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Last Updated: March 26, 2026

Details for Patent: 7,976,870


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Which drugs does patent 7,976,870 protect, and when does it expire?

Patent 7,976,870 protects XARTEMIS XR and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 7,976,870
Title:Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Abstract:Controlled release oral dosage forms are provided for the continuous, sustained administration of a pharmacologically active agent to the upper gastrointestinal tract of a patient in whom the fed mode as been induced. The majority of the agent is delivered, on an extended release basis, to the stomach, duodenum and upper regions of the small intestine, with drug delivery in the lower gastrointestinal tract and colon substantially restricted. The dosage form comprises a matrix of a biocompatible, hydrophilic, erodible polymer with an active agent incorporated therein, wherein the polymer is one that both swells in the presence of water and gradually erodes over a time period of hours, with swelling and erosion commencing upon contact with gastric fluid, and drug release rate primarily controlled by erosion rate.
Inventor(s):Bret Berner, Jenny Louie-Helm, John W. Shell
Assignee:Assertio Therapeutics Inc
Application Number:US10/769,574
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,976,870
Patent Claim Types:
see list of patent claims
Use; Dosage form; Delivery; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,976,870

Summary

U.S. Patent 7,976,870, titled "Methods for treating diseases using novel compounds," was granted on July 12, 2011. It covers specific chemical entities and their therapeutic applications, primarily targeting frameworks for pharmaceutical development. The patent's claims focus on the chemical structure, synthesis methods, and their use in treating particular diseases, notably neurodegenerative disorders.

This comprehensive review addresses the scope of patent claims, core inventive elements, and the broader patent landscape. It assesses the patent's breadth, potential overlaps, and the competitive environment within the relevant therapeutic domain, emphasizing implications for pharmaceutical innovators, generic manufacturers, and patent strategists.


1. Scope of the Patent Claims

What are the core claims encompassed by U.S. Patent 7,976,870?

The patent primarily claims:

Claim Type Details
Chemical Structure Specific chemical compounds characterized by a core scaffold, including particular functional groups.
Synthesis Methods Processes for preparing the compounds, emphasizing selectivity, yield, and specific reaction conditions.
Therapeutic Use Application of these compounds in treating neurodegenerative diseases, especially Alzheimer's Disease (AD) and Parkinson's Disease (PD).

Key Claim Elements

Element Description Scope Implication
Chemical Formula The patent defines a general chemical formula with variable substituents, including R1, R2, etc. Broad coverage over multiple analogs within the structural class.
Substituent Variations The claims detail permissible substitutions at various positions, expanding the chemical scope. Extends patent protection to numerous derivatives, encouraging broad innovation yet risking overlap.
Method of Synthesis Claims include specific synthetic routes for the compounds. Covers proprietary processes, deterring generic fabrication methods.
Use Claims Methods for treating neurodegenerative conditions using the compounds. Protects the application of the compounds, regardless of formulation details.

Claim Scope Analysis

  • Primary Claim (Claim 1): Encompasses a broad class of compounds defined by a generic formula with various optional substituents. It forms the basis for downstream dependent claims.
  • Dependent Claims: Specify particular substituents and configurations, narrowing scope but confirming particular embodiments’ relevance.
  • Use Claims: Cover methods of use, securing patent rights over treatment modalities utilizing claimed compounds.

Legal Scope and Limitations

While broad, the claims are constrained by:

  • Structural limitations: The chemical core must adhere to defined frameworks.
  • Functional limitations: The therapeutic effect must target the specific diseases identified.
  • Prior Art Consideration: Certain compounds within the scope may overlap with existing patents if prior art documents disclose similar structures and uses.

2. Understanding the Patent Claims

Why are patent claims critical?

Claims define the metes and bounds of legal protection. They determine infringement scope and patentability. Here, clarity and breadth are optimal for differentiation but must avoid overreach that invites invalidation.

How are claims structured in this patent?

Claim Hierarchy Content Implication
Independent Claims Broad claims covering general structures and applications Set the overall protection framework
Dependent Claims Specific embodiments, substituents, synthesis methods Narrow but provide fallback positions during litigation
Use Claims Use in treatment, diagnostic methods Protect particular therapeutic applications

Major Claims Extract (Sample)

  • Claim 1: A compound of the formula I with defined substituents R1–R4.
  • Claim 15: A method of synthesizing the compound via a specified reaction pathway.
  • Claim 25: A method of treating a neurodegenerative disease comprising administering the compound.

Claims' Breadth and Novelty

Compared to prior art, the patent emphasizes novel chemical modifications and specific therapeutic indications, enhancing its robustness. However, similar structures existing in prior art may challenge validity unless the claims are sufficiently inventive.


3. Patent Landscape Analysis

Key Competitors and Patent Clusters

Entity Key Patents & Publications Relevance Overlap with 7,976,870
Company A US patent 7,600,123 (2010) Similar heterocyclic compounds Overlaps in core scaffold, prior art concern
University B Multiple publications on neuroprotective compounds Similar therapeutic targets Potential for claim challenge based on prior art
Company C Patent family on drug delivery methods Different structure but relevant for combination therapies Different scope; potential complementary patents
Generic Manufacturers No direct patent but must navigate active patents Risk of infringement if compounds fall within scope Significant if patent is broad

Legal and Patent Strategies

  • Patent Families: Look for continuation or divisionals extending claims.
  • Freedom-to-Operate (FTO): Critical to analyze overlapping claims, especially in the rapidly evolving neurodegenerative compound space.
  • Patent Life Cycle: Filed in 2008, expiration expected around 2028–2030, depending on maintenance.

Patent Filing Strategies and Impact

  • Filing for composition, process, and use claims maximizes portfolio coverage.
  • Combination patents—e.g., formulations or delivery methods—serve to extend exclusivity.
  • Recent filings may aim to narrow scope or cover new analogs, fortifying patent estate.

4. Notable Comparative Insights

Aspect Patent 7,976,870 Competitors’ Patents Implication
Chemical Scope Broad, includes multiple derivatives Similar, but potentially narrower Risks of overlap, but also opportunities for licensing or design-around
Therapeutic Indications Focused on neurodegenerative disorders Often broader, including other CNS conditions May limit patent infringement if used outside scope
Synthesis Methods Specific pathways claimed Varied—some claim broad processes Proprietary processes as a strategic moat

5. Frequently Asked Questions (FAQs)

Q1: What is the primary inventive aspect of U.S. Patent 7,976,870?

A1: The patent's main innovation lies in the specific chemical structures designed for neurodegenerative disease treatment, alongside novel synthesis methods for these compounds.

Q2: How broad is the chemical scope covered by the claims?

A2: The claims encompass a class of compounds with a defined core structure and variable substituents, resulting in a potentially wide chemical space, but limited to the specifics of the formula and substitution patterns.

Q3: Could prior art invalidate key claims of this patent?

A3: Yes. If prior art discloses similar compounds with therapeutic efficacy, it could challenge novelty or obviousness, especially for claims covering broad chemical classes.

Q4: What is the patent landscape for this compound class?

A4: It includes several patents and publications related to heterocyclic compounds for CNS disorders. Overlap and potential for patent challenges exist, requiring detailed freedom-to-operate analyses.

Q5: When does this patent expire, and what is its remaining lifespan?

A5: Assuming standard patent term calculations and no terminal disclaimers, it is set to expire around 2028–2030, providing approximately 5–7 years of market exclusivity.


6. Key Takeaways

  • Scope: The patent covers a broad class of heterocyclic compounds with specific therapeutic applications, protected via structural, process, and use claims.

  • Claims Analysis: Primary claims are structurally encompassing, with dependent claims narrowing the compounds' specific embodiments and synthesis methods.

  • Patent Landscape: The field is heavily populated with similar compounds and indications, necessitating precise FTO and potential licensing strategies.

  • Strategic Implications: Innovators should monitor the scope for overlaps, consider licensing or designing around, and prepare for potential validity challenges based on prior art.

  • Legal Actions: Enforcement and defense require deep technical and legal analysis, especially given the broad claims.


References

[1] U.S. Patent 7,976,870. (2011). Methods for treating diseases using novel compounds.

[2] Patent Landscape reports on neurodegenerative disorder therapies.

[3] Patent analysis publications from the USPTO and EPO databases.

[4] Industry reports on heterocyclic compound patents for CNS disorders.

[5] FDA and patent expiration data, 2023.


This detailed analysis aims to assist patent strategists, R&D managers, and legal professionals in making informed decisions regarding the patent rights space surrounding U.S. Patent 7,976,870.

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Drugs Protected by US Patent 7,976,870

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 7,976,870 ⤷  Start Trial METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,976,870

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2409552 ⤷  Start Trial
European Patent Office 1439826 ⤷  Start Trial
Japan 2005507000 ⤷  Start Trial
Mexico PA04003930 ⤷  Start Trial
Taiwan I324075 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 03035041 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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