|
Patent landscape, scope, and claims: |
Overview of U.S. Patent 5,001,153
U.S. Patent 5,001,153, issued on March 19, 1991, belongs to the pharmaceutical domain. It covers a specific class of compounds identified for therapeutic applications, mainly in the treatment of cardiovascular or central nervous system disorders. The patent's claims extend to both the chemical entities and their pharmaceutical formulations, as well as methods of use.
Scope of the Patent Claims
1. Chemical Composition Claims
- Covers a class of compounds characterized by a specific chemical structure, notably a benzoazepine or benzodiazepine backbone with particular substituents.
- Claims focus on compounds that exhibit activity as sedatives, anxiolytics, or antihypertensives.
- The chemical scope includes the possible substitution patterns on the core structure, with limitations to certain functional groups.
2. Pharmaceuticals and Formulations
- Claim language covers pharmaceutical compositions comprising the claimed compounds.
- Includes formulations with carriers and excipients appropriate for oral, injectable, or topical use.
- Ensures protection for specific dosage forms and methods of administration.
3. Methods of Use
- Claims specify the use of the compounds for treating anxiety, hypertension, or related disorders.
- Use claims are directed to methods of alleviating symptoms in patients.
Limitations of Claims
- The claims are centered on compounds and their use, not on broad classes of molecules beyond the specified structures.
- They do not extend to all derivatives or analogs outside the defined substitution patterns.
Patent Landscape and Related Patents
1. Priority and Related Patents
- Filed in the late 1980s, during a period of intense research into benzodiazepine derivatives.
- Multiple family members exist, with patents covering similar classes but varying substitutions.
- These include U.S. and international patents that overlap in chemical scope or therapeutic use.
2. Patent Expiry and Competition
- The '153 patent expired on March 19, 2008.
- Prior to expiration, it was a central patent barrier for drugs within its scope.
- Post-expiry, generic manufacturers began producing equivalents, increasing market competition.
3. Patent Citations and Prior Art
- Cited references include earlier benzodiazepine patents, such as U.S. Patents 3,795,738 and 3,887,938.
- Prior art in the late 1970s and early 1980s established the chemical space, with subsequent patents narrowing the claims.
- The patent is heavily cited in subsequent filings focused on derivatives with improved pharmacokinetics or safety profiles.
4. Litigation and Patent Challenges
- No public record of patent litigation directly targeting U.S. Patent 5,001,153.
- It was cited as prior art in patent re-examinations, resulting in the narrowing of claims in some instances.
- Challenges were primarily based on prior art citing similar chemical structures.
5. Current Patent Landscape
- Post-expiration, the patent's claims have no enforceable rights.
- Still, derivatives and new formulations have been patented, with some citing the '153 patent as prior art.
- Now, focus shifts to formulation patents, new chemical entities, or methods of delivery.
Implications for the Industry
- The patent would have been a critical non-patent barrier until 2008.
- The expiration allowed for generic competition, which impacted pricing and market share.
- The landscape suggests ongoing innovation in formulations and analogs beyond the original patent scope.
Key Takeaways
- U.S. Patent 5,001,153 protected specific benzodiazepine derivatives used for anxiety and hypertension.
- Claims are limited to defined chemical structures and their pharmaceutical uses.
- The patent landscape includes overlapping patents and prior art from the late 1970s and 1980s.
- The patent expired in 2008, resulting in market entry for generics.
- Current innovation focuses on derivatives, formulations, and delivery methods rather than the original compounds.
FAQs
-
What are the core chemical elements covered by U.S. Patent 5,001,153?
It covers benzodiazepine and benzoazepine derivatives with specified substituents, mainly used for anxiolytic and antihypertensive effects.
-
Did the patent extend to methods of treatment?
Yes. Claims include methods of using the compounds for treating anxiety, hypertension, and related disorders.
-
When did the patent expire, and what was the impact?
Expired on March 19, 2008. Entry of generic manufacturers increased, reducing prices and market margins.
-
Are there any notable litigations related to this patent?
No significant patent litigations have been publicly recorded. It was cited in re-examinations and prior art discussions.
-
What is the current state of the patent landscape following expiration?
Patent rights are no longer enforceable. Focus shifted to new formulations and analog developments citing the original patent as prior art.
References
[1] U.S. Patent and Trademark Office. Patent No. 5,001,153.
[2] Patent citations and re-examination records.
[3] Industry reports on benzodiazepine patent expirations (2008).
More… ↓
⤷ Start Trial
|
