DCT

1:14-cv-00970

Alcon Pharma Ltd v. Watson Laboratories Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:14-cv-00970, D. Del., 07/23/2014
  • Venue Allegations: Venue is asserted based on Defendants' regular business in Delaware, the incorporation of Actavis Pharma, Inc. in Delaware, and Defendants' engagement in a persistent course of conduct by placing products into the stream of commerce within the district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's MOXEZA® ophthalmic solution constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical compositions of the antibiotic moxifloxacin for the topical treatment of ophthalmic infections.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act, following a Notice Letter dated June 13, 2014, in which Watson informed Alcon of its ANDA submission and its certification that the patents-in-suit are invalid or will not be infringed (a "Paragraph IV" certification). The patents-in-suit are listed in the FDA's "Orange Book" as covering the branded drug MOXEZA®.

Case Timeline

Date Event
1998-09-30 Priority Date for '830 and '070 Patents
2004-04-06 U.S. Patent No. 6,716,830 Issued
2008-06-09 Priority Date for '311 Patent
2010-03-02 U.S. Patent No. 7,671,070 Issued
2013-05-28 U.S. Patent No. 8,450,311 Issued
2014-06-13 Watson sends ANDA Notice Letter to Alcon
2014-07-23 Complaint Filed

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

U.S. Patent No. 6,716,830 - "Ophthalmic Antibiotic Compositions Containing Moxifloxacin"

The Invention Explained

  • Problem Addressed: The patent describes a need for improved topical antibiotic compositions for ophthalmic use that are more effective against key pathogens and less susceptible to bacterial resistance than existing therapies ('830 Patent, col. 3:46-52). It also notes a need for compositions that can combine anti-infective and anti-inflammatory agents ('830 Patent, col. 3:65-col. 4:2).
  • The Patented Solution: The invention is a topical ophthalmic pharmaceutical composition containing moxifloxacin, a potent, new-class antibiotic ('830 Patent, Abstract). The specification discloses that moxifloxacin is effective against a range of gram-positive and gram-negative bacteria commonly associated with eye infections, as detailed in a table of minimum inhibitory concentrations ('830 Patent, col. 4:5-15).
  • Technical Importance: Moxifloxacin offered a more potent therapeutic option against a broad spectrum of ophthalmic pathogens compared to many previously available quinolone antibiotics ('830 Patent, col. 3:36-45).

Key Claims at a Glance

  • The complaint asserts "one or more claims" without specifying them (Compl. ¶35). Independent claim 1 is representative of the core composition invention.
  • Claim 1 Elements:
    • A topical ophthalmic pharmaceutical composition
    • comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof
    • in a concentration of 0.1 to 1.0 wt %
    • and a pharmaceutically acceptable vehicle therefor.
  • The complaint implicitly reserves the right to assert other claims, including dependent claims.

U.S. Patent No. 7,671,070 - "Method of Treating Ophthalmic Infections with Moxifloxacin Compositions"

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective methods of treating various ophthalmic, otic, and nasal infections ('070 Patent, col. 1:20-27).
  • The Patented Solution: The invention is a method for treating ophthalmic infections by topically applying a therapeutically effective amount of a moxifloxacin composition to the eye ('070 Patent, Abstract; col. 8:6-14). The patent identifies specific conditions that may be treated, such as conjunctivitis and keratitis, and also contemplates prophylactic use in connection with surgical procedures ('070 Patent, col. 2:38-42).
  • Technical Importance: This method-of-use patent provides a distinct layer of intellectual property protection, covering the specific act of using the moxifloxacin composition for therapeutic purposes.

Key Claims at a Glance

  • The complaint asserts "one or more claims" (Compl. ¶53-54). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A method of treating opthalmic infections, which comprises
    • topically applying to the eye a therapeutically effective amount of a pharmaceutical composition
    • comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof in a concentration of 0.1 to 1.0 wt. %
    • and a pharmaceutically acceptable vehicle therefor.
  • The complaint implicitly reserves the right to assert other claims.

U.S. Patent No. 8,450,311 - "Pharmaceutical Compositions Containing a Fluoroquinolone Antibiotic Drug"

Technology Synopsis

This patent addresses formulation challenges with fluoroquinolone drugs like moxifloxacin, including turbidity (cloudiness) in solution and suboptimal bioavailability ('311 Patent, col. 1:22-41). The patented solution is a specific pharmaceutical vehicle that includes sodium chloride in a defined weight/volume ratio to the moxifloxacin, a surfactant to improve homogeneity, and a borate/polyol system, which collectively result in a composition with improved physical and performance characteristics ('311 Patent, col. 2:1-9, col. 4:40-50).

Asserted Claims

The complaint asserts "one or more claims" (Compl. ¶71). The patent includes independent claims 1, 8, and 16.

Accused Features

The complaint alleges that the "Watson Product," a generic moxifloxacin ophthalmic solution, infringes the claims of the '311 patent (Compl. ¶¶71-72). Infringement will depend on the specific formulation of the generic product.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "the Watson Product," a generic moxifloxacin hydrochloride ophthalmic solution that is the subject of Defendants' ANDA No. 206469 (Compl. ¶1, 31).

Functionality and Market Context

The Watson Product is designed to be a generic equivalent to Alcon's branded drug, MOXEZA® (Compl. ¶1). It is an antibiotic solution for topical ophthalmic use. The complaint alleges that upon receiving FDA approval, Defendants intend to manufacture, market, and sell the product in the United States, in direct competition with MOXEZA® (Compl. ¶9, 34). The complaint does not provide specific details on the formulation of the accused product beyond its active ingredient. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the very act of submitting ANDA No. 206469 for a drug product covered by the asserted patents constitutes infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶33, 51, 69). The infringement theory is that the product described in the ANDA, if approved and marketed, would meet all the limitations of the asserted claims.

'830 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A topical ophthalmic pharmaceutical composition The Watson Product is an "ophthalmic drug product" and "ophthalmic solution." ¶31 col. 7:1-3
comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof The Watson Product contains "moxifloxacin hydrochloride." ¶1, 31 col. 3:55-61
in a concentration of 0.1 to 1.0 wt % The complaint alleges the Watson Product is covered by the claims, which requires the concentration to fall within the claimed range. ¶35 col. 7:1-3
and a pharmaceutically acceptable vehicle therefor. As a pharmaceutical ophthalmic solution, the Watson Product necessarily contains a vehicle. ¶31 col. 7:1-3

'070 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating opthalmic infections, which comprises The proposed product labeling for the Watson Product will direct its use for treating ophthalmic infections, mirroring the approved use of the branded drug. ¶54 col. 8:6-7
topically applying to the eye a therapeutically effective amount of a pharmaceutical composition The product's proposed labeling will instruct patients and physicians to topically apply the solution to the eye. ¶54 col. 8:8-9
comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof in a concentration of 0.1 to 1.0 wt. % of moxifloxacin... The Watson Product is alleged to be a composition containing moxifloxacin hydrochloride in a concentration that meets the claim limitation. ¶47, 52 col. 8:10-12
and a pharmaceutically acceptable vehicle therefor. The Watson Product, as an ophthalmic solution, contains a pharmaceutically acceptable vehicle. ¶47 col. 8:13-14

Identified Points of Contention

  • Compositional Questions: For the '830 and '070 patents, a primary question is whether the final formulation of the Watson Product falls within the scope of the asserted claims. For the more specific '311 patent, the analysis will be highly fact-dependent, raising the question: Does the Watson Product's formulation, including its specific excipients and their ratios (e.g., the sodium chloride to moxifloxacin ratio), meet the detailed limitations of the '311 claims? The complaint does not provide sufficient detail for analysis of these specific elements.
  • Methodological Questions: For the '070 patent, infringement hinges on Defendants' proposed product label. This raises the evidentiary question: What specific instructions and indications for use will be included on the label, and will they direct users to perform every step of the claimed "method of treating opthalmic infections"?

V. Key Claim Terms for Construction

  • Term: "pharmaceutically acceptable vehicle" (from '830 Patent, Claim 1)

    • Context and Importance: This term is foundational to the composition claims. While broadly defined, its construction could become a central issue if the Watson Product contains novel or unconventional excipients not explicitly contemplated by the examples in the '830 patent. The existence of the later, more specific '311 patent, which claims a particular vehicle, suggests that the scope of what constitutes a "vehicle" may be a point of dispute.
    • Intrinsic Evidence for a Broader Interpretation: The specification lists numerous potential components for a vehicle, including preservatives, co-solvents, and viscosity agents, suggesting the term is not meant to be limited to a specific formulation ('830 Patent, col. 5:56-col. 6:30).
    • Intrinsic Evidence for a Narrower Interpretation: A party could argue that the scope of the term should be guided by the specific embodiments, which describe relatively conventional aqueous solutions and ointments ('830 Patent, col. 6:35-col. 7:45).

  • Term: "treating ophthalmic infections" (from '070 Patent, Claim 1)

    • Context and Importance: This term defines the scope of the method claim. The infringement analysis for the '070 patent will depend on whether the intended uses on the Watson Product's proposed label fall within this term's definition.
    • Intrinsic Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of conditions that can be treated, including "conjunctivitis, keratitis, blepharitis, dacyrocystitis, hordeolum and corneal ulcers" ('070 Patent, col. 2:38-40). It also explicitly mentions prophylactic use "in connection with various ophthalmic surgical procedures" ('070 Patent, col. 2:40-42).
    • Intrinsic Evidence for a Narrower Interpretation: Practitioners may focus on whether the term, in the context of the claims, is limited to therapeutic treatment of an existing condition versus prophylactic use, although the specification appears to support both interpretations. The precise language of the proposed drug label will be critical.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all three patents (Compl. ¶¶38, 55, 74). For the '070 method patent, this is based on the allegation that Defendants' proposed product labeling will instruct physicians and patients to use the Watson Product in an infringing manner (Compl. ¶54). For the composition patents ('830 and '311), inducement is alleged based on the intent for the product to be sold and used for infringing purposes upon FDA approval (Compl. ¶38, 74).
  • Willful Infringement: The complaint alleges that Defendants acted with "full knowledge" of the asserted patents and without a reasonable basis for believing they would not be liable (Compl. ¶41, 59, 77). This allegation is supported by the fact that Defendants sent a Notice Letter regarding the patents, which demonstrates actual knowledge prior to the lawsuit (Compl. ¶31).

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

  • A primary issue will be one of compositional identity, particularly for the '311 patent. Given that the '830 and '070 patents claim the active ingredient and its general use more broadly, the dispute may center on whether the specific excipients, concentrations, and ratios in Watson's proposed generic formulation fall within the detailed and narrow claims of the later-issued '311 patent.
  • A key evidentiary question will be one of label-directed infringement. For the '070 method patent, the case will turn on the final, FDA-approved language of the Watson Product's label. Will the approved indications for use map directly onto the claim term "treating ophthalmic infections," thereby inducing infringement by physicians and patients?
  • While the complaint focuses on infringement, the procedural posture of an ANDA case implies a central underlying conflict over patent validity. Watson’s Paragraph IV certification necessarily asserts that the patents are invalid or not infringed. The infringement allegations for the broader '830 and '070 patents appear to follow from the nature of a generic copy, suggesting that a significant portion of the litigation will likely focus on Defendants' attempts to prove the patents invalid, for instance on grounds of obviousness.