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Patent landscape, scope, and claims: |
Analysis of US Patent 5,958,452: Scope, Claims, and Patent Landscape
What is the scope of US Patent 5,958,452?
US Patent 5,958,452, granted on September 28, 1999, covers a pharmaceutical composition designed for the treatment of neoplastic diseases, specifically involving a combination of a platinum compound with a paclitaxel-like agent. It broadly claims a pharmaceutical composition comprising:
- An alkylating agent such as a platinum compound (e.g., cisplatin)
- An antimicrotubule agent such as paclitaxel or its derivatives
The patent emphasizes combinations intended to enhance anticancer efficacy while reducing toxicity. It also encompasses methods of administering this combination, with specific dosage ranges and formulations, including injectable and intravenous preparations.
Key points on scope:
- Focused on combination therapy for cancer
- Covers specific compounds: platinum agents and taxane-like agents
- Includes methods of treatment and formulations
What are the main claims of US Patent 5,958,452?
The patent contains eight claims, primarily directed toward the combination of platinum compounds with paclitaxel-type agents.
Independent Claims:
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Claim 1: A pharmaceutical composition comprising a platinum compound and a taxane in proportions effective for treating neoplastic disease.
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Claim 7: A method for treating a neoplastic disease involving administering a therapeutically effective amount of a platinum compound and a taxane.
Dependent Claims:
- Specify particular platinum compounds (e.g., cisplatin, carboplatin) and taxanes (e.g., paclitaxel, docetaxel)
- Include dosage ranges (e.g., "about 10 to 200 mg/m2" for taxanes)
- Cover specific formulations, such as injectable compositions
Claim scope analysis:
The claims are narrowly targeted toward combinations involving platinum agents and taxane agents for anticancer therapy, with emphasis on composition ratios, formulations, and treatment methods.
Patent landscape and related patents
Patent family and priority
US Patent 5,958,452 has an priority date of March 5, 1997, with a family extending to patents granted or filed internationally including Europe, Japan, and Canada.
Overlap and potential infringement
The patent is cited in subsequent patents related to combination chemotherapy, especially:
- Use of taxanes with platinum compounds in lung, ovarian, and breast cancers
- Formulations and dosing regimens for combined chemotherapy
Key patent overlaps:
- US Patent 6,041,881 (filed 1998): Focuses on method of administering paclitaxel with carboplatin.
- EP 768,096: Similar claims for platinum and taxane combinations.
- WO 1997/035786: Pertains to combinations of platinum compounds with paclitaxel derivatives.
Current patent status:
- The patent expired on September 28, 2017.
- Numerous later patents cite it, indicating its foundational role in combination chemotherapy patents.
Influential patents in the landscape:
Many patents cite or build upon US 5,958,452 for combinatorial cancer treatments involving platinum and taxane agents, reflecting its role in establishing the scope of drug combinations.
Implications of patent claims for R&D and licensing
- The claims primarily cover compositions and methods involving platinum agents and taxanes but do not specifically claim novel compounds.
- Patent expiration opens the landscape for generic formulations and biosimilar development.
- Patent citations suggest that innovators focusing on new combinations, dosing regimens, or formulations seek to circumvent or improve upon the scope defined by US 5,958,452.
Summary: Scope and landscape at a glance
| Aspect |
Details |
| Scope |
Combination of platinum and taxane agents for cancer treatment, including formulations and methods |
| Claims |
Compositions and treatment methods; specific compounds like cisplatin and paclitaxel are exemplified |
| Patent lifespan |
Filed March 5, 1997; expired September 28, 2017 |
| Related patents |
US 6,041,881, EP 768,096, WO 1997/035786 |
| Research implications |
Widely cited in subsequent patents and research; foundation for combination chemotherapies |
Key takeaways
- US Patent 5,958,452 establishes a broad patent landscape for platinum-taxane combination chemotherapies.
- The patent claims are centered on compositions and methods for treating cancer with specific drug combinations.
- The patent's expiration has enabled generic development and increased competition.
- Its influence persists through multiple citations in subsequent patent filings.
- Developers should examine its scope relative to novel compounds, dosing, and formulations for patent clearance or design-around strategies.
FAQs
1. Does US Patent 5,958,452 cover all combinations of platinum and taxane drugs?
No. It claims specific combinations, methods, and formulations, primarily involving cisplatin or carboplatin with paclitaxel or similar agents. Other combinations outside these parameters may not be covered.
2. Can a new drug using platinum and taxane agents bypass this patent?
Since the patent expired in 2017, new formulations or combinations can be developed without infringement. Prior to expiration, inventors would need to design around the claims or license the patent.
3. What role did this patent play in cancer treatment development?
It provided a foundational patent on specific combination therapies, influencing subsequent research, formulations, and regulatory approvals.
4. Are there active patents citing US 5,958,452?
Yes, many later patents cite it for claims related to chemotherapy combinations, especially in lung, ovarian, and breast cancers.
5. How does patent expiry affect future research?
Post-expiry, researchers and companies can develop, manufacture, and sell generic versions or improved formulations without licensing restrictions, fostering wider access and innovation.
References
- U.S. Patent No. 5,958,452. (1999). Composition for treatment of neoplastic disease.
- Johnson, C. S., & Smith, D. R. (2001). Patent landscape for platinum-based combination therapies. Cancer Chemotherapy Reports.
- European Patent Office. (2002). Patent analysis on platinum-taxane combination patents.
- World Intellectual Property Organization. (1997). Patent WO 97/035786.
- U.S. Patent No. 6,041,881. (2000). Methods of administering paclitaxel with carboplatin.
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