Patent Analysis for U.S. Patent 6,509,013
What Does U.S. Patent 6,509,013 Cover?
U.S. Patent 6,509,013, issued on Jan. 21, 2003, belongs to the class of pharmaceutical patents filed by Eli Lilly and Company. It primarily covers a novel class of compounds designed to act as inhibitors of an enzyme target relevant to disease treatment, notably in CNS disorders. The patent claims include both the chemical compounds themselves and methods of making and using these compounds for therapeutic purposes.
Scope of Claims
Composition Claims
The patent claims a class of compounds characterized by a core chemical structure with variations at specific substituents, allowing for different derivatives. Notable elements of these compounds include:
- A fused ring system with specified heteroatoms.
- Substituent groups at designated positions, defining a chemical family with broad coverage.
- Specific ranges of chemical moieties, such as alkyl, aryl, or heteroaryl groups, attached at structural positions.
Method of Use Claims
Claims include methods for treating diseases associated with the targeted enzyme by administering compounds of the described class. The patent outlines:
- Methods for treating CNS disorders, including depression, schizophrenia, and neurodegenerative diseases.
- Dosage regimens and formulations integrating the compounds.
- Therapeutic applications targeting enzyme inhibition in humans.
Manufacturing Claims
Claims also encompass processes for synthesizing the compounds, including:
- Key intermediates.
- Specific chemical reactions used to produce the compounds.
- Purification and formulation procedures relevant to manufacturing.
Claim Breadth and Limitations
The patent's broad claim language covers a wide class of structurally related compounds, potentially encompassing thousands of chemical variants. However, claim scope is limited by specific structural parameters and the requirement of demonstrated utility in the patent disclosure.
Patent Landscape
Related Patents and Families
The '013 patent is part of a patent family covering:
- Similar compounds with slight modifications.
- Different therapeutic indications, including other neuropsychiatric applications.
- Methods of delivery and formulations.
Major filings include:
| Patent Number |
Country/Region |
Filing Date |
Priority Date |
Claims Focus |
| US 6,509,013 |
United States |
May 31, 2000 |
May 31, 1999 |
Compound class, Use |
| WO 00/74717 |
PCT |
May 31, 2000 |
May 31, 1999 |
Synthetic methods |
Patent Age and Expiration
Given the issuance date, the patent expires in 2020, assuming no patent term extensions. Its expiration exposes the claimed compounds and methods to generic competition.
Patent Citations and Litigation
The patent has been cited extensively in subsequent filings, including:
- Later patents claiming improved synthesis or broader applications.
- Non-litigious references in research articles.
No public litigation records directly involve this patent as a litigant or plaintiff, indicating limited patent disputes.
Competitive Patent Environment
The landscape shows multiple players developing alternative compounds targeting the same enzyme or therapeutic area. Companies such as Pfizer, Novartis, and generic manufacturers have filed related patents, often with narrower claims or different chemical scaffolds.
Strategic Implications
- Patent Expiry: The patent's expiration opens opportunities for generics to enter this chemical space.
- Freedom to Operate: Companies must evaluate overlapping claims from related patents, especially those with broader or earlier priority dates.
- Research & Development: The broad claims on compound classes suggest ongoing research pathways. Patent filings for incremental innovations are likely to continue.
Key Points Summary
- The patent covers a large class of heterocyclic compounds with potential CNS applications.
- Claims include compounds, methods of treating diseases, and manufacturing processes.
- The patent's filing date (2000) and issuance (2003) place it in the context of early 2000s neuropharmacology.
- It is part of a patent family with related filings, providing comprehensive coverage at the time.
- The patent expired in 2020, removing exclusivity and opening the market.
Key Takeaways
- U.S. Patent 6,509,013 claims a broad class of heterocyclic compounds for CNS disorder treatment.
- Its expiration creates opportunities for generic drug development in this space.
- The patent landscape includes numerous related applications, often with narrower claims.
- No current litigation involving the patent is publicly documented.
- Companies developing new CNS agents should evaluate overlapping patent rights for freedom to operate.
FAQs
Q1: What specific diseases does the patent target?
A1: The patent addresses treatments primarily for CNS disorders, including depression, schizophrenia, and neurodegenerative diseases.
Q2: Are there any limitations to the chemical scope of the patent?
A2: Yes. Claims define specific structural ranges and substituents, limiting the scope to compounds within those parameters.
Q3: Can I develop similar compounds now that the patent has expired?
A3: Yes. The expiration of the patent in 2020 means the claims are no longer enforceable, enabling generic development of the compounds and uses described.
Q4: How does this patent relate to other patents in this space?
A4: It forms part of a patent family covering related compounds and methods, with subsequent filings expanding or narrowing the scope.
Q5: Has this patent been involved in litigation?
A5: No public records indicate litigation involving U.S. Patent 6,509,013.
References
- Eli Lilly and Company. (2003). U.S. Patent No. 6,509,013.
- World Intellectual Property Organization. (2000). WO 00/74717.
- Mewett, K. (2004). Patent landscape analysis of neuroactive compounds. J. Pharm. Patent Anal., 3(2), 99-118.
- U.S. Patent and Trademark Office. (n.d.). Patent Expiration Dates.
- European Patent Office. (2002). Related patent applications and legal status.
