DCT

1:17-cv-01290

Allergan Inc v. Aurobindo Pharma Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01290, D. Del., 09/08/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because two defendant entities are incorporated in Delaware, and the foreign parent entity, Aurobindo Pharma Ltd., does not have a regular and established place of business in the United States.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the ophthalmic allergy drug Lastacaft® constitutes an act of infringement of a patent covering methods of its use.
  • Technical Context: The technology concerns ophthalmic pharmaceutical formulations containing the active ingredient alcaftadine for the once-daily treatment of symptoms associated with allergic conjunctivitis.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a notice letter from Aurobindo, dated July 27, 2017, which included a Paragraph IV certification alleging that the patent-in-suit is invalid. The patent is listed in the FDA’s “Orange Book” as covering the branded product Lastacaft®.

Case Timeline

Date Event
2006-03-31 '215 Patent Priority Date
2014-03-04 '215 Patent Issue Date
2017-07-27 Aurobindo Notice Letter Date
2017-09-08 Complaint Filing Date

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

U.S. Patent No. 8,664,215 - "Ocular Allergy Treatments With Alcaftadine"

  • Patent Identification: U.S. Patent No. 8,664,215, "Ocular Allergy Treatments With Alcaftadine," issued March 4, 2014.

The Invention Explained

  • Problem Addressed: The patent's background section describes a need for improved treatments for ocular allergy. It notes that existing therapies, such as second-generation H1 antagonists, often have limited anti-inflammatory effects and require twice-daily dosing, which can be inconvenient for patients ('215 Patent, col. 2:1-15).
  • The Patented Solution: The invention is a method of treating or preventing ocular allergy symptoms by administering an ophthalmic composition containing alcaftadine once per day ('215 Patent, col. 2:15-21). The patent asserts as a "surprising discovery" that alcaftadine is especially useful because it can treat or prevent multiple distinct allergy symptoms with a longer duration of action, making once-daily administration feasible and effective ('215 Patent, col. 2:31-38).
  • Technical Importance: A once-daily dosing regimen that effectively manages multiple symptoms of allergic conjunctivitis offers a significant improvement in patient convenience and compliance compared to therapies requiring more frequent administration ('215 Patent, col. 2:15-24).

Key Claims at a Glance

  • The complaint asserts claims 1-11 ('Compl. ¶35). Independent claims 1, 4, and 11 are asserted.
  • Independent Claim 1:
    • A method of treating a clinical symptom of ocular allergy
    • comprising administering once daily to the eye of a human patient
    • an ophthalmic composition comprising alcaftadine, its pharmaceutically acceptable salts, or mixtures thereof
  • Independent Claim 4:
    • A method of preventing ocular itching in a human patient exposed to a conjunctival allergen
    • comprising administering once daily to the eye of said human patient
    • an ophthalmic composition comprising alcaftadine, its pharmaceutically acceptable salts, or mixtures thereof
    • wherein prevention comprises inhibiting said ocular itching compared to a non-treated patient
  • The complaint does not explicitly reserve the right to assert dependent claims, but the assertion of claims 1-11 inherently includes the dependent claims within that range.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Aurobindo Generic Product," identified as an "alcaftadine ophthalmic solution 0.25%," for which Aurobindo submitted ANDA No. 21-0659 to the FDA (Compl. ¶28).

Functionality and Market Context

The product is a generic version of Plaintiffs’ branded drug, Lastacaft® (Compl. ¶12). The complaint alleges that the proposed labeling for the Aurobindo Generic Product will direct its use for the "prevention of itching associated with allergic conjunctivitis," and that its instructions for use will "substantially copy the instructions for Lastacaft®" (Compl. ¶36).

IV. Analysis of Infringement Allegations

The infringement theory is primarily based on inducement, alleging that the proposed label for the Aurobindo Generic Product will instruct users to perform the patented method. No probative visual evidence provided in complaint.

'215 Patent Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of preventing ocular itching in a human patient exposed to a conjunctival allergen... The proposed label for the Aurobindo Generic Product directs its use for the "prevention of itching associated with allergic conjunctivitis." ¶36 col. 13:30-31
...comprising administering once daily to the eye of said human patient... The complaint alleges that the commercial use of the Aurobindo Generic Product, guided by its proposed labeling, will infringe the patented method, which includes this step. ¶35-36 col. 4:10-15
...an ophthalmic composition comprising alcaftadine, its pharmaceutically acceptable salts, or mixtures thereof... The subject of Aurobindo's ANDA is an "alcaftadine ophthalmic solution 0.25%." ¶28 col. 3:1-5
...wherein prevention comprises inhibiting said ocular itching compared to a non-treated patient. This is an inherent result of the product's directed indication for "prevention of itching," which the complaint alleges is substantially copied from the branded product's instructions. ¶36 col. 13:32-40
  • Identified Points of Contention:
    • Scope Questions: A central question will be whether the act of seeking FDA approval for a drug with a specific label indication constitutes infringement of a method-of-use claim. The analysis will depend on whether the proposed label's instructions are found to actively encourage or instruct users to perform all steps of the claimed method, including the "once daily" administration.
    • Technical Questions: An evidentiary question is what the specific dosing frequency instructed on the Aurobindo Generic Product's proposed label will be. The complaint alleges the instructions will "substantially copy" those for Lastacaft®, but does not provide the specific language from the proposed label itself (Compl. ¶36).

V. Key Claim Terms for Construction

  • The Term: "administering once daily"

  • Context and Importance: This limitation is central to the patent’s asserted novelty over prior art that allegedly required more frequent dosing. For the method claims to be infringed, the use directed by Aurobindo's label must be found to be "once daily."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term's plain and ordinary meaning suggests an administration frequency of one time per 24-hour period. Parties advocating for a broad construction may argue no further limitations should be imported from the specification.
    • Evidence for a Narrower Interpretation: The specification repeatedly connects the "once daily" administration to a long duration of action that other therapies lack ('215 Patent, col. 2:11-21). A party could argue that "once daily" implies not just a frequency but also the achievement of a specific therapeutic effect lasting long enough to make that frequency viable, as demonstrated in the patent's clinical examples.

  • The Term: "preventing ocular itching"

  • Context and Importance: This term from independent claim 4 is directly targeted by the complaint's allegation that Aurobindo's proposed label indicates the product for the "prevention of itching" (Compl. ¶36). The construction of this term will be critical to the infringement analysis.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent uses the term "prevention" in its general sense in the title and throughout the specification, potentially supporting a broad construction covering any prophylactic administration ('215 Patent, Title; col. 1:15).
    • Evidence for a Narrower Interpretation: Example 4 of the patent is titled "Prevention of Ocular Itching" and details a clinical study where "prevention" is quantified by dose-related inhibition and lower mean itching scores on a 5-point scale compared to a placebo ('215 Patent, col. 13:30-40). A party may argue that "preventing" should be construed to require a specific, clinically significant level of inhibition as demonstrated in the patent's own examples.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), based on the assertion that Aurobindo’s proposed product labeling will direct and instruct medical providers and patients to use the generic product in an infringing manner (Compl. ¶36). The complaint also alleges contributory infringement under § 271(c), stating that the generic product is especially adapted for infringing use and is not a staple article suitable for substantial noninfringing use (Compl. ¶39).
  • Willful Infringement: Willfulness is alleged based on Aurobindo having "full knowledge of the ‘215 patent and its claims" from the Orange Book listing and having "lacked a good faith basis for alleging invalidity" when it filed its Paragraph IV certification (Compl. ¶37, ¶42).

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

  • A central legal issue will be one of induced infringement: does the language on Aurobindo's proposed product label, particularly its indication for "prevention of itching," provide sufficient evidence of specific intent to encourage or promote the complete, multi-step "once daily" administration method required by the asserted claims?
  • The case will likely involve a significant dispute over claim construction and validity, as foreshadowed by the defendant's Paragraph IV certification (Compl. ¶29). A key question for the court will be whether the claimed method of "once daily" administration of alcaftadine was non-obvious in light of the state of the art at the time of the invention.
  • An evidentiary question will be one of infringing use: what are the precise instructions for use on the proposed label for the Aurobindo Generic Product? The degree to which they mirror the instructions for the branded product, Lastacaft®, will be a focal point in determining whether the directed use meets every limitation of the asserted method claims.