Allergan v. Saptalis Pharma LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Allergan, Inc. (Delaware) and Saint Regis Mohawk Tribe (New York)
  • Defendant: Saptalis Pharmaceuticals, LLC (Delaware)
  • Plaintiff’s Counsel: Fish & Richardson P.C.; Drinker Biddle & Reath LLP
• Case Identification: 1:18-cv-01231, D. Del., 08/10/2018
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Saptalis Pharmaceuticals, LLC is a Delaware corporation and therefore resides in the district.
• Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the dry-eye treatment Restasis® constitutes an act of infringement of two patents related to methods of using cyclosporine ophthalmic emulsions.
• Technical Context: The technology involves oil-in-water ophthalmic emulsions containing the immunosuppressant cyclosporine, used for increasing tear production in patients with chronic dry eye disease.
• Key Procedural History: The complaint notes prior litigation in the Eastern District of Texas where Plaintiffs asserted the patents-in-suit alongside four other patents against different generic drug manufacturers; in that action, the other four patents were found invalid for obviousness, and Plaintiffs elected not to proceed to trial on the two patents-in-suit at issue here. An appeal of that judgment was pending when this complaint was filed. Notably, subsequent Inter Partes Review (IPR) proceedings resulted in the cancellation of all claims of both patents-in-suit, as reflected in IPR certificates issued in June 2021.

Case Timeline

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

U.S. Patent No. 8,633,162 - Methods of Providing Therapeutic Effects Using Cyclosporin Components

Issued January 21, 2014

The Invention Explained

• Problem Addressed: The patent addresses the need for enhanced methods of treating ophthalmic conditions with cyclosporin-containing emulsions that provide substantial therapeutic efficacy while reducing the risk of side effects and potential drug interactions associated with existing formulations ('162 Patent, col. 2:9-25).
• The Patented Solution: The invention is a method of treatment using a specific low-dose oil-in-water emulsion. It claims that by using a therapeutically effective amount of cyclosporine of less than 0.1% by weight, and maintaining a weight ratio of the cyclosporine component to the hydrophobic component (e.g., castor oil) of less than 0.08, the formulation achieves a therapeutic benefit comparable to higher-dose compositions but with improved safety and tolerability, such as reduced vision distortion ('162 Patent, Abstract; col. 2:33-52). The patent suggests this formulation allows the emulsion to break down more rapidly in the eye, improving patient comfort without sacrificing efficacy ('162 Patent, col. 15:1-9).
• Technical Importance: This approach sought to optimize the therapeutic window for topical cyclosporine, a cornerstone treatment for chronic dry eye, by creating a formulation that could be used chronically with minimized side effects, thereby improving patient compliance and overall outcomes ('162 Patent, col. 2:40-52).

Key Claims at a Glance

• The complaint does not specify which claims it asserts. Independent claim 1 appears to be representative of the core invention. Subsequent to the complaint's filing, all claims (1-24) of the patent were cancelled in an Inter Partes Review proceeding ('162 Patent, IPR Certificate, p. 2).
• Independent Claim 1 of the '162 Patent recites:
  • A method of treating dry eye disease,
  • comprising topically administering to the eye of a human an emulsion twice a day,
  • wherein the emulsion comprises specific components: cyclosporin A (about 0.05%), polysorbate 80, an acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil (about 1.25%),
  • and wherein the emulsion is effective in treating dry eye disease.

U.S. Patent No. 8,642,556 - Methods of Providing Therapeutic Effects Using Cyclosporin Components

Issued February 4, 2014

The Invention Explained

• Problem Addressed: Like its counterpart, the '556 Patent seeks to provide cyclosporine emulsion formulations that enhance patient safety and flexibility in treatment without compromising the desired therapeutic effect ('556 Patent, col. 2:14-29).
• The Patented Solution: The '556 Patent claims a topical ophthalmic emulsion with a specific low-dose formulation (about 0.05% cyclosporine A). A key feature of the asserted claims is a functional limitation: the claimed low-dose emulsion must provide "overall efficacy substantially equal to" a higher-concentration (0.1%) cyclosporine emulsion ('556 Patent, col. 16:6-12). This frames the invention in terms of its comparative therapeutic performance.
• Technical Importance: This patent attempted to secure protection not just for a specific formulation, but for a low-dose formulation that achieves a specific, advantageous therapeutic outcome relative to a higher-dose standard, providing a different angle of patentability ('556 Patent, col. 2:37-40).

Key Claims at a Glance

• The complaint does not specify which claims it asserts. Independent claims 1 and 13 appear representative. Subsequent to the complaint's filing, all claims (1-20) of the patent were cancelled in an Inter Partes Review proceeding ('556 Patent, IPR Certificate, p. 2).
• Independent Claim 1 of the '556 Patent recites:
  • A first topical ophthalmic emulsion for treating an eye,
  • comprising cyclosporin A (about 0.05%), polysorbate 80, an acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil (about 1.25%),
  • which is therapeutically effective in treating dry eye disease,
  • and which provides overall efficacy "substantially equal to a second topical ophthalmic emulsion comprising cyclosporin A in an amount of about 0.1% by weight."

III. The Accused Instrumentality

Product Identification

Defendant Saptalis’s proposed "Cyclosporine Ophthalmic Emulsion, 0.05%," which is the subject of Abbreviated New Drug Application (ANDA) No. 211943 submitted to the FDA (Compl. ¶¶ 7, 29).

Functionality and Market Context

The accused product is a generic version of Plaintiffs’ Restasis® product, intended for the same therapeutic use of treating chronic dry eye (Compl. ¶7). As a generic drug, it is designed to have the same active ingredient, concentration, dosage form, and route of administration as the branded reference product (Compl. ¶¶ 7, 29). Plaintiffs allege that the Saptalis product, if approved, will be sold and distributed nationwide and will directly compete with and displace sales of Restasis® (Compl. ¶¶ 9, 10).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the act of submitting ANDA No. 211943 to the FDA for the purpose of obtaining approval to market a generic drug before the expiration of the patents-in-suit constitutes an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶ 36, 62). The infringement theory is predicated on the allegation that the product described in the ANDA, if commercially manufactured and sold, would meet the limitations of the asserted patents.

'162 Patent Infringement Allegations

'556 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: A central dispute for the '556 Patent would concern the functional limitation requiring efficacy "substantially equal to" a 0.1% formulation. The court would have to determine if this language is definite and how a plaintiff would prove that an accused product meets this comparative standard.
• Technical Questions: While the complaint alleges the ANDA product infringes, a core technical question is whether the precise formulation in Saptalis's confidential ANDA actually meets every compositional limitation of the claims, including the concentrations of excipients, when interpreted in light of the term "about."

V. Key Claim Terms for Construction

The Term: "about" (e.g., "about 0.05% by weight")

• Context and Importance: This term, appearing in the compositional limitations of both patents, is critical for determining the scope of the claims. The infringement analysis depends on whether the precise concentrations in Saptalis's ANDA product fall within the range implied by "about." Practitioners may focus on this term because the breadth of its construction could capture or exclude formulations with minor variations from the recited values.
• Intrinsic Evidence for a Broader Interpretation: The repeated use of "about" in the claims and specification suggests the inventors did not intend for the numerical values to be rigid limits, allowing for some degree of standard manufacturing tolerance or approximation ('162 Patent, Claim 1).
• Intrinsic Evidence for a Narrower Interpretation: The specification provides a specific example (Composition II) with precise values of 0.05% cyclosporine A and 1.25% castor oil ('162 Patent, col. 14:31-40). A party could argue that this example cabins the meaning of "about" to a very narrow range around the stated figures.

The Term: "provides overall efficacy substantially equal to"

• Context and Importance: This functional limitation in claim 1 of the '556 Patent is a primary point of distinction and potential vulnerability. Its construction is central to both infringement and validity, as a defendant would likely argue the term is fatally indefinite under 35 U.S.C. § 112.
• Intrinsic Evidence for Interpretation (Supporting Enforceability): Plaintiffs would argue that the patent provides its own objective standard for this term. The specification's Example 1 explicitly compares a 0.05% formulation (Composition II) to a 0.1% formulation (Composition I) and concludes they provide "substantially equal" efficacy, thereby defining the scope of the term by example ('556 Patent, col. 15:15-24).
• Intrinsic Evidence for Interpretation (Supporting Indefiniteness): A defendant would argue the term is subjective and ambiguous. The patent does not define what metrics constitute "overall efficacy" (e.g., tear production, symptom scores, corneal staining) or what degree of similarity is "substantially equal," potentially failing to inform a person of ordinary skill in the art of the claim's boundaries with reasonable certainty.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Saptalis knows its product will be used to practice the patented methods, and the product's future label will instruct users to perform the infringing acts (e.g., twice-daily administration for dry eye) (Compl. ¶¶ 47-51, 83-87). Contributory infringement is based on the allegation that Saptalis's product is especially made for an infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶ 52-55, 88-91).

Willful Infringement

Willfulness is alleged based on Saptalis having "actual notice" of the patents-in-suit, at the latest from their listing in the FDA's Orange Book, and proceeding to seek approval for its generic product in "disregard of Plaintiffs' rights" (Compl. ¶¶ 60, 96).

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

Given the facts alleged in the complaint and the procedural history contained in the provided documents, the litigation would likely center on the following questions:

• A threshold, and likely dispositive, procedural question is one of patent viability: given the post-filing cancellation of all asserted claims of both patents-in-suit in Inter Partes Review, what legal basis, if any, remains for the continuation of an infringement action?
• A central claim construction question for the '556 Patent would have been one of definitional scope and clarity: can the functional limitation "provides overall efficacy substantially equal to a second... emulsion" be construed with sufficient certainty to be enforceable, or is it indefinite under 35 U.S.C. § 112 for failing to provide an objective boundary?
• A key evidentiary question for both patents would have been one of compositional identity: does the specific formulation disclosed in Saptalis's confidential ANDA filing meet every recited compositional element of the asserted claims, particularly after the term "about" is construed by the court?