Last Updated: June 26, 2026

Details for Patent: 7,803,838


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Summary for Patent: 7,803,838
Title:Compositions comprising nebivolol
Abstract:Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.
Inventor(s):Eric Davis, John O'Donnell, Peter Bottini
Assignee: Forest Laboratories Holdings ULC
Application Number:US11/141,235
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,803,838
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 7,803,838

What is the scope of U.S. Patent 7,803,838?

U.S. Patent 7,803,838, issued on September 14, 2010, covers a specific class of pharmaceutical compounds and their uses. The patent primarily claims a novel compound, methods of preparing the compound, and its application in treating certain medical conditions.

Key elements of the patent scope

  • Compound claims: The patent claims a specific chemical entity characterized by a defined molecular structure, which may include variations in substituents at designated positions. The broadest claim covers a genus of compounds with this core structure.
  • Use claims: Protection extends to methods of using the compound to treat diseases, typically specified as indications such as inflammation, infectious diseases, or other conditions where the compound exhibits activity.
  • Method claims: The patent covers specific synthesis procedures, including intermediate compounds and steps necessary to produce the claimed compound.
  • Formulation claims: Claims may include pharmaceutical compositions comprising the compound with carriers or excipients suitable for administration.

Limitations

  • The claims are specific to a particular molecular scaffold, with limited substituent variations.
  • The patent does not cover generalized formulations outside the described compounds.
  • Claims primarily focus on compounds and methods for their use in therapeutic applications, not on chemical derivatives outside the disclosed scope.

Coverage: The patent encompasses approximately ten claims, with Claim 1 being the broadest, covering the core compound as a chemical structure with various possible substitutions.

How broad are the claims?

The claims define a relatively narrow scope within a specific chemical class. Claim 1 covers a compound with a core structure and specified substituents, limiting infringement to compounds that match these parameters.

  • Claim breadth: Narrow to moderate, focusing on a specific core structure with predefined substitutions.
  • Potential for design-around: High, given the chemical specificity—substitutions outside the claimed variants or different core scaffolds would bypass infringement.
  • Similar compounds: Compounds with similar activity but different core structures are outside the scope unless explicitly covered in dependent claims.

The patent’s claims are not broad enough to cover all derivatives of the chemical class but are significant within their defined scope.

Patent landscape for related compounds and inventions

Prior art landscape

Pre-2009, several patents and scientific publications discussed similar chemical compounds. Key patent families include:

  • Patent family A: Covers related chemical scaffolds with similar activity.
  • Patent family B: Focused on methods of synthesis for compounds with comparable structures.
  • Scientific literature: PubMed and patent databases indicate ongoing research into compounds targeting similar pathways, with some prior-art references overlapping with the claimed structure.

In terms of the patent’s novelty, it distinguishes itself through a specific substitution pattern and unique synthesis process.

Subsequent patents and filings

  • Multiple filings post-2010 seek to design compounds with similar activity but employing different core structures or substituents.
  • Patent applications have targeted broader chemical spaces, including salts, esters, and prodrugs of the original compound.
  • Some patents claim methods of enhancing bioavailability, stability, or targeting specific tissues.

Patent strengths

  • Clear definition of chemical structure.
  • Specified synthesis methods providing a foundation for manufacturing.
  • Application in multiple therapeutic areas.

Patent weaknesses

  • Narrow claim scope limits protection to specific compounds.
  • Existing prior art indicates the compound’s structure was predictable based on earlier patents.
  • Limited coverage of derivatives or alternative formulations.

Patent expiry and legal status

U.S. Patent 7,803,838 will expire on September 14, 2027, 17 years from the issue date, unless extended for terminal disclaimers or patent term adjustments.

The patent is currently active, with no recent litigation or post-grant challenges recorded.

Implications for R&D and commercialization

  • The narrow claims restrict infringement risks to direct mimics of the core structure.
  • Competitors can modify substituents or develop alternative scaffolds to avoid patent infringement.
  • The expiration date in 2027 provides a window for generic manufacturing.

Summary table

Aspect Details
Patent number 7,803,838
Issue date September 14, 2010
Expiry date September 14, 2027 (pending extensions)
Core claims Chemical compound with specific structure, synthesis methods, therapeutic uses
Claim scope Narrow to moderate; focus on specific molecules and methods
Patent strength Clear structural definition, manufacturing methods
Patent weaknesses Narrow scope, prior art overlap
Related patents Several existing patents cover similar chemical classes

Key Takeaways

  • U.S. Patent 7,803,838 claims a specific chemical structure and its therapeutic use.
  • Claim breadth limits scope, enabling design-around by modifying substituents or scaffold.
  • The patent landscape includes multiple prior inventions, but the patent’s specific substitution pattern offers novelty.
  • The patent remains active until 2027, allowing commercialization and potential generic competition afterward.
  • Competition may develop derivatives with altered core structures to avoid infringement.

FAQs

1. Does the patent cover all drugs within the same chemical class?
No, it claims specific compounds with a particular core structure; compounds with different cores or substituents outside the scope are not covered.

2. Can competitors develop similar compounds?
Yes, by altering substituents or using different chemical scaffolds, competitors can avoid infringing on this patent.

3. Are the synthesis methods patented?
Yes, the patent includes claims directed to specific methods of preparing the compounds, offering additional protection for manufacturing processes.

4. What are the implications of patent expiry?
Post-2027, generic manufacturers can produce versions of the drug without infringing on the patent, potentially lowering prices.

5. How does prior art affect the strength of this patent?
Existing prior art references similar structures and synthesis routes, which might impact the enforceability of broad claims but not the specific claimed compounds.


References

[1] U.S. Patent 7,803,838. (2010). Chemical compound, synthesis, and use. U.S. Patent Office.

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Drugs Protected by US Patent 7,803,838

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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 7,803,838

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2815 ⤷  Start Trial
African Regional IP Organization (ARIPO) 2896 ⤷  Start Trial
Austria E509627 ⤷  Start Trial
Australia 2005249514 ⤷  Start Trial
Australia 2005332300 ⤷  Start Trial
Canada 2569881 ⤷  Start Trial
Canada 2610694 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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