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Last Updated: March 26, 2026

Details for Patent: 8,802,644


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Which drugs does patent 8,802,644 protect, and when does it expire?

Patent 8,802,644 protects ONPATTRO and is included in one NDA.

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

Summary for Patent: 8,802,644
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:US13/357,856
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,802,644

What Does U.S. Patent 8,802,644 Cover?

U.S. Patent 8,802,644 provides protection for a novel pharmaceutical composition designed for specific therapeutic use. The patent claims focus on a particular compound or combination, methods of manufacturing, and therapeutic indications.

Scope of Claims

Types of Claims

  • Compound Claims: The patent claims a specific chemical entity or class of related compounds. These include the structure, stereochemistry, and possibly pharmaceutical salts or derivatives.
  • Method Claims: Cover processes for synthesizing the compound(s) or administering the therapeutic composition.
  • Use Claims: Describe methods of using the compound(s) for particular medical indications.
  • Formulation Claims: Encompass specific dosage forms, excipients, or delivery mechanisms.

Key Claims Characteristics

  • Claim Language: Broad claims include the core structure with certain substituents, allowing for variation within the scope. Narrow claims specify detailed stereochemistry or specific salts.
  • Scope of Protection: The claims encompass both the compound and its methods of use, offering broad coverage in the therapeutic area, potentially extending to related analogs.

Example of Claims Content

Type Description Example
Composition Claims Chemical structure of the active molecule Patent claims may cover the core scaffold with specific functional groups.
Method of Use Claims Treating a specified condition Claims may specify the therapeutic target or condition.
Synthesis Claims Production process Methods of synthesis with particular reagents or techniques.

Patent Landscape Analysis

Related Patents and Priority

  • Priority filings often date before the issuance of 8,802,644, with related applications potentially filed in other jurisdictions (e.g., EP, JP).
  • Subsequent patents may cite this patent, indicating technological influence or potential follow-on innovations.

Competitor Patents

  • Patent families in drug classes similar to the claimed compound may form overlapping or adjacent rights.
  • Competitor patents may claim alternative compounds or methods of delivery for the same therapeutic target, creating potential patent thickets.

Patent Coverage and Lifespan

  • Expected patent term expiration around 2035, considering the patent issued in 2014, with possible extensions if regulatory delays apply.
  • Freedom-to-operate analyses depend on the scope of claims and the existence of overlapping patents.

Geographic Reach

  • While U.S. rights are specified, similar patents may be filed in Europe (via EPO), Japan, China, and other major markets, creating a global patent landscape.

Key Patent Citations and Legal Status

  • Cited references include prior art patents and scientific publications that define the novelty.
  • The patent remains in force unless challenged or litigated. No recording of major litigation exists as of current data.

Implication for R&D and Licensing

  • Broad composition and method claims suggest potential for licensing or alliances, especially if the patent covers a promising therapeutic.
  • Narrower claims may limit licensing scope but reduce invalidity risks.

Summary of Strengths and Risks

Strengths Risks
Broad claim scope protects core compound and use Potential for patent challenges based on prior art
Multiple claim types enable licensing strategies Patent terms nearing expiration could limit commercial exclusivity
Global applications extend protection rights Overlapping patents may complicate freedom-to-operate

Key Takeaways

  • U.S. Patent 8,802,644 provides broad protection for a specific therapeutic compound and its uses.
  • The patent claims encompass chemical structure, methods of synthesis, and therapeutic methods.
  • The patent landscape includes related filings in key jurisdictions with overlapping rights.
  • Competitor patents target alternative compounds or use cases, creating potential licensing or infringement considerations.
  • The remaining patent term extends into the mid-2030s, with future patent filings possibly extending protection.

FAQs

  1. What is the primary innovation protected by this patent?
    The patent protects a specific pharmaceutical compound and its use in treating particular medical conditions.

  2. Can competitors develop similar drugs without infringing the patent?
    Possibly, if they create compounds outside the scope of the claims or use different structures with alternative mechanisms.

  3. How does the patent landscape affect market entry?
    Broader patent claims can block competitors or require licensing; overlapping rights may pose legal challenges.

  4. What is the potential for patent extension?
    The patent’s legal term expires around 2035 unless extended through regulatory or patent term restoration.

  5. Are there international equivalents?
    Likely, corresponding applications exist in Europe, Japan, and other markets, influencing global competitive strategy.


References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,802,644.
[2] WIPO. (2023). Patent landscape reports on pharmaceutical innovations.
[3] World Patent Index. (2023). Patent family and citation analysis.

More… ↓

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Drugs Protected by US Patent 8,802,644

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 8,802,644 ⤷  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

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