Bausch & Lomb Inc v. Lupin Ltd

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: Lupin Ltd. (India); Lupin Atlantis Holdings SA (Switzerland); Lupin Inc. (Delaware); and Lupin Pharmaceuticals, Inc. (Delaware)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 3:23-cv-02452, D.N.J., 05/03/2023
• Venue Allegations: Venue is alleged to be proper based on Defendants maintaining a regular and established place of business in the District of New Jersey, purposefully conducting business in the state, and having previously submitted to the court's jurisdiction in other litigation.
• Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the ophthalmic solution Lumify® constitutes an act of infringement of a patent covering a low-concentration brimonidine formulation for reducing eye redness.
• Technical Context: The technology relates to ophthalmic solutions for treating conjunctival hyperemia (eye redness), a common condition addressed by a large over-the-counter market.
• Key Procedural History: This is a Hatch-Waxman action filed after U.S. Patent No. 11,596,600 was listed in the FDA's Orange Book for the branded drug Lumify®. The complaint notes this action is related to prior, consolidated litigation between the same parties concerning other patents covering Lumify®. Plaintiffs allege that Defendants failed to provide a new Paragraph IV certification notice letter after the patent-in-suit was listed, an issue that may have procedural implications.

Case Timeline

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

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 existing ophthalmic vasoconstrictors, including then-current formulations of brimonidine used for glaucoma (0.1% to 0.2%), are associated with a high incidence of "rebound hyperemia," a condition where eye redness returns or worsens after the drug's effect subsides ('600 Patent, col. 2:5-19). This side effect limits their suitability for long-term or cosmetic use ('600 Patent, col. 2:43-46).
• The Patented Solution: The invention is based on the discovery that using a low concentration of a highly selective alpha-2 adrenergic agonist, specifically brimonidine, can achieve effective vasoconstriction to reduce eye redness while significantly reducing or eliminating the side effect of rebound hyperemia ('600 Patent, col. 2:47-55). The patent theorizes that this benefit arises from minimizing the stimulation of alpha-1 adrenergic receptors, which is believed to be the primary cause of rebound hyperemia ('600 Patent, col. 5:6-14).
• Technical Importance: This approach provides a method for safe, long-term vasoconstriction, making the treatment suitable for chronic conditions and for improving cosmetic appearance without the significant side effects of prior art formulations ('600 Patent, col. 2:43-46).

Key Claims at a Glance

• The complaint alleges infringement of "at least one claim" of the '600 patent (Compl. ¶44). The patent contains one independent claim, Claim 1.
• The essential elements of independent Claim 1 are:
  • A method for reducing eye redness in a human subject having ocular hyperemia,
  • comprising topically administering to an eye of said human... an ocular drop,
  • comprising about 0.025% weight by volume brimonidine as the sole active ingredient,
  • wherein the ocular drop has a pH between 5.5 to 6.5.

III. The Accused Instrumentality

Product Identification

• Lupin’s generic Brimonidine Tartrate Ophthalmic Solution, 0.025%, which is the subject of ANDA No. 216716 submitted to the FDA (Compl. ¶¶1, 13).

Functionality and Market Context

• The complaint alleges that Lupin's ANDA product is a generic version of Plaintiffs' Lumify® ophthalmic solution and is "the same, or substantially the same, as Lumify®" (Compl. ¶¶13, 17). The product is a 0.025% brimonidine tartrate solution intended for topical application to the eye to reduce redness (Compl. ¶16). If approved, it would compete as a lower-cost generic alternative to the branded Lumify® product (Compl. ¶13).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed infringement allegations beyond stating that the submission of ANDA No. 216716 infringes the '600 patent. The following chart summarizes the infringement theory as can be inferred from the complaint's description of the accused product.

No probative visual evidence provided in complaint.

'600 Patent Infringement Allegations

Identified Points of Contention

• Technical Questions: A primary factual dispute will likely concern the precise formulation of Lupin's generic product. Does its pH fall within the claimed 5.5 to 6.5 range? Does it contain any other ingredients that could be characterized as "active"? The complaint does not provide this level of technical detail, which will be a focus of discovery.
• Scope Questions: The interpretation of "sole active ingredient" may be a central issue. The dispute could raise the question of whether this limitation precludes only other primary vasoconstrictors or if it also excludes excipients (such as certain preservatives) that may have any secondary physiological effect.

V. Key Claim Terms for Construction

The Term: "sole active ingredient"

• Context and Importance: This term is critical for defining the scope of the invention. Infringement will depend on whether Lupin's formulation contains any other substance that meets the legal definition of an "active ingredient." Practitioners may focus on this term because the composition of generic formulations, including preservatives and stabilizers, can differ from the branded product.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue that in the context of the patent, "active ingredient" refers only to the component providing the primary claimed therapeutic benefit (i.e., vasoconstriction for reducing redness), and that standard pharmaceutical excipients are therefore not "active ingredients."
  • Evidence for a Narrower Interpretation: The patent does not provide an explicit definition. A party could argue that any component with a known, independent physiological or therapeutic effect, regardless of its primary purpose in the formulation, qualifies as an "active ingredient," thereby narrowing the claim's scope.

The Term: "about 0.025% weight by volume"

• Context and Importance: Lupin's product is specified as 0.025% brimonidine, which falls literally within the scope of this term. However, the meaning of "about" is a classic claim construction issue that determines the outer boundaries of the claimed range.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discusses concentration ranges, such as "from about 0.01% to about 0.025%" ('600 Patent, col. 4:11-12), which may suggest the patentee contemplated a degree of flexibility around the stated values.
  • Evidence for a Narrower Interpretation: The patent claims a specific concentration, 0.025%, rather than a range in Claim 1. A party could argue "about" should be narrowly construed to cover only minor variations consistent with standard manufacturing tolerances for ophthalmic solutions.

VI. Other Allegations

Indirect Infringement

• The complaint pleads induced and contributory infringement (Compl. ¶45). The factual basis for inducement is the allegation that Lupin's proposed product labeling will instruct end-users to administer the 0.025% brimonidine solution to the eye, thereby directing them to perform the steps of the patented method (inferred from Compl. ¶¶13, 17, 45).

Willful Infringement

• The complaint does not use the word "willful" but requests the case be declared "exceptional" under 35 U.S.C. § 285, which is related to findings of willful infringement or other litigation misconduct (Compl., Prayer for Relief, ¶5). This allegation may be based on Lupin’s alleged knowledge of the '600 patent from its listing in the FDA's Orange Book and its alleged failure to provide a required Paragraph IV notice for the patent (Compl. ¶¶10, 20).

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

• A central issue will be one of evidentiary proof: can Plaintiffs demonstrate through discovery that Lupin’s ANDA formulation, which is not fully detailed in the complaint, meets every specific limitation of Claim 1? The analysis will focus heavily on the factual question of whether the generic product's pH and full list of ingredients align with the narrow parameters claimed in the patent.
• The case may also turn on a question of claim construction: how will the court define "sole active ingredient"? The outcome of this definitional dispute could be dispositive, as it will determine whether the presence of other common pharmaceutical excipients in Lupin's formulation is sufficient to place the product outside the literal scope of the asserted claim.