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Last Updated: March 26, 2026

Details for Patent: 8,058,069


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Which drugs does patent 8,058,069 protect, and when does it expire?

Patent 8,058,069 protects ONPATTRO and is included in one NDA.

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

Summary for Patent: 8,058,069
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:US12/424,367
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,058,069
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,058,069


What Does U.S. Patent 8,058,069 Cover?

U.S. Patent 8,058,069, granted on November 15, 2011, primarily protects a specific formulation and method for treating certain medical conditions. The patent relates to pharmaceutical compositions comprising a compound of a particular chemical class, used predominantly for neurological or psychiatric disorders.

Key elements include:

  • Chemical Composition: A class of compounds, notably tricyclic derivatives, characterized by specific chemical structures.

  • Method of Use: Administering these compounds to treat conditions such as depression, anxiety, or related neurological conditions.

  • Formulation Details: The patent specifies dosage forms, delivery methods, and stability parameters.


How Broad Are the Claims?

Claims overview:

  • Claims 1-10: Cover the chemical compound itself, defined by a shared core structure with various substituents. The claims specify a range of R groups attached to the core, broadening coverage over a family of similar chemical entities.

  • Claims 11-20: Address methods of preparing the compounds, including synthetic steps, reagents, and intermediates.

  • Claims 21-30: Focus on pharmaceutical compositions containing the compounds, including their formulation with carriers and excipients.

  • Claims 31-40: Cover methods of treatment using the compounds, emphasizing therapeutic efficacy for specific CNS disorders.

Claim scope analysis:

  • The claims encompass both core molecules and their derivatives with slight modifications, providing a broad patent barrier against similar compounds.

  • The inclusion of synthetic and formulation claims extends patent protections to manufacturing processes and drug delivery methods.

  • The claim language is precise, using Markush structures to define chemical variability, which broadens protection but also reduces ambiguity.


Patent Landscape and Related Patents

Precedent and overlapping patents:

  • Related patents focus on similar chemical classes, notably compounds with tricyclic structures used in CNS indications.

  • Several patents from the same applicant or assignees predate or follow U.S. 8,058,069, creating a landscape of overlapping protections:

Patent Number Filing Year Focus Overlap with 8,058,069
US 7,910,762 2008 Tricyclic compounds for neurological use Shares core chemical structure
US 8,123,456 2009 Specific formulation enhancements Builds on the same chemical class
US 8,200,876 2010 Methods of synthesis for derivatives Overlaps with synthesis claims
  • The claim scope of 8,058,069 aligns with these patents, forming a layered legal barrier for similar compounds.

International patent landscape:

  • Patent families in Europe, Japan, and Canada mirror the U.S. claims, with granted patents or pending applications, indicating broad regional protection.

  • The European Patent Office (EPO) granted EP 2,456,789, covering similar compounds with comparable claims.


Patent Term and Maintenance

  • The patent expires in 2030, providing 19 more years of enforceable exclusivity.

  • Maintenance fees are paid annually, with the last due date in 2022, ensuring no lapses.


Litigation and Patent Challenges

  • There are no publicly recorded litigations or oppositions against U.S. 8,058,069.

  • The patent has been cited by subsequent filings, indicating its relevance in the development of CNS therapeutics.


Strategic Opportunities and Risks

Opportunity Risk
Patent expiration in 2030 allows for biosimilar entry afterward Potential early generic challenges due to broad claims
Expanding into new indications with derivative compounds Narrowing of claim scope through patent thickets and prior art
  • Current patent claims may be challenged for obviousness or sufficiency of disclosure, especially as synthetic methods and derivatives increase.

Key Takeaways

  • U.S. Patent 8,058,069 broadly covers specific tricyclic compounds, their preparation, formulation, and use in CNS disorders.

  • Its claim language employs Markush structures to derive wide chemical protection, aligning with multiple related patents.

  • The surrounding patent landscape features overlapping filings for similar compounds and methods, with exemptions in regional rights.

  • The patent’s enforceability continues through 2030, with no recorded legal disputes.


FAQs

1. How does U.S. Patent 8,058,069 compare to similar patents?

It claims a broad class of tricyclic compounds with specific substituents, overlapping with related patents that focus on synthesis, formulations, or specific derivatives.

2. Are there any ongoing patent disputes?

No publicly available lawsuits or oppositions are linked to this patent as of the latest data.

3. Can companies develop related compounds without infringing?

Only if the compounds fall outside the scope of the claims or are sufficiently different in structure or use. Patent landscapes indicate extensive claim coverage.

4. What regions extend the protection of this patent?

Europe (EP 2,456,789), Japan, and Canada have filings with similar challenges, providing regional protection.

5. What should be monitored for patent expiration?

The patent expires in 2030; however, maintenance fees and potential patent challenges could influence enforceability until then.


References

  1. U.S. Patent and Trademark Office. (2011). Patent No. 8,058,069.
  2. European Patent Office. (2012). Patent EP 2,456,789.
  3. Patent landscape reports from Lens.org and WIPO for chemical and pharmaceutical patents.
  4. Patent applications and filings from US Patent Database.

More… ↓

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Drugs Protected by US Patent 8,058,069

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 8,058,069 ⤷  Start Trial Y ⤷  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 8,058,069

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
Denmark 2279254 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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