Virility Medical Ltd v. Morari Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Virility Medical Ltd. (Israel)
  • Defendant: Morari, Inc. (Delaware)
  • Plaintiff’s Counsel: Stevens & Lee
• Case Identification: 1:25-cv-00338, D. Del., 03/18/2025
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Morari, Inc. is a Delaware corporation.
• Core Dispute: Plaintiff alleges that Defendant’s MOR wearable neurostimulation device infringes three patents related to transcutaneous electrical muscle stimulation for treating premature ejaculation.
• Technical Context: The technology involves wearable, non-pharmacological medical devices that use electrical stimulation to address sexual dysfunction, an area of significant activity in the consumer health market.
• Key Procedural History: The complaint alleges that Defendant Morari, Inc. cited Plaintiff’s FDA-approved "vPatch" product as a predicate device in its own 510(k) submission to the FDA. It further alleges that Morari cited the earliest-issued patent-in-suit as prior art during the prosecution of its own patent application and received a pre-suit notice letter from Plaintiff identifying two of the three asserted patents.

Case Timeline

Date	Event
2015-11-25	Earliest Priority Date ('072, '666, '289 Patents)
2016	Virility Medical founded
2020-09-15	U.S. Patent No. 10,773,072 Issued
2021-03-10	Morari receives Int'l Search Report citing '072 Patent
2021-11-23	Virility Medical's vPatch receives De Novo FDA grant
2022-06-27	Morari submits IDS citing '072 Patent in its own patent prosecution
2022-10-18	U.S. Patent No. 11,471,666 Issued
2023-05-01	Virility Medical's in2 product receives 510(k) FDA grant
2024-03-06	Virility Medical sends notice letter to Morari
2025-01-14	U.S. Patent No. 12,194,289 Issued
2025-02-13	Morari's MOR product receives FDA clearance
2025-02-17	Morari begins offering MOR product for sale
2025-03-18	Complaint Filed

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

U.S. Patent No. 10,773,072 - “Transcutaneous Electrical Muscle Stimulation Device For The Treatment Of Premature Ejaculation Or Erectile Dysfunction, And Methods Of Use Thereof”

The Invention Explained

• Problem Addressed: The patent background identifies existing treatments for premature ejaculation such as SSRIs and botulinum neurotoxin, implying a need for an alternative, non-systemic, and on-demand treatment method ('072 Patent, col. 1:26-30).
• The Patented Solution: The invention is a self-contained, wearable skin patch designed for application to the perineum ('072 Patent, col. 4:54-60). The patch contains electrodes that deliver electrical impulses through the skin to the bulbospongiosus muscle, which is involved in ejaculation ('072 Patent, Abstract). The theory of operation is that inducing a continuous contraction of this muscle with electrical stimulation inhibits the rhythmic contractions necessary for ejaculation, thereby delaying it ('072 Patent, col. 8:1-5).
• Technical Importance: This technology offers a localized, user-controlled, non-pharmacological treatment for a common medical condition, which may avoid the systemic side effects associated with existing drug-based therapies ('072 Patent, col. 10:1-4).

Key Claims at a Glance

• The complaint asserts independent claims 1 (a device claim) and 9 (a method claim).
• Independent Claim 1 recites a device comprising:
  • a skin patch for attachment to the perineum containing at least two electrodes configured to deliver transcutaneous electrical impulses to the bulbospongiosus muscle to delay ejaculation;
  • an integrated electronic circuit housing with a battery sufficient for at least 15 minutes of operation and a controller;
  • circuitry configured to deliver impulses during sexual intercourse and to stop delivery to allow ejaculation; and
  • the device being flexible and shaped and sized to be placed "entirely at the perineum."
• Independent Claim 9 recites a method of:
  • attaching a device with at least two electrodes to the perineum;
  • delivering electrical impulses to the bulbospongiosus muscle during sexual intercourse to delay ejaculation; and
  • stopping the delivery of impulses during intercourse to allow ejaculation.

U.S. Patent No. 11,471,666 - “Transcutaneous Electrical Muscle Stimulation Device For The Treatment Of Premature Ejaculation Or Erectile Dysfunction, And Methods Of Use Thereof”

The Invention Explained

• Problem Addressed: As a continuation of the same patent family, the '666 Patent addresses the same need for alternative treatments for premature ejaculation ('666 Patent, col. 1:30-33).
• The Patented Solution: The technology is substantively the same as that of the '072 Patent: a wearable skin patch for the perineum that uses electrical stimulation ('666 Patent, Abstract). The claims, however, are framed more broadly. For example, claim 1 requires delivering impulses to "a tissue of said perineum" with parameters suitable to "affect a physiological ejaculatory process," rather than specifying the bulbospongiosus muscle and the outcome of delaying ejaculation ('666 Patent, cl. 1).
• Technical Importance: The technical importance is identical to that of the '072 Patent, relating to a localized, non-pharmacological treatment modality ('666 Patent, col. 10:1-4).

Key Claims at a Glance

• The complaint asserts independent claim 1.
• Independent Claim 1 recites a device comprising:
  • a skin patch with a surface for attaching to a perineum;
  • the patch body containing at least two electrodes and an operationally connected electronic circuitry and power supply;
  • the circuitry and power supply configured to deliver electrical impulses to "a tissue of said perineum" with an intensity, frequency, current, and/or pulse width suitable to "affect a physiological ejaculatory process"; and
  • the device being flexible and shaped to conform to the perineum, with the patch configured to attach the circuitry and power supply to the perineum.

U.S. Patent No. 12,194,289 - “Transcutaneous Electrical Muscle Stimulation Device For The Treatment Of Premature Ejaculation Or Erectile Dysfunction, And Methods Of Use Thereof”

The Invention Explained

This patent, also in the same family, describes a wearable skin patch for treating premature ejaculation by delivering electrical impulses to the bulbospongiosus muscle ('289 Patent, col. 1:34-44). A distinguishing feature of its claims is the requirement that the device delivers these impulses in response to signals received from a separate remote device, which a user can operate to control the stimulation ('289 Patent, cl. 1).

Key Claims and Accused Features

The complaint asserts independent claim 1 ('289 Patent, cl. 1; Compl. ¶103). The complaint alleges that the MOR product, as a wearable neurostimulation device, infringes the '289 Patent by embodying its claimed features (Compl. ¶103).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "MOR" product (Compl. ¶31).

Functionality and Market Context

The MOR product is described as a "wearable technology" that uses "Neurostimulation technology" and is intended to "help men last longer" (Compl. ¶¶31-32). The complaint alleges that for its FDA 510(k) clearance, Morari's application asserted "substantial equivalence" to Plaintiff's approved "vPatch" product, which embodies the patented technology (Compl. ¶37). The complaint includes a visual from an instructional video showing the MOR product as a small, white, self-contained device designed to be worn on the body (Compl. ¶33). Morari allegedly began offering the product for sale on or about February 17, 2025, following FDA clearance (Compl. ¶¶34-35).

IV. Analysis of Infringement Allegations

The complaint references claim-chart exhibits that were not provided; therefore, the infringement allegations are summarized in prose.

'072 Patent Infringement Allegations

The complaint alleges that the MOR product directly infringes at least device claim 1 and that its sale and instructions indirectly infringe at least method claim 9 (Compl. ¶¶66, 68). The infringement theory posits that the MOR product is a "skin patch" (Compl. ¶31) with electrodes that attaches to the perineum to deliver "Neurostimulation" (Compl. ¶32), which corresponds to the claimed delivery of electrical impulses to the bulbospongiosus muscle ('072 Patent, cl. 1). The complaint includes a screenshot from Morari's instructional video, depicting a contoured, self-contained wearable patch (Compl. ¶33). For indirect infringement, the complaint alleges that Morari’s user instructions actively induce customers to perform the claimed method steps of attaching and using the device to delay ejaculation (Compl. ¶69).

'666 Patent Infringement Allegations

The complaint alleges that the MOR product directly infringes at least claim 1 of the '666 Patent (Compl. ¶87). The theory is that the MOR product is a flexible skin patch with integrated circuitry and electrodes (Compl. ¶¶31-33) that delivers electrical impulses to the "tissue of said perineum" to "affect a physiological ejaculatory process," as recited in the broader language of claim 1 ('666 Patent, cl. 1). The complaint supports this by pointing to Morari's marketing claims that the product uses "Neurostimulation technology" to "help men last longer" (Compl. ¶¶31-32) and its FDA submission claiming substantial equivalence to Plaintiff's device (Compl. ¶37). The complaint provides an image of Plaintiff's own in2 device, suggesting a direct competitive overlap in form and function (Compl. ¶30).

Identified Points of Contention

• Scope Questions: A potential point of contention for the '072 Patent is whether the MOR product meets the limitation of being configured to "stop said electrical impulses delivery during said sexual intercourse to allow ejaculation" ('072 Patent, cl. 1). The complaint does not detail the MOR product's user controls, raising the question of what evidence will be presented to prove this specific functionality.
• Technical Questions: For the '666 Patent, a key technical question is whether the MOR product's general "Neurostimulation" for "help[ing] men last longer" (Compl. ¶¶31-32) performs the function of "affect[ing] a physiological ejaculatory process" as the term is construed ('666 Patent, cl. 1). The analysis may turn on whether the claim requires the specific mechanism of inhibiting muscle contractions described in the specification or can be read more broadly to cover any electrical stimulation that results in delayed ejaculation.

V. Key Claim Terms for Construction

'072 Patent

• The Term: "to be placed entirely at the perineum" ('072 Patent, cl. 1)
• Context and Importance: This term defines the physical placement and boundaries of the claimed device. Practitioners may focus on this term because its construction could be pivotal if the MOR product has any components that could be argued to sit outside a strict anatomical definition of the perineum.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification describes the placement area broadly as between the scrotum and anus and between the left and right groin creases, which could support a more expansive definition ('072 Patent, col. 7:7-11).
  • Evidence for a Narrower Interpretation: The patent’s Figure 8 provides a specific anatomical diagram labeling the "Anogenital Distance," and the text emphasizes precise positioning to target the bulbospongiosus muscle, which could support a more constrained interpretation of the required placement ('072 Patent, Fig. 8; col. 7:12-18).

'666 Patent

• The Term: "affect a physiological ejaculatory process" ('666 Patent, cl. 1)
• Context and Importance: This functional language is central to the scope of infringement. Practitioners may focus on this term because its interpretation will determine whether infringement requires proof of a specific biological mechanism or merely the end result of delayed ejaculation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain language of "affect" is broad. The specification also discusses treating both premature ejaculation and erectile dysfunction via multiple potential mechanisms, suggesting the term was not intended to be limited to a single mode of action ('666 Patent, col. 2:26-45).
  • Evidence for a Narrower Interpretation: The specification repeatedly describes the invention's operation in terms of stimulating specific muscles (e.g., bulbospongiosus) to achieve a specific result (e.g., a continuous contraction), which could be used to argue that "affect a physiological ejaculatory process" should be limited to these disclosed mechanisms ('666 Patent, col. 6:8-13).

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement of method claim 9 of the '072 Patent, asserting that Morari's instructions for the MOR product direct users to perform the infringing steps (Compl. ¶69). It also alleges contributory infringement, stating the MOR product is especially adapted for infringement and is not a staple article of commerce (Compl. ¶¶71-72).

Willful Infringement

Willfulness is alleged for all three patents. The complaint alleges pre-suit knowledge of the '072 and '666 Patents based on an international search report Morari received in 2021, an Information Disclosure Statement Morari filed in its own patent prosecution in 2022, and a direct notice letter sent from Plaintiff's CEO in March 2024 (Compl. ¶¶46-50, 55). The complaint alleges Morari was on notice of the pending application that became the '289 Patent via the same letter (Compl. ¶61). The claim is further supported by allegations that Morari deliberately proceeded with development and commercialization after gaining this knowledge, including by relying on Plaintiff’s product as a predicate device for FDA clearance (Compl. ¶¶82-84, 98-100).

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

• A core issue will be one of claim construction and proof: can Plaintiff establish that the MOR product's "Neurostimulation technology" meets the specific functional limitations of the asserted claims—such as the '072 Patent’s requirement to "stop... delivery... to allow ejaculation"—or will a court construe these terms narrowly to the specific mechanisms detailed in the specification, creating a potential non-infringement defense?
• A second pivotal question will concern willful infringement: given the complaint's detailed timeline of Morari's alleged knowledge of the patents, including its own patent prosecution activities and its use of Plaintiff's product as an FDA predicate, a key focus of the litigation will be whether Morari's conduct constitutes the type of egregious behavior that warrants enhanced damages under 35 U.S.C. § 284.