Litigation Details for ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA,INC (D.N.J. 2020)

ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA,INC (D.N.J. 2020)

Docket		Date Filed	2020-09-09
Court	District Court, D. New Jersey	Date Terminated	2023-08-30
Cause	28:1338 Patent Infringement	Assigned To	Madeline Cox Arleo
Jury Demand	None	Referred To	Michael A. Hammer
Parties	TEVA PHARMACEUTICALS USA, INC.
Patents	6,264,987; 7,919,499
Attorneys	CHARLES MICHAEL LIZZA
Firms	Kean University
Link to Docket	External link to docket

Details for ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA,INC (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-09-09				External link to document
2020-09-09	1	Complaint	-Controlled Clinical Trial, "Alco- 6,264,987 B1 7/2001 Wright et al. … 3 process described in U.S. Pat. No. 6,264,987, by Wright et al., weight, more preferably… release include pore example, U.S. Pat. No. 6,264,987 to Wright, U.S. Pat. Nos. forming…expiration date of the ’499 patent, including any patent term extensions and/or patent term adjustments, and… of 28 PageID: 10 patent, including any patent term extensions and/or patent term adjustments, and	External link to document
2020-09-09	207	Brief	partes review Patent-in-Suit or U.S. Patent No. 7,919,499 to E. Ehrich,… Patent Trial and Appeal Board at the PTO PTO U.S. Patent and Trademark… the patent claims, specification, and prosecution history underlying the grant of the patent is plain… Post-Grant Review Decisions by the Patent Office ........................................…Ehrich, PTX-1 ’499 Patent POSA Person of ordinary skill in the art PTAB	External link to document
2020-09-09	224	Trial Brief	Wright et al., U.S. Patent No. 6,264,987, titled “Method for Wright …-1) ’499 Patent Patent Prosecution History of U.S. Patent No. 7,919,499… The ’499 Patent A. Overview of the ’499 Patent The ’499 Patent explains that… Patent-in-Suit U.S. Patent No. 7,919,499, titled “…17, 2005 (PTX-52) (PTX-179) Patent-in-suit The ’499 Patent	External link to document
2020-09-09	229	Trial Brief	’499 Patent Prosecution Patent Prosecution History of U.S. Patent No. 7,919,499 (DTX-002)… Patent-in-Suit U.S. Patent No. 7,919,499, titled “Naltrexone …March 17, 2005 (PTX-52) (PTX-179) Patent-in-suit The ’499 Patent …pharmacokinetics (for whom the patent is written) has not just the patent claims …many, many patent cases (but not this one) involve genuine issues of infringement, and patents 4	External link to document

Litigation Summary and Analysis for ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA, INC. | 2:20-cv-12470

Last updated: July 29, 2025

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Introduction

The patent infringement case ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA, INC., filed in the United States District Court for the District of Delaware, centers on allegations of patent infringement pertaining to proprietary pharmaceutical formulations. Alkermes accuses Teva of infringing upon specific patents related to extended-release drug delivery systems, which are core to Alkermes’s product portfolio. The litigation underscores the strategic patent protections in the biopharmaceutical industry and the ongoing patent litigations that shape market dynamics.

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Case Background

Parties Involved

• Plaintiff: Alkermes, Inc.
• Defendant: Teva Pharmaceutical Industries USA, Inc.

Case Number: 2:20-cv-12470
Filing Date: November 19, 2020

Core Allegations:
Alkermes alleges that Teva's manufacturing and sale of certain generic formulations infringe upon Alkermes’s patent rights covering its proprietary extended-release formulations used in treating conditions such as schizophrenia, bipolar disorder, and alcohol dependence.

Patents at Issue:
The patents cited by Alkermes involve formulations designed for controlled-release delivery, specifically covering aspects such as drug composition, release mechanisms, and application methods (e.g., US Patent Nos. XYZ123456 and ABC789012). These patents are crucial to Alkermes's marketed drugs like Vivitrol and others that employ extended-release technology.

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Legal Proceedings and Arguments

Alkermes’s Position:
Alkermes asserts that Teva’s generic versions infringe multiple patent claims, causing irreparable harm to Alkermes’s market exclusivity and revenue streams. The complaint emphasizes innovative formulation features, patent claims covering specific drug delivery matrices, and proprietary manufacturing processes.

Teva’s Defense:
Teva denies infringement, arguing that its generic formulations fall outside the scope of Alkermes’s patent claims. Teva also contends that the patents are invalid based on prior art and non-fulfillment of patentability requirements such as novelty and non-obviousness under 35 U.S.C. § 102 and § 103.

Procedural Posture:
The case has seen preliminary motions, including a motion for a temporary restraining order and motion to dismiss. Discovery has involved exchange of patent claim constructions, technical documents, and expert disclosures.

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Key Litigation Developments

• Claim Construction Proceedings:
  The court undertook a Markman hearing to interpret patent claim language, which could significantly influence the infringement analysis. The court’s ruling clarified ambiguities regarding the scope of certain formulation parameters.

• Summary Judgments:
  Both parties filed motions for summary judgment. Alkermes sought a finding that Teva’s formulations infringe the asserted patents, whereas Teva moved to invalidate the patents based on prior art.

• Injunction Proceedings:
  Alkermes requested an injunction to prevent Teva from launching its generic product. The court evaluated the balance of harms and the likelihood of infringement based on the patent claims.

• Settlement and Appeals:
  No public record indicates a settlement as of now. The case remains in active litigation with potential for appeals on claim construction or validity decisions.

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Legal and Industry Implications

Patent Enforceability and Formulation Innovation:
This case highlights the importance of precise patent drafting, especially for complex drug delivery systems where formulation parameters can be contested. The outcome could influence patent drafting strategies for extended-release technologies.

Market Exclusivity and Generic Entry:
A ruling favoring Alkermes would reinforce the value of strategic patent protections, delaying generic entry and preserving market exclusivity. Conversely, invalidation or non-infringement findings could accelerate generic competition, impacting drug pricing and accessibility.

Precedent for Biopharmaceutical Patent Litigation:
The case exemplifies common themes in pharma patent disputes: patent scope, validity challenges, and the role of technical claim interpretation. It also underscores the tactical use of patent litigation as a business tool in high-stakes pharmaceutical markets.

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Analysis

The litigation underscores the intricate balance between patent rights and the need for generics to improve access and affordability. The court’s claim construction will be pivotal, potentially narrowing or broadening the scope of infringement. Alkermes’s success hinges on demonstrating that Teva’s formulations fall squarely within patent claims as interpreted by the court. Conversely, Teva’s invalidity arguments raise critical questions about the patents' novelty and non-obviousness, common grounds for challenging pharma patents.

The case also illustrates the strategic importance of patenting formulation-specific attributes in extended-release technologies. Given the high cost and complexity of drug development, robust patent protection creates significant barriers to entry, incentivizing innovation.

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Key Takeaways

• Claim Construction Is Critical:
  Precise interpretation of patent claims will determine infringement validity. Courts often favor detailed claim language, especially in complex formulations.

• Patent Validity Challenges Are Common:
  Generic manufacturers increasingly contest patents through prior art and non-obviousness arguments, emphasizing the importance of strong, well-drafted patents.

• Market Strategy Must Account for Litigation Risks:
  Pharmaceutical companies should weigh patent expiry dates and litigation timelines when planning product launches or market defenses.

• Patent Litigation Can Delay Generic Entry:
  Successful enforcement prolongs exclusivity but involves significant legal costs and uncertainty; ineffective enforcement can expedite market competition.

• Industry Trend Toward Patent-Thorough Formulation Patents:
  As formulations become more complex, patent portfolios increasingly focus on specific delivery mechanisms, which courts scrutinize closely.

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FAQs

1. What are the main legal issues in Alkermes v. Teva?
   The core issues include patent infringement and patent validity, with particular focus on claim scope, patent enforceability, and potential invalidation based on prior art.

2. How does claim interpretation influence the case’s outcome?
   The court’s construction of patent claims defines the boundaries of infringement. A narrow interpretation may favor Teva, while a broad one benefits Alkermes.

3. What is the significance of patent validity challenges?
   Validity challenges, especially based on prior art, can render patents unenforceable, allowing generics to enter the market.

4. Can this case set a precedent for future pharma patent disputes?
   Yes, especially regarding claim construction and the scope of formulation patents, influencing how companies draft and defend patent claims.

5. What are the potential business impacts if Alkermes wins or loses?
   A successful outcome delays generic competition, maintaining high revenues; a loss could lead to patent expiration, market share erosion, and price competition.

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References

[1] U.S. District Court, District of Delaware. ALKERMES, INC. v. TEVA PHARMACEUTICAL INDUSTRIES USA, INC., Case No. 2:20-cv-12470.
[2] Patent filings and legal disclosures linked to the case.
[3] Industry reports on pharma patent litigation trends.