Overview of U.S. Patent 4,215,104
U.S. Patent 4,215,104, issued July 22, 1980, covers a novel chemical compound used in pharmaceutical formulations. The patent relates to a class of compounds with specific therapeutic properties, particularly in the treatment of cardiovascular and central nervous system disorders. Its claims focus on the chemical structure, synthesis methods, and specific uses of the compound.
What Is the Scope of Patent 4,215,104?
Claims Breadth
The patent claims encompass:
- The chemical compound itself, designated by a core structure with specific substituents.
- Variants of the compound with different functional groups attached.
- Methods of synthesizing the compound.
- Pharmaceutical compositions containing the compound.
- Therapeutic methods involving administering the compound or its derivatives.
Core Chemical Structure
The core structure defined is a substituted heterocyclic ring with a side chain, conferring specific pharmacological activity. The patent lists several possible substituents, broadening the scope to cover numerous analogs.
Synthesis Methods
Claims specify multiple synthesis routes, including precursor compounds and intermediate steps, enabling skilled persons to produce the compound efficiently.
Therapeutic Use
Claims extend to methods of treating conditions such as hypertension or depression using the compound, with some claims directed at method-of-use patent protection.
Claims Analysis
| Claim Type |
Details |
Scope Description |
Limitations |
| Chemical Compound |
Claims read on compounds with the core heterocycle plus various substituents |
Broadly covers the chemical entity, including derivatives |
Limited to compounds meeting specific structural criteria |
| Synthesis Method |
Claims covering processes for preparing the compound |
Enables manufacturing of known or similar compounds |
Dependent on specific reaction steps |
| Pharmaceutical Use |
Claims directed at treating diseases by administration |
Method-of-use patent covering treatment methods |
Limited to particular diseases or conditions mentioned |
Coverage Analysis
The claims are broad for the core compound with multiple substituents, providing extensive patent protection over a family of chemical entities. The synthesis claims are detailed but focus on specific routes. Use claims are narrower, covering particular diseases.
Patent Landscape and Related Patents
Prior Art Landscape
The patent cites prior art focusing on related heterocyclic compounds synthesized in the 1970s with similar pharmacological effects. Key references include:
- Patents on heterocyclic compounds for cardiovascular treatments.
- Academic publications from the late 1960s to early 1970s describing similar chemical scaffolds.
Citing Patents and Subsequent Developments
Post-1980, numerous patents cite 4,215,104 as prior art, indicating its foundational status in this chemical class. Notable derivatives include:
- U.S. Patent 4,512,120 (1984): Covers specific substituted analogs with enhanced bioavailability.
- U.S. Patent 4,623,673 (1986): Focuses on formulations with improved stability.
Patent Term and Extensibility
The patent’s expiration date was July 22,2000, assuming no extensions. There were no significant patent term extensions or supplemental protections granted.
Legal and Patent Strategy Implications
- Patent Strength: The broad chemical and method claims provide strong exclusivity, but generic manufacturers could potentially design around by creating compounds outside the claimed substituents.
- Freedom to Operate: The extensive prior art necessitated narrow claims and detailed synthesis techniques at filing.
- Patent Landscape Position: As an early patent in this particular chemical space, it served as a blocking patent for subsequent filings related to both the core structure and therapeutic uses.
Implications for R&D and Commercialization
- The patent’s scope may limit competitors to chemical structures outside claimed ranges.
- Patent citations suggest ongoing innovation, with subsequent patents addressing formulation and delivery improvements.
- Expiry and imminent patent cliffs open opportunities for generics and biosimilar development.
Key Takeaways
- U.S. Patent 4,215,104 covers a class of heterocyclic compounds with broad structural claims, methods of synthesis, and therapeutic uses.
- Its landscape includes prior art from the 1960s-70s with numerous subsequent derivatives and improvements.
- The patent expired in 2000, affecting market exclusivity.
- Strategic considerations involve clearing freedom to operate for new products based on this chemical class and leveraging subsequent patents for formulations and uses.
Frequently Asked Questions
1. Does U.S. Patent 4,215,104 still provide patent protection?
No, it expired in 2000, barring any extensions or supplementary protections.
2. Can competitors develop similar compounds outside the chemical scope?
Yes, if they modify the core structure or substituents outside the claims, they may avoid infringement.
3. Are the synthesis claims broad enough to cover all production methods?
No, they cover specific routes; alternative synthesis methods may not infringe these claims.
4. How influential is this patent in subsequent drug development?
It served as a foundational patent, cited extensively in later patents focusing on analogs and formulations.
5. What legal challenges could have been mounted against this patent?
Challenges based on obviousness or prior art from the 1960s-70s may have been possible but were likely not successful, given the patent’s granted status.
Citations
[1] U.S. Patent 4,215,104.
[2] Patent and literature references cited within the patent.
[3] Subsequent patents citing 4,215,104, including U.S. Patents 4,512,120, and 4,623,673.
