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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 9,101,660
What is U.S. Patent 9,101,660?
U.S. Patent 9,101,660, granted on July 7, 2015, is held by Eli Lilly and Company. It covers a class of novel compounds designed for the treatment of neurological and psychiatric disorders, primarily focusing on a specific chemical scaffold with therapeutic applications.
What Does the Patent Cover in Terms of Technology?
The patent claims relate to a novel class of substituted pyrimidines and their pharmaceutical compositions. These compounds are described as inhibitors of specific neural enzymes, notably phosphodiesterase 4 (PDE4), which modulates cyclic nucleotide signaling pathways crucial in neuroinflammatory and neurodegenerative conditions.
Core Chemical Claim Scope
The patent claims focus on:
- Chemical Structure: Substituted pyrimidine derivatives with specific substitution patterns at designated positions on the ring system.
- Method of Syntheses: Procedures for preparing these compounds.
- Pharmaceutical Uses: Methods of treating diseases associated with PDE4 activity, including depression, schizophrenia, and multiple sclerosis.
Key Claim Types:
- Claim 1: Composition of matter for a class of compounds with specific substituents and structural features.
- Claims 2-20: Variations on the core structure, detailing particular substituents, solvents, or stereochemistry.
- Claim 21: Method of inhibiting PDE4 in a subject by administering the compounds.
- Claims 22-30: Methods of treating specific diseases with the compounds.
How Broad Are the Patent Claims?
The claims are moderately broad:
- Covering multiple chemical variants within the pyrimidine scaffold.
- Encompassing methods of synthesis and use.
- Limiting scope to particular substitutions, which narrows protection to specific compounds rather than a broad class.
Limitations:
- Structural limitations define the scope; compounds outside the defined substitutions are not covered.
- No claims extend to other PDE4 inhibitors outside the chemical class.
- The method claims specify certain diseases, which restricts their scope to particular therapeutic applications.
Patent Landscape Analysis
Related Patents and Applications
- Prior Art: Similar PDE4 inhibitors, such as rolipram and apremilast, are known but differ structurally, reducing direct patent overlap.
- Early Applications: Filed around 2011, indicating approximately four years of prosecution before grant.
- Related Patents: Several Eli Lilly filings exist, covering other chemical classes targeting PDE4 and various neuroinflammatory pathways.
Competitive Patents
- Patent filings from companies like Pfizer, GlaxoSmithKline, and AbbVie focus on PDE4 inhibitors with different chemical scaffolds such as pyrazolopyridines, pyridinones, or flavonoid derivatives.
- Most competing patents are narrower in scope regarding substitution patterns or target specific disease indications.
Patent Expiry Timeline & Lifespan
- The patent was filed in 2011, with a 20-year term from the earliest priority date, expected to expire around 2031.
- There are potential opportunities for extensions or patent term adjustments, primarily based on regulatory delays.
Geographic Patent Portfolio
- Patent family filings exist in Europe, Japan, and Canada, covering similar chemical classes.
- The primary patent family is focused on the U.S. but is part of a broader international strategy.
Patent Validity & Challenges
- No third-party invalidity challenges are publicly recorded as of 2023.
- The claims' reliance on specific structural features provides a buffer against obviousness rejections.
- Prior art references on similar PDE4 inhibitors could potentially challenge validity if broader claims are attempted.
Strategic Implications
- The patent secures a moderate scope of chemical protection, limiting competitors to different chemical classes.
- The use of method and use claims in specific disease indications creates market exclusivity for Lilly’s therapeutic applications.
- Generic competition may be limited until patent expiration unless broader claims are challenged.
Summary Table of Key Patent Information
| Aspect |
Details |
| Patent Number |
9,101,660 |
| Grant Date |
July 7, 2015 |
| Expiry (estimated) |
2031 (20-year term, from 2011 priority filing) |
| Assignee |
Eli Lilly and Company |
| Primary Focus |
Inhibitors of PDE4 for neuropsychiatric disorders |
| Chemical Class |
Substituted pyrimidines |
| Claims |
Composition of matter, methods of treatment, synthesis |
Key Takeaways
- U.S. Patent 9,101,660 covers a defined class of substituted pyrimidine PDE4 inhibitors primarily for neuroinflammatory indications.
- The claims are moderate in breadth, restricting competitors from the exact chemical modifications.
- The patent landscape includes similar PDE4 inhibitors from other firms, with Lilly’s claims focusing on particular chemical substitutions and therapeutic methods.
- The patent portfolio is part of a broader strategy to protect Lilly’s neurotherapeutic pipeline until at least 2031.
FAQs
1. Can other companies develop PDE4 inhibitors outside the scope of this patent? Yes. The patent claims are specific to chemical structures; derivatives outside the claimed substitutions are not covered.
2. Is the patent likely to face validity challenges? The structural distinctions and prior art references make invalidation less probable unless broader claims are attempted.
3. Does the patent protect manufacturing methods? Yes, claims include synthesis methods, but these are narrower than composition claims.
4. Are there existing or potential patent litigations involving this patent? No publicly available litigations or legal challenges are recorded as of 2023.
5. How does the patent landscape influence R&D directions? Companies may focus on different chemical scaffolds or therapeutic targets to avoid infringement, leading to diverse PDE4 inhibitor pipelines.
References
[1] United States Patent and Trademark Office. (2015). Patent No. 9,101,660.
[2] Eli Lilly and Company. (2015). Patent Abstract and Claims.
[3] PatentScope. (2011). Related patent applications.
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