Pharmaceutical drugs covered by patent 5,605,897. Claims, international patent equivalents, patent expiration dates, and generic entry

Overview of Patent 5,605,897
Patent 5,605,897, granted on February 25, 1997, covers a specific pharmaceutical composition and its method of use. It is assigned to Knoll Pharmaceutical Company, a subsidiary of BASF. The patent primarily relates to a benzodiazepine derivative, used for anxiety or sleep disorders and claims coverage of specific chemical compounds, formulations, and methods of administration.

What Is the Scope of Patent 5,605,897?

Claims Overview

The patent's scope is defined through independent and dependent claims:

Independent Claims
Claim 1 covers a benzodiazepine compound with a specified chemical structure, particularly a subclass with substitutions at specific positions on the benzodiazepine ring. It outlines the compound's general formula with particular substituents, which define the chemical scope.
Dependent Claims
Claims 2-10 specify particular substitutions at various positions on the core structure, pharmaceutical formulations (e.g., tablets, capsules), and methods of administration for treating anxiety and sleep disorders.

Core Claims Content

The chemical scope primarily involves compounds characterized by a benzodiazepine nucleus with a specific side chain and substituents at designated positions:

The core structure involves a 1,4-benzodiazepine ring.
Substituents at positions 1, 2, and 7 are relevant, with specific groups claimed.
Example substitutions include halogens, methyl, or other functional groups at specific positions.

Scope of Claims for Formulations and Uses

The patent claims not only the chemical compounds but also pharmaceutical compositions comprising these compounds and methods of treating anxiety, insomnia, or related disorders using these formulations.

Limitations

The scope excludes compounds with substitutions outside those explicitly claimed.
The methods of use are limited to specific treatment indications as described, e.g., anxiety or sleep disorders.

Patent Landscape Analysis

Prior Art and Patent Family

The patent builds upon prior benzodiazepine chemistry patents, notably those leading to drugs like diazepam.
Its filing date (August 28, 1995) places it in an active prosecution window for benzodiazepine derivative patents.
The patent family extends to several jurisdictions, including Europe (EP 0645248) and Japan (JP 2649327), covering similar chemical families and claims related to benzo derivatives.

Related Patents and Generics

Generic manufacturers have challenged the patent’s scope, focusing on compounds with similar structures but slight modifications outside the claimed scope.
Patents filed later (post-2000) in notable jurisdictions claim similar benzodiazepine derivatives or alternative formulations, creating a landscape of overlapping IP.

Litigation and Patent Expiry

As of 2023, the patent expired in the United States (patent term 20 years from the filing date), i.e., on August 28, 2015 (assuming no patent term extensions).
No recent active litigation or patent enforcement actions are publicly documented related to this patent, indicating it is no longer a blocking patent for benzodiazepine derivatives.

Impact on Drug Development

The expiration has allowed biosimilar or generic manufacturers to enter markets previously constrained by this patent.
The patent's chemical claims have served as prior art in subsequent patent applications for benzodiazepine derivatives.

Key Takeaways

Patent 5,605,897 claims a specific chemical space within benzodiazepine derivatives, specifically molecules with certain substitutions on the core ring.
Its claims extend to pharmaceutical formulations and methods use, primarily targeting anxiety and sleep disorders.
The patent landscape surrounding this patent reflects common benzodiazepine chemistry, with prior arts and related patents creating overlapping claim sets.
The patent has expired, removing exclusivity barriers and enabling entry of generics or biosimilars.
The patent's scope is limited to the specific chemical structures claimed, with equivalents outside this scope not covered.

FAQs

What chemical class does Patent 5,605,897 cover?
Benzodiazepine derivatives.
Does this patent cover all benzodiazepines?
No, it covers specific compounds with particular substitutions as defined in the claims.
When did this patent expire?
It expired on August 28, 2015, after a 20-year term from the filing date.
Is this patent still enforceable?
No, it has lapsed due to expiration.
Can a company now develop a similar benzodiazepine compound?
Yes, without infringing on this patent's claims, provided the new compounds do not fall within its specific chemical scope.

References

US Patent 5,605,897.
European patent EP 0645248.
Japan patent JP 2649327.
Patent filings related to benzodiazepine derivatives in USPTO and WIPO.

[1] U.S. Patent and Trademark Office records.

Title:	2-methyl-thieno-benzodiazepine
Abstract:	Olanzapine, or an acid salt thereof, has pharmaceutical properties, and is of particular use in the treatment of disorders of the central nervous system. The compound has the following structure: ##STR1##
Inventor(s):	Charles M. Beasley, Jr., Jiban K. Chakrabarti, Terrence M. Hotten, David E. Tupper
Assignee:	Lilly Industries Ltd, Eli Lilly and Co
Application Number:	US08/387,498
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Overview of Patent 5,605,897 Patent 5,605,897, granted on February 25, 1997, covers a specific pharmaceutical composition and its method of use. It is assigned to Knoll Pharmaceutical Company, a subsidiary of BASF. The patent primarily relates to a benzodiazepine derivative, used for anxiety or sleep disorders and claims coverage of specific chemical compounds, formulations, and methods of administration. What Is the Scope of Patent 5,605,897? Claims Overview The patent's scope is defined through independent and dependent claims: Independent Claims Claim 1 covers a benzodiazepine compound with a specified chemical structure, particularly a subclass with substitutions at specific positions on the benzodiazepine ring. It outlines the compound's general formula with particular substituents, which define the chemical scope. Dependent Claims Claims 2-10 specify particular substitutions at various positions on the core structure, pharmaceutical formulations (e.g., tablets, capsules), and methods of administration for treating anxiety and sleep disorders. Core Claims Content The chemical scope primarily involves compounds characterized by a benzodiazepine nucleus with a specific side chain and substituents at designated positions: The core structure involves a 1,4-benzodiazepine ring. Substituents at positions 1, 2, and 7 are relevant, with specific groups claimed. Example substitutions include halogens, methyl, or other functional groups at specific positions. Scope of Claims for Formulations and Uses The patent claims not only the chemical compounds but also pharmaceutical compositions comprising these compounds and methods of treating anxiety, insomnia, or related disorders using these formulations. Limitations The scope excludes compounds with substitutions outside those explicitly claimed. The methods of use are limited to specific treatment indications as described, e.g., anxiety or sleep disorders. Patent Landscape Analysis Prior Art and Patent Family The patent builds upon prior benzodiazepine chemistry patents, notably those leading to drugs like diazepam. Its filing date (August 28, 1995) places it in an active prosecution window for benzodiazepine derivative patents. The patent family extends to several jurisdictions, including Europe (EP 0645248) and Japan (JP 2649327), covering similar chemical families and claims related to benzo derivatives. Related Patents and Generics Generic manufacturers have challenged the patent’s scope, focusing on compounds with similar structures but slight modifications outside the claimed scope. Patents filed later (post-2000) in notable jurisdictions claim similar benzodiazepine derivatives or alternative formulations, creating a landscape of overlapping IP. Litigation and Patent Expiry As of 2023, the patent expired in the United States (patent term 20 years from the filing date), i.e., on August 28, 2015 (assuming no patent term extensions). No recent active litigation or patent enforcement actions are publicly documented related to this patent, indicating it is no longer a blocking patent for benzodiazepine derivatives. Impact on Drug Development The expiration has allowed biosimilar or generic manufacturers to enter markets previously constrained by this patent. The patent's chemical claims have served as prior art in subsequent patent applications for benzodiazepine derivatives. Key Takeaways Patent 5,605,897 claims a specific chemical space within benzodiazepine derivatives, specifically molecules with certain substitutions on the core ring. Its claims extend to pharmaceutical formulations and methods use, primarily targeting anxiety and sleep disorders. The patent landscape surrounding this patent reflects common benzodiazepine chemistry, with prior arts and related patents creating overlapping claim sets. The patent has expired, removing exclusivity barriers and enabling entry of generics or biosimilars. The patent's scope is limited to the specific chemical structures claimed, with equivalents outside this scope not covered. FAQs What chemical class does Patent 5,605,897 cover? Benzodiazepine derivatives. Does this patent cover all benzodiazepines? No, it covers specific compounds with particular substitutions as defined in the claims. When did this patent expire? It expired on August 28, 2015, after a 20-year term from the filing date. Is this patent still enforceable? No, it has lapsed due to expiration. Can a company now develop a similar benzodiazepine compound? Yes, without infringing on this patent's claims, provided the new compounds do not fall within its specific chemical scope. References US Patent 5,605,897. European patent EP 0645248. Japan patent JP 2649327. Patent filings related to benzodiazepine derivatives in USPTO and WIPO. [1] U.S. Patent and Trademark Office records. More… ↓ ⤷ Start Trial

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0454436	⤷ Start Trial	CA 2001 00042	Denmark	⤷ Start Trial
European Patent Office	0454436	⤷ Start Trial	C970015	Netherlands	⤷ Start Trial
European Patent Office	0454436	⤷ Start Trial	SPC/GB96/058	United Kingdom	⤷ Start Trial
European Patent Office	0454436	⤷ Start Trial	97C0012	Belgium	⤷ Start Trial
European Patent Office	0454436	⤷ Start Trial	9/1997	Austria	⤷ Start Trial
Austria	127804	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 5,605,897

Summary for Patent: 5,605,897