DCT

2:18-cv-00219

Promius Pharma LLC v. Perrigo Uk FINCO Ltd Partnership

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: [Promius Pharma LLC](https://ai-lab.exparte.com/party/promius-pharma-llc) v. [Perrigo UK FINCO Limited Partnership](https://ai-lab.exparte.com/party/perrigo-uk-finco-ltd), et al., 2:18-cv-00219, E.D. Tex., 05/22/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendants, upon receiving FDA approval, intend to manufacture, market, and sell their generic products throughout the United States, including within the district. The complaint also alleges Defendants derive substantial revenue from existing product sales in the district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of Abbreviated New Drug Applications (ANDAs) to the FDA seeking to market generic versions of Plaintiff's SERNIVO® spray product constitutes an act of infringement of six patents related to topical steroid formulations.
  • Technical Context: The technology concerns aqueous, propellant-free, sprayable emulsion formulations for delivering topical corticosteroids, such as betamethasone dipropionate, to treat skin conditions like psoriasis.
  • Key Procedural History: The patents-in-suit are listed in the FDA's "Orange Book" as covering Plaintiff's SERNIVO® product. The litigation was triggered by Defendants sending "Notice Letters" to Plaintiff, certifying under Paragraph IV of the Hatch-Waxman Act that their proposed generic products would not infringe the patents-in-suit or that the patents are invalid. This action was filed within the 45-day statutory window following receipt of those letters.

Case Timeline

Date Event
2009-10-30 Earliest Priority Date for all Patents-in-Suit
2016-06-14 U.S. Patent No. 9,364,485 Issued
2016-09-06 U.S. Patent No. 9,433,630 Issued
2016-09-13 U.S. Patent No. 9,439,911 Issued
2017-05-23 U.S. Patent No. 9,655,907 Issued
2017-10-03 U.S. Patent No. 9,775,851 Issued
2018-01-30 U.S. Patent No. 9,877,974 Issued
2018-04-09 Perrigo UK sends Notice Letter to Plaintiff
2018-04-10 Taro sends Notice Letter to Plaintiff
2018-05-22 Complaint Filed

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

U.S. Patent No. 9,364,485 - Topical Formulations Comprising a Steroid

Issued June 14, 2016.

The Invention Explained

  • Problem Addressed: The patent describes drawbacks of conventional topical steroid treatments for skin conditions like psoriasis, noting they are often greasy, irritating (due to components like alcohol or propylene glycol), difficult to apply, or delivered via costly and environmentally undesirable propellants (’485 Patent, col. 3:19-53). Conventional formulations may also lead to poor patient compliance due to their aesthetic and physical properties (e.g., foam formation) ('485 Patent, col. 3:54-57).
  • The Patented Solution: The invention is a sprayable, aqueous-based topical emulsion that is propellant-free and substantially non-foaming ('485 Patent, Abstract). This formulation is designed to improve the delivery of the steroid to the skin, enhance patient comfort and compliance, and provide sustained release of the active agent, thereby creating a more effective and user-friendly treatment ('485 Patent, col. 4:3-9; col. 6:5-12).
  • Technical Importance: The formulation aims to solve the dual problems of patient compliance and effective drug delivery in topical treatments for chronic skin disorders.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 against Defendant Taro (Compl. ¶143).
  • The essential elements of Claim 1 are:
    • A sprayable topical pharmaceutical composition comprising a steroid.
    • A non-polymeric emulsifying agent comprising sorbitan stearate.
    • A polymer selected from a group including cellulose, a gum, an alginate, and a phthalate.
    • Water.
    • A water-immiscible substance.
    • A penetration enhancer.
    • The composition is substantially free of a propellant, an alcohol, and propylene glycol.
    • The composition forms droplets upon application and is substantially non-foaming and substantially non-occlusive to the skin.

U.S. Patent No. 9,433,630 - Topical Formulations Comprising a Steroid

Issued September 6, 2016.

The Invention Explained

  • Problem Addressed: Similar to the '485 Patent, this patent addresses the challenges associated with existing topical steroid formulations, including skin irritation, poor aesthetics (greasiness, foaming), inconvenient application, and the use of propellants (’630 Patent, col. 3:32-62). These issues can negatively impact patient compliance and treatment outcomes ('630 Patent, col. 4:11-15).
  • The Patented Solution: The patent discloses a propellant-free, substantially non-occlusive topical spray composition for delivering a steroid ('630 Patent, Abstract). The formulation is designed as an aqueous-based emulsion that avoids common irritants, improves the feel on the skin, and allows for convenient application, thereby aiming to increase the ease of use and effectiveness of the treatment ('630 Patent, col. 4:21-27).
  • Technical Importance: The invention provides an alternative formulation for topical steroid delivery that prioritizes patient comfort and ease of use, which are critical factors in managing chronic conditions requiring long-term treatment.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1 and dependent Claim 24 against Defendant Taro (Compl. ¶162, 163).
  • The essential elements of Claim 1 are:
    • A sprayable topical pharmaceutical composition with an active agent consisting of at least one steroid.
    • A non-polymeric emulsifying agent comprising sorbitan stearate.
    • A polymer selected from a group including a cellulose, a gum, an alginate, and a phthalate.
    • Water.
    • A water-immiscible substance.
    • The composition is substantially free of a propellant and propylene glycol.
    • The composition is substantially non-occlusive to the skin.

Multi-Patent Capsule: U.S. Patent No. 9,439,911

  • Patent Identification: U.S. Patent No. 9,439,911, Topical Formulations Comprising a Steroid, issued September 13, 2016 (Compl. ¶28).
  • Technology Synopsis: This patent, from the same family as the lead patents, discloses sprayable, propellant-free, non-foaming, and non-occlusive topical compositions containing a steroid. The invention is directed at improving patient compliance and drug delivery for skin disorders by providing a more user-friendly formulation (’911 Patent, Abstract; col. 4:2-9).
  • Asserted Claims: At least Claim 1 and Claim 29 are asserted against Defendants Perrigo UK and Perrigo Israel (Compl. ¶63, 64).
  • Accused Features: The accused instrumentality is Perrigo's proposed generic betamethasone dipropionate, 0.05%, spray product described in ANDA No. 211540 (Compl. ¶58).

Multi-Patent Capsule: U.S. Patent No. 9,655,907

  • Patent Identification: U.S. Patent No. 9,655,907, Topical Formulations Comprising a Steroid, issued May 23, 2017 (Compl. ¶30).
  • Technology Synopsis: This patent also relates to propellant-free topical steroid spray formulations designed to be non-foaming and non-occlusive. The technology aims to overcome the drawbacks of conventional creams, ointments, and aerosol foams by providing a formulation that is less irritating and more convenient to apply (’907 Patent, Abstract; col. 3:32-54).
  • Asserted Claims: At least Claim 8 is asserted against Defendants Perrigo UK and Perrigo Israel (Compl. ¶84, 85).
  • Accused Features: The accused instrumentality is Perrigo's proposed generic betamethasone dipropionate, 0.05%, spray product described in ANDA No. 211540 (Compl. ¶79).

Multi-Patent Capsule: U.S. Patent No. 9,775,851

  • Patent Identification: U.S. Patent No. 9,775,851, Topical Formulations Comprising a Steroid, issued October 3, 2017 (Compl. ¶32).
  • Technology Synopsis: This patent describes topical spray compositions comprising a steroid in a propellant-free, substantially non-foaming aqueous emulsion. The formulation seeks to enhance patient compliance and provide improved delivery of the active agent for treating skin disorders like psoriasis (’851 Patent, Abstract; col. 6:5-12).
  • Asserted Claims: At least Claim 1 and Claim 6 are asserted against Defendants Perrigo UK and Perrigo Israel (Compl. ¶102, 103).
  • Accused Features: The accused instrumentality is Perrigo's proposed generic betamethasone dipropionate, 0.05%, spray product described in ANDA No. 211540 (Compl. ¶97).

Multi-Patent Capsule: U.S. Patent No. 9,877,974

  • Patent Identification: U.S. Patent No. 9,877,974, Topical Formulations Comprising a Steroid, issued January 30, 2018 (Compl. ¶34).
  • Technology Synopsis: Continuing the themes of the patent family, this patent discloses topical, sprayable, propellant-free steroid formulations. The invention is designed as a non-foaming, non-occlusive emulsion to provide a more convenient and less irritating treatment option for skin diseases (’974 Patent, Abstract; col. 4:2-9).
  • Asserted Claims: At least Claim 1 and Claim 10 are asserted against Defendants Perrigo UK and Perrigo Israel (Compl. ¶122, 123).
  • Accused Features: The accused instrumentality is Perrigo's proposed generic betamethasone dipropionate, 0.05%, spray product described in ANDA No. 211540 (Compl. ¶117).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are the "Proposed Generic Betamethasone Dipropionate, 0.05%, Spray Product" described in ANDA No. 211540, submitted by Perrigo UK, and the "Proposed Generic Betamethasone Dipropionate, 0.05%, Spray Product" described in ANDA No. 211722, submitted by Taro (Compl. ¶40, 49).
  • Functionality and Market Context: The complaint alleges that the proposed products are generic versions of Plaintiff's SERNIVO® spray, intended for the treatment of mild to moderate plaque psoriasis (Compl. ¶2, 40, 49). It is alleged that upon FDA approval, these products will be sold with instructions for use that substantially copy the instructions for SERNIVO® (Compl. ¶46, 54). The complaint further asserts that Defendants claim their respective products are bioequivalent to SERNIVO® (Compl. ¶45, 53). As generic products, they are positioned to compete directly with SERNIVO® in the U.S. market.
    No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element comparison of the accused products to the asserted claims, as is common in ANDA litigation where the specifics of the proposed generic formulation are confidential. The infringement theory is based on the statutory act of filing an ANDA for a drug claimed in a patent (Compl. ¶59, 80, 98, 118, 139, 158). The complaint alleges that the products described in ANDA No. 211540 and ANDA No. 211722 are covered by one or more claims of each of the patents-in-suit, and that their future manufacture and sale will constitute direct and indirect infringement (Compl. ¶58, 62-64, 138, 143-144).

  • Identified Points of Contention:
    • Scope Questions: The dispute may turn on whether the specific formulations detailed in the confidential ANDA filings fall within the scope of the claims. A key question for the court will be whether the specific emulsifiers, polymers, and other excipients used by Defendants are the same as or equivalent to those required by the claims, such as the "non-polymeric emulsifying agent comprising sorbitan stearate" recited in Claim 1 of the '485 and '630 patents.
    • Technical Questions: A central technical question will be one of functional properties: do the Defendants' proposed formulations exhibit the claimed characteristics of being "substantially non-foaming" and "substantially non-occlusive to the skin"? The evidence regarding these physical properties and the court's interpretation of these functional limitations may be dispositive.

V. Key Claim Terms for Construction

  • The Term: "substantially non-foaming"

  • Context and Importance: This term is critical for distinguishing the claimed invention from prior art aerosol foam products. Practitioners may focus on this term because infringement could hinge on whether the amount of foam generated by the accused products is considered "substantial." The absence of a quantitative metric in the patent for what constitutes "substantial" foam creates a potential point of dispute.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification does not provide a precise numerical cutoff for foam volume or stability, which may support an interpretation based on the plain and ordinary meaning as understood by a person of ordinary skill in the art.
    • Evidence for a Narrower Interpretation: The specification contrasts the invention with formulations that "cause substantial foam formation upon spraying onto the skin, which is highly undesirable to a patient" ('485 Patent, col. 3:54-57). Defendants may argue this language implies that any amount of foam that would be aesthetically undesirable to a patient is "substantial," potentially narrowing the claim scope.

  • The Term: "substantially non-occlusive to the skin"

  • Context and Importance: This functional limitation is presented as a key benefit, allowing the skin to "breathe." The infringement analysis will require a determination of whether the accused products create a film on the skin that is considered occlusive.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent describes the benefit as "allowing 'breathing' of the skin" ('485 Patent, col. 14:16-17), a qualitative description that could support a broad, functional interpretation.
    • Evidence for a Narrower Interpretation: The patent does not define a specific test or threshold for measuring occlusivity (e.g., transepidermal water loss). This may lead Defendants to argue for a narrow construction based on technical definitions that their products do not meet.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement against all Defendants. The inducement theory is based on the allegation that Defendants' proposed product labels will instruct healthcare providers and patients to administer the generic products for the treatment of plaque psoriasis, thereby directing them to perform the infringing use (Compl. ¶46, 54, 66, 104). The contributory infringement theory alleges that the proposed products are especially made or adapted for this infringing use and are not suitable for substantial non-infringing use (Compl. ¶67, 105).
  • Willful Infringement: The complaint alleges willful infringement against all Defendants. The basis for this allegation is Defendants' pre-suit knowledge of the patents, evidenced by their filing of ANDAs containing Paragraph IV certifications against the patents-in-suit listed in the Orange Book (Compl. ¶44, 52, 70, 88). The complaint further alleges that the legal and factual bases for non-infringement and invalidity asserted in Defendants' notice letters are "devoid of an objective good-faith basis" (Compl. ¶72, 90).

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

  • A core issue will be one of factual correspondence: do the specific, confidential formulations described in Perrigo’s and Taro’s ANDA submissions meet every limitation of the asserted claims? The outcome will depend on evidence concerning the precise chemical composition and measured physical properties of the proposed generic products.
  • A second key issue will be one of definitional scope: how will the court construe the functional limitations "substantially non-foaming" and "substantially non-occlusive"? The breadth of these definitions will be critical in determining whether Defendants' formulations, which may have minor differences from the patented embodiment, fall within the scope of the claims.
  • Finally, a central question will be one of validity: can the Defendants prove by clear and convincing evidence that the asserted claims are invalid, as they asserted in their Paragraph IV notice letters? The strength of the prior art and arguments regarding obviousness or anticipation will be a primary focus of the defense.