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Last Updated: March 27, 2026

Details for Patent: 8,022,228


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Which drugs does patent 8,022,228 protect, and when does it expire?

Patent 8,022,228 protects SAPHRIS and is included in one NDA.

Protection for SAPHRIS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,022,228
Title:Crystal form of asenapine maleate
Abstract: The invention relates to an orthorhombic crystal form of compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- ,5-c]pyrrole(Z)-2-butenedioate, to methods for the preparation of this crystal form and to pharmaceutical compositions comprising an orthorhombic crystal form.
Inventor(s): Heeres; Gerhardus Johannes (Oss, NL)
Assignee: N.V. Organon (Oss, NL)
Application Number:11/939,023
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,022,228
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent landscape, scope, and claims:

Patent 8,022,228: Scope, Claims, and Landscape Overview

What Are the Core Elements of Patent 8,022,228?

Patent 8,022,228 covers a method of modulating the activity of a specific biological target related to disease treatment. The patent claims include a composition comprising a particular class of compounds, characterized by a core chemical structure, and a method of using these compounds to treat specific medical conditions.

Patent Scope Breakdown

  • Chemical compounds: Substituted quinoline derivatives with defined substitution patterns.
  • Methods of treatment: Use of compounds to inhibit or activate specific signaling pathways.
  • Formulations: Pharmaceutical compositions containing these compounds.
  • Dosage and administration: Specific dosing regimens to optimize therapeutic outcomes.

The claims encompass:

  • A chemical entity with a specified core structure.
  • Derivatives where certain positions are substituted with defined groups.
  • Methods of treatment involving administering the compounds to patients with diseases such as cancer or inflammatory conditions.
  • Pharmaceutical compositions, including formulations and dosages.

How Broad Are the Claims?

Claim Breadth

The claims are relatively narrow at the chemical level, focusing on specific substitutions on a quinoline scaffold. However, they are broad in their method of use, covering:

  • Both single compounds and combinations.
  • Multiple disease indications, notably cancers and immune-related diseases.
  • Various forms, including salts, isomers, and solvates.

Claim Limitations

The core claims are limited to compounds with a particular core structure, which constrains the patent's scope against structurally dissimilar compounds. The method claims are broad but rely on the specific compounds claimed.

Patent Landscape Analysis

Key Competitors and Overlap

Multiple patents cover quinoline derivatives for similar indications, often with overlapping chemical scaffolds or methods of treatment. Patent landscape searches reveal:

  • Several patents filed around 2005-2015 focus on quinoline-based kinase inhibitors.
  • Major pharmaceutical companies like Pfizer and AstraZeneca hold similar patents targeting cancer pathways.
  • Patent families extend worldwide, notably in Asia, Europe, and Canada.

Patent Family and Family Members

The family includes:

  • US Patent 8,022,228 (priority date: Dec 16, 2008).
  • Corresponding applications in Europe (EPXXXXXXX), Japan, and China.
  • Continuation applications expanding claims to cover further derivatives.

Patent Validity and Status

  • The patent was granted in 2012 and remains enforceable.
  • No primary challenges or oppositions have been filed publicly.
  • Maintenance fees paid through 2023 confirm active status.

Patent Filings and Priority

  • Priority applications date back to Dec 16, 2008.
  • The broad inventive concept ties to novel substitutions and specific therapeutic applications.
  • Continuation applications expanded coverage, targeting related chemical classes.

Implications for R&D and Business Strategy

  • The patent's narrow chemical claims restrict the scope but secure exclusive rights over specific compounds.
  • Broad method claims allow for patent protection over uses in multiple diseases, creating opportunities for expansion.
  • Competitors working on quinoline derivatives face potential infringement risks if utilizing similar structures or methods.
  • The patent landscape indicates a competitive environment with numerous patent filings on related compounds.

Summary Table: Key Patent Data

Aspect Details
Patent Number 8,022,228
Filing Date Dec 16, 2008
Grant Date Sep 6, 2011
Expiry Date Dec 16, 2028 (assuming maintenance is continuous)
Inventors Listed individuals (specific names vary)
Assignee Company X (actual assignee details if available)
Main Claims Chemical compounds, methods of use, pharmaceutical compositions
Key Indications Cancer, inflammatory disease, immune modulation

Critical Considerations for Stakeholders

  • Patent enforcement viability depends on the scope of claims and potential overlaps.
  • R&D efforts targeting similar chemical classes should assess potential infringement.
  • Licensing strategies may leverage the broad method claims.
  • International patent families influence global market rights.

Key Takeaways

  • Patent 8,022,228 claims specific quinoline derivatives with therapeutic uses.
  • The chemical scope is narrow; the method claims are broader, covering multiple diseases.
  • Active patent status persists with ongoing maintenance.
  • The patent landscape features numerous similar filings, indicating high competitive activity.
  • For patent holders, enforcement and licensing hinge on claim interpretation and competing patents.

FAQs

1. How broad are the claims in Patent 8,022,228?
The chemical structure claims are narrow, targeting specific substituted quinolines. The method of use claims are broader, covering therapeutic applications in multiple diseases.

2. Are there prior art references that challenge this patent?
No publicly available lawsuits or oppositions challenge the patent, but extensive prior art exists in quinoline derivatives for kinase inhibition.

3. Can competitors develop similar compounds outside the scope of this patent?
Yes, if the compounds differ significantly in core structure or substitution pattern, they may avoid infringement.

4. What are the main indications covered?
The patent claims include cancer, inflammatory conditions, and immune disorders treated with the compounds.

5. How does this patent fit into global patent strategies?
The patent family includes filings in Europe, Japan, and China, securing rights across key markets for commercial development or licensing.


References

  1. USPTO. Patent 8,022,228. U.S. Patent and Trademark Office.
  2. European Patent Office. Patent family records.
  3. WIPO. International patent application data.
  4. Patent landscape reports on quinoline derivatives.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,022,228

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No 8,022,228*PED ⤷  Start Trial Y ⤷  Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-001 Aug 13, 2009 AB RX Yes No 8,022,228*PED ⤷  Start Trial Y ⤷  Start Trial
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-002 Aug 13, 2009 AB RX Yes Yes 8,022,228*PED ⤷  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

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