DCT

3:25-cv-03395

Bausch & Lomb Inc v. Somerset Therap LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-03395, D.N.J., 04/28/2025
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendants have principal places of business in the district, have registered to do business there, and have purposefully conducted business in the district, including acts related to the submission of the Abbreviated New Drug Application (ANDA) at issue.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an ANDA to market a generic version of Plaintiffs’ Lumify® ophthalmic solution constitutes an act of infringement of four patents related to low-concentration brimonidine formulations for reducing eye redness.
  • Technical Context: The technology concerns ophthalmic solutions using low concentrations of brimonidine, a selective alpha-2 adrenergic agonist, to achieve vasoconstriction (eye redness reduction) while minimizing side effects common to prior art treatments.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act, triggered by Plaintiffs' receipt of a Notice of Paragraph IV Certification from Defendants. The notice informed Plaintiffs that Defendants had filed an ANDA seeking FDA approval to market a generic version of Lumify® prior to the expiration of the asserted patents, which are listed in the FDA's Orange Book.

Case Timeline

Date Event
2008-08-01 Earliest Patent Priority Date (’742, ’600, ’245 Patents)
2009-12-17 Earliest Patent Priority Date (’425 Patent)
2012-10-23 ’742 Patent Issued
2016-02-16 ’425 Patent Issued
2017-12-22 FDA Approved NDA for Lumify®
2023-03-07 ’600 Patent Issued
2023-12-05 ’245 Patent Issued
2025-03-28 Plaintiffs Received Defendants’ Paragraph IV Notice Letter
2025-04-28 Complaint Filed

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

U.S. Patent No. 8,293,742 - "Preferential Vasoconstriction Compositions and Methods of Use"

The Invention Explained

  • Problem Addressed: The patent describes the problem of eye redness (conjunctival hyperemia) caused by the dilation of small blood vessels. It notes that commercially available treatments, including higher-concentration brimonidine formulations used for glaucoma, can cause undesirable side effects such as significant "rebound hyperemia," where eye redness returns, sometimes worse than the initial condition. (’742 Patent, col. 1:11-16, col. 2:1-7).
  • The Patented Solution: The invention proposes using low concentrations of highly selective alpha-2 adrenergic receptor agonists, specifically brimonidine, to induce effective vasoconstriction (eye whitening) while significantly reducing or eliminating rebound hyperemia and other side effects. The patent explains that this approach allows for safe, long-term vasoconstriction by minimizing the a-1 agonist activity believed to cause the rebound effect. (’742 Patent, col. 2:40-49, col. 4:50-65).
  • Technical Importance: The claimed technical approach suggests a method to decouple the therapeutic vasoconstrictive effect of brimonidine from the side effects that limited its cosmetic and long-term use at higher concentrations. (’742 Patent, col. 2:30-38).

Key Claims at a Glance

  • The complaint asserts at least one claim of the '742 patent (Compl. ¶49). Independent claim 1 is representative:
  • A method for reducing eye redness consisting essentially of administering 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.

U.S. Patent No. 9,259,425 - "Compositions and Methods for Eye Whitening"

The Invention Explained

  • Problem Addressed: The patent addresses the cosmetic desire for "whiter eyes," noting that conventional eye redness relievers using selective a-2 adrenergic receptor agonists at higher concentrations (0.1% or more) are associated with undesirable side effects like rebound hyperemia. (’425 Patent, col. 1:49-56).
  • The Patented Solution: The invention is directed to methods and compositions that whiten eyes, including healthy eyes, beyond simply reducing redness from a disease or condition. It achieves this by using low concentrations of selective a-2 adrenergic receptor agonists like brimonidine, which cause microvascular vasoconstriction in the sclera (the white layer of the eye) with reduced side effects, thereby improving cosmetic appearance. (’425 Patent, Abstract; col. 2:21-27, col. 4:8-19).
  • Technical Importance: This patent extends the low-concentration brimonidine concept specifically to cosmetic eye whitening, suggesting an ability to enhance whiteness beyond a person's normal baseline, not just treat hyperemia. (’425 Patent, col. 3:60-64).

Key Claims at a Glance

  • The complaint asserts at least one claim of the '425 patent (Compl. ¶60). 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 specified group including brimonidine,
  • or a pharmaceutically acceptable salt thereof.

U.S. Patent No. 11,596,600 - "Vasoconstriction Compositions and Methods of Use"

  • Technology Synopsis: This patent describes methods for reducing eye redness by topically administering an ocular drop containing about 0.025% brimonidine as the sole active ingredient. The invention aims to provide effective vasoconstriction for cosmetic and therapeutic purposes with a low incidence of rebound hyperemia. (’600 Patent, Abstract; col. 22:35-46).
  • Asserted Claims: The complaint asserts at least one claim of the '600 patent (Compl. ¶71).
  • Accused Features: The accused features are embodied in Somerset's generic brimonidine ophthalmic solution, which allegedly contains 0.025% brimonidine tartrate (Compl. ¶1, 17).

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

  • Technology Synopsis: This patent discloses methods for reducing eye redness in a subject with ocular hyperemia by administering an ocular drop consisting of 0.025% brimonidine as the sole active ingredient. The formulation is intended to improve the aesthetic appearance of the eye while retaining normal intraocular pressure. (’245 Patent, Abstract; col. 23:1-8).
  • Asserted Claims: The complaint asserts at least one claim of the '245 patent (Compl. ¶82).
  • Accused Features: The accused features are embodied in Somerset's generic brimonidine ophthalmic solution, which allegedly contains 0.025% brimonidine tartrate (Compl. ¶1, 17).

III. The Accused Instrumentality

Product Identification

  • Somerset's generic Brimonidine Tartrate Ophthalmic Solution, 0.025%, for which Somerset has filed ANDA No. 219823 with the FDA (Compl. ¶1, 16).

Functionality and Market Context

  • The complaint alleges that Somerset's product is a generic version of Bausch & Lomb's Lumify® ophthalmic solution and is "the same, or substantially the same, as Lumify®" (Compl. ¶17, 21). The product is an ophthalmic solution intended for topical administration to the eye to reduce redness. Somerset seeks FDA approval to engage in the commercial manufacture, use, and sale of this product in the United States upon approval of its ANDA (Compl. ¶17).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint's infringement theory is based on 35 U.S.C. § 271(e)(2), which makes the submission of an ANDA an act of infringement if the generic product, upon approval, would infringe a valid patent (Compl. ¶49, 60). The allegations contend that the use of Somerset's generic product as directed by its proposed label will directly infringe the asserted method claims, and the product itself will infringe any composition claims.

'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... Defendants' ANDA seeks approval for a product intended to be a generic version of Lumify®, a product sold for reducing eye redness. The proposed label for the generic product will instruct users to administer it for this purpose. ¶1, 17, 21 col. 10:20-24
...to a patient having an ocular condition, The accused product is an ophthalmic solution intended for patients with ocular conditions such as eye redness. ¶1, 15, 17 col. 12:36-38
...wherein brimonidine is present at a concentration between about 0.001% and about 0.05% weight by volume. The accused product is identified as "Brimonidine Tartrate Ophthalmic Solution, 0.025%," which is a concentration that falls within the claimed range. ¶1, 20 col. 11:59-63

'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... The accused product is a generic version of Lumify®, an ophthalmic solution for reducing eye redness, which inherently involves increasing the whiteness of the eye. Its proposed label will instruct users on this administration. ¶1, 17, 21 col. 1:44-48
...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] brimonidine... Somerset's product is an ophthalmic solution containing 0.025% brimonidine tartrate. Brimonidine is a selective a-2 adrenergic receptor agonist, and the 0.025% concentration falls within the claimed range. ¶1, 20 col. 2:10-20

Identified Points of Contention

  • Scope Questions: A central dispute may involve the construction of the phrase "consisting essentially of" in the ’742 Patent. The analysis will question whether the specific excipients and other inactive ingredients in Defendants' formulation introduce new characteristics that remove the product from the scope of claims using this transitional phrase. For the ’425 Patent, a question may be whether "increasing whiteness" requires an effect beyond merely reducing hyperemia, and whether the accused product is intended for or achieves such an effect.
  • Technical Questions: While the concentration of the active ingredient (0.025% brimonidine) appears to read directly on the claims, disputes could arise over whether the specific salt form (tartrate) and formulation of the accused product perform the method in the same way as contemplated by the patents. The primary defense in an ANDA case, however, will likely center on the validity of the patents, raising the question of whether using this low concentration of brimonidine for eye redness was obvious over prior art uses of higher concentrations for glaucoma.

V. Key Claim Terms for Construction

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

  • Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." Its construction is critical because Defendants' generic formulation will contain various inactive ingredients (excipients, preservatives). The case may turn on whether these additional ingredients materially affect the basic and novel properties of the invention—namely, vasoconstriction with reduced rebound hyperemia.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification's focus on brimonidine as the agent responsible for the therapeutic effect, while mentioning various acceptable carriers and excipients, may support an interpretation that allows for any inactive ingredients that do not interfere with this primary function (e.g., ’742 Patent, col. 17:5-12).
    • Evidence for a Narrower Interpretation: The patent emphasizes that the invention's novelty lies in avoiding side effects like rebound hyperemia, which it attributes to a-1 agonist activity (’742 Patent, col. 4:59-65). An argument could be made that any excipient that introduces or enhances such side effects would fall outside the scope of "consisting essentially of."

"about 0.025%" (’600 Patent, Claim 1; ’245 Patent, Claim 1)

  • Context and Importance: The accused product is formulated at precisely 0.025% brimonidine tartrate (Compl. ¶1). While this appears to be a direct match, the term "about" provides some flexibility. Its scope will be relevant to potential arguments regarding manufacturing tolerances and whether minor deviations would still infringe. Practitioners may focus on this term to understand the permissible boundaries of the claimed concentration.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "about" itself implies a range. The specifications of the related patents discuss a range of effective concentrations, suggesting the invention is not limited to a single, exact value (e.g., ’742 Patent, col. 11:59-63, claiming "between about 0.001% and about 0.05%").
    • Evidence for a Narrower Interpretation: The patents in the family may contain examples or data suggesting that the 0.025% concentration is an optimal point that best balances efficacy with minimal side effects. For example, the patents distinguish their low-dose approach from higher glaucoma doses (0.1% to 0.2%), suggesting the upper and lower bounds of the claimed ranges are technically significant (’742 Patent, col. 2:1-7). This could be used to argue for a narrow interpretation of "about."

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Defendants will contributorily infringe and induce infringement through the future manufacture, use, and sale of their generic product (Compl. ¶51, 62, 73, 84). The basis for inducement is the allegation that Defendants' product label will instruct medical professionals and patients to administer the drug in a manner that directly infringes the patented methods.

Willful Infringement

  • The complaint does not contain a specific count for willful infringement. However, it alleges that Defendants "know or should know" that the branded product, Lumify®, is manufactured for Bausch & Lomb (Compl. ¶41) and that Defendants' Paragraph IV letter demonstrates knowledge of the asserted patents. The prayer for relief asks the court to declare this an "exceptional case" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees, often in cases of willfulness or litigation misconduct (Compl., Prayer for Relief ¶8).

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

This ANDA litigation will likely focus on questions of claim scope and, centrally, patent validity, rather than factual disputes over the composition of the accused generic product.

  • A core issue will be one of claim validity and obviousness: was it obvious to a person of ordinary skill in the art to use a low concentration of brimonidine (e.g., 0.025%) for the sole purpose of reducing eye redness, given prior art knowledge of brimonidine's vasoconstrictive properties and its use at higher concentrations (0.1-0.2%) to treat glaucoma?
  • A second key issue will be one of definitional scope: how will the court construe the term "consisting essentially of"? The outcome will determine whether the specific blend of excipients in the Defendants' ANDA product is sufficient to place it outside the bounds of the asserted claims of the ’742 patent.
  • Finally, a key question for the later-issued patents (’600 and ’245) will be one of patentability over the prior art, including Plaintiffs' own earlier patents: can the claims, which recite 0.025% brimonidine as the "sole active ingredient," be successfully defended as non-obvious in light of the earlier patents in the same family that claim broader ranges encompassing 0.025%?