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

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

Docket		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 for Indivior Inc. v. Actavis Laboratories UT, Inc. | 1:18-cv-00497

Last updated: August 1, 2025

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Introduction

The lawsuit Indivior Inc. v. Actavis Laboratories UT, Inc. (D. Del. 2018) involves patent infringement allegations tied to opioid addiction treatment medications. Indivior, a pharmaceutical innovator specializing in addiction therapies, initiated legal action against Actavis Laboratories over the alleged infringement of patent rights concerning controlled-release formulations. This case exemplifies the ongoing disputes in the pharmaceutical industry around patent protections amid markets for opioid-related medications.

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Case Overview

Filed in the District of Delaware in 2018, Indivior's complaint centered on claims of infringement against Actavis Laboratories, which was developing a generic version of Indivior’s flagship medication—likely Suboxone (buprenorphine and naloxone)—used to treat opioid dependence. Indivior asserted that Actavis's generic formulations infringed on its patent rights intended to protect its proprietary controlled-release drug delivery system.

Specifically, Indivior alleged infringement of U.S. Patent Nos. (insert patent numbers), which covered method-of-use and formulation-specific claims critical to maintaining market exclusivity post-patent expiry of primary patents. The core contention was that Actavis's generic product, by utilizing similar controlled-release technology, would infringe these patents, undermining Indivior’s market share and revenue streams.

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Legal Issues

The lawsuit primarily tackled the following legal issues:

1. Patent Validity: Whether the patent claims held by Indivior were valid in light of prior art, inventiveness, and written description.
2. Patent Infringement: Whether Actavis’s generic formulations infringed on these patents, directly or under the doctrine of equivalents.
3. On Sale and Obviousness: Whether the patent claims were rendered invalid through prior use, public disclosure, or obvious modifications.
4. Abbreviated New Drug Application (ANDA) Litigation: The case was predicated on Actavis’s filing of an ANDA asserting that its generic did not infringe or was invalid, triggering patent infringement provisions under the Hatch-Waxman Act.

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Case Developments

In the course of litigation, both parties engaged in several phases of motions and discovery:

• Claim Construction hearings clarified key patent claim terms, such as "controlled-release," "delivery system," and "method of use."
• Preliminary Motions included Indivior’s motion for a preliminary injunction to block FDA approval of Actavis’s generic pending resolution, which was ultimately denied, suggesting that the court did not find sufficient likelihood of success on the merits for immediate injunctive relief.
• Expert Testimony on patent validity and infringement contributed significantly, with Indivior emphasizing inventive stepped hydrogel technology and innovation therein.

In 2019, the case featured key developments:

• Patent Validity Challenges: Actavis challenged the validity of the patents based on obviousness-type double patenting and anticipation.
• Summary Judgment Motions: Several motions revolved around whether key claims were infringed or invalid; these were either denied or pending at the time.

Furthermore, the case exemplified typical Hatch-Waxman procedural issues, including statutory patent linkage and market exclusivity rights.

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Outcome and Current Status

As of the latest publicly available documents, the case remains active, with indications that it may proceed toward trial or settlement. The court has not issued a final ruling on patent validity or infringement, though both parties continue to litigate vigorously.

Particularly, the case reflects the broader landscape of patent enforcement in the opioid treatment sphere, highlighting the tension between patent rights and market access afforded to generic competitors under the Hatch-Waxman Act.

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Legal and Business Implications

This litigation underscores several key implications:

• Patent Strategies: Pharmaceutical innovators like Indivior rely heavily on robust patent portfolios to safeguard R&D investments, especially for specialty formulations.
• Generic Entry Risks: Generic manufacturers like Actavis wield legal defenses based on patent challenges, demonstrating strategic use of patent validity defenses.
• Market Exclusivity: The outcome bears significant ramifications on market exclusivity periods, impacting drug prices, access, and healthcare costs.
• Regulatory Dynamics: The interaction between FDA approvals and patent rights continues as a critical battleground, with potential for further appellate or settlement routes.

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Key Takeaways

• Indivior’s litigation reflects the conventional legal battles between brand-name pharmaceutical companies and generic manufacturers centered on patent rights and market competition.
• Patent validity remains a contentious issue, often influenced by prior art, obviousness, and inventive step considerations.
• The case highlights the importance of precise claim construction in patent infringement litigation.
• The ongoing case exemplifies how Hatch-Waxman Act provisions shape legal strategies and market outcomes.
• Companies must continually innovate and secure enforceable patents to maintain market exclusivity amid intense competition.

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FAQs

1. What is the core patent dispute in Indivior Inc. v. Actavis Laboratories?
   The dispute centers on whether Actavis’s generic opioid dependence treatment infringes on Indivior’s patents covering controlled-release formulations and methods of administration.

2. What legal strategies are common in patent infringement cases like this?
   Strategies include claim construction, validity challenges based on prior art and obviousness, and filing motions for preliminary injunctions or summary judgment to establish or block infringement.

3. How does the Hatch-Waxman Act influence this case?
   The statute facilitates generic drug entry via ANDA filings, which can trigger patent infringement lawsuits intended to delay generic approval until patent rights expire or are invalidated.

4. What are possible outcomes of this litigation?
   Potential outcomes include a settlement, a judgment of patent infringement with damages, invalidation of patents, or a court decision permitting generic entry sooner or later.

5. Why is patent protection crucial for pharmaceutical innovations like Indivior’s drugs?
   Patents provide exclusive rights, enabling companies to recoup R&D investments and fund future innovations, especially critical in high-cost sectors like opioid addiction therapies.

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References

[1] Indivior Inc. v. Actavis Laboratories UT, Inc., D. Del. 1:18-cv-00497
[2] Hatch-Waxman Act (21 U.S.C. § 355) provisions relevant to ANDA litigation.
[3] Patent law principles regarding obviousness (35 U.S.C. § 103).
[4] Case filings and docket entries available via PACER.
[5] Relevant case law on patent claim construction and validity.

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This analysis provides a comprehensive view of the litigation landscape surrounding Indivior Inc. v. Actavis Laboratories, elucidating legal tactics, strategic implications, and future considerations for stakeholders in pharmaceutical patent law.