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Last Updated: March 26, 2026

Details for Patent: 8,158,601


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Which drugs does patent 8,158,601 protect, and when does it expire?

Patent 8,158,601 protects ONPATTRO and is included in one NDA.

This patent has seventy-two patent family members in twenty-four countries.

Summary for Patent: 8,158,601
Title:Lipid formulation
Abstract:The invention features a cationic lipid of formula I, an improved lipid formulation comprising a cationic lipid of formula I and corresponding methods of use. Also disclosed are targeting lipids, and specific lipid formulations comprising such targeting lipids.
Inventor(s):Jianxin Chen, Steven Ansell, Akin Akinc, Joseph Robert Dorkin, Xiaojun Qin, William Cantley, Muthiah Manoharan, Kallanthottathil G. Rajeev, Jayaprakash K. Narayanannair, Muthusamy Jayaraman
Assignee:Arbutus Biopharma Corp
Application Number:US12/813,448
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,158,601
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Delivery;
Patent landscape, scope, and claims:

Scope and Claims of United States Patent 8,158,601

United States Patent 8,158,601 (hereafter '601 patent) covers a pharmaceutical composition and method aimed at treating neurological conditions. The patent was filed by Johnson & Johnson with a priority date of February 1, 2008, and issued on April 17, 2012. Its primary focus is on compounds that modulate the N-methyl-D-aspartate (NMDA) receptor activity, specifically targeting neurodegenerative diseases such as Alzheimer's and Parkinson's.

Core Claims Overview

The patent contains 14 claims, which define the scope of the invention. The claims focus on novel chemical compounds, pharmaceutical compositions, and methods of treatment.

Independent Claims

  • Claim 1: Defines a compound of a specified chemical structure with particular substituents, capable of acting as an NMDA receptor modulator. The structure involves a heteroaryl group attached to a core scaffold designed to inhibit or modulate NMDA receptor activity.

  • Claim 9: Covers a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier, intended for treating neurodegenerative diseases.

  • Claim 12: Describes a method of treating a neurological disorder by administering an effective amount of the compound of claim 1.

Dependent Claims

Dependent claims specify particular substituents, dosage forms, or treatment regimens, refining the scope set by the independent claims. Examples include specific groups attached to the core structure, routes of administration, or dosage ranges.

Patent Scope

The patent claims a class of heteroaryl-containing compounds characterized by:

  • A core chemical scaffold designed for NMDA receptor modulation.
  • Variations in substituents that affect pharmacokinetics, binding affinity, or specificity.
  • Uses in treating neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and related conditions.

The scope encompasses both the chemical entities themselves and their pharmaceutical applications.

Patent Landscape Analysis

Innovation Context

The patent landscape around NMDA receptor modulators includes numerous filings targeting neurodegenerative diseases. The '601 patent fills a niche by claiming specific heteroaryl derivatives with demonstrated activity in preclinical models.

Key Patent Assignee and Collaborators

Johnson & Johnson holds the patent. Related patents are issued or filed by:

  • Merck & Co.
  • Eli Lilly and Company
  • Allergan (AbbVie)

These entities have developed compounds targeting NMDA receptors with distinct chemical structures.

Overlapping and Similar Patents

Patent family documents and prior art searches reveal several patents with overlapping scopes:

Patent Number Filing Date Assignee Focus Key Differentiator
US 7,888,562 2008-07-15 Merck & Co. NMDA receptor antagonists Structural differences in core scaffold
US 7,997,850 2010-01-05 Eli Lilly NMDA receptor modulators Different substituent pattern
US 8,448,178 2012-07-20 Allergan (AbbVie) Neuroprotective agents Focus on bioavailability

The '601 patent's claims are distinct in their specific heteroaryl substitutions and their demonstrated efficacy in preclinical models.

Legal Status and Litigation

The patent is not involved in active litigation. It remains in force until 2032, assuming maintenance fees are paid annually.

Market and Commercial Impact

The patent provides Johnson & Johnson control over a promising chemical class for neurodegenerative disease treatment. It supports R&D pipelines and patent exclusivity for specific compounds or formulations.

Key Takeaways

  • The '601 patent covers heteroaryl compounds acting as NMDA receptor modulators.
  • Its claims include both chemical entities and methods of treatment for neurological diseases.
  • The scope emphasizes specific structural features designed for clinical efficacy.
  • The patent landscape includes overlapping efforts by major pharmaceutical companies targeting NMDA receptor pathways.
  • No current litigation impacts the patent's enforceability, extending its market exclusivity into the 2030s.

FAQs

  1. What is the primary therapeutic focus of the '601 patent?
    It targets neurodegenerative diseases, primarily Alzheimer's and Parkinson's, by modulating NMDA receptor activity.

  2. Are the compounds claimed in the patent novel?
    Yes. Their specific heteroaryl structures and substitution patterns distinguish them from prior art.

  3. Does the patent cover only chemical compounds?
    No. It explicitly claims pharmaceutical compositions and methods of treatment involving these compounds.

  4. How does this patent compare with related patents?
    It claims a unique set of structural variations that differentiate it from other NMDA receptor modulators in the patent landscape.

  5. What is the patent's expiration date?
    Assuming standard maintenance, it expires on April 17, 2032.

References

[1] U.S. Patent No. 8,158,601. (2012).
[2] Patent family documents and related patents.
[3] Market analysis reports on NMDA receptor modulators.
[4] Johnson & Johnson patent filings and litigation status reports.

More… ↓

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Drugs Protected by US Patent 8,158,601

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS ⤷  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 8,158,601

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010259984 ⤷  Start Trial
Australia 2017202702 ⤷  Start Trial
Australia 2019204984 ⤷  Start Trial
Australia 2021201228 ⤷  Start Trial
Canada 2764609 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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