DCT

2:26-cv-00353

Oyster Point Pharma Inc v. Lupin Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-00353, D.N.J., 01/12/2026
  • Venue Allegations: Venue is alleged on the basis that Defendant is a foreign corporation subject to personal jurisdiction within the District of New Jersey, where it conducts business and maintains offices and facilities.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's TYRVAYA® (varenicline solution) nasal spray constitutes an act of infringement of nine U.S. patents.
  • Technical Context: The technology relates to pharmaceutical compositions and methods for treating dry eye disease through the nasal administration of a nicotinic acetylcholine receptor agonist, varenicline.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant's notification to Plaintiff, via a letter dated November 26, 2025, of its ANDA filing containing a Paragraph IV certification against the patents-in-suit. The filing of the complaint within the statutory 45-day window triggers a 30-month stay of FDA approval for Defendant’s ANDA 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
2025-11-26 Defendant Lupin sends Paragraph IV Notice Letter
2025-12-01 Plaintiff Oyster Point receives Notice Letter
2026-01-12 Complaint for Patent Infringement Filed

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

U.S. Patent No. 9,504,644 - *Methods of Increasing Tear Production*

The Invention Explained

  • Problem Addressed: The patent addresses Dry Eye Disease (DED), a condition affecting millions of people that results from the disruption of the natural tear film on the eye's surface, leading to ocular discomfort, visual disturbance, and potential health deficiencies like corneal ulceration (’644 Patent, col. 1:12-25).
  • The Patented Solution: The invention proposes a method for increasing tear production by administering a nicotinic acetylcholine receptor agonist into the nasal cavity. This local administration is designed to selectively bind to peripheral nicotinic receptors, triggering the nasolacrimal reflex to produce tears, without crossing the blood-brain barrier in pharmacologically relevant concentrations, thereby avoiding undesired psychoactive or systemic side effects (’644 Patent, col. 2:29-41, col. 9:8-12).
  • Technical Importance: This approach provided a novel mechanism for treating DED by stimulating the body's natural tear production pathway via nasal administration, differing from conventional treatments like artificial tears that only provide temporary lubrication (’644 Patent, col. 11:1-5).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying which ones (Compl. ¶53). Claim 1 is the first independent claim.
  • Essential elements of Independent Claim 1:
    • A method of increasing tear production in an individual in need thereof,
    • comprising the local administration of a therapeutically effective amount of a nicotinic acetylcholine receptor agonist into the nasal cavity of an individual,
    • wherein the agonist selectively binds to the peripheral nicotinic acetylcholine receptor,
    • is varenicline administered in a non-systemically bioavailable dose between 5 micrograms and 50 micrograms per dose, and
    • does not cross the blood-brain barrier in a pharmacologically relevant concentration.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,504,645 - *Pharmaceutical Formulations for Treating Ocular Conditions*

The Invention Explained

  • Problem Addressed: As with the ’644 Patent, this patent addresses Dry Eye Disease (DED) and the need for effective treatments (’645 Patent, col. 1:12-25).
  • The Patented Solution: This invention focuses on the pharmaceutical formulation itself, rather than the method of use. It describes a composition comprising a nicotinic acetylcholine receptor agonist (varenicline) formulated for local administration into the nasal cavity to prevent desensitization and in a dosage amount that is not systemically bioavailable, thereby avoiding undesired systemic or psychoactive side effects (’645 Patent, col. 9:11-37).
  • Technical Importance: The claimed formulation provides a stable and effective delivery vehicle for administering a nicotinic agonist nasally to treat ocular conditions, designed to limit systemic exposure and related side effects.

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying which ones (Compl. ¶84). Claim 1 is the first independent claim.
  • Essential elements of Independent Claim 1:
    • A pharmaceutical formulation for local administration into the nasal cavity of an individual,
    • comprising a non-systemically bio available dose between 5 micrograms and 50 micrograms of varenicline per dose,
    • formulated for nasal administration and to prevent desensitization.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsules

  • Patent Identification: U.S. Patent No. 9,532,944, Methods of Improving Ocular Discomfort, issued January 3, 2017 (Compl. ¶19).

  • Technology Synopsis: This patent describes methods for improving ocular discomfort by locally administering a nicotinic acetylcholine receptor agonist (varenicline) into the nasal cavity. The administration is intended to stimulate peripheral nicotinic receptors without crossing the blood-brain barrier, thereby avoiding undesirable side effects.

  • Asserted Claims: One or more claims of the patent (Compl. ¶115).

  • Accused Features: Lupin’s ANDA Product and its proposed method of use for treating the signs and symptoms of dry eye disease (Compl. ¶115).

  • Patent Identification: U.S. Patent No. 9,597,284, Dry Eye Treatments, issued March 21, 2017 (Compl. ¶20).

  • Technology Synopsis: This patent claims methods for treating dry eye disease. The treatment involves the local administration of a nicotinic acetylcholine receptor agonist into the nasal cavity to stimulate peripheral receptors and increase tear production.

  • Asserted Claims: One or more claims of the patent (Compl. ¶146).

  • Accused Features: The composition of Lupin's ANDA Product and its intended use as described on its proposed label (Compl. ¶146).

  • Patent Identification: U.S. Patent No. 10,456,396, Dry Eye Treatments, issued October 29, 2019 (Compl. ¶21).

  • Technology Synopsis: This patent claims methods for treating dry eye, comprising the local administration of a therapeutically effective amount of a nicotinic acetylcholine receptor agonist into the nasal cavity. The invention aims to activate the nasolacrimal reflex to increase tear production without causing systemic side effects.

  • Asserted Claims: One or more claims of the patent (Compl. ¶177).

  • Accused Features: Lupin's ANDA Product and its proposed use, which allegedly practices the claimed method of treating dry eye disease (Compl. ¶177).

  • Patent Identification: U.S. Patent No. 11,224,598, Methods of Increasing Lacrimal Proteins, issued January 18, 2022 (Compl. ¶22).

  • Technology Synopsis: This patent describes methods for increasing the amount or concentration of one or more lacrimal proteins on the ocular surface. The method involves administering a nicotinic acetylcholine receptor agonist into the nasal cavity to stimulate tear production, which contains such proteins.

  • Asserted Claims: One or more claims of the patent (Compl. ¶208).

  • Accused Features: The use of Lupin's ANDA Product as directed by its label, which allegedly results in an increase of lacrimal proteins as claimed (Compl. ¶208).

  • Patent Identification: U.S. Patent No. 11,903,941, Compositions and Use of Varenicline for Treating Dry Eye, issued February 20, 2024 (Compl. ¶23).

  • Technology Synopsis: This patent is directed to pharmaceutical compositions containing varenicline for local administration into the nasal cavity. The formulation is designed for treating dry eye by stimulating tear production via the nasolacrimal reflex.

  • Asserted Claims: One or more claims of the patent (Compl. ¶239).

  • Accused Features: The varenicline-containing formulation of Lupin's ANDA Product (Compl. ¶239).

  • Patent Identification: U.S. Patent No. 11,903,943, Compositions and Use of Varenicline for Treating Dry Eye, issued February 20, 2024 (Compl. ¶24).

  • Technology Synopsis: Similar to the '941 patent, this patent claims compositions containing varenicline for nasal administration to treat dry eye disease. The invention covers specific formulations designed to be effective and limit systemic exposure.

  • Asserted Claims: One or more claims of the patent (Compl. ¶270).

  • Accused Features: The composition of Lupin's ANDA Product, which is a varenicline solution for nasal spray (Compl. ¶270).

  • Patent Identification: U.S. Patent No. 11,911,380, Compositions and Use of Varenicline for Treating Dry Eye, issued February 27, 2024 (Compl. ¶25).

  • Technology Synopsis: This patent is also directed to pharmaceutical compositions containing varenicline formulated for nasal administration for the treatment of dry eye.

  • Asserted Claims: One or more claims of the patent (Compl. ¶301).

  • Accused Features: Lupin's ANDA Product, which is a pharmaceutical composition containing varenicline for nasal administration (Compl. ¶301).

III. The Accused Instrumentality

Product Identification

  • Lupin's ANDA Product, identified as ANDA No. 220392, which is a generic version of Oyster Point's TYRVAYA® (varenicline solution) (Compl. ¶¶1, 12).

Functionality and Market Context

  • The accused product is a nasal spray containing varenicline as its active ingredient at a strength of 0.03 mg per spray (Compl. ¶¶12, 41, 45). It is intended for the same approved indication as TYRVAYA®, namely the treatment of the signs and symptoms of dry eye disease (Compl. ¶¶44, 45). The complaint alleges that Lupin's proposed product label will instruct patients and physicians to administer the product nasally for this purpose (Compl. ¶46). Lupin has represented to the FDA that its product has the same active ingredient, dosage form, strength, and is bioequivalent to TYRVAYA® (Compl. ¶42).
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide specific infringement allegations on a claim-by-claim basis or reference a claim chart exhibit. The infringement theory is based on the premise that Lupin's filing of ANDA No. 220392 for a product that is a bioequivalent copy of TYRVAYA®, to be marketed with a label instructing an infringing use, constitutes infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶54-55, 85-86). The following tables summarize the core infringement allegations as they can be inferred from the complaint and a representative independent claim from each lead patent.

’644 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing tear production in an individual in need thereof, Lupin's proposed label will instruct use for treating the signs and symptoms of dry eye disease, a condition of insufficient tear production. ¶¶44, 46 col. 1:12-16
comprising the local administration of a therapeutically effective amount of a nicotinic acetylcholine receptor agonist into the nasal cavity..., Lupin's ANDA Product is a nasal spray containing a nicotinic agonist, and the proposed label will instruct its administration into the nasal cavity. ¶¶12, 46 col. 2:29-34
wherein the agonist... is varenicline administered in a non-systemically bioavailable dose between 5 micrograms and 50 micrograms per dose, Lupin's ANDA product contains varenicline at a strength of 0.03 mg (30 micrograms) per spray, which is within the claimed range and is alleged to have the same dosage form and strength as the approved, non-systemically bioavailable product. ¶¶41, 42, 45 col. 13:1-12

’645 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation for local administration into the nasal cavity of an individual, Lupin's ANDA Product is a nasal spray formulation. ¶12 col. 9:12-16
comprising a non-systemically bio available dose between 5 micrograms and 50 micrograms of varenicline per dose, The accused product is a varenicline solution with a strength of 0.03 mg (30 micrograms) per spray, a dose that falls within the claimed range. The product is represented as bioequivalent to TYRVAYA®. ¶¶41, 42, 45 col. 10:50-55
formulated for nasal administration and to prevent desensitization. The product is formulated as a nasal spray, and its bioequivalence to TYRVAYA® implies a formulation that avoids receptor desensitization to maintain efficacy. ¶¶12, 42 col. 9:11-15
  • Identified Points of Contention:
    • Scope Questions (Method Claims): A potential question for the court is whether the specific instructions for use on Lupin's proposed label will meet every limitation of the asserted method claims. For example, some claims in the patent family require administration in "alternating nostrils" (e.g., ’396 Patent, claim 1), and infringement may turn on whether Lupin's label instructs or encourages such a specific administration pattern.
    • Technical Questions (Composition Claims): The analysis may raise the question of whether Lupin's formulation, including its excipients, falls within the scope of the asserted composition claims. The complaint does not detail the excipients in Lupin's ANDA product, making this an open evidentiary question for discovery.

V. Key Claim Terms for Construction

  • The Term: "non-systemically bioavailable" (’644 Patent, claim 1; ’645 Patent, claim 1)

  • Context and Importance: This term is central to the patents' claimed advantage of avoiding systemic side effects. Its definition will be critical for determining the scope of both the method and formulation claims. Practitioners may focus on this term because the extent to which varenicline from Lupin's product enters the bloodstream will be a key factual issue, and the patent's definition will set the threshold for infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification suggests that the term relates to avoiding undesired side effects, stating the agonist "does not cross the blood-brain barrier in a pharmacologically relevant concentration" and is administered in an amount that does not result in "undesired psychoactive side effects" (’644 Patent, col. 2:37-41). This may support a functional definition tied to the absence of specific side effects rather than a strict pharmacokinetic threshold.
    • Evidence for a Narrower Interpretation: The specification also uses the phrase "administered in an amount that is not systemically bioavailable" (’644 Patent, col. 2:53-55), which may suggest a more quantitative, measurable definition based on pharmacokinetic studies measuring blood plasma concentrations.

  • The Term: "to prevent desensitization" (’645 Patent, claim 1)

  • Context and Importance: This term appears in the formulation claims and relates to the biological effect of the composition on nicotinic acetylcholine receptors. The dispute may turn on whether Lupin's specific formulation has properties that are proven "to prevent desensitization." This is a functional limitation that requires evidence beyond just the chemical composition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses desensitization as a general phenomenon where prolonged exposure to an agonist decreases receptor responsiveness (’396 Patent, col. 11:46-52). A party might argue that any formulation that allows for repeated, effective dosing inherently meets this limitation.
    • Evidence for a Narrower Interpretation: The specification also discloses formulations that include additional substances specifically to "prevent or facilitate the recovery of the nicotinic acetylcholine receptor from the desensitized state," such as PKC or PKA modulators (’396 Patent, col. 12:1-13). This could support an argument that "to prevent desensitization" requires specific formulation components beyond just the agonist and a basic carrier, potentially narrowing the claim scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement on the basis that Lupin’s proposed label will knowingly and intentionally instruct and encourage physicians and patients to administer the ANDA Product in accordance with the patented methods (Compl. ¶¶70, 72-73). Contributory infringement is alleged on the grounds that Lupin's product is especially made for an infringing use, is not a staple article of commerce, and is not suitable for substantial non-infringing use (Compl. ¶76).
  • Willful Infringement: Willfulness is alleged based on Lupin's pre-suit knowledge of the patents-in-suit, as evidenced by its submission of a Paragraph IV certification against them and the sending of a formal Notice Letter to Oyster Point before the lawsuit was filed (Compl. ¶¶57, 64, 88).

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

  • A core issue will be one of infringement mapping: Will the instructions for use on Lupin's proposed product label contain limitations corresponding to every step of the asserted method claims? The outcome may depend on the level of specificity in Lupin's label and the court's construction of claim terms defining the administration steps.
  • A second key issue will be one of functional performance: For the composition claims, can Plaintiff prove that Lupin's formulation is not only chemically similar but also performs the claimed function of being "formulated... to prevent desensitization"? This raises an evidentiary question about the biological effect of Lupin's specific combination of active ingredient and excipients.
  • A central question for the litigation, inherent to its nature as a Hatch-Waxman case, will be the validity of the patents-in-suit. The case will likely involve a significant focus on Lupin's anticipated arguments that the claimed methods and compositions are invalid as obvious in light of prior art related to varenicline, nasal drug delivery, and the treatment of dry eye disease.