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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,346,227
Summary
U.S. Patent 4,346,227, granted in 1982, primarily covers a specific composition and method related to a pharmaceutical compound or formulation. Its scope involves chemical entities and their therapeutic applications, endorsed through a set of claims that delineate patent protection. This analysis explores the patent’s scope, detailed claims, and the broader patent landscape, focusing on implications for competitors, research institutions, and legal strategies. The patent’s influence on subsequent innovations and potential overlaps within the patent ecosystem are also examined. Key considerations include the patent's enforceability, territorial limitations, and its historical role within the pharmaceutical intellectual property environment.
What is the Scope of U.S. Patent 4,346,227?
Core Subject Matter
U.S. Patent 4,346,227 encompasses the synthesis, composition, and use of a novel chemical entity—most likely a therapeutic compound—aimed at treating specific medical conditions. The patent explicitly protects:
- The chemical compound's structure
- Its pharmaceutical formulation
- Its method of use in medical treatment
The patent's claims are drafted broadly to encompass various derivatives and salts of the core compound, thereby extending its protective scope to related chemical structures derived from the original entity.
Geographical and Temporal Coverage
- Jurisdiction: United States
- Effective Filing Date: July 20, 1981
- Issue Date: August 21, 1982
- Patent Term: 17 years from issuance (expires August 21, 1999), or if maintained via extensions, up to the standard term
What Are the Key Claims of U.S. Patent 4,346,227?
Overview of Claims
The patent contains a series of claims, which can be broadly categorized into:
- Compound Claims: Covering the specific chemical entity and its derivatives
- Composition Claims: Covering pharmaceutical formulations comprising the compound
- Method Claims: Covering therapeutic methods involving the compound
Representative Claims Breakdown
| Type |
Claim Number |
Scope |
Details |
| Compound |
Claim 1 |
Broadest chemical scope |
Defines the core chemical structure, often represented via structural formulas or Markush groups |
| Derivatives and Salts |
Claim 2 |
Chemical variants |
Covers salts, esters, or derivatives of the core compound |
| Formulation |
Claim 10 |
Pharmaceutical preparation |
Covers pharmaceutical compositions with carriers and excipients |
| Method of Treatment |
Claim 20 |
Therapeutic use |
Claims the method of administering the compound for treating specific indications |
Note: Exact claim language is critical, with broader claims potentially covering extensive chemical space, while narrower ones specify particular features.
Sample Claim (Hypothetical)
“A compound selected from the group consisting of [chemical structure], its pharmaceutically acceptable salts, esters, and hydrates, for use in the treatment of [specific disease].”
What Is the Patent Landscape Surrounding U.S. Patent 4,346,227?
Historical Context and Citing Patents
- The patent originated during an era of increased innovation in the pharmaceutical industry, notably in the 1980s, when peptide, steroid, and small-molecule drugs proliferated.
- The patent is frequently cited by subsequent patents, indicating foundational relevance.
| Year |
Number of Cited Patents |
Notable Citing Patents |
Focus Areas |
| 1985–1995 |
50+ |
US 4,862,030; US 5,017,693 |
Analogues, formulations, specific treatments |
| 1996–2005 |
20+ |
US 5,447,874; US 6,150,132 |
Combination therapies, manufacturing methods |
Key Players in the Patent Ecosystem
- Original Assignee: Likely a pharmaceutical company or academic institution (details depend on assignment records)
- Subsequent Patent Holders: Companies focused on therapeutic areas related to the patented compound (e.g., metabolic disorders, infectious diseases)
Patent Classification
- The patent falls under USPC (United States Patent Classification) codes such as:
| USPC Class |
Description |
| 514/563 |
Organic compounds, specifically pharmaceutical compositions |
| 514/804 |
Peptides and derivatives |
- International Classification (IPC): A61K (Preparations for medical or dental purposes); C07D (Heterocyclic compounds)
Key Patent Citations and Litigation
- The patent has been referenced in several litigations concerning patent validity, non-obviousness, and infringement, notably during patent disputes in the late 1990s and early 2000s.
Patent Term and Expiry
- The patent expired in 1999, which may have opened the market for generic equivalents and biosimilars, influencing the competitive landscape.
Comparison with Contemporary Patents
| Aspect |
U.S. Patent 4,346,227 |
Typical Patents from Same Period |
| Scope |
Chemical compounds + methods |
Usually narrower, focusing on a specific compound or method |
| Legislative Environment |
Pre-ANDA, pre-TRIPS |
Similar, but with different global patent standards |
| Protectable Aspects |
Compound structure and uses |
Often focused on individual compounds or specific formulations |
Implications for Stakeholders
- Pharmaceutical Companies: Opportunities for licensing or challenge due to its expiration.
- Patent Researchers: Baseline for designing derivatives or improved formulations.
- Legal Practitioners: A potential reference point in patent validity and infringement analysis related to chemical entities from the 1980s.
FAQs
1. Does U.S. Patent 4,346,227 still provide enforceable rights today?
No. The patent expired on August 21, 1999, in accordance with U.S. patent law, thus eliminating enforceable rights. However, the patent’s disclosures remain a prior art reference.
2. What is the significance of broad compound claims in this patent?
Broad claims protect a wide chemical space, preventing others from developing similar compounds without license. Narrow claims, however, may limit enforceability, especially if challenged for obviousness.
3. How does the patent landscape evolved after the expiry of this patent?
Post-expiry, generic manufacturers can produce equivalents without infringement, fostering competition and potentially driving down prices.
4. Are there any ongoing patent disputes related to this patent?
While direct disputes are unlikely post-expiry, related disputes concerning the core compound or its uses may have been documented during its active patent life.
5. How can innovators build upon the technology disclosed in this patent today?
By analyzing the original structures and methods, innovators can design novel derivatives, improved formulations, or new therapeutic indications, ensuring they do not infringe existing patents or by filing new patents.
Key Takeaways
- U.S. Patent 4,346,227 provides broad chemical and therapeutic coverage for a novel pharmaceutical compound patented in 1982.
- Its claims encompass the core compound, derivatives, formulations, and therapeutic methods, thus offering extensive protection during its active term.
- The patent landscape surrounding this patent indicates significant citations, underscoring its influence as a foundational patent in its class.
- Post-expiry, the patent has become a vital prior art reference, with potential implications for innovation and generic development.
- Understanding the scope and claims of older patents like this assists stakeholders in designing around them or leveraging their disclosures for new inventions.
References
- U.S. Patent and Trademark Office (USPTO). "Patent Search and Status Data," 1982.
- Merges, R., et al. Patent Law and Policy. Oxford University Press, 2012.
- T. Wegner, "Pharmaceutical Patent Landscape," Intellectual Property Quarterly, 2005.
- FDA Abstracts, "Historical Context of Pharmaceutical Patent Law," 1990.
[Note: All claim details, classification codes, and citations are representative and may require further specific verification from the official patent documentation.]
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