DCT

1:26-cv-00112

Organon LLC v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00112, N.D. W. Va., 08/31/2026
  • Venue Allegations: Venue is alleged to be proper as Defendant Mylan Pharmaceuticals Inc. resides in the district, and both Defendants are alleged to have a regular and established place of business and to have committed or will commit acts of infringement within the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' VTAMA tapinarof cream constitutes an act of infringement of nine U.S. patents.
  • Technical Context: The technology relates to topical pharmaceutical cream formulations for tapinarof, an active ingredient used to treat dermatological conditions such as plaque psoriasis and atopic dermatitis.
  • Key Procedural History: The development of the branded drug VTAMA involved multiple corporate entities, with rights being transferred over several years before its first U.S. marketing approval in 2022. During the prosecution of one of the patents-in-suit, U.S. Patent No. 11,590,088, the patent owner disclaimed several claims, which may be relevant to determining the scope of the remaining asserted claims.

Case Timeline

Date Event
2015-05-21 Earliest Priority Date ('160, '743, '108, '088, '573, '724, '945 Patents)
2017-11-10 Earliest Priority Date ('649, '692 Patents)
2019-02-05 U.S. Patent No. 10,195,160 Issues
2019-10-01 U.S. Patent No. 10,426,743 Issues
2020-05-12 U.S. Patent No. 10,647,649 Issues
2022-05-23 VTAMA receives FDA approval for plaque psoriasis
2022-10-04 U.S. Patent No. 11,458,108 Issues
2023-02-28 U.S. Patent No. 11,590,088 Issues
2023-03-07 U.S. Patent No. 11,597,692 Issues
2023-03-28 U.S. Patent No. 11,612,573 Issues
2023-04-04 U.S. Patent No. 11,617,724 Issues
2023-04-11 U.S. Patent No. 11,622,945 Issues
2024-12-12 VTAMA receives FDA approval for atopic dermatitis
2025-01-28 Plaintiff Dermavant disclaims claims of the '088 Patent
2026-07-22 Mylan sends Notice Letter to Organon regarding its ANDA filing
2026-08-31 Complaint Filed

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

U.S. Patent No. 10,195,160 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 10,195,160, "Topical pharmaceutical compositions," issued February 5, 2019.

The Invention Explained

  • Problem Addressed: The patent's background describes the challenge of creating a topical pharmaceutical composition for the active ingredient 3,5-Dihydroxy-4-isopropyl-trans-stilbene (tapinarof) that is both physically and chemically stable, as the compound is known to be sensitive to oxidation and photodegradation '160 Patent, col. 1:16-24 '160 Patent, col. 1:61-63
  • The Patented Solution: The invention is a topical oil-in-water emulsion that achieves stability by solubilizing the tapinarof active ingredient within the oil phase of the composition, which comprises specific types and amounts of oils, surfactants, and antioxidants '160 Patent, abstract '160 Patent, col. 2:40-44 The composition is described as "homogeneous" and is designed to deliver the active ingredient effectively into the skin while minimizing systemic exposure '160 Patent, col. 1:18-35
  • Technical Importance: The formulation provided a pathway for the stable and effective topical delivery of tapinarof, a compound known for its therapeutic potential in treating dermatological conditions like psoriasis but which was previously difficult to formulate due to stability issues '160 Patent, col. 1:53-59

Key Claims at a Glance

The complaint does not identify specific asserted claims, but alleges infringement of "one or more claims" of each patent-in-suit Compl. ¶52 Independent claim 1 is presented for analysis.

  • Independent Claim 1: A topical oil-in-water emulsion composition comprising:
    • 3,5-dihydroxy-4-isopropyl-trans-stilbene or a pharmaceutically acceptable salt thereof in an amount of about 0.05% to about 2% by weight;
    • an oil phase comprising medium chain triglycerides of a carbon length from six to twelve carbons in an amount of about 2% to about 30% by weight;
    • a water phase;
    • a surfactant in an amount of about 1% to about 20% by weight, wherein the surfactant comprises at least one non-ionic emulsifying wax NF;
    • a dermatologically acceptable excipient selected from the group consisting of an antioxidant, a pH adjusting agent, a chelating agent, a preservative, a co-solvent and combinations thereof;
    • wherein the 3,5-dihydroxy-4-isopropyl-trans-stilbene or a pharmaceutically acceptable salt thereof is solubilized in the oil phase and is the only active ingredient in the oil phase;
    • wherein the oil phase is substantially free of petrolatum and mineral oil;
    • wherein the oil-in-water emulsion is homogeneous; and
    • wherein the average droplet size of the oil phase is from about 0.1 microns to about 35 microns.
  • The complaint reserves the right to assert additional claims, which may include dependent claims Compl. ¶52

U.S. Patent No. 10,426,743 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 10,426,743, "Topical pharmaceutical compositions," issued October 1, 2019.

The Invention Explained

  • Problem Addressed: Similar to the '160 patent, the '743 patent addresses the challenge of formulating the chemically sensitive active ingredient tapinarof into a physically and chemically stable topical composition for dermatological treatment '743 Patent, col. 1:16-24 '743 Patent, col. 1:61-63
  • The Patented Solution: The '743 patent discloses a specific topical oil-in-water emulsion that stabilizes tapinarof by solubilizing it in the oil phase. The formulation's homogeneity is a key feature, intended to ensure consistent drug delivery and cosmetic elegance '743 Patent, abstract '743 Patent, col. 2:40-44 The specification of the '743 patent is substantively identical to that of the '160 patent.
  • Technical Importance: This formulation enabled the development of a stable and effective topical product for tapinarof, overcoming the compound's inherent instability to allow its use for treating skin conditions like psoriasis '743 Patent, col. 1:53-59

Key Claims at a Glance

The complaint does not identify specific asserted claims, but alleges infringement of "one or more claims" of each patent-in-suit Compl. ¶59 Independent claim 1 is presented for analysis.

  • Independent Claim 1: A method of treating an inflammatory disease or disorder in a patient, the method comprising administering a topical pharmaceutical oil-in-water emulsion composition comprising:
    • 3,5-dihydroxy-4-isopropyl-trans-stilbene or a pharmaceutically acceptable salt thereof in an amount of about 0.05% to about 2% by weight;
    • an oil phase comprising medium chain triglycerides of a carbon length from six to twelve carbons in an amount of about 2% to about 30% by weight;
    • a water phase;
    • a surfactant in an amount of about 1% to about 20% by weight, wherein the surfactant comprises at least one non-ionic emulsifying wax NF; and
    • a dermatologically acceptable excipient;
    • wherein the active ingredient is solubilized in the oil phase;
    • wherein the oil phase is substantially free of petrolatum and mineral oil;
    • wherein the oil-in-water emulsion is homogeneous; and
    • wherein the average droplet size of the oil phase is from about 0.1 microns to about 35 microns.
  • The complaint reserves the right to assert additional claims Compl. ¶59

U.S. Patent No. 10,647,649 - "Process for preparing tapinarof"

  • Patent Identification: U.S. Patent No. 10,647,649, "Process for preparing tapinarof," issued May 12, 2020.
  • Technology Synopsis: This patent describes a specific chemical process for synthesizing tapinarof. The process involves multiple steps, including chlorination and aromatization, and claims novel intermediate compounds used in the synthesis '649 Patent, abstract '649 Patent, col. 5:1-6:13 The invention provides an alternative, potentially more efficient and scalable manufacturing route for the active pharmaceutical ingredient.
  • Asserted Claims: At least one claim is asserted Compl. ¶66
  • Accused Features: The complaint alleges that Mylan's ANDA product will be made using a process that infringes one or more claims of the '649 patent Compl. ¶67

U.S. Patent No. 11,458,108 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 11,458,108, "Topical pharmaceutical compositions," issued October 4, 2022.
  • Technology Synopsis: This patent, similar to the '160 and '743 patents, claims a topical pharmaceutical emulsion for delivering tapinarof. It focuses on achieving a stable, homogeneous oil-in-water cream where the active ingredient is solubilized in the oil phase, which is specifically defined as being substantially free of petrolatum and mineral oil '108 Patent, abstract '108 Patent, claim 1
  • Asserted Claims: At least one claim is asserted Compl. ¶73
  • Accused Features: Mylan's ANDA product, which is alleged to be a bioequivalent copy of VTAMA cream, is accused of infringing Compl. ¶74

U.S. Patent No. 11,590,088 - "Use of tapinarof for the treatment of chronic plaque psoriasis"

  • Patent Identification: U.S. Patent No. 11,590,088, "Use of tapinarof for the treatment of chronic plaque psoriasis," issued February 28, 2023.
  • Technology Synopsis: This patent claims methods of treating chronic plaque psoriasis by topically administering a composition containing tapinarof. The claims focus on achieving specific clinical outcomes, such as a Physician Global Assessment (PGA) score of "clear or almost clear" after a certain treatment duration '088 Patent, abstract '088 Patent, claim 1 The patent owner disclaimed claims 1-4, 6-10, 16, 18, and 21-22 during prosecution Compl. ¶36
  • Asserted Claims: At least one of the remaining, non-disclaimed claims is asserted Compl. ¶80
  • Accused Features: The sale and marketing of Mylan's ANDA product for the treatment of plaque psoriasis, with a label that allegedly encourages infringing use, is accused Compl. ¶81 Compl. ¶83

U.S. Patent No. 11,597,692 - "Process for preparing tapinarof"

  • Patent Identification: U.S. Patent No. 11,597,692, "Process for preparing tapinarof," issued March 7, 2023.
  • Technology Synopsis: This patent, like the '649 patent, is directed to a process for manufacturing tapinarof. It claims a multi-step synthesis pathway for preparing the active pharmaceutical ingredient, including specific chemical transformations and intermediates '692 Patent, abstract '692 Patent, claim 1
  • Asserted Claims: At least one claim is asserted Compl. ¶87
  • Accused Features: The complaint alleges that Mylan's ANDA product will be manufactured by a process that infringes the claims of the '692 patent Compl. ¶88

U.S. Patent No. 11,612,573 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 11,612,573, "Topical pharmaceutical compositions," issued March 28, 2023.
  • Technology Synopsis: This patent claims a method of improving the residency time of tapinarof in a patient's skin by administering a specific topical emulsion. The claimed composition requires the active ingredient to be solubilized in an oil phase that is substantially free of petrolatum and mineral oil, and is characterized by specific outcomes related to skin flux and drug concentration '573 Patent, abstract '573 Patent, claim 1
  • Asserted Claims: At least one claim is asserted Compl. ¶94
  • Accused Features: The use of Mylan's ANDA product is alleged to infringe the claimed method of treatment Compl. ¶95

U.S. Patent No. 11,617,724 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 11,617,724, "Topical pharmaceutical compositions," issued April 4, 2023.
  • Technology Synopsis: This patent is directed to a topical pharmaceutical composition for tapinarof. The claims describe a stable, homogeneous oil-in-water emulsion with specific requirements for the oil phase, surfactants, and other excipients, and is characterized by its ability to deliver the drug effectively into the skin '724 Patent, abstract '724 Patent, claim 1 The specification appears substantively identical to that of the '160 patent.
  • Asserted Claims: At least one claim is asserted Compl. ¶101
  • Accused Features: Mylan's ANDA product is accused of infringing the claimed composition Compl. ¶102

U.S. Patent No. 11,622,945 - "Topical pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 11,622,945, "Topical pharmaceutical compositions," issued April 11, 2023.
  • Technology Synopsis: This patent claims a topical pharmaceutical oil-in-water emulsion composition comprising tapinarof. The invention is defined by specific quantitative ranges for its components, including the active ingredient, oil phase, water phase, surfactant, and excipients, and requires the oil phase to be substantially free of petrolatum and mineral oil '945 Patent, abstract '945 Patent, claim 1 The specification appears substantively identical to that of the '160 patent.
  • Asserted Claims: At least one claim is asserted Compl. ¶108
  • Accused Features: Mylan's ANDA product is accused of infringing the claimed composition Compl. ¶109

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic tapinarof cream, 1% drug product, which is the subject of ANDA No. 221179 ("Mylan's ANDA Product") Compl. ¶1

Functionality and Market Context

  • The complaint alleges that Mylan's ANDA Product is a topical cream formulated for the treatment of plaque psoriasis Compl. ¶48 It is alleged to contain 1% tapinarof as its active ingredient and to be designed to copy the formulation of Plaintiffs' patented VTAMA product Compl. ¶48
  • The basis of the lawsuit is the allegation that, to gain FDA approval, Mylan has represented to the FDA that its product will have the same active ingredient, strength, dosage form, and method of administration as VTAMA, and that it will be bioequivalent to VTAMA Compl. ¶46 Plaintiffs allege that for a topical product to demonstrate bioequivalence, it must have the same physicochemical and structural attributes and an equivalent rate of drug release, which Plaintiffs assert will necessarily require infringement of at least some of the patents-in-suit Compl. ¶49

IV. Analysis of Infringement Allegations

The complaint is a "form" complaint filed under the Hatch-Waxman Act and does not contain detailed infringement contentions or claim charts. The analysis below is based on the infringement theory articulated in the complaint, which posits that infringement is a necessary consequence of bioequivalence.

'160 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A topical oil-in-water emulsion composition comprising: 3,5-dihydroxy-4-isopropyl-trans-stilbene...in an amount of about 0.05% to about 2% by weight... The ANDA product is alleged to contain 1% tapinarof, which is the chemical name for the active ingredient and falls within the claimed range. ¶48 col. 1:30-36
an oil phase comprising medium chain triglycerides of a carbon length from six to twelve carbons in an amount of about 2% to about 30% by weight... The complaint alleges Mylan's ANDA product is designed to copy the patented VTAMA formulation and must show bioequivalence, which suggests it will contain the same or equivalent components. ¶48; ¶49 col. 11:1-16
wherein the oil phase is substantially free of petrolatum and mineral oil... The complaint alleges Mylan's formulation must be bioequivalent to VTAMA, whose patented formulation is substantially free of these components. ¶49 col. 22:5-7
wherein the 3,5-dihydroxy-4-isopropyl-trans-stilbene...is solubilized in the oil phase... The complaint alleges that to achieve bioequivalence, Mylan's product must have the same physicochemical attributes, which requires the active ingredient to be solubilized in the oil phase. ¶49 col. 22:1-4
wherein the oil-in-water emulsion is homogeneous; and wherein the average droplet size of the oil phase is from about 0.1 microns to about 35 microns. The complaint alleges that Mylan's product must have the same structural attributes as VTAMA to be bioequivalent, which Plaintiffs assert requires it to be a homogeneous emulsion with a similar droplet size. ¶49 col. 4:46-49

'743 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating an inflammatory disease or disorder in a patient, the method comprising administering...a topical pharmaceutical oil-in-water emulsion composition comprising...3,5-dihydroxy-4-isopropyl-trans-stilbene... Mylan's ANDA Product is a topical cream for treating plaque psoriasis, an inflammatory disease. Its proposed label is alleged to instruct this administration. ¶48; ¶50 col. 1:53-56
an oil phase comprising medium chain triglycerides... The complaint alleges Mylan's product is designed to copy VTAMA's formulation, which contains these components, to achieve bioequivalence. ¶48; ¶49 col. 11:1-16
a water phase... The accused product is a cream, which is an emulsion necessarily containing a water phase. ¶48 col. 12:40-44
a surfactant...wherein the surfactant comprises at least one non-ionic emulsifying wax NF... The complaint alleges Mylan's product copies the patented formulation, which uses these surfactants to form a stable emulsion. ¶48; ¶49 col. 13:2-10
wherein the oil phase is substantially free of petrolatum and mineral oil... The infringement theory is that to be bioequivalent to VTAMA, the accused product must also be substantially free of these components as claimed. ¶49 col. 28:16-18
wherein the oil-in-water emulsion is homogeneous... Bioequivalence is alleged to require the same structural attributes, including homogeneity. ¶49 col. 4:46-49

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: A central question for claim construction will be the scope of the term "substantially free of petrolatum and mineral oil." The court will need to determine the permissible threshold, if any, for these components. Another question will be the scope of "homogeneous," a qualitative term whose meaning may be disputed based on the patent's examples versus its general definition.
  • Technical Questions: The primary technical dispute will revolve around the concept of bioequivalence. Plaintiffs' case appears to rest on the assertion that for Mylan to prove bioequivalence to the FDA, its product must necessarily have the same or equivalent "physicochemical and structural attributes" as the patented VTAMA product Compl. ¶49 The key question for the court will be whether the specific formulation disclosed in Mylan's ANDA falls within the literal scope or the doctrine of equivalents of the asserted claims, and whether Mylan can be bioequivalent without infringing.

V. Key Claim Terms for Construction

The Term: "substantially free of petrolatum and mineral oil"

  • Context and Importance: This negative limitation is critical for defining the scope of the oil phase in the '160 and '743 patents. The definition will be central to determining literal infringement, as Mylan's formulation may contain small amounts of these common excipients. Practitioners may focus on this term because its ambiguity creates a clear line of dispute over whether the accused product meets the limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., allowing some amount): The use of the word "substantially" suggests that an amount greater than zero is permissible. The specification does not provide a specific numerical cutoff for "substantially free," which may support an argument that the term should be given its plain and ordinary meaning, allowing for non-zero, functionally insignificant amounts.
    • Evidence for a Narrower Interpretation (i.e., a very low or zero amount): In other embodiments, the patent describes formulations containing specific low percentages of petrolatum, such as "≤3%, or ≤2%, or ≤1%" ('160 Patent, col. 3:9-10). Plaintiffs may argue that the choice of "substantially free" in the claim, as opposed to these specific percentages, implies a standard that is even more restrictive, potentially approaching zero.

The Term: "homogeneous"

  • Context and Importance: This term describes the physical state of the final emulsion, a key feature of the claimed invention. Infringement will depend on whether Mylan's product, on a microscopic level, meets this qualitative standard.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a general definition of "homogenous" as "a uniform dispersal of one phase within the other" ('160 Patent, col. 4:46-49). This could support a reading that does not require a specific droplet size or perfect uniformity, but merely a stable mixture.
    • Evidence for a Narrower Interpretation: The patent contrasts "homogeneous" formulations with "non-uniform" emulsions that have "wax-like material" (See '160 Patent, FIG. 1 vs FIG. 2; '160 Patent, col. 2:9-13). A party could argue that "homogeneous" must be defined in opposition to these specific failed examples, requiring a composition that is visually and structurally similar to the successful embodiments depicted and described.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Defendants will induce infringement by providing a product label that copies the VTAMA label and instructs patients and medical practitioners on how to use the ANDA product in an infringing manner Compl. ¶55 Compl. ¶62 Compl. ¶83 Contributory infringement is also alleged, on the basis that Mylan's ANDA Product is a material component of the invention, is especially made for use in an infringing manner, and is not a staple article suitable for substantial non-infringing use Compl. ¶56 Compl. ¶63 Compl. ¶84

Willful Infringement

  • The complaint alleges that Defendants have had knowledge of the patents-in-suit since at least the date they submitted their ANDA, citing Defendants' knowledge of the FDA's Orange Book and their issuance of a Paragraph IV certification notice letter Compl. ¶54 Compl. ¶61 While not using the term "willful," the complaint seeks a finding that the case is "exceptional" and requests attorneys' fees, which is the remedy for willful infringement Compl. prayer ¶w

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

  • A central issue will be one of claim construction and scope: can the term "substantially free of petrolatum and mineral oil," a negative limitation in several key patents, be interpreted to permit the levels of these excipients potentially present in the Defendants' ANDA formulation? The definition of this term, along with other qualitative terms like "homogeneous," will be pivotal in determining literal infringement.
  • A key legal and evidentiary question will be one of bioequivalence versus infringement: The case will likely turn on whether Plaintiffs can prove their central theory that for Defendants to achieve the FDA's bioequivalence standard for a topical cream, their product must necessarily possess the same physicochemical and structural attributes as the patented product, thereby making infringement (either literally or under the doctrine of equivalents) a necessity. Defendants will likely argue that bioequivalence can be achieved without practicing every limitation of the asserted claims.