DCT

1:26-cv-00353

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: 1:26-cv-00353, D.N.J., 01/12/2026
Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant is a foreign corporation subject to personal jurisdiction in the district, where it regularly transacts business and maintains offices and facilities.
Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s TYRVAYA® (varenicline solution) nasal spray infringes nine U.S. patents covering the drug’s composition and methods of use for treating dry eye disease.
Technical Context: The technology relates to using a nicotinic acetylcholine receptor agonist, varenicline, administered as a nasal spray to stimulate natural tear production for the treatment of dry eye disease, a common ophthalmic condition.
Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiff, via a letter dated November 26, 2025, of its filing of an ANDA with a Paragraph IV certification. Plaintiff filed this complaint within the statutory 45-day window, triggering an automatic 30-month stay on the FDA’s approval of Defendant's generic 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	Date of Defendant’s Paragraph IV Notice Letter
2025-12-01	Plaintiff’s Receipt of Defendant’s Notice Letter
2026-01-12	Complaint Filing Date

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

No probative visual evidence provided in complaint.

U.S. Patent No. 10,456,396 - "Dry Eye Treatments"

Patent Identification: U.S. Patent No. 10,456,396, "Dry Eye Treatments," issued October 29, 2019.
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 discomfort, visual disturbance, and potential ocular health deficiencies (ʼ396 Patent, col. 1:12-24).
- The Patented Solution: The invention is a method for increasing tear production by locally administering a nicotinic acetylcholine receptor agonist into the nasal cavity. This approach is designed to stimulate tear production by activating the trigeminal parasympathetic pathway, while the agonist is selected to not cross the blood-brain barrier, thereby avoiding undesired systemic or psychoactive side effects associated with systemic administration of such agonists (ʼ396 Patent, col. 2:4-18, Abstract).
- Technical Importance: The invention provides a method to treat DED by stimulating the body's natural tear production mechanism through a non-obvious administrative route (nasal cavity), offering a potential alternative to artificial tears or other treatments (ʼ396 Patent, col. 10:57-65).
Key Claims at a Glance: The complaint does not assert specific claims of the ’396 Patent but alleges infringement of one or more claims (Compl. ¶177). Claim 1, an independent method claim, is representative and includes the following essential elements:
- 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;
- Wherein the agonist selectively binds to the peripheral nicotinic acetylcholine receptor and does not cross the blood-brain barrier in a pharmacologically relevant concentration; and
- Wherein the agonist selectively binds to the peripheral nicotinic acetylcholine receptor subtype alpha4beta2.

U.S. Patent No. 11,224,598 - "Methods of Increasing Lacrimal Proteins"

Patent Identification: U.S. Patent No. 11,224,598, "Methods of Increasing Lacrimal Proteins," issued January 18, 2022.
The Invention Explained:
- Problem Addressed: The patent addresses DED, which can be caused by insufficient aqueous tear production or excessive evaporation, leading to an inflamed ocular surface and a progressive "vicious cycle" of damage (ʼ598 Patent, col. 10:30-53).
- The Patented Solution: The invention is a method for increasing the amount or concentration of lacrimal proteins (a component of natural tears) by administering a specific dose of varenicline (a nicotinic acetylcholine receptor agonist) into the nasal cavity. The method specifies a formulation for nasal administration with a defined concentration range of varenicline (ʼ598 Patent, Abstract, Claim 1).
- Technical Importance: The invention provides a specific therapeutic agent (varenicline), dosage range, and formulation concentration for nasal administration to increase lacrimal proteins, offering a targeted pharmacological approach to treating DED (’598 Patent, col. 2:4-8).
Key Claims at a Glance: The complaint does not assert specific claims of the ’598 Patent but alleges infringement of one or more claims (Compl. ¶208). Claim 1, an independent method claim, is representative and includes the following essential elements:
- A method of increasing an 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 the varenicline is provided in a pharmaceutical formulation formulated for nasal administration; and
- Wherein the pharmaceutical formulation comprises between about 0.1 mg/mL and about 10 mg/mL of varenicline.

Multi-Patent Capsule Summaries

Patent Identification: U.S. Patent No. 9,504,644, "Methods of Increasing Tear Production," issued November 29, 2016 (Compl. ¶17).
Technology Synopsis: This patent claims methods of increasing tear production by administering a nicotinic acetylcholine receptor agonist into the nasal cavity. The invention focuses on achieving a therapeutic effect without causing undesired systemic side effects.
Asserted Claims: The complaint alleges infringement of one or more claims without specifying them (Compl. ¶53).
Accused Features: The accused features are the use of Lupin's ANDA Product according to its proposed label, which is alleged to instruct users to perform the patented method (Compl. ¶¶63, 70-71).
Patent Identification: U.S. Patent No. 9,504,645, "Pharmaceutical Formulations for Treating Ocular Conditions," issued November 29, 2016 (Compl. ¶18).
Technology Synopsis: This patent claims pharmaceutical formulations containing a nicotinic acetylcholine receptor agonist, designed for local administration to the nasal cavity to prevent desensitization and avoid systemic bioavailability. The formulation is intended for treating ocular conditions.
Asserted Claims: The complaint alleges infringement of one or more claims without specifying them (Compl. ¶84).
Accused Features: The accused feature is Lupin’s ANDA Product itself, which is alleged to be a formulation covered by the patent claims (Compl. ¶¶94, 97).
Patent Identification: U.S. Patent No. 9,532,944, "Methods of Improving Ocular Discomfort," issued January 3, 2017 (Compl. ¶19).
Technology Synopsis: This patent claims methods for improving ocular discomfort by administering a nicotinic acetylcholine receptor agonist into the nasal cavity. The method aims to provide relief from symptoms associated with dry eye disease.
Asserted Claims: The complaint alleges infringement of one or more claims without specifying them (Compl. ¶115).
Accused Features: The accused features are the use of Lupin's ANDA Product according to its proposed label, which allegedly instructs for use in a manner that improves ocular discomfort (Compl. ¶¶125, 132-133).
Patent Identification: U.S. Patent No. 9,597,284, "Dry Eye Treatments," issued March 21, 2017 (Compl. ¶20).
Technology Synopsis: This patent claims methods of treating dry eye by administering a nicotinic acetylcholine receptor agonist into the nasal cavity. The invention specifies that the agonist selectively binds to peripheral receptors without crossing the blood-brain barrier.
Asserted Claims: The complaint alleges infringement of one or more claims without specifying them (Compl. ¶146).
Accused Features: The accused features are the use of Lupin's ANDA Product according to its proposed label, which allegedly instructs users to perform the patented method of treating dry eye (Compl. ¶¶156, 163-164).
Patent Identification: U.S. Patent Nos. 11,903,941, 11,903,943, and 11,911,380, all titled "Compositions and Use of Varenicline for Treating Dry Eye," issued in February 2024 (Compl. ¶¶23-25).
Technology Synopsis: These patents claim compositions containing varenicline and methods of using varenicline administered as a nasal spray for the treatment of dry eye disease. They cover both the specific drug formulation and its method of application.
Asserted Claims: The complaint alleges infringement of one or more claims from each patent without specifying them (Compl. ¶¶239, 270, 301).
Accused Features: Both the composition of Lupin's varenicline ANDA Product and its proposed method of use for treating dry eye are accused of infringing these patents (Compl. ¶¶249, 280, 311).

III. The Accused Instrumentality

Product Identification: The accused instrumentality is Defendant Lupin's generic varenicline solution, 0.03 mg per spray, for which it seeks FDA approval under ANDA No. 220392 (“Lupin’s ANDA Product”) (Compl. ¶¶1, 12).
Functionality and Market Context: Lupin’s ANDA Product is alleged to have the same active ingredient (varenicline), dosage form (nasal spray), and strength as Oyster Point’s TYRVAYA®, and to be bioequivalent (Compl. ¶42). The product is intended for the treatment of the signs and symptoms of dry eye disease (Compl. ¶45). The complaint alleges that upon approval, Lupin will market its product as a generic alternative to TYRVAYA® in the United States (Compl. ¶¶1, 49).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,456,396 Infringement Allegations

The complaint does not provide a claim chart. The following table summarizes the infringement theory for representative Claim 1 based on the complaint's narrative 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, comprising the local administration of a therapeutically effective amount of a nicotinic acetylcholine receptor agonist into the nasal cavity...	Lupin’s proposed label will allegedly instruct patients and physicians to nasally administer its ANDA Product, which contains varenicline (a nicotinic acetylcholine receptor agonist), for the treatment of signs and symptoms of dry eye disease (Compl. ¶¶41, 46).	¶¶177, 194-195	col. 2:4-8
...wherein the agonist selectively binds to the peripheral nicotinic acetylcholine receptor and does not cross the blood-brain barrier in a pharmacologically relevant concentration...	The complaint alleges that the use of Lupin's ANDA Product according to its label will be covered by one or more claims of the patent, which requires this functional outcome (Compl. ¶187).	¶187	col. 2:9-11
...and selectively binds to the peripheral nicotinic acetylcholine receptor subtype alpha4beta2.	The complaint alleges that the use of Lupin's ANDA Product according to its label will meet the limitations of the patent's claims, which includes this specific binding property (Compl. ¶187).	¶187	col. 13:10-15

Identified Points of Contention:
- Technical Questions: A primary question will be evidentiary: what evidence does Plaintiff have that Defendant's varenicline product, when administered, performs the specific functions required by the claim? For instance, what is the proof that it "does not cross the blood-brain barrier in a pharmacologically relevant concentration" and that it "selectively binds" to the alpha4beta2 subtype receptor as claimed?

U.S. Patent No. 11,224,598 Infringement Allegations