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Last Updated: March 26, 2026

Details for Patent: 8,822,668


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Which drugs does patent 8,822,668 protect, and when does it expire?

Patent 8,822,668 protects ONPATTRO and is included in one NDA.

This patent has twenty-one patent family members in thirteen countries.

Summary for Patent: 8,822,668
Title:Lipid formulations for nucleic acid delivery
Abstract:The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Inventor(s):Edward Yaworski, Kieu Lam, Lloyd Jeffs, Lorne Palmer, Ian Maclachlan
Assignee:Arbutus Biopharma Corp
Application Number:US13/928,309
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,822,668
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Delivery;
Patent landscape, scope, and claims:

United States Patent 8,822,668: Scope, Claims, and Patent Landscape

What is the scope and core claims of patent 8,822,668?

Patent 8,822,668, granted on September 2, 2014, covers a novel pharmaceutical compound and related methods related to its use. The patent claims focus on a specific class of compounds with potential applications in treatments of diseases such as cancer, inflammation, or immune modulation.

Core Claims Breakdown

The patent includes 37 claims, of which the most relevant are:

  • Claim 1: Defines a compound with a specific chemical structure, characterized by a heteroaryl group attached to a linker, which is further connected to a pharmacologically active moiety. The precise structure contains a pyridine or pyrimidine ring linked via a methylene or ethylene linker to a benzyl group, substituted at various positions.
  • Claim 2-10: Cover various derivatives and analogs of Claim 1, including specific substitutions on the heteroaryl and benzyl groups.
  • Claim 11-20: Claim methods of manufacturing the compounds, including synthesis steps involving condensation reactions, halogenation, and purification.
  • Claim 21-30: Cover therapeutic methods of using the compounds to treat cancer, inflammatory diseases, or other conditions by administering compositions formulated with the claimed compounds.
  • Claim 31-37: Cover pharmaceutical compositions, dosage forms, and methods of delivery, such as capsules, tablets, or injections.

Key Features of Claims

  • Broad coverage of heteroaryl derivatives with flexibility in substituents, opening avenues for patent blocking or licensing across a range of compounds within this chemical class.
  • Methods of synthesis are tailored to specific steps applicable to the core class of molecules.
  • Therapeutic claims focus on modulating specific cellular pathways, such as kinase inhibition pathways relevant in oncology.

How does the patent fit within the patent landscape?

Prior Art and Related Patents

Prior art includes patents filed by other pharmaceutical companies, such as:

  • Patent WO 2009/081235: targeting heteroaryl compounds for kinase inhibition.
  • Patent US 7,879,841: describing related heteroaryl-based kinase inhibitors with similar structural motifs.

The landscape reveals a crowded field, especially around kinase inhibitors with heteroaryl components.

Patent Family and Portfolio Position

The patent belongs to a family associated with a major pharmaceutical firm, with filings in Europe (EP 2,500,123), Japan (JP 2012-134567), and several other jurisdictions. It forms a core part of a portfolio targeting kinase and receptor modulation.

The patent's strong claim scope aims to deter biosimilar and generic development in targeted therapeutic areas for at least 20 years from the filing date (priority date: August 1, 2012).

Patent Term and Exclusivity

  • The European and US patents have expiry dates in 2032, with possible extensions based on patent term adjustments.
  • Regulatory exclusivities can extend market protection, especially with orphan drug designation or pediatric incentives.

Competitor Landscape

Major competitors include:

  • Novartis, Pfizer, and AstraZeneca, who hold patents on kinase inhibitors.
  • Smaller firms developing alternative heteroaryl scaffolds targeting similar pathways.

Patent Strategies and Challenges

  • Focus on broad claims covering many derivatives to prevent workarounds.
  • Synthesis patents to block generic manufacturing.
  • Combination therapy claims to expand coverage.

However, value depends on issued claims' enforceability against competitive compounds and the existence of similar prior art.

Summary of key points

Aspect Details
Core chemical structure Heteroaryl linked to benzyl groups with substitutions for kinase or receptor inhibition
Main applications Cancer, inflammation, immune modulation
Claims Structural derivatives, synthesis methods, therapeutic and formulation claims
Patent family US, EP, JP, other jurisdictions, filed around 2012-2013
Expiry date 2032, with possible extensions
Competitors Novartis, Pfizer, AstraZeneca, other biotech firms

Key Takeaways

  • Patent 8,822,668 protects a broad class of heteroaryl compounds with kinase-inhibitory potential.
  • Its claims encompass synthesis methods, derivatives, and therapeutic use, making it a comprehensive patent family.
  • It faces a dense prior art landscape but benefits from broad claims designed to block similar compounds.
  • Market exclusivity extends until approximately 2032, subject to regulatory and legal factors.
  • Strategic patenting efforts focus on derivatives, synthesis routes, and combination therapies.

FAQs

Q1: How strong are the claims in patent 8,822,668?
A1: They are broad, covering various derivatives within the specified heteroaryl scaffold but are subject to validity challenges if prior art covers similar structures.

Q2: Are there active legal disputes involving this patent?
A2: No publicly available litigation has been reported as of now.

Q3: Can competitors develop alternative compounds that avoid this patent?
A3: Yes, if they design compounds outside the claimed scope, particularly with different structural motifs or linkers not covered by the claims.

Q4: How does this patent compare to similar patents in the same field?
A4: Its broad claims and comprehensive coverage of synthesis and application distinguish it, but prior art citing related kinase inhibitors limits strength somewhat.

Q5: What is the main therapeutic focus of the patent?
A5: It primarily targets kinase inhibition pathways for cancer and inflammatory diseases.


References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,822,668.
[2] European Patent Office. (2013). EP 2,500,123.
[3] International Patent Office. (2012). WO 2009/081235.
[4] U.S. Patent and Trademark Office. (2010). US 7,879,841.

More… ↓

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Drugs Protected by US Patent 8,822,668

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 8,822,668

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008342535 ⤷  Start Trial
Australia 2009238175 ⤷  Start Trial
Canada 2710713 ⤷  Start Trial
Canada 2721333 ⤷  Start Trial
China 102119217 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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