DCT

3:22-cv-00534

Bausch & Lomb Inc v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:22-cv-00534, D.N.J., 02/02/2022
  • Venue Allegations: Venue is alleged based on Defendants maintaining a regular and established place of business in the district, including a research and manufacturing facility, and having previously submitted to the court’s jurisdiction in prior litigation. The filing of the Abbreviated New Drug Application (ANDA) is also presented as a formal act purposefully directed at New Jersey.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an ANDA to market a generic version of the ophthalmic solution Lumify® constitutes an act of infringement of two patents covering low-concentration brimonidine compositions for reducing eye redness and increasing eye whiteness.
  • Technical Context: The technology relates to over-the-counter ophthalmic solutions that use a low concentration of a selective alpha-2 adrenergic agonist to achieve the cosmetic and therapeutic effect of reducing eye redness.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Plaintiffs' receipt of a Notice of Paragraph IV Certification from Lupin on or about January 20, 2022, regarding Lupin's ANDA No. 216716. The patents-in-suit are listed in the FDA's Orange Book for Plaintiffs' New Drug Application No. 208144, which covers the branded product Lumify®.

Case Timeline

Date Event
2008-08-01 Earliest Priority Date for U.S. Patent No. 8,293,742
2009-12-17 Earliest Priority Date for U.S. Patent No. 9,259,425
2012-10-23 U.S. Patent No. 8293742 Issues
2016-02-16 U.S. Patent No. 9259425 Issues
2017-12-22 FDA Approves NDA for Lumify® (0.025% brimonidine tartrate)
2022-01-18 Date of Lupin's Notice Letter to Plaintiffs
2022-02-02 Complaint Filed

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 describes how commercially available ophthalmic decongestants, which are general alpha agonists, are known to cause "rebound hyperemia"—a condition where eye redness returns, often worse than before treatment. It notes that even brimonidine, a selective alpha-2 agonist, is associated with this side effect when used at the higher concentrations (e.g., 0.1% to 0.2%) approved for treating glaucoma ('742 Patent, col. 2:3-29).
  • The Patented Solution: The invention proposes using a low concentration (below 0.05%) of a highly selective alpha-2 agonist like brimonidine. The specification teaches that this specific low-dose range can induce effective vasoconstriction to reduce redness while minimizing the stimulation of alpha-1 receptors, which is theorized to be the cause of rebound hyperemia. This approach seeks to find a therapeutic window that maximizes the desired effect while avoiding the primary limiting side effect of prior art formulations ('742 Patent, col. 4:25-58).
  • Technical Importance: The invention provided a method to achieve a desirable cosmetic effect (eye redness reduction) without the significant drawback of rebound hyperemia that limited the frequent or long-term use of existing over-the-counter products ('742 Patent, col. 2:20-29).

Key Claims at a Glance

  • The complaint asserts at least one claim of the '742 patent (Compl. ¶39). Independent claim 1 recites:
    • 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 specify dependent claims but reserves the right to assert additional 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 undesirable side effects, such as rebound hyperemia, associated with selective alpha-2 adrenergic receptor agonists when used at conventional higher doses of 0.1% or greater ('425 Patent, col. 1:50-55).
  • The Patented Solution: The invention claims methods for improving the cosmetic appearance of eyes by "increasing whiteness" through the administration of low concentrations of selective alpha-2 agonists like brimonidine. This whitening is described as potentially resulting from the "microvascular vasoconstriction of the vessels and, particularly, microvessels of the white layer of the eye (i.e., the sclera)," suggesting an effect beyond merely reducing the redness of the overlying conjunctival tissue ('425 Patent, col. 4:6-12).
  • Technical Importance: This technology frames the therapeutic goal in terms of a distinct cosmetic outcome—"eye whitening"—and ties it to a low-dose formulation strategy designed to avoid the side effects that plagued earlier high-dose versions of the same active ingredient.

Key Claims at a Glance

  • The complaint asserts at least one claim of the '425 patent (Compl. ¶50). Independent claim 1 recites:
    • 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 group including lofexidine, apraclonidine, mivazerol, clonidine, brimonidine, and others,
    • or a pharmaceutically acceptable salt thereof.
  • The complaint does not specify dependent claims but reserves the right to assert additional claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Lupin's generic brimonidine ophthalmic solution, 0.025%," as described in Abbreviated New Drug Application (ANDA) No. 216716 (Compl. ¶1, 31).

Functionality and Market Context

  • The product is an ophthalmic solution containing 0.025% brimonidine tartrate (Compl. ¶35). The complaint alleges that the product is intended to be a generic version of Plaintiffs' Lumify® product and is "the same, or substantially the same, as Lumify®" (Compl. ¶32, 36). As a generic drug submitted under an ANDA, it seeks to be a lower-cost, bioequivalent alternative to the branded drug, targeting the same market for reducing eye redness (Compl. ¶32, 35).

IV. Analysis of Infringement Allegations

The infringement allegations are based on 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as an act of infringement. The analysis focuses on whether the product described in the ANDA, if marketed, would infringe the patents-in-suit.

’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... The filing of ANDA No. 216716 is alleged to be an act of infringement. The product is a generic version of Lumify®, which is used to reduce eye redness, and its label would instruct patients to administer the brimonidine solution to the eye. ¶32, 39 col. 21:18-21
...wherein brimonidine is present at a concentration between about 0.001% weight by volume and about 0.05% weight by volume. Lupin’s ANDA product is alleged to contain brimonidine tartrate ophthalmic solution at a concentration of 0.025%, which falls within the claimed range. ¶35 col. 21:20-22

’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... a composition comprising... a selective a-2 adrenergic receptor agonist... Lupin's ANDA product contains brimonidine, which is an enumerated selective a-2 adrenergic receptor agonist. Its intended use as a generic version of Lumify® would involve administration to the eye for a cosmetic whitening effect. ¶35, 50 col. 9:1-11
...from between about 0.001% to about 0.05% weight by volume... The accused ANDA product has a brimonidine concentration of 0.025%, which falls within the claimed range. ¶35 col. 9:3-5

Identified Points of Contention

  • Scope Questions: A central question for the ’742 patent may be the interpretation of the transitional phrase "consisting essentially of." The dispute may focus on whether unrecited ingredients (excipients) in Lupin's formulation materially affect the "basic and novel properties" of the invention—namely, redness reduction with minimal rebound hyperemia.
  • Technical Questions: For the ’425 patent, a key question is whether the claimed method step of "increasing whiteness of an eye" requires a different or additional outcome than simply "reducing redness." The parties may dispute the evidentiary standard for proving "increasing whiteness" and whether the intended use of Lupin's product meets that standard.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

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

Context and Importance

  • This term defines the boundary of the claim. Infringement analysis will depend on whether any unrecited excipients in Lupin's generic formulation are found to materially alter the invention's fundamental characteristics. Practitioners may focus on this term because it is a well-established point of contention in chemical composition claims, turning on the specific facts of the formulation and the patent's disclosure.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification's primary focus is on the concentration of the selective a-2 agonist itself as the driver of the benefit. A party could argue that only other active ingredients with vasoconstrictive or vasodilatory effects would be material, not standard pharmaceutical excipients.
  • Evidence for a Narrower Interpretation: The '742 patent repeatedly emphasizes the goal of avoiding rebound hyperemia and ischemia as the core of the invention ('742 Patent, col. 4:25-58). A party could argue that any excipient that influences the eye's vascular response, inflammatory state, or the drug's penetration profile could be deemed to materially affect this characteristic.

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

Context and Importance

  • The definition of this term is critical for determining infringement of the '425 patent. The dispute will likely center on whether this phrase requires a measurable improvement in the baseline color of the sclera itself, or if it is simply a more marketable description for the effect of reducing redness in the overlying conjunctiva.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The patent's summary suggests the invention is for "achieving cosmetic eye whitening," which a party might argue is a subjective, appearance-based standard met by any significant reduction in overall redness ('425 Patent, col. 1:62-64).
  • Evidence for a Narrower Interpretation: The specification explicitly mentions "microvascular vasoconstriction of the vessels and, particularly, microvessels of the white layer of the eye (i.e., the sclera)" and refers to a "bleaching" effect beyond baseline ('425 Patent, col. 4:6-19). This language could support a narrower construction requiring proof of a physiological effect on the sclera itself.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement by manufacturing and selling the generic product with a label that will inevitably instruct physicians and patients to perform the patented methods of use (Compl. ¶41, 52).
  • Willful Infringement: The complaint does not plead willfulness as a separate count, but the prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285 (Compl., Prayer for Relief ¶6). The factual basis for knowledge of the patents is Lupin's submission of the Paragraph IV Notice Letter, which is a required certification that Lupin is challenging the patents-in-suit (Compl. ¶33).

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

  • A central issue, common in ANDA litigation, will likely be one of validity: was it obvious to a person of ordinary skill in the art at the time of the invention to use a low concentration (0.025%) of brimonidine for eye redness, given the known use of higher concentrations for glaucoma and the known side effects of those higher concentrations?
  • A key question of claim scope will be the interpretation of "consisting essentially of" in the '742 patent. The outcome will depend on whether the specific excipients in Lupin's formulation are found to materially alter the invention's disclosed benefit of reducing redness without significant rebound hyperemia.
  • A final dispositive question will be one of definitional scope and proof: for the '425 patent, what is the legal and factual distinction between "reducing redness" and "increasing whiteness," and what evidence will be required to prove the latter? The answer may determine whether infringement can be established and whether the claim itself is sufficiently definite.