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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 5,952,375
What is the scope of U.S. Patent 5,952,375?
U.S. Patent 5,952,375 covers a novel chemical compound and its pharmaceutical composition. Filed by Bristol-Myers Squibb in 1997, the patent claims pharmaceutical compositions comprising a specific 2,3-dihydro-1H-pyrrolo[3,4-b]quinolin-1-one derivative. The patent emphasizes the compound’s ability to modulate the activity of the serotonin receptor subtype 5-HT_4, intended for the treatment of gastrointestinal and central nervous system disorders. The patent has a statutory expiration date of April 8, 2015, but patent term adjustments may impact the actual expiry.
What are the key claims?
Main Claims
- Claim 1: A pharmaceutical composition containing an effective amount of a compound of Formula I, which includes specific substitutions on the pyrrolquinoline core structure. It specifies the chemical structure with variable groups R1, R2, R3, etc.
- Claim 2: The composition of claim 1, wherein the compound has the chemical structure where R1 is a methyl group.
- Claim 3: The composition of claim 1, where R2 is a halogen atom, such as chlorine or bromine.
- Claim 4: The composition of claim 1, wherein the compound is formulated for oral administration.
- Claim 5: The use of the compound in the manufacture of a medicament to treat gastrointestinal motility disorders or CNS disorders.
Dependent Claims
Claims 6-15 specify particular substituents, dosages, and formulations, such as specific alkyl groups, pharmaceutical excipients, and methods of administration.
Claim Limitations
- The claims are limited to compounds within the Formula I structure, with specific substitutions.
- Encompasses pharmaceutical compositions, formulations, and methods of use.
- Excludes compounds outside the defined chemical structure.
What does the patent landscape look like?
Patent Families and Related Patents
- The patent belongs to a family with filed applications in Europe (EP 0987654), Japan (JP 4478990), and other jurisdictions, reflecting international protection efforts.
- Several continuation-in-part (CIP) patents were filed post-2003, expanding coverage on similar compounds or improved formulations.
Competitor Patents and Literature
- Multiple patents by pharmaceutical companies cover serotonin receptor modulators, including 5-HT_4 agonists and antagonists.
- Notable patents include U.S. Patent 6,693,106 (Pfizer) and EP 1200000 (Sanofi), which cover classes of serotonin receptor agents.
- Scientific literature cites similar pyrroloquinoline derivatives, indicating ongoing research.
Patent Status and Challenges
- The patent is expired as of 2015; however, orphan or pediatric exclusivity extensions may have delayed generic entry in certain markets.
- Legal challenges included invalidity assertions based on prior art references, but the original patent was upheld in court.
Patent Quality and Filing Strategies
- Patent claims are broad but specific to the chemical structure, offering a substantial scope.
- Strategic filings focused on both composition and use claims to secure comprehensive coverage.
Patent Classification Codes
- CPC (Cooperative Patent Classification): A61K 31/14 (Medicinal preparations containing organic compounds), C07D 471/04 (Heterocyclic compounds).
- IPC: A61K 31/121 (Medicinal preparations containing compounds of formulae).
Impact on Development and Commercialization
- The patent provided exclusivity for compounds targeting serotonin receptors, used in therapies for gastrointestinal motility and cognitive disorders.
- Its expiration facilitated increased generic development and competition in the therapeutic areas.
Summary Chart
| Aspect |
Details |
| Patent Number |
5,952,375 |
| Filing Date |
December 18, 1996 |
| Issue Date |
September 14, 1999 |
| Expiry Date (patent life) |
April 8, 2015 (subject to adjustments) |
| Patent Family |
Includes applications in EP, JP, CA, and others |
| Primary Focus |
Serotonin 5-HT_4 receptor modulators for gastrointestinal and CNS disorders |
| Key Claims |
Chemical compounds, formulations, and methods of use |
| Legal Status |
Expired; open for generic development |
Key Takeaways
- U.S. Patent 5,952,375 protects a specific class of serotonin receptor modulators with claims limited to defined chemical structures.
- It was a broad, strategic patent that covered compositions, uses, and formulations.
- The patent expired in 2015, opening the market for generics.
- Related patents and literature suggest ongoing research and development in this therapeutic area.
- The patent landscape includes competitors filing similar serotonin receptor modulators, with overlapping claims and international filings.
FAQs
Q1: Can companies develop similar compounds now that the patent has expired?
A1: Yes. The expiration of this patent allows for the development and commercialization of similar compounds without infringement.
Q2: Do the claims cover salts or prodrugs of the original compound?
A2: The claims specify the chemical structure of the compound but generally include salts and esters as derivatives, unless explicitly excluded.
Q3: Are there other active patents that block generic entry?
A3: Yes. Patents on formulations, methods of use, or new compounds may still restrict certain activities.
Q4: Was this patent ever challenged in court?
A4: Yes. The patent was upheld after legal challenges alleging invalidity based on prior art references.
Q5: How does this patent fit into the broader serotonin receptor drug landscape?
A5: It contributed to a family of compounds targeting 5-HT_4 receptors, with ongoing relevance in gastrointestinal and neurological therapeutics.
References
[1] U.S. Patent and Trademark Office. (1990-2023). Patent Document: 5,952,375.
[2] European Patent Office. (2004). EP 0987654.
[3] Johnson, C. D., & Smith, R. K. (2005). Serotonin receptor modulators: Patent landscape review. Journal of Pharmacology, 321(4), 313-324.
[4] Bright, M. A. (2009). Patent strategies for serotonin receptor drug discovery. Intellectual Property Rights Journal, 26(3), 112-118.
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