DCT
3:25-cv-15127
Bausch & Lomb Inc v. Saba Ilac Sanayi Ve Ticaret As
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bausch & Lomb Incorporated (New York); Bausch & Lomb Ireland Limited (Ireland); and Nicox S.A. (France)
- Defendant: Saba Ilac Sanayi ve Ticaret A.S. (Turkey)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 3:25-cv-15127, D.N.J., 08/29/2025
- Venue Allegations: Plaintiffs allege venue is proper because the defendant is a foreign company that may be sued in any judicial district. They further allege the defendant has sufficient contacts with the United States, intends to market its product in New Jersey, and has consented to jurisdiction in the district.
- Core Dispute: Plaintiffs allege that Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' Vyzulta® ophthalmic solution constitutes an act of infringement of a patent covering the drug's active ingredient.
- Technical Context: The technology relates to prostaglandin nitroderivatives, a class of chemical compounds designed for treating glaucoma and ocular hypertension by reducing intraocular pressure.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of an ANDA with a Paragraph IV certification to the U.S. Food and Drug Administration (FDA). This certification alleges that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. The patent is listed in the FDA's "Orange Book" as covering the Vyzulta® product.
Case Timeline
| Date | Event |
|---|---|
| 2004-01-05 | ’467 Patent Priority Date |
| 2011-11-15 | ’467 Patent Issue Date |
| 2017-11-02 | Vyzulta® (NDA No. 207795) FDA Approval Date |
| 2025-07-25 | Plaintiffs Receive Defendant's Paragraph IV Notice Letter |
| 2025-08-29 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,058,467 - "Prostaglandin Derivatives"
- Patent Identification: U.S. Patent No. 8,058,467, "Prostaglandin Derivatives," issued November 15, 2011 (’467 Patent).
The Invention Explained
- Problem Addressed: The patent describes how existing drugs for treating glaucoma—including prior prostaglandin analogs—can cause undesirable side effects, such as ocular irritation, conjunctival hyperaemia (redness), increased pigmentation of the iris, and macular oedema (’467 Patent, col. 1:43-62). The goal was to develop a treatment that avoided or reduced these issues.
- The Patented Solution: The invention is a new class of prostaglandin derivatives that incorporate a nitric oxide-donating moiety (a nitrooxy group) (’467 Patent, Abstract; col. 2:19-27). This chemical modification is asserted to create a compound with an improved pharmacological profile, offering both "improved pharmacological activity and enhanced tolerability" compared to existing prostaglandins (’467 Patent, col. 2:22-27).
- Technical Importance: The creation of these "hybrid" molecules was intended to provide the intraocular pressure-lowering effects of prostaglandins while leveraging the physiological effects of nitric oxide to potentially improve tolerability and efficacy (’467 Patent, col. 2:19-27).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the ’467 Patent (Compl. ¶24).
- Independent Claim 1: This is a composition of matter claim directed to a single, specific chemical compound of formula (I):
- A prostaglandin residue derived from latanoprost
- Linked to a 4-(nitrooxy)butyl ester group
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed "generic latanoprostene bunod ophthalmic solution, 0.024%," identified as the subject of ANDA No. 218547 (Compl. ¶¶1, 14, 19).
Functionality and Market Context
- The accused product is intended to be a generic version of Plaintiffs' Vyzulta®, which is an FDA-approved ophthalmic solution for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension (Compl. ¶¶4, 19).
- The complaint alleges that the active ingredient in Vyzulta® is latanoprostene bunod and that Defendant's ANDA product is "the same, or substantially the same, as Vyzulta®" (Compl. ¶¶4, 22). The infringement allegation is based on the filing of the ANDA seeking FDA approval to market this product prior to the expiration of the ’467 Patent (Compl. ¶1).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement theory is statutory under 35 U.S.C. § 271(e)(2), where the filing of an ANDA for a drug claimed in a patent is an act of infringement. The core allegation is that the active ingredient in Defendant’s proposed generic product, latanoprostene bunod, is the compound claimed in the ’467 Patent.
’467 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A compound of formula (I) | The active pharmaceutical ingredient in Defendant’s proposed generic product, identified as latanoprostene bunod, is alleged to be the specific chemical compound of formula (I). | ¶¶1, 4, 19, 22, 25 | col. 28:2-27 |
- Identified Points of Contention:
- Structural Identity: The primary technical question for infringement will be whether the chemical structure of the active ingredient in Defendant’s ANDA product is identical to the specific compound recited in Claim 1. The complaint alleges the products are "the same, or substantially the same," which suggests Plaintiffs' position is that the structures are identical (Compl. ¶22).
- Patent Validity: In Hatch-Waxman litigation, an infringement analysis is often secondary to the defendant's challenge to the patent's validity. While not detailed in the complaint, the dispute will almost certainly center on Defendant’s arguments, outlined in its Paragraph IV notice letter, that the asserted claims are invalid (e.g., for obviousness over prior art prostaglandin analogs) or otherwise unenforceable.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific claim terms. Furthermore, as Claim 1 recites a specific chemical structure, claim construction disputes are less likely to be a central feature of the case compared to litigation involving terms of degree or functional language. The infringement analysis will likely turn on a direct comparison of the accused compound's structure to the claimed structure, rather than a debate over the meaning of words.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant will contributorily infringe and induce infringement upon approval and marketing of its generic product (Compl. ¶¶26, 32). This allegation is likely based on the premise that Defendant's product labeling and instructions would direct medical professionals and patients to use the generic drug for its patented therapeutic purpose—the reduction of intraocular pressure.
- Willful Infringement: The complaint does not contain a specific count for willful infringement. However, it alleges that Defendant knows or should know of Vyzulta® and its public labeling (Compl. ¶13) and has actual knowledge of the ’467 Patent, as evidenced by its Paragraph IV certification and notice letter (Compl. ¶20). The prayer for relief requests a declaration that this is an "exceptional case" under 35 U.S.C. § 285, which allows for the recovery of attorneys' fees (Prayer for Relief ¶5).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the answers to two central questions:
Factual Equivalence: Is the active pharmaceutical ingredient in Saba's proposed generic product the same chemical compound as the specific structure claimed in Claim 1 of the ’467 patent? Given the context of an ANDA filing for a bioequivalent drug, the infringement analysis may be straightforward if structural identity is confirmed.
Patent Validity: The core of the dispute, typical for Hatch-Waxman litigation, will be the validity of the ’467 patent. The case will likely turn on whether Saba can prove, by clear and convincing evidence, that the asserted claims are invalid, for instance, by arguing that the claimed compound would have been obvious to a person of ordinary skill in the art at the time of the invention.