DCT

1:16-cv-01565

Medicis Pharmaceutical Corp v. Zydus Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-01565, D.N.J., 03/21/2016
  • Venue Allegations: Venue is asserted based on Defendant Zydus USA’s principal place of business in the District of New Jersey and because the district is a likely destination for the accused generic product.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Vanos® (fluocinonide topical cream, 0.1%) constitutes an act of infringement of four patents covering the drug's formulation and methods of use.
  • Technical Context: The technology concerns pharmaceutical vehicle formulations designed to enhance the potency and skin penetration of topical corticosteroids, a widely used class of anti-inflammatory drugs.
  • Key Procedural History: This is a Hatch-Waxman action filed in response to a Paragraph IV certification notice letter from Zydus. The patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" for the approved brand-name drug, Vanos®, which signifies the patents cover the approved drug product or its methods of use.

Case Timeline

Date Event
2001-12-21 Earliest Priority Date for all Patents-in-Suit (’001, ’424, ’738, ’264)
2004-07-20 U.S. Patent No. 6,765,001 Issued
2005-02-11 FDA Approves New Drug Application for Vanos®
2007-05-22 U.S. Patent No. 7,220,424 Issued
2010-09-14 U.S. Patent No. 7,794,738 Issued
2012-07-31 U.S. Patent No. 8,232,264 Issued
2016-02-05 Zydus sends Notice of Certification letter to Medicis
2016-03-21 Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 6,765,001 - “Compositions and Methods for Enhancing Corticosteroid Delivery,” Issued July 20, 2004

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of increasing the clinical potency of topical corticosteroids. It notes that the effectiveness of such drugs is strongly influenced by the "vehicle"—the formulation carrying the active ingredient—and its ability to facilitate absorption into the skin (’001 Patent, col. 3:13-26).
  • The Patented Solution: The invention is a novel pharmaceutical vehicle that enhances the potency of a corticosteroid. The solution is not a new drug, but a specific formulation comprising at least two "penetration enhancers" (such as propylene glycol and dimethyl isosorbide) that are present in a high ratio relative to the total amount of enhancers, solvents, and emulsifiers (’001 Patent, Abstract; col. 3:59-65). This specific ratio is described as producing an unexpected increase in the drug's potency.
  • Technical Importance: This technology provides a way to increase the therapeutic effect of a known drug, potentially allowing a formulation to be classified in a higher potency class without chemically altering the active pharmaceutical ingredient itself (’001 Patent, col. 4:32-35).

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶26). Independent claim 1 is representative of the composition claims.
  • Essential Elements of Claim 1:
    • A composition comprising fluocinonide.
    • Two or more penetration enhancers selected from the group consisting of diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexanetriol, and benzyl alcohol.
    • One or more solvents and emulsifiers.
    • The penetration enhancers are present in a ratio to the total of the penetration enhancers, solvents, and emulsifiers of at least about 0.90.
  • The complaint does not specify any dependent claims but reserves the right to assert them.

U.S. Patent No. 7,220,424 - “Compositions and Methods for Enhancing Corticosteroid Delivery,” Issued May 22, 2007

The Invention Explained

  • Problem Addressed: As a divisional of the application leading to the '001 Patent, this patent addresses the same technical problem: enhancing the delivery and potency of topical corticosteroids ('424 Patent, col. 2:4-10).
  • The Patented Solution: This patent claims a method of delivering a corticosteroid to the skin. The method consists of topically applying the specific formulation described in the '001 Patent, which is characterized by its high ratio of at least two penetration enhancers to other vehicle components (’424 Patent, col. 7:6-18). The core inventive concept remains the specific vehicle composition that enhances drug delivery.
  • Technical Importance: The patent protects the act of using the novel formulation for treatment, complementing the composition claims of the parent '001 Patent.

Key Claims at a Glance

  • The complaint asserts infringement of at least one claim (Compl. ¶36). Independent claim 1 is representative of the method claims.
  • Essential Elements of Claim 1:
    • A method of delivering corticosteroids to skin comprising:
    • Topically applying a composition that contains one or more corticosteroids.
    • The composition also contains two or more penetration enhancers (from the same list as in the '001 Patent) and one or more solvents/emulsifiers.
    • The penetration enhancers are present in a ratio to the total of the enhancers, solvents, and emulsifiers of at least about 0.90.
  • The complaint does not specify any dependent claims but reserves the right to assert them.

U.S. Patent No. 7,794,738 - “Compositions and Methods for Enhancing Corticosteroid Delivery,” Issued September 14, 2010

  • Technology Synopsis: This patent, part of the same family, claims methods for delivering corticosteroids. It focuses on the topical application of a composition containing a high concentration of specific penetration enhancers (such as propylene glycol) relative to other vehicle ingredients to increase the drug's potency and percutaneous absorption (’738 Patent, col. 9:60–col. 10:11).
  • Asserted Claims: At least one claim is asserted (Compl. ¶46).
  • Accused Features: The formulation of Zydus’s generic fluocinonide topical cream, which, upon FDA approval, would be used according to the claimed methods (Compl. ¶46-48).

U.S. Patent No. 8,232,264 - “Compositions and Methods for Enhancing Corticosteroid Delivery,” Issued July 31, 2012

  • Technology Synopsis: This patent, also in the same family, claims compositions containing a corticosteroid. The invention lies in the specific vehicle formulation, which requires at least two penetration enhancers (e.g., propylene glycol, dimethyl isosorbide) to be present in a ratio of at least 0.9 relative to the vehicle's other solvents and emulsifiers, thereby enhancing drug potency (’264 Patent, col. 9:18–col. 10:4).
  • Asserted Claims: At least one claim is asserted (Compl. ¶56).
  • Accused Features: The formulation of Zydus’s generic fluocinonide topical cream, which is alleged to contain the claimed composition (Compl. ¶56-58).

III. The Accused Instrumentality

Product Identification

  • "Zydus's generic fluocinonide topical cream, 0.1%," as described in ANDA No. 208-989 (Compl. ¶6, 19).

Functionality and Market Context

  • The accused product is a topical cream intended to be a generic substitute for Plaintiffs' brand-name drug, Vanos® (Compl. ¶20, 22). As a corticosteroid, its function is to provide anti-inflammatory and anti-pruritic effects when applied to the skin. The complaint alleges that the formulation of the accused generic product is "the same, or substantially the same, as Vanos®" (Compl. ¶23). In the context of ANDA litigation, this allegation is the foundation of the infringement claim, as it implies the generic product will have the same formulation that is protected by the Orange Book-listed patents.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or specific evidence of the accused product's formulation. The infringement theory is based on the statutory framework of 35 U.S.C. § 271(e)(2), where the filing of the ANDA is the act of infringement, and the allegation that the proposed generic product is the same as the patented Vanos® product (Compl. ¶23).

'001 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition comprising...fluocinonide; The accused product is identified as "Zydus's generic fluocinonide topical cream, 0.1%." ¶6, 22 col. 8:23-26
Two or more penetration enhancers selected from the group consisting of diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexapetriol, and benzyl alcohol; The complaint alleges the accused generic is intended to be a version of Vanos® and is the same or substantially the same, implying its formulation contains the same claimed penetration enhancers as the patented brand-name product. ¶23, 27 col. 8:27-33
one or more of the group consisting of solvents and emulsifiers... The complaint alleges the accused generic is the same or substantially the same as Vanos®, implying its formulation contains the same claimed solvents and emulsifiers as the patented brand-name product. ¶23, 27 col. 8:49-59
wherein the penetration enhancers are present in a ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90. By alleging the accused generic product is the same as Vanos®, the complaint implies that the formulation of the generic product meets the claimed ratio, which is a feature of the patented Vanos® formulation. ¶23, 27 col. 8:33-37

'424 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of delivering corticosteroids to skin comprising: Topically applying a composition... The accused product is a "topical cream." The product's future label and instructions for use will allegedly direct medical professionals and patients to topically apply the cream, thereby inducing infringement of the method. ¶37, 38 col. 7:6-8
[composition comprising one or more corticosteroids with two or more penetration enhancers...and a ratio...of at least about 0.90] As described above for the '001 Patent, the complaint alleges the formulation of the accused generic product is the same or substantially the same as the patented Vanos® product, and therefore meets the compositional requirements of the claimed method. ¶23, 37 col. 7:9-18

Identified Points of Contention

  • Factual Question: The central dispute will be factual: does the precise formulation submitted in Zydus’s ANDA actually meet all the limitations of the asserted claims? Specifically, discovery will focus on whether the generic formulation contains the claimed penetration enhancers and, most critically, whether the ingredients meet the claimed ratio of "at least about 0.90."
  • Scope Question: A potential dispute may arise over the meaning of "the same, or substantially the same" (Compl. ¶23). While this may be sufficient for an initial pleading, the legal question for infringement is not bioequivalence but whether the accused formulation literally meets every element of the asserted claims. The case will depend on the actual ingredients and their percentages in Zydus's ANDA, not on the FDA's regulatory assessment of equivalence.

V. Key Claim Terms for Construction

  • The Term: "penetration enhancers"

  • Context and Importance: This term is foundational to the invention. The claims recite a specific list of chemicals as penetration enhancers. Practitioners may focus on this term because the infringement analysis depends entirely on which ingredients in the accused formulation are classified as "penetration enhancers" for the purpose of calculating the claimed ratio. If Zydus's formulation uses a chemically similar but unlisted substance, the question of whether the list is exhaustive will be dispositive.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the invention as using "at least two penetration enhancers" and then provides examples, which a party might argue are illustrative rather than limiting ('001 Patent, col. 3:65–col. 4:2).
    • Evidence for a Narrower Interpretation: Claim 1 of the '001 Patent uses the phrase "selected from the group consisting of," followed by a specific list of five chemicals. This language is typically interpreted in patent law as creating a closed group, meaning no other unlisted substances can be considered a "penetration enhancer" for the purposes of that claim.

  • The Term: "a ratio...of at least about 0.90"

  • Context and Importance: The claimed numerical ratio is the key feature that allegedly provides the "unexpected increase in potency" ('001 Patent, col. 5:21-23). The case will turn on how this ratio is calculated. The definitions of "penetration enhancers," "solvents," and "emulsifiers" are critical, as an ingredient's classification determines whether it is part of the numerator or denominator (or neither), directly impacting the final calculated ratio.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (supporting Plaintiff): The patent provides examples of formulations where the ratio is calculated and results in a high vasoscore, linking the ratio to potency ('001 Patent, Table 2; col. 6:26-35). A party would argue that any calculation method consistent with these examples is appropriate. The term "about" also provides some flexibility at the boundary of the 0.90 value.
    • Evidence for a Narrower Interpretation (supporting Defendant): A party could argue that for an ingredient to be a "solvent" or "emulsifier," that must be its primary function in the formulation. If an ingredient (e.g., propylene glycol) acts as both a penetration enhancer and a solvent, a dispute will arise as to how it should be treated in the ratio calculation, a question the patent does not explicitly resolve. The patent lists examples of solvents and emulsifiers, which could be argued to be a limiting set for definitional purposes ('001 Patent, col. 8:49-59).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will contributorily infringe and induce infringement of the asserted claims (Compl. ¶28, 38, 48, 58). For the method claims ('424 and '738 Patents), the inducement theory is central. It is based on the allegation that Defendants will market the generic cream with a product label and instructions that will inevitably lead doctors and patients to topically apply the cream, thus performing the steps of the patented methods.
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, the prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which would entitle Plaintiffs to an award of attorney's fees (Compl. p. 12, ¶8). Such a finding is often predicated on willful infringement or other litigation misconduct. The Defendants' knowledge of the patents is established, at minimum, by the filing of the lawsuit.

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

  • A core issue will be one of factual proof: does the specific formulation in Zydus's confidential ANDA submission contain the combination of ingredients that, when categorized, meets the numerical ratio of "at least about 0.90" as required by the independent claims? The outcome of the case hinges on the answer to this technical question, which will be revealed during discovery.
  • A second key issue will be one of claim construction: how should ingredients with multiple pharmaceutical functions be categorized? The court's definition of "penetration enhancer," "solvent," and "emulsifier," and its guidance on how to classify an ingredient like propylene glycol that can serve as both, will be determinative in calculating the claimed ratio and resolving the question of infringement.
  • Finally, for the method patents, a central question will be one of induced infringement: assuming the generic formulation is found to be infringing, will the evidence show that Zydus's proposed product label provides sufficient instruction and encouragement for users to apply the product in a manner that performs all steps of the claimed methods, thereby establishing the requisite intent for inducement?