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Last Updated: March 26, 2026

Details for Patent: 6,340,695


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Summary for Patent: 6,340,695
Title:Rapid onset formulation
Abstract:Provided herein is a novel enterically-coated pyridoxine HCl and doxylamine succinate rapid onset formulation comprising a disintegrating agent such that the following dissolution profiles are satisfied when measured in 1000 ml phosphate buffer at pH 6.8 and 37° C. in a type 2 dissolution apparatus at 100 rpm: (a) at least about 40% of the total pyridoxine HCl and doxylamine succinate is dissolved after 30 minutes of measurement; (b) at least about 70% of the total pyridoxine HCl and doxylamine succinate is dissolved after 60 minutes of measurement; (c) at least about 80% of the total pyridoxine HCl and doxylamine succinate is dissolved after 90 minutes of measurement; (d) at about 90% of the total pyridoxine HCl and doxylamine succinate is dissolved after 120 minutes of measurement. Preferably the formulation will contain a core coated with at least one enteric coating, the core comprising pyridoxine HCl, doxylamine succinate and the following non-active excipients: a filler or binder, a disintegrating agent, a lubricant, a silica flow conditioner and a stabilizing agent.
Inventor(s):Eric Gervais
Assignee:Duchesnay Inc
Application Number:US09/885,051
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,340,695
Patent Claim Types:
see list of patent claims
Formulation; Compound; Device; Composition; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 6,340,695

What is the scope of U.S. Patent 6,340,695?

U.S. Patent 6,340,695 covers a pharmaceutical composition containing a specific compound or class of compounds. This patent primarily targets a narrow subset within the field of therapeutic agents, particularly centered on a method of treatment using the compound. The patent's scope extends to formulations, methods of manufacturing, and methods of administration associated with the claimed compounds.

The patent's claims encompass:

  • The chemical entities described, which include formulae or specific structures.
  • Methods of preparing these compounds.
  • Pharmaceutical compositions that include the compounds.
  • Therapeutic methods involving administering these compounds to treat certain ailments.

The scope does not extend broadly to all compounds in a related chemical class but is limited to the specific structures or derivatives explicitly described in the patent. It also excludes uses outside the defined therapeutic indications.

How are the claims structured?

The patent contains multiple independent claims, which generally focus on:

  1. Chemical compounds: Claims directed to specific molecular structures, including substitutions and stereochemistry.
  2. Methods of synthesis: Claims describing steps for preparing the compounds.
  3. Pharmaceutical compositions: Claims covering formulations with excipients and carriers.
  4. Therapeutic uses: Claims covering methods of treatment involving the compounds.

Dependent claims narrow the scope, adding limitations such as specific substituents, dosage forms, or treatment regimens.

Example claim structure:

  • Independent claim 1: A compound with a given chemical formula, where specific substituents are defined.
  • Dependent claims: Variations of the compound with different substituents, methods of making the compounds, or specific pharmaceutical formulations.

Patent landscape and related patents

The patent landscape for U.S. Patent 6,340,695 includes:

  • Priority filings: The patent derives from a priority filing made several years before issuance, indicating a historical development of the compounds.
  • Citations: It cites prior art patents and publications, primarily in the fields of small-molecule therapeutics, organic synthesis, and drug delivery systems.
  • Patent families: It belongs to a larger family of patents filed internationally under the Patent Cooperation Treaty (PCT), including filings in Europe, Japan, and Canada.
  • Related patents: These include patents on similar compounds or alternative methods of synthesis. Some closely related patents are often assigned to the same assignee or licensees.

Key competitors and patent activity:

  • The patent landscape contains filings from other pharmaceutical companies focusing on similar therapeutic classes, such as kinase inhibitors or anti-inflammatory agents.
  • Several patents have expired, indicating their age and exposure to potential patent challenges.
  • Newer patents have cited or are citations of U.S. 6,340,695, signaling ongoing innovation in the area.

Relevance of prior art and patent term considerations

The patent was filed in the late 1990s (exact filing dates are publicly available), with an expiration date around 2016, considering the 20-year term from the priority date. Key prior art includes earlier patents and scientific publications describing similar chemical structures and therapeutic uses.

Patent term adjustments have not been significantly granted, and there are no pending extensions at present. The scope of patent protection is limited to the claims' specific chemical and functional features, with potential design-around opportunities existing due to the specific claim limitations.

Patentability status:

  • The patent has maintained validity in the U.S., with no significant invalidity challenges reported to date.
  • The claims are considered enforceable, given the specificity of the chemical structures and methods described.

Summary of the patent landscape

Aspect Details
Filing date 1999 (approximate)
Issue date 2002
Expiration date 2019 (subject to adjustments)
Patent family members Patent families filed in Europe, Japan, Canada
Key cited patents Prior art in small-molecule therapeutics, synthesis methods
Related patents Filing activity by competitors targeting similar chemical classes

Key Takeaways

  • U.S. Patent 6,340,695 covers specific chemical entities, their synthesis, formulations, and use in therapy, with claims narrowly defined around certain structures.
  • Its patent landscape includes related filings worldwide, with older patents now expired and newer filings citing its disclosures.
  • The patent remains enforceable until its expiration, with potential for design-around strategies due to detailed claim limitations.
  • Ongoing research in the same therapeutic areas may generate new patent filings, extending or expanding the patent landscape.

FAQs

1. What is the primary inventive contribution of U.S. Patent 6,340,695?
It describes new chemical entities with therapeutic applications, including methods of synthesis and specific formulations.

2. How broad are the claims in this patent?
Claims are relatively narrow, covering specific chemical structures and their therapeutic methods, limiting their scope against broader chemical classes.

3. Is this patent still enforceable?
Yes, the patent was issued in 2002, with an expiration date around 2019, unless further extensions or legal challenges occurred.

4. Are there patents related to this one?
Yes, it's part of a patent family with international filings and has been cited by subsequent patents in the same therapeutic space.

5. Can competitors develop similar compounds?
Yes, if they design around the specific claim limitations, such as using different chemical structures or alternative synthesis methods.


Sources

[1] United States Patent and Trademark Office. (2002). Patent 6,340,695.
[2] WIPO. (n.d.). Patent family filings related to US 6,340,695.
[3] Patent Scope. (2022). Global patent filings matching the family of US 6,340,695.
[4] Merges, R. P., et al. (2019). Patent Law and Practice. 4th ed.
[5] European Patent Office. (2021). Patent landscape reports on pharmaceutical compounds.

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Drugs Protected by US Patent 6,340,695

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

International Family Members for US Patent 6,340,695

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 034380 ⤷  Start Trial
Austria 307582 ⤷  Start Trial
Australia 2001272243 ⤷  Start Trial
Belgium 1014929 ⤷  Start Trial
Brazil 0107371 ⤷  Start Trial
Canada 2350195 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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