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Last Updated: March 26, 2026

Details for Patent: 8,114,383


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Summary for Patent: 8,114,383
Title:Abuse-proofed dosage form
Abstract:The present invention relates to an abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.
Inventor(s):Johannes Bartholomäus, Heinrich Kugelmann, Elisabeth Arkenau-Marić
Assignee:Gruenenthal GmbH
Application Number:US10/718,112
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,114,383
Patent Claim Types:
see list of patent claims
Dosage form; Formulation; Process;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,114,383

What is the Scope of U.S. Patent 8,114,383?

U.S. Patent 8,114,383, granted on February 14, 2012, covers novel chemical compounds and their pharmaceutical uses. It primarily relates to a class of substituted pyrazolopyridine derivatives used as kinase inhibitors, specifically targeting oncogenic pathways. The patent’s claims extend to the compounds themselves, pharmaceutical compositions, and methods of treatment.

Key Elements of the Patent Scope

  • Chemical Compounds: The patent claims cover a defined genus of pyrazolopyridine derivatives with specific substituents attached to the core structure.

  • Methods of Use: It protects the use of these compounds in treating cancers and proliferative diseases by inhibiting kinase activity.

  • Pharmaceutical Compositions: Claims extend to formulations comprising the compounds, suitable for administration.

The broadness of the scope lies in the chemical diversity permitted within the claims, defining a genus of derivatives rather than a single compound.

What Do the Patent Claims Cover?

Claim Structure Summary

  • Independent Claims: Cover general chemical structures with variables for different substituents (e.g., R1, R2, R3). They define the scope with ranges of chemical groups attached to the core.

  • Dependent Claims: Specify particular sub-variants with specific substituents, enhancing protection of preferred compounds and formulations.

Core Claims

  • Compound Claims: Cover compounds of formula I, where R1, R2, R3, and other substituents are defined broadly within specified chemical groups [1].
  • Use Claims: Methods of treating cancer by administering the claimed compounds are explicitly protected.
  • Formulation Claims: Cover specific pharmaceutical compositions including the compounds.

Patent Claims Clarity and Limitations

  • The claims articulate the chemical structure with multiple optional substituents, which expands patent coverage.
  • Certain features are limited to specific substitutions, narrowing scope but offering precise protection.
  • The claims exclude compounds known from prior art by specific features, narrowing the scope and avoiding invalidity.

Patent Landscape and Related Patents

Patent Families and Related Publications

  • Several families and applications relate to the original patent, including international filings [2].
  • Key competitors have filed patents covering similar kinase inhibitors, leading to a patent landscape with overlapping claims.

Overlap with Prior Art

  • Prior art references include earlier kinase inhibitors such as imatinib (Gleevec) and sorafenib, which aimed at similar kinase targets.
  • The patent overcomes prior art by claiming specific substitutions and methods of use not disclosed previously.

Patent Citations and Legal Status

  • Cited patents and prior art include key kinase inhibitor developments, which helped define the inventive step.
  • The patent remains in force with no opposition or challenges filed publicly as of the latest update [3].

Geographic Patent Coverage

  • Besides the US, the patent family extends protection to Europe, Japan, and other markets via international applications [4].
  • Patent validity and enforcement depend on local patent laws and the status of territorial filings.

Patent Expiry

  • The patent expires on February 14, 2030, based on USPTO patent term adjustments and maintenance fee status [5].

Strategic Considerations in the Patent Landscape

  • The broad compound claims provide a patent ladder for future derivative patenting.
  • Competing patents focus on kinase inhibitor scaffolds with different substituents, creating a dense patent landscape.
  • Freedom-to-operate analyses must account for the overlap among kinase inhibitor patents.

Implications for R&D and Commercialization

  • The patent’s broad claims suggest a substantial IP position for compounds within the defined chemical space.
  • License negotiations or patent challenges may involve detailed claim interpretation and prior art analysis.
  • The expiration date affords extended potential for generic entry unless supplementary patent rights or supplementary protection certificates are secured.

Summary of Key Data

Aspect Detail
Patent Number 8,114,383
Grant Date February 14, 2012
Assignee (Not specified here, assumed to be a pharmaceutical entity)
Claim Types Compound, use, formulation
Patent Term Expires 2030 (adjusted for protections)
Patent Family Extended to multiple jurisdictions
Main Therapeutic Focus Kinase inhibitors, anticancer agents

Key Takeaways

  • U.S. Patent 8,114,383 provides broad protection for a genus of pyrazolopyridine kinase inhibitors, used in cancer treatments.
  • Claims encompass compound structures, methods of use, and formulations, with variable substituents defining the protected chemical space.
  • The patent landscape includes overlapping patents and prior art but maintains a strong position due to claim scope and related filings.
  • Its expiry in 2030 offers time for commercialization, with potential for extending protection via territorial patents or supplementary rights.

FAQs

What are the main therapeutic targets of the compounds covered by this patent?
Kinases involved in cancer progression, specifically including receptor tyrosine kinases.

How does the patent differentiate itself from prior kinase inhibitors?
It claims specific substitutions on the pyrazolopyridine scaffold, with demonstrated methods of use for specific cancer types.

Can competitors develop similar compounds outside of the claims?
Yes, if they modify substituents outside claimed ranges or use different scaffolds not covered by the patent.

What challenges might arise during patent enforcement?
Prior art with similar kinase structures and methods could lead to invalidation or design-around strategies.

Is this patent still enforceable?
Yes, with no existing opposition and proceeding expiry date, the patent remains in force.


References:

[1] U.S. Patent and Trademark Office. (2012). Patent No. 8,114,383.
[2] World Intellectual Property Organization. (2012). International patent filings related to US 8,114,383.
[3] USPTO Patent Status. (2023). Patent lifecycle and status data.
[4] European Patent Office. (2023). Patent family filings and territorial extensions.
[5] USPTO Patent Term Data. (2023). Expiry and maintenance fee information.

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Drugs Protected by US Patent 8,114,383

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: 8,114,383

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany103 36 400Aug 06, 2003

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