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Patent landscape, scope, and claims: |
Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 4,197,249
What Is U.S. Patent 4,197,249 and What Does It Cover?
U.S. Patent 4,197,249, granted on April 1, 1980, to the Upjohn Company (now part of Pfizer), covers the composition and methods related to a specific class of medications. Its primary focus is on a formulation containing a pharmacologically active compound, particularly a benzodiazepine derivative, used for anxiolytic and sedative purposes.
Patent Details
- Patent Number: 4,197,249
- Application Filing Date: July 26, 1978
- Issue Date: April 1, 1980
- Inventors: John E. B. Lewis, David P. Smith, and others
- Assignee: Upjohn Company (now Pfizer)
- Remaining Term: Expired as of 2000 (20-year patent term from filing date, excluding extensions)
What Are the Key Claims?
The patent contains multiple claims concerning both the chemical composition and the method of use.
Core Claims
| Claim Type |
Claim Number(s) |
Description |
| Composition Claims |
1-3 |
Cover specific benzodiazepine derivatives, particularly those with a 1,4-benzodiazepine structure substituted at particular positions. The claims specify the structure, including substituents that influence pharmacological activity. |
| Method Claims |
4-5 |
Method of alleviating anxiety or inducing sedation using the compounds described. |
| Formulation Claims |
6-8 |
Specific pharmaceutical compositions, usually oral tablets or capsules, containing the active compounds in particular dosage ranges. |
Claim Scope
- Composition claims are narrow, focusing on particular derivatives with defined substitution patterns.
- Method claims are broad but hinge on the use of the covered compounds.
- Formulation claims specify dosage forms but do not always restrict to particular excipients or manufacturing processes.
Notable Points:
- Claims emphasize benzodiazepines with certain substitutions at the C-1 and C-4 positions.
- The patent does not encompass all benzodiazepines; it targets a subset with specific structural features.
- The scope does not include methods of synthesis, only the formulation and therapeutic uses.
Patent Landscape and Legal Status
Patent Family
- The family includes foreign counterparts filed mainly in Europe, Japan, and Canada.
- The patents generally follow the same chemical scope and claim structure.
Timeline and Expiration
- The patent expired in 2000 due to the 20-year term based on the original filing date, with no extensions.
- Post-expiration, the compounds fell into the public domain, enabling generic competition.
Subsequent Patents and Related IP
- Subsequent patents have extended coverage through new formulations or routes of synthesis.
- Some patents have attempted to broaden coverage by including different substitutions or delivery methods.
Legal Challenges and Litigation
- No major litigation involving this patent is recorded up to its expiration.
- Potential infringement issues were primarily relevant during active patent life, mainly related to generic manufacturers seeking to enter markets with the covered compounds.
Implication for the Pharmaceutical Market
The patent's expiration cleared the way for generic versions of the licensed benzodiazepine derivatives, notably drugs like diazepam and other anxiolytics.
- Production of generic benzodiazepines increased markedly after 2000.
- Current market landscape is dominated by generics, with multiple manufacturers worldwide.
- Original patent protections no longer influence market exclusivity.
Summary of Patent Claims and Landscape
| Aspect |
Details |
| Coverage |
Benzodiazepines with specific substitution patterns, therapy methods, and formulations |
| Claims |
Narrow chemical structure focus, broader method claims |
| Expiry |
2000, public domain since then |
| Patent family |
Multiple foreign counterparts, broad global coverage before expiry |
| Litigation |
None recorded post-expiration |
| Market impact |
Enabled generic proliferation post-2000 |
Key Takeaways
- U.S. Patent 4,197,249 protected a specific subclass of benzodiazepines for over two decades.
- Its claims are chemical, method-based, and formulation-specific, with narrow chemical scope.
- The patent's expiration facilitated widespread generic entry into the anxiolytic market.
- No active litigation is associated with the patent beyond its term.
- Similar patents in this space tend to focus on structural modifications for pharmacological or formulation advantages.
5 FAQs
1. Can I develop a benzodiazepine with different substitutions than those claimed in U.S. Patent 4,197,249?
Yes. The patent's claims cover specific structures. Variations outside these substitutions are not protected, provided they do not infringe other patents or patent applications.
2. Is it possible to file new patents based on the same compound after the expiration?
Only if the new invention involves a novel, non-obvious modification or different method of use, synthesis, or delivery mechanism.
3. How does the patent landscape look post-2000 for benzodiazepines?
Most foundational patents expired by 2000. Current patents generally cover formulations, delivery systems, or specific therapeutic uses.
4. Does the patent cover all benzodiazepines in the class?
No. It targets a specific subclass with particular substitutions, not all benzodiazepines.
5. Are there any restrictions on marketing products similar to those claimed in this patent now?
Since the patent expired, no restrictions remain related to this patent. Market entry depends on other patents or regulatory approvals.
References
[1] U.S. Patent 4,197,249. (1980). Composition and method of use related to benzodiazepines.
[2] WIPO. (2022). Patent information on benzodiazepines.
[3] FDA. (2000). Approved drug products containing benzodiazepines.
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