DCT

3:23-cv-22906

Bausch & Lomb Inc v. Slayback Pharma LLC

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-22906, D.N.J., 12/05/2023
  • Venue Allegations: Venue is alleged to be proper based on the New Jersey incorporation and principal places of business for some defendants, their purposeful direction of activities at the state, and prior submissions to the court's jurisdiction in related litigation.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' Lumify® eye drops constitutes an act of infringement of a patent covering methods of using a specific brimonidine formulation to reduce eye redness.
  • Technical Context: The technology concerns low-concentration ophthalmic solutions of brimonidine, an alpha-2 adrenergic agonist, used as an over-the-counter treatment for reducing ocular redness (hyperemia).
  • Key Procedural History: This is a Hatch-Waxman action triggered by an ANDA filing. The complaint notes that during the prosecution of the patent-in-suit, the applicant disclosed to the USPTO a Final Written Decision from an inter partes review (IPR) that found claims of a different, related patent to be unpatentable. Following this disclosure, the applicant amended the claims that ultimately issued in the patent-in-suit, a fact that may be relevant to future claim construction and estoppel arguments. The complaint also references prior, consolidated litigation between the parties involving other patents.

Case Timeline

Date Event
2008-08-01 ’245 Patent Priority Date
2017-12-22 FDA approves NDA for Lumify®
2021-08-16 Plaintiffs receive Paragraph IV Notice Letter from Slayback regarding ANDA No. 216361
2023-08-09 Plaintiffs receive Paragraph IV Notice Letter from Dr. Reddy's regarding ANDA No. 216361
2023-12-05 ’245 Patent Issued
2023-12-05 Complaint Filed

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

U.S. Patent No. 11,833,245 - Vasoconstriction Compositions and Methods of Use

  • Patent Identification: U.S. Patent No. 11,833,245, "Vasoconstriction Compositions and Methods of Use," issued December 5, 2023.

The Invention Explained

  • Problem Addressed: The patent's background describes a problem with then-existing ophthalmic decongestants (a-adrenergic receptor agonists), which, while causing vasoconstriction to reduce redness, were associated with a high incidence of "rebound hyperemia" (a return or worsening of redness) and other side effects that limited their long-term use (’245 Patent, col. 2:7-21).
  • The Patented Solution: The invention claims to solve this problem by using a low concentration of a highly selective alpha-2 adrenergic receptor agonist, specifically brimonidine. This approach is asserted to achieve effective vasoconstriction while minimizing or avoiding the rebound hyperemia associated with prior art formulations, which often had higher concentrations or less selective active agents (’245 Patent, Abstract; col. 2:50-58). The patent posits that rebound hyperemia is primarily associated with alpha-1 agonist activity, which is minimized by using a highly selective alpha-2 agonist (’245 Patent, col. 5:6-15).
  • Technical Importance: The invention purports to provide a method for achieving the cosmetic and therapeutic benefits of eye redness reduction without the significant drawback of rebound effects, potentially enabling safer, long-term, and more frequent use than was feasible with older products (’245 Patent, col. 2:46-49).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" without specifying which ones (Compl. ¶50). Independent claim 1 is representative of the asserted technology.
  • Independent Claim 1: A method for reducing eye redness, with the following essential elements:
    • A method for reducing eye redness in a human subject having ocular hyperemia.
    • The method consists of topically administering a composition in the form of an ocular drop.
    • The composition consists of 0.025% weight by volume brimonidine as the "sole active ingredient."
    • The composition also includes "one or more non-therapeutic components including benzalkonium chloride."
    • The ocular drop has a pH between 5.5 to 6.5.
    • The administration results in the reduction of ocular hyperemia.

III. The Accused Instrumentality

Product Identification

  • Defendants' generic Brimonidine Tartrate Ophthalmic Solution, 0.025%, for which Abbreviated New Drug Application (ANDA) No. 216361 was filed with the FDA (Compl. ¶1, 18).

Functionality and Market Context

  • The accused product is an ophthalmic solution intended for topical administration to the eye (Compl. ¶19). As an ANDA product, its purpose is to be a generic version of the reference listed drug, Lumify®, which is used to relieve eye redness (Compl. ¶19, 21).
  • The complaint alleges that the ANDA submission contains data demonstrating bioequivalence to Lumify® and that the proposed generic product is the "same, or substantially the same" (Compl. ¶22, 28). The act of filing the ANDA to seek approval for commercial manufacture, use, and sale before the expiration of the ’245 Patent is the statutory act of infringement alleged in the complaint (Compl. ¶19, 50).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart exhibit. The infringement theory is based on the premise that to secure FDA approval, the Defendants' ANDA product must have the same active ingredient, concentration, and method of administration as the branded Lumify® product, which Plaintiffs contend is covered by the '245 Patent.

'245 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing eye redness in a human subject having ocular hyperemia... The proposed label for Defendants' ANDA product will instruct users to administer the solution to reduce eye redness. ¶19, 21 col. 23:36-40
...consisting of topically administering to an eye of said human in need of said reduction of eye redness a composition in the form of an ocular drop... The accused ANDA product is an ophthalmic solution intended to be used as an eye drop. ¶19, 22 col. 23:38-44
...consisting of 0.025% weight by volume brimonidine as the sole active ingredient... Defendants' ANDA is for a generic brimonidine tartrate ophthalmic solution at a concentration of 0.025%. ¶1, 22 col. 23:40-42
...and one or more non-therapeutic components including benzalkonium chloride... The complaint does not provide specific detail for analysis of this element. col. 23:42-44
...wherein the ocular drop has a pH between 5.5 to 6.5... The complaint does not provide specific detail for analysis of this element. col. 23:44-45
...wherein the ocular hyperemia is reduced. The intended therapeutic outcome of using Defendants' product, per its proposed label, will be the reduction of hyperemia. ¶19 col. 23:45-46
  • Identified Points of Contention:
    • Compositional Questions: A primary factual dispute will be whether the Defendants' ANDA product formulation meets the specific limitations of Claim 1. The complaint does not allege facts showing the generic product contains "benzalkonium chloride" or has a "pH between 5.5 to 6.5." Proving these elements will be critical for the Plaintiffs.
    • Scope Questions: Claim 1 uses the transition phrase "consisting of," which is highly restrictive in patent law. This raises the question of whether the Defendants' formulation includes any unrecited ingredients that could be construed as an "active ingredient." If it does, it may fall outside the scope of the claim. The interpretation of "sole active ingredient" will be central.

V. Key Claim Terms for Construction

  • The Term: "sole active ingredient"
  • Context and Importance: This term is dispositive for infringement. The claim's validity and scope depend on whether brimonidine is the only component in the formulation providing a therapeutic effect. Practitioners may focus on this term because Defendants could argue that another excipient in their formulation has some therapeutic or pharmacological activity, thereby taking the product outside the scope of a claim limited to a "sole" active ingredient.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to provide explicit language supporting a broad interpretation of "sole." The term itself is inherently limiting.
    • Evidence for a Narrower Interpretation: The claim language itself, which recites brimonidine "as the sole active ingredient" and separately lists "one or more non-therapeutic components" (col. 23:42-44), creates a strong implication of mutual exclusivity. The specification's focus on avoiding side effects from other, less-selective alpha agonists (which would be other "active ingredients") further supports a narrow reading where no other component contributes to the primary therapeutic mechanism (’245 Patent, col. 5:6-15).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement (Compl. ¶52). The basis for inducement is the filing of the ANDA itself. The allegation is that Defendants' proposed product label will necessarily instruct medical professionals and patients to use the generic product in a manner that directly infringes the method claims of the ’245 patent (Compl. ¶19, 51).
  • Willful Infringement: The complaint does not make a direct allegation of willful infringement. However, the prayer for relief requests a declaration that this is an "exceptional case" under 35 U.S.C. § 285, which could entitle Plaintiffs to attorneys' fees (Compl., Prayer for Relief ¶5).

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

  • A central evidentiary question will be one of compositional identity: Can Plaintiffs establish through discovery that the Defendants' ANDA product formulation precisely matches every limitation recited in the asserted claims, particularly the requirements for the presence of "benzalkonium chloride" and a specific "pH between 5.5 to 6.5," which are not detailed in the complaint?
  • The case will also turn on a question of claim scope and prosecution history: How will the court construe the highly restrictive "consisting of" and "sole active ingredient" language in Claim 1? Furthermore, did the amendments made during prosecution, following the invalidation of claims in a related patent's IPR, create any prosecution history estoppel that limits the enforceable scope of the asserted claims against the accused generic product?
  • A final core issue is one of statutory timing and effect: As the patent issued on the same day the complaint was filed, a question may arise regarding the accrual of liability for the pre-issuance act of filing the ANDA, though 35 U.S.C. § 271(e)(2) defines the submission of an ANDA for a patented drug as an act of infringement.