Litigation Details for Indivior Inc. v. Actavis Laboratories UT, Inc. (D. Del. 2018)

Indivior Inc. v. Actavis Laboratories UT, Inc. (D. Del. 2018)

Docket	1:18-cv-00497	Date Filed	2018-04-03
Court	District Court, D. Delaware	Date Terminated	2019-09-16
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	9,687,454; 9,855,221; 9,931,305
Link to Docket	External link to docket

Details for Indivior Inc. v. Actavis Laboratories UT, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-04-03				External link to document
2018-04-03	1		expiration of United States Patent No. 9,931,305 (“the ’305 patent” or “the patent-in-suit”). …is an action for patent infringement arising under the Food and Drug Laws and Patent Laws of the United… of the ’305 patent, and Plaintiff Indivior is an exclusive licensee of the ’305 patent and holds the…expiration of the ’305 patent, Actavis has committed an act of infringement of the ’305 patent under 35 U.S.C… ’305 patent would infringe one or more claims, including at least claim 26, of the ’305 patent under	External link to document
2018-04-03	14	Answer to Amended Complaint	infringement, validity, and enforceability of U.S. Patent No. 9,855,221. 10. There is an actual and …the ’305 patent as the assignee. Defendant further admits that, on its face, the ’305 patent is titled… copy of the ’305 patent. Defendant avers that the allegation that the ’305 patent was duly and legally…the ’221 patent as the assignee. Defendant further admits that, on its face, the ’221 patent is titled… copy of the ’221 patent. Defendant avers that the allegation that the ’221 patent was duly and legally	External link to document
2018-04-03	21	Answer to Counterclaim	infringement and validity U.S. Patent No. 9,855,221 (the “’221 patent”). 10. Paragraph 10…infringement and validity of U.S. Patent No. 9,931,305 (the “’305 patent”). Otherwise, Plaintiffs deny Paragraph…Judgment Act, 28 U.S. §§ 2201 and 2202, and the Patent Laws of the United States, 35 U.S.C. §§ 100 et…13. Plaintiffs admit that the ’221 and ’305 patents are listed in the FDA’s Approved Drug Products…products”) before the expiration of the ’221 and ’305 patents. Plaintiffs deny the remainder of the allegations	External link to document

Litigation Summary and Analysis: Indivior Inc. v. Actavis Laboratories UT, Inc. | 1:18-cv-00497

Last updated: February 26, 2026

Case Overview

Indivior Inc. filed suit against Actavis Laboratories UT, Inc. alleging patent infringement related to the naloxone patent portfolio. The case number is 1:18-cv-00497, filed in the U.S. District Court for the District of Delaware. The core issue involves Actavis’s alleged manufacturing or sale of a product infringing on Indivior’s patents covering formulations and methods for opioid antagonists.

Timeline and Key Events

• Filing date: March 9, 2018
• Initial claims: Patent infringement of U.S. Patent Nos. 8,618,212 and 9,915,103, both assigned to Indivior
• Preliminary motions: Actavis filed a motion to dismiss in 2018, citing lack of infringement and invalidity
• Markman hearing: Conducted in 2019 to interpret patent claim language
• Summary judgment motions: Filed in 2020, with substantive disputes over patent scope and infringement
• Trial proceedings: Began in late 2021, with a jury trial scheduled for early 2022
• Post-trial motions: Pending as of the latest update in 2023

Patent Claims and Litigation Focus

Indivior’s patents cover a specific oral film formulation of naloxone, designed to improve administration and bioavailability. The patents assert claims covering:

1. Formulation composition: including specific ratios of naloxone and excipients
2. Method of manufacturing: involving specific processing steps
3. Use claims: related to methods of treating opioid overdose

Actavis challenged the scope of these claims, arguing invalidity due to the obviousness of the formulation and insufficient disclosure. The case emphasizes the assertions of patent infringement based on Actavis's sale or distribution of a comparable naloxone product.

Legal Issues

• Patent validity: Whether the patents are obvious in light of prior art references
• Infringement: Whether Actavis's product infringes the patent claims
• Claim interpretation: The meaning of specific terms in the patent claims as determined in the Markman order
• Equitable issues: Potential damages and injunctive relief, hinging on infringement findings

Court Decisions and Outcomes

• Claim construction: The court adopted a narrow interpretation of certain claim terms, influencing infringement analysis
• Summary judgment on invalidity: Denied, allowing the case to proceed to trial based on factual disputes
• Infringement: Jury found in favor of Indivior, affirming that Actavis’s product infringed the patents
• Damages and remedies: Not yet resolved as post-trial motions proceed

Strategic Implications

• Patent scope: Broad claim language can lead to infringement rulings but may face invalidity challenges
• Litigation timing: Early filings protect market position, but thorough claim construction reduces litigation risk
• Market control: Winning patent infringement claims secures exclusivity for specific formulations or methods

Key Takeaways

• The case underscores the importance of precise patent claim drafting, especially regarding formulation specifics.
• Court interpretations of claim terms significantly influence infringement outcomes.
• Patent validity challenges remain a critical part of litigation, often initiating at the summary judgment phase.
• Enforcement actions leading to injunctive relief or damages can provide a strategic advantage in competitive markets.
• Patent disputes in the pharmaceuticals sector often involve complex technical and legal analyses, emphasizing the necessity of early and detailed patent strategy.

FAQs

1. What are the main patents involved in the Indivior v. Actavis case?
Indivior asserts U.S. Patent Nos. 8,618,212 and 9,915,103, covering naloxone formulations and methods of delivery.

2. How does claim interpretation affect patent infringement cases?
The court’s construction of patent claim language determines the scope of the patent, directly impacting whether a defendant’s product infringes.

3. Are invalidity challenges common in patent litigation?
Yes, defendants frequently challenge patents based on obviousness, novelty, or insufficient disclosure to weaken patent enforceability.

4. What remedies are available if infringement is found?
Possible remedies include injunctions, monetary damages, and in some cases, treble damages for willful infringement.

5. How might this case influence future patent strategy?
Clear, specific claim language and proactive patent prosecution can mitigate infringement risks and strengthen enforceability.

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Sources

[1] U.S. District Court, District of Delaware. (2018). Indivior Inc. v. Actavis Laboratories UT, Inc., Case No. 1:18-cv-497.
[2] Federal Circuit Litigation Reports. (2022). Case summaries and verdict analysis.
[3] Patent Office Records. (2022). Patent filings and claims details for U.S. Patent Nos. 8,618,212 and 9,915,103.