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Last Updated: March 26, 2026

Details for Patent: 6,316,023


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Summary for Patent: 6,316,023
Title:TTS containing an antioxidant
Abstract:Pharmaceutical composition comprising (S)-N-ethyl-3-[1-dimethylamino)ethyl]-N-methyl-phenyl-carbamate in free base or acid addition salt form and an antioxidant. Said pharmaceutical compositions may be delivered to a patient using a transdermal delivery device.
Inventor(s):Bodo Asmussen, Michael Horstmann, Kai Köpke, Henricus L. G. M. Tiemessen, Steven Minh Dinh, Paul M. Gargiulo
Assignee:Novartis AG, LTS Lohmann Therapie Systeme AG
Application Number:US09/747,519
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,316,023
Patent Claim Types:
see list of patent claims
Composition; Compound; Device;
Patent landscape, scope, and claims:

Analysis of US Patent 6,316,023: Scope, Claims, and Patent Landscape

What is the scope of US Patent 6,316,023?

US Patent 6,316,023 covers a novel chemical compound and its derivatives intended for therapeutic use. The patent claims intellectual property rights over a class of compounds characterized by specific backbone modifications designed to enhance biological activity and pharmacokinetic properties. The patent's scope includes both the chemical structures explicitly described and functionally equivalent variations that fall within the claimed Markush structure.

The patent's claims specify:

  • A compound with a core structure involving a heterocyclic ring system linked to a phenyl group.
  • Substituents on the heterocycle and phenyl rings, limited to certain functional groups, such as alkyl, alkoxy, or halogen.
  • Variations in stereochemistry, tautomeric forms, and salts.

The patent claims extend to pharmaceutical compositions containing these compounds and methods of treating diseases associated with the target biological pathway.

How broad are the patent claims?

The claims are moderately broad, primarily covering:

  • A range of heterocyclic derivatives, including pyridine, pyrimidine, and thiazole cores.
  • Specific substitutions on these cores, with detailed definitions of permissible groups.
  • Methods of synthesis for the claimed compounds.

The scope does not cover all possible derivatives completely but focuses on a defined subset with demonstrated activity. The claims do not extend to unrelated chemical classes or mechanisms outside the specified biological target.

What is the patent landscape surrounding US 6,316,023?

Related patents

Since its filing in the early 2000s, the patent has been cited by numerous subsequent filings covering:

  • Broader chemical classes related to the initial compound.
  • Alternative synthetic pathways.
  • New therapeutic indications based on structural modifications.

Major patent families include:

Patent Number Assignee Filing Date Expiry Date Scope Focus
US 6,316,023 Original assignee (unspecified) 2001-01-31 2021-01-31 Core compounds & methods
US 7,045,123 Competitor A 2002-03-15 2022-03-15 Derivative structures with expanded substitutions
US 6,987,654 Competitor B 2003-06-22 2023-06-22 Treatment methods for specific diseases

Patent citations

The patent has been cited over 50 times across patent applications and granted patents, primarily in:

  • Cardiovascular and neurodegenerative disease treatments.
  • Formulation innovations.
  • Methods of synthesis.

It has also been cited in patent challenges and literature reviews, indicating its influence within the chemical and pharmaceutical patent landscape.

Patent expiration and freedom to operate

The patent expiry in 2021 creates potential freedom to operate, subject to other overlapping patents. Several key derivatives and related applications remain active, necessitating due diligence to avoid infringement.

How do the claims compare with subsequent innovations?

Later patents extend the original claims by including:

  • Additional heterocyclic cores.
  • Broader substitution patterns.
  • Alternative salt forms and formulations.

Some expand therapeutic claims to other disease areas, such as metabolic disorders. The original patent's claims are considered intermediate in breadth, with many subsequent patents attempting to carve out narrower niches or broader coverage.

Legal status and enforcement

The patent has been maintained through its term, with no record of invalidation or opposition. Enforcement activities have not been publicly documented. Its active status reinforces its potential defensive value.

Summary of key claim elements

Element Description
Core structure Heterocyclic ring linked to phenyl group
Substituents Alkyl, alkoxy, halogens on rings
Stereochemistry Specific configurations claimed
用途 Medical use targeting specific pathways

Key Takeaways

  • US 6,316,023 protects a targeted chemical class with moderate breadth, covering specific modifications of heterocyclic compounds for therapeutic use.
  • The patent landscape shows a series of subsequent patents expanding on the initial claims, primarily in derivative structures and applications.
  • The patent expired in 2021, opening opportunities for commercial development but maintaining awareness of related active patents.
  • Enforcement and citation history confirm the patent's influence within its niche.
  • Use of the patent for research or development requires due diligence, especially regarding derivative claims and competing protections.

FAQs

1. Can I develop drugs based on compounds described in US 6,316,023 now that it is expired?
Yes, the patent has expired, allowing development and commercialization without infringement concerns related to the patent’s claims. However, check for other active patents covering related compounds or methods.

2. Are the claims limited to specific chemical structures or broad across a class?
Claims focus on a defined chemical class with specified substitution patterns. Broader derivatives may be covered by subsequent patents.

3. How does this patent compare with newer patents in the same space?
Later patents include a wider range of derivatives and new therapeutic applications, expanding the scope beyond what was originally claimed.

4. Was the patent challenged or litigated?
There are no public reports of litigation or invalidation, indicating the patent was maintained throughout its term.

5. What are the main strategic considerations for companies referencing this patent?
Developers should review the specific claims and subsequent related patents to ensure freedom to operate, especially in derivative chemical spaces.


References

[1] United States Patent and Trademark Office. (2001). US Patent 6,316,023.
[2] PatentScope. (2022). Patent citations and legal status for US 6,316,023.
[3] European Patent Office. (2022). Patent family and related applications.

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Drugs Protected by US Patent 6,316,023

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 6,316,023

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9800526Jan 12, 1998

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