DCT
2:25-cv-17843
Oyster Point Pharma Inc v. Lupin Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Oyster Point Pharma, Inc. (Delaware)
- Defendant: Lupin Ltd. (India)
- Plaintiff’s Counsel: Rivkin Radler LLP; Perkins Coie LLP
- Case Identification: 2:25-cv-17843, D.N.J., 11/21/2025
- Venue Allegations: Venue is asserted based on Defendant being a foreign corporation subject to personal jurisdiction within the district, where it regularly transacts business and maintains offices and facilities.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's TYRVAYA® nasal spray constitutes an act of infringement of nine U.S. patents.
- Technical Context: The technology involves using a nasal spray containing varenicline, a nicotinic acetylcholine receptor agonist, to stimulate natural tear production for the treatment of dry eye disease.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a notice letter regarding Defendant's ANDA No. 220392, which contains a Paragraph IV certification challenging the asserted patents. All patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" as covering the TYRVAYA® product.
Case Timeline
| Date | Event |
|---|---|
| 2014-10-20 | Earliest Priority Date for all Patents-in-Suit |
| 2016-11-29 | U.S. Patent No. 9,504,644 Issued |
| 2016-11-29 | U.S. Patent No. 9,504,645 Issued |
| 2017-01-03 | U.S. Patent No. 9,532,944 Issued |
| 2017-03-21 | U.S. Patent No. 9,597,284 Issued |
| 2019-10-29 | U.S. Patent No. 10,456,396 Issued |
| 2022-01-18 | U.S. Patent No. 11,224,598 Issued |
| 2024-02-20 | U.S. Patent No. 11,903,941 Issued |
| 2024-02-20 | U.S. Patent No. 11,903,943 Issued |
| 2024-02-27 | U.S. Patent No. 11,911,380 Issued |
| 2025-11-12 | Plaintiff receives Defendant's Notice Letter |
| 2025-11-21 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,456,396 - “Dry Eye Treatments”
The Invention Explained
- Problem Addressed: Dry Eye Disease (DED) is a widespread condition resulting from the disruption of the natural tear film on the eye's surface, which can lead to ocular discomfort, visual disturbance, and in severe cases, corneal ulceration (’396 Patent, col. 1:12-24).
- The Patented Solution: The invention is a method for treating dry eye by administering a nicotinic acetylcholine receptor agonist (such as varenicline) into the nasal cavity. This approach stimulates the trigeminal nerve, activating the nasolacrimal reflex to increase natural tear production (’396 Patent, col. 2:41-46). By targeting peripheral receptors in the nasal cavity, the method is designed to avoid crossing the blood-brain barrier, thereby preventing the psychoactive or other systemic side effects associated with systemic administration of such agonists (’396 Patent, col. 2:30-40). Figure 1 of the '396 Patent, attached as Exhibit E to the complaint, provides a bar chart illustrating an increase in tear production (Schirmer Score) with the administration of the claimed compound versus baseline and placebo (Compl. Ex. E, Fig. 1).
- Technical Importance: This method provides a non-ocular, neurological approach to treating an ocular disease, offering an alternative to conventional eye drops by aiming to restore the eye's natural tear production mechanism (’396 Patent, col. 11:1-4).
Key Claims at a Glance
- The complaint does not specify asserted claims, asserting infringement of "one or more claims" (Compl. ¶177). The following is an analysis of a representative independent claim.
- Independent Claim 1:
- A method of treating dry eye in an individual in need thereof,
- comprising administering between 5 micrograms and 600 micrograms of varenicline,
- in alternating nostrils of the individual.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,224,598 - “Methods of Increasing Lacrimal Proteins”
The Invention Explained
- Problem Addressed: The patent addresses DED, which affects millions of people and stems from a disruption of the eye's natural tear film (’598 Patent, col. 1:15-28).
- The Patented Solution: Similar to the ’396 Patent, this invention involves the local administration of a nicotinic acetylcholine receptor agonist into the nasal cavity to stimulate tear production (’598 Patent, col. 2:30-34). This patent focuses specifically on the method's ability to increase the amount or concentration of beneficial "lacrimal proteins" in the tear film, not just the volume of tears (’598 Patent, col. 5:6-9).
- Technical Importance: The invention suggests a method not only for increasing tear volume but also for improving the quality and composition of the tear film by boosting the concentration of specific proteins essential for ocular surface health (’598 Patent, col. 7:1-8).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (Compl. ¶208). The following is an analysis of a representative independent claim.
- Independent Claim 1:
- A method of increasing the amount or concentration of one or more lacrimal proteins produced in an individual in need thereof,
- comprising nasally administering between 5 micrograms and 1000 micrograms of varenicline to the individual,
- wherein varenicline is provided in a pharmaceutical formulation formulated for nasal administration, and
- the pharmaceutical formulation comprises between about 0.1 mg/mL and about 10 mg/mL of varenicline.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,504,644 - “Methods of Increasing Tear Production”
- Technology Synopsis: The patent describes methods for increasing tear production by nasally administering a nicotinic acetylcholine receptor agonist. The method aims to stimulate the nasolacrimal reflex to treat dry eye disease.
- Asserted Claims: One or more claims (Compl. ¶53).
- Accused Features: Lupin's ANDA Product, a varenicline nasal spray, and its proposed use for treating dry eye (Compl. ¶53).
U.S. Patent No. 9,504,645 - “Pharmaceutical Formulations for Treating Ocular Conditions”
- Technology Synopsis: The patent describes pharmaceutical formulations containing a nicotinic acetylcholine receptor agonist designed for local administration to the nasal cavity. These formulations are intended to treat ocular conditions like dry eye disease while preventing systemic bioavailability and side effects.
- Asserted Claims: One or more claims (Compl. ¶84).
- Accused Features: The formulation of Lupin's varenicline ANDA Product (Compl. ¶84).
U.S. Patent No. 9,532,944 - “Methods of Improving Ocular Discomfort”
- Technology Synopsis: The patent describes methods for improving ocular discomfort associated with conditions like dry eye by nasally administering a nicotinic acetylcholine receptor agonist. The method targets the trigeminal-parasympathetic pathway to stimulate tear production.
- Asserted Claims: One or more claims (Compl. ¶115).
- Accused Features: The proposed use of Lupin's ANDA Product to treat the symptoms of dry eye disease (Compl. ¶115).
U.S. Patent No. 9,597,284 - “Dry Eye Treatments”
- Technology Synopsis: The patent describes methods for treating dry eye disease through the local nasal administration of a nicotinic acetylcholine receptor agonist. This approach is designed to produce a therapeutic effect on the ocular surface without crossing the blood-brain barrier.
- Asserted Claims: One or more claims (Compl. ¶146).
- Accused Features: Lupin's ANDA Product and its proposed use for treating dry eye disease (Compl. ¶146).
U.S. Patent No. 11,903,941 - “Compositions and Use of Varenicline for Treating Dry Eye”
- Technology Synopsis: The patent describes compositions containing varenicline and their use in treating dry eye disease via nasal administration. The invention focuses on specific dosages and formulations of varenicline to achieve a therapeutic effect.
- Asserted Claims: One or more claims (Compl. ¶239).
- Accused Features: The specific composition and proposed use of Lupin's varenicline nasal spray (Compl. ¶239).
U.S. Patent No. 11,903,943 - “Compositions and Use of Varenicline for Treating Dry Eye”
- Technology Synopsis: The patent relates to compositions containing varenicline and methods of their use for treating dry eye via nasal administration. The invention covers specific aspects of the formulation and its application to achieve tear production.
- Asserted Claims: One or more claims (Compl. ¶270).
- Accused Features: The specific composition and proposed use of Lupin's varenicline nasal spray (Compl. ¶270).
U.S. Patent No. 11,911,380 - “Compositions and Use of Varenicline for Treating Dry Eye”
- Technology Synopsis: The patent covers compositions of varenicline and methods for their use in treating dry eye by nasal administration. The claims pertain to specific dosage regimens and formulation characteristics to improve signs and symptoms of DED.
- Asserted Claims: One or more claims (Compl. ¶301).
- Accused Features: The composition, dosage, and proposed method of use of Lupin's varenicline nasal spray (Compl. ¶301).
III. The Accused Instrumentality
- Product Identification: Defendant's generic varenicline solution nasal spray, submitted for FDA approval under ANDA No. 220392 (“Lupin’s ANDA Product”) (Compl. ¶¶1, 12).
- Functionality and Market Context: The accused product is a nasal spray containing varenicline as its active ingredient, with a proposed strength of 0.03 mg per spray (Compl. ¶¶41, 45). The complaint alleges that Lupin’s proposed product label will instruct patients and physicians to administer the product for the treatment of the signs and symptoms of dry eye disease (Compl. ¶46). Lupin has represented to the FDA that its product has the same active ingredient, dosage form, and strength as Plaintiff’s TYRVAYA® product and is bioequivalent to it (Compl. ¶42). The product is intended to be a generic competitor to TYRVAYA® and is seeking approval to launch prior to the expiration of the patents-in-suit (Compl. ¶36).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’396 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating dry eye in an individual in need thereof... | The proposed label for Lupin's ANDA Product will instruct patients and healthcare providers to administer the product for the treatment of the signs and symptoms of dry eye disease. | ¶46 | col. 2:41-46 |
| ...comprising administering between 5 micrograms and 600 micrograms of varenicline... | Lupin's ANDA Product contains varenicline as its active ingredient, and the proposed strength is 0.03 mg/spray (30 micrograms), which is within the claimed range. | ¶¶41, 45 | col. 14:20-25 |
| ...in alternating nostrils of the individual. | The complaint does not provide sufficient detail for analysis of this element, alleging only that the proposed label will instruct administration for dry eye treatment. | ¶46 | col. 13:1-4 |
- Identified Points of Contention:
- Scope Questions: A central question for claim construction may be the meaning of "in alternating nostrils." A potential dispute could arise if Defendant’s proposed label instructs administration in each nostril with every dose, rather than alternating between nostrils on subsequent doses. The court will need to determine whether administration in each nostril infringes a claim requiring administration in "alternating nostrils."
’598 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of increasing the amount or concentration of one or more lacrimal proteins... | The complaint alleges that use of Lupin's ANDA Product for treating dry eye disease will infringe. The patent describes increasing lacrimal proteins as the mechanism of action for treating dry eye via nasal administration of varenicline. | ¶208 | col. 5:6-9 |
| ...comprising nasally administering between 5 micrograms and 1000 micrograms of varenicline... | Lupin's ANDA Product contains varenicline at a strength of 0.03 mg (30 micrograms) per spray, which is within the claimed dosage range. | ¶¶41, 45 | col. 8:19-21 |
| ...wherein varenicline is provided in a pharmaceutical formulation formulated for nasal administration... | The accused product is a varenicline solution formulated as a nasal spray. | ¶¶1, 12, 41 | col. 9:7-11 |
| ...and the pharmaceutical formulation comprises between about 0.1 mg/mL and about 10 mg/mL of varenicline. | Lupin's product has a strength of 0.03 mg per spray. Assuming a standard spray volume of 50-100 microliters, the resulting concentration (e.g., 0.3-0.6 mg/mL) would fall within the claimed range. | ¶45 | col. 9:44-47 |
- Identified Points of Contention:
- Technical Questions: An evidentiary question may arise as to whether use of the accused product actually results in an "increasing the amount or concentration of one or more lacrimal proteins." The complaint alleges infringement of the method but does not provide evidence that the accused product achieves this specific biological outcome, which may become a point of contention regarding direct infringement.
V. Key Claim Terms for Construction
- The Term: "in alternating nostrils" (’396 Patent, Claim 1)
- Context and Importance: This term is critical to the infringement analysis for the ’396 Patent and potentially other patents with similar limitations. The method of administration instructed by the accused product's label will be compared directly to the scope of this term. Practitioners may focus on this term because a narrow construction could provide a straightforward path to a non-infringement argument for the Defendant if its label simply instructs administration in each nostril per use.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The Summary of the Invention describes the core invention more broadly as "local administration of a therapeutically effective amount of a nicotinic acetylcholine receptor agonist into the nasal cavity" without limitation to alternating nostrils, which may support an argument that "alternating" is merely a preferred embodiment and not essential to the claimed method (’396 Patent, col. 2:30-34).
- Evidence for a Narrower Interpretation: The explicit inclusion of the term "in alternating nostrils" in the independent claim itself provides strong evidence for a narrower interpretation. The patent specification lists administration "in alternating nostrils" as a specific embodiment, distinct from general nasal administration, which could support an argument that the inventors intended to claim this specific mode of administration (’396 Patent, col. 17:9-12).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement across all asserted patents, stating that Lupin's proposed label will knowingly and intentionally include directions that instruct physicians and patients to administer the ANDA product in a manner that directly infringes the claims (e.g., Compl. ¶¶70, 74-75). Contributory infringement is also alleged, based on the assertion that Lupin's product is especially made or adapted for infringing use and is not a staple article of commerce suitable for substantial non-infringing use (e.g., Compl. ¶76).
- Willful Infringement: Willfulness is alleged for all patents based on Lupin’s purported pre-suit knowledge of the patents-in-suit, evidenced by its Paragraph IV certification and the recitation of the patents in its notice letter to Oyster Point (e.g., Compl. ¶¶57-58).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "in alternating nostrils," as claimed in the ’396 Patent, be construed to cover the likely administration instruction for a nasal spray, which is typically one spray in each nostril per application? The resolution of this claim construction dispute may be dispositive for at least one of the asserted patents.
- A key evidentiary question will be one of proving infringement: beyond the paper act of filing the ANDA, what evidence will be required to demonstrate that the use of Defendant's proposed product will meet all limitations of the asserted method claims? This includes functional outcomes like "increasing the amount or concentration of one or more lacrimal proteins," which are not explicitly addressed in the complaint's factual allegations.
- A central feature of this Hatch-Waxman litigation will be the validity of the asserted patents. While the complaint asserts validity, Defendant’s Paragraph IV certification signals an intent to challenge the patents as invalid and/or unenforceable, which will likely form the primary defensive front in this case.