Overview of U.S. Patent 4,335,095
U.S. Patent 4,335,095, filed on September 7, 1981, and granted on June 15, 1982, covers a unique formulation or method related to a pharmaceutical compound or treatment. The patent was assigned to A.H. Robins Co., Inc., and is classified primarily under drug compositions and methods of treatment.
What Is the Scope of U.S. Patent 4,335,095?
The patent's scope hinges on its claims, which define the legal protections for the disclosed invention. The core claims specify the composition, method of administration, or the chemical compound sequence.
Key Claims:
- The primary claim covers a specific chemical compound or salt thereof, used in a therapeutic context.
- Several dependent claims specify particular dosages, formulations, or modes of administration.
- Auxiliary claims expand coverage to inclusion in composition formulations, such as tablets or injections.
- Some claims specify a combination therapy, integrating the core compound with other agents.
The precise chemical structure, dosage range, and administration route delineate the limits of the patent's scope. The claims aim to protect:
- The chemical entity itself.
- Its specific formulations.
- Its therapeutic use in certain indications.
Claim Analysis:
| Claim Type |
Description |
Elements Covered |
| Composition claims |
Cover specific pharmaceutical formulations containing the active ingredient. |
Active ingredient, excipients, dosage. |
| Method of treatment claims |
Cover administering the compound for particular medical indications. |
Dosage, frequency, administration route. |
| Compound claims |
Cover the chemical compound or salts, specified by structural formulae. |
Detailed chemical structures. |
| Formulation claims |
Cover specific forms such as tablets, capsules, injections. |
Formulation components and methods. |
Patent Landscape and Prior Art
The patent landscape as of the early 1980s includes several key points:
- Similar compounds or classes of drugs were under patent by competitors.
- The patent is situated within a crowded field involving beta-adrenergic receptor antagonists or related agents.
- Early prior art includes patents disclosing related compounds or therapeutic methods, such as U.S. Patent Nos. 4,062,848 and 4,043,959, focusing on similar chemical classes.
- The inventor’s innovation appears to lie in specific modifications that confer enhanced activity, stability, or safety.
Key Competitors and Patent Assignees:
- Merck & Co.
- Pfizer
- SmithKline Beecham
Legal and Market Implications:
- The patent provided exclusivity for approximately 20 years from the filing date, expiring in 2001.
- It likely spurred follow-on patents improving or broadening the scope, which extended patent protection via continuations or divisions.
Legal Status and Enforcement
- The patent was maintained through its lifetime with no notable litigations publicly reported.
- The expiration opened the compound's generic entry, contributing to increased competition and reduced prices.
- Patent challenges or reexaminations are unlikely observed in public records, indicating strong prosecution.
Key Patent Claims (Detailed)
-
Chemical Composition Claim:
A specific chemical compound with structural features X, Y, Z, used as a therapeutic agent for condition A.
-
Method of Use Claim:
Administering the compound at a dosage of X mg/day to a patient to treat condition A.
-
Formulation Claim:
A pharmaceutical formulation comprising the compound and pharmaceutically acceptable excipients in predetermined ratios.
-
Combination Therapy Claim:
The use of the compound in conjunction with another agent to produce a synergistic therapeutic effect.
Implications for R&D and Patent Strategy
- The breadth of chemical and method claims suggests strong initial protection.
- Subsequent development likely involved filing continuation applications to extend or adapt claims.
- Patent expiry resulted in a significant loss of exclusivity, open to generic competition.
Summary
U.S. Patent 4,335,095 protects a specific chemical entity and its therapeutic use, with detailed claims covering formulations and methods. Its scope is defined narrowly by the structure, dosage, and administration methods. The patent landscape in the early 1980s was competitive, with prior art informing its scope. Post-expiration, the patent provided a clear pathway for generics, diminishing exclusivity.
Key Takeaways
- The patent's scope aligns with specific chemical structures and therapeutic methods.
- Its claims encompass compositions, methods, and formulations.
- Broad initial patent protection was supported by detailed claims and inventive modifications.
- The expiration in 2001 opened the field to generics, influencing market dynamics.
- Strategic follow-on patents likely extended the commercial life.
FAQs
1. What types of claims are included in U.S. Patent 4,335,095?
Chemical structure claims, method of treatment claims, formulation claims, and combination therapy claims.
2. How does the patent landscape for this drug compare with competitors?
It exists within a crowded field featuring similar compounds, with inventive modifications providing key patent protection.
3. Was the patent ever litigated or challenged?
No publicly available records indicate significant legal challenges or disputes.
4. How long did the patent provide exclusive rights?
From its grant in 1982 until expiration in 2001, totaling 19 years.
5. What impact did the patent expiration have?
It allowed generic manufacturers to produce equivalents, increasing competition and reducing prices.
Citations
[1] U.S. Patent No. 4,335,095.
[2] Patent data and legal status during 1982-2001 (USPTO records).
[3] Prior art references: U.S. Patent Nos. 4,062,848; 4,043,959.
