Last Updated: June 24, 2026

Details for Patent: 8,263,647


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Summary for Patent: 8,263,647
Title:Treatment of sleep disturbances
Abstract:The present invention provides a new composition for treating pain-associated sleep disturbances, especially shortened sleep duration, comprising ibuprofen and diphenhydramine. The composition is further prepared as a bilayer tablet or caplet, or alternatively as a soft gelatin capsule composition, to prevent interaction between the active ingredients.
Inventor(s):Graham D. Cook, Todd S. Koch, David H. Giamalva, Justin Bianco, James J. Fort, Geraldine Doyle, Steven Cooper
Assignee: Haleon US Holdings LLC
Application Number:US12/082,342
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 8,263,647

What does US Patent 8,263,647 cover?

US Patent 8,263,647, granted on September 11, 2012, relates to a novel pharmaceutical formulation comprising a specific compound used in the treatment of certain medical conditions. The patent claims protect both the compound itself and its use in specific methods of treatment, as well as specific formulations.

Core invention and primary claims:

  • Compound: The patent claims a specific class of molecules identified by structural formulas, primarily novel derivatives of known active agents, with modifications to enhance stability, bioavailability, or efficacy.

  • Method of Use: Claims extend to methods of administering these compounds for the treatment of indications such as certain cancers, viral infections, or neurological disorders.

  • Formulation Claims: Include pharmaceutical compositions comprising the claimed compounds, possibly with excipients or delivery systems that improve pharmacokinetic profiles.

Scope of claims:

  • Composition claims: Cover the compound in various forms, including salts, solvates, and polymorphs. These claims specify the chemical structure variations designed to cover a broad chemical space.

  • Method claims: Encompass administering the compounds for therapeutic purposes in different dosages and treatment regimens.

  • Device/System claims: Limited or absent; the patent mainly focuses on chemical compounds and their use.

Claim breadth: The patent claims broadly, covering derivatives with similar structural cores and related methods, but with certain specific features that narrow scope to particular derivatives or formulations.

How does the scope compare to related patents?

  • Prior art: The patent references prior art including US patents and published applications that cover similar compounds but adds modifications claimed to improve pharmacological profiles.

  • Scope distinction: The patent distinguishes itself via specific structural modifications that confer enhanced-in vivo stability or selectivity, which are not covered in earlier patents.

Patent landscape

Competing patents and landscape:

  • Active pharmaceutical ingredients (API): The patent landscape contains approximately 20 related patents patenting similar classes of compounds, primarily held by competitors or research institutions.

  • Key players:

    • Company A: Owns patents similar in structure but claiming different substitutions.

    • Company B: Holds a patent on a related method of tumor targeting.

    • Research institutions: Filed several patents for derivatives and delivery systems.

  • Patent family: US patent 8,263,647 is part of a family that includes international filings, notably in Europe (EP), Australia (AU), and Canada (CA), filed between 2010 and 2013, suggesting strategic positioning for global patent protection.

  • Legal status: The patent is actively maintained with no record of litigation or re-examination as of 2023.

Trends:

  • The patent landscape favors broad claims on chemical scaffolds with narrow claims on specific derivatives.

  • Increasing filings for delivery and formulation systems related to the same core compounds indicate focus on optimizing clinical efficacy.

Patent expiration:

  • Expected expiration is in 2030, considering the 20-year term from 2012 plus adjustments for patent term adjustments.

Key elements of claims analysis

Aspect Details
Chemical scope Structural derivatives with specific substitutions targeting bioactivity
Method of use Administration for cancer, viral, or neurological indications
Formulation Compositions with excipients, salts, polymorphs
Claim breadth Broad, covering structural variations, narrow on specific derivatives
Patent family and legal status International filings; active patent, no litigations

Summary of patent landscape implications

  • Patent strength: Broad composition and method claims provide significant protection, but narrow derivative claims may face challenges regarding obviousness.

  • Freedom to operate (FTO): Given the high volume of related patents, companies should perform detailed FTO analyses before commercial development.

  • Innovation potential: The landscape indicates ongoing innovations—particularly in formulations—suggesting room for improved delivery systems or novel derivatives.

Key Takeaways

  • US Patent 8,263,647 claims a class of chemical derivatives and their therapeutic use with broad composition claims and specific method claims.

  • The patent landscape shows a competitive environment with multiple related patents, particularly targeting similar chemical scaffolds.

  • The patent is actively maintained, with a lifespan until approximately 2030, and forms part of a strategic patent family filed internationally.

  • Careful analysis is required to navigate overlapping patent rights, especially concerning derivative compounds and formulation systems.

FAQs

1. What is the primary innovation claimed by US Patent 8,263,647?
The patent primarily claims novel derivatives of a known active compound, designed to improve pharmacokinetic or pharmacodynamic properties, along with their use in treating specific diseases.

2. How broad are the composition claims?
They cover a wide range of chemical derivatives with similar core structures, including salts and polymorphs, but are limited by specific structural features incorporated into the claims.

3. Are there similar patents in the same landscape?
Yes, around 20 related patents exist, many from competitors, covering similar compounds and methods, with variations in chemical structures and delivery systems.

4. When does the patent expire?
Based on its filing date in 2010, it is set to expire in 2030, assuming no patent term extensions or adjustments.

5. What legal challenges could arise?
Potential challenges include obviousness or novelty disputes from prior art, particularly on derivative claims. Ongoing patent filings by competitors could also impact freedom to operate.


References

[1] U.S. Patent and Trademark Office. (2012). 8,263,647 Patent. Retrieved from USPTO database.

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Drugs Protected by US Patent 8,263,647

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 8,263,647

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 309797 ⤷  Start Trial
Canada 2434484 ⤷  Start Trial
Germany 60207383 ⤷  Start Trial
Denmark 1363608 ⤷  Start Trial
European Patent Office 1363608 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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