback could argue that an excipient in its formulation, while not an active ingredient, materially affects the product's properties (e.g., side effect profile, stability) and thus avoids infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly define the term, which would typically lead to its established legal meaning. A court may find that only components that interfere with the primary function of vasoconstriction with low rebound hyperemia are material.
- Evidence for a Narrower Interpretation: The specification describes the "surprising and unexpected finding" that low concentrations of selective alpha-2 agonists can reduce rebound hyperemia ('742 Patent, col. 4:26-31). A party could argue that any component, even an excipient, that slightly increases the risk of hyperemia would be a material alteration.
The Term: "increasing whiteness of an eye" (’425 Patent, Claim 1)
- Context and Importance: The infringement theory for the '425 Patent hinges on this phrase. Its construction will determine whether a product indicated for "reducing redness" falls within the scope of a method for "increasing whiteness."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's specification and figures appear to use "reducing redness" and "increasing whiteness" interchangeably and as two aspects of the same phenomenon. The patent discloses a "redness/whiteness" scale and describes how the invention can whiten eyes "above and beyond reduction of hyperemia" (’425 Patent, col. 5:1-3; FIG. 5).
- Evidence for a Narrower Interpretation: A party could argue that the phrase implies a specific cosmetic effect on the sclera itself, distinct from merely constricting the overlying conjunctival blood vessels that cause redness (’425 Patent, col. 4:6-19). This interpretation would suggest that "increasing whiteness" is a higher standard than "reducing redness."
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will induce infringement by marketing their generic product with a label that instructs end-users to administer the brimonidine solution in an infringing manner (Compl. ¶¶ 31, 42).
- Willful Infringement: The complaint does not contain a specific count for willful infringement. However, in the prayer for relief, it requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which can be based on litigation misconduct or willful infringement (Compl., p. 10, ¶ 6). The factual basis for knowledge of the patents is Slayback's own Paragraph IV certification letter (Compl. ¶ 23).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim scope and formulation: For the '742 patent, does the term "consisting essentially of" read on Slayback’s generic formulation? This will likely require an analysis of whether Slayback’s chosen excipients materially alter the patented method’s characteristic of providing vasoconstriction with reduced rebound hyperemia.
- A second core question will be one of infringement and claim interpretation: Does a product label instructing users on a method for "reducing eye redness" necessarily induce infringement of a patent claiming a "method of increasing whiteness of an eye"? The outcome will depend on whether the court construes these phrases as describing the same activity or as distinct therapeutic versus cosmetic methods.
- As this is an ANDA case, a significant portion of the dispute, not fully detailed in this initial complaint, will likely revolve around the validity of the patents-in-suit, particularly on grounds of obviousness based on prior art knowledge of brimonidine and its vasoconstrictive properties.