DCT
1:19-cv-00917
Kaleo Inc v. Adamis Pharma Corp
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Kaleo, Inc. (Virginia)
- Defendant: Adamis Pharmaceuticals Corp. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Cooley LLP
- Case Identification: 1:19-cv-00917, D. Del., 05/16/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Adamis Pharmaceuticals Corp. is incorporated in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s submission of a New Drug Application to the FDA for a proposed naloxone hydrochloride auto-injector constitutes an act of infringement of three patents related to medicament delivery devices and formulations for opioid antagonists.
- Technical Context: The technology concerns auto-injector devices designed for the emergency administration of naloxone, a drug used to rapidly reverse opioid overdoses, a critical tool in addressing the public health opioid crisis.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of New Drug Application (NDA) No. 212854 to the U.S. Food and Drug Administration. Defendant provided Plaintiff with notice of its NDA submission via a letter dated April 3, 2019. The patents-in-suit are listed in the FDA's "Orange Book" as covering Plaintiff's approved naloxone auto-injector product, EVZIO®.
Case Timeline
| Date | Event |
|---|---|
| 2006-08-23 | Earliest Priority Date for ’022, ’792, and ’806 Patents |
| 2014-04-03 | FDA approves Plaintiff's EVZIO® (0.4 mg) auto-injector |
| 2015-05-05 | U.S. Patent No. 9,022,022 Issues |
| 2016-10-19 | FDA approves Plaintiff's EVZIO® (2 mg) auto-injector |
| 2018-12-04 | U.S. Patent No. 10,143,792 Issues |
| 2019-03-06 | U.S. Patent No. 10,238,806 Issues |
| 2019-04-03 | Defendant provides Plaintiff with notice of its NDA filing |
| 2019-05-16 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,022,022, “Medicament Delivery Device for Administration of Opioid Antagonists Including Formulations for Naloxone,” issued May 5, 2015 (’022 Patent)
The Invention Explained
- Problem Addressed: The patent's background section describes the difficulty and potential for error when untrained individuals attempt to administer naloxone during an opioid overdose emergency using traditional syringes. It notes that manually generated force can be "sporadic," leading to incomplete delivery, and that known naloxone formulations are often not stable enough for long-term storage outside of controlled environments, such as being carried by a patient or family member. (’022 Patent, col. 1:21-2:22).
- The Patented Solution: The invention is an apparatus, such as an auto-injector, that combines a user-friendly delivery mechanism with a specially formulated, stable naloxone composition. The device includes an "energy storage member" (e.g., a spring) to automatically produce the force needed for injection, solving the problem of manual, sporadic force. (’022 Patent, Abstract). The medicament container holds a naloxone composition with specific pH and osmolality ranges, using particular adjusting agents, to enhance its stability for long-term storage under varying conditions. (’022 Patent, col. 16:21-51).
- Technical Importance: The claimed invention provides a self-contained, pre-filled, and automatic injection device with a stable formulation, intended to make emergency overdose reversal accessible and reliable for non-medical personnel. (’022 Patent, col. 1:21-2:22).
Key Claims at a Glance
- The complaint asserts independent claim 18 and dependent claim 19. (Compl. ¶35).
- The essential elements of independent claim 18 are:
- An apparatus, comprising: a housing;
- A medicament container assembly within the housing that includes:
- A naloxone composition with a tonicity-adjusting agent and a pH adjusting agent, where the pH is between about 3-5; and
- A silicone-based material making the container assembly compatible with the naloxone composition;
- A plunger; and
- An actuator movably coupled to the housing, configured to force the plunger to expel the naloxone. (’022 Patent, col. 50:11-30).
U.S. Patent No. 10,143,792, “Medicament Delivery Device for Administration of Opioid Antagonists Including Formulations for Naloxone,” issued December 4, 2018 (’792 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the same core problem as the ’022 Patent: the complexity and potential for failure when untrained users administer naloxone in high-stress emergency situations. It highlights the series of operations required that, if done improperly, can limit the drug's effectiveness. (’792 Patent, col. 1:40-2:24).
- The Patented Solution: This patent claims a method for delivering a single dose of naloxone using a medical injector. The claimed steps include removing the injector from a case, receiving an instruction, placing the device against the patient, and actuating it to deliver a pre-filled, specially formulated dose of naloxone. (’792 Patent, col. 49:1-51:22 (Claim 16)). By claiming the specific sequence of user actions, the patent provides a different layer of protection than an apparatus patent.
- Technical Importance: This patent protects the intended use-case and workflow of the auto-injector system, aiming to prevent others from instructing users to perform the same patented method with a similar device. (’792 Patent, col. 1:40-2:24).
Key Claims at a Glance
- The complaint asserts independent claim 16 and dependent claims 17-26. (Compl. ¶68).
- The essential elements of independent claim 16 are:
- A method of delivering a single dose of a naloxone composition, comprising:
- Removing a medical injector from a case, the injector containing a prefilled naloxone composition with a tonicity-adjusting agent, a pH adjusting agent, and a pH of 3-5;
- Receiving an instruction associated with using the injector;
- Placing a portion of the injector into contact with the patient; and
- Actuating the injector to cause an elastomeric member to move and convey the single dose via a needle. (’792 Patent, col. 49:1-51:22).
Multi-Patent Capsule: U.S. Patent No. 10,238,806, “Medicament Delivery Devices for Administration of a Medicament Within a Prefilled Syringe,” issued March 6, 2019 (’806 Patent)
- Technology Synopsis: This patent claims an apparatus focused on the specific mechanical design of a delivery device that uses a prefilled syringe. The claims recite a system of interacting components, including a cover member, a syringe enclosure removably disposed within the cover, and distinct first and second stop surfaces that precisely limit the movement of the piston and the syringe assembly during injection to ensure reliable operation. (’806 Patent, Abstract).
- Asserted Claims: Claims 1-3, 6-9, and 12-13 are asserted. Claim 1 is independent. (Compl. ¶98).
- Accused Features: The complaint alleges that the Adamis NDA Product includes a cover member, a prefilled syringe assembly, a syringe enclosure, a piston member, and stop surfaces that function in the manner described by claim 1. (Compl. ¶¶99-111).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's proposed Naloxone Hydrochloride (5mg/0.5mL) injection drug product, identified as the "Adamis NDA Product" and associated with New Drug Application No. 212854 submitted to the FDA. (Compl. ¶1, ¶8).
Functionality and Market Context
- The Adamis NDA Product is an auto-injector designed for the emergency treatment of opioid overdose. (Compl. ¶1, ¶3). The complaint alleges, "on information and belief," that the product contains specific technical features that correspond to the elements of the asserted patents, including a housing, a plunger, an actuator, and a naloxone formulation with specific chemical properties. (Compl. ¶¶36-43). The complaint alleges the product would compete with Plaintiff's own EVZIO® auto-injector. (Compl. ¶1, ¶3). The complaint includes an exploded view of the injector's internal components, labeled with reference numbers from the patents, to illustrate the allegedly infringing structures. (Compl. p. 7, FIG. 2; ¶37).
IV. Analysis of Infringement Allegations
’022 Patent Infringement Allegations
| Claim Element (from Independent Claim 18) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an apparatus, comprising: a housing | The Adamis NDA Product apparatus includes a housing. | ¶36 | col. 16:36-38 |
| a medicament container assembly ... including: a naloxone composition including a tonicity-adjusting agent and a pH adjusting agent | The Adamis NDA Product includes a medicament container assembly including a naloxone composition with a tonicity-adjusting agent and a pH adjusting agent. | ¶38 | col. 5:52-59 |
| the pH of the naloxone composition ranging from about 3-5 | The Adamis NDA Product includes a naloxone composition with a pH in the range of 3-5. | ¶39 | col. 5:60-62 |
| a silicone-based material such that the medicament container assembly is compatible with the naloxone composition | The Adamis NDA Product includes a silicone-based material. | ¶40 | col. 5:32-40 |
| a plunger | The Adamis NDA product includes a plunger. | ¶41 | col. 17:50-54 |
| an actuator moveably coupled to the housing, the actuator configured to cause a force to be exerted on the plunger to expel the naloxone composition... | The Adamis NDA Product includes an actuator configured to cause a force to be exerted on the plunger to expel the naloxone composition. | ¶42-43 | col. 16:21-35 |
’792 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| removing a medical injector containing the naloxone composition from a case | Use of the Adamis NDA Product includes removing a medical injector containing the naloxone composition from a case. | ¶70 | col. 4:45-48 |
| the medical injector including: a housing, a prefilled medicament container assembly ... and a needle | The Adamis NDA Product includes a housing, prefilled medicament container assembly, and a needle. | ¶71 | col. 3:51-64 |
| the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3-5 | The Adamis NDA Product includes a naloxone composition with these agents and a pH ranging from 3-5. | ¶75-76 | col. 5:35-44 |
| receiving an instruction associated with a use of the medical injector | Use of the Adamis NDA Product includes receiving instructions associated with its use, such as visual instructions on the device. | ¶78 | col. 3:10-21 |
| placing a portion of the medical injector into contact with the patient | On information and belief, use of the Adamis NDA Product includes placing a portion of the medical injector into contact with the patient. | ¶79 | col. 3:40-44 |
| actuating the medical injector to cause the elastomeric member to move within the container body to convey the single dose... | On information and belief, the Adamis NDA Product includes manually actuating the medical injector to cause the elastomeric member to move and convey the naloxone dose. | ¶80 | col. 4:1-12 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint’s allegations regarding the specific chemical formulation of the Adamis NDA Product (e.g., pH of 3-5, presence of a tonicity-adjusting agent) and material composition (e.g., "silicone-based material") are made "on information and belief." This raises the question of what factual basis, if any, Plaintiff possesses to support these claims for a product that is not yet on the market.
- Scope Questions: For the ’792 Patent, the claim requires "receiving an instruction." The complaint alleges the accused product has "visual instructions on the device." (Compl. ¶78). This raises the question of whether reading a static printed label satisfies this claim element, or if the term, in light of the patent's extensive description of an electronic instruction system, requires receiving an active, electronically generated output. The complaint includes an illustration of the injector being removed from its case, a key step in the asserted method claim. (Compl. p. 13, FIG. 5C; ¶70).
V. Key Claim Terms for Construction
The Term: "silicone-based material" (’022 Patent, Claim 18)
- Context and Importance: Infringement of claim 18 requires the accused device's medicament container assembly to include a "silicone-based material" that is compatible with the naloxone. Practitioners may focus on this term because the defendant could argue its product uses a different, non-silicone compatible material, or that the term is indefinite without further clarification in the specification.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad. The specification does not appear to provide an explicit definition of "silicone-based material," which may support giving the term its plain and ordinary meaning to one of skill in the art.
- Evidence for a Narrower Interpretation: The specification describes an elastomeric member that can be coated with polydimethylsiloxane, which is a type of silicone. (’792 Patent, col. 17:54-60). A defendant may argue that this disclosure limits the term to a silicone coating on another material, rather than a material that is itself substantively "silicone-based."
The Term: "receiving an instruction" (’792 Patent, Claim 16)
- Context and Importance: This method step is critical to finding infringement of the asserted method claims. The dispute may center on whether simply reading a printed label on the device constitutes "receiving an instruction" in the context of the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim is not expressly limited to any particular type of instruction (e.g., electronic, audio, visual). Plaintiff will likely argue this language covers any form of instruction provided to the user, including printed text on the device or its packaging.
- Evidence for a Narrower Interpretation: The detailed description of the ’792 Patent repeatedly and extensively describes an "electronic circuit system" configured to "produce an output," such as an audible or visual instruction. (’792 Patent, col. 3:10-21, col. 19:1-20:51). Defendant may argue that this heavy emphasis on an electronic system limits the scope of "receiving an instruction" to receiving an active, electronically-generated output, thereby excluding devices with only passive, printed labels.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents-in-suit. The inducement allegations state that Defendant knows of the patents and that its commercial product and associated instructions will actively encourage end-users to perform the infringing acts. (Compl. ¶¶ 29, 62, 93). The contributory infringement allegations state that the Adamis NDA Product is especially made for infringing use and is not a staple article of commerce suitable for substantial non-infringing use. (Compl. ¶¶ 30, 63, 94).
- Willful Infringement: Willfulness is alleged for all three patents. The complaint asserts that Defendant has "actual notice" or "full knowledge" of the patents and is proceeding with preparations to manufacture and sell its product in "disregard of kaleo's rights," rendering the case "exceptional." (Compl. ¶¶ 45, 89, 113).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary sufficiency: As the infringement action was filed based on an NDA submission for a not-yet-marketed product, a key threshold question is what factual basis supports the complaint's "information and belief" allegations regarding the precise chemical and material composition of the accused device, and whether these allegations are sufficient to state a plausible claim for relief.
- The case will also likely involve a core question of claim scope: Can the method claim term "receiving an instruction" be broadly construed to cover reading a static printed label on a device, or does the patent’s detailed disclosure of an electronic instruction system implicitly limit the term to receiving an active, electronically-generated output?
- A third key question will be one of technical specificity: Will the infringement analysis for the apparatus claims hinge on whether the accused product's components meet the exact structural and compositional limitations recited, such as the use of a "silicone-based material" and a formulation with a pH "ranging from about 3-5", or will there be a dispute over equivalency?