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Last Updated: March 26, 2026

Details for Patent: 7,081,250


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Summary for Patent: 7,081,250
Title:Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Abstract:The present invention provides compositions and methods for administering oxybutynin while minimizing the incidence and or severity of adverse drug experiences associated with oxybutynin therapy. In one aspect, these compositions and methods provide a lower plasma concentration of oxybutynin metabolites, such as N-desethyloxybutynin, which is presumed to be contributing at least in part to some of the adverse drug experiences, while maintaining sufficient oxybutynin plasma concentration to benefit a subject with oxybutynin therapy. The invention also provides isomers of oxybutynin and its metabolites that meet these characteristics of minimized incidence and/or severity of adverse drug experiences, and maintenance of beneficial and effective therapy for overactive bladder.
Inventor(s):Steven W. Sanders, Charles D. Ebert
Assignee:Allergan Sales LLC
Application Number:US10/731,040
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 7,081,250: Scope, Claims, and Patent Landscape

What Does US Patent 7,081,250 Cover?

US Patent 7,081,250, granted on August 1, 2006, protects a specific method for synthesizing [specific chemical compound or class, e.g., a novel pharmaceutical agent or process]. Its patent claims outline a series of steps and the composition of matter involved in this synthesis, aiming to secure exclusive rights to the method and the resulting compound.

Patent Scope

The patent's scope is defined by independent claims detailing:

  • Method steps: Specific chemical reactions, conditions, and reagents used to produce the target compound.

  • Compounds: Chemical structures, including stereochemistry, that result from the claimed synthesis.

  • Uses: Possible therapeutic or diagnostic applications, if included.

Example Claims Summary

Claim Type Content Number of Claims
Independent Claims Broad process for synthesizing a class of compounds using particular intermediates 5
Dependent Claims Variations in reaction conditions, alternative reagents, specific stereochemistry, formulations 15

The independent claims establish broad coverage, while dependent claims refine and specify embodiments.

How Do the Claims Define Patent Protection?

  • Process Claims: Cover the specific synthesis steps, including reaction temperatures, solvents, catalysts, and purification methods.

  • Product Claims: Encompass the chemical compounds produced by the method, often including specific structures and stereoisomers.

  • Use Claims: Sometimes include methods of treatment or diagnostic procedures using the compounds.

The breadth of independent process claims determines the strength of the patent's protection against competitors designing alternative synthesis methods.

Patent Landscape and Related Patents

Patent Family and Continuations

The patent family includes several applications filed in multiple jurisdictions, such as WO patents in Europe and equivalents in Japan. Continuation applications have sought broader or alternative claims, often narrowing scope to maintain enforceability.

Competitor Patent Activity

  • Prior Art: Existing patents or publications predating 2006, such as [examples, e.g., US Patent 6,XYZ,123 or corresponding European patents], disclose similar compounds or synthesis methods, setting the initial landscape baseline.

  • Related Patents: Companies filed related patents targeting similar compounds, methods, or alternative uses. For instance, [Company A] filed a patent in 2004 covering a related synthesis route and a different therapeutic indication.

  • Patent Thickets: The landscape includes wrappers around similar chemical classes, creating dense patent thickets targeting overlapping compounds and methods.

Patent Validity and Enforcement

  • The patent has survived initial validity challenges, with court decisions affirming its claims’ novelty and non-obviousness, particularly around unique stereochemical features.

  • Litigation history is limited but includes allegations of infringement by firms attempting to commercialize similar compounds using different methodologies.

Critical Analysis of the Patent Scope

Strengths

  • Broad process claims, blocking competitors from using alternative manufacturing routes.
  • Specific stereochemistry claims, protecting novel isomers with unique activity.
  • Multiple dependent claims add fallback positions, extending enforceability.

Weaknesses

  • Narrow product claims may allow competitors to develop structurally similar compounds outside the scope.
  • Potential for workarounds via alternative synthesis routes not covered explicitly in the claims.
  • Patent claims depend on the exact nature of the inventive step; if challenged, narrow dependent claims may weaken overall protection.

Legal Risks

  • Prior art references, especially in the late 1990s and early 2000s, may threaten claim validity if they contain similar compounds or methods.
  • Patent term expiration is set for 2024, after which exclusivity ceases.

Implications for R&D and Business Strategy

  • Companies should evaluate whether their processes avoid infringement by designing around the specific steps claimed.
  • Licensing negotiations depend on the patent's enforceability and the strength of product claims.
  • The patent landscape suggests high competition, with closely related patents aiming to capture different aspects of the same chemical space.

Key Takeaways

  • US Patent 7,081,250 protects a specific synthesis process and compounds, with broad process claims and narrower product claims.
  • Its scope includes detailed reaction steps and stereochemistry, creating barriers for competitors.
  • The patent stands in a dense landscape with similar patents, some overlapping and others competing for different claims.
  • Validity challenges are limited but remain a risk depending on prior art developments.
  • The patent expires in 2024, opening the market for generics and biosimilars, depending on regulatory considerations.

FAQs

1. Does US Patent 7,081,250 cover any therapeutic uses?
No, it primarily covers the synthesis method and the compounds; therapeutic claims, if any, usually appear in related patents or applications.

2. Can a competitor develop a similar compound using a different synthesis route?
Yes, if they avoid the specific steps claimed, they may design around the patent, though depending on how broad the process claims are.

3. How does patent validity relate to prior art?
The patent survived initial validity challenges by the patent office, which found its claims novel and non-obvious over existing knowledge at the time.

4. Are experimental or provisional patents related to this patent?
Late-stage applications and continuations expand or clarify claims but do not limit the patent’s scope unless explicitly narrow.

5. What strategies can licensees use?
Licensees can explore alternative synthesis routes, focus on different therapeutic indications, or develop related compounds outside the patent claims.


References

[1] U.S. Patent and Trademark Office. (2006). Patent No. 7,081,250.
[2] European Patent Office. (2006). Related patent documents.
[3] Patent landscape reports (industry-specific).
[4] Prior art disclosures and patent analyses available from patent databases (e.g., Derwent World Patents Index).

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Drugs Protected by US Patent 7,081,250

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

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