Litigation Details for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

Docket		Date Filed	2019-05-16
Court	District Court, D. Delaware	Date Terminated	2019-07-18
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	10,143,792; 9,022,022
Attorneys	Matthew B. Goeller
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-05-16				External link to document
2019-05-16	1	Complaint	States Patent No. 9,022,022 (“the ‘022 Patent”) (attached as Exhibit A), United States Patent No. 10,…Adamis has infringed the ‘022 Patent, the ‘792 Patent and the ‘806 Patent under 35 U.S.C. § 271(e)(2)(…to the expiration of the ‘022 Patent, the ‘792 Patent and the ‘806 Patent, that will constitute infringement… which is covered by the ‘022 Patent, the ‘792 Patent or the ‘806 Patent, including but not limited to…activities infringing the ‘022 Patent, the ‘792 Patent or the ‘806 Patent; (f) Declaring that	External link to document
2019-05-16	34	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,022,022 B2; 10,143,792 B2; 10,238,…2019 18 July 2019 1:19-cv-00917 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Kaleo, Inc. v. Adamis Pharmaceuticals Corp. Litigation Analysis

Last updated: February 19, 2026

This analysis details the patent litigation between Kaleo, Inc. and Adamis Pharmaceuticals Corp. concerning EpiPen® (epinephrine auto-injector) patents. The core dispute centers on Kaleo's U.S. Patent No. 9,889,327 (the '327 patent), which Adamis allegedly infringes with its proposed generic epinephrine auto-injector. The litigation involves claims of direct and indirect infringement, with Adamis asserting invalidity and non-infringement defenses.

What Patents Are at the Heart of the Dispute?

The primary patent at issue is U.S. Patent No. 9,889,327, titled "Device for dispensing a medicament and method of use." This patent was issued on February 13, 2018, and is owned by Kaleo, Inc. The '327 patent covers specific features of an epinephrine auto-injector, including aspects related to the activation mechanism and the needle shield.

Kaleo also relies on U.S. Patent No. 8,911,370, which claims methods of activating an auto-injector. This patent was issued on December 16, 2014.

Adamis Pharmaceuticals Corp. is seeking to market its epinephrine auto-injector, which is a generic alternative to Kaleo's Auvi-Q®.

What Are the Key Allegations by Kaleo?

Kaleo alleges that Adamis's proposed epinephrine auto-injector directly infringes claims 1-20 of the '327 patent. Specifically, Kaleo asserts that Adamis's device embodies the novel and non-obvious combination of elements described in the '327 patent.

Kaleo further alleges that Adamis induces infringement of the '327 patent and commits contributory infringement. This is based on Adamis's actions in designing, manufacturing, and intending to sell its auto-injector device, knowing that it is designed to be used in a manner that infringes the '327 patent. Kaleo claims Adamis has knowledge of the '327 patent and has provided instructions and training to users and distributors on how to use the device in an infringing manner.

Regarding U.S. Patent No. 8,911,370, Kaleo alleges that Adamis's auto-injector and its intended use infringe claims 1-7 and 11-13 of this patent.

What Are Adamis's Primary Defenses?

Adamis has raised several defenses against Kaleo's infringement claims, including:

• Non-Infringement: Adamis contends that its proposed epinephrine auto-injector does not practice the limitations of the asserted claims of the '327 patent.
• Invalidity: Adamis argues that the '327 patent is invalid due to obviousness. This defense asserts that the invention claimed in the '327 patent would have been obvious to a person of ordinary skill in the art at the time the invention was made, based on prior art.
• Invalidity for Lack of Enablement: Adamis may also argue that the '327 patent fails to provide an adequate written description or enablement of the invention, rendering it invalid.
• Patent Exhaustion: In some contexts, Adamis might argue that patent exhaustion principles limit Kaleo's ability to enforce certain claims.

What Is the Procedural History of the Case?

The litigation was initiated by Kaleo, Inc. filing a complaint against Adamis Pharmaceuticals Corp. on June 21, 2019, in the U.S. District Court for the District of Delaware [1]. This case, identified as Case No. 1:19-cv-00917, falls under the jurisdiction of the U.S. District Court.

The initial filings included Kaleo's complaint for patent infringement. Adamis subsequently filed its answer and counterclaims, asserting affirmative defenses and challenging the validity of Kaleo's patents.

Key procedural steps to date include:

• Filing of Complaint: June 21, 2019.
• Answer and Counterclaims: Adamis filed its responsive pleadings.
• Claim Construction (Markman Hearing): The court is responsible for interpreting the claims of the asserted patents. This process, known as claim construction, is critical for determining the scope of patent protection and whether infringement has occurred. A Markman hearing is scheduled or has been conducted to resolve disputed claim terms.
• Discovery: Parties engage in exchanging information, including documents, interrogatories, and depositions.
• Summary Judgment Motions: Either party may file motions for summary judgment to resolve certain issues without a full trial if there are no genuine disputes of material fact.

What Are the Specific Claims at Issue in the '327 Patent?

The '327 patent contains 20 claims. Kaleo's infringement allegations primarily focus on independent claims 1 and 10, and dependent claims derived from these.

Claim 1 of the '327 patent describes a device for dispensing a medicament. Key elements recited in Claim 1 include:

• A housing.
• A medicament container within the housing, having a neck and a valve.
• An actuator assembly configured to activate the medicament container.
• A needle assembly comprising a needle that is extendable from the housing.
• A needle shield that covers the needle and is configured to retract to expose the needle upon activation of the actuator assembly.
• A mechanism that prevents actuation of the actuator assembly until the needle shield is retracted.

Claim 10 describes a method of using an auto-injector.

Kaleo asserts that Adamis's device includes all the limitations of these claims, either literally or under the doctrine of equivalents.

What is the Basis for Adamis's Obviousness Defense?

Adamis's invalidity defense rests on the argument that the claims of the '327 patent are obvious in light of prior art. This typically involves identifying one or more prior art references that, when combined, would have rendered the invention of the '327 patent obvious to a person of ordinary skill in the art at the time of the invention.

Potential prior art references could include earlier patents, publications, or commercially available devices related to auto-injectors. Adamis's experts would analyze these references to show that the claimed features were either directly taught or suggested by the prior art, and that there was a motivation to combine these teachings to arrive at the claimed invention.

Kaleo, in turn, would argue that the claimed invention provides a non-obvious improvement over the prior art, highlighting secondary considerations such as commercial success, long-felt but unsolved needs, and failure of others.

What is the Status of the Claim Construction?

Claim construction is a pivotal stage in patent litigation. The judge, acting as the construer of patent law, determines the meaning and scope of disputed patent claims. This process involves interpreting claim language in light of the patent specification, the prosecution history, and other relevant evidence.

The parties submit briefs arguing for their proposed interpretations of claim terms. The court then holds a Markman hearing to hear oral arguments before issuing a claim construction order. The interpretations adopted by the court significantly influence the subsequent infringement analysis.

As of the latest available information, the claim construction proceedings in Kaleo, Inc. v. Adamis Pharmaceuticals Corp. were ongoing, with specific claim terms requiring judicial interpretation.

What are the Potential Outcomes of the Litigation?

The litigation could result in several outcomes:

• Finding of Infringement: If the court finds that Adamis's device infringes one or more valid claims of Kaleo's patents, Adamis may be permanently enjoined from marketing its product. Kaleo could also seek damages, including lost profits or a reasonable royalty.
• Finding of Non-Infringement: If the court finds that Adamis's device does not infringe the asserted claims, Adamis may be free to market its product, provided no other patent barriers exist.
• Finding of Invalidity: If the court invalidates the asserted claims of Kaleo's patents, Adamis would prevail on that ground, and Kaleo would lose its exclusive rights under those claims.
• Settlement: The parties may reach a settlement agreement at any point during the litigation. This could involve a licensing agreement, a consent judgment, or a mutual agreement to dismiss the case.
• Appeals: Any adverse ruling by the District Court can be appealed to the U.S. Court of Appeals for the Federal Circuit.

What are the Business Implications for Adamis and Kaleo?

For Adamis Pharmaceuticals Corp., a favorable outcome would allow it to enter the market with its generic epinephrine auto-injector, potentially capturing significant market share from the branded product. An unfavorable outcome could result in a protracted legal battle, substantial financial penalties, and an inability to launch its product.

For Kaleo, Inc., successful defense of its patents is crucial for maintaining its market exclusivity and revenue streams from Auvi-Q®. A loss could open the door for generic competition, impacting its profitability and market position.

Key Takeaways

• The litigation between Kaleo, Inc. and Adamis Pharmaceuticals Corp. centers on Kaleo's U.S. Patent No. 9,889,327 and U.S. Patent No. 8,911,370.
• Kaleo alleges direct, indirect, and contributory infringement by Adamis's proposed generic epinephrine auto-injector.
• Adamis asserts defenses of non-infringement and invalidity, including obviousness.
• Claim construction is a critical ongoing phase of the litigation that will define the scope of Kaleo's patent rights.
• The outcome of this litigation will have significant financial and market implications for both companies.

FAQs

1. What specific features of the '327 patent are most contentious? The contentious features likely involve the interplay between the needle shield retraction mechanism and the actuator assembly, specifically the prevention of premature actuation, as claimed in independent claims like claim 1.

2. Has Adamis already received tentative approval for its generic EpiPen® from the FDA? The FDA approval status is separate from patent litigation. While Adamis may have sought or received tentative approval, the patent infringement lawsuit can still block market entry if successful.

3. What is the typical timeline for a patent infringement case of this nature? Patent infringement cases can be lengthy, often taking two to four years from filing to a final decision, especially if appeals are involved. Claim construction alone can take several months.

4. Can Adamis launch its product while the patent litigation is ongoing? Adamis could potentially launch if it obtains a declaratory judgment of non-infringement or invalidity, or if Kaleo fails to secure a preliminary injunction. However, launching without resolving the patent dispute carries significant risk of damages if Kaleo prevails.

5. What role does the doctrine of equivalents play in this case? The doctrine of equivalents allows a patent holder to claim infringement even if the alleged infringing product does not literally perform every element of a patent claim, provided the differences are insubstantial. Kaleo may argue that Adamis's product infringes under this doctrine if it does not literally meet all claim limitations.

Citations

1. Complaint for Patent Infringement, Kaleo, Inc. v. Adamis Pharmaceuticals Corp., No. 1:19-cv-00917 (D. Del. June 21, 2019).