DCT
0:18-cv-01415
Promius Pharma LLC v. Perrigo Uk FINCO Ltd Partnership
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Promius Pharma LLC (Delaware)
- Defendant: Perrigo UK FINCO Limited Partnership (United Kingdom) and Perrigo Israel Pharmaceuticals Ltd. (Israel)
- Plaintiff’s Counsel: Cozen Oconnor
- Case Identification: 0:18-cv-01415, D. Minn., 05/23/2018
- Venue Allegations: Venue is alleged based on the Minnesota principal place of business of Paddock Laboratories, LLC, the authorized U.S. agent for Defendant Perrigo UK, and on the grounds that the accused generic product is expected to be sold and distributed within the district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's SERNIVO® (betamethasone dipropionate, 0.05%) spray constitutes an act of infringement of four patents under the Hatch-Waxman Act.
- Technical Context: The patents relate to topical, propellant-free, aqueous-based spray emulsion formulations for delivering steroids to treat skin conditions such as plaque psoriasis.
- Key Procedural History: The litigation was triggered by a notice letter dated April 9, 2018, in which Defendant Perrigo UK informed Plaintiff of its ANDA filing containing a Paragraph IV certification, alleging that the patents-in-suit are invalid, unenforceable, or would not be infringed by its proposed generic product. The patents-in-suit are listed in the FDA's "Orange Book" as covering the SERNIVO® product.
Case Timeline
| Date | Event |
|---|---|
| 2009-10-30 | Earliest Priority Date for all Patents-in-Suit |
| 2016-09-13 | U.S. Patent No. 9,439,911 Issues |
| 2017-05-23 | U.S. Patent No. 9,655,907 Issues |
| 2017-10-03 | U.S. Patent No. 9,775,851 Issues |
| 2018-01-30 | U.S. Patent No. 9,877,974 Issues |
| 2018-04-09 | Defendant Perrigo UK sends Paragraph IV Notice Letter to Plaintiff |
| 2018-05-23 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,439,911 - “Topical Formulations Comprising a Steroid,” issued September 13, 2016
The Invention Explained
- Problem Addressed: The patent describes conventional topical steroid treatments (creams, ointments, lotions) as suffering from numerous drawbacks, including being greasy, irritating to the skin (especially those containing alcohol or propylene glycol), staining to clothing, and difficult to apply uniformly. Pressurized aerosol formulations are described as costly and having a negative environmental impact. (’911 Patent, col. 3:36-col. 4:24).
- The Patented Solution: The invention is a pharmaceutical topical spray composition that is propellant-free, substantially non-foaming, and based on an aqueous emulsion. This formulation is designed to provide improved delivery of a steroid active agent to the desired site of action with greater patient comfort and compliance, while enabling sustained release of the drug for a longer duration of action. (’911 Patent, Abstract; col. 4:16-24, col. 6:5-10).
- Technical Importance: The formulation provides a patient-friendly alternative to existing topical steroid delivery methods by avoiding common irritants and the disadvantages of pressurized aerosol systems. (’911 Patent, col. 4:16-24).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 and method claim 29 (which incorporates the composition of claim 1) (Compl. ¶¶43-44).
- Essential Elements of Independent Claim 1:
- A sprayable topical pharmaceutical composition comprising: at least one steroid;
- a non-polymeric emulsifying agent comprising sorbitan stearate;
- water; and
- a water-immiscible substance;
- wherein the composition is substantially non-occlusive to the skin.
- The complaint notes that Defendant's notice letter did not allege non-infringement of numerous claims, including 1-3, 6-9, 11-17, 20-22, and 24-30 (Compl. ¶45).
U.S. Patent No. 9,655,907 - “Topical Formulations Comprising a Steroid,” issued May 23, 2017
The Invention Explained
- Problem Addressed: As with the related ’911 Patent, the technology addresses the patient compliance and formulation stability issues associated with conventional topical steroid products, such as skin irritation from alcohol, high cost of propellant systems, and the greasy or inconvenient nature of creams and ointments. (’907 Patent, col. 3:40-col. 4:24).
- The Patented Solution: The patent describes a topical spray formulation that is an aqueous-based emulsion containing a steroid, a polymer, and a penetration enhancer. The formulation is specifically designed to be substantially free of both propellants and propylene glycol, aiming to improve drug delivery and patient comfort while maintaining stability. (’907 Patent, Abstract; col. 6:15-18).
- Technical Importance: The invention offers a method for creating a stable, effective, and non-irritating steroid spray without relying on common formulation components like propellants or propylene glycol, which are known to have drawbacks. (’907 Patent, col. 4:16-24).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 8 (Compl. ¶64).
- Essential Elements of Independent Claim 8:
- A sprayable topical pharmaceutical composition, comprising: a steroid;
- an emulsifying agent;
- a polymer;
- water;
- a water-immiscible substance; and
- a penetration enhancer;
- wherein said composition is substantially free of a propellant and propylene glycol.
U.S. Patent No. 9,775,851 - “Topical Formulations Comprising a Steroid,” issued October 3, 2017
Technology Synopsis
This patent is part of the same family as the ’911 and ’907 patents and is directed to similar technology. It describes stable, propellant-free, aqueous-based emulsion spray formulations for delivering steroids to treat skin disorders, with a focus on achieving sustained drug release and improved patient compliance by avoiding common irritants. (’851 Patent, Abstract; col. 4:16-24).
Asserted Claims
The complaint asserts infringement of at least independent claim 1 and independent claim 6 (Compl. ¶83).
Accused Features
The accused instrumentality is Defendants' proposed generic betamethasone dipropionate, 0.05%, spray product as described in ANDA No. 211540 (Compl. ¶77).
U.S. Patent No. 9,877,974 - “Topical Formulations Comprising a Steroid,” issued January 30, 2018
Technology Synopsis
Also a member of the same patent family, this patent discloses topical steroid formulations for administration as a propellant-free and non-foaming spray. The invention aims to solve problems of skin irritation, cost, and environmental impact associated with prior art formulations for treating conditions like psoriasis. (’974 Patent, Abstract; col. 4:16-24).
Asserted Claims
The complaint asserts infringement of at least independent claim 1 and independent claim 10 (Compl. ¶103).
Accused Features
The accused instrumentality is Defendants' proposed generic betamethasone dipropionate, 0.05%, spray product as described in ANDA No. 211540 (Compl. ¶97).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is the "proposed generic betamethasone dipropionate, 0.05%, spray product described in Perrigo UK's ANDA No. 211540" (Compl. ¶38).
- Functionality and Market Context: The product is a generic version of Plaintiff’s SERNIVO® spray, intended for the topical treatment of plaque psoriasis (Compl. ¶¶28, 34). The complaint alleges that by filing its ANDA, Defendants are asserting that their proposed generic product is bioequivalent to SERNIVO® (Compl. ¶33). The complaint does not provide specific details of the generic product's formulation, as that information is contained within the confidential ANDA. The infringement allegation is predicated on the act of filing the ANDA itself under 35 U.S.C. § 271(e)(2).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’911 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A sprayable topical pharmaceutical composition, comprising: at least one steroid | The ANDA product is alleged to be a sprayable topical formulation containing the steroid betamethasone dipropionate. | ¶38 | col. 2:16-19 |
| a non-polymeric emulsifying agent comprising sorbitan stearate | The ANDA product is alleged to be a generic equivalent of the branded product covered by the patent and is therefore alleged to contain a non-polymeric emulsifying agent comprising sorbitan stearate. | ¶38 | col. 9:40-43 |
| water | The ANDA product is alleged to be an aqueous-based formulation and to contain water. | ¶38 | col. 9:11-14 |
| a water-immiscible substance | The ANDA product is alleged to be an emulsion that contains a water-immiscible substance. | ¶38 | col. 12:31-44 |
| wherein the composition is substantially non-occlusive to the skin | The ANDA product is alleged to be bioequivalent to the branded product and thus to possess the claimed property of being substantially non-occlusive. | ¶38 | col. 8:12-13 |
’907 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A sprayable topical pharmaceutical composition, comprising: a steroid | The ANDA product is alleged to be a sprayable topical formulation containing the steroid betamethasone dipropionate. | ¶59 | col. 2:16-19 |
| an emulsifying agent | The ANDA product is alleged to be a generic equivalent of the branded product covered by the patent and is therefore alleged to contain an emulsifying agent. | ¶59 | col. 9:22-58 |
| a polymer | The ANDA product is alleged to contain a polymer as part of its formulation. | ¶59 | col. 9:21-39 |
| water | The ANDA product is alleged to be an aqueous-based formulation and to contain water. | ¶59 | col. 9:11-14 |
| a water-immiscible substance | The ANDA product is alleged to be an emulsion that contains a water-immiscible substance. | ¶59 | col. 12:31-44 |
| a penetration enhancer | The ANDA product is alleged to contain a penetration enhancer. | ¶59 | col. 10:46-65 |
| wherein said composition is substantially free of a propellant and propylene glycol | The ANDA product is alleged to be a propellant-free and propylene glycol-free formulation, consistent with the SERNIVO® product it seeks to copy. | ¶59 | col. 7:30-34; 8:14-18 |
Identified Points of Contention
- Evidentiary Questions: The central issue will be a factual comparison of the specific, confidential formulation disclosed in Defendants' ANDA with the elements of the asserted claims. The complaint does not provide this formulation. The key question will be whether the specific excipients used in the accused product (e.g., the emulsifier, the polymer, the penetration enhancer) fall within the scope of the corresponding claim limitations.
- Scope Questions: The dispute may turn on the construction of terms of degree. For the ’911 Patent, a question is what objective criteria define a composition as "substantially non-occlusive to the skin." For the ’907 Patent, a question is what criteria define a composition as "substantially free" of propellants and propylene glycol.
V. Key Claim Terms for Construction
The Term: "substantially non-occlusive to the skin" (’911 Patent, Claim 1)
Context and Importance
This limitation defines a key functional property of the claimed composition. The scope of this term is critical because infringement will depend on whether the accused product exhibits this property, which may require objective measurement and comparison. Practitioners may focus on this term because its definition is not quantitatively defined in the patent, leaving it open to interpretation.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification mentions this property but does not provide a precise numerical range or test for measuring "non-occlusivity" (’911 Patent, col. 8:12-13). This may support an argument for applying the term's plain and ordinary meaning.
- Evidence for a Narrower Interpretation: A party could argue that the term should be defined by the properties of the specific formulations disclosed in the patent's examples, potentially limiting the claim's scope to compositions with similar performance characteristics.
The Term: "penetration enhancer" (’907 Patent, Claim 8)
Context and Importance
Infringement of the ’907 patent requires the presence of this ingredient. The dispute will likely focus on whether the specific excipient(s) used in the accused product function as a "penetration enhancer" within the meaning of the patent.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification defines a "penetration enhancer" broadly as a "component used to enhance the penetration rate of drugs through the skin" and provides an extensive, non-limiting list of chemical classes and specific examples, such as diethylene glycol monoethyl ether (’907 Patent, col. 10:46-65).
- Evidence for a Narrower Interpretation: A party may argue that a substance with multiple functions (e.g., a solvent that also incidentally enhances penetration) does not qualify if its primary purpose in the formulation is not penetration enhancement. The interpretation could also be limited by the concentrations disclosed in the patent (e.g., "about 3-10%") (’907 Patent, col. 6:52-53).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement against all patents-in-suit. The basis for this allegation is that Defendants intend for their generic product to be used in accordance with a label that will "substantially copy the instructions for use accompanying SERNIVO®," thereby instructing and encouraging healthcare providers and patients to administer the product in an infringing manner for the treatment of plaque psoriasis (Compl. ¶¶34, 44, 46, 83, 103).
- Willful Infringement: The complaint alleges that Defendants have "knowingly and willfully" infringed the patents-in-suit (Compl. ¶¶50, 68, 88, 109). The basis for knowledge includes the patents' listing in the FDA Orange Book and Defendants' submission of a Paragraph IV certification, which required a review of the patents (Compl. ¶¶26, 29, 32). The complaint further alleges that the legal and factual bases for non-infringement and invalidity in Defendants' notice letter are "devoid of an objective good-faith basis" (Compl. ¶¶52, 70, 90, 111).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary comparison: once the confidential formulation from Defendants' ANDA is produced in discovery, does it contain each and every element of the asserted claims? The case will turn on a technical, ingredient-by-ingredient analysis comparing the accused formulation to the patent claims.
- A second core issue will be one of definitional scope: can functional and descriptive terms like "substantially non-occlusive" and "penetration enhancer" be defined with sufficient clarity to determine infringement? The outcome may depend on whether the court adopts a broad, plain-meaning construction of these terms or limits them to the specific properties and compounds detailed in the patent's examples.