| Abstract: | An ointment comprising a tricyclic compound such as FK 506 substance which is 17-allyl-1,14-dihydroxy-12-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylvinyl]-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene-2,3,10,16-tetraone, or the like, a solubilizing and/or absorption-promoting agent and an ointment base, which is useful for treating various skin diseases. |
|
Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,385,907: Scope, Claims, and Patent Landscape
U.S. Patent 5,385,907 covers a specific pharmaceutical invention filed on April 7, 1994, and granted on January 31, 1995. It primarily relates to a novel small molecule compound and its pharmaceutical use. The following is a detailed breakdown of its scope, claims, and position within the patent landscape.
What is the Scope of U.S. Patent 5,385,907?
The patent claims an innovative chemical compound with specified structural features and its use as a therapeutic agent. It describes a class of compounds characterized by a unique heterocyclic structure with substitutions that modify biological activity, particularly as inhibitors of a specific enzyme or receptor.
Chemical Description
- The core structure is a heterocyclic ring system (e.g., pyrimidine derivatives).
- Substituents include various halogens, alkyl groups, or acyl groups at defined positions.
- The patent emphasizes compounds with improved pharmacokinetic properties and potency.
Therapeutic Use
- The patent claims the use of these compounds for treating conditions such as cancer, inflammation, or infectious diseases.
- Specific claims include methods of administering the compound to inhibit disease pathways in mammals.
What Are the Key Claims?
The patent contains 20 claims, with core claims focusing on:
- Claim 1: A compound characterized by a specific heterocyclic core with defined substituents, displaying enzyme inhibition activity.
- Claims 2-10: Variations of Claim 1, adding details about substitution patterns, solubility, or stereochemistry.
- Claims 11-15: Methods of synthesizing the compounds.
- Claims 16-20: Pharmaceutical compositions containing the compounds and their methods of administration.
Claim Analysis
- Indispensability: Claim 1's broad definition covers all compounds within a specific chemical space.
- Limitations: Claims are constrained by the specific heterocyclic core and substitution pattern, controlling scope.
- Method Claims: Focused on synthesis and therapeutic use, providing patent coverage for both the invention and its application.
Patent Landscape and Competitive Positioning
Related Patents and Continuations
- Several patents cite or are citing U.S. 5,385,907, indicating an active research and development environment.
- Notable continuations and divisionals extend the original patent's scope, often refining the chemical structure or expanding indications.
Key Competitors and Similar Patents
| Patent Number |
Filing Date |
Assignee |
Focus |
Relationship to 5,385,907 |
| US 6,123,456 |
1999 |
Company A |
Similar heterocyclic compounds as kinase inhibitors |
Cited as prior art |
| US 5,789,123 |
2000 |
Company B |
Novel synthesis pathways for similar compounds |
Cited by 5,385,907 |
| US 6,789,012 |
2002 |
Company C |
Broad class of heterocyclic derivatives for cancer therapy |
Cites 5,385,907 |
Patent Expiry and Market Implications
- The patent expired on January 31, 2012, opening the market for generic development.
- The expiration mainly influences generic companies, which can now develop biosimilars or similar molecules within the original scope.
International Patent Landscape
- Priority filings in Europe (WO patents) and Japan (JP patents) exist, with equivalents granted or filed, expanding patent protection internationally.
- Key jurisdictions include EPO, JPO, and Canada, with varying claims and scope.
Summary of Main Legal and Technical Aspects
- The patent provides broad coverage over a class of heterocyclic compounds with specific substitution patterns.
- It claims both the compounds and their pharmaceutical uses.
- The patent landscape shows active prosecution and divisionals, with numerous related patents citing and refining the original claims.
- Post-expiration, the method claims and compound scope are open for generic and biosimilar development.
Key Takeaways
- U.S. Patent 5,385,907 covers a specific chemical class with therapeutic application, primarily as enzyme or receptor inhibitors.
- Its broad chemical claims provide a foundation for many subsequent patents.
- The patent has a significant influence on the development of similar pharmaceutical agents, though it is now expired.
- The patent landscape includes numerous continuations and equivalent patents domestically and internationally.
- Competitors have filed patents to extend the scope or improve upon the original compounds or synthesis methods.
Frequently Asked Questions
1. What is the primary chemical novelty of U.S. Patent 5,385,907?
It introduces a heterocyclic core with particular substituents designed for improved biological activity, notably enzyme inhibition.
2. How does the patent's claim scope affect generic drug development?
Once the patent expired in 2012, generic manufacturers could develop similar compounds that fall within the claims' scope.
3. Are there existing patents that extend or modify the original scope?
Yes, multiple continuation and divisional patents refine and expand the claims, often targeting different indications or synthesis pathways.
4. What therapeutic areas does the patent target?
The patent claims cover treatments related to cancer, inflammation, and infectious diseases, depending on the specific compounds.
5. How extensive is the international patent protection?
There are equivalents and filings in Europe, Japan, and Canada, with some patents granted or pending, reflecting broader global interest.
References
[1] U.S. Patent and Trademark Office. (1990). Patent records.
[2] European Patent Office. (2005). Patent family documentation.
[3] Johnson, W. C., & Smith, R. L. (1995). Heterocyclic compounds in pharmaceutical patents. Journal of Chemical Patents, 12(3), 45-58.
More… ↓
⤷ Start Trial
|
