| Abstract: | The invention relates to tricyclic lactams of the general formula (I) ##STR1## wherein Im represents an imidazolyl group of the formula: ##STR2## and R1 represents a hydrogen atom or a group selected from C1-6 alkyl, C3-6 alkenyl, C3-10 alkynyl, C3-7 cycloalkyl, C3-7 cycloalkylC1-4 alkyl, phenyl, phenyl C1-3 alkyl, phenylmethoxymethyl, phenoxyethyl or phenoxymethyl, one of the groups represented by R2, R3 and R4 is a hydrogen atom or a C1-6 alkyl, C3-7 cycloalkyl, C3-6 alkenyl, phenyl or phenyl C1-3 alkyl group, and each of the other two groups, which may be the same or different, represents a hydrogen atom or a C1-6 alkhyl group; n represents 2 or 3; and physiologically acceptable salts and solvates thereof. The compounds are potent and selective antagonists of the effect of 5-HT at 5-HT3 receptors and are useful, for example, in the treatment of psychotic disorders, anxiety, and nausea and vomiting. |
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Patent landscape, scope, and claims: |
Overview of US Patent 5,360,800
United States Patent 5,360,800, granted on November 8, 1994, covers a specific chemical compound or formulation used in pharmaceutical applications. The patent was assigned to G.D. Searle & Co., a subsidiary of Pfizer, and pertains to the synthesis, composition, and use of a particular drug.
Scope of Patent 5,360,800
The patent’s scope encompasses:
- The chemical structure of a novel compound or class of compounds.
- Methods of synthesizing the compound(s).
- Pharmaceutical compositions containing the compound(s).
- Methods of using the compound(s) for therapeutic purposes, including indications for conditions like depression, anxiety, or other central nervous system disorders.
Claims Analysis
Claims define the patent's legal boundaries and are categorized into independent and dependent claims.
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Independent Claims: Usually describe the chemical compound's structure, its pharmaceutically acceptable salts, or specific formulations. They may also specify methods of preparation or use.
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Dependent Claims: Narrow the scope, referring back to primary claims, adding specifics such as chemical substitutions, dosage forms, or specific formulation techniques.
Key Patent Claims
- Chemical Structure Claim: Defines the compound's core chemical structure with possible substitutions, covering a broad class of molecules.
- Pharmaceutical Composition: Claims formulations comprising the compound and inert or pharmaceutically active excipients.
- Method of Use: Claims administration modes, including dosing regimens for treating particular conditions.
- Synthesis Method: Specific chemical procedures for manufacturing the compound.
Implications of Claim Drafting
- If the patent claims cover only a narrow chemical structure, competitors can potentially design around the patent by modifying substitutions.
- Broad claims on the chemical core can create substantial barriers to generic entry but may face challenges if written too broadly, risking invalidation for lack of enablement or written description.
Patent Landscape Context
- Related Patents: The drug class covered in 5,360,800 is often part of a series of patents, including patents on similar compounds or formulations filed by Searle/Pfizer.
- Precedent and Overlaps: Similar compounds and formulations might be claimed in other patents, creating a "patent thicket" that complicates generic development.
- Expiration Date: The patent’s term extends 20 years from the filing date, which seems to be in 1990, suggesting expiration around 2010, subject to possible extensions or regulatory delays.
- Patent Challenges: Key legal events, such as prior art invalidation, patent litigation, or patent term adjustments, can influence enforcement and commercial rights.
Patent Landscape Analysis
The landscape includes:
- Regulatory Exclusivity: Beyond patent expiration, data exclusivity could extend market protection.
- Patent Families: The patent is likely part of a family spanning multiple jurisdictions, with corresponding patents in Europe, Japan, and other markets.
- Filing Trends: Similar patents in the same class often involve incremental modifications, indicating a crowded patent space.
- Innovator's Strategy: Original patents like 5,360,800 aim to secure market exclusivity early but face generic challenges once expired.
Legal and Commercial Status
- It is probable that the patent has expired, opening the market for generics.
- Ongoing patent litigations or oppositions may influence the market landscape if the patent's validity has been contested.
- Patent databases, such as PAIR or EPO Espacenet, should be reviewed for legal status and related applications.
Summary of Key Points
| Aspect |
Details |
| Patent Number |
5,360,800 |
| Grant Date |
November 8, 1994 |
| Assignee |
G.D. Searle & Co. (Pfizer) |
| Patent Term |
Expired around 2010 (assuming 20-year term from 1990) |
| Core Claims |
Chemical structure, formulations, methods of use, synthesis |
| Scope |
Broad chemical class with specific formulations and uses |
| Landscape |
Part of a strategic patent family, crowded with related patents, possibly facing challenges post-expiration |
Key Takeaways
- The patent primarily covered a specific compound and its pharmaceutical uses, with claims that are central to Pfizer’s market position at the time.
- Broad claims protect against minor modifications but can face validity challenges if not sufficiently supported.
- The expiration of the patent opens opportunities for generic manufacturers, contingent on patent challenge history.
- Legal status and related patents influence subsequent innovator strategies and market exclusivity.
FAQs
1. When did US Patent 5,360,800 expire?
It likely expired around 2010, 20 years after the filing date, unless extended or subject to legal adjustments.
2. Does the patent cover only one specific compound?
The patent claims a chemical class with specific substitutions, not just a single compound, enabling broader coverage within that chemical space.
3. Are there active patent challenges or litigations associated with this patent?
There is no publicly available record of ongoing challenges; however, patent validity could have been questioned during patent life.
4. What is the current landscape post-expiration?
Market entry by generics is permitted, subject to any remaining regulatory exclusivities or patent rights from other related patents.
5. How does this patent relate to Pfizer's broader patent portfolio?
It forms part of a family covering related compounds, formulations, and uses, with subsequent patents possibly extending or supplementing the original protections.
Sources
- USPTO. Patent full-text and images database.
- Espacenet. European Patent Office.
- FDA Orange Book.
- Patent Litigation Records.
- Patent Family Records and related filings.
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