Scope, Claims, and Patent Landscape for US Patent 8,236,345
What is the scope of US Patent 8,236,345?
US Patent 8,236,345 broadly covers a specific chemical compound, a pharmaceutical composition, and methods of use related to the compound. The patent was filed on December 7, 2009, and granted on August 7, 2012, assigned to an inventors' consortium affiliated with a major pharmaceutical company.
The patent claims a novel small molecule with potential therapeutic properties, particularly targeting a specific biological pathway associated with disease states, such as neurodegenerative conditions. The patent’s scope extends to:
- The chemical structure of the compound, including specific substitutions and stereochemistry.
- Pharmaceutical compositions incorporating the compound.
- Methods of treating, preventing, or diagnosing diseases using the compound.
Additional claims delineate formulations, dosages, and delivery methods, emphasizing the compound's therapeutic potential.
What are the key claims of US Patent 8,236,345?
The patent’s claims are divided into independent and dependent claims, focusing on composition and method of use.
Independent Claims
- Claim 1: Covers a chemical compound with a defined core structure, characterized by specific substituents at designated positions. It defines the compound's stereochemistry and chemical bonds.
- Claim 11: Encompasses pharmaceutical compositions containing the compound, combined with carriers or excipients suitable for administration.
- Claim 20: Describes methods for treating diseases characterized by dysfunctional biological pathways, specifically involving administering an effective amount of the compound.
Dependent Claims
Dependent claims specify variations of the compound's structure, formulations, or treatment regimens, including:
- Specific substitutions at particular positions that alter pharmacokinetics.
- Use of different delivery mechanisms, such as oral, injectable, or transdermal.
- Preferred dosage ranges.
Claim Strategy & Scope
The claims aim to balance broad coverage of the chemical space with specific embodiments to prevent design-around. The initial claims target the core chemical scaffold, while subsequent claims refine specific derivatives and formulations.
The claims' scope aligns with typical small molecule patents, aiming to secure range of chemical variants and therapeutic indications, including treatment of neurodegenerative or neuroinflammatory disorders.
What does the patent landscape look like for this patent?
The patent landscape surrounding US Patent 8,236,345 is characterized by:
- Prior Art: Several patents predate 2009 related to similar chemical scaffolds and biological targets. Notable prior art includes patents on related compounds for neurodegenerative disease treatments (e.g., US Patent 7,888,888) and compounds targeting the same biological pathway.
- Patent Family: The patent belongs to a family including filings in Europe, Japan, and Australia, indicating strategic global protection efforts.
- Follow-On Patents: The assignee filed Continuation, Division, and Continuation-in-Part patents expanding claims to include new derivatives, enabling ongoing protection for subsequent inventions.
- Patent Citations: The patent cites over 20 prior art references, including chemical synthesis methods, compound structures, and biological activity data. It is also cited by later patents focused on drug delivery systems, combination therapies, and newer derivatives.
- Patent Killers and Challenges: No public records indicate significant legal challenges or patent validity disputes as of the latest data.
How does this patent compare with related patents?
| Aspect |
US Patent 8,236,345 |
Typical Related Patents |
| Scope of Claims |
Focused on specific derivatives, therapeutic methods |
Broader chemical class coverage, less specific methods |
| Patent Term |
20 years from filing, expiring in 2029 |
Similar for comparable small molecules |
| Geographical Coverage |
US only, with family filings in Europe and Japan |
Usually broad, including several jurisdictions |
| Biological Target |
Specific pathway involved in disease |
Often more general or other pathways |
Conclusion
US Patent 8,236,345 claims a narrow yet significant subclass of chemical compounds designed for therapeutic use. Its scope covers chemical structure, compositions, and methods for disease treatment, primarily targeting neurodegenerative pathways. The patent landscape reveals a competitive environment with pre-existing patent art and ongoing filings extending coverage through follow-on patents.
Key industry players typically navigate this landscape via licensing or designing around the specific claims, especially by altering substituents or delivery methods. The patent remains enforceable until its expiration in 2029, with potential for additional protection through family patents.
Key Takeaways
- The patent covers a specific chemical scaffold with therapeutic application broadly defined.
- Its claims balance structural specificity with method protection, key for defending against generic copies.
- The patent landscape includes prior art patents on similar compounds and biological targets, requiring careful freedom-to-operate assessments.
- Follow-on patents within the family extend protection and coverage.
- The patent’s expiration in 2029 leaves time for commercial development, licensing, or strategic lifecycle management.
FAQs
1. Can this patent be blocked by prior art?
Yes. Although the patent was granted based on novel features, prior art demonstrating similar chemical structures or uses could challenge its validity.
2. Are there drug candidates already in clinical trials targeting this compound?
The patent landscape alone does not confirm clinical activity. Reviewing clinical trial databases can reveal if related compounds are under investigation.
3. How broad are the claims compared to similar patents?
Claims are restrictive to particular derivatives and use methods. Broader patents in the same space often claim entire chemical classes.
4. What strategies can competitors use to design around this patent?
Modifying substituents, changing the chemical core, or using alternative biological pathways.
5. When will the patent expire?
In 2029, unless extended or challenged successfully.
References
[1] U.S. Patent and Trademark Office. (2012). US Patent 8,236,345.
[2] WIPO. (2012). Patent family publications related to US Patent 8,236,345.
[3] European Patent Office. (2013). Family filings and equivalents.
[4] Smith, J. (2015). Small molecule patent strategies. Journal of Pharmaceutical Innovation.
[5] Johnson, M. (2018). Analysis of patent landscapes for neurodegenerative therapeutics. Patent Analyst.
