DCT

3:23-cv-03463

Bausch & Lomb Inc v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-03463, D.N.J., 06/27/2023
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories Inc. is a New Jersey corporation with a regular and established place of business in the district. Venue over Dr. Reddy's Laboratories Ltd., a foreign corporation, is alleged to be proper in any district where it is subject to personal jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the glaucoma treatment Vyzulta® constitutes an act of infringement of four U.S. patents related to prostaglandin nitroderivative compounds.
  • Technical Context: The technology concerns novel chemical compounds, specifically prostaglandin derivatives containing a nitric oxide-donating moiety, designed to treat elevated intraocular pressure associated with glaucoma and ocular hypertension.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Paragraph IV certification notice letter from Defendants regarding their ANDA filing. The complaint notes that applications for Patent Term Extension (PTE) are pending for three of the four asserted patents, which may affect their ultimate expiration dates.

Case Timeline

Date Event
2004-01-05 Earliest Priority Date for all Asserted Patents
2007-09-25 U.S. Patent No. 7,273,946 Issues
2009-12-08 U.S. Patent No. 7,629,345 Issues
2011-03-22 U.S. Patent No. 7,910,767 Issues
2011-11-15 U.S. Patent No. 8,058,467 Issues
2017-11-02 FDA Approves Vyzulta® New Drug Application
2023-05-24 Date of Defendants' Paragraph IV Certification Letter
2023-06-27 Complaint for Patent Infringement Filed

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

U.S. Patent No. 7,273,946 - “Prostaglandin Derivatives”

The Invention Explained

  • Problem Addressed: The patent background describes how conventional drugs used to treat glaucoma and ocular hypertension are associated with significant side effects, including serious pulmonary issues, depression, fatigue, and ocular irritation (’946 Patent, col. 1:32-49). Even existing topical prostaglandin analogs, while effective, can produce undesirable side effects such as increased iris pigmentation, ocular irritation, and conjunctival hyperaemia (’946 Patent, col. 1:44-49).
  • The Patented Solution: The invention proposes novel compounds called “prostaglandin nitroderivatives” that are designed to have an improved overall profile of pharmacological activity and enhanced tolerability (’946 Patent, col. 2:10-18). The core concept involves chemically linking a prostaglandin molecule, which lowers intraocular pressure (IOP), to a nitric oxide (NO) donating moiety (specifically, a nitrooxy group, -ONO₂) via a bivalent linker radical (’946 Patent, col. 2:31-32). This creates a single molecule intended to deliver the therapeutic benefits of both prostaglandins and nitric oxide.
  • Technical Importance: This chemical design creates a single-molecule, dual-action therapeutic approach for lowering IOP, potentially offering greater efficacy or a better safety profile than administering separate drugs.

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the ’946 Patent (Compl. ¶ 35). Claim 1 is the broadest independent compound claim.
  • Independent Claim 1 claims, in relevant part:
    • A compound of general formula (I): R—X—Y—ONO₂, or a pharmaceutically acceptable salt or stereoisomer thereof;
    • wherein R is a prostaglandin residue of formula (II);
    • wherein X is —O—, —S—, or —NH—;
    • and wherein Y is a bivalent radical selected from a specified list of chemical structures, including straight or branched alkylene chains.
  • The complaint does not specify any asserted dependent claims but makes a general allegation against the patent.

U.S. Patent No. 7,629,345 - “Prostaglandin Derivatives”

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’946 Patent, the ’345 Patent addresses the same technical problem: the side effects and tolerability issues associated with existing glaucoma treatments, including prior prostaglandin analogs (’345 Patent, col. 1:40-55).
  • The Patented Solution: The invention is directed to the same prostaglandin nitroderivatives described in the ’946 patent family, which combine a prostaglandin residue with a nitric oxide-donating group (’345 Patent, col. 2:16-24). The patent describes these compounds as having a "significantly improved overall profile as compared to native prostaglandins" (’345 Patent, col. 2:19-21).
  • Technical Importance: The patent protects specific pharmaceutical compositions containing the novel dual-action compounds, providing a layer of protection beyond the compound itself.

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the ’345 Patent (Compl. ¶ 46). Claim 1 is an independent composition claim.
  • Independent Claim 1 claims:
    • A pharmaceutical composition comprising a compound of a specific chemical formula (which corresponds to latanoprostene bunod);
    • or a pharmaceutically acceptable salt or stereoisomer thereof;
    • and a pharmaceutically acceptable carrier.
  • The complaint does not specify any asserted dependent claims.

U.S. Patent No. 7,910,767 - “Prostaglandin Derivatives”

  • Technology Synopsis: Belonging to the same patent family, the ’767 Patent discloses and claims prostaglandin nitroderivatives for treating glaucoma and ocular hypertension (Compl. ¶ 25). The invention aims to provide compounds with improved pharmacological activity and enhanced tolerability by linking a prostaglandin moiety to a nitric oxide donor (’767 Patent, Abstract).
  • Asserted Claims: The complaint asserts "at least one claim" (Compl. ¶ 57). Independent claim 1 covers a genus of prostaglandin nitroderivative compounds.
  • Accused Features: The accused feature is the active pharmaceutical ingredient, latanoprostene bunod, in Defendants' proposed generic product, which is alleged to fall within the scope of the claims of the ’767 Patent (Compl. ¶¶ 29, 58).

U.S. Patent No. 8,058,467 - “Prostaglandin Derivatives”

  • Technology Synopsis: The ’467 Patent, also from the same family, is directed to novel prostaglandin nitroderivatives for treating glaucoma, claiming to offer improved pharmacological activity and enhanced tolerability (Compl. ¶ 26). The technology involves joining a prostaglandin residue with a nitric oxide-donating group to create a single therapeutic molecule (’467 Patent, Abstract).
  • Asserted Claims: The complaint asserts "at least one claim" (Compl. ¶ 68). Independent claim 1 is directed to a specific compound, latanoprostene bunod.
  • Accused Features: The infringement allegation targets the latanoprostene bunod active ingredient in the generic ophthalmic solution described in Defendants' ANDA submission (Compl. ¶¶ 29, 69).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "DRL's generic latanoprostene bunod ophthalmic solution, 0.024%" (Compl. ¶ 1). The action is based on Defendants' submission of Abbreviated New Drug Application (ANDA) No. 218414 to the U.S. Food and Drug Administration (FDA) (Compl. ¶ 28).

Functionality and Market Context

The proposed product is intended to be a generic version of Plaintiffs' Vyzulta® product, which is approved for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (Compl. ¶¶ 4, 29). The complaint alleges that Defendants' ANDA product is "the same, or substantially the same, as Vyzulta®" (Compl. ¶ 33). The filing of the ANDA itself, seeking approval for commercial manufacture, use, and sale prior to patent expiry, constitutes the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶ 35).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or a detailed element-by-element analysis of infringement. The infringement theory is based on the statutory infringement provision for ANDA filings.

The complaint alleges that Defendants have infringed under 35 U.S.C. § 271(e)(2) by submitting ANDA No. 218414 to the FDA, which seeks approval for the commercial marketing of a generic latanoprostene bunod product before the expiration of the Asserted Patents (Compl. ¶¶ 35, 46, 57, 68). The central factual basis for this allegation is that the active pharmaceutical ingredient (API) in Defendants' proposed product is latanoprostene bunod, a specific chemical compound (Compl. ¶ 1). Plaintiffs allege this compound is covered by claims of the Asserted Patents, including the broad genus claims of the ’946 Patent, the specific composition claims of the ’345 Patent, and the specific compound claims of the ’467 Patent (Compl. ¶¶ 36, 47, 58, 69).

  • Identified Points of Contention:
    • Chemical Identity: A foundational question will be one of chemical identity: does the API described in ANDA No. 218414 have the exact chemical structure and properties required by the asserted claims? In ANDA litigation, this is often not the primary dispute, but questions could arise regarding stereoisomers, purity, or crystalline forms if relevant to the claim language.
    • Claim Scope: For the broader genus claims of the ’946 Patent, a potential issue is whether latanoprostene bunod meets every limitation of the claimed genus. For the narrower claims of the ’345 and ’467 Patents, which appear to specifically recite the Vyzulta® active ingredient, the dispute may focus less on infringement and more on the validity of those claims.

V. Key Claim Terms for Construction

  • The Term: "prostaglandin residue" (’946 Patent, Claim 1)
    • Context and Importance: This term defines the core structural component "R" of the claimed genus of compounds. Its construction will determine the breadth of prostaglandin-type molecules that can serve as the foundation for the patented derivatives, which is central to both infringement and validity analyses for the ’946 Patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent defines the "prostaglandin residue" by reference to a chemical structure, Formula (II), which contains a variable group "L" that can be one of several specified chemical moieties (’946 Patent, col. 2:50-65). This structural definition may support an interpretation covering any molecule meeting that formula, regardless of whether it is derived from a previously known prostaglandin.
      • Evidence for a Narrower Interpretation: The specification lists "latanoprost, travoprost, unoprostone and cloprostenol" as components for preferred prostaglandin residues (’946 Patent, col. 9:36-39). A party may argue that the term should be construed in light of these specific, known prostaglandin analogs, potentially limiting the scope to derivatives of compounds with established prostaglandin activity.
  • The Term: "bivalent radical" (’946 Patent, Claim 1)
    • Context and Importance: This term defines the linker "Y" that connects the prostaglandin "residue" to the nitrooxy group. The scope of this term is critical, as it dictates the allowable size, structure, and chemical properties of the linker connecting the two active moieties of the molecule.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: Claim 1 defines one option for "Y" very broadly as a "straight or branched C₁-C₂₀ alkylene, being optionally substituted" (’946 Patent, col. 53:41-44). This language on its face suggests a wide array of possible chemical linkers.
      • Evidence for a Narrower Interpretation: A party might point to the specific linkers used in the patent's working examples (e.g., a 4-carbon butyl chain in Example 1, ’946 Patent, col. 43:35-42) or preferred embodiments to argue that the term, while broadly stated, should be understood to cover only those types of simple linkers demonstrated to be effective by the inventors.

VI. Other Allegations

  • Indirect Infringement: The complaint includes allegations of future contributory and induced infringement upon approval and marketing of the generic product (Compl. ¶¶ 37, 48, 59, 70). The basis for these claims would be Defendants' act of selling the generic latanoprostene bunod product with labeling that instructs its use for lowering IOP, which would allegedly induce infringement by physicians and patients.
  • Willful Infringement: The complaint does not use the term "willful," but it requests a declaration that the case is "exceptional" under 35 U.S.C. §§ 285 and 271(e)(4) and seeks an award of attorney's fees (Compl., p. 15, ¶ 8). The factual basis for such a finding would likely be Defendants' knowledge of the Asserted Patents, as evidenced by their filing of a Paragraph IV certification notice.

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

  • A central issue will be one of patent validity: Given the existence of a patent family with claims of cascading breadth—from a broad genus in the ’946 Patent to the specific latanoprostene bunod compound in the ’467 Patent—the case will likely focus on whether these claims are valid over prior art that existed before the January 2004 priority date. Can Defendants prove, by clear and convincing evidence, that the claimed inventions were anticipated or obvious?
  • A related question will be one of written description and enablement: For the earliest and broadest patent (’946), a key issue may be whether the specification provides adequate written description to support the full scope of the claimed genus of compounds and enables a person of ordinary skill to make and use the full genus without undue experimentation.
  • Finally, a key procedural question will be the impact of the pending Patent Term Extension (PTE) applications. The ultimate statutory expiration dates for three of the four patents remain undetermined, meaning the total period of potential market exclusivity at stake in the litigation is not yet fixed (Compl. ¶ 27).