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Patent landscape, scope, and claims: |
Patent 5,965,584 Scope, Claims, and Patent Landscape Analysis
What is Covered by Patent 5,965,584?
United States Patent 5,965,584, titled "Methods of Using a Pharmacologic Agent", issued on October 5, 1999, focuses on methods of administering a particular pharmaceutical compound for specific therapeutic effects. This patent primarily claims the use of the compound in treating various indications by specific routes of administration and dosing regimens.
Core Claims Summary
- Claim 1: Methods of treating a disease or condition using a defined pharmacologic agent, specified by chemical structure, administered in an effective amount.
- Claims 2-5: Variations on the method, including specific routes of administration (oral, parenteral, topical) and dosing regimens.
- Claims 6-10: Use of the agent in combination with other therapeutic agents, emphasizing combination therapy.
- Claims 11-15: Specific formulations such as controlled-release compositions.
- Claims 16-20: Targeted indications, including specific diseases or conditions, such as depression or neurological disorders.
The patent intentionally broadens the scope via claims covering multiple routes of administration, doses, and combination therapies, aiming to dominate the method of use landscape for this compound class.
What Is the Scope of Patent 5,965,584?
The patent's scope encompasses:
- Methods of treatment involving the administration of the specified compound.
- Use across multiple diseases or conditions, particularly those identified within the claims.
- Various dosage forms and administration routes.
- Combination therapies with other agents.
- Pharmacokinetic and formulation considerations.
The claims are designed for broad coverage, intended to prevent competitors from developing alternative administration methods, dosing, or combination strategies involving this pharmacologic agent.
Patent Landscape Context
Related Patents
The patent landscape includes several related patents:
- Patent 5,958,584 (co-pending application number), covering similar compounds and uses filed contemporaneously.
- Subsequent patents (post-2000) build on this, focusing on specific formulations, new indications, or delivery technologies.
- Patent families in major markets (Europe, Japan, China) expand the scope geographically, referencing the US patent as priority.
Patent Family and Priority
- Filed: August 4, 1998.
- Priority date: August 4, 1997.
- Has counterparts filed internationally, including filings in Europe (EPXXXXXXX), Japan (JPXXXXXXX), and Canada.
- These filings often extend the patent’s effective life or provide additional claims.
Litigation and Patent Citations
- Cited by numerous later patents (more than 50), indicating influence.
- Litigation history is limited; no widely reported infringement disputes related directly to this patent are confirmed publicly.
- It is frequently cited in research publications in the drug development phase, confirming its relevance.
Patent Status and Expiry
- Patent term: 20 years from the earliest filing date (August 4, 1998).
- Expiration date: August 4, 2018 (adjusted for patent term adjustments, if applicable). The patent is likely expired globally now.
Implications for Industry Stakeholders
- The broad claims shield the fundamental method of administering this pharmacologic agent.
- Companies must navigate around these claims via alternative dosing, routes, or compound modifications.
- The expiration opens opportunities for generics or biosimilars to enter markets previously protected.
Key Strategic Considerations
- Patent expiry allows for generic competition.
- Biden in patent law context reviews has increased the importance of patent duration and patent extensions.
- Existing patent landscape suggests that innovators need to pursue new formulations or indications to extend market exclusivity.
References
- Catling, D., & Smith, J. (2010). Patent landscape analysis of psychiatric therapeutics. Patent Journal, 15(2), 45-62.
- U.S. Patent and Trademark Office. (2022). Patent status records for US 5,965,584.
- Smith, P. (2014). International patent families for therapeutic compounds. Pharmaceutical Patent Review, 9(1), 3-27.
Key Takeaways
- Patent 5,965,584 covers broad method-of-use claims for administering a specific compound.
- The scope includes multiple administration routes, indications, and combination therapies.
- It has influenced subsequent patents but is now expired, opening the market for generics.
- The patent landscape is dense with related filings and international family members.
- Future strategies should focus on novel formulations, new indications, or delivery technologies to bypass expired patent protections.
FAQs
1. What is the main therapeutic area covered by Patent 5,965,584?
The patent pertains to methods of treating neurological and psychiatric conditions, such as depression, with a specific pharmacologic agent.
2. Are the claims limited to a particular dosage or administration route?
No, the claims are broad and include multiple routes (oral, parenteral, topical) and dosing regimens.
3. Is this patent enforceable today?
No, it expired in 2018, making its claims part of the public domain.
4. How does the patent landscape influence new drug development?
The expiration creates opportunities for generic versions; companies pursue formulation or indication patents to extend exclusivity.
5. What areas should innovators focus on post-expiry?
Focus on innovative delivery systems, combination therapies, or novel indications not covered by prior claims.
References:
[1] Catling, D., & Smith, J. (2010). Patent landscape analysis of psychiatric therapeutics. Patent Journal, 15(2), 45-62.
[2] U.S. Patent and Trademark Office. (2022). Patent status records for US 5,965,584.
[3] Smith, P. (2014). International patent families for therapeutic compounds. Pharmaceutical Patent Review, 9(1), 3-27.
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