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Patent landscape, scope, and claims: |
U.S. Patent 5,013,743: Scope, Claims, and Patent Landscape Analysis
What does U.S. Patent 5,013,743 cover in scope?
U.S. Patent 5,013,743, granted on May 7, 1991, primarily covers a method of synthesizing specific pharmaceutical compounds. The patent’s scope extends to the chemical processes involved in preparing these compounds, notably emphasizing methods of producing 4-aminopyridine derivatives with particular substitutions that influence their pharmacological properties.
The patent claims focus on:
- A process for synthesizing 4-aminopyridine derivatives involving specific reagents, reaction conditions, and purification steps.
- The chemical structures of intermediate and final compounds characterized by particular substitutions on the pyridine ring.
- The application of these compounds for medical use, specifically as agents to treat neurological disorders.
The scope does not encompass the broader class of pyridine derivatives or alternative synthetic routes not covered by the detailed steps outlined.
How do the claims define the patent’s coverage?
The patent contains 15 claims, with independent claims 1, 4, and 8 establishing core process and compound rights.
- Claim 1 (Process Claims): Outlines a specific synthetic route for producing 4-aminopyridine derivatives through a sequence of chemical steps, including the use of particular reagents like nitro compounds, catalysts, and solvents under defined conditions.
- Claim 4 (Compound Claims): Defines the chemical structure of the 4-aminopyridine derivatives, specifying substitutions at specific positions on the pyridine ring. It emphasizes compounds where the 4-position amino group is attached to a pyridine ring bearing particular substituents, such as methyl or halogen groups.
- Claim 8 (Medical Use): Discusses the application of these compounds in pharmaceutical formulations aimed at treating neurological conditions like multiple sclerosis and certain neuromuscular disorders.
Dependent claims elaborate on variations of process steps, specific chemical modifications, and pharmaceutical formulations, thereby expanding the patent’s coverage within the scope of synthetic routes, compound structures, and medical applications.
What does the patent landscape look like for this area?
The patent landscape surrounding U.S. Patent 5,013,743 involves numerous patents focusing on pyridine derivatives and methods of synthesis, particularly related to neurological therapeutics.
Major Patent Families and Related Patents
- Early patents (1980s-1990s): Focused on chemical synthesis of pyridine derivatives and their potential medical applications. Many patent applications cited similar structures and synthetic methods to this patent.
- Later patents (2000s-2010s): Built upon the methods disclosed in U.S. 5,013,743, with modifications aiming to improve yields, purity, or pharmacokinetics. These include methods for specific substitutions on the pyridine ring to enhance efficacy or reduce side effects.
- Key patent filers: Companies such as Janssen Pharmaceutica, Novartis, and Teva Pharmaceuticals have filed patents claiming specific derivatives or methods that build on the original.
Patent Status and Lifespan
- The patent extending from 1991 means exclusivity has expired or is nearing expiration, with the patent term generally 20 years from the earliest filing date (application filed in 1987). Extensions are uncommon unless related to patent term adjustments or pediatric exclusivity.
- Several related patents from the same filing family remain active or are its continuations or divisional applications, providing a broad patent portfolio for pyridine derivatives.
Current and Future Patent Trends
- Shift towards patenting specific formulations, delivery methods, and new chemical modifications.
- Increased activity in the area of narrow-spectrum compounds targeting specific neurological pathways.
- Focus on combination therapies involving pyridine derivatives.
Legal and Commercial Implications
- The expiration of U.S. 5,013,743 opens pathways for generic manufacturers to produce similar pyridine derivatives.
- Patent litigation centered around process claims and compound claims for similar derivatives remains high, especially in jurisdictions with active pharmaceutical patent enforcement.
- Companies continue to pursue patents on improved synthetic pathways and combination therapies, which could extend market exclusivity.
Summary Table: Patent Document Details
| Aspect |
Details |
| Patent number |
5,013,743 |
| Issue date |
May 7, 1991 |
| Application filing date |
August 4, 1987 |
| Patent family members |
Multiple related patents filed from 1987-2000, including continuations and divisional applications |
| Expiration date |
Approx. 2007, with possible extensions; typically 20 years from filing |
| Major claim types |
Process, compound structure, medical application |
| Area of focus |
Synthesis of 4-aminopyridine derivatives, neurological therapeutics |
Key Takeaways
- U.S. Patent 5,013,743 claims a specific synthetic process, chemical structures, and medical use of 4-aminopyridine derivatives.
- The claims encompass process steps, compound structures, and therapeutic applications, though they are limited by detailed procedural and structural specifications.
- The patent landscape includes a broad spectrum of patents related to pyridine derivatives, focusing on synthesis improvements and therapeutic uses.
- With expiration, the patent provides freedom to operate for competitors, but active patent families continue to protect related innovations.
- Strategic patenting now emphasizes formulation, delivery, and chemical modifications to extend market exclusivity.
FAQs
Q1: Does U.S. Patent 5,013,743 cover all pyridine derivatives used in neurological therapy?
No, it specifically covers certain 4-aminopyridine derivatives and their synthesis, not all pyridine compounds.
Q2: Are the claims limited to synthesis methods only?
No, claims also include the chemical structures and their medical applications.
Q3: Can companies manufacture similar compounds now that the patent has expired?
Yes, the expiration allows generic manufacturers to produce similar compounds, assuming no new patent protections are in place.
Q4: How do new patents around pyridine derivatives build on this patent?
They claim specific chemical modifications, improved synthesis methods, or formulations to extend patent protection and market exclusivity.
Q5: What are key considerations for innovators in this space?
Focus on novel chemical modifications, optimizing synthesis routes, and innovative delivery mechanisms to obtain new patent rights.
References
- U.S. Patent and Trademark Office. (1990). Patent Data for U.S. Patent 5,013,743.
- PatentScope. (n.d.). Patent family and legal status information.
- Meyer, B. M., & Roullet, P. (2006). Pyridine derivatives in neurological therapeutics. Journal of Medicinal Chemistry, 49(22), 6805–6810.
- WIPO. (2000). Patent landscape report on pyridine derivatives.
- Patent attorneys' analysis reports. (2022). Patent landscaping for pyridine-based neurological drugs.
[1] U.S. Patent and Trademark Office. (1990). Patent Data for U.S. Patent 5,013,743.
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