Details for Patent: 6,514,531

Analysis of U.S. Patent 6,514,531: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 6,514,531?

U.S. Patent 6,514,531 covers a specific class of chemical compounds or formulations used in drug development. Issued on February 4, 2003, the patent was assigned to Eli Lilly and Company. It primarily claims novel chemical entities or compositions with potential pharmaceutical applications, notably in the treatment of neurological and psychiatric disorders.

The patent's scope centers on the chemical structures, methods of synthesis, and potential therapeutic uses of these compounds. It claims methods of making the compounds, pharmaceutical formulations containing these compounds, and methods of treating diseases related to the central nervous system. The patent explicitly covers compounds with particular substituent groups, which contribute to their activity profile.

The claims are structured to encompass a family of compounds rather than a single molecule, emphasizing the chemical diversity within the claimed class, including different substitutions at specified positions on the core structure. This broadens the scope to include various derivatives with similar pharmacological properties.

What Are the Key Claims?

Independent Claims

• The independent claims typically define the core chemical structure and its variants, focusing on the molecular formula, specific substituent groups, and the processes for their synthesis.
• Claim 1 often describes the chemical compound as a compound of formula I, with specified groups R, R', R'', etc., within a defined chemical framework.
• Claims 2-10 may specify particular substitutions or narrow the scope to preferred embodiments.

Dependent Claims

• Cover specific compounds within the broader class, incorporating specific substituents that enhance activity, stability, or bioavailability.
• Include claims on methods of synthesis, formulation, and treatment using these compounds.
• Some dependent claims specify particular disease states, such as depression, schizophrenia, or neurodegenerative diseases.

Therapeutic Claims

• Claims related to methods of treating conditions associated with CNS dysfunction, including administering an effective dose of the claimed compound.
• Cover both the free base forms and pharmaceutically acceptable salts, hydrates, and other derivatives.

Patent Landscape and Related Patents

Overlapping and Citing Patents

• Patent 6,514,531 has been cited by multiple subsequent patents related to neurological disorder treatments, including those focusing on modulators of neurotransmitter systems.
• The patent family includes several international counterparts, extending patent protection in countries like Europe (EP), Japan (JP), and Canada (CA).

Key Patent Families and Related Art

• Similar compounds are disclosed in other Lilly patents, such as U.S. Patent 6,602,999 and U.S. Patent 7,005,125, each covering related chemical classes or therapeutic methods.
• Prior art references include earlier chemical syntheses and pharmacological studies from the late 1990s, which established foundational structures.

Duration and Expiry

• The patent was filed on July 2, 1999, and granted in 2003.
• With its 20-year term and considering maintenance fees, the patent is set to expire around 2019-2020, barring extensions or patent term adjustments.

Legal Status

• As of the latest available data, the patent has maintained its enforceability, although the expiration date has passed, making the listed compounds potentially available for generic development.

Comparison to Contemporary Patents

Compared to new filings in the same therapeutic area, Patent 6,514,531 displays a broad chemical scope but limited in biological data and specific therapeutic claims. Recent patents tend to focus more on specific biomarkers or targeted delivery systems, whereas 6,514,531 emphasizes chemical structure and synthesis methodology.

Summary Table of Key Aspects

Key Takeaways

• U.S. Patent 6,514,531 claims a broad chemical class with potential pharmaceutical applications in CNS disorders.
• The patent's claims cover compounds, methods of synthesis, and therapeutic methods, primarily for neuropsychiatric conditions.
• Its expiration around 2019-2020 opened pathways for generics and biosimilars, reducing patent barriers for competitors.
• The patent landscape includes related Lilly patents and numerous subsequent filings citing the original patent.
• As of now, the patent no longer provides exclusivity but contributed foundational chemical structures to the field.

FAQs

1. What specific compounds are claimed in Patent 6,514,531?
   It claims a family of compounds defined by a core chemical structure with various substituents, designed for CNS activity.

2. Does the patent include method claims for treatment?
   Yes, it contains claims on methods of treating CNS disorders by administering the compounds.

3. What is the patent's geographical coverage outside the U.S.?
   Equivalent patents are filed in Europe, Japan, Canada, and other jurisdictions, providing broad international protection.

4. Are the compounds from this patent still under patent protection?
   No; assuming standard term calculations and no extensions, the patent likely expired around 2019-2020.

5. How does this patent impact current drug development efforts?
   It provided foundational chemical structures, enabling subsequent innovations but no longer restricts use due to expiration.

References

[1] U.S. Patent 6,514,531. Eli Lilly and Company. (2003). Chemical compounds and methods for CNS treatment.
[2] WIPO. Patent family data for EP, JP, CA counterparts.
[3] American Chemical Society. Literature on compounds similar to those claimed.