DCT

1:18-cv-00997

Duke University v. Sandoz Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00997, D. Colo., 04/03/2018
  • Venue Allegations: The complaint, originally filed in the Eastern District of Texas, alleges venue is proper because Defendants have a regular and established place of business in the district and have committed acts of patent infringement there, including through the manufacture and sale of the accused product.
  • Core Dispute: Plaintiffs allege that Defendants’ generic bimatoprost ophthalmic solution, a copy of Allergan's LATISSE® product, infringes a patent covering methods of using specific non-naturally occurring prostaglandin analogs to treat hair loss.
  • Technical Context: The technology involves using synthetically modified prostaglandin F analogs for the cosmetic and therapeutic purpose of stimulating hair growth, particularly for eyelashes.
  • Key Procedural History: This lawsuit follows prior litigation between the same parties concerning a parent patent ('029 Patent) to the one currently in suit. In that earlier case, the U.S. Court of Appeals for the Federal Circuit invalidated the asserted claims of the '029 Patent as obvious because they were too broad. The complaint alleges that the currently asserted '270 Patent contains narrower claims, specifically limited to the chemical structures (C-1 amides) that showed unexpected results, thereby overcoming the deficiencies identified by the Federal Circuit. The '270 Patent was listed in the FDA's Orange Book for LATISSE® in March 2017.

Case Timeline

Date Event
2000-03-31 '270 Patent Priority Date
2008-XX-XX FDA approves LATISSE®
2013-01-24 District court decision in prior litigation concerning parent '029 Patent
2014-XX-XX Federal Circuit reverses non-obviousness finding for '029 Patent
2016-04-19 Sandoz obtains FDA approval for generic LATISSE®
2016-12-07 Sandoz announces U.S. market launch of generic LATISSE®
2017-02-28 U.S. Patent No. 9,579,270 issues
2017-03-XX '270 Patent listed in FDA Orange Book for LATISSE®
2018-04-03 Complaint filed

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

  • Patent Identification: U.S. Patent No. 9,579,270, "Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued February 28, 2017.

The Invention Explained

  • Problem Addressed: The patent background describes the ongoing search for safe and effective treatments for hair loss, noting that prior attempts using prostaglandins had been unsuccessful and that other potent compounds, like thyroid hormones, carried significant risks of side effects such as cardiotoxicity ('270 Patent, col. 2:10-20, col. 3:10-19).
  • The Patented Solution: The invention is a method for treating hair loss by topically applying compositions containing a specific, narrow class of synthetic prostaglandin F (PGF) analogs. The key insight described in the specification is the selection of PGF analogs that selectively activate the FP receptor—which stimulates hair growth—without activating other prostaglandin receptors that could cause undesirable side effects like inflammation or pain ('270 Patent, col. 3:25-33).
  • Technical Importance: This targeted approach aimed to isolate the beneficial hair-growth properties of prostaglandin stimulation from the negative side effects associated with naturally occurring or less specific prostaglandin analogs, thereby offering a potentially safer and more effective therapeutic pathway (Compl. ¶¶ 45-46, 65).

Key Claims at a Glance

  • The complaint asserts dependent claims 22 and 30, which rely on independent claim 17.
  • Independent Claim 17: The essential elements are:
    • A method of growing hair,
    • which comprises topically applying to mammalian skin,
    • a safe and effective amount of a composition,
    • comprising an active ingredient that is a prostaglandin F analog with a defined chemical structure, where the R¹ group at the C-1 position is selected from a group including amides and other non-carboxylic acid moieties (e.g., C(O)NHR³), and the Z group is a substituted or unsubstituted aromatic or heterocyclic ring system.
  • The complaint reserves the right to assert additional claims ('270 Patent, Claims 17, 22, 30).

III. The Accused Instrumentality

Product Identification

  • Defendants' generic copy of LATISSE®, identified as bimatoprost ophthalmic solution, 0.03% (Compl. ¶¶ 57, 72).

Functionality and Market Context

  • The product is a liquid solution containing the active ingredient bimatoprost, a synthetic prostaglandin analog (Compl. ¶¶ 42, 75). The complaint references the product's label (Exhibit A), which instructs users to apply one drop of the solution nightly to the skin of the upper eyelid margin at the base of the eyelashes using a sterile applicator (Compl. ¶ 77). The complaint includes a chemical structure diagram of bimatoprost, the active ingredient in the accused product (Compl. ¶ 42).
  • The product is marketed as a generic equivalent to Allergan's commercially successful LATISSE® product and is indicated to treat hypotrichosis (inadequate eyelashes) by increasing hair growth, length, thickness, and darkness (Compl. ¶¶ 69, 76). The complaint alleges its launch caused a significant decline in LATISSE® sales (Compl. ¶ 30).

IV. Analysis of Infringement Allegations

'270 Patent Infringement Allegations

Claim Element (from Independent Claim 17, as narrowed by dependent claims 22 and 30) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of growing hair, wherein the method comprises topically applying to mammalian skin a safe and effective amount of a composition... The product label instructs users to apply the 0.03% bimatoprost solution to the "skin of the upper eyelid margin at the base of the eyelashes" to treat "hypotrichosis of the eyelashes by increasing their growth." This is alleged to be a safe and effective amount. ¶76, ¶77, ¶79 col. 47:48-52
...comprising: A) an active ingredient selected from the group consisting of a prostaglandin F analog of the following structure... The active ingredient is bimatoprost, which the complaint alleges is a prostaglandin F analog that falls within the claimed chemical structure. ¶42, ¶43, ¶49 col. 7:36 - 8:52
...wherein R¹ is C(O)NHR³... The complaint states that bimatoprost contains an ethyl amide group at the C-1 position, which corresponds to the C(O)NHR³ structure required by dependent claim 22. ¶43, ¶47, ¶49 col. 8:12-19
...wherein Z is phenyl. The complaint states that bimatoprost contains a phenyl group at the C-17 position, which corresponds to the phenyl group required for Z by dependent claim 25 (a predicate for claim 30). ¶43, ¶48, ¶49 col. 8:48-52

Identified Points of Contention

  • Scope Questions: The complaint alleges indirect infringement based on the Defendants' product label. A central question for the court will be whether the label's instructions to apply the product to the "skin of the upper eyelid margin" for the purpose of "increasing their growth" are sufficient to prove that Defendants specifically intended to induce, and knew they were inducing, infringement of the claimed "method of growing hair."
  • Technical Questions: The infringement allegation relies on a direct structural mapping of the bimatoprost molecule to the patent's claims. While the complaint presents this as a straightforward match (Compl. ¶ 49), a potential point of dispute could arise if Defendants challenge whether bimatoprost, as manufactured and sold, meets every structural limitation of the asserted claims, including stereochemistry, which the patent notes is important ('270 Patent, col. 8:4-9).

V. Key Claim Terms for Construction

The Term: "growing hair"

  • Context and Importance: This phrase defines the overall purpose and scope of the claimed method. Its construction is critical because it determines what type of activity constitutes infringement. In the prior litigation involving the parent patent, this term was construed to mean "arrest hair loss, reverse hair loss, or promote hair growth in the alternative" (Compl. ¶ 58). The parties may either adopt this prior construction or re-litigate the term's meaning.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification uses broad language, stating the compositions can "arrest hair loss, reverse hair loss, and promote hair growth" ('270 Patent, Abstract). This supports the expansive construction from the prior case.
    • Evidence for a Narrower Interpretation: The patent’s examples and experimental data focus specifically on converting hair from the resting (telogen) to the growth (anagen) phase ('270 Patent, col. 59:15-24). A party could argue this context limits the term to the initiation of new hair growth, rather than merely affecting the characteristics of existing hair.

The Term: "a safe and effective amount"

  • Context and Importance: This is a standard limitation in pharmaceutical method claims. Practitioners may focus on this term because its definition relies on external factors, such as FDA approval and clinical data. While FDA approval of the 0.03% bimatoprost solution suggests it is "safe and effective" for its indicated use, the parties could still dispute whether this amount is "safe and effective" for the specific method as claimed in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not define a specific numerical range for a "safe and effective amount," instead linking it to the IC₅₀ of the compound ('270 Patent, col. 53:39-51). This suggests a functional definition that could encompass a range of concentrations.
    • Evidence for a Narrower Interpretation: A defendant might argue that the term must be limited by the specific dosages and effects described in the patent's own examples, potentially creating a mismatch with the accused product's concentration if the data differs.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement. The inducement claim is based on allegations that Defendants’ product label, press releases, and website actively instruct and encourage patients and healthcare providers to use the generic product in a manner that directly infringes claims 22 and 30 (Compl. ¶¶ 72-74, 83). The contributory infringement claim is based on the allegation that the accused product is a material component of the patented method, is especially made for this infringing use, and has no substantial non-infringing use (Compl. ¶¶ 89, 94).

Willful Infringement

  • The complaint alleges willfulness based on Defendants' alleged knowledge of the '270 Patent and its relation to LATISSE®. This knowledge is alleged to stem from Defendants' monitoring of the patent's prosecution, the patent's listing in the FDA Orange Book in March 2017, and, most significantly, Defendants' direct involvement in the prior litigation over the parent '029 patent, which concerned the same bimatoprost compound (Compl. ¶¶ 80-82, 85).

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

  • A key evidentiary question will be one of induced infringement: Is the evidence of Defendants' marketing and, in particular, the instructions for use on the generic product's label, sufficient to establish that Defendants possessed the specific intent to encourage end-users to perform every step of the patented method?
  • A central legal issue, which will inform the entire case, is one of patentability in context: Although validity is a separate inquiry, the dispute is framed by the history of the parent '029 patent. Therefore, a dispositive question will be whether the asserted claims of the '270 Patent—narrowed to a specific chemical sub-genus (C-1 amides)—are sufficiently distinct to overcome the Federal Circuit's prior holding that broader claims covering the same compound were obvious.
  • A final question will be one of willfulness and damages: Given the extensive litigation history between the parties over the same core technology, a court will need to determine whether Defendants' decision to launch their generic product after the '270 Patent issued constituted willful infringement, which could expose them to enhanced damages.