DCT

1:18-cv-00652

Duke University v. Alcon Laboratories Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00652, D. Del., 04/03/2018
  • Venue Allegations: The complaint, originally filed in the Eastern District of Texas, alleges venue is proper because Defendants maintain a regular and established place of business in that district and have committed acts of patent infringement there, including managing marketing and sales from a Texas office and selling products to Texas pharmacies.
  • Core Dispute: Plaintiffs allege that Defendants’ generic bimatoprost ophthalmic solution, a generic version of the eyelash growth treatment LATISSE®, infringes a patent related to methods for growing hair using specific non-naturally occurring prostaglandin F analogs.
  • Technical Context: The technology concerns pharmaceutical compositions for treating hypotrichosis (inadequate or not enough eyelashes), a condition addressed by a significant cosmetic and therapeutic market.
  • Key Procedural History: The complaint describes prior litigation between Allergan and Sandoz concerning a parent patent (U.S. Patent No. 7,388,029), which the '270 Patent-in-Suit claims priority to. In that case, the Federal Circuit invalidated the parent patent’s claims for obviousness, reasoning they were too broad. The current complaint alleges that the '270 Patent’s claims are narrower and specifically limited to the chemical structures found to have unexpected results, thereby overcoming the deficiencies identified by the Federal Circuit.

Case Timeline

Date Event
2000-03-31 '270 Patent Priority Date
2008-01-01 FDA approves LATISSE® (bimatoprost ophthalmic solution)
2016-04-19 Sandoz obtains FDA approval for its generic copy of LATISSE®
2016-12-07 Sandoz announces U.S. market launch of its generic product
2017-02-28 U.S. Patent No. 9,579,270 is issued
2017-03-01 '270 Patent is listed in the FDA's "Orange Book"
2018-04-03 Complaint for Patent Infringement is filed

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

U.S. Patent No. 9,579,270 - "Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins"

The Invention Explained

  • Problem Addressed: The patent addresses the common problem of hair loss and the limitations of previous treatments ('270 Patent, col. 1:31-38). The background notes that while prostaglandins were explored for hair growth, their administration could cause undesirable side effects like inflammation and pain due to their interaction with multiple biological receptors ('270 Patent, col. 3:9-19).
  • The Patented Solution: The invention claims to solve this problem by using a specific, narrow class of synthetic prostaglandin F analogs that are designed to selectively activate the FP receptor, which is associated with hair growth, without activating other receptors that cause side effects ('270 Patent, Abstract; col. 3:25-34). The chemical modifications, particularly at the C-1 position of the prostaglandin structure, are identified as key to this selective activity (Compl. ¶¶ 43-46, 65).
  • Technical Importance: This selective approach sought to isolate the therapeutic, hair-growth-promoting effects of prostaglandin activity from other biological functions, thereby offering a potentially more targeted and safer treatment for hair loss than broader, less-selective compounds (Compl. ¶¶ 46, 65).

Key Claims at a Glance

  • The complaint asserts dependent claims 22 and 30, which rely on independent claim 17.
  • Independent Claim 17 recites a method of growing hair with the following essential elements:
    • A method of growing hair.
    • The method comprises topically applying to mammalian skin a safe and effective amount of a composition.
    • The composition comprises an active ingredient which is a prostaglandin F analog having a specific chemical structure defined by variables R¹, R², R³, R⁴, X, Y, and Z.
  • The complaint does not explicitly reserve the right to assert other claims but focuses entirely on claims 22 and 30 (Compl. ¶¶ 1, 72, 89).

III. The Accused Instrumentality

Product Identification

  • Defendants' generic copy of LATISSE® (bimatoprost ophthalmic solution, 0.03%) (Compl. ¶57).

Functionality and Market Context

  • The accused product is a liquid solution containing 0.03% bimatoprost by weight, which is the active ingredient (Compl. ¶¶ 42, 75). Its product label instructs users to apply one drop of the solution nightly along the skin of the upper eyelid margin at the base of the eyelashes (Compl. ¶77). The complaint provides a diagram of the chemical structure of naturally occurring PGF2α (Compl. ¶40) and a separate diagram for the chemical structure of bimatoprost, the active ingredient in the accused product, to highlight their structural differences (Compl. ¶42). The product is indicated to treat hypotrichosis of the eyelashes by "increasing their growth including length, thickness and darkness" (Compl. ¶76).
  • The complaint alleges that since its launch, the accused product has caused sales of Allergan's LATISSE® to decline by approximately 50% in the Texas region, and that Defendants intend for their product to be used as a substitute for LATISSE® (Compl. ¶¶ 30, 69).

IV. Analysis of Infringement Allegations

'270 Patent Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of growing hair... The accused product's label states it is indicated to treat hypotrichosis of the eyelashes by "increasing their growth including length, thickness and darkness." ¶76 col. 3:9-12
...comprising topically applying to mammalian skin a safe and effective amount of a composition... The product label instructs patients to "[o]nce nightly, place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator... and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes." ¶77 col. 65:1-3
...comprising... an active ingredient selected from the group consisting of a prostaglandin F analog of the following structure... The active ingredient in the accused product is bimatoprost, which the complaint alleges is a synthetic PGF2α analog encompassed by the claimed structure. The complaint explicitly maps the structure of bimatoprost to the claim variables. ¶¶43, 49 col. 7:38-41
  • Identified Points of Contention:
    • Technical Questions: A potential issue arises from the complaint's own technical distinctions. It alleges that bimatoprost has a "different pharmacological activity" than other prostaglandins because it binds to a "prostamide receptor," which is a "splice variant of the FP receptor," rather than the "FP receptor" itself (Compl. ¶¶ 44, 46). This raises the question of whether a compound that allegedly does not bind to the primary "FP receptor" can infringe a claim for a method using an "FP agonist" that must "selectively activate the FP receptor" ('270 Patent, col. 3:29-32). The resolution may depend on the construction of "FP receptor," as discussed in Section V.
    • Scope Questions: The complaint frames the dispute in the context of prior litigation where the parent patent was found obvious due to its breadth (Compl. ¶¶ 62-64). A central question for the court will be whether the narrower limitations of the asserted claims (e.g., requiring a C-1 amide group) are sufficient to render the claims non-obvious, or if they represent an obvious selection from a known class of compounds.

V. Key Claim Terms for Construction

  • The Term: "FP receptor"

  • Context and Importance: The definition of this term is critical because the infringement case hinges on whether bimatoprost, the accused active ingredient, activates the claimed "FP receptor." The complaint alleges bimatoprost does not bind to the primary "FP receptor" but instead binds to a "splice variant" called the "prostamide receptor" (Compl. ¶44). Practitioners may focus on this term because the plaintiff's infringement theory appears to depend entirely on this term being construed broadly enough to cover the prostamide receptor.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification provides an explicit definition: "'FP receptor' means known human FP receptors, their splice variants, and undescribed receptors that have similar binding and activation profiles as the known human FP receptors." ('270 Patent, col. 4:26-29). This express inclusion of "splice variants" may support the plaintiff's position that the prostamide receptor is covered.
    • Evidence for a Narrower Interpretation: A defendant may argue that because bimatoprost has a "different pharmacological activity" (Compl. ¶46), it does not have a "similar binding and activation profile" as required by the patent's definition. This could support an argument that the prostamide receptor, despite being a splice variant, falls outside the scope of the patent's definition of "FP receptor."

  • The Term: "growing hair"

  • Context and Importance: In the prior litigation on the parent patent, the court construed the related phrase "treating hair loss" to mean the invention could "arrest hair loss, reverse hair loss, or promote hair growth in the alternative" (Compl. ¶58). The definition of "growing hair" will determine the scope of the method claim and what constitutes an act of direct infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent's abstract states that the claimed compositions can "arrest hair loss, reverse hair loss, and promote hair growth" ('270 Patent, Abstract). This language suggests an encompassing definition that includes more than just the generation of new hair.
    • Evidence for a Narrower Interpretation: A defendant could argue that "growing hair" is a more specific and active process than "treating hair loss" and requires a demonstrable increase in hair length or density, not merely the prevention of loss.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on allegations that Defendants' product label and marketing materials actively instruct and encourage patients and healthcare providers to perform the patented method of applying bimatoprost to the skin to grow eyelashes (Compl. ¶¶ 72-74, 83). The contributory infringement claim is based on the allegation that Defendants' product is a material part of the invention, is especially adapted for an infringing use, and has no substantial non-infringing use (Compl. ¶¶ 89, 94).
  • Willful Infringement: The willfulness claim is based on alleged pre-suit knowledge. The complaint alleges Defendants monitored the prosecution of the patent family, knew of the patent's issuance and its listing in the FDA's "Orange Book" in March 2017, and were aware from the prior litigation that their product could infringe narrower, valid claims (Compl. ¶¶ 80-82, 85).

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

  • A core issue will be one of biological definition and scope: Can the term "FP receptor," which the patent defines to include "splice variants," be construed to cover the "prostamide receptor" that the complaint itself alleges is the target of the accused product? The case may turn on whether the accused product's "different pharmacological activity" removes it from the patent's definition requiring a "similar binding and activation profile."
  • A key question of validity will be whether the '270 Patent’s claims, which are narrowly tailored to the C-1 amide prostaglandin structures, are non-obvious over the prior art that led the Federal Circuit to invalidate the broader claims of the parent patent. The outcome will likely depend on whether the evidence of unexpected results for this narrow subclass is commensurate with the claim scope.