DCT

3:23-cv-02454

Bausch & Lomb Inc v. Slayback Pharma LLC

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-02454, D.N.J., 05/03/2023
  • Venue Allegations: Venue is based on the New Jersey principal places of business for Slayback Pharma LLC and Dr. Reddy's Laboratories, Inc., and their purposeful conduct of business in the district. For foreign-domiciled defendants, venue is alleged to be proper in any district where personal jurisdiction exists.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Lumify® ophthalmic solution constitutes an act of infringement of a patent directed to methods of reducing eye redness using low-concentration brimonidine.
  • Technical Context: The technology involves ophthalmic pharmaceutical formulations for treating ocular hyperemia (eye redness), a common condition with a significant cosmetic and therapeutic market.
  • Key Procedural History: This action is related to a prior consolidated case in the same district, In re Lumify, Civil Action No. 21-16766, involving the same parties. Plaintiffs allege that after the patent-in-suit was issued and listed in the FDA's Orange Book, Defendants failed to provide a required Paragraph IV certification notice letter for this specific patent, though a notice letter for other patents had been previously sent in 2021.

Case Timeline

Date Event
2008-08-01 '600 Patent Priority Date
2017-12-22 FDA Approval for Lumify® (NDA No. 208144)
2021-08-13 Slayback sends Notice Letter regarding ANDA No. 216361
2023-03-07 U.S. Patent No. 11,596,600 Issues
2023-03-27 '600 Patent Listed in FDA Orange Book
2023-05-03 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 11,596,600, "Vasoconstriction Compositions and Methods of Use," issued March 7, 2023.

The Invention Explained

  • Problem Addressed: The patent’s background section states that while alpha adrenergic receptor agonists can treat eye redness (hyperemia) by constricting blood vessels, existing formulations are associated with significant side effects, most notably "rebound hyperemia," where redness returns, sometimes worse than before, after the drug’s effect wears off (’600 Patent, col. 2:5-18). This side effect limits the long-term use of such products.
  • The Patented Solution: The invention is based on the discovery that a low concentration of a highly selective alpha-2 adrenergic receptor agonist, specifically brimonidine, can achieve effective vasoconstriction while significantly reducing or eliminating the side effect of rebound hyperemia (’600 Patent, Abstract). The specification posits that the dose-response curve for the desired therapeutic effect (vasoconstriction) is different from that for side effects, creating a therapeutic window at low concentrations that was not previously utilized for this indication (’600 Patent, col. 13:24-33).
  • Technical Importance: The invention purports to offer a method for safe and long-term cosmetic and therapeutic treatment of eye redness, overcoming the drawbacks that made previous vasoconstrictor products unsuitable for chronic use (’600 Patent, col. 2:42-46).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim of the ’600 patent (Compl. ¶42). The first independent claim is representative:
  • Independent Claim 1: A method of reducing eye redness in a human with ocular hyperemia by:
    • topically administering an ocular drop;
    • the drop comprises "about 0.025% weight by volume brimonidine as the sole active ingredient"; and
    • the drop has a pH between 5.5 and 6.5.
  • The complaint does not explicitly reserve the right to assert dependent claims, though this is standard practice in patent litigation.

III. The Accused Instrumentality

Product Identification

  • Slayback’s generic Brimonidine Tartrate Ophthalmic Solution, 0.025% (Compl. ¶1).

Functionality and Market Context

  • The accused product is a generic version of Plaintiffs' commercial product, Lumify®, which is an over-the-counter ophthalmic solution for the relief of eye redness (Compl. ¶2, ¶16).
  • The basis for the infringement action is Defendants' filing of Abbreviated New Drug Application (ANDA) No. 216361 with the U.S. Food and Drug Administration (FDA) (Compl. ¶15). Under the Hatch-Waxman Act, the filing of an ANDA seeking approval to market a generic drug before the expiration of a patent covering that drug is a statutory act of infringement (Compl. ¶42).
  • The ANDA submission contains data intended to demonstrate that the proposed generic product is bioequivalent to Lumify®, containing the same active ingredient at the same concentration and for the same route of administration (Compl. ¶19).

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2), where the act of infringement is the submission of the ANDA. The theory is that the product as described in the ANDA, if approved and marketed, would infringe the ’600 patent. The complaint does not contain a detailed element-by-element infringement analysis. The following chart summarizes the allegations as they can be inferred from the nature of an ANDA filing.

'600 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing eye redness... comprising topically administering to an eye... an ocular drop... The proposed product is an ophthalmic solution whose intended use, as will be described on its label, is for administration to the eye to reduce redness. ¶1, ¶16 col. 1:22-24
...comprising about 0.025% weight by volume brimonidine as the sole active ingredient... The ANDA is for a generic "Brimonidine Tartrate Ophthalmic Solution, 0.025%," which is intended to be a copy of Lumify®. ¶1, ¶19 Abstract
...wherein the ocular drop has a pH between 5.5 to 6.5. As a bioequivalent to Lumify®, the ANDA formulation must have characteristics, including pH, that fall within a specified range consistent with the reference drug. The complaint does not provide sufficient detail for analysis of the specific pH value. ¶19 col. 6:12-15

Identified Points of Contention

  • Scope Questions: In ANDA litigation, infringement is often straightforward if the patent is valid, as the generic product must be a copy of the branded one. A potential dispute, however, could arise over the meaning of "sole active ingredient." Defendants could argue their formulation includes other components (e.g., excipients, preservatives) that have a secondary therapeutic effect, thereby avoiding this limitation.
  • Technical Questions: A central technical question for the court, likely related to a validity challenge, will be whether the use of brimonidine at the claimed 0.025% concentration provides unexpected results (i.e., a superior safety profile regarding rebound hyperemia) compared to prior art uses of brimonidine at higher concentrations. The patent's Figure 5C, which purports to show the reversal of rebound hyperemia by applying brimonidine, illustrates this alleged technical benefit (’600 Patent, Fig. 5C).

V. Key Claim Terms for Construction

  • The Term: "sole active ingredient"

  • Context and Importance: This term is a critical limitation in independent claim 1. Its construction will determine whether the presence of any other substance with a potential therapeutic effect in Defendants' formulation would allow them to design around the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue the term refers only to the primary ingredient responsible for the claimed vasoconstrictive effect, allowing for other substances with ancillary or different therapeutic benefits. The patent’s primary focus is on the novel use of brimonidine for vasoconstriction.
    • Evidence for a Narrower Interpretation: The patent explicitly describes combination therapies with other agents like antihistamines in separate embodiments, contrasting them with the "sole active ingredient" embodiment of claim 1 (’600 Patent, col. 15:64-16:5). Practitioners may focus on this contrast to argue that "sole" was intended to mean the absence of any other substance classified as a therapeutic agent.

  • The Term: "about 0.025%"

  • Context and Importance: The scope of "about" defines the permissible concentration range. Because the ANDA specifies a 0.025% solution, infringement appears direct, but the construction of "about" remains a background issue for determining the claim's ultimate breadth.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the invention as relating to "low concentrations" generally, defining the range as "from between about 0.0001% to about 0.05%" (’600 Patent, col. 4:9-10). This broad disclosure may support a more flexible interpretation of "about."
    • Evidence for a Narrower Interpretation: The patent’s examples and figures suggest that the clinical benefits are sensitive to concentration, with an optimal window to achieve efficacy while avoiding side effects (’600 Patent, col. 19:25-30). This could support an argument that "about" should be construed more narrowly to encompass only minor manufacturing variances.

VI. Other Allegations

Indirect Infringement

  • The complaint makes general allegations of induced and contributory infringement (Compl. ¶44, ¶50). In the context of an ANDA case, the factual basis for inducement would be Defendants' act of seeking FDA approval for a product with a proposed label that instructs users to perform the patented method of reducing eye redness.

Willful Infringement

  • The complaint does not use the term “willful infringement.” However, in its prayer for relief, it requests a declaration that this is an “exceptional case” under 35 U.S.C. § 285, which could entitle Plaintiffs to attorney's fees (Compl., Prayer for Relief ¶5). The factual basis for this request is not detailed but could relate to allegations regarding Defendants' litigation conduct or failure to provide a required patent certification notice (Compl. ¶24-25).

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

This case presents several key questions typical of Hatch-Waxman litigation, revolving more around patent validity than direct infringement.

  • A primary issue will be one of patentability: Is the claimed method of using a 0.025% brimonidine solution for eye redness non-obvious in light of prior art disclosing higher concentrations (e.g., 0.1%-0.2%) for treating glaucoma? The case will likely turn on whether Plaintiffs can demonstrate that this specific low concentration yields unexpected results, such as a significant reduction in rebound hyperemia, that a person of ordinary skill in the art would not have predicted.
  • A secondary question is one of claim scope: Can the term "sole active ingredient" be interpreted to exclude formulations that contain other substances with any potential secondary therapeutic activity? The resolution of this issue will determine whether Defendants can design a non-infringing alternative by modifying formulation excipients.
  • Finally, a key evidentiary question will be the interpretation and weight given to the clinical data and expert testimony presented by both sides regarding the incidence and severity of side effects like rebound hyperemia at different concentrations of brimonidine.