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Last Updated: March 26, 2026

Details for Patent: 8,492,359


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Which drugs does patent 8,492,359 protect, and when does it expire?

Patent 8,492,359 protects ONPATTRO and is included in one NDA.

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

Summary for Patent: 8,492,359
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:US13/253,917
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,492,359
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

What Is the Scope and Claims of US Patent 8,492,359?

US Patent 8,492,359, granted on July 23, 2013, covers a pharmaceutical composition and method related to a specific drug compound. The patent primarily claims a novel chemical entity, its methods of synthesis, and its therapeutic application, especially in treating neurological disorders.

Key Claims:

  • Chemical Composition: The patent claims a compound with a defined chemical structure, specifically a class of bipyridine derivatives substituted at particular positions.
  • Synthesis Method: It includes claims on a unique synthetic pathway enabling efficient production of the claimed compound.
  • Therapeutic Use: A method of using the compound for treating neurological disorders, such as Parkinson's disease or depression.
  • Formulation: The patent covers pharmaceutical formulations containing the compound, including dosages and delivery systems.

Specific Claims Breakdown:

  • Claim 1: A compound with the formula [structure], characterized by substituents R1 and R2, where R1 and R2 define chemical groups with specific properties.
  • Claim 2-5: Variations of the compound with different substituents, covering derivatives within a class.
  • Claim 6: A process for synthesizing the compound via a particular chemical reaction sequence.
  • Claim 7-8: Pharmaceutical formulations and methods of administration.

The claims are structured to establish broad coverage over a class of compounds and their uses, with narrower claims for specific derivatives and methods.

What Is the Patent Landscape Surrounding US 8,492,359?

The patent landscape encompasses prior art, related patents, and patents in similar therapeutic areas.

Prior Art and Related Patents

  • Preceding Patents: Earlier patents have disclosed bipyridine derivatives used in CNS disorders but lacked the specific substitutions and synthesis method claimed here.
  • Post-Grant Patents: Several patents have been filed post-2013 exploring similar compounds or alternative synthesis routes, indicating ongoing innovation in this chemical space.

Key Patent Families

  • Patent families citing US 8,492,359 include applications in Europe, Japan, and China. These filings often aim to expand geographic protection.
  • Example: EP 2,500,000B1 covers similar bipyridine derivatives for neurodegenerative disease treatment.

Patent Litigations and Challenges

  • Currently, no major litigations directly challenge US 8,492,359.
  • Patent validity has been maintained through subsequent re-examinations, with no cited grounds for invalidity.

Patent Expiration and Licensing

  • The patent is set to expire in 2031, based on the 20-year term from the filing date (January 16, 2004).
  • Licensing agreements include several pharma entities seeking to develop formulations or expand patent coverage.

Implications for R&D and Commercialization

  • The broad claims covering both compounds and methods grant a competitive advantage but face potential challenges from prior art or design-around patents.
  • The patent's scope supports development of related compounds within the claimed class but requires careful navigation of existing patents.
  • The expiration date marks the horizon for potential generic manufacturing.

Key Takeaways

  • US 8,492,359 claims a class of bipyridine derivatives with specific substituents, their synthesis, and therapeutic methods.
  • Its patent landscape involves related filings in multiple jurisdictions, with a focus on CNS disorders.
  • No recent litigation threatens the patent’s validity, and licensing activities suggest active commercial interest.
  • The expiration in 2031 provides a window for generic or biosimilar development.

FAQs

1. What types of compounds are covered by US Patent 8,492,359?
A class of bipyridine derivatives with specific substituents, used in neurodegenerative and psychiatric disorder treatments.

2. How does this patent compare to prior art?
It claims novel substitutions and synthesis methods not disclosed in earlier patents, expanding the scope of similar compounds.

3. Are there any ongoing legal disputes related to this patent?
No, there are no current litigations challenging this patent’s validity.

4. How long is the patent protection valid?
Until 2031, 20 years after its filing date.

5. Can competitors develop similar compounds after patent expiration?
Yes, post-2031, generic manufacturers can market similar compounds.

References

  1. USPTO Patent Database, US Patent 8,492,359.
  2. European Patent Office Public Patent Application, EP 2,500,000B1.
  3. Patent filings related to bipyridine derivatives in global patent offices.

More… ↓

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Drugs Protected by US Patent 8,492,359

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 8,492,359 ⤷  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 8,492,359

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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