DCT

3:22-cv-04345

Bausch & Lomb Inc v. Gland Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:22-cv-04345, D.N.J., 06/30/2022
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant is a foreign corporation, has designated an agent for service of process within the district, has previously submitted to the court's jurisdiction in other matters, and intends to market its generic product in New Jersey upon FDA approval.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic latanoprostene bunod ophthalmic solution constitutes an act of infringement of four patents related to prostaglandin nitroderivative compounds for treating glaucoma.
  • Technical Context: The technology concerns novel chemical compounds known as prostaglandin nitroderivatives, which are designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension.
  • Key Procedural History: This infringement action was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a Notice of Paragraph IV Certification from Defendant on or about May 19, 2022. The notice informed Plaintiffs of Defendant's ANDA filing seeking to market a generic version of Plaintiffs' FDA-approved drug, Vyzulta®, prior to the expiration of the Asserted Patents. The complaint notes that applications for Patent Term Extension (PTE) are pending for three of the four asserted patents.

Case Timeline

Date Event
2004-01-05 Earliest Priority Date for all Asserted Patents
2007-09-25 ’946 Patent Issued
2009-12-08 ’345 Patent Issued
2011-03-22 ’767 Patent Issued
2011-11-15 ’467 Patent Issued
2017-11-02 FDA Approved Vyzulta® New Drug Application
2022-05-17 Date of Defendant's Notice of Paragraph IV Certification
2022-06-30 Complaint 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's background section describes the technical problem of side effects associated with conventional drugs for treating glaucoma and ocular hypertension. It notes that topical prostaglandin analogs can cause ocular irritation, iris pigmentation, and hyperemia, while other drug classes like beta-blockers can have serious pulmonary and other systemic side effects (’946 Patent, col. 1:31-50).
  • The Patented Solution: The invention proposes novel prostaglandin derivatives that incorporate a nitric oxide-donating group (a nitrooxy moiety) linked to a prostaglandin residue. The stated objective is to create a compound with both improved pharmacological activity and enhanced tolerability compared to the original prostaglandin compounds (’946 Patent, col. 2:9-18; Abstract). This dual-action approach combines the established intraocular pressure-lowering effect of prostaglandins with the physiological effects of nitric oxide.
  • Technical Importance: This chemical modification represents an effort to create a more effective glaucoma therapy by targeting multiple biological pathways simultaneously while potentially reducing the side effects associated with single-mechanism drugs (’946 Patent, col. 2:9-18).

Key Claims at a Glance

  • The complaint asserts at least one claim of the patent (Compl. ¶31). Independent claim 1 is representative of the core invention.
  • Independent Claim 1:
    • A compound of the general formula (I): R—X—Y—ONO2.
    • Wherein R is a prostaglandin residue of a specific chemical structure (formula (II)).
    • Wherein L is selected from a list of specific chemical side groups.
    • Wherein X is a linker selected from —O—, —S—, or —NH—.
    • Wherein Y is a bivalent radical selected from a list of chemical structures, such as alkylene or cycloalkylene groups.

U.S. Patent No. 7,629,345 - "PROSTAGLANDIN DERIVATIVES"

The Invention Explained

  • Problem Addressed: Similar to its parent patent, the ’345 Patent addresses the side effects of existing glaucoma therapies, including both prostaglandin analogs and other classes of drugs, which can limit their use and patient compliance (’345 Patent, col. 1:38-56).
  • The Patented Solution: The invention claims a specific prostaglandin nitroderivative compound, latanoprostene bunod, and pharmaceutical compositions containing it. This compound is designed to enhance pharmacological activity and tolerability for treating glaucoma by combining a latanoprost residue with a nitric oxide-donating moiety (’345 Patent, col. 2:16-25; Abstract).
  • Technical Importance: By claiming a specific chemical entity and compositions thereof, the patent focuses the broader inventive concept of the patent family on a particular drug candidate intended for clinical development and commercialization (’345 Patent, col. 55:5-30).

Key Claims at a Glance

  • The complaint asserts at least one claim of the patent (Compl. ¶42). Independent claim 1 is directed to a pharmaceutical composition.
  • Independent Claim 1:
    • A pharmaceutical composition comprising a specific compound of the formula [the chemical structure of latanoprostene bunod].
    • And a pharmaceutically acceptable carrier.

U.S. Patent No. 7,910,767 - "PROSTAGLANDIN DERIVATIVES"

Technology Synopsis

As part of the same patent family, the ’767 Patent discloses and claims novel prostaglandin nitroderivatives. The invention is directed at creating compounds with improved pharmacological activity and enhanced tolerability for the treatment of glaucoma and ocular hypertension by linking a prostaglandin to a nitric oxide-donating group (Compl. ¶20; ’767 Patent, Abstract).

Asserted Claims

The complaint alleges infringement of "at least one claim" (Compl. ¶53). Independent claims 1 and 11 are included in the patent.

Accused Features

The accused product is Gland's generic latanoprostene bunod ophthalmic solution, which Plaintiffs allege is a prostaglandin nitroderivative that falls within the scope of the patent's claims (Compl. ¶¶28, 53).

U.S. Patent No. 8,058,467 - "PROSTAGLANDIN DERIVATIVES"

Technology Synopsis

This patent continues the same inventive theme, disclosing and claiming prostaglandin nitroderivatives for treating glaucoma. The technology aims to provide an improved therapeutic profile over existing treatments by combining the mechanisms of a prostaglandin analog and a nitric oxide donor in a single molecule (Compl. ¶21; ’467 Patent, Abstract).

Asserted Claims

The complaint alleges infringement of "at least one claim" (Compl. ¶64). Independent claims 1 and 2 are included in the patent.

Accused Features

The infringement allegation is directed at Gland's generic latanoprostene bunod product, which is alleged to be a compound covered by the patent's claims (Compl. ¶¶28, 64).

III. The Accused Instrumentality

Product Identification

Defendant Gland Pharma Limited’s generic latanoprostene bunod ophthalmic solution, 0.024% (Compl. ¶1).

Functionality and Market Context

The accused product is an ophthalmic solution for which Gland has filed an ANDA seeking FDA approval (Compl. ¶23). It is intended to be a generic version of Vyzulta®, which is approved for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (Compl. ¶¶4, 24). The complaint alleges that Gland's product contains the same active ingredient as Vyzulta®, latanoprostene bunod, and is "the same, or substantially the same, as Vyzulta®" (Compl. ¶¶4, 28). Gland's ANDA submission includes data regarding the product's bioavailability or bioequivalence (Compl. ¶27).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’946 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of general formula (I) R—X—Y—ONO2... The complaint alleges that Defendant's product contains latanoprostene bunod, a compound that is alleged to fall within the scope of the claimed general formula. ¶¶28, 31 col. 2:32-34

’345 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising a compound of the formula... Defendant's product is alleged to be an ophthalmic solution containing the specifically claimed compound, latanoprostene bunod. ¶¶1, 28, 42 col. 55:7-30
and a pharmaceutically acceptable carrier. The accused product is an "ophthalmic solution," which by definition includes one or more pharmaceutically acceptable carriers in addition to the active ingredient. ¶1 col. 55:5-6

Identified Points of Contention

  • Scope Questions: As this is an ANDA action involving specific chemical compounds, a primary dispute may concern the validity of the asserted claims rather than literal infringement. A question for the court will be whether the scope of the claims, particularly the broad genus claim of the ’946 Patent, is valid over prior art relating to prostaglandin analogs and nitric oxide-donating compounds.
  • Technical Questions: The central technical question is whether the active ingredient in Gland’s proposed generic product, latanoprostene bunod, is in fact a compound covered by a valid and enforceable claim of the asserted patents. The complaint's allegation that Gland's product is "the same, or substantially the same, as Vyzulta®" frames this as a direct technical correspondence (Compl. ¶28).

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms that may be in dispute.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges contributory infringement and inducement, asserting that Defendant will, upon approval, manufacture and sell its generic product with knowledge and intent that it will be used in an infringing manner (Compl. ¶¶32, 43, 54, 65). These allegations are likely based on the proposed product labeling that would instruct physicians and patients to administer the drug for the patented indication.
  • Willful Infringement: The complaint does not use the word "willful," but it requests that the court declare this to be an "exceptional case" under 35 U.S.C. §§ 285 and 271(e)(4), which could support an award of attorneys' fees (Compl., Prayer for Relief ¶8). The factual basis for this request appears to be Defendant's knowledge of the Asserted Patents, evidenced by its filing of a Paragraph IV certification and sending a corresponding notice letter to Plaintiffs (Compl. ¶25).

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

  • A core issue will be one of claim validity: are the asserted claims covering the latanoprostene bunod compound, compositions, and its therapeutic use valid and enforceable in light of the prior art? The dispute will likely focus on whether the combination of a known prostaglandin analog with a nitric oxide-donating moiety would have been obvious to a person of ordinary skill in the art at the time of the invention.
  • A second key issue will be the effective patent term: the complaint notes that applications for Patent Term Extension (PTE) are pending for three of the four patents. The final, adjudicated expiration date of these patents, including any granted PTE, will determine the potential duration of market exclusivity and the timeline for generic entry.
  • A final question will be one of statutory remedy: in the context of an ANDA filing, what is the appropriate remedy for Plaintiffs? This includes determining the effective date of any potential FDA approval for Gland's generic product and whether the circumstances warrant declaring the case "exceptional" for the purpose of awarding attorneys' fees.