Overview of U.S. Patent 4,753,935
U.S. Patent 4,753,935, granted on June 28, 1988, covers the composition and method related to a specific pharmaceutical compound. The patent primarily claims a method for preparing an anti-inflammatory agent, with particular emphasis on the compound's chemical structure and its therapeutic use. It has a term expiration date of June 28, 2005, considering patent term adjustments.
What Is the Scope of Patent 4,753,935?
Claims Language and Core Inventions
The patent's claims delineate rights over a specific chemical compound with anti-inflammatory activity and the methods of synthesizing that compound. Key points include:
- Main compound: The patent claims a methylated derivative of a known anti-inflammatory agent, characterized by a particular chemical structure with defined substituents.
- Method of synthesis: It covers a process involving methylation of a precursor compound, specifying reaction conditions, reagents, and purification steps.
- Therapeutic use: Claims include the application of the compound for treating inflammation, pain, or related conditions.
The claims are categorized broadly, covering the chemical entity, its preparation, and its use. The scope encompasses:
- Chemical composition: Claims for the specific methylated compound, including possible variants within designated structural parameters.
- Manufacturing process: Claims for the methylation process, with optional steps and reagents.
- Clinical application: Use claims in treating inflammation, pain, and associated disorders.
Claim Hierarchy and Limitations
The first claim is a composition claim, identified as an independent claim, covering the compound broadly, with subsequent dependent claims narrowing to specific chemical variants, synthesis steps, and treatment protocols.
Limitations include:
- Focus on chemical structure: Claims specify the precise molecular structure, thereby excluding compounds outside this structure.
- Reaction conditions: Claims for synthesis are limited by the described reagents and process steps, making modifications potentially non-infringing.
- Medical indications: Claims relate specifically to inflammatory and pain conditions, not broader therapeutic uses.
Patent Landscape and Related IP
Prior Art
The patent cites prior references on anti-inflammatory agents, methylation techniques, and related compounds, with key references prior to 1988. Notable prior art includes:
- Patent literature on methylated derivatives of similar anti-inflammatory compounds.
- Scientific publications on syntheses of methylated compounds with anti-inflammatory activity.
Subsequent Patents and Litigation
Following issuance, multiple patents cite or reference 4,753,935, especially in:
- Patent applications claiming broader or alternative methylated derivatives.
- Secondary patents covering formulations, dosage forms, and manufacturing improvements.
- No major litigation cases directly involving this patent are publicly documented up to 2022.
Patent Term and Extensions
The patent's expiration in 2005 led to a potential void by 2005, but patent term adjustments could have extended effective patent protection slightly longer. No extensions under patent term extension (PTE) or pediatric exclusivity appear to have been granted.
Geographic Patent Family
The patent's family includes filings in Europe, Japan, and other jurisdictions, primarily covering similar compounds and methods, often with narrower claims or different chemical variations.
Legal and Commercial Implications
- The patent was likely a barrier in the late 1980s and 1990s for competitors developing methylated derivatives of similar anti-inflammatory agents.
- Given its expiration, it no longer constrains the market, opening space for generic development.
- The scope, centered on a specific methylated compound and process, limited claims to that particular structure, permitting chemical alternatives.
Summary
U.S. Patent 4,753,935 claims a methylated anti-inflammatory compound, its synthesis, and medical application. Its scope is narrowly defined by the chemical structure and synthesis method, with claims encompassing the compound and its use in inflammatory conditions. The patent landscape includes prior art relevant to methylation of anti-inflammatory agents, with subsequent patents refining or expanding the scope in formulations and uses. The patent expired in 2005, opening the market for generics and related innovations.
Key Takeaways
- The patent's claims focus on a specific chemical structure, limiting infringement to similar compounds.
- Its expiration in 2005 shifted the competitive landscape.
- Subsequent patents target formulations and alternative derivatives.
- The patent landscape reveals broad but gradually narrowing claims on methylation techniques in anti-inflammatory compounds.
- Related patents in jurisdictions outside the U.S. often parallel but vary in claim scope.
FAQs
1. Does the patent cover all methylated derivatives of the parent compound?
No. The claims specify a particular chemical structure, limiting coverage to that compound and its direct derivatives within defined parameters.
2. Are synthesis process claims enforceable independently of compound claims?
Yes, process claims are enforceable if the process is used to produce the patented compound. However, alternative methylation methods not described in the patent may avoid infringement.
3. Have any infringing products been identified during the patent term?
No publicly available evidence indicates patent infringement or legal actions during the patent's active period.
4. Can modern compounds be designed to avoid infringement?
Yes. Variations outside the patent’s specific structural claims or employing different synthesis routes may avoid infringement.
5. What is the significance of the patent landscape post-expiration?
Examination of subsequent patents shows ongoing innovation in methylated anti-inflammatory compounds, but the original patent itself no longer constrains market entry.
References
- U.S. Patent 4,753,935.
- Patent and Trademark Office (USPTO) Database.
- Scientific literature on methylated anti-inflammatory agents.
- Patent landscape reports on anti-inflammatory compounds (e.g., WIPO and EPO databases).
- Legal case summaries related to patent expiration and generic entry.
[1] USPTO Patent Database.
[2] European Patent Office (EPO) Patent Family Data.
