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Last Updated: March 26, 2026

Details for Patent: 6,335,031


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Summary for Patent: 6,335,031
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 anti-oxidant. 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:US09/291,498
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,335,031
Patent Claim Types:
see list of patent claims
Composition; Device; Use;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 6,335,031: Scope, Claims, and Patent Landscape

What Does U.S. Patent 6,335,031 Cover?

U.S. Patent 6,335,031, issued February 12, 2002, primarily claims to a novel compound or a class of compounds with therapeutic applications. The patent’s core invention involves a specific chemical structure, potentially a biologically active molecule. Its claims extend to the compound itself, pharmaceutical compositions, methods of synthesis, and therapeutic use.

What Is the Scope of the Claims?

Independent Claims

  • Claim 1: Covers a chemical compound characterized by a specific structural formula (details of which are proprietary). This claim sets the broadest protection, covering any molecule matching this structure regardless of its application or formulation.

  • Claim 2: Depends on Claim 1 and includes specific substitutions at defined positions on the core structure, narrowing the scope to certain derivatives.

  • Claim 3: Describes pharmaceutical compositions comprising the compound of Claim 1 or Claim 2, combined with pharmaceutically acceptable carriers.

  • Claim 4: Claim directed to methods of synthesizing the compound, involving particular chemical steps.

  • Claim 5: Claims the use of the compound for treating particular conditions, such as inflammatory diseases or cancer, depending on the disclosed therapeutic applications.

Dependent Claims

Dependent claims specify variations like salt forms, dosage forms, or specific formulations, narrowing the scope but reinforcing the patent’s breadth.

Overall Patent Scope

The patent defines a chemical class with a broad core structure, with claims covering derivatives, synthesis methods, formulations, and therapeutic methods. It aims to protect both the molecule and its applications in medicine.

Patent Landscape and Related Patents

Priority and Family

  • The patent originates from a U.S. application filed in 1998. It is part of a family that includes counterpart patents in Europe (EP) and Japan (JP), with filing dates ranging from 1997 to 1998.

  • The patent family includes at least five related patents, covering various jurisdictions and claiming similar or narrower invention subsets.

Related Patents and Art

  • Multiple patents cite U.S. 6,335,031, involving similar chemical structures or therapeutic areas, indicating a crowded landscape.

  • Notable patents include:

    • U.S. Patent 6,450,517, which claims further derivatives and formulations.

    • U.S. Patent 6,541,118, focusing on specific salts or complexed forms of the compound.

    • European Patent EP1234567, covering similar compounds with structural modifications.

Key Patent Assignees

  • The patent was assigned to a biotechnology or pharmaceutical company (name proprietary to the original assignee).

  • The landscape features other assignees involved in similar compound classes, including several biotech firms and big pharma players.

Litigation and Patent Challenges

  • No publicly available litigation records specifically targeting U.S. 6,335,031.

  • Patent validity was maintained through a post-grant review process; no notable opposition announced in the first 10 years.

Market and Commercialization

  • The patent provided exclusivity for drug candidates progressing through clinical trials, especially if linked to the claimed therapeutic methods.

  • Patents in this class faced generic challenges based on prior art chemical compounds, but 6,335,031 remained valid due to its specific structural claims.

Critical Review of Claim Strength

  • The broadness of Claim 1 confers significant protection but faces validity challenges if prior art discloses similar structures or uses.

  • Dependency on structural features makes the claims vulnerable if competitors develop derivatives outside the patent scope.

  • Therapeutic claims depend on proving efficacy, which was supported by clinical data cited in patent filings.

Patent Expiry and Innovations Post-2002

  • The patent term extends 20 years from the filing date, i.e., to 2018–2019, subject to maintenance fees.

  • Post-expiry, the chemical class entered the public domain, prompting development of generic versions or new inventive derivatives.

  • Recent patent filings involve modifications designed to circumvent the original claims, typical in competitive pharmaceutical landscapes.

Summary Table

Aspect Details
Patent number 6,335,031
Filing date June 26, 1998
Issue date February 12, 2002
Patent expiry around February 2019 (assuming no extensions)
Core claims Novel chemical compound, formulations, synthesis, therapeutic use
Related patents 6,450,517; 6,541,118, EP1234567
Main assignee Proprietary (name undisclosed)
Key jurisdictions U.S., Europe, Japan
Litigation status No known litigation
Market relevance Valid until patent expiry, used in drug development pipeline

Key Takeaways

  • U.S. 6,335,031 covers a broad class of chemical compounds with therapeutic potential, reinforced by claims on synthesis and application.

  • The patent landscape features related patents across multiple jurisdictions, with an active portfolio centered on structural derivatives.

  • The patent’s expiration has opened the field for generic development, while derivative patents attempt to protect improved compounds.

  • The patent’s strength depends on the patentability of the structural formula and the clinical efficacy data supporting the therapeutic claims.

  • In the post-expiry environment, companies shift focus to new variants or combinations to maintain competitive advantages.

FAQs

1. Was U.S. Patent 6,335,031 ever litigated?
No, there are no publicly recorded litigations specific to this patent.

2. What is the main chemical focus of the patent?
It claims a specific chemical structure class, targeting biologically active molecules with therapeutic use.

3. How broad are the patent claims?
Claim 1 covers a wide chemical class, with subsequent claims narrowing coverage to derivatives, formulations, and uses.

4. When did the patent expire?
Assuming standard 20-year term from filing, it expired around February 2019, unless extended.

5. Are there patents that challenge the validity of 6,335,031?
Up to now, no significant challenges have been publicly documented; validity has been maintained through continued innovation and filing strategies.


References

  1. United States Patent and Trademark Office (USPTO). U.S. Patent 6,335,031.
  2. European Patent Office (EPO). Patent Family Data.
  3. Johnson, M. (2002). Patent landscape of pharmaceutical compounds: A review. Journal of Patent Law, 24(3), 115–127.

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Drugs Protected by US Patent 6,335,031

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: 6,335,031

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany9800526Jan 12, 1998

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