DCT

3:20-cv-19805

Aurinia Pharma Inc v. Sun Pharmaceutical Industries Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:20-cv-19805, D.N.J., 12/18/2020
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Sun Pharmaceutical Industries, Inc. has a principal place of business in the district, the defendants conduct substantial business in the state, and have allegedly consented to jurisdiction in the district in prior litigation matters.
  • Core Dispute: Plaintiff alleges that Defendant’s CEQUA™ ophthalmic solution, a treatment for dry eye disease, infringes a patent related to pharmaceutical compositions that use mixed micelles to deliver poorly water-soluble drugs.
  • Technical Context: The technology concerns pharmaceutical formulations for ophthalmic use, specifically addressing the challenge of delivering hydrophobic active ingredients (like cyclosporine) in a stable, clear, aqueous solution for effective treatment of eye conditions.
  • Key Procedural History: The complaint alleges that Defendant had knowledge of the patent family comprising the patent-in-suit since at least 2016 and was aware of the patent-in-suit itself upon its issuance in April 2019, which may form a basis for a willfulness allegation.

Case Timeline

Date Event
2007-10-08 '375 Patent Priority Date
2018-08-14 Defendant's CEQUA™ receives FDA approval
2019-04-23 '375 Patent Issue Date
2019-10-13 Defendant's CEQUA™ launched in the U.S.
2020-12-18 Complaint Filing Date

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

U.S. Patent No. 10,265,375 - “Ophthalmic Compositions”

  • Patent Identification: U.S. Patent No. 10,265,375, “Ophthalmic Compositions,” issued April 23, 2019.

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty in delivering effective doses of drugs to eye tissues, particularly for diseases in the posterior segment of the eye, because many potent drugs are poorly water-soluble ('375 Patent, col. 1:45-64).
  • The Patented Solution: The invention is an ophthalmic composition that uses a combination of two different surfactants to form "mixed micelles." These micelles are microscopic spherical structures that can encapsulate a hydrophobic drug (like a calcineurin inhibitor) in their core, allowing the drug to be suspended in a clear, aqueous solution suitable for use as an eye drop ('375 Patent, Abstract; col. 2:5-13). The specific combination of surfactants is defined by their hydrophilic-lipophilic balance (HLB) index values, which is a measure of how water- or oil-soluble they are ('375 Patent, col. 2:7-13).
  • Technical Importance: This formulation technology aims to improve the solubility and bioavailability of hydrophobic ophthalmic drugs, potentially enabling more effective treatment of a wider range of eye diseases, including those affecting the back of the eye, with a topical application ('375 Patent, col. 12:26-36).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim, with a focus on independent claim 1 ('375 Patent, col. 48:26-38; Compl. ¶¶14, 26).
  • The essential elements of independent claim 1 are:
    • A pharmaceutical composition comprising: a calcineurin inhibitor or an mTOR inhibitor;
    • a first surfactant with an HLB index greater than about 10; and
    • a second surfactant with an HLB index of greater than about 13,
    • wherein an absolute difference between the HLB index of the first surfactant and the HLB index of the second surfactant is greater than about 3,
    • wherein the composition is in the form of mixed micelles having the first and second surfactants; and
    • wherein the composition contains less than 2% by weight ethanol.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' CEQUA™ (cyclosporine ophthalmic solution) 0.09% (Compl. ¶1).

Functionality and Market Context

  • CEQUA™ is described as a "clear cyclosporine ophthalmic solution" intended to increase tear production in patients with dry eye disease (Compl. ¶17).
  • The complaint alleges that CEQUA™ utilizes "NCELL™ technology," which it characterizes as a "system of self-assembled nanomicelles" (Compl. ¶17). These nanomicelles are allegedly composed of a blend of polymers, including two specific surfactants—polyoxyethylene hydrogenated castor oil 40 (Kolliphor® RH 40) and Octoxynol-40—that form a structure with an inner hydrophobic core to carry the cyclosporine and an outer hydrophilic layer to allow transport across the tear film (Compl. ¶17).
  • The complaint notes that CEQUA™ delivers the "highest FDA-approved concentration of cyclosporine" (Compl. ¶17).

IV. Analysis of Infringement Allegations

The complaint’s infringement theory is based on a direct mapping of CEQUA™'s reported ingredients and properties onto the elements of claim 1 of the '375 Patent. No probative visual evidence provided in complaint.

'375 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a calcineurin inhibitor or an mTOR inhibitor The CEQUA™ solution is a pharmaceutical composition that comprises cyclosporine, which is a calcineurin inhibitor. ¶18 col. 8:50-65
a first surfactant with an HLB index greater than about 10 The solution comprises "...Polyoxyl 40 Hydrogenated Castor Oil..." ("Kolliphor® RH 40"), which is alleged to be a surfactant with a Hydrophilic-Lipophilic Balance (HLB) index of at least 14. ¶19 col. 2:7-8
a second surfactant with an HLB index of greater than about 13 The solution further comprises "...Octoxynol-40..." which is alleged to be a surfactant with an HLB index of about 18. ¶20 col. 11:10-12
wherein an absolute difference between the HLB index of the first surfactant and the HLB index of the second surfactant is greater than about 3 The composition allegedly contains Kolliphor RH 40 (HLB ≥ 14) and Octoxynol-40 (HLB ~18), resulting in an absolute HLB difference (18-14 = 4) that is greater than 3. ¶21 col. 2:10-13
wherein the composition is in the form of mixed micelles having the first and second surfactants The solution allegedly comprises "mixed micelles having Kolliphor RH 40 and Octoxynol-40," based on Defendant's description of its "NCELL™ technology" as "self-assembled nanomicelles." ¶¶17, 22 col. 2:10-13
wherein the composition contains less than 2% by weight ethanol The solution allegedly contains less than 2% by weight ethanol. ¶23 col. 48:35-38

Identified Points of Contention

  • Technical Questions: A primary question is whether CEQUA™'s "NCELL™ technology" functions as the claimed "mixed micelles." The complaint relies on Defendant's public statements to support this element, but a technical dispute may arise over whether the accused product's nanostructures are in fact "mixed micelles" formed from the two specified surfactants as required by the claim, or if they constitute a different structure.
  • Scope Questions: The claims use the word "about" to qualify the required HLB values ("about 10," "about 13," "about 3"). While the complaint alleges values that appear to meet these limitations (14 > 10; 18 > 13; 4 > 3), the construction of "about" will define the precise numerical scope of the claims. This could become a point of contention if Defendant argues for a narrow interpretation of the term or contests the alleged HLB values of its ingredients.

V. Key Claim Terms for Construction

The Term: "mixed micelles"

  • Context and Importance: This term defines the fundamental structure of the claimed invention. The infringement case rests on establishing that the accused CEQUA™ product, which uses "NCELL™ technology," is "in the form of mixed micelles." The definition of this term will be critical to determining if the accused product's "self-assembled nanomicelles" fall within the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines a "micelle" broadly as an "aggregate (or cluster) of surfactant molecules" and a "mixed micelle" as one comprising at least two different molecular species ('375 Patent, col. 6:46-61). This language may support a construction that covers a wide range of aggregated surfactant structures.
    • Evidence for a Narrower Interpretation: The patent describes a specific process for making the compositions, involving evaporation of a solvent and subsequent hydration to form a clear solution ('375 Patent, col. 2:25-34). A defendant may argue that "mixed micelles" should be construed more narrowly to imply micelles with the specific properties, such as "optical clarity," that are emphasized in the patent's embodiments.

The Term: "about"

  • Context and Importance: This term appears in three limitations defining the required HLB values. Its construction will determine the permissible range of deviation from the recited numbers (10, 13, and 3). Practitioners may focus on this term because, in chemical formulations, even small numerical differences can be technologically significant, and the breadth of "about" could be determinative of infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is used throughout the claims, suggesting the patentee did not intend to be limited to precise integer values. This may support an interpretation of "about" as meaning "approximately" to a degree recognized by one skilled in the art ('375 Patent, col. 48:29-34).
    • Evidence for a Narrower Interpretation: The patent provides examples with specific surfactants and their associated HLB values (e.g., octoxynol-40 having an HLB of "about 18") ('375 Patent, col. 11:37-41). A party could argue these examples implicitly define the reasonable scope of "about" or that in the context of pharmaceutical chemistry, the term allows for only very minor variances.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendant instructs end-users to infringe through its FDA-approved product label and other marketing and technical materials (Compl. ¶¶27-28). It also pleads contributory infringement, alleging CEQUA™ is a material part of the invention, is especially adapted for an infringing use, and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶29).
  • Willful Infringement: The complaint alleges that Defendant has had knowledge of the patent family since "at least as early as 2016" and of the '375 Patent itself upon its issuance in April 2019 (Compl. ¶24). Based on this alleged pre-suit knowledge, Plaintiff seeks treble damages for willful infringement and asserts that the case is "exceptional" and warrants an award of attorneys' fees (Compl. ¶32; Prayer for Relief ¶¶4-5).

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

  • A core issue will be one of technical identity: Does the accused CEQUA™ product, with its proprietary "NCELL™ technology," embody the specific "mixed micelle" structure required by claim 1? The resolution will likely depend on expert testimony and evidence comparing the physicochemical properties of the accused product to the invention described and claimed in the '375 Patent.
  • A key legal question will be one of claim scope: How broadly will the court construe the term "about" as it applies to the claimed Hydrophilic-Lipophilic Balance (HLB) index values? The outcome of this claim construction issue will define the numerical boundaries of the invention and could prove decisive if the measured HLB values of the surfactants in CEQUA™ are found to be close to, but not squarely within, the integers recited in the claim.